Background: Occumedica Health Care System Corp

1045 ME Governor’s Drive Oregano St. Brgy.
Maduya, Carmona, Cavite

Tel.No.: 0977-854-7577, (046)430-3456 (Cavite line)
(049)527-4556 (Laguna line), (02)330-4173 (Manila line)
Email add.: occumedica.clinic@yahoo.com
This manual contains the Standard Operating Procedures of
OCCUMEDICA HEALTH CARE SYSTEM CORP.
These Procedures are designed to ensure the accuracy of the test as well as to
preserve the integrity of the laboratory.
Background
OCCUMEDICA HEALTH CARE SYSTEM CORP.
was established on January 12, 2009. The clinic is located at
1045 ME Governor Drive, Brgy. Maduya, Carmona, Cavite
We are an institution based screening drug-testing laboratory.
We see to it that we are functioning in accordance to the RA9165 or the

Comprehensive Dangerous Drug act of 2002.
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1045 ME Governor’s Drive Oregano St. Brgy.Maduya, Carmona, Cavite
ADMINISTRATIVE
POLICIES
AND
PROCEDURES
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MISSION
Occumedica Health Care System Corp. is committed

to its patients and companies in providing the most
accurate and reliable Drug Test result through the use
of highest quality yet cost- efficient methods approved
by the Department of Health and professionals with
proper training, Honesty and Integrity to perform the
test.
Our Mission is to help our clients ensure safe work

place and to offer exceptional and professional
costumer service, we measure ourselves not against our
competitors but by our client’s satisfaction.
VISION
To continually enhance the level of client

satisfaction.
To be recognized as a great place to work and grow

professionally.
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OBJECTIVES
Support the fight against drug-addiction and the

many crimes and accidents involving the abuse of illegal
drugs by providing quality service.
To up hold the standards set by the Department of

Health through the Bureau of Health Facilities &
Services and the National Reference Laboratory.
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POLICIES FOR HIRING, ORIENTATION AND

PROMOTION FOR ALL LEVELS OF PERSONNEL
HIRING AND EMPLOYMENT
Section 1: Eligibility Requirements

A. Head of the Laboratory
 A licensed physician certified in Clinical Pathology by the

Philippine Board of Pathology; or
 A licensed physician trained in laboratory management and drug

testing operation
B. Analyst
 Must be a registered Chemist; or
 Chemical Engineer; or
 Medical Technologist
 Pharmacist
C. Authorized Specimen Collector
 Must be at least high school graduate
 Must have undergone appropriate training
As a matter of policy, the clinic will not allow the hiring of immediate
relatives. In principle, these would refer to parents, spouse, brothers, sisters
and children.
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Section 2: Duties and Responsibilities of Personnel

A. Head of the Laboratory:
 Supervise the facilities and all aspects of Laboratory work;
 Supervise all the Laboratory Personnel;
 Implements the Standard Operation Manual that governs the

Operation of the Screening Drug Testing Laboratory;
 Supervise and directs all analytical procedures of the Laboratory;
 Assures Quality of all Laboratory Test Results;
 Issues, signs out and interpret Laboratory Test Results;
 Evaluate and recommends reagents, supplies and equipment;
 Reviews the CCF and reports received from Authorized collectors;
 Interviews Client/Donor/Subject for alternative medical

explanations, if necessary;
 Reviews pertinent medical records of Client/Donor/Subject if

necessary;
 Cancels the results of all specimen which are not collected;
 Review rejects and refers for retesting, reconfirmation all

specimen and test results that are Positive, Adulterated,
Substituted or Invalid;
 Implements remedial actions necessary to maintain satisfactory

operation and performance in the laboratory;
 Directs protocol for preventive maintenance of equipment
 Provides comprehensive, continuing training and education of

personnel related to conduct of drug testing laboratory.
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B. Analyst :
 Verifies completeness of CCF;
 Prepares specimen for analyses;
 Examines, processes and analyzes specimen for drug testing;
 Interprets, records, releases and sign out laboratory reports;
 Assist in the implementation of quality assurance program;
 Assists in the evaluation of reagents, supplies and equipment;
 Perform specimen validation test;
 Institute corrective measures to prevent cancelation of test;
 Laboratory documentation and reports;
 Refers to the Head of Laboratory as the need arises.
C. Authorized Specimen Collector:
 Restricts unauthorized personnel to enter the collection site

during collection;
 Verifies the identity of Client/Donor/Subject;
 Provides security to specimen supplies, records and

documents at collection site;
 Informs the Client/Donor/Subject the procedures of specimen

collection;
 Performs only one specimen collection at a time;
 Accepts and seals the specimen container in the presence of

Client/Donor/Subject;
 Accomplishes CCF correctly.
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Section 3: Employment Status

a. Probationary Employees – A person who is hired by the clinic for
the purpose of occupying a regular position. Before a
probationary employee can become a regular employee, the
employee is required to undergo a probationary employment
period of a maximum of six (6) months and after meeting the
conditions of Section 3, the status may be elevated to that of a
regular employee.
b. Regular Employees – An employee who, after passing the

probationary period of a maximum of (6) months and meeting the
conditions of Section 3 is elevated to regular status and placed in
the regular payroll of the company and enjoys the benefits and
services extended to the employees subject to guidelines covering
the availment of such benefits and service.
c. Contractual Employee – A person whose employment has been

fixed to a specific project or undertaking the completion or
termination of which has been determined at the time of
employment of the employee.
Section 4: Regularization
A probationary employee will be elevated to regular status if he/she
meets the following:
a. Employee passes the performance evaluation to be conducted by

the chief/head of the department during the probationary
employment. This evaluation shall cover the attendance and
adherence to the rules and regulations.
b. That the employee passes the physical and health requirements of

the clinic.
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Section 5: Personal Data

Employees are required to submit the following documents upon
joining the company:
 Resume with job description and 1 x 1 size picture
 Passport size picture with background
 Transcript of records and diploma
 PRC ID and Certification
 Certificate of training and seminar (if any)
 Previous employer’s certificate/clearance
 Barangay certificate
 Police clearance
 SSS E1 or ID
 Philhealth ID/No.
 TIN No./ID
Section 6: Promotion
A promotion is defined as an advancement of an employee from one position
to another usually accompanied by an increase in duties and responsibilities
as authorized by law and accompanied by an increase in salary.
The following guidelines are followed in the promotion selection process:
 Promotions are based upon merit;
 Evaluations are job-related and will be done annually;
 Management retains the right to select or not select candidates from any
source it determines is appropriate.
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ORIENTATION GUIDELINES AND CHECKLIST

The following checklist has been designed for use with new staff
members. It is the responsibility of the supervisor to ensure the induction can
take place including arranging the necessary resources and organizing
meetings. It is the responsibility to the new staff member to complete the
checklist. The supervisor will be available to support the new employee to
complete the checklist and answer any questions.
Employee’s Name:___________________________________________________ Start Date: ___________
Position: _______________________________________________________
First day- to be completed with employee
 Clinic policy Overview

 Introduce to the staff
 Tour of premises
 Instruction on entry and exit, including lights
 Use of equipment (photocopier/scanner)
 Use of communications (phone, email, fax, and computer file system)
Employee has received an Induction Pack that includes:
 Employment Contract
 Job /Position Description
First week
 Informed of three (3) month probationary period

 Performance and development review process explained
 Attendance, leave and holidays explained (work hours, etc.)
 Benefits explained
 Pay periods explained
 Clarify position role and responsibilities
 Orient on laboratories procedure or laboratory flow
 Releasing of results
Conducted By: Conformed:
__________________________________ _________________________________
Clinic Supervisor Signature of Employee
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POLICY PROGRAM FOR CONTINUING PROGRAM ON

STAFF DEVELOPMENT AND TRAINING
 The clinic provides a comprehensive, continuing training and

education of personnel related to conduct of drug testing
laboratory.
 Assistance will be given to the staff who will attend

seminars/convention for the promotion and implementation of
quality assurance program of a drug testing laboratory.
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POLICIES FOR DISCIPLINE, SUSPENSION,

DEMOTION AND TERMINATION OF PERSONNEL AT
ALL LEVELS; OFFENSES AND ITS CORRESPONDING
DISCIPLINARY ACTION
TIMECARD
 Any employee who does not find his timecard on the rack should
immediately notify the timekeeper or in his absence, the HRD staff.
 Punching the timecard of another employee or having one’s timecard

punched by another employee or falsifying entry in is penalized as
follows:
1st offense = 3 days suspension
2nd offense = 7 days suspension
3rd offense = Termination
 At the end of each payroll period, all employees should certify to the
accuracy of all entries on their timecards by signing their names on the
space provided at the bottom part of the timecard
 Disfigurement or mutilation of timecard
1st offense = Written warning and 3 days suspension
3rd offense = 7 days suspension
4th offense = 15 days suspension
5th offense = Termination
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TARDINESS
 All employees are expected to report for work on time. Therefore,

tardiness would mean as coming to work past the required time which
the work should start. For purposes of discipline, the company
considers tardiness as an offense if it is committed six (6) times or more
at any given month.
1st offense = Written warning and 3 days suspension
ABSENCES
 The employee is considered absent when he fails to report for work

during his regular working day, or reports one (1) hour beyond his
regular schedule and not allowed to work.
 If because of illness, accident for any reason an employee cannot report

for work, he or his representative must promptly notify the HRD office
as soon as possible within 24 hours so that arrangements, if necessary,
can be made for a temporary replacement. At any rate, the employee or
his representative should file a duly authorized leave form on or before
the scheduled absent to HRD office.
 Unauthorized absences or absence from work without official leave

(AWOL) or without notice, or even if with notice if in the opinion of the
company, the cause for absence is not justified, the penalties are as
follows:
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 AWOL for one (1) day:
1st offense = Verbal warning
2nd offense = Written warning
 AWOL for 2-5 consecutive days:
 AWOL for 6-10 consecutive days:
 AWOL for more than 10 consecutive days
1st offense = Termination
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WORKING HOURS
 The company conforms to labor rulings that no employee shall be

required to work regularly more than eight (8) hours a day, unless
otherwise authorized.
 No employee shall render overtime work and shall not be paid if the
employee is absent the day before the specified overtime and no
employee shall work on regular Sundays and Holidays unless prior to
such overtime work, approval thereto is given by the employee’s
department head. A copy of this overtime request must be furnished to
the HRD office.
 Leaving the clinic premises during working time or clinic hours without
excuse slip duly approved by the supervisor and that of the HRD office:
1st offense = Written warning
PERSONAL PHONE CALLS
 Telephones are strictly limited for business calls. In case of emergencies,

you will receive telephone messages from our receptionist or you can
ask special permission from your supervisor to make urgent outgoing
telephone calls for a fee.
IDENTIFICATION CARD (ID)
 Whenever inside the clinic premises, everyone is expected to wear their

respective ID’s. Any loss or stolen ID’s should be reported once to the
clinic administrator. Unreported loss or stolen ID’s or inappropriately
used ID is the sole responsibility of the owner.
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 Failure of any employee to wear or misuse her or others ID while inside

the premises shall be penalized as follows:
OFFENSES AGAINST PERSON

 INSUBORDINATION OR REFUSAL TO OBEY A COMPANY/CLINIC
ORDER OR WORK ASSIGNMENT
 Any reasonable and justifiable verbal or written order from the

superiors related to work assignment must be promptly obeyed.
Refusal to work on compulsory overtime falls under this rule:
 INTRIGUING AGAINST ANOTHER EMPLOYEE BY ANY MEANS TO

CAST DISHONOR, DISCREDIT OR CONTEMPT, OR PUBLIC HATRED
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PROCEDURES FOR HANDLING OF COMPLAINTS

AND LABORATORY ACCIDENTS
 Any complaints by the clients/patients (written or verbal) should be

given proper attention and be referred to the Clinic Supervisor.
 The Clinic Supervisor evaluates the gravity of the complaints/grievance

made by the clinic staff/personnel.
 Apologize to the client’s base on the complaints made by the clinic staff.
 Based on the evaluation and investigation of the complaints/grievances

made by the clinic staff the Clinic Supervisor must have the equivalent
disciplinary action stated on clinic policy.
 An official meeting will be scheduled to the Medical Director for the

approval or any consideration with regards to the complaints and the
disciplinary action for the said clinic staff.
 All complaints and disciplinary action must be properly documented.
I. For Laboratory Accidents
 Any laboratory accidents such as Specimen rejection, disposal of

specimen not due for disposal and others must be recorded.
 If in case a specimen submitted spills before analysis, a new specimen

from the donor should be collected. This accident must also be
documented.
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II. Handling Complaints And Work Ethics

A. Job Performance:
First offense: Written warning
Second offense: Suspension
Third offense: Dismissal
Criteria:
 Gross inefficiency in the performance of duties.
 Negligence or carelessness in the performance of duties resulting to

loss or damage of the company property.
 Abuse of authority.
B. Decorum and Discipline:
Criteria:
 Discourtesy, rudeness or indifference in dealing with clients, company

officers and staff members.
 Any act of disloyalty in word or deed and/or circulation of malicious

rumors which could discredit or damage the reputation of the company,
its management and staff.
 Trespassing or unauthorized use of company facilities.
 Unauthorized disclosure of confidential information or divulging

company trade secrets.
 Vandalism, willful or malicious destruction or defacement of company

property.
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 Unauthorized entry into restricted areas.
 Insubordination or willful refusal of a subordinate to follow proper

orders from his superior in connection with the official performance of
assigned duties and responsibilities.
 Sleeping during working hours.
 Reporting for work drunk or drinking liquor while on duty.
 Prolonged use of the telephone for unofficial business.
 Acting in a disorderly manner in company premises thereby creating

disturbance as interpreting the normal flow of activities.
 Entertaining guest while on duty for unofficial business.
 Threatening, intimidating or coercing fellow employees in company

premises.
 Making personal gain out of company material on property.
 Commission and/ or conviction of a crime, or commission of a offense

within or outside the company involving damage or turpitudes.
C. Acts of Dishonesty:
Criteria:
 Malversation of company funds.
 Theft of pilferage of property of those belongings to other

personnel.
 Failure to disclosure serious ailment which may endanger the

health of company employee
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QUALITY PLAN
WRITTEN PROGRAM/ PLAN OF MANAGEMENT
TO ASSURE COMPETENCE, INTEGRITY OF DRUG
TESTING
 Drug test kit purchased and used must be with BFAD papers/BFAD
approved.
 Collection area must be free from any materials that can be used for
tampering of specimens. No source of water in the collection site.
 The authorized specimen collector must be very vigilant in observing

the collection process.
 The analyst must run a control daily to assure that the kits used are in
good condition.
 The results being released must be IDTOMIS generated to assure quality

& integrity.
 The head of the laboratory must continue to meet and orient the ACS
and the analyst (at least twice a month) new things regarding the
process of drug testing.
 The screening drug testing laboratory must conduct a proficiency

testing form the NRL’S. All procedure associated with the handling
testing of the proficiency testing sample shall to the greatest extent
possible be carried out in a manner identical to that applied to routine
specimens, unless otherwise specified.
 The laboratory must submit to the NRL the results of the test performed
on the unknown sample within 3 weeks after the receipt of the sample.
Results must be kept confidential.
 Regular updating of the records must be done.
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 Quality control program must be done.
 Regular meeting of the staff must be observed to be able to correct all

possible errors or negligence.
 The chain of custody procedure must be observed all the time.
 Releasing of results should be always confidential to both parties.
 Any error or negligence in the process must be corrected immediately

and must be documented.
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POLICY FOR WASTE MANAGEMENT
I. Identification of Hazardous and Non-Hazardous Waste

1. Hazardous Waste
1.1 Biohazard Samples. Biohazard wastes are solid or

concentration of solid waste which because of its quantity,
concentration, physical, chemical, or infectious characteristics
pose a substantial or potential threat to human health or
environment when improperly treated, stored, transported or
disposed.
1.2 Chemical Waste. Toxic waste must undergo pre-treatment

prior to disposal. Non-chemical hazardous waste can be disposed
of directly into the sink or treated as ordinary domestic waste.
2.Non-hazardous Waste
2.1 Biodegradable waste
2.1.1 Use of sanitary landfill
2.1.2 Composing of biodegradable waste materials
2.1.3 Recycling scheme for factory returnable, feed, fermentable,
fertilizer, fine crafts, and filling materials.
2.1.4 Where a municipal or city collection system is available,

non-hazardous waste can be disposed of with
domestic/municipal/city waste.
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2.2 Biodegradable waste: Recycling of
2.2.1 Papers
2.2.2 Glass
2.2.3 Metals
2.2.4 Plastic
2.2.5 Computer
2.2.6 Cartridges
2.2.7 Others
II. Policies for Proper Waste Segregation and Disposal

Recycling Of Non-Biodegradable Waste Such As:
a) Papers - used papers are collected and sold to a nearby junk shop.
b) Plastics – reuse for other purposes; or sold.
c) Computer Ink Cartridge – COLLECTED AND SOLD.
d) Specimens – flushed in the toilet bowl or sink with sufficient amount of

water.
e) Used Kits – submitted with forms to the department of health for

recording
III. Protocol for Disposal of Used Kits
 The personnel in the laboratory should check the expiration date of the
kits stored.
 Used TEST KITS ARE BEING SUBMITTED TOGETHER WITH FORMS TO

THE Department of Health for documentation.
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POLICY FOR HOUSEKEEPING
 Eating, drinking and smoking should not be permitted in any area

where activities might adversely influence product quality or where
staff may be exposed to potentially harmful agents.
 Keep floors free of oil, grease or/ any other liquid. Clean spilled liquids
immediately because they are slipping hazard.
 Store material or kit in such way that there is no direct sunlight

exposure.
 Always clean the machine after use and maintain the cleanliness of the
working area.
 Use the appropriate cleaning materials or device for a certain machine.
 Expired reagents OR SPECIMEN READY FOR DISPOSAL SHOULD BE

flushed in the sink or toilet bowl with a sufficient amount of water.
 Waste basket must be placed in logical, convenient locations and

observe segregation of waste materials.
 Practice 5S in Housekeeping in the workplace.
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PROGRAM FOR PEST AND VERMIN CONTROL
 Use sticky traps to locate pests and vermin habitats and prioritize areas.
 Put garbage in a container with a tight-fitting lid or in a sealed plastic

bag.
 Seal small holes with ¼ galvanized hardware cloth or copper mesh and
caulk.
 Promptly fix leaky drains or garbage disposal units to prevent entry of

pests and vermin.
 Set up a schedule to regularly clean dumpsters, garbage cans, and other

trash containers thoroughly.
 Do not leave food or crumbs or counters, tables or on the floor

overnight.
 Mop floors regularly.
 Kill all food waste should be separated from other garbage, drained and
then stored in sealed plastic bags before disposal.
 Maintain the cleanliness and orderliness of the working area.
 Monthly using or spraying of insecticide for the effective control of pest

and vermin.
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POLICY FOR EQUIPMENT MAINTENANCE AND

REPAIR
 Calibration of equipment should be done at least once a month to

maintain the accuracy of the results released.
 Calibration of the equipment should be done be an authorized person.
 Maintenance of the equipment should be done by the laboratory

personnel by regularly cleaning and disinfecting.
 Repairing of the worn out equipment must be done by an authorized

technician.
 Logbook must be provided as a record of calibration, repair and

maintenance done.
 Quarterly updating and installing of anti-viruses of the computers.
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SCHEDULE OF PREVENTIVE MAINTENANCE

ACTIONS TO BE
NAME OF EQUIPMENT SCHEDULE/FREQUENCY
DONE
Drug Test Specimen
Clearing, Cleaning Every Saturday/Weekly
Refrigerator
Dusting Daily
DTO Computer Update/Antivirus
Quarterly
run
Dusting Daily
Inspect for Ink
DTO Printer
refill/Head Twice a month
Cleaning
Aircon Unit Cleaning Twice a year
Aircon Filter Cleaning Monthly
ACTIONS TO BE
NAME OF FACILITY/AREA SCHEDULE/FREQUENCY
DONE
Stock room Cleaning Weekly
Specimen Collection Area Cleaning Daily
Clinical Working Area Cleaning, Clearing Daily
Specimen Receiving/Test
Cleaning Daily
Result Releasing Area
Client Waiting Area Cleaning Daily
Windows Cleaning Weekly
Cleaning,
Sink Daily
Declogging
Cabinets Clearing, Dusting Weekly
Countertops Cleaning Daily
Ceiling Dusting Weekly
Tables Cleaning Daily
Chairs Cleaning Weekly
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TECHNICAL
POLICIES
AND
PROCEDURES
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SPECIMEN COLLECTION /SAMPLING

(within the laboratory)
I. Observed Specimen Collection for Urine

- Observed samples are collected in the presence of the Authorized
Specimen Collector.
A. The Preliminary procedures for specimen collection.
The Authorized Specimen Collector shall:
1. Prepare and secure all collection supplies, materials and record
2. Verify the Client/Donor/Subject’s identification
3. Explain the basic collection procedure to the

Client/Donor/Subject;
4. Answer any reasonable and appropriate questions the

Client/Donor/Subject may ask regarding the collection procedure
B. Basic steps in collecting urine specimen for drug testing;
1. The Client/Donor/Subject removes all unnecessary outer garments

(such as coat or jacket), after which, he/she will be subjected to a
bodily search.
2. The Authorized Specimen Collector directs Client/Donor/Subject to
empty his/her pockets and checks items that may be used to
adulterate the specimen.
3. The Client/Donor/Subject washes and dries hands prior to
collection. After washing hands, the Client/Donor/Subject must
remain in the presence of the Authorized Specimen Collector and
must not have access to anything that could be used to affect the
specimen.
4. The Authorized Specimen Collector either gives or allows the
Client/Donor/Subject to select the collection container from
available supplies. The specimen container is opened in full view of
the Client/Donor/Subject.
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5. The Authorized Specimen Collector directs the Client/Donor/Subject

to in the toilet facility for urination and to provide at least 60-ml
either collected in single or split specimen.
6. The authorized Specimen Collector shall observe closely the entire
collection procedure and take note of the conduct and demeanor of
Client/Donor/Subject for attempts of substitution, adulteration and
dilution of specimen.
7. A tampered specimen is sent to the laboratory for validity testing and
the Authorized Specimen Collector shall document the tampering on
the CCF with appropriate remarks. The Authorized Specimen
Collector shall instruct the Client/Donor/Subject to provide another
urine specimen immediately, under direct observed collection. This
second specimen shall also be sent for examination.
8. After the Client/Donor/Subject hands the specimen, the Authorized
Specimen Collector must measure the temperature, check volume
and inspect its physical characteristics.
9. The Authorized Specimen Collector and Client/Donor/Subject must
keep the specimen in full view at all times prior to sealing of all
specimen containers.
10. A tamper-evident label/seal must be used to secure the entire
specimen container.
11. Both Authorized Specimen Collector and Client/Donor/Subject
must affix their signature on the seal together with the date and time
of collection.
12. The Authorized Specimen Collector must complete steps 1 and 2
and initiates step 4 of CCF
13. The Client/Donor/Subject must affix his/her signature at Step 5 of
CCF. The Authorized Specimen Collector may ask the
Client/Donor/Subject to list any prescription, medication he/she
may have taken for the past two weeks at the back of the CCF
(Analyst Copy). Authorized Specimen Collector shall distribute each
copy as required.
14. In case of specimen collection at a remote site and transport via a
courier/mail, the specimen container together with the CCF shall be
placed in a sealed, labeled and secured transparent plastic bag.
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PROTOCOL FOR RECEIVING, ACCESSIONING

AND RELEASING OF SPECIMEN
I. Integrity of urine specimen received

The Authorized Specimen Collector must adopt procedures to minimize
risk of adulteration, substitution or dilution of the specimen during the
collection procedure. The following precautions shall be taken to ensure the
integrity of the specimen:
a. To deter the dilution of the specimen at the collection site, toilet

water coloring agents should be placed in toilet tanks or in the toilet
bowl. Any other sources of water in the enclosure where urination
occurs (e.g. taps, shower) will be secured prior to collection.
b. The Authorized Specimen Collector will ask Client/Donor/Subject to

remove any unnecessary outer garments such as a coat or jacket that
might conceal items or substance that could be used to tamper with
or adulterate the Client/Donor/Subject’s urine specimen. He/She
shall be subjected to bodily search. The Authorized Specimen
Collector will ensure that all personal belongings such as purse or
briefcase remain with the outer garments.
c. The Client/Donor/Subject will be instructed to wash and dry his/her

hands prior to urination. After washing hands, the
Client/Donor/Subject will remain in the presence of an Authorized
Specimen Collector and will not have access to any unregulated
source of water, soap dispenser, cleaning agent, or any other
materials that could be used to adulterate the specimen.
d. The Authorized Specimen Collector will give or the

Client/Donor/Subject will choose a clean specimen container from
the available supplies. The Client/Donor/Subject may provide
his/her specimen in the privacy of a toilet cubicle or otherwise
partitioned area that allows for individual privacy. The
Client/Donor/Subject will be instructed not to flush the toilet until
the specimen is handed to the Authorized Specimen Collector.
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II. Receiving and releasing of specimen

Upon receiving the specimen from the Client/Donor/Subject, the
Authorized Specimen Collector will:
a. Check the volume of urine in the specimen container.
b. Check the temperature of the urine specimen.
c. Inspect the specimen to determine its color and appearance for any
signs of contaminants. Any unusual findings will be noted on the
Custody and Control Form.
d. The specimen bottle will have an identification label that contains

pertinent information such as date and time of specimen collection,
signatures of the Client/Donor/Subject and Authorized Specimen
Collector and specimen ID number,
e. The Authorized Specimen Collector will fill-up steps 1 and 2 and

initiates Step 4 of the Custody and Control Form and pack together
with the urine specimen immediately for dispatch to the analytical
laboratory.
III. Accessioning/receiving
The laboratory must provide an outline regarding chain-of-custody
procedures during accessioning/receiving of specimen consistent with the
laboratory’s actual procedures. The laboratory must:
 Provide a unique accession number upon entry of the specimen to

the laboratory;
 Inspect the specimen submitted and the CCF to verify the integrity
and identity of the specimen;
 Examine the packaging for evidence of tampering in transit;
 Compare the information on the accompanying CCF; and
 Document all discrepancies.

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CRITERIA FOR SPECIMEN

REJECTION/CANCELLATION
All rejected specimens should be reported to the head of the laboratory

stating the reason(s) of rejection.
I. Criteria for specimen rejection that is non-correctable
 Incompatible ID number on the specimen received by the

laboratory with the number on the CCF.
 Absence of ID number of the specimen.
 No printed Authorized Specimen Collector’s name and

signature on the CCF.
 Broken or tampered seal on the specimen container.
 Insufficient quantity of specimen.
II. Criteria for specimen rejection that are non-correctable

 Failure of the Authorized Specimen Collector to sign CCF.
 Failure to check and record the specimen temperature with

appropriate remarks.
III. Appropriate remedial measures for correctable errors:
 All errors must be properly documented, recorded in a

Memorandum For Record (MFR) and duly signed by the
Authorized Specimen Collector.
33 | P a g e
 If the Authorized Specimen Collector’s signature cannot be

corrected by a Memorandum For Record (MFR), the laboratory
must report the specimen rejected for testing and provide a
reason on the report.
 If the Authorized Specimen Collector cannot provide an MFR to

attest to the fact that he or she did measure the specimen
temperature, the laboratory may report the test result for the
specimen but indicate that the Authorized Specimen Collector
could not provide an MFR to recover the omission.
IV. Conditions that will not cause specimen rejection or

cancellation of test
A. At the receiving area:
 Discrepancies of the laboratory name and address
 Incomplete/incorrect/unreadable employer name or address;
 Name of the Head of the Laboratory is not indicated;
 Incomplete/incorrect address of the Head of the Laboratory;
 Incorrect entry of the Client/Donor/Subject’s ID number;
 Unmarked “reason for test” box;
 Unmarked “drug tests to be performed” box;
 The collection site address is not indicated;
 Unmarked “specimen collection” box (if applicable);
 The date and time of collection is not indicated;
 Incorrect entry of name of delivery/courier service;
 The Client/Donor/Subject’s name inadvertently appears on the

laboratory copy of the CCF or on the tamper-evident labels
used to seal the specimen bottles.
34 | P a g e
B. Within the laboratory:
 Failure to print and sign the accessioner’s name;
 Failure to print and sin the Analyst’s name;
 The Analyst accidentally initials the CCF rather than providing

the signature for a non-negative result (Analyst’s initials are
acceptable for a negative result);
 The accessioner fails to mark one of the “primary specimen

bottle seal intact” boxes, but the laboratory reported a
“rejected testing’ result with an appropriate comment on the
“Remarks” line.
C. Situations/errors that may require the Head of the

Laboratory to cancel a test
 The Client/Donor/Subject’s signature is missing on the

Laboratory copy of the CCF and the Authorized Specimen
Collector failed to provide a comment that the
Client/Donor/Subject refused to sign the form;
 The Analyst failed to sign the CCF for a specimen being

reported drug positive, adulterated, substituted, rejected for
testing or invalid test result; or
 The electronic report provided by the laboratory does not

contain all the data elements required for the DOH standard
electronic laboratory report for a specimen being reported
drug positive, substituted, rejected for testing, or invalid test
result.
D. Corrective measures that the Head of the Laboratory must do

prior to cancellation of the test in the above situation.
 The Head of the Laboratory must contact the Authorized

Specimen Collector to obtain a statement to verify that the
Client/Donor/Subject refused to sign the Laboratory copy. If
35 | P a g e
the Authorized Specimen Collector cannot provide such

statement, the Head of the Laboratory must cancel the test.
 The Head of the Laboratory must obtain a statement from the

Analyst that he or she inadvertently forgot to sign the CCF, but
did, in fact, properly conduct the certification review.
 The Head of the Laboratory must require the laboratory to

modify and retransmit a corrected electronic report.
36 | P a g e
PROTOCOL FOR REFERRAL TO

CONFIRMATORY LABORATORY
(when positive results was obtained)
 If the screening test yields a Positive Result, a request for confirmatory

is accomplished by the analyst.
 The specimen container must be properly indicating the signature of the

donor. The seal of the specimen bottle on the other hand must contain
the printed name and signature of the ASC so as to create a ‘’ tamper
proof seal’’
 During transportation, the number of the personnel handling the

specimen must be minimized. An authorized person of the screening
drug test center should be the one to transport the specimen from the
screening laboratory to the confirmatory laboratory.
 Minimum amount of sample to be sent to the confirmatory laboratory is

60ml. specimen below the said amount will not be accepted. The 60ml.
volume will be used when the donor request for a retest or a challenge
test. An amount of the specimen will be sent to another DOH licensed
and accredited confirmatory laboratory to verify the result.
 Make sure that the CCF have been properly filled up.
 The screening laboratory will submit the following to the confirmatory

laboratory:
 accomplished chain of custody form
 letter or request for confirmatory
 Positive urine specimens should be frozen. Transport the specimen

bottle in a water jug with dry ice inside, firmly sealed, thus decreasing
probabilities of undetected tampering.
37 | P a g e
 The confirmatory laboratory after the analyst will send back to the
screening laboratory the confirmatory result form of the sample and the
used test kit.
 Result will be released within three to five working days.
38 | P a g e
PROTOCOL FOR REMOTE COLLECTION
1. Remote collection shall be done for random drug testing only.
2. No drug testing examination shall be conducted at a temporary

collection facility.
3. Only drug testing laboratories accredited by the Department of Health

shall be allowed to perform collection of drug testing specimen at a
temporary/remote facility.
4. No collection of drug testing specimen at a temporary/ remote facility

shall be done without PERMIT FOR REMOTE COLLECTION OF DRUG TESTING
SPECIMEN (PCR-DTS) secured only from the DOH-BHFS 10 working days
prior to the scheduled collection. PRC-DTS is not required for random drug
test in cases of reasonable/suspicious cause, post-accident and critically
ill/disabled patients.
5. The following are the documentary requirements:
i. Letter of request to conduct remote collection containing the

following information- date, time, venue of collection and estimate
numbers of donors/clients/subjects.
ii. Notarized MOA/contract between the contracting parties.
iii. List of authorized personnel employed at the laboratory designated

for remote collection.
iv. Operational procedures for remote collection and transport

(collection, transport, handling) in accordance with DOH-MANOPS
for drug testing.
v. List of supplies, transport materials e.g. Ice chest
6. A permit fee of ₱500.00 for each site shall be collected from the
laboratory.
7. The PRC-DTS shall be valid only for 2 weeks from the date of issuance.
39 | P a g e
8. The collection site should be located within the same administrative

region as the applicant laboratory.
9. The permit shall be posted in a conspicuous area within the laboratory

and temporary facility located at a remote site.
10. The DOH-BHFS may inspect the remote collection site prior to the
issuance of the permit or monitor during the actual collection. A collection site
shall have a controlled, secured and suitable area for specimen
collection/storage, supplies and records.
11. The minimum number of clients/ donor for a remote collect ion site
shall not be less than 20.
12. The laboratory shall maintain records of all remote collections

performed.
13. In case of failure to perform the collection at the specified date, the
laboratory shall inform DOH-BHFS/CHD in writing, facsimile, e-mail or
through telephone within 48 hours before the scheduled date of collection.
The DOH-BH FS shall be informed of the new schedule/s.
14. Violation s of the guidelines stated herein and in the I RR governing

accreditation of DTLs and Manual of Operations for Drug Testing Laboratories
shall be the basis for suspension/revocation of the PRC-DTS and the
accreditation of the laboratory.
40 | P a g e
Analytical Methods
Screening Laboratory
A laboratory that performs a validated test to differentiate negative
specimen from a specimen that requires further testing for drugs and/or
metabolite.
The method used may be:
 A registered testing kits approved by the DOH
 Instrumented screening method
A screening laboratory may conduct repeat screening tests on the same

sample prior to the confirmatory test.
The screening laboratory must submit all samples with positive results
to any DOH accredited confirmatory Drug testing laboratory. Together with
the sample, the following documents shall be submitted:
 Accomplished Custody and Control Form
 Initial Laboratory results
 Letter Request for Confirmatory Test
The release of the result will be dependent on the:
 Availability of confirmatory laboratory
 Distance of confirmatory laboratory from the

screening laboratory
41 | P a g e
Testing Kits
The laboratory will only use a DOH-approved test kit and will follow the
test kit package insert for the procedures of testing.
 Quick Profile™ Methamphetamine/Marijuana (THC) Test Card –

provides a built-in process control with a different
antigen/antibody reaction at the control region (C). This control
lone should always appear regardless the presence of drug or
metabolite. If the control line does not appear, the test device
should be discarded and obtained result is invalid. The presence
of this control band in the control region serve as 1) verification
that sufficient volume is added, 2) that proper flow is obtained.
Procedure:
1. Bring all materials and specimen to room temperature.

Remove the test card from the sealed foil pouch.
2. Place the transfer pipette in the specimen and depress the

bulb to withdraw a sample.
3. Hold the pipette in a vertical position over the sample well

of the test card and deliver 3 drops (120-150 μL) of sample
in to the sample well.
4. Read the results at 5 minutes after adding the sample.
42 | P a g e
MECHANISM OF REPORTING RESULTS
The laboratory shall maintain specimen test results supported by data

and are reported in accordance with the following written guidelines.
Procedure must be in placed to ensure confidentiality of records.
I. Interpretation of specimen results
 Both MAMP and THC Negative (Fig. 1): Three colored bands form.
The appearance of three colored bands, one aligned with "CTRL",
one aligned with "MAMP", and another aligned with ''THC",
indicates negative results of Methamphetamine and THC.
 MAMP Positive and THC Negative (Fig. 1): Two colored bands
form. The appearance of two colored bands, one aligned with
"CTRL" and one aligned with ''THC''. No colored band develops
aligned with "MAMP". This indicates a negative result of THC and
a positive result of MAMP.
 THC Positive and MAMP Negative (Fig. 1): Two colored bands
form. The appearance of two colored bands, one aligned with
"CTRL" and one aligned with "MAMP". No colored band develops
aligned with ''THC". This indicates a negative result of MAMP and
a positive result of THC.
 Both MAMP and THC Positive (Fig. I): Only a colored band forms.
The appearance of one colored band aligned with "CTRL". Neither
line develops aligned neither with ‘‘MAMP” nor with ''THC". This
indicates negative results of Methamphetamine and THC.
 Invalid (Fig. 2): Lf there develops no colored band aligned with
"CTRL", the test result is invalid. Retest the sample with a new
43 | P a g e
device. Note: A borderline (+/-) in test line zone should be

considered as a negative result.
NOTE: A negative result does not indicate the absence of drug in the
specimen; it only indicates that the tested drug level in the specimen is
less than the cut-off level.
II. Guidelines for reporting a laboratory result

a. All Specimen submitted shall have a corresponding laboratory
result issued within 15 days.
b. A positive screening result shall be subjected to confirmatory
analysis. The final report shall be based on the confirmatory
results.
c. The screening laboratory shall be the only authorize laboratory to
release the final report.
d. All laboratory reports of a screening laboratory shall bear the
signature of the Analyst and the Head of the Laboratory. For a
confirmatory laboratory, the reports shall bear the signatures of
the Analyst, Chief Chemist and Head of the Laboratory.
e. All confirmatory drug test results should specify the
concentration of the limit of detection (LOD) of the method of the
drug or metabolites.
f. A laboratory shall report all test results using the IDTOMIS
laboratory report form. The electronic report must be transmitted
in a manner that ensures the confidentiality and security of the
information.
g. Reports for an adulterated or substituted test result must be
based on an initial and confirmatory validity test.
h. The laboratory must report the specific validity test result(s) for a
specimen that is reported adulterated or substituted.
i. No result can be relayed through telephone
44 | P a g e
III. Statistical summary of the laboratory report

A. A laboratory must submit annually to the BHFS a report
containing the following:
i. Total number of specimen received and examined as

classified according to:
a. Mandatory
b. Random
c. Other reason
ii. The number of specimen that were reported as:
a. Positive for each drug (listed separately)
b. Adulterated
c. Substituted
d. Rejected for Testing
e. Invalid Result
iii. The number of specimen sent for confirmatory testing

(for screening laboratory)
B. The report must be submitted to the BHFS by mail, fax or email

within 10 working days after the end of the year.
C. Reviewing a positive, adulterated, substituted, or invalid test

result
Prior to making a final decision on a specimen that was

reported positive, adulterated, substituted, on an invalid test
result by the laboratory, the Head of the Laboratory shall:
i. Allow the Client/Donor/Subject to explain any

circumstance leading to the test result.
45 | P a g e
ii. Evaluate alternative medical explanations for the positive,

adulterated, substituted, or invalid test result.
iii. Review current medical records of the

Client/Donor/Subject that could have resulted from
taking legally prescribed medication.
D. When the laboratory reports an invalid result due to the possible

presence of an unidentified interfering substance/adulterant, the
Head of the Laboratory shall:
i. Send the specimen to another DOH accredited laboratory

capable of identifying the interfering
substance/adulterant;
ii. Report the result as “Test Cancelled” if the explanation

provided by the Client/Donor/Subject is:
a. Acceptable then an immediate direct observed

collection is not required;
b. Not acceptable then an immediate direct

observed collection is required.
E. For verification, the Client/Donor/Subject may obtain other

documents.
The Client/Donor/Subjects must submit a written request

addressed to the Head of the Drug Testing Laboratory to
obtain a certified true copy of the COC and pertinent
analytical data.
46 | P a g e
PROCEDURE FOR SECURITY AND

CONFIDENTIALITY OF RECORDS, SUPPLIES AND
SPECIMEN
 To assure the security of records, a filling cabinet with lock must be

provided.
 Only authorized personnel must have access to the records.
 The analyst is only the authorized person to record any information in

their respective logbooks.
 Supplies are also kept in a cabinet provided with lock.
 Only the laboratory personnel should have access to the supplies.
 Specimens are kept in the freezer for 5 days for negative results and
disposed after.
 Specimens that yield a positive result should be sent to the confirmatory

laboratory.
 All specimen kept in the freezer, disposed and sent to the confirmatory
laboratory should be recorded in the logbook.
47 | P a g e
POLICY ON STORAGE AND DISPOSAL OF SPECIMEN
I. Storage of Specimen
Proper handling and storage of specimen must be taken to ensure the
integrity of the drug and/or metabolite.
 All the urine specimen collected and analyze must be kept or restored to
the refrigerator;
 Initial: between 2-6℃for not more than 1day
 Prolonged storage: -20℃
II. Urine Specimen Disposal

 The personnel in the laboratory should check the urine specimen before
disposal.
 Urine specimen that yields negative results on screening must be

disposed after five (5) days from the date of collection.
 Urine specimen disposal are flushed in the toilet bowl or sink with
sufficient amount of water.
 All disposals done must be recorded in the logbook.
48 | P a g e
QUALITY CONTROL MEASURES
I. Internal Quality Assurance Program

A. Validation of a screening drug test
i. The laboratory must demonstrate the ability to differentiate and

document:
 The ability to differentiate positive and negative samples.
 The performance of the test around the cut-off concentration.
 The performance of the test results at several concentrations 0-

150 percent of the cut-off concentration.
ii. Performance characteristic of new testing kits must evaluate

prior to use.
 Batch quality control requirements when conducting a screening drug test
B. For Test Kits
Each batch of specimen must contain the following types of quality

control samples:
i. At least one control registered and validated by the DOH to

contain no drug metabolite;
ii. At least one control that has the concentration of the drug or
metabolite at 25% above the cut-off concentration; and
iii. At least one control that has the concentration of the drug
metabolite at 25% below the cut-off concentration.
49 | P a g e
II. External Quality Assurance Program

The DOH National Reference Laboratory (NRL) conducts a Proficiency
Test (PT) for screening and confirmatory drug testing laboratories. A
screening laboratory must pass the proficiency test conducted by the NRL
before the renewal of their accreditation.
A. Certificate of Proficiency (COP)
i. The laboratory shall submit to NRL a letter of intent for PT,

properly accomplished application form and protocol prior to the
scheduled PT.
ii. The application form includes detailed related information on

both administrative and analytical procedures.
B. Qualitative and quantitative specifications of a proficiency test

sample
i. A PT sample may contain:
a. The drug and/or metabolites in the drug classes that each laboratory must
have the capability to test for; or
b. No more than two drug classes to imitate real Client/Donor/Subject

specimen.
ii. A negative PT sample does not contain a measurable amount of a target

drug and/or metabolite.
iii. A PT sample may contain an interfering substance, an adulterant, or a

specimen that meets the criteria for a substituted specimen.
iv. For each PT cycle, the set of PT samples for each laboratory will vary but,
within each calendar year, each laboratory will analyse the same total set
of samples.
v. The laboratory must, to the greatest extent possible, handle, test, and
report a PT sample in a manner identical to that used for a
Client/Donor/Subject, unless otherwise specified.
50 | P a g e
GOOD LABORATORY PRACTICE
 Eating, drinking and smoking should not be permitted in any area

where activities might influence product quality or staff may be exposed
to the hazards. There should be designated areas for eating, drinking
and rest personnel
 Pest control is needed, as in the case of storage of papers and records
 Proper handwashing technique must always be observed by all the

staffs.
 Clinic staffs must practice 5’s in Housekeeping.
 Wear proper PPE’s
 Promotes and Observed Waste Segregation Management
51 | P a g e
PROGRAM FOR THE PROPER MAINTENANCE AND

MONITORING OF PHYSICAL PLANT AND
FACILITIES
 Scheduled a regular cleaning of the physical plant and facilities
 Practice and Implement the 5’s in Housekeeping
 Practice of waste segregation effectively
 Regular cleaning and sanitized urine collection area and floors.
 Regular cleaning of the air conditioning unit be observed
 Electrical system should be safe and provide appropriate lighting to the

workplace to prevent hazards to the clinic staff
 Light fixtures such as outlets , sockets and switches to avoid the entry of
vermin
 Pest Control must be in a regular scheduled
 Regular cleaning and checking of the storage area
 Wearing of PPE’s is a MUST
52 | P a g e

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1045 ME Governor’s Drive Oregano St. Brgy.

Maduya, Carmona, Cavite

This manual contains the Standard Operating Procedures of

OCCUMEDICA HEALTH CARE SYSTEM CORP.

OCCUMEDICA HEALTH CARE SYSTEM CORP.

was established on January 12, 2009. The clinic is located at

1045 ME Governor Drive, Brgy. Maduya, Carmona, Cavite

We are an institution based screening drug-testing laboratory.

We see to it that we are functioning in accordance to the RA9165 or the

Occumedica Health Care System Corp. is committed

Our Mission is to help our clients ensure safe work

To continually enhance the level of client

To be recognized as a great place to work and grow

Support the fight against drug-addiction and the

To up hold the standards set by the Department of

POLICIES FOR HIRING, ORIENTATION AND

HIRING AND EMPLOYMENT

Section 1: Eligibility Requirements

 A licensed physician certified in Clinical Pathology by the

 A licensed physician trained in laboratory management and drug

 Must be a registered Chemist; or

C. Authorized Specimen Collector

 Must be at least high school graduate

 Must have undergone appropriate training

Section 2: Duties and Responsibilities of Personnel

 Supervise the facilities and all aspects of Laboratory work;

 Supervise all the Laboratory Personnel;

 Implements the Standard Operation Manual that governs the

 Supervise and directs all analytical procedures of the Laboratory;

 Assures Quality of all Laboratory Test Results;

 Issues, signs out and interpret Laboratory Test Results;

 Evaluate and recommends reagents, supplies and equipment;

 Reviews the CCF and reports received from Authorized collectors;

 Interviews Client/Donor/Subject for alternative medical

 Reviews pertinent medical records of Client/Donor/Subject if

 Cancels the results of all specimen which are not collected;

 Review rejects and refers for retesting, reconfirmation all

 Implements remedial actions necessary to maintain satisfactory

 Directs protocol for preventive maintenance of equipment

 Provides comprehensive, continuing training and education of

 Verifies completeness of CCF;

 Prepares specimen for analyses;

 Examines, processes and analyzes specimen for drug testing;

 Interprets, records, releases and sign out laboratory reports;

 Assist in the implementation of quality assurance program;

 Assists in the evaluation of reagents, supplies and equipment;

 Perform specimen validation test;

 Institute corrective measures to prevent cancelation of test;

 Laboratory documentation and reports;

 Refers to the Head of Laboratory as the need arises.

C. Authorized Specimen Collector:

 Restricts unauthorized personnel to enter the collection site

 Verifies the identity of Client/Donor/Subject;

 Provides security to specimen supplies, records and

 Informs the Client/Donor/Subject the procedures of specimen

 Performs only one specimen collection at a time;

 Accepts and seals the specimen container in the presence of

 Accomplishes CCF correctly.

Employee’s Name:_________________________________________ Start Date: _