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Laboratory Medicine Quality Indicators A Review of The Literature
Laboratory Medicine Quality Indicators A Review of The Literature
Key Words: Laboratory medicine; Quality indicator; Quality measure; Laboratory test utilization; Laboratory service delivery;
Health outcome
DOI: 10.1309/AJCPJF8JI4ZLDQUE
Upon completion of this activity you will be able to: The ASCP is accredited by the Accreditation Council for Continuing
• identify and apply standard evaluation criteria for health-related Medical Education to provide continuing medical education for physicians.
quality indicators/performance measures. The ASCP designates this educational activity for a maximum of 1 AMA PRA
• describe how current laboratory medicine quality indicators/measures Category 1 Credit ™ per article. This activity qualifies as an American Board
meet these criteria and what the main gaps in our knowledge are. of Pathology Maintenance of Certification Part II Self-Assessment Module.
The authors of this article and the planning committee members and staff
have no relevant financial relationships with commercial interests to disclose.
Questions appear on p 443. Exam is located at www.ascp.org/ajcpcme.
zTable 1z
Laboratory Medicine Quality Indicators by Stage of the Total Testing Process
Test ordering
Test order appropriateness† Effectiveness, efficiency, timeliness
Patient identification/specimen collection
Inpatient wristband identification error Safety
Patient satisfaction with phlebotomy Patient-centeredness
Specimen identification, preparation, and transport
Specimen inadequacy/rejection Effectiveness, efficiency, safety, timeliness
Blood culture contamination Efficiency, safety
Specimen container information error Efficiency, safety
Analysis
Proficiency testing performance Safety
Gynecologic cytology-biopsy discrepancy Effectiveness, efficiency, safety
with laboratory testing or services and (2) having the potential were associated with patient-centeredness, and none of these
to be related to at least 1 IOM health care domain.7 Indicators indicators were associated with equity. Based on the relatively
meeting the inclusion criteria were then categorized accord- small number of indicators and their lack of widespread use
ing to the following 6 stages of the total laboratory testing in practice, the stages of the total testing process and IOM
process1: (1) test ordering; (2) patient identification and domains do not seem to be well covered.
specimen collection; (3) specimen identification, preparation, The AHRQ NQMC categorizes measures into the follow-
and transport; (4) analysis; (5) result reporting; and (6) result ing 7 primary domains: access, outcome (health state), patient
interpretation and ensuing action. experience, process, structure, use of service, and population
health.17 All of the laboratory medicine quality indicators
identified except one (patient satisfaction with phlebotomy)
are process measures, compared with about half of the NQMC
Laboratory Quality Indicators
measures. (The NQMC health care measure domains relate
The 14 laboratory quality indicators identified are grouped to the following descriptions: [1] process: health care service
according to the stage of the total laboratory testing process. provided to or on behalf of a patient appropriately based on
The indicators are listed in zTable 1z, along with the related scientific evidence of efficacy or effectiveness; [2] outcome:
IOM domains. health state of a patient resulting from health care; [3] access:
The indicators identified span the stages of the total patient’s or enrollee’s attainment of timely and appropriate
laboratory testing process; however, they do not provide health care; [4] patient experience: patient’s or enrollee’s
comprehensive coverage. The stages with the least coverage report concerning observations of and participation in health
based on the number and nature of the identified indicators care; [5] structure of care: feature of a health care organiza-
are result interpretation and ensuing action, analysis, and tion or clinician relevant to its capacity to provide health care;
patient identification and specimen collection. However, the [6] use of service: provision of a service to, on behalf of, or
general lack of reported use of all of the identified indicators by a group of persons defined by nonclinical characteristics
may result in insufficient monitoring of all stages of the total without determination of the appropriateness of the service;
testing process. and [7] population health: state of health of a group of persons
The indicators identified address multiple IOM health defined by nonclinical characteristics.) With the exception
care domains, with safety, timeliness, effectiveness, and of test order appropriateness, none of the quality indicators
efficiency being the most frequent. Relatively few indicators identified in this review is listed in any form in the AHRQ
zTable 2z
Selected Quality Measures and Guidelines for Recommended Laboratory Tests by Disease and Condition in the Agency
for Healthcare Research and Quality National Quality Measures and Guideline Clearinghouses
Disease/Condition Sources
NQMC and, based on the results of this review, the indicators on laboratory test orders, the denominators for most of the
do not seem to satisfy their inclusion criteria.17 In particular, measures in Table 2 are population-based, and they target not
one NQMC criterion for process measures requires that a cur- only improving health care quality but also public health. (2)
rent review of the evidence supports that the measured clinical Percentage of laboratory test orders duplicated within defined
process has led to improved health outcomes. Other potential intervals.20-22
US sources of quality indicators and guidelines for clinical There is no standard definition for what constitutes an
laboratories (eg, regulatory, standard-setting, and accrediting inappropriate, incorrect, or duplicative test order.
organizations) were not included in the AHRQ NQMC and Rationale.—(1) Assess appropriateness of laboratory tests
NGC clearinghouses. ordered for screening, management, diagnosis, and monitor-
Summarized information for each of the 14 reviewed lab- ing of various diseases or clinical conditions consistent with
oratory medicine quality indicators is provided in the follow- guidelines. (2) Reduce wasteful and unnecessary testing.
ing format: definition, rationale (brief statement describing Quality Gap.—Many laboratory test orders are not
supporting health-related reasons), quality gap (AHRQ health supported by guidelines18,19 or are unnecessary duplicate
importance and potential for improving health), and evidence tests.20-22 These test orders add unnecessary costs and poten-
base (AHRQ scientific soundness—clinical logic criteria tially contribute to delayed, inappropriate, and potentially
associated with quality of care outcomes and interventions). harmful clinical decisions. On the other hand, evidence-based
laboratory testing may be underutilized. Evaluating underuti-
Test Ordering lization requires population-based measures. For many guide-
lines specifying appropriate use of laboratory tests, including
Test Order Appropriateness those in the AHRQ NGC, there are no quality indicators, and
Definition.—Two types of quality indicators were identi- there is a notable lack of guidelines and indicators related to
fied. The first measures test order appropriateness, and the anatomic pathology.23
second measures inappropriateness: (1) Percentage of labora- Evidence Base.—Principal sources of guidelines relating
tory test orders that meet specific testing guidelines18,19: A to utilization of laboratory tests are various health care, medi-
list of quality measures has been compiled by the AHRQ in cal, and condition-specific organizations, many of which are
its NQMC database; many involve laboratory tests recom- listed in the AHRQ NQMC and NGC databases and identified
mended for specific diseases and conditions (see zTable 2z in Table 2.8 Although a few studies have shown a significant
for a selected list).8 Unlike this measure, which is based decrease in hospital length of stay (LOS) associated with
greater test order appropriateness,24,25 most studies did not Patient Satisfaction With Phlebotomy
indicate an effect on outcomes.18,19,26-29 Underuse of recom- Definition.—This indicator is the percentage of patients
mended laboratory tests has been shown to have a negative satisfied with phlebotomy services. There is no standard
impact in relation to specific conditions.30-33 Promotion of definition of patient satisfaction with phlebotomy that has
guidelines18,34,35 and provision of education,18,36,37 periodic been assessed using questionnaires in several hospital-based
feedback,18,35,37-40 reminders,21,41 and electronic decision- outpatient55,56 and inpatient57 studies.
support systems42,43 to clinicians and changes in laboratory Rationale.—Specimen collection is one of the few areas
requisition forms34 and in funding policy34 may decrease the of laboratory medicine that involves direct patient contact.
number of inappropriately ordered laboratory tests, result- As a result, phlebotomy services provide one opportunity to
ing in cost savings. Linking clinicians to electronic medical measure patients’ perceptions of their experience with labora-
records may decrease errors of omission and improve adher- tory services.
ence to practice guidelines.44 Quality Gap.—When asked if they were satisfied with
Blood Culture Contamination between 0.01% and 0.03% for chemistry and hematology
Definition.—This indicator is defined as the percentage specimens50,55,60,61 and between 0.4% and 2% for surgical
of positive blood cultures identified as contaminated.62 The pathology specimens.71,73
term contaminated has not been uniformly defined. Evidence Base.—Inaccurate or inadequate specimen infor-
Rationale.—Laboratory evaluation and clinical interven- mation may impact clinical processes and/or outcomes50,61;
tion associated with blood culture contamination consume however, no direct evidence was found relating this indicator
substantial health care resources.63-70 Clinicians rely on blood to any outcome. Aside from whether personnel were from the
culture results to diagnose and monitor febrile patients. When laboratory or elsewhere,60,61 no interventions were identified
acting on a potentially contaminated blood culture, clinicians that improved performance using this indicator.
must choose to ignore a result that could be potentially life-
threatening or take a conservative approach of fighting an Analysis
infection that might not exist.
microbiology failure rates decreased for positive and negative demonstrating that any intervention to reduce gynecologic
cultures between 1994 and 2004. Similar downward trends cytology-histology discrepancy rates is effective or that this
for PT failure (defined as unsatisfactory PT performance [<4 indicator is associated with any actual outcomes.
of 5 PT samples with an acceptable result in a testing event
as determined by CLIA criteria74] on 2 consecutive or 2 of 3 Result Reporting
testing events) rates were also observed using the 1999-2003
Centers for Medicare & Medicaid Services data for COLA- Inpatient Laboratory Result Availability
inspected laboratories (failure rate decreasing from 13% to Definition.—This indicator is the percentage of test
11%) and for state-inspected laboratories (from 9% to 8%).80 results available for morning rounds as stipulated in the insti-
There is no published evidence for the effectiveness of any tution policy.89 There are no standard definitions for what
intervention to improve PT performance. In one study of constitutes compliance because this indicator is institution-
PT, despite consistent feedback on PT errors, there was no specific.89,90
Result Interpretation and Ensuing Action and usefulness of most of these indicators, particularly those
typically used for internal QI because laboratories do not gen-
Follow-up of Abnormal Cervical Cytologic Results erally publish their internal monitoring data.
Definition.—This indicator is the percentage of abnormal For the laboratory indicators reviewed, standardized
cervical cytologic (Pap smear) results that were not followed terminology, measurement specifications, data collection
up within 6 months.128 Follow-up procedures, however, have methods and evidence establishing quality gaps, and relation-
not been uniformly defined. ships to process, clinical, health, and economic outcomes are
Rationale.—For Pap smear screening to be effective in needed. The relevance of the identified quality indicators to
preventing cervical cancer, appropriate and timely clinical various health system stakeholders and their use to positively
follow-up for patients with abnormal findings is needed.128 impact the health care system were typically not addressed in
Quality Gap.—A survey of more than 300 hospital the information that was available, indicating their selection
laboratories reported follow-up information for approxi- was not made on the basis of evidence-based evaluation but
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