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Theranos 2567 04-25-2016
Theranos 2567 04-25-2016
Theranos 2567 04-25-2016
l3:EE8EEDOMfjJJJNFO~ONACT
PRiNTED: 01/26/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES. FORM APPROVED
CENTERS FOR MEDiCARJ: & MEDICAID SERVICES OMB NO. 0938~0391
:I~.'I:ATEMENT:()F DEFIQIENOIES ()(1) .PRQV113ER/$1,JPPLIE.R7CLIA Q<?) MULT!PLE:CONStRllCTlON (X3) OATE SURVfN
.V' ''1PLAN 0:F CORRECTION IDE:NTIFlCA'flON NUMBER: A. EiUl(P.lNG _ _ _ _ _ _---'-_ . COMPLETEb
t
B.. WING _ _ _ _ _ _ _ __
05020257.1.4 11/20/2015
NAME OF PRO\ilDEROR SUPPLIER STREET ADDRESS; CITY; STATE. ZIP COJ;)E
· 7333 GATEWAY BLVD
TliERANOS INC
NEWARK, CA 9.4560.
(X?).!D SUMMARYSTATgMENT !'.)FbEFiCIENClES. 10 PROVIDER'S PLAN OF CORRECTION (XS) ..
PREFIX {g-AC,J-l DEflCIENCY MUST BE PRECEDED BY FULL PREFIX (i:,ACH CORR~CTIVEAGT!ON SflOULD BE . COMP~cTlON
OATE .
TAG . REGULATORY OR LSC lDENTIFYING INFO.RMATION) TAG CROSS;REFERF.NCEO TO THE APPROPRIATE
DEFICIENCY)
-
02094 493,841 (a) ROUTINE CHEMISTRY o;we4 D2094
(1 ). for any uns~isfactory a'nc!lyte or test the lab has investigated this ungraded
2/12/16
1
perfqrmance or testing event for reasom,1 other .PT event for ALP and has documented
than a failure to participate, the,laboratory must its investigation and conc)usion:;.
undertake appropriate trainlng and emplo,y the
teohrtir;al assisfamoe ne0$ssary to c<irrec.~t .· • • The new li:!b director has approved
pro,blems assoct-ated With a prof[cienoy t~st1ri;g
failure. enhanced procedures for prbficiency
(2) For any unacceptable analyte or testing event .testing, which l'einforcethe lab's
soore; remedial actlon must be taken :and systems for the.investigation of
documented; .and the d6.cumehtation must b.e 1ID.,grade.d ,PT results. The fab •s
.maintained by the l!:iboratory tor two years from technical supervisors will be
thf;! date of participation in tMiptoflofency testing
event respunsibfo for ensuring that these
This StAN:DARO ls· not met as evidenced by: proce4utes are itnpl¢1rte;nted and
B.ased on review of proficiency testing {PTI followed.
ct·ooutiientatlon and lntervlejl' with the General
sup1;3rvisor (GS), 'the laboratory failed to The lab will provide oversigbt thr01.J,gh
lnvei;itrgate and dqoumenfthe lnvestation .df monthly QA meetings by revi¢wing
ungraded alk-aflne phosphatase (ALP) Pf results
for the 3rd event of 2014. Findings triclude::
investig.a,tions and:corrective .action
for t.m,grli}de<;l p.roficiency tests with
a. The laboratory was E!nroUed With the conege "outcomes of less, than 100%. In
of American Patl1ologlsts {CAP) Pi- progrE!m for adqitfon, th9 lab will monitor,
ALP for the·a'rd event 2014. compliance through its improved
o<;cun:ence management, and audit
b. The CAP results showed JhaUlve. oflive
$amples(GHMw06 t~rough CHM~10) were procedru:es..
ungradedwlffr:a code [ZO); .'
r,. . .
Any deficiency statement ending w!lh ~n ~sterlsk (*) denotes a d:etlclenoy whloh the lnstitullon may .be excus.ed from correclliiQ providing lt ls-determ fned that
r$afe11.uards pr\lV!de .suffl<ilent. pr.otection to the. patients. (See: lnstr:uc.Uo11s.). Exceptfor nul'Slng .homes, the findings state:d above ar.e dlscilosab.le 90 'days
!l 1lng the date of sutl/eywliethet-or not a plan .ofcorrecilciil fs ptbvlded .. For nursing horn.es, (he aboveflndlngs ahd plans. ofcorrectlonare disdlosable 14
'li...,1 .s fi:lllowlhg l)ie date these document!> are made available to the faf!llly. If deficletitiles lire cited; an approved plan of correction Is requisite lb continued
progra~ partlbip.atlon. · · · · ·
FORM CMS,2:S6.7(Q2~99) ·Ptevtous Versions Qbsolet!3·• Evenl'ID;WS4211 FacliftylO: CA2204ll272 Jr continuation sheet Page 1 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
!fff:: STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\;j;;j •AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE OATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 2 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Faclllty ID: CA22046272 If continuation sheet Page 3 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM GMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: GA22046272 If conlinuatiori sheet Page 4 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
{%') STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~{D , AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 5 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
[ } } STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
I':( ) PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5391 #1
05391 493.1249(a) PREANALYTIC SYSTEMS QUALITY 05391
ASSESSMENT As noted in the findings, if a patient 2/12/16
110H specimen did not meet the lab's
120H The laboratory must establish and follow written acceptance criteria, the lab's practice
140H policies and procedures for an ongoing was to describe the issue in its
2108 mechanism to monitor, assess, and when
2208
electronic system, to notify relevant
indicated, correct problems identified in the lab personnel, and to take, and
3108
320M
preanalytic systems specified at §§493.1241
through 493.1242. electronically note, appropriate
3308
3408
corrective action. Patient specimens
4008 This STANDARD is not met as evidenced by: that did not meet the lab's acceptance
510M criteria were not used for testing.
1. Based on laboratory personnel interviews and
pre-analytic remedial action record review on
September 23, 2015, the laboratory failed to
The new lab director has approved
establish written policies and procedures for an enhanced specimen rejection
ongoing mech.anism to monitor, assess, and procedures, which require the relevant
when indicated, correct problems identified in the lab personnel to further monitor and
laboratory's preanalytic systems when received assess received patient specimens and
patient specimens did not meet the laboratory's to correct problems as needed. These
criteria for acceptability. Findings included:
procedures also require a supervisor to
a. According to laboratory personnel, during the review and approve daily a list of
accessioning of patient specimens, if a patient requested redraws. The lab has
specimen was received that did not meet the conducted training on these ·
laboratory's criteria for acceptability, a description procedures.
as to why the specimen did not meet the
laboratory's criteria for acceptability would be
electronically noted, applicable laboratory During monthly QA meetings, the lab
personnel would be notified, appropriate will review, among other things,
corrective actions would be taken and specimen rejection rates and any
electronically noted, and the incident would be associated issues. In addition, the lab
captured for quality assessment review. will monitor compliance through its
improved occurrence management,
b. The laboratory maintained no written policies
and procedures detailing this quality assessment and audit procedures, both of which
process. address preanalytic activities.
c. According to laboratory records, the The new lab director is responsible for
laboratory performed approximately 890,000
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 6 of 121
I
i
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
,t@) STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\]@{;. AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event IO:W34211 Faclllty ID: CA22046272 If continuation sheet Page 7 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tfiW: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~w:w AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 8 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION COMPLETED
~r1Iwt IDENTIFICATION NUMBER:
A. BUILDING
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 9 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVEACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
,mm,
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STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5403 #1 (continued)
05403 Continued From page 10
procedure record review on November 19, 2015,
o54 o3 The lab will provide oversight through
the laboratory failed to have a procedure manual
monthly QA meetings, and will
that included the corrective action to take when monitor compliance through its
calibration or quality control results failed to meet improved occurrence management,
the laboratory's criteria for acceptability. Findings and audit procedures.
included:
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
j:ffa/ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
'qjf AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
D5403 #2 (continued)
05403 Continued From page 11
o54 o3fails to meet the lab's acceptability
5/9/2014.
cri!e:ia, and the lab has conducted
05407 493.1251(d) PROCEDURE MANUAL 05407
tra1mng on those procedures.
Procedures and changes in procedures must be
approved, signed, and dated by the current Lab management, including technical
laboratory director before use. supervisors, the lab director, and the
This STANDARD is not met as evidenced by: quality director, will be responsible
Based on review of procedures and interview
for ensuring compliance with these
with the technical supervisor, the current
laboratory director (LD) failed to sign, date and procedures. The lab will provide
approve procedures prior to use. Findings oversight through monthly QA
include: meetings, and will monitor
compliance through its improved
a. The current LO start date was 2/10/2015. occurrence management, and audit
b. Eight procedures were reviewed. Seven of procedures.
seven procedures did not include a LO signature
prior to putting into use and one of one was not
signed by the current LO.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 12 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY ·
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 12 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
i(i::) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY .
\)!@;) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5407 (continued)
05407 Continued From page 12 05407 QA meetmgs,
. and w1.11 momtor
.
f. CL SOP-15036, Revision A (Edison 3.5
Theranos System Daily QC Procedure) showed
compliance through its new audit
an effective date of 12/5/2014, but was not signed procedures.
by the LD until 9/19/2015.' The procedure was
not signed, dated and approved by any LO prior
to 9/19/2015.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 13 of 121
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J@) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
Qd,U AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5413 #1 (continued)
05413 Continued From page 13 05413
The new lab director has approved
fluctuations and interruptions in electrical current
that adversely affect patient test results and test
enhanced temperature management
reports. procedures to reinforce monitoring of
This STANDARD is not met as evidenced by: temperature and environmental
1. Based on observation and document review, conditions and storage of materials
the laboratory failed to define freezer temperature according to the manufacturer's
ranges that were consistent with the temperature range. The lab has
manufacturer's instructions for freezers which
stored reference materials and patient
conducted training on those
specimens. Findings include: procedures.
a. A tour of the laboratory where the freezers The lab's management, including the
were kept showed that the freezer doors were new lab director and quality systems
labeled with the laboratory's acceptable
director, will ensure compliance with
temperature ranges.
these procedures, including by making
/' b. Four of four -80 C freezers were marked with sure that supervisors perform their
a temperature range of -60 to -90 C. respective duties effectively. The lab
will also provide oversight through
c. Six of six -20 C freezers were marked with a monthly QA meetings, and will
temperature range of-17 to -25 C.
monitor compliance through its
d. Review of two manufacturer instructions for improved occurrence management,
samples stored in the -80 freezers required that and audit procedures. ·
the samples be kept at "at least -80 C."
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
~f' \ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\j( AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5413 #2 2/12/16
05413 Continued From page 14 05413
This PT/INR issue related to one lot.
observation, the laboratory failed to follow the
manufacturer instructions for expiration date of
The lab paused testing on the Siemens
lnnovin (thromboplastin) used for Prothrombin BCS XP, including PT/INR, during
Time/International Normafized Ratio (PT/INR) the survey. The lab has completed an
testing. Findings.include: assessment to identify any patients
affected or having the potential to be
a. Dade lnnovin (thromboplastin) lot number affected by this issue. ·
539280 was put into use by the laboratory at the
end of March 2015.
The new lab director has approved
\ '
b. The general supervisor stated that the enhanced reagent qualification and
package inserts were usually white. management procedures that reinforce
the lab's practice of ensuring that
c. The package insert for lot number 539280 manufacturer inserts and notifications
was pink whJch indicated that the manufacturer
had included special instructions for the specific are reviewed and followed. The lab
lot number of lnnovin. · has conducted training on those
procedures.
d. Review of the Pl revealed an "important note"
that this specific lot number was only stable for 2 Before the lab resumes PT/INR
days instead of 10 days after reconstitution when
stored at 2-8 C.
testing, the lab will reinforce with
relevant testing personnel the
e. The current vial of lnnovin reagent was importance of reviewing and ·
observed in the 2-8 C refrigerator with a 5 day following instructions on
expiration date. manufacturer inserts and notifications,
including instructions concerning
f. CL SOP-10001 Reyision A, "Measuring
Prothrombin Time ... " stated on page 10, section
expiration dates. The same type of
12.1 that "the package insert for a new lot must training will occur for personnel
be reviewed for any changes before use. 11 - conducting other tests. These
trainings, along with competency
g. The general supervisor confirmed on 9/23/15 testing, will ensure that practice is
that the change in storage and stability of the consistent with these procedures.
lnnovin reagent had not been identified from
March 2015 through September 2015.
05421 493.1253(b)(1) ESTABLISHMENT AND 05421 Lab management, including the new
VERIFICATION OF PERFORMANCE lab director, technical supervisors, and
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CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY -
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5413 #2 (continued)
05413 Conti_nued From page 14 05413
quality director, is responsible for
observation, the laboratory failed to follow the
manufacturer instructions for expiration date of
ensuring that these procedures are
lnnovin (thromboplastin) used for Prothrombin followed. The lab will provide
Time/International Normattzed Ratio (PT/INR) oversight through monthly QA
testing. Findings· include: meetings, and will monitor
compliance through its improved
a. Dade lnnovin (thromboplastin) lot number occurrence management, and audit
539280 was put into use by the laboratory at the
end of March 2015. procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility JD: CA22046272 If continuation sheet Page 15 of 121
J.::)V NOIJ.Vli'ffiOilNI ilO WOCTHffilil HHJ. 1IHCINfl ffiID.SO'I::)Sia W01Iil J.dJAJIIXH NOIJ.Vli'ffiOiINI 'IVI::)1IHWYl!0::) 'IVIJ.NHOI.ilNO::)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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~@)\' STATEMENT OF DEFICIENCIES (X1) PROVIDERJSUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\%)$ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5421 #1:
05421 Continued Fro_m page 15 05421
The lab proactively paused testing on 2/12/16
Each laboratory that introduces an unmodified,
the Advia XPT during the survey.
FDA-cleared or approved test system must do the The lab has completed an assessment
following before reporting ..patient test results: to identify any patients affected or
(1 )(i) Demonstrate that·it can obtain performance having the potential to be affected by
specifications comparable to those established by this issue.
the manufacturer for the following performance
characteristics:
(1)(i)(A) Accuracy. Before the lab resumes any test on the
(1 )(i)(B) Precision. Advia XPT, the lab will ensure that
(1 )(i)(C) Reportable range·of test results for the the test has been re-verified pursuant
test system. to the lab's improved method
(1)(ii) Verify that the manufacturer's reference verification procedures that have been
intervals (normal values) are appropriate for the approved by the new lab director.
laboratory's patient population.
This STANDARD is not met as evidenced by: These improved procedures reinforce
1. Based on review of the performance · that the lab's testing personnel are
specification verification documentation and required to actively participate in
interview with the general supervisor and method verification and document
technical supervisor, the laboratory failed to their participation.
maintain any documentation that the laboratory
had participated in conducting the verification of
the performance specifications on the Advia XPT. Before any verification studies are
Findings include: performed, these improved procedures
require the lab director's review and
a. The general supervisor and techincal approval of a detailed method
supervisor stated that the manufacturer verification plan containing defined
performed all of the performance specification
verification activities on· the Advia XPT. acceptance criteria. The lab director
must also review and approve the
b. They further stated that the laboratory staff verification report before any patient
were available to prepare quality control material testing begins.
and gathering patient samples for the
manufacturer representative to perform the The lab has conducted training on
verification.
these procedures to ensure that
c. The Director of Assays confirmed that the practice is consistent with them.
manufacturer had performed the verification of
performance specifications on the Advia XPT.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 16 of 121
.l:)V NOI.LVli\nIO.iNI IIO Ji\IOCTHIDIII 'tlRL 1IHCINO. IDID.SO'I:)Sla W01III .LclWHX'tl NOI.LVli\nIOdNI 'T\II:)1Iffi"i!W0:) 'IVI.LNHCIIIINO:)
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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tOW? STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY _
\;@}; AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5421 #1 (continued)
05421 Conti_nued From page 15 05421
Lab management, including the new
Each laboratory that introduces an unmodified,
lab director, technical supervisors, and 2/12/16
FDA-cleared or approved test system must do the quality systems director, is responsible
following before reporting l)atient test results: for ensuring compliance with these
(1 )(i) Demonstrate tharn can obtain performance procedures. The lab will provide
specifications comparable to those established by oversight through monthly QA
the manufacturer for the following performance meetings, and will monitor ·
characteristics:
(1 )(i){A) Accuracy. compliance through its improved
(1 )(i)(B) Precis~on. . occurrence management and audit
(1 )(i)(C) Reportable range of test results for the procedures.
test system.
(1)(ii) Verify that the manufacturer's reference
intervals (normal values) are appropriate for the
laboratory's patient population.
·.
This STANDARD is not met as evidenced by:
1. Based on review of the performance·
specification verification documentation and
interview with the general supervisor and
technical supervisor, the laboratory failed to
maintain any documentation that the laboratory
had participated in conducting the verification of
the performance specifications on the Advia XPT.
Findings include:
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
J.:JV NOI.L'\>'li'nIOtlNI 110 WOCTHffiTII ffill 1IH<INO. tflli1SO'I:JSICT W01III J.clJilJI!XH NOIJ.VW1IOIINI 'IVI:J1!3WWO:J 'IVIJ.NHaIIINO:J
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
fl~!]~) AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
COMPLETED
Albumin
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~[il ;t
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. BUILDING
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
Apolipoprotein
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ffJ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
Triglyceride
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f!)!l:'!l AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
COMPLETED
Glucose
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
·THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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,11:~;) AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING COMPLETED
. '·.\
iii. The accuracy study included samples which
ranged from 12.9-34.3 mEq/L.
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iW\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\frji AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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iiflj); STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\fad; AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5423 (continued)
05423 Continued From page 25 05423
require the lab director's review and
reportable range for alkaline phosphatase.
Findings include: approval of a detailed method
verification plan containing defined
a. Standard Operating Procedure (SOP) CL acceptance criteria. The lab director
SOP-09102 Revision B, "Alkaline Phosphatase must also review and approve the
(ALP) in serum or plasma on the Advia Chemistry verification report before any patient
Systems" indicated that the reportable range for testing begins.
serum and plasma samples was 0-1100 IU/L.
b. The Director of Assays stated that the The lab has conducted training on
reportable range was 10-1100 IU/L and that the these procedures to ensure that
SOP was incorrect. practice is consistent with them.
c. The manufacturer performed the verification
The lab's management, including the
of performance specifications for serum on
..
10/23/14. There was no documentation that the new lab director, technical
performance specifications had been verified for supervisors, and quality systems
plasma samples. director, is responsible for ensuring
compliance with these procedures.
d. The accuracy study included samples which The lab will provide oversight through
ranged from 23.70-423.0 IU/L.
monthly QA meetings, and will
e. The accuracy study did not include samples monitor compliance through_its
across the entire reportable range. improved occurrence management and
audit procedures.
f. The accuracy study did not include a
comparison study as required by the laboratory's
procedure.
J::JV NOI.LVJi\IB:O.iNI i:IO woamnri:13H.L 1[3(Ili[(l 3:llilSO'I;)SIQ :W01[i:l .LclJi'tHX3 NOI.LVJi'ffiO.iNI 'IVI:)1[3Ji\!WQ;) 'IVI.LN30Ii:IN0;)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
i\t
iuui > STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 27 of 121
J.:JV NOIJ.VYrnOdNI i[Q wornrillH ffill <IHCINO ffiillSO'I:JSia WOTul J.cIWHXH NOIJ.VW<IO!lNI 'IVI:J<IBJi'lWO:J 'IVIJ.NHaiilNO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
{@{) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@'] AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5429 (continued)
05429 Continued From page 27 05429
followed. The lab will provide
c. In August 2015, the laboratory performed and
oversight of required maintenance
reported 844 patient HIV Ag/Ab test results using through monthly QA meetings, and
the Evolis system. will monitor compliance through its
05437 493.1255(a) CALIBRATION AND CALIBRATION 05437 improved occurrence management and
VERIFICATION audit procedures.
400M
Unless otherwise specified in this subpart, for
each applicable test system the laboratory must
perform and document calibration procedures--
(1) Following the manufacturer's test system
instructions, using calibration materials provided
or specified, and with at least the frequency
recommended by the manufacturer;
(2) Using the criteria verified or established by the
laboratory as specified in §493.1253(b)(3)--
(2)(i) Using calibration materials appropriate for
the test system and, if possible, traceable to a
reference method or reference material of known
value; and
(2)(ii) Including the number, type, and
concentration of calibration materials, as well as
acceptable limits for and the frequency of
calibration; and
(3) Whenever calibration verification fails to meet
the laboratory's acceptable limits for calibration
verification.
This STANDARD is not met as evidenced by: (D5437#1 begins on next page)
1. Based on laboratory personnel interviews and
complete blood counts (CBC) calibration
documentation record reviews on September 23,
2015, the laboratory failed to document all CBC
instrument calibrations performed using the Drew
3 instruments. Findings included:
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 28 of 121
.L:J\f NOI.LVW1IO.!INI tlO WOOH'.31Itl HH.L 1IHCCNO. '.31IOSO'I:)Sia WOTu:I .LdW'iIXH NOI.LVJi'ffiO.!INI 'IVI::rnHW:wo::> 'IVI.LNHaitlNO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
,ff:
QfaW
\ STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 28 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDERISUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
D5437 #1 (continued)
05437 Continued From page 28
patient capillary CBC specimens using two Drew
o5437 oversight through monthly QA
meetings, and will monitor
3 instruments the laboratory designated as "Drew
#2" and "Drew #3." On September 23, 2015, compliance through its improved
information recorded on "Drew #2" indicated that occurrence management, and audit
the "Drew #2" was calibrated on August 24, 2015, procedures.
and information recorded on "Drew #3" indicated
that the "Drew #3" was calibrated on August 31,
2015.
(,
I
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tf@\. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\(@}/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
D5437 #2 (continued)
05437 Continued From page 29 05437
The new lab director has also
2015, the laboratory performed and reported
2,395 patient CBC test results using the Advia approved specific calibration
2120i #1. From November 6, 2015 to November procedures for CBC on the Advia
19, 2015, the laboratory performed and reported 2120i. Before the lab resumes any
67 patient CBC test results using the Advia 21201 tests on the Advia 2120i, it will
#2. conduct training on those procedures.
05447 493.1256(d)(3)(i)(g) CONTROL PROCEDURES 05447 In addition, testing personnel will be
required to demonstrate competency
400H Unless CMS Approves a procedure, specified in
Appendix C of the State Operations Manual to ensure that practice is consistent
(CMS Pub. 7), that provides equivalent quality with those procedures.
testing, the laboratory must--
Lab management, including the new
At least once a day patient specimens are lab director, technical supervisors, and
assayed or examined perform the following for--
quality director, is responsible for
Each quantitative procedure, include two control ensuring that these procedures are
materials of different concentrations; followed. The lab will provide
oversight through monthly QA
(g) The laboratory must document all control meetings, and will monitor
procedures performed. compliance through its improved
This STANDARD is not met as evidenced by:
Based on laboratory personnel interviews and occurrence management and. audit
WBC differential quality control record review on procedures.
November 19, 2015, the laboratory failed to
include two quality control materials with differing
WBC differential patterns at least once each day
patient WBC differential specimens were
examined using the Cellavision instrument.
Findings included:
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 30 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
p;{'.}; STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%]UY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
Each quantitative procedure, include two control The new lab director has approved
materials of different concentrations; enhanced QC procedures that
reinforce the need to perform QC with
(g) The laboratory must document all control at least two levels of control, unless
procedures performed. otherwise specified, and the lab has
This STANDARD is not met as evidenced by:
Based on laboratory personnel interviews and conducted training on those .
WBC differential quality control record review on procedures.
November 19, 2015, the laboratory failed to
include two quality control materials with differing The new lab director has also
WBC differential patterns at least once each day approved enhanced procedures for the
patient WBC differential specimens were
Cellavision instrument to reinforce
examined using the Cellavision instrument.
Findings included: that the daily WBC differential must
include two QC materials with
a. It was the practice of the laboratory to use the differing WBC patterns. Before the
Cellavision instrument to aid in the examination lab resumes any tests on the
and reporting of patient WBC differentials Cellavision, it will conduct training
performed from stained slides.
and competency testing on those
b. According to laboratory personnel, although procedures to ensure that practice is
the laboratory performed a function check (cell consistent with them.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 30 of 121
.L:JV NOI.LVJ!'raO!lNI !IO womI'illIII 'iIHL 1IHCINO. 3}l{1.S0'1:JSIQ W01Id .LcIW:HX'il NOI.LVWRO!INI 'IVI:J1!3]i'{W0:J 'IVI.LN'ilaitlNO:J
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
(111:I: AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING
COMPLETED
D5447 (continued)
05447 Continued From page 30 05447
Lab management, including technical
locator) each day the Cellavision was used to
examine patient stained slides, the laboratory did
supervisors, will be responsible for
not examine two quality control materials with ensuring that these procedures are
differing WBC differential patterns each day the followed. The lab will provide
Cellavision was used to examine patient stained oversight through monthly QA
slides. Laboratory personnel also stated that all meetings, and will monitor
Cellavision examinations were reviewed by compliance through its improved
testing personnel and revised, if necessary,
before the examination was release for reporting. occurrence management, and audit
However, the Cellavision did perform the primary procedures.
WBC differential screening of patient stained
slides.
At least once a day patient specimens are The lab has completed an assessment
assayed or examined perform the following for-- to identify any patients affected or
having the potential to be affected by
Each qualitative procedure, include a negative this issue.
and positive control material;
(g) The laboratory must document all control The new lab director has approved
procedures performed. enhanced QC procedures that
This STANDARD is not met as evidenced by: reinforce the need to perform QC with
Based on technical supervisor interview and at least two levels of control, unless
CT/NG quality control record review on
otherwise specified, and the lab has
November 17, 2015, at least once a day patient
specimens were assayed, the laboratory failed to conducted training on those
include a positive CT/NG quality control material. procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 31 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXE1\.1PT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
trnu
\jjij'
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A. BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 32 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tff:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%1:Y AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5469 #1
05469 Continued From page 32 05469
The lab has completed an assessment
Establish or verify the criteria for acceptability of
all control materials.
to identify any patients affected or
having the potential to be affected by
(i) When control materials providing quantitative this issue.
results are used, statistical parameters (for
example, mean and standard deviation) for each The new lab director has approved
batch and lot number of control materials must be enhanced procedures to reinforce the
defined and available.
(ii) The laboratory may use the stated value of a practice of parallel testing each new
commercially assayed control material provided lot of control material with the lot of
the stated value is for the methodology and control material in use, and
instrumentation employed by the laboratory and is establishing a range based on the
verified by the laboratory. manufacturer's range. The lab has
(iii) Statistical parameters for unassayed control
conducted training on those
materials must be established over time by the
laboratory through concurrent testing of control procedures.
materials having previously determined statistical
parameters. Lab management, including technical
supervisors and the quality director,
(g) The laboratory must document all control will be responsible for ensuring that
procedures performed.
This STANDARD is not met as evidenced by:
these procedures are followed. The
1. Based on laboratory personnel interviews and lab will provide oversight through
complete blood counts (CBC) quality control monthly QA meetings, and will
record review on September 23, 2015, the monitor compliance through its
laboratory failed to verify the stated values of the improved occurrence management and
commercially assayed CBC quality control audit procedures.
materials in use at the time of the survey.
Findings included:
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
t:fff), STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
ii]@)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
Af@!\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
l(f{)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5469 #2 (continued)
05469 Continued From page 33 05469
oversight through monthly QA
c. The laboratory maintained no documentation
meetings, and will monitor
to indicate that the stated values of CBC quality compliance through its improved
control material lot number EX075 had been occurrence management and audit
verified by the laboratory. procedures.
d. According to laboratory personnel, between
June 27, 2015 and September 24, 2015, the
laboratory used one of the Drew 3 instruments on
30 different days to perform and report patient
CBC specimens, and used the other Drew 3
instrument on 87 different days to perform and
report patient CBC specimens.
(.
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TIIB FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
&F>. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\&) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T.HERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facillty ID: CA22046272 If continuation sheet Page 35 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tW\, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\j@j) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID; W34211 Faclllty ID: CA22046272 If continuation sheet Page 36 of 121
l:JV NOilYmO.iNI iIO woamrna: 3Hl clHCINfl ffiIO.SO'I:JSia WOcld: ldWHXH NOI.LVMIOa:NI 'IVI::nIHWWO::> 'IVIlNHaI.!INO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER Tim FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1} PROVIDER/SUPPLIER/CUA (X2} MULTIPLE CONSTRUCTION (X3) DATE SURVEY
fil;llllt AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
D5481 #1 (continued)
05481 Continued From page 36 05481
through monthly QA meetings, and
mean.
will monitor compliance through its
d. On 9/7/15, Citrol 3 was run seven times improved occurrence management and
without obtaining an acceptable QC value. audit procedures.
',,
h. The Rule Check report revealed that 13 of 13
QC values in April 2015, 2 of 17 in May 2015, 7 of
7 in June 2015, 13 of 13 in July 2015, 16 of 16 in
August, and 24 of 24 during September 1-16,
2015 showed rule violation messages related to
Citrol 3.
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
(fi}: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
%@ ) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20(2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5481 #2 (continued)
05481 Continued From page 37 05481
when QC results are not acceptable.
b. Section 11.1.1 of CL SOP-15026 Revision A
The lab has conducted training and
further stated that "Daily QC automatically competency on those procedures to
expires 24 hours after use." ensure that practice is consistent with
them.
c. The general supervisor stated that when the
QC was unacceptable, the TPS device locked out
Lab management, including technical
patient testing for 24 hours or until the QC was
acceptable and if the QC was unacceptable supervisors and the quality systems
another device would be used for testing. director, is responsible for ensuring
that these procedures are followed.
d. QC records for Sex Hormone Binding The lab will also provide oversight
Globulin (SHBG) showed that on Device E001025 through monthly QA meetings, and
QC Level 2's (QC2) 24 hour expiration was on
will monitor compliance through its
8/14/14 at 18:54 and was not run again until
8/15/14 at 00:05. Patient data showed that improved occurrence management and
patient Accession #94389 was run on 8/14/14 at audit procedures.
19:09.
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tfF> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
\{fa}i AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T.HERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TIIE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
T!iERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER TIIE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
tHERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
t.
Levey-Jennings charts revealed that VB12
Device E000187 QC1 had 14 consecutive days
and QC2 had 12 consecutive days that the
results were at least 2 SDs above the mean from
2/10/14 through 2/27/14.
05775 493.1281 (a)(c) COMPARISON OF TEST
D5775 D5775 #1
RESULTS
4008 The lab proactively paused testing on 2/12/16
(a) If a laboratory perform$ the same test using the Cellavision during the survey. The
different methodologies or instruments, or lab has completed an assessment to
performs the same test at multiple testing sites, identify any patients affected or
the laboratory must have a system that twice a having the potential to be affected by
year evaluates and defines the relationship
between test results using the different this issue.
methodologies, instruments, or testing sites.
(c) The laboratory must document all test result The new lab director has approved
comparison activities. enhanced method comparison
This STANDARD is not met as evidenced by: procedures, which reinforce that the
1. Based on laboratory personnel interview and lab will compare the results of any
manual WBC differential record review on
November 19, 2015, the laboratory failed to have instruments running the same test(s) at
a system that twice a year evaluated and defined least twice each year to ensure that
the relationship between WBC differential test their results are comparable and within
results examined by multiple testing personnel. defined acceptance criteria. The lab
Findings included: has conducted training on those
a. It was the practice of the laboratory for
procedures.
multiple testing personnel to examine and report
patient WBC differentials from stained slides. The new lab director has also
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 41 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
("cf@) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
''{Jj} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
!%}> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@ \ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
a. Undated documentation provided by the The new lab director has approved
laboratory revealed a comparison study between enhanced method comparison
the Theranos Proprietary System (TPS) (i.e., procedures, which reinforce that the
Edison) and a predicate device (lmmulite,
Centaur, or Liaison) for Sex Hormone Binding
lab will compare the results of any
Globulin (SHBG), Total T3 (TT3), Vitamin D (Vito) instruments running the same test(s) at
and Vitamin 812 (VB12). least twice each year, to ensure that
their results are comparable and within
b. The method comparison documentation defined acceptance criteria. The lab
showed that the following devices (i.e., readers) has conducted training on those
E000026, E001025 and E001036 were used for
SHBG comparison testing. SHBG testing
procedures.
occurred from 7/28/14 through 6/25/15.
The lab's technical supervisors and the
c. Quality control (QC) monthly reports revealed quality systems director will be
that seven devices were used for SHBG from responsible for ensuring that these
February 2015 through June 2015 but only three procedures are followed. The lab will
devices were included in the comparison study.
provide oversight through monthly
d. QC and patient result documentation for QA meetings, and will monitor
SHBG also revealed that devices E000040,
E001007 and E001035 were used for patient
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Fac!lity ID: CA22046272 If continuation sheet Page 42 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
l.:JV NOil.V})IIBOdNI .ilO WOQHffild HH.L 1IHCINfl ffiIOS0'1:JSIQ W01Id l.cJlilJI!XH NOil.VJllrnOdNI '1VI:J1IHWWO:J 'lVIl.NHOidNO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
f@}O, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\!EN AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
l'HERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5775 #2 (continued)
05775 Continued From page 42 05775 comp1·iance through its
. rmprove
. d
testing and were not included in the comparison
study.
occurrence management, and audit
procedures.
e. The method comparison documentation
showed that the following devices E000162,
E000187, E00195, E001011, E001032, and
E001049 were used for TT3 testing. TT3 testing
occurred from 2/2/14 through 2/4/15.
.L:JV NOI.LVli'nIO.!INI 110 woa'iiffiTll 'iIHL 1I'iICINfl ffiT(lSO'I:JSia W01!11.L~3X'iI NOI.LVJArnO.!INI 'IVI:J1I'iIWWO:J 'IVI.LN'iIGIIINO:J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
{@:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~t;:;O AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE. ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 44 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES JD PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
D5779 (continued)
05779 Continued From page 44 05779 comp1'rnnce wit
. h these procedures.
ii. "Step 211 of the procedure was to "repeat with
fresh controls" "if the rerun of controls failed." The lab will also provide oversight
through monthly QA meetings, and
iii. "Step 3" of the procedure was to "check the will monitor compliance through its
operation of the instrument" "if the rerun of [fresh] improved occurrence management and
controls failed." audit procedures.
iv. "Step 4" of the procedure was to "repeat
using a new reagent kit" and "recalibrate" if
quality control test results continued to fall outside
the laboratory's criteria for acceptability.
.L:)V NOllv'WNOdNI tlO WOQ3:ffiltl fill "a3:CINfl ffilfl.SO'l:.)SIQ WO~ .LclW3X3: NOI.LVWNOdNI '1VI:.)"a3WW0:.) 'lVI.LN3:QitlN0:.)
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 46 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4}1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION} CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 47 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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fi:) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~;;;]{) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5791 #1 (continued)
05791 Continued From page 47 05791
The lab has identified and discarded
§§493.1251 through 493.1283.
(c) The laboratory must document all analytic
any materials that had the potential to
systems assessment activities. have been affected. The lab has also
completed an assessment to identify
This STANDARD is not met as evidenced by: any patients affected or having the
1. Based on the SensoScientific Monitoring potential to be affected by this issue.
Audit Node Report and intervew, the laboratory
failed to identify and perform corrective action
when ten of ten freezer temperatures did not
The new lab director has approved
meet the manufacturer temperature enhanced temperature management
requirements. Findings include: procedures to reinforce monitoring of
temperature and environmental
a. The Audit Node Reports for July 2015 and conditions and storage of materials
September 2015 were reviewed.
according to the manufacturer's
b. Six -20 C freezers were identified: 7059 -20 temperature range. The lab has
Freezer Sanyo JP lab, 7061 BUGS -20 Freezer 4, conducted training on those
7063 -20 Freezer Accessioning, 7066 -20 Freezer procedures.
1 Normandy, 7075 -20 Freezer 2 JP, and 7077
-20 Freezer 3JP. The lab's management, including the
c. Four -80 C freezers were identified: 7098 -80
new lab director and quality systems
Freezer 1 Nuair, 7111 -80 Freezer 2 Thermo, director, will ensure compliance with
7113 -80 Freezer 2 CLIA Lab, and 7120 -80 these procedures, including by making
Freezer 1 BUGS. sure that supervisors perform their
respective duties effectively. The lab
d. The Audit Node Report for 7/6/15 through will also provide oversight through
7/31/15 revealed the following number of days
that the freezers did not meet the required
monthly QA meetings, and will
acceptable temperature range of greater than or monitor compliance through its
equal to -20 C or greater that or equal to -80 C: improved occurrence management and
audit procedures.
7059 -20 Freezer Sanyo JP Lab 25/26 days
7098 -80 Freezer 1 Nuair 7/26 days
7111 -80 Freezer 2 Thermo 18/26 days
7113 -80 Freezer 2 CLIA Lab 14/26 days
7120 -80 Freezer 1 BUGS 25/26 days
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
.,ff\\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
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h. Refer to 05413.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
,w::.
t]{Q)
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
05791 #2 (continued)
05791 Continued From page 49 05791
approved enhanced quality systems
Devices" in section 13.4.5 requires the %CV of
replicates to be not more than 15% (20% at the
and related procedures. The lab has
lower and upper limits of detection). also appointed a Quality Director who
will provide additional oversight.
b. QC results were reviewed from June 2014
through November 2014 and January through These improved systems include QC
February2015 for Vitamin 812 (VB12), Vitamin D
procedures to reinforce that QC is
(Vito), and Sex Hormone Binding Globuin
(SHBG) which were used for patient testing on effectively reviewed to identify
the TPS devices. precision that is inconsistent with the
lab's CV requirements and that
c. VB12 QC Level 1 and Level 3 (QC1 and documented investigations and
QC3) on Device E000110 revealed the following corrective action occur. In addition,
%CV (coefficient of variation): 34.3% and 48.5%,
the procedures clarify which
respectively, from 1/5/15 through 1/30/15.
employees are responsible for
d. V812 QC1 and QC3 on.DeviQe E001085 performing and documenting these
revealed the following %CVs: 52.5% and 35.2%, activities, and require regular technical
respectively, from 1/5/15 through 1/30/15. supervisor review and analysis of QC
results. The lab has conducted training
e. VB12 QC1 and QC3 on Device E001102
revealed the following %CVs: 39.0% and 20.0%,
and competency testing on those
respectively, from 2/10/15 through 2/27/15. procedures to ensure that practice is
consistent with them.
f. VB12 QC1 and QC3 on Device E001000
revealed the following o/oCVs: 34.7% and 39.9%, Lab management, including technical
respectively, from 1/2/15 through 1/31/15. supervisors and the quality director,
g. VB12 QC1 and QC3 on Device E001102
are responsible for compliance with
revealed the following %CVs: 39.0% and 20.0%, these procedures. The lab will also
respectively, from 2/10/15 through 2/27 /15. provide oversight through monthly
QA meetings, and will monitor
h. Vito QC Level 1 and Level 2 (QC1 and QC2) compliance through its improved
on Device E000053 revealed the following o/oCVs:
occurrence management and audit
63.8% and 26.4%, respectively, from 8/21/14
through 8/30/14. procedures.
J.:::>v NOilVJ!'IBOdNI dO WOG3IITul ffifl ~3CINO. ffiID.S01::>SIG WOfil ldW3X3 NOUVJIIIBOdNI 1VI::>113WWO::> 1VIJ.N3GldNO::>
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
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l:)V NOllVJ-'ffiOdNI dO Ji\l:OCTHffilil 3:H.L 1!3:CIN!1 ffiillSO'DSia W01Id .LdW3X3: NOllVVffiOdNI 'TVI::mHWWO::> 'TVI.LN3:GidNO::>
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
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NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6J
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
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.L:::>V NOllVY'IBO.iNI dO WOG3:3}B 3:H.L 113:CINfl ffililSO'l:::>SIG WOfil .LdJIII3:X3: NOI.LVY'IBO.iNI 'lVI:::>113:WWO:::> 'lVI.LN3:GidNO:::>
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
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NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
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J..:)V NOJ.LVJ."raO.':lNI dO WOG3ffild 3HJ.. 1:13CINfl ffiillSO'USIG W01:Id J..dli'J:3X3 NOIJ..VJ."raOdNI '1VJ:)1:13WW0:) '1VIJ..N3GidNO:)
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
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c. The laboratory's quality assessment The new lab director has also
mechanism failed to ensure that the stated values approved enhanced procedures
of commercially assayed CBC quality control addressing equipment systems and
materials were verified. See 05469.
reinforcing that calibration
d. The laboratory's quality assessment documentation must be organized and
mechanism failed to ensure that laboratory maintained. The lab has conducted
personnel followed the established corrective training on those procedures.
action protocol when CBC quality control test
results failed to meet the laboratory's criteria for
The new lab director has also
acceptability even though the laboratory
maintained documentation to indicate that the approved an enhanced SOP for CBC
documented CBC quality control corrective on the Advia 2120i that addresses the
actions had been reviewed during a quality corrective actions to take when
assessment audit on August 6, 2015. In addition, calibration or QC fail to meet the lab's
the laboratory maintained no documentation it criteria for acceptability. Before the
had recognized and investigated possible
problems with the high quality control material
lab resumes any tests on the Advia
being used as it had failed to meet the 2120i, it will conduct training on those
laboratory's criteria for acceptability upon initial procedures. In addition, lab staff will
testing for 5 of 7 days of patient specimen testing be required to demonstrate
from July 11, 2015 to July 17, 2015. See 05779. competency to ensure that practice is
consistent with these procedures.
2. Based on laboratory personnel interviews and
WBC differential flow cytometer performance
report record review on November 17, 2015, the Lab management, including technical
laboratory failed to have an analytic systems supervisors and the quality director, is
quality assessment mechanism that included a responsible for compliance with these
review of the effectiveness of flow cytometer procedures. The lab will provide
corrective actions taken to resolve problems. oversight through monthly QA
Findings included:
meetings, and will monitor
a. For patient capillary specimens, it was the compliance through its improved
practice of the laboratory to use flow cytometry occurrence management, and audit
instrumentation to perform and report patient procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty JD: CA22046272 If continuation sheet Page 55 of 121
l:.)V NOLL"WffiOdNI dO WOGHffild 3:H.L 113:CINfl ffilf1S01:.)SIG W011d ldW3:X3: NOLL"WffiOdNI 1VI:.)1J:3:WWQ:.) 1VIlN3:GidN0:.)
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
8. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
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.L::)V NOI.LVM:1000 tlO WOCT3:ffiltl 3H.L 1:l:3:CINf1 ffilflSO'lJSia WO~ .Ldli\I3:X3: NOI.LVWl:IOtlNI 'lVI:::ma:wwo::> '1VI.LN3:aitlNO::>
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tlH\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%@jj) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
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D5793 #2 (continued)
05793 Continued From page 55
o5793 The new lab director is responsible for
WBC differentials.
the lab's QA program and has
b. On August 23, 2015, in which the flow approved enhanced quality systems
cytometer was used to perform and report patient and related procedures. The lab has
WBC differentials, laboratory "Cytometer also appointed a Quality Director who
Performance Reports" indicated that at 09:30 the will provide additional oversight.
flow cytometer performance check failed. The
performance check was repeated and again
failed at 1O: 18. At 12:49, laboratory The new lab director has approved
documentation indicated that the flow cytometer enhanced procedures to reinforce the
performance check passed. practice of addressing a performance
check fail through documented
c. The laboratory maintained no documentation investigations and corrective action.
to indicate that the actions taken on August 23, The lab has conducted training on
2015 to "pass" the flow cytometer performance
check had been reviewed for the effectiveness of those procedures.
the actions under the laboratory's quality
assessment mechanism. Lab management, including technical
supervisors and the quality director,
3. Based on technical supervisor interviews and are responsible for compliance with
human chorionic gonadotropin {HCG) quality
control record review on November 19, 2015, the
these procedures. The lab will provide
laboratory failed to have an analytic systems oversight through monthly QA
quality assessment mechanism that included a meetings, and will monitor
review of the effectiveness of HCG quality control compliance through its improved
corrective actions taken to resolve problems. occurrence management, and audit
Findings included: procedures.
a. It was the practice of the laboratory to use the
lmmulite 2000 XPi instrument to perform and
report patient quantitative HCG test results. It
was also the practice of the laboratory to use
three levels of assayed quality control materials
and the stated values of the commercially
assayed quality control materials as the
laboratory's criteria for acceptability to monitor
patient quantitative HCG testing.
l:::>V NOllVW}!OiINI tlO WOGt!ffiltl 3:H.L 113:CINfl ffilf1S0'1:::>SIG W011tl ldW'3X3: NOllVW}!OiINI '1VI:::>11HWWO:::> '1VIlN3:GitlNO:::>
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
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l:)V NOllVffi!O.iNI dO WOQ3:ffild 3H.L 1:13:CINfl ffil11S0'1:)SIQ WO'&! .ldW3X3: NOI.LVffi!O.iNI '1VI:)1J:9Ji'JW0:) '1VI.LN3:Gii!N0:)
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\@Q AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING JNFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
a. It was the practice of the laboratory to use the The new lab director is responsible for
lmmulite 2000 XPi instrument to perform and the lab's QA program and has
report patient HBsAb test results. It was also the approved enhanced quality systems
practice of the laboratory to use three levels of and related procedures. The lab has
assayed quality control materials and the stated
values of the commercially assayed quality
also appointed a Quality Director who
control materials as the laboratory's criteria for will provide additional oversight.
acceptability to monitor patient HBsAb testing.
The new lab director has approved
b. A review of the criteria for acceptability for the enhanced QC procedures to reinforce
three quality control materials (Siemens, lot the need to document investigations
number 0134, expiration date 11/2016) in use on
November 19, 2015 indicated that for the
and the reasons for corrective action
negative quality control material the criteria for when QC fails to meet the lab's
acceptability used to monitor patient HBsAb acceptability criteria, including the
testing was 0.0 - 4.0, the low positive quality reasons for any changes to QC
control material's criteria for acceptability used to parameters. The lab has conducted
monitor patient HBsAb testing was 10.3 - 19.6, training on those procedures.
and the positive quality control material's criteria
for acceptability used to monitor patient HBsAb
testing was 234 - 345. These procedures require the technical
l:)V NOLLV1"IBO.iNI dO Ji\IOQ33}ld 3H.L 1!3CINfl ffililS01:>SIQ WOfil .Ld}'i[3X3 NOLLV1"IBOdNI 1VI:>1!3WWO:> 1VI.LN3GidNO:>
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~fo)) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
D5793 #4 (continued)
05793 Continued From page 58 05793 supervisors
. to regul arl y review
. QC
insert, the assayed values of the three quality
control materials in use on November 19, 2015 to
and to initiate investigations and
monitor patient HBsAb testing was 0.0 - 4.0 for corrective action when QC fails to
the negative quality control material, 11 - 21 for meet the lab's acceptability criteria. In
the low positive quality control material, and 226 - addition, oversight of QC reviews,
340 for the positive quality control material. investigations and corrective action
occurs through monthly QA meetings.
d. According to laboratory records, the criteria
for acceptability for two of the three quality control The lab will also monitor compliance
materials in use on November 19, 2015 to through its improved occurrence
monitor patient HBsAb testing was changed on management, and audit procedures.
September 11, 2015 to the criteria for
acceptability that was used until November 19,
2015. According to laboratory personnel, the
change to the criteria for acceptability was made
on September 11, 2015 because there was an
apparent "shift" in the laboratory's quality control
materials test results. The laboratory conducted
no further investigation or review prior to
changing the criteria for acceptability for the three
quality control materials.
.L:::>V NOI.LVWNOdNI tlO Ji\IOGHffiltl illll 'MHCIN.fl ffilfl.SO'lJSIG Ji\IO'Mtl .Lc1Ji\I3XH NOI.LVWNOdNI 'IVI:J'MHJi\IJi\IO:J 'IVI.LNHGitlNO:J
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'6?) STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
%HY AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5793 #5 2/12/16
05793 Continued From page 59
o5793 The lab proactively paused testing on
the effectiveness of LH quality control corrective
actions taken to resolve problems. Findings
the Siemens Advia Centaur XP
included: Immunoassay System during the
survey.
a. It was the practice of the laboratory to use the
Siemens Advia Centaur XP Immunoassay The lab has completed an assessment
System instrument to perform and report patient to identify any patients affected or
LH test results. It was also the practice of the
laboratory to use three levels of assayed quality having the potential to be affected by
control materials and the stated values of the this issue.
commercially assayed quality control materials as
the laboratory's criteria for acceptability to monitor The new lab director is responsible for
patient LH testing. the lab's QA program and has
approved enhanced quality systems
b. A review of the criteria for acceptability for the
three quality control materials (Bio-Rad, lot and related procedures. The lab has
number 50980, expiration date 11/30/2016) in also appointed a Quality Director who
use on November 19, 2015 indicated that for the will provide additional oversight.
level 1 quality control material the criteria for
acceptability used to monitor patient LH testing These new procedure reinforce the
was 2.86 - 4.18 mlU/mL, the level 2 quality
control material's criteria for acceptability used to
need to document investigations and
monitor patient LH testing was 16.98 - 25.48 the reasons for corrective action when
mlU/mL, and the level 3 quality control material's QC fails to meet the lab's acceptability
criteria for acceptability used to monitor patient criteria, including the reasons for any
LH testing was 57.6 - 84.8 mlU/mL. changes to QC parameters. The lab
has conducted training on those
c. According to the manufacturer's package
insert, the assayed values of the three quality
procedures.
control materials in use on November 19, 2015 to
monitor patient LH testing was 2.86 - 4.18 These procedures require the technical
mlU/mL for level 1, 16.6 - 23.9 mlU/mL for level supervisors to regularly review QC
2, and 57.6 - 84.8 mlU/mL for level 3. and to initiate investigations and
corrective action when QC fails to
d. According to laboratory records, the criteria
for acceptability for one of the three quality control meet the lab's criteria for
materials in use on November 19, 2015 to acceptability. In addition, oversight of
monitor patient LH testing was changed on July 9, QC reviews, investigations and
2015 to the criteria for acceptability that was used corrective action occurs through
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facll!ty ID: CA22046272 If continuation sheet Page 60 of 121
1:)V NOI.LVJAIBO.iNI dO WOG3:ffild 3RL "M3:cINfl ffilflS01::)SIG WO"Mtl .I.dW3:X3: NOI.LVJAIBO.iNI 1VI::)"M3:WW0::) 1VI.LN3:GidN0::)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01 /25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5793 #5
05793 Continued From page 60 05793
monthly QA meetings. The lab will
until November 19, 2015. According to laboratory
personnel, the change to the criteria for also monitor compliance through its
acceptability was made on July 9, 2015 because improved occurrence management and
there was an apparent "shift" in the laboratory's audit procedures.
quality control materials test results. The
laboratory conducted no further investigation or
review prior to changing the criteria for
acceptability for the three quality control
materials.
a. It was the practice of the laboratory to use the The lab proactively paused testing on
lmmulite 2000 XPi instrument to perform and the Siemens Advia Centaur XP
report patient CA-125 test results. It was also the Immunoassay System during the
practice of the laboratory to use three levels of
assayed quality control materials and the stated survey.
values of the commercially assayed quality
control materials as the laboratory's criteria for The lab has completed an assessment
acceptability to monitor patient CA-125 testing.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 61 of 121
.L:)V NOLLVY'rnOdNI dO Ji\J:003:ffild fill "'i13:CINfl ffiillSO'l:)SIG WO"'ild l.dit\T3X3: NOilVY'rnOdNI '1VI::)"'il3J'®\I0::) '1VllN3:G.ldN0::)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTfylENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5793 #6 (continued)
05793 Continued From page 61 05793 to 1"dent1"fy any patients
. af~.1ecte d or
b. A review of the criteria for acceptability for the
having the potential to be affected by
three quality control materials (Bio-Rad, lot this issue.
number 19980, expiration date 09/30/2016) in
use on November 19, 2015 indicated that for the The new lab director is responsible for
level 1 quality control material the criteria for the lab's QA program and has
acceptability used to monitor patient CA-125 approved enhanced quality systems
testing was 18.6 - 28.7 U/ml, the level 2 quality
control material's criteria for acceptability used to and related procedures. The lab has
monitor patient CA-125 testing was 53.5 - 82.2 also appointed a Quality Director who
U/ml, and the level 3 quality control material's will provide additional oversight.
criteria for acceptability used to monitor patient
CA-125 testing was 92.5 - 141 U/ml. The new lab director has approved
enhanced QC procedures to reinforce
c. According to the manufacturer's package
insert for quality control materials Bio-Rad, lot the need to document investigations
number 19980, there were no assayed values for and the reasons for corrective action
the three quality control materials in use on when QC fails to meet the lab's
November 19, 2015 to monitor patient CA-125. acceptability criteria, including the
According to laboratory personnel, the quality reasons for any changes to QC
control material's manufacturer could not publish
the criteria for acceptability at the time the quality
parameters. The lab has conducted
control material was received by the laboratory, training on those procedures.
and was told by the manufacturer to use the
criteria for acceptability from the previous lot of These procedures require the technical
quality control materials. The laboratory supervisors to regularly review QC
maintained no documentation to support the and to initiate investigations and
manufacturer's instructions for the use of the
criteria for acceptability from the previous lot of
corrective action when QC fails to
quality control materials. meet the lab's criteria for
acceptability. In addition, oversight of
d. A review of the manufacturer's criteria for QC reviews, investigations and
acceptability from the previous lot of CA-125 corrective action occurs through
quality control materials revealed that the criteria monthly QA meetings. The lab will
for acceptability for the quality control materials
used by the laboratory on November 19, 2015 to also monitor compliance through its
monitor patient CA-125 testing did not match the improved occurrence management,
criteria for acceptability from the previous lot of and audit procedures.
CA-125 quality control materials.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA.22046272 If continuation sheet Page 62 of 121
l::)V NOI.l~OiINI tIO WOCT33"1:ItI 3H.L 'M3CINfl ffilflS01:::>Sia WO'Mtl ldW3X3 NOI.l~OOO 1VI:::>'M3WWO:::> 1VIlN3aitINO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
a. To comply with the CUA requirement at 42 The new lab director is responsible for
C.F.R. 493.1281(a), the laboratory maintained a the lab's QA program and has
protocol titled "Proficiency Testing for Theranos approved enhanced quality systems
Lab-Developed Tests" that included a laboratory
process called AAP in which tests performed and related procedures. The lab has
using the b4 would be evaluated and also appointed a Quality Director who
defined in relationship to the Advia XPT. will provide additional oversight.
b. A review of laboratory documents indicated The new lab director has approved
that for the following AAP events, the laboratory's enhanced procedures requiring that
evaluation was not timely and, therefore,
ineffective: alternative assessments must be
subject to timely review and
i. On April 1, 2014, the laboratory completed
testing for 18 routine chemistry analytes using the
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 63 of 121
l::)V NOil"WffiO.iNI dO WOml'.3.Tul HHl "}13ClNfl ffiillSO'I::)SIG WO"}ld lcIW3X3 NOil"WffiO.iNI 'IVI::)"}13:WWO::) '1VllN3GidN0::)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
&]\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\)fad) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5793 #7 (continued)
05793 Continued From page 63
b4
o5793 evaluation by the lab director and/or a
and compared these test results to
test results on the same samples using the Advia
technical supervisor.
XPT. Laboratory records indicated that the
review of this MP was not completed until The lab will provide oversight through
November 16, 2015 by appropriate laboratory monthly QA meetings, and will also
personnel and was not reviewed by the laboratory monitor compliance through its
director as required by laboratory protocol. improved occurrence management and
ii. On May 15, 2014, the laboratory completed
audit procedures.
testing for 14 routine chemistry analytes using the
b4 and compared these test results to
test results on the same samples using the Advia
XPT. Laboratory records indicated that the
review of this MP was not completed until
November 15, 2015 by appropriate laboratory
personnel.
J.:JV NOIJ.VW1£0.!:IN[ IIO WOCTHffiB 3HL 113:0NO. ITTUlSO'I:JSia W01Ill J.dYilIIXH NOIJ.VW1IOl:lNI '1VI:J1IHWWO:J '1\l'IJ.NHCTIIINO:J
CONFIDENTIAL COMJ\1ERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tf?f::}. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
~MID AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D5793 #8
05793 Continued From page 64
results and quality assessment (QA)
o5793 The lab has completed an assessment
documentation the laboratory failed to take to identify any patients affected or
corrective actions when chemistry QC in the having the potential to be affected by
venipuncture laboratory was observed ten this issue.
consecutive times on the same side of the mean.
Findings include: The new lab director is responsible for
the lab's QA program and has
a, CL QOP-00013 Revision D, "Quality Control
in Chemistry", stated in section 6.3.1. 7.2 that QC approved enhanced quality systems
is deemed to have passed when ... Westgard rules and related procedures. The lab has
hae not been violated (see following monthly QC also appointed a Quality Director who
section 6.3.2)." will provide additional oversight.
b. CL QOP-00013 Revision D also stated in
section 6.3.2.5 that ten consecutive observations
The new lab director has approved
on the same side of the mean should be enhanced QC procedures to reinforce
monitored. that regular review of QC data is
required and that investigations and
c. The Advia XPT was put into use for chemistry corrective actions must be taken when
testing on 12/18/14. Prior to 12/18/14, the Advia QC fails to meet the lab's criteria for
1800 was used for chemistry testing.
acceptability. The lab has conducted
Albumin training on those procedures to ensure
that practice is consistent w1th them.
i. Review of the PT results for albumin for the
1st and 2nd events of 2015 revealed that the These procedures require the technical
submitted results showed a negative bias ranging supervisors to regularly review QC
from -3.3 to -4.9 and -1.8 to -3.5, respectively.
and to initiate investigations and
ii. Review of Levey-Jenning reports from April corrective action when QC fails to
2014 and September 2014, revealed that meet the lab's criteria for
MultiQual Level 1 (MQ1) and Multi Qual Level 2 acceptability. In addition, oversight of
(MQ2) had at least 10 consecutive results below QC reviews, investigations and
the mean but within 2 standard deviations (SD). corrective action occurs through
iii. Review of Levey-Jenning reports for January monthly QA meetings. The lab will
2015 through April 2015 revealed MQ1 (Lot also monitor compliance through its
number 45661) had 1O consecutive results below improved occurrence management,
the mean, MQ2 (Lot number 45662) had 10 and audit procedures.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation· sheet Page 65 of 121
.1:)V NOI.lVW}IO!INI !IO WOOHffiltl filll 1IHONC1 ffilflSO'I::>SIO W01Itl .ldWHXH NOI.LVW}IOtlNI 'IVC:)1!8:WWO;) 'IVI.LNHOI.!INO;)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015.
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
.1::)V NOI.LVJi'IBO.dNI .m woaaffili fill 118:CINfl ffiIDSO'I:::>Sia wmw: .La:waxa NOI.LVJi'IBOdNI '1VI:::>1IHWWO:::> '1VI.LN8:CII.!:INO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1} PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER; A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4}1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
Calcium
other Chemistries
J.:J\f NOIJ.Vli'IBQtlN[ i[Q woamr&I HH.L 1:IHCINfl ffiiflSO'J::)SIO W01Itl J.cil'\IHXH NOIJ.VW1IOtlNI 'I\fI::)1:IfilillWO::) 'I\fIJ.NHartlNO::)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
fJ)C STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
1(£): AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5793 #9 2/12/16
05793 Continued From page 67 05793
The lab directors during the period
Theranos Propietary System (TPS) was not
covered by the survey no longer hold
performed every 6 months and was not reviewed
and reviewed and approved by the laboratory any position with the lab. The new lab
(LD) in a timely manner as required by the director was hired after the on-site
laboratory's procedures, and therefore, survey had been completed.
ineffective. Findings include:
The new lab director is responsible for
a. CL SOP-00020 Revision B, "Proficiency
testing for Theranos Lab-Developed Tests the lab's QA program. The lab has
(lmmunoassays)", effective 1/1/2014, stated in also appointed a Quality Director who
section 3.1 that the technical supervisor (TS) was will provide additional oversight.
responsible for ensuring that the AAP was
conducted every 6 months for all analytes. The new lab director has approved
enhanced quality systems to ensure
b. Section 3.3.2 of the procedures stated that
the TS was reponsible for evaluating testing that the lab's procedures are followed.
samples results and section 3.4 stated that the Among other things, the lab's
LD was responsible for reviewing and approving management, including the new lab
each testing event documentation. director and new quality systems
director, will provide oversight over
c. Review of the AAP result forms (CL
proficiency testing and AAP through
FRM-00022-F3) revealed that the AAP was
performed on 8/18/14, 10/21 /14, and 3/13/15. monthly QA meetings. The lab will
also monitor compliance through its
d. All three result forms did not include a improved occurrence management,
documented evaluation by the TS. and audit procedures.
.L:::>V NOI.LVli'rnOif.NI .m woaa:3.1Iil Hill -aa:mm ffiIO.SO'T:::>Sra W0""8:il .Lc:l1"ilIIXH NOI.LVli'rnOif.NI 'TVI:::>""8:t!WWO:::> 'TVI.LNHOiilNO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tK?> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\}f/ AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT.OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 69 of 121
.L;)V NOI.LYmOtlNI .!IO woaa:'tnLI HHL 118:CINfl ffil.O.SO'I::)SIQ WOlfiI .LdWHXH NOI.LYmOdNI 'IV[;)1J:3WW0;) 'NI.LNHaidNQ;)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 69 of 121
J.:::>V NOIJ.VW'dO!lNI dO wom[ffi!d filll 1UICINfl 31lO.SO~:::>Sia WO'Ri! J.dJi'IIHXH NOIJ.VW'dO!lNI 'IVI:::>1Iffiilni\IO:::> 'IVIJ.NHaidNO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CUA {X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 70 of 121
J..'JV NOIJ..Vli'rnOtINI .m WOOHillI.!:13IU 'RHCINfl ffilflSO'I:::>Sia WO'R.!:1 J..dWHXH NOIJ..VW'RO.!:INI 'IVI81Iffi'\IWO'J 'IVIJ..NHaI.!:INO'J
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
A. B U I L D I N G - - - - - - - -
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D5805 (continued):
05805 Continued From page 70 05805
The lab has completed an assessment
(c)(2) The name and address of the laboratory
to identify any patients affected or
location where the test was performed.
(c)(3) The test report date. having the potential to be affected by
(c)(4) The test performed. this issue.
(c)(5) Specimen source, when appropriate.
(c)(6) The test result and, if applicable, the units The new lab director has approved
of measurement or interpretation, or both. enhanced reporting procedures that
(c)(7) Any information regarding the condition and
disposition of specimens that do not meet the require the technical supervisor to
laboratory's criteria for acceptability. verify that interpretive information is
This STANDARD is not met as evidenced by: accurate and to obtain approval from
Based on review of final reports and interview the lab director or clinical consultant
with the Senior Vice President, the laboratory before any updates are implemented.
failed to differentiate the intrepretive data for
Warfarin therapy vs. Non-Warfarin Therapy.
Findings include: The lab will provide oversight through
monthly QA meetings, and will also
a. Thirteen of thirteen final patient test reports monitor compliance through its
reviewed indicated that the International improved occurrence management,
Normalized Ratio (INR) interpretive data on the and audit procedures.
final report was identical for Warfarin therapy and
non-Warfarin therapy.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 71 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Faclllty ID: CA22046272 If continuation sheet Page 72 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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tff\\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\faf AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 73 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6079 (continued)
06079 Continued From page 73
o5o79 revised QC procedures to ensure the
performance of his or her responsibilities, he or
appropriate supervisors are involved
she remains responsible for ensuring that all
duties are properly performed. in review of quality metrics. The lab
This STANDARD is not met as evidenced by: has conducted training on those
Based on the Plan of Correction (POC) from the procedures. The new lab director is
12/3/2013 recertification survey and review of the technical supervisor for chemistry,
quality control (QC) and quality assessment (QA) hematology, and immunohematology.
documentation and the Laboratory Personnel
Report (CMS-209), the laboratory director (LO) During the survey, CMS determined
failed to ensure that the laboratory's QC and QA that Technical Supervisor #3 was
programs were delegated to a qualified technical qualified in bacteriology, mycology,
supervisor (TS). Findings include: virology, and diagnostic immunology.
These technical supervisors are now
a. The POC from the laboratory's 12/3/2013 responsible for QC assessments in
recertification survey stated that a QA/QC
Manager Wal:! hired and began employment on their respective specialties.
12/10/13.
The lab will ensure that the new lab
b. The QA/QC Manager stated on 9/23/15 and director is effective in overseeing
again on 11/19/15 that evaluating and monitoring compliance with these procedures
the QA and QC programs was solely the QA/QC
through audits performed pursuant to
Manager's responsibility.
the lab's new audit procedures,
c. The QA/QC Manager was not listed on the through oversight during monthly QA
CMS-209 forms dated 9/19/15, 9/23/15, or meetings, and through use of a new
11 /15/15 in any capacity. on-site visit log that records the lab
director's time spent physically in the
d. The QA/QC Manager was not qualified to
oversee and maintain the QC and QA programs. lab.
06083 493.1445(e)(2) LABORATORY DIRECTOR 06083
RESPONSIBILITIES D6083 2/12/16
The lab directors during the period
The laboratory director must ensure that the covered by the survey no longer hold
physical plant and environmental conditions of the any position with the lab. The new
laboratory are appropriate for the testing
lab director was hired after the on-site
performed.
This STANDARD is not met as evidenced by: survey had been completed.
Based on review of temperature documentation
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 74 of 121
.L:JV NOI.LVli'fl!O.iINI iIO WOCTHffiiiI ffilL 118:CINO. ITTID.SO'I:JSICT W01IiI .LdWHXH NOI.LVJi'fl!O.iINI 'JVI:)118:WWO:J 'IVI.LNHCIIiINO:J
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 8. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation- sheet Page 75 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6083 (continued)
06083 Continued From page 74 06083
The lab has conducted training on
and interview with the Director of Assay Systems,
the laboratory director failed to ensure that the
those procedures
freezer temperatures were appropriate for
storage of reference materials and patient
specimens. Refer to 05413 and 05791. D6085 2/12/16
06085 493.1445(e)(3) LABORATORY DIRECTOR 06085 The lab directors during the period
RESPONSI Bl LIT! ES covered by the survey no longer hold
any position with the lab. The new lab
The laboratory director must ensure that the test
methodologies selected have the capability of director was hired after the on-site
providing the quality of results required for patient survey had been completed.
care.
This STANDARD is not met as evidenced by: The lab has completed an assessment
Based on review of validation documents on the to identify any patients affected or
Theranos Proprietary System (TPS), the
laboratory director failed to ensure that the quality
having the potential to be affected by
of results on the TPS; failed to ensure the this issue.
establishment of performance specifications
followed the laboratory's procedures to establish The lab will ensure that the new lab
accuracy, precision, reportable range, and/or director effectively implements and
reference range. Findings include: monitors lab procedures, including
a. Validations Reports for Vitamin D (VitD), Total verification and validation procedures,
T3 (TT3), Human Chorionic Gonadotropin (HCG), through oversight during monthly QA
and Sex Hormone Binding Globulin (SHBG) were meetings, through audits performed
reviewed. pursuant to the lab's new audit
procedures, and through use of a new
b. The laboratory presented the procedure, CL on-site visit log that records the lab
PLN-14003 Revision A, "Master Validation Plan
for Routine Chemistry Assays on Theranos director's time spent physically in the
Devices", when the surveyor requested their lab.
procedure for establishing performance
specifications. This improved oversight will ensure
that the new lab director implements
c. VitD, HCG, and SHBG validation reports
the lab's enhanced procedures for
included "Theranos-corrected" results without an
explanation as to how the "Theranos Result" was method verification. Before any
corrected or which result was reported.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 75 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICE:S OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
D6085 (continued)
06085 Continued From page 75 . stud'1es are per1orme
06085 ven'fi1cat10n -C'. d,
d. Accuracy for Vito, TT3, HCG, and SHBG was these improved procedures require the
not determined following CL PLN-14003. lab director's review and approval of a
detailed method verification plan
e. Precision for VitD, TT3, and SHBG was not containing defined acceptance criteria.
determined following CL PLN-14003. The lab director must also review and
approve the verification report before
f. Reportable range data for VitD, TT3, and
SHBG was not determined following CL any patient testing begins. The lab has
PLN-14003. conducted training on those
procedures.
g. Percent(%) Recovery did not meet the
laboratory's accetable criteria for Vito, TT3, and The lab will ensure that the new lab
SHBG.
director also implements enhanced
h. Allowable· Bias did not meet the laboratory's validation procedures, which will
acceptable criteria for Vito, TT3, and SHBG. include review processes and
acceptance criteria similar to the
i. Refer to 06115. improved method verification
06086 493.1445(e)(3)(ii) LABORATORY DIRECTOR 06086 procedures, along with other required
RESPONSIBILITIES procedures. Relevant lab personnel
The laboratory director must ensure that will receive training and competency
verification procedures used are adequate to on those procedures to ensure that
determine the accuracy, precision, and other practice is consistent with them.
pertinent performance characteristics of the
method.
This STANDARD is not met as evidenced by:
1. Based on laboratory personnel interview and
establishment of vitamin 812 performance
specifications record review on September 22,
2015, the laboratory director failed to ensure that
verification procedures used were adequate to
determine pertinent performance characteristics
for the laboratory's vitamin 812 testing methods.
Findings included:
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 76 of 121
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
i. Refer to 06115.
06086 493.1445(e)(3)(ii) LABORATORY DIRECTOR 06086 D6086 #1 2/12/16
RESPONSIBILITIES The lab directors during the period
The laboratory director must ensure that covered by the survey no longer hold
verification procedures used are adequate to any position with the lab. The new
determine the accuracy, precision, and other lab director was hired after the on-site
pertinent performance characteristics of the survey had been completed.
method.
This STANDARD is not met as evidenced by: The lab has completed an assessment
1. Based on laboratory personnel interview and
establishment of vitamin 812 performance to identify any patients affected or
specifications record review on September 22, having the potential to be affected by
2015, the laboratory director failed to ensure that this issue.
verification procedures used were adequate to
determine pertinent performance characteristics
for the laboratory's vitamin 812 testing methods.
Findings included:
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation· sheet Page 76 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
AF?'\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@j} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE OATE
TAG TAG
DEFICIENCY)
D6086 #1 (continued)
06086 Continued From page 76 06086
The lab will ensure that the new lab
establishment of performance specifications
document indicated that the laboratory obtained
director effectively implements and
an allowable bias greater than the laboratory's monitors lab procedures, including
criteria for acceptability. When asked to explain verification and validation procedures,
this discrepant result, upon close examination, through oversight during monthly QA
laboratory personnel indicated that there was an meetings, through audits performed
error in the written information provided and pursuant to the lab's new audit
reviewed. The laboratory was able to provided
corrected data and appropriate supporting procedures, and through use of a new
documents. on-site visit log that records the lab
director's time spent physically in the
b. In spite of the erroneous information included lab.
in the vitamin 812 establishment of performance
specifications document provided during this
This improved oversight will ensure
survey for review on September 22, 2015,
laboratory records indicated that eleven people that the new lab director implements
from the laboratory's staff approved this the lab's enhanced procedures for
document between August 5, 2014 and method verification. Before any
September 19, 2015 without recognizing the verification studies are performed,
document error. these improved procedures require the
2. Based on laboratory personnel interviews and
lab director's review and approval of a
establishment of performance specifications detailed method verification plan
policies and procedures record review on containing defined acceptance criteria.
September 22, 2015, the laboratory director failed The lab director must also review and
to ensure that verification procedures used are approve the verification report before
adequate to determine the accuracy, precision, any patient testing begins. The lab has
and other pertinent performance characteristics
of the laboratory's b4 testing methods. conducted training on those
Findings included: procedures.
a. It was the practice of the laboratory to use the The lab will ensure that the new lab
b4 to perform and report patient director also implements enhanced
routine chemistry serum testing. Examples of validation procedures, which will
analytes the laboratory tested using the b 4
b 4 included ALT, BUN, calcium, glucose, and
include review processes and
sodium. acceptance criteria similar to the
improved method verification
b. According to the laboratory's protocol titled
FORM CMS-2667(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation 'sheet Page 77 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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{fa:\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\]% AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
l.:JV NOil.VW1IOtlNI d:0 WOO'ilffild: 'iIH.L 1I'iIONfl ffilflSO'l:JSIO WOU l.clli'l'iIX'iI NOil.vw.1IOtlNI 'IVI:J'fil!WWO:J 'IVIl.N'iiaitlNO:J
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
D6086 #2 (continued)
06086 Continued From page 77 06086
director effectively implements and
"Master Validation Plan for Routine Chemistry
Assays on Theranos Devices," "for establishing
monitors lab procedures, including
the trueness or comparability of two procedures .. verification and validation procedures,
.at least 50% of samples should be outside the through oversight during monthly QA
reference interval." meetings, through audits performed
pursuant to the lab's new audit
c. A review of the test results used by the procedures, and through use of a new
laboratory to establish "the trueness or
comparability of two procedures" for ALT, BUN, on-site visit log that records the lab
calcium, glucose, and sodium testing using the director's time spent physically in the
b4 showed that the laboratory did not lab.
follow its established protocol and use "at least
50% of samples ... outside the reference interval." This improved oversight will ensure
that the new lab director implements
i. For a validation document dated April 2,
2015, ALT test results used to establish "the the lab's enhanced procedures for
trueness or comparability of two procedures" for method verification. Before any
tests performed using the b4 6 of 110 verification studies are performed,
ALT test results used were outside the these improved procedures require the
laboratory's reference interval. lab director's review and approval of a
ii. For a validation document dated April 21,
detailed method verification plan
2015, BUN test results used to establish "the containing defined acceptance criteria.
trueness or comparability of two procedures" for The lab director must also review and
tests performed using the b4 , 1 of 109 approve the verification report before
BUN test result used was outside the laboratory's any patient testing begins. The lab has
reference interval. conducted training on those
iii. For a validation document dated April 21,
procedures.
2015, calcium test results used to establish "the
trueness or comparability of two procedures" for The lab will ensure that the new lab
tests performed using the b4 1 of 110 director also implements enhanced
calcium test result used was outside the validation procedures, which will
laboratory's reference interval. nclude review processes and
iv. For a validation document dated April 21, acceptance criteria similar to the
2015, glucose test results used to establish "the improved method verification
trueness or comparability of two procedures" for
tests performed using the b4 6 of 11 O
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation 'sheet Page 78 of 121
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f%f: STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\{@@ PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVEACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG .CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
D6086 #3 (continued)
06086 Continued From page 79 06086
that the new lab director implements
ii. For BUN, based on a laboratory document
the lab's enhanced procedures for
dated April 21, 2015, the laboratory determined method verification. Before any
BUN b4 CV's between 2.1-2.7. The verification studies are performed,
manufacturer's established BUN CVs were these improved procedures require the
between 1.7 - 2.4. lab director's review and approval of a
detailed method verification plan
iii. For calcium, based on a laboratory document
dated April 21, 2015, the laboratory determined containing defined acceptance criteria.
calcium b4 CV's between 2.0 - 3.6. The The lab director must also review and
manufacturer's established calcium CV's were approve the verification report before
between 0.8 - 2.1. any patient testing begins. The lab has
conducted training on those
iv. For glucose, based on a laboratory document
procedures.
dated April 21, 2015, the laboratory determined
glucose b4 CV's between 1.5 - 2.2. The
manufacturer;s established glucose CV's were The lab will ensure that the new lab
between 0.7 - 0.9. director also implements enhanced
validation procedures, which will
v. For sodium, based on a laboratory document include review processes and
dated April 1, 2015, the laboratory determined
sodium CVs between 1.2 - 1.3. The
acceptance criteria similar to the
b4
manufacturer's established sodium CV's were improved method verification
between 0.6 - 1.1. procedures, along with the other
required procedures. Relevant lab
c. The laboratory provided no written personnel will receive training and
explanation/investigation as to why the laboratory competency on those procedures to
obtained CV's for ALT, BUN, calcium, glucose,
and sodium using the b4 that were
ensure that practice is consistent with
greater than the CV's established by the them.
manufacturer. Laboratory records Indicated that
these laboratory documents were approved by
the laboratory director on September 19, 2015.
D6086 #4 2/12/16
4. Based on laboratory personnel interviews and
establishment of performance specifications The lab directors during the period
record review on November 17, 2015, the covered by the survey no longer hold
laboratory director failed to ensure that ALT, BUN, any position with the lab. The new
calcium, and glucose verification procedures
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 80 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIERICLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B.WING
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
06068 #4 (continued)
06086 Continued From page 80 06086
lab director was hired after the on-site
used were adequate to determine pertinent
performance characteristics, such as reference
survey had been completed.
range, of the laboratory's b4 testing
methods. Findings included: The lab has completed an assessment
to identify any patients affected or
a. It was the practice of the laboratory to use the having the potential to be affected by
b4 to perform and report patient
this issue.
routine chemistry serum testing. Examples of
analytes the laboratory tested using the b 4
b 4 included ALT, BUN, calcium, and glucose. The lab will ensure that the new lab
director effectively implements and
b. A review of laboratory documents monitors lab procedures, including
establishing performance specifications for ALT, verification and validation procedures,
BUN, calcium, and glucose performed using the
b4
through oversight during monthly QA
indicated that the reference range
determined by the laboratory's testing differed meetings, through audits performed
from the reference range on the laboratory's test pursuant to the lab's new audit
reports. procedures, and through use of a new
on-site visit log that records the lab
i. For ALT, based on a laboratory document director's time spent physically in the
dated April 2, 2015, the laboratory determined the
ALT b4 reference range as O - 52 U/L.
lab.
However, the laboratory's reference range on the
test reports was 8 - 41 U/L. This improved oversight will ensure
that the new lab director implements
ii. For BUN, based on a laboratory document the lab's enhanced procedures for
dated April 21, 2015, the laboratory determined method verification. Before any
the BUN b4 reference range as 5.3 -
22.5 mg/dL. However, the laboratory's reference
verification studies are performed,
range on the test reports was 6 - 24 mg/dL. these improved procedures require the
lab director's review and approval of a
iii. For calcium, based on a laboratory document detailed method verification plan
dated April 21, 2015, the laboratory determined containing defined acceptance criteria.
the calcium b4 reference range as 8.18 -
10.3 mg/dL. However, the laboratory's reference
range on the test reports was 8.3 - 10.6 mg/dL.
\
\.
.L:::>V NOIJ,VYraO.!IN[ .!IO W003ffihl 3H.L 113CIN!l ffiIDSO'I;)SIO WOTuI .LdW3X3 NOI.LVYraOdNI '1VI:::>1J:3WWO;) '1VILN3aiilNO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
D6068 #4 (continued)
06086 Continued From page 81 06086
The lab director must also review and
the glucose b4 reference range as 64. O -
112.3 mg/dl. However, the laboratory's
approve the verification report before
reference range on the test reports was 73 - 99 any patient testing begins. The lab has
mg/dL. conducted training on those
procedures.
c. The laboratory provided no written
explanation/investigation as to why the laboratory Any update to a reference range is
obtained reference ranges for ALT, BUN, calcium,
and glucose were different than than the reviewed and approved by the lab
reference ranges indicated on the test reports .. director or a clinical consultant, and
Laboratory records indicated that these laboratory the lab has procedures to ensure that
documents were approved by the laboratory data on patient reports are consistent
director on September 19, 2015. with established reference ranges. In
addition, the lab will ensure that the
5. Based on laboratory personnel interviews and
complete blood counts (CBC) verification of new lab director also implements
method specifications record review on enhanced validation procedures,
November 19, 2015, the -laboratory director failed which will include review processes
to ensure that verification procedures used were and acceptance criteria similar to the
adequate to determine the accuracy, precision, improved method verification
and other pertinent performance characteristics
procedures, along with the other
for the two Siemens Advia 2120i instruments.
Findings included: required procedures. Relev~t lab
personnel will receive training and
a. It was the practice of the laboratory to test competency on those procedures to
patient venous CBC specimens using two ensure that practice is consistent with
Siemens Advia 2120i instruments, designated as them.
#1 and #2.
.L:::>V NOI.LYmO!I.NI .!IO woaa:ffiTII HHL 1IHCINO. ffiIDSO~:::>sm W01Ill .LdWHXH NOI.LVli'llliOtlNI 'IVI:::>1J:HWW0;) 'IVI.LNHaIIINO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
)
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
b. Although the laboratory maintained The lab will ensure that the new lab
verification of test performance specifications director effectively implements and
documents for the two Advia 2120i instruments, monitors lab procedures, including
the laboratory maintained no documentation to verification procedures, through
indicate that verification results for the two oversight during monthly QA
instruments were acceptable to the laboratory, no
evidence that the laboratory director had meetings, through audits performed
reviewed and approved the verification pursuant to the lab's new audit
documents, and no date the verification
documents were reviewed and approved.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuatiori sheet Page 82 of 121
J.:::>V NOIJ.VW1:IO.!lNI .!IO WOOHffiltl ffill 1IHCINfl ffilflSO'DSia WOM J.dli'IIHXH NOIJ.VW1!0.!lNI 'IVI:::>1!8:WWO:::> 'IVI.LNHGitlNO:::>
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 83 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tfVi\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA {X2) MULTIPLE CONSTRUCTION {X3) DATE SURVEY
\@} AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION {X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 83 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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CONFIDENTIAL COMl'vIBRCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
cnt
\(fa)
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION
A BUILDING _ _ _ _ _ _ __
(X3) DATE SURVEY
COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tf]%, STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\'.jj) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6093 #2 (continued)
06093 Continued From page 84 06093
In addition, the lab paused testing on
deviations (SD) from April 2015 through
September 2015. Findings include:
the Siemens BCS XP, including
PT/INR, during the survey. The lab
a. CL SOP-10001 Revision A, "Measuring has also completed an assessment to
Prothrombin Time-lnnovin (PT on the Siemens identify any patients affected or
BCS XP Instrument" stated on page 6, section having the potential to be affected by
8.6 that if control values are outside of the
this issue.
determined range, the controls, reagents and
instrument performance should be checked and
that identification and correction of the problem The lab will ensure that the new lab
shoud be documented prior to reporting patient director effectively implements and
results. monitors lab procedures, including QC
procedures, through oversight during
b. QC records for Citrol 3 (Lot number 548425)
monthly QA meetings, through audits
were reviewed from 4/1 /15 through 9/23/15.
performed pursuant to the lab's new
c. The general supervisor stated that QC was audit procedures, and through use of a
acceptable if the values were +I- 2 SD from the new on-site visit log that records the
mean. lab director's time spent physically in
the lab.
d. From April 1, 2015 through September 16,
2015, 32 of 69 days showed Citro I 3 QC values
were greater than 2 SD (- 2 SD) below the mean. This improved oversight wi~l ensure
that the new lab director implements
e. On 4/7/15, Citrol 3 was run six times before the lab's enhanced QC procedures,
an acceptable QC value was obtained. which reinforce and detail the required
investigation and corrective action that
f. On 9/7/15, Citrol 3 was run seven times
without obtaining an acceptable QC value.
must occur to address QC issues
before patient tests are performed and
g. On 9/8/15, Citrol 3 was run twelve times clarify which employees are
without obtaining an acceptable QC value. responsible for performing and
documenting these activities. The lab
h. On 25 of 32 days, Citrol 3 was not retrun has conducted training and
when the QC value was greater than - 2 SD.
competency testing on those
i. On 5/15/15, 8/13/15, 8/21 /15 and 9/10/15, procedures to ensure that practice is
Citrol 3 was run twice. All QC results were consistent with them.
unacceptable.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 85 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
6fl\ STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
IQ]) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 86 of 121
.L:)V NOI.LVJi'raO.iNI 110 woamnw: filI.L 1IHCINC1 ffiiflSO'I::)SIG W01Ill .LdW:'.3X1I NOI.LVJi'raO.iNI 'IVI:)'fillli\lli'iJ:0:) 'IVI.LN1ICIIllN0:)
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
LE> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\JU> AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6094 #1 (continued)
06093 Continued From page 85 06093
The lab will ensure that the new lab
j. TheRule Check report revealed that 13 of 13 director effectively implements and
QC values in April 2015, 2 of 17 in May 2015, 7 of monitors these procedures through
7 in June 2015; 13 of 13 in July 2015, 16 of 16 in audits performed pursuant to the lab's
August and 24 of 24 9/1-9/16 2015 showed rule new audit procedures, through
violation messages related to Citro! 3. oversight during monthly QA
meetings, and through use of a new
k. On approximately 9/16/15, the labortory
adjusted the acceptable range for Citro! 3 to on-site visit log that records the lab
match the data. This change was implemented director's time spent physically in the
without any investigation as to the reason for the lab.
shift in control values.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 86 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
ll} STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@b: AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6094 #2 (continued)
06094 Continued From page 86
identify failures in Prothrombin Time/International
oeo 94 hold any position with the lab. The
Normalized Ratio (PT/INR) testing which affected
new lab director was hired after the
the quality of the PT/INR patient results. Findings on-site survey had been completed.
include:
In addition, the lab paused testing on
a. The Dada lnnovin (thromboplastin) reagent the Siemens BCS XP, including
was used past the expiration date. Refer to
PT/INR, during the survey. The lab
05413.
has also completed an assessment to
b. The quality control data from 4/1/2015 identify any patients affected or
through 9/16/15 revealed that patient results having the potential to be affected by
above normal were biased low (i.e., reported this issue.
value was lower than it should have been
reported).
The lab will ensure that the new lab
c. The target INR value for patients on Warfarin director effectively implements and
therapy was 2-3. monitors lab procedures, including QC
procedures, through oversight during
d. 81 patients were reported from 4/1/15 monthly QA meetings, through audits
through 9/21/15. performed pursuant to the lab's new
e. 44 of 81 patients had IN Rs greater than or
audit procedures, and through use of a
equal to 2 reported and of the 44, 16 of the 44 new on-site visit log that records the
had INR greater than or equal to 3 reported. lab director's time spent physically in
the lab.
f. There was no quality assessment (QA) or
other documentation to indicate that the PT/INR
This improved oversight will ensure
failure had been identified and corrected.
that the new lab director implements
06098 493.1445(e)(8) LABORATORY DIRECTOR 06098
RESPONSIBILITIES the lab's enhanced QC procedures,
which reinforce and detail the required
The laboratory director must ensure that reports investigation and corrective action that
of test results include pertinent information must occur to address QC issues
required for interpretation. before patient tests are performed,
This STANDARD is not met as evidenced by:
Based on review of final test reports and
and clarify which employees are
interview with the Senior Vice President, the responsible for performing and
laboratory director failed to ensure that the
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 87 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
j(J:; STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\)$) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
D6094 #2 (continued)
06094 Continued From page 86 06094
documenting these activities. The lab
identify failures in Prothrombin Time/International
Normalized Ratio (PT/INR) testing which affected
has conducted training and
the quality of the PT/INR patient results. Findings competency testing on those
include: procedures to ensure that practice is
consistent with them.
a. The Dada lnnovin (thromboplastin) reagent
was used past the expiration date. Refer to
05413.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 87 of 121
.L8V NOI.LVJi'raOtlN[ ilO WOQH~tl Hill <lHGNfl ffi!O.S0'1:::>Sra WOTuI .LclWHXH NOI.LVJi'raO.iNI 'IVI::rna:wwo:::> 'IVI.LNHOitlNO:)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
tU> STATEMENT OF DEFICIENCIES
\[@) AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CUA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6098 (continued)
06098 Continued From page 87 06098
interpretive note appears only under
interpretive data on the Prothrombin
the heading for patients under therapy.
Time/International Normalized Ratio (PT/INR)
final reports was clear to differentiate between The lab has completed an assessment
Warfarin therapy and non-Warfarin therapy. to identify any patients affected or
Refer to 05805. having the potential to be affected by
06102 493.1445(e)(12) LABORATORY DIRECTOR 06102 this issue.
RESPONSIBILITIES
The new lab director has approved
The laboratory director must ensure that prior to
testing patients' specimens, all personnel have revised reporting procedures that
the appropriate education and experience, require the technical supervisor to
receive the appropriate training for the type and verify that interpretive information is
complexity of the services offered, and have accurate and to obtain approval from
demonstrated that they can perform all testing the lab director or clinical consultant
··.. operations reliably to provide and report accurate
before any updates are implemented.
results.
This STANDARD is not met as evidenced by:
Based on review of training documents and The lab will ensure that the new lab
interview with the QNQC (Quality director effectively implements and
Assurance/Quality Control) Manager, technical monitors these procedures through
supervisor and testing personnel, the laboratory audits performed pursuant to the lab's
failed to document training of testing personnel
on the Theranos Proprietary System (TPS) prior new audit procedures, through
to patient testing and failed to document training oversight during monthly QA
in the vacutainer laboratory of testing personnel meetings, and through use of a new
prior to patient testing. Findings include: on-site visit log that records the lab
director's time spent physically in the
a. Theranos Proprietary System (TSP) lab.
i. The QNQC Manager and technical
supervisor stated that all training documentation (D6102 begins on next page)
was kept in each testing person's employee file.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 88 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICl;S FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
iff\ ' STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@ } AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 88 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
i{'.I} STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
l{J{) AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
B. WING _ _ _ _ _ _ _ __
0502025714 11/20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6102 (continued)
06102 Continued From page 88 06102
audit procedures, through oversight
during monthly QA meetings, and
b. Venipuncture Laboratory
through use of a new on-site visit log
a. The QA/QC Manager and technical that records the lab director's time
supervisor stated that all training documentation spent physically in the lab.
was kept in each testing person's employee file.
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuatiori sheet Page 89 of 121
(
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
.(:}}', STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\@)' AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
f/T\ STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
\faj AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ,
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6108 (continued)
06102 Continued From page 89 06102
having the potential to be affected by
i. The general supervisor stated that TP31 had
this issue (see 06111, 06115).
been running and releasing patient test results.
j.
The general supervisor confirmed that the The new lab director has approved
training documents were missing or incomplete enhanced policies and procedures
for three of three testing personnel on 11/19/15 at governing personnel qualification and
11:40 am. defining, among other things, the
06108 493.1447 LABORATORY TECHNICAL 06108
education and experience
SUPERVISOR
requirements for a technical
The laboratory must have a technical supervisor supervisor (see 06111). The new lab
who meets the qualification requirements of director has also approved enhanced
§493.1449 of this subpart and provides technical procedures related to the
supervision in accordance with §493.1451 of this establishment of performance
subpart.
specifications (see 06115). The lab
( ·,
l,, This CONDITION is not met as evidenced by: has conducted training on these
Based on the number and severity of the procedures to ensure that its practice is
deficiencies cited herein, the Condition: consistent with them (see 06111 and
Laboratories performing high complexity testing; 06115).
technical supervisor was not met. Two of three
technical supervisors failed to meet the training or
experience requirement In one or more
In addition, the lab has improved its
specialties/subspecialties (see 06111 ), and the quality systems and procedures-
technical supervisors failed to ensure the including quality assurance review,
establishment of performance specifications for monitoring, and audits-to prevent
the Theranos Proprietary System (TPS) were recurrence (see 06111 and 06115).
complete and followed the laboratory's procedure
(see 06115).
06111 493.1449 TECHNICAL SUPERVISOR 06111
(D6111 begins on next page)
QUALi Fl CATIONS
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 90 of 121
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
COMPLETED
{!!Ii!> AND PLAN OF CORRECTION IDENTIFICATION NUMBER:
A. BUILDING
D6111 (continued)
06111 Continued From page 90 06111
immunohematology. CMS already
specialties and subspecialties of services except
qualified the lab's other technical
histocompatibility and clinical cytogenetics
services provided the individual functioning as the supervisor for microbiology and
technical supervisor-- diagnostic immunology.
(b)(1) Is a doctor of medicine or doctor of
osteopathy licensed to practice medicine or TS 1 and TS2 are no longer technical
osteopathy in the State in which the laboratory is supervisors for the lab. It is worth
located; and
(b)(2) Is certified in both anatomic and clinical noting, however, that CMS qualified
pathology by the American Board of Pathology or TS 1 as a technical supervisor for
the American Osteopathic Board of Pathology or chemistry and found that she was just
Possesses qualifications that are equivalent to months away from qualifying for
those required for such certification. hematology and immunology. In
(c) If the requirements of paragraph (b) of this
addition, TS2 is still endeavoring to
section are not met and the laboratory performs
tests in the subspecialty of bacteriology, the obtain documents from his former
individual functioning as the technical supervisor employers to show that he has the
must-- requisite experience (see 06111).
(c)(1 )(i) Be a doctor of medicine or doctor of
osteopathy licensed to practice medicine or The lab has completed an assessment
osteopathy in the State in which the laboratory is
to identify any patients affected or
located; and
(c)(1)(ii) Be certified in clinical pathology by the having the potential to be a(fected by
American Board of Pathology or the American this issue (see 06111, 06115).
Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required The new lab director has approved
for such certification;· or enhanced policies and procedures
(c)(2)(i) Be a doctor of medicine, doctor of
governing personnel qualification and
osteopathy, or doctor of podiatric medicine
licensed to practice medicine, osteopathy, or defining, among other things, the
podiatry in the State in which the laboratory is education and experience
located; and requirements for a technical
(c)(2)(ii) Have at least one year of laboratory supervisor (see 06111). The new lab
training or experience, or both, in high complexity director has also approved enhanced
testing within the specialty of microbiology with a
procedures related to the
minimum of 6 months experience in high
complexity testing within the subspecialty of
bacteriology; or
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 91 of 121
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STATEMENT OF DEFICIENCIES {X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
{X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX {EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 .
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
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NEWARK, CA 94560
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7333 GATEWAY BLVD
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NEWARK, CA 94560
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AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11 /20/2015 ·
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX {EACH CORRECTJVEACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
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FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 102 of 121
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED'TO THE APPROPRIATE DATE
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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TAG TAG
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
cn.J. STATEMENT OF DEFICIENCIES
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11/20/2015
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7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)10 SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICE:S OMB NO 0938-0391
&Et. STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
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FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 109 of 121
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Precision
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
{X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
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Reportable Range
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
(X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
DEFICIENCY)
Reference Range
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 112 of 121
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
(X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
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PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
dO> STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
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0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6168: 2/12/16
06168 493.1487 TESTING PERSONNEL 06168
The lab has corrected this issue by
The laboratory has a sufficient number of ensuring that all of its testing
individuals who meet the qualification personnel who perform high
requirements of complexity testing are qualified, with
§493.1489 of this subpart to perform the functions strict adherence to the regulatory
specified in §493.1495 of this subpart for the
volume and complexity of testing performed.
requirements (see D6170, D6171).
This CONDITION is not met as evidenced by: The lab has completed an assessment
Based on the number and severity of the to identify any patients affected or
deficiencies cited herein, the Condition: having the potential to be affected by
Laboratories performing high complexity testing; this issue (see D6170, D6171).
testing personnel was not met. The laboratory
failed to have qualified testing personnel
performing high complexity testing. Refer to The new lab director has approved
06170 and 06171. enhanced policies and procedures
06170 493.1489(a) TESTING PERSONNEL 06170 governing personnel qualification and
QUALIFICATIONS defining, among other things, the
responsibilities of licensed and
Each individual performing high complexity
testing must possess a current license issued by
unlicensed personnel, respectively.
the State in which the laboratory is located, if The lab has conducted training on
such licensing is required. these procedures to ensure that its
This STANDARD is not met as evidenced by: practice is consistent with them (see
Based on laboratory personnel interviews and 06170 and 06171).
WBC differential record review on November 17,
2015, each individual performing high complexity
WBC differential testing failed to possess a In addition, the lab has improved its
current license issued by the State of California. quality systems and procedures-
Findings included: including quality assurance review,
monitoring, and audits-to prevent
a. For patient capillary specimens, it was the recurrence (see 06170 and 06171).
practice of the laboratory to use flow cytometry
instrumentation to perform and report patient
WBC differentials.
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) TAG CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY}
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
er>
\J{f
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
(X2) MULTIPLE CONSTRUCTION (X3} DATE SURVEY
COMPLETED
A. BUILDING _ _ _ _ _ _ __
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4} ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION} CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY}
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: W34211 Facility ID: CA22046272 If continuation sheet Page 117 of 121
(
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF JNFORMATION ACT
PRINTEP: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X6)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 117 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
TAG REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 118 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 119 of 121
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CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CUA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOS INC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Facility ID: CA22046272 If continuation sheet Page 120 of 121
CONFIDENTIAL COMMERCIAL INFORMATION EXEMPT FROM DISCLOSURE UNDER THE FREEDOM OF INFORMATION ACT
PRINTED: 01/25/2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: A. BUILDING _ _ _ _ _ _ __ COMPLETED
0502025714 B. WING _ _ _ _ _ _ _ __
11/20/2015
NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
7333 GATEWAY BLVD
THERANOSINC
NEWARK, CA 94560
(X4)1D SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (XS)
PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
D6178 (continued)
06178 Continued From page 120 06178 the new lab director and newly
Findings included: appointed quality director, is
esponsible for ensuring that practice
a. It was the practice of the laboratory to use the
stated values of commercially assayed quality is consistent with these procedures. In
control materials to monitor patient CBC testing addition, the lab will monitor the
using the Drew 3 instrument. In the event any implementation of these procedures
CBC quality control material test results did not through audits performed pursuant to
fall within the stated assay values, laboratory .he lab's new audit procedures.
personnel were to follow the procedure detailed in
the protocol titled "Quality Control (document
number CL QOP-00013, revision F)."
FORM CMS-2567(02-99) Previous Versions Obsolete Event ID:W34211 Faclllty ID: CA22046272 If continuation sheet Page 121 of 121
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