Administrative Order No. 2021 – 0037

 11 June 2021

 

NEW RULES AND REGULATIONS GOVERNING THE REGULATON OF CLINICAL LABORATORIES IN THE PHILIPPINES

I.     RATIONALE

By virtue of RepublicAct No. 4688 s. 1966, “An  Act Regulation the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for Violation Thereof, and for Other Purposes,” the Department of Health (DOH) through the Bureau of Medical Services, now known as the Health Facilities and Services Regulatory Bureau (HFSRB), was mandate to ensure public health, safety and welfare through enforcement of the Act and was authorized to issue such rules and regulations as may be necessary to carry out the law. Clinical laboratory services play an important role in the diagnosis, treatment, prevention, and control of disease. Thus, it is imperative that the laboratories generate accurate, precise, and reliable laboratory test results in a timely manner to aid the Physicians in assuring the quality of patient care.

Through the years, several laboratory technological advancements have been introduced. As such, certain provisions in the current Administrative Order (AO) No. 2007 – 0027, dated August 22, 2007, titled “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines,” may have become outdated. This policy is being issued to align the laboratory procedure with the requirements of A.O. 2020 – 0047 titled “Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines.”

The necessity to review the current A.O. and to revise and update the minimum standards and technical requirements for licensing clinical laboratories in the Philippines is aligned with the main objective of Republic Act No. 11123 or the Universal Health Care Act which is to guarantee access to quality and affordable health products, devices, facilities, and services.

 

II.    OBJECTIVE 

These rules and regulations shall serve as the new guidelines in the licensing of diagnostic clinical laboratories in the Philippines which shall ensure accountability of the laboratory on generation of accurate, precise, and reliable results in a timely manner through continuous compliance.

 

III.  SCOPE OF APPLICATION

This order shall apply to all individuals, agencies, partnerships, or corporations whether private or government–owned, involved in the application for DOH license to operate and those in the operation of diagnostic clinical laboratories in the Philippines.

This order shall also apply to Bangsamoro Autonomous Region in Muslim Mindanao (BARMM) subject to the applicable provisions of R.A. 11054 or the Bangsamoro Organic Act” and subsequent rules and policies issued by the Bangsamoro Government.

 

IV.   DEFINITION OF TERMS

A.   Applicant – refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation, or agency seeking license to operate and maintain a clinical laboratory.

B.    Assessment Tool – the checklist which prescribes the minimum standards and requirements for licensure of a clinical laboratory.

C.    Clinical Laboratory (CL) – a facility that is involved in the (a) pre– analytical, (b) analytical, (c) and post–analytical procedures, where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases. These tests include, but are not limited to, the following disciplines: anatomic pathology, clinical chemistry, clinical microscopy, endocrinology, hematology, immunology and serology, microbiology, toxicology, as well as molecular and nuclear diagnostics.

D.   Department of Health – License to Operate (DOH – LTO) – a formal authorization issued by the DOH to an individual, partnership, corporation, association, or any government agency/unit seeking to perform laboratory tests in the compliance with the requirements prescribed in this Order.

E.     Department of Health – Permit to Construct (DOH – PTC) – a permit issued by DOH through HFSRB or Center for Health Development Regulation, Licensing and Enforcement Division (CHD – RLED) to an applicant who will establish and operate a hospital or health facility, upon compliance with required documents prior to the actual construction of the said facility. A DOH – PTC is also required for hospitals and other health facilities with substantial alteration, expansion, renovation, increase in the number of beds, transfer of site, or for additional services (add–ons) beyond their service capability. It is a prerequisite for License to Operate.

F.     External Quality Assessment Program (EQAP) – a program where participating CL are given unknown samples for analysis. These samples should be treated as ordinary human specimens for the usual processing and examination. The quality of performance of the CL shall be assessed through the closeness of its results to the pre–determined value or reference value generated by the participating CL through peer group analysis.

G.   Initial Application – refer to application by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovations.

H.   Mobile Clinical Laboratory (MCL) – a laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH–licensed CL as its main laboratory.

I.      National External Quality Assessment Scheme (NEQAS) – an EQAP activity conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.

J.      National Reference Laboratory (NRL) – the highest level of laboratory in the country performing highly complex procedures, including confirmatory testing, that is not commonly performed by the lower level of laboratory. It is the responsible entity for facilitating NEQAS to ensure compliance to quality standards for regulation and licensing of all laboratories in the Philippines.

K.    Physician’s Office Laboratory (POL) – refers to a doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patient’s only, wherein NO official result shall be issued. In this Order, POL within the premises of a DOH–regulated facility shall be under the supervision of the CL.

L.     Point of Care Testing (POCT) – refers to a diagnostic testing done at or near the site of patient care rather than in the CL. It maybe in the emergency room, operating suites, wards, and ambulances.

M.  Satellite Clinical Laboratory (SCL) – refers to an extension of the main CL located within the facility’s compound or premises. It shall have the same service capability as the main laboratory.

N.   Referral Tests – refers to CL tests that are either sent–out or outsourced to other DOH–licensed CL with the same or higher service capability.

 

V.    GENERAL GUIDELINES

A.   All CL shall secure DOH – LTO prior to its operation and must always comply with the minimum regulatory standards and requirements.

B.     The DOH – LTO shall be secured from the DOH regulatory office in accordance with DOH guidelines.

C.    Only DOH–licensed CL may have a SCL which shall be located within the premises of the regulated health facility. 

D.   A DOH–licensed CL may have MCL services as listed in Section IV of Annex A, provided, they adhere to the standard testing protocols.

E.     The DOH–licensed CL shall not perform any examinations or testing beyond its authorized service capability. However, it may be allowed to offer laboratory services other than the respective stipulated minimum services such as but not limited to, MCL, SCL, confirmatory testing for Glucose–6–Phosphate Dehydrogenase (G6PD) Deficiency, and Rapid HIV Diagnostic Algorithm (rHIVda), provided that the additional services have been approved and indicated as add–ons services in the DOH – LTO of the CL.

F.     Unit/Section of health facilities performing diagnostic CL test such as, but not limited to, arterial blood gas and/or Radioimmunoassay for Thyroid Function Tests and Prostate Specific Antigen shall be under the DOH– licensed CL.

G.    The head of the CL shall be a Pathologist certified by a professional organization recognized as the Accredited Professional Organizations/Accredited Integrated Professional Organizations of the Professional Regulation Commission. The head of laboratory shall ensure the optimal overall operations and maintenance of the CL and if applicable, of its SCL and MCL.

H.   There shall be an adequate number of competent personnel assigned in the different services provided by the DOH–licensed CL, which includes the MCL, SCL, remote collection activities, if applicable.

I.      CLs that are operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH – HFSRB.

J.      The DOH designated NRL shall be covered by the license of the CL of the hospital where they are affiliated with. Independent NRLs, or those designated by DOH but are not affiliated with any DOH–regulated health facility, shall secure a DOH – LTO from HFSRB.

K.    All CLs shall make their prices for laboratory services accessible to the public as mandated by the UHC Law and related DOH issuances.

L.     At the Central Office, the Director IV, or in his/her absence or unavailability or when delegated, the Director III of HFSRB, shall approve the issuance of the DOH – LTO of the CL.

M.  At the CHD, the Director IV, shall approve the issuance of the DOH – LTO of the CL.

N.   In the advent of new technologies or diagnostic platforms that shall affect the current licensing standards for CL, Department Circulars shall be issued, as needed, as supplements to this Order.

O.   The CL shall be compliant with the prescribed standards and requirements (Annex A), Assessment Tool for Licensing Clinical Laboratories (Annex B1 and B2) and other relevant laws and issuances. These standards shall also apply to MCLL and SCL.

P.     The DOH – LTO may be revoked, suspended, or modified in full or in part for any false statement by the applicant, or as shown by the record of inspection or for violation of, or failure to comply with any of the terms and conditions and provisions of these rules and regulations.

 

VI.  SPECIFIC GUIDELINES

A.   Classification of Clinical Laboratories

1. Classification by Ownership

a. Government – operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city or municipal), any other political unit or any department, division, board, or agency thereof.

b. Private – privately owned, established, and operated with funds through donation, principal, investment, or other means, by an individual, corporation, association, or organization.

2. Classification by Institutional Character

a. Institution–based – a laboratory that is located within the premises and operates as part of a DOH licensed health facility.

b. Non–institution based – a laboratory that operates independently and is not attached to any DOH licensed health facility.

3. Classification by Function

a. Clinical Pathology – deals with the chemical and cellular analyses of blood and other body fluids (includes, but not limited to, clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology, and serology, hematology and coagulation), identification and examination of microbes and parasites (bacteriology/parasitology/mycology/virology).

b. Anatomic Pathology – provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues, such as, but not limited to, surgical pathology, cytopathology, immunohistochemical techniques, autopsies, and forensic pathology.

c. Molecular Pathology – deals with the analysis of certain genes, proteins, and other molecules in samples from organs, tissues, or bodily fluids to diagnose disease and/or to guide the prevention and treatments of disease based on the principles, techniques, and tools of molecular biology as they are applied to diagnostic medicine in the laboratory.

4. Classification by Service Capability

a. Clinical Laboratory for Clinical and Anatomic Pathology

	Provides the following minimum service capabilities:	Provides the minimum service capabilities of a primary category plus the following:	Provides the minimum service capabilities of a secondary category plus the following:	Provides one (1) or two (2) specialized tests that are not classified under Anatomic or Molecular Pathology as exemplified below:
Clinical Microscopy	– Urinalysis – Fecalysis – Fecal Occult Blood Test – Pregnancy Test (Rapid Test Kits – Lateral Flow) – Wet Smear for Trichomonas			Molecular Pathology as exemplified below:   – Hormones – Trace Metals – Tumor Markers – Allergy Panel   – This classification shall also apply to facilities offering DOH –program related tests, e.g. Kato Katz for Schisotosomiasis, Malarial Smear, Filaria Smear, Slit– skin smear, Rapid Plasm Reagin for Syphilis
Clinical Chemistry	– Fasting and Random Blood Sugar – Oral Glucose Tolerance Test – Lipid Profile (Total Cholesterol, HDL, LDL, Triglycerides) – Creatinine – Blood Urea Nitrogen – Blood Uric Acid	– Serum Electrolytes (Sodium, Potassium, Chloride) – ALT – AST	– Other Clinical Chemistry Examinations   Hospital – based: Arterial Blood Gases
Hematology	– Complete Blood Count (Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with Differential Count, Quantitative Platelet count) – Forward and reverse ABO grouping and Rh (D) typing (tube method)	For Hospital – based:   – Coagulation studies (PT, aPTT)
Serology/ Immunology	– Dengue – Syphillis – Hepatitis B (Screening) – HIV (Screening) Using Rapid Test Kits			Any machine – based serological and immunological test such as, but not limited to: tumor markers, thyroid function tests and hepatitis profile
Microbiology	– TB (DSSM) or Nucleic Acid Amplification Test – for government facilities	– Gram Stain – KOH		– Culture and sensitivity (aerobic and anaerobic)
Anatomic Pathology		– Pap smear		For Hospital – based:   – Cytology and Histopathology

b. Clinical Laboratory for Anatomic Pathology only – provides services for any of the following, but not limited to cytology and histopathology.

c. Clinical Laboratory for Molecular Pathology only – provides services for genetics, immuno/hematopathology and infectious disease. COVID–19 testing laboratories shall be covered by another order.

 

VII. PROCEDURAL GUIDELINES

A.   Permit to Construct

1. A filled-out application form for DOH – PTC (downloadable at www.hfrsb.doh.gov.ph), whether manual or online, shall be submitted to the DOH regulatory offices, as specified in Section V.B of this Order.

2. A DOH – PTC shall be required for construction of a new CL and for renovation or expansion of existing CL, including change in ownership and transfer of location.

3. The application shall be processed in accordance with the procedural guidelines set forth in A.O. No. 2016 – 0042, also known as, “Guidelines in the Application for Department of Health Permit to Construct (DOH – PTC).”

B.    License to Operate (LTO)

1. Any person, firm or corporation desiring to establish, operate, and maintain CL shall submit an accomplished application form to HFRSB/CHD – RLED in accordance with the current DOH guidelines, whether manual or through the Online Licensing and Regulatory System (OLRS), once it is fully functional.

2. A complete application for DOH – LTO or CL shall consist of the following:

a. Completely filled out application Form 1 and its attachments (downloadable at www.hfrsb.doh.gov.ph);

(1)   Notarized Acknowledgement

(2)   Any of the following proof of ownership and name of health facility

·       DTI/SEC/CDA Registration including Articles of Incorporation/Cooperation and By – laws

·       Enabling Act/LGU Resolution (for government health facility)

(3)   Accomplished Self–Assessment Tool

(4)   Health Facility Geographic Form

b. Copy of Official Receipt payment

c. Certificate from NRL – SLH/SACCL for rHIVdaA Confirmatory, if applicable.

d. Certificate from Newborn Screening Reference Center (NSRC), if applicable.

3. Upon receipt of the complete application forms, the HFRSB/CHD – RLED representative, in accordance with the current DOH guidelines, reviews the application and conducts an on–site assessment of the laboratory to determine full compliance with the standards and technical requirements.

4. If upon assessment, the laboratory is not fully compliant with the licensing requirements, the HFRSB/CHD – RLED, in accordance with the current DOH guidelines, shall provide a written report outlining the laboratory’s deficiencies. The laboratory must comply with the deficiencies withing thirty (30) days. Otherwise, the application shall automatically be denied.

5. The DOH – LTO, whether initial or renewal, shall only be issued after the HFRSB/CHD – RLED, in accordance with the current DOH guidelines, has determined that the laboratory is fully compliant.

6. Submitted complete applications that are not processed within twenty (20) days by the HFRSB/CHD – RLED, in accordance with the current DOH guidelines, due to force majeure, shall automatically be granted the LTO, and a post–licensing visit shall be scheduled.

7. Only DOH licensed CL identified by the program and has already secured a certificate of “Certified rHIVda Confirmatory Laboratory (CCL)” from the NRL – SLH/SACCL or its designated regional counterpart, shall be allowed to apply for a license CrCL.

8. A DOH – licensed hospital – based tertiary CL, already certified by the NSRC, may apply as G6PD Deficiency confirmatory laboratory to HFRSB.

9. For institution–based CL, the One–Stop Shop (OSS) Licensing System, pursuant to Administrative Order No. 2018 – 0016 dated June 4, 2018, titled “Revised Guidelines in the Implementation of the One–Stop Shop Licensing System,” shall be followed. The DOH-LTO of the institution based CL shall be subsumed in the DOH-LTO of the health facility.

10.  The DOH – LTO is non–transferable and a new application for DOH – LTO shall be required in case of change of ownership or transfer of location.

11.  The HFRSB/CHD – RLED, in accordance with the current DOH guidelines, shall be notified in writing of any change in management name, ownership or headship or laboratory personnel. Failure to notify of any substantial change in the condition of the laboratory, i.e., changes in the physical plant, equipment, or personnel, in writing within fifteen (15) days, may be a basis for the suspension or revocation of the DOH – LTO.

12.  Different branch(es) of a CL, even if owned by the same entity shall secure separate DOH – LTO.

13.  Application for DOH – LTO shall follow A.O. No. 2019 – 0004 dated April 30, 2019, titled “Guidelines on the Annual Cut–off Dates for Receipt of Complete Applications for Regulatory Authorizations Issued by the Department of Health.”

14.  The DOH – LTO shall be placed in an area that can be readily seen by the public, always.

C.    Certificate of Registration (COR)

1. COR is required for research and teaching laboratories.

2. Applicants shall submit an accomplished registration form (downloadable at www.hfrsb.doh.gov.ph) together with the necessary attachments to HFSRB, which includes Annex for services.

3. The applicant shall be required to pay a non–refundable application fee before submission of the requirements as part of complete application.

4. The HFSRB shall evaluate and accept applications based on the due execution of forms and completeness of attachments.

D.   Validity

1. The DOH – LTO is valid for one (1) year.

2. COR for CL that is operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH – HFSRB every three (3) years.

E.     Fees

1. All fees shall follow the prescribed fees by the DOH.

2. All fees/checks shall be paid to the order of DOH Central Office/CHD Cashier, whichever is applicable in person, through postal money order or online payments approved by the DOH.

F.     Monitoring

1. Authorized representatives from the HFRSB/CHD – RLED in accordance with the current DOH guidelines, may conduct unannounced on–site visits of licensed CL and registered research and teaching laboratories to monitor and document the continuous compliance of the CL to the set standards.

2. If upon monitoring visit, the CL is found to be violating any of the rules and regulations stated herein relative to its operation, the HFSRB/CHD – RLED in accordance with the current DOH guidelines, may immediately impose preventive suspension.

3. CL that are operated and maintained exclusively for research and teaching purposes shall not issue official results for diagnostic purposes. They may be monitored to ensure that they are not operating beyond allowed capabilities.

 

VIII.  ROLES AND RESPONSIBILITIES

A.   Health Facilities and Services and Regulatory Bureau shall:

1. Set standards for the regulation of CL and strictly enforce the provisions of this order.

2. Disseminate regulatory policies, standards, and forms for information and guidelines of the DOH – CHDs.

3. Provide consultation and technical assistance to stakeholders, including regulatory officers from the DOH – CHDs in line with the regulations of CL.

4. Respond promptly to complaints relative to the operation of CL under its jurisdiction.

B.  Center for Health Development – Regulatory, Licensing and Enforcement Division shall:

1. Strictly enforce the provision of this Order.

2. Submit quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL not later than the 15^th day of the following month after the covered quarter.

3. Provide consultation and technical assistance to stakeholders in line with the regulations of CL.

4. Respond promptly to complaints relative to the operation of CL under its jurisdiction.

C.  National Reference Laboratories shall:

1. Provide laboratory reference/referral services for confirmatory testing.

2. Train laboratory personnel and recognize other training institutions.

3. Maintain the National External Quality Assessment Scheme (NEQAS).

4. Perform technical evaluation of reagents and diagnostic kits.

D.   DOH–licensed Clinical Laboratories shall:

1. Continuously comply with the rules and regulations, licensing standards and requirements for CL, as provided in this Order and related issuances.

2. Participate in EQAP that may be administered by a designated NRL or other local and international EQAP approved by the DOH, surveys, and other activities that will be required from them by the DOH.

3. In times of Pandemic of Public Health Event, be mandated to submit timely reports and data.

 

IX.   VIOLATIONS, SANCTIONS AND APPEAL

A. A CL shall be sanctioned and penalized by the HFSRB/CHD Director upon violation of any these guidelines and its related issuance and laws, or upon committal (commission/omission) of prohibited acts (Annex C) by the persons owning or operating the CL, and/or the persons under their authority.

B. For non–institution–based CL that are not under the OSSOLS, the following are the penalties and sanctions that shall be imposed for the commission of any the violations in this Order and other relevant issuances:

1.     1^st Offense:    Stern Warning

2.     2^nd Offense:   Thirty thousand pesos (Php 30,000.00)

3.     3^rd Offense:    Fifty thousand pesos (Php 50,000.00)

4.     4^th Offense:    Revocation of DOH – LTO 

C.  For CL that are part of hospital and other facilities that are subject to comply with the OSS Licensure system, A.O. No. 2007 – 0022, dated June 6, 2007, titled “Violations under the One–Stop Shop Licensure System for Hospitals,” sanctions shall be governed by the order.

D. Any person who operates a CL without securing the necessary DOH – PTC and corresponding DOH – LTO shall be issued a Cease–and–Desist Order (CDO) and shall pay the administrative penalty of fifty thousand pesos (Php 50,000.00).

E. Section 4 of Republic Act No. 4688 shall still be impossible aside from the administrative penalty provided in this order.

F. In case of complaints, the CL, upon receipt of such HFSRB/CHD – RLED shall be given due process wherein an investigation shall be conducted and the appropriate sanctions for its violation/s. A 60–day preventive suspension may be given go the CL during the investigation depending on the seriousness of the violation.

G.  Any CL or any of its personnel not amenable with the decision of the HFSRB/CHD – RLED may, within ten (10) days after the receipt of notice of decision, file a notice of appeal to the Head of the Health Regulation Team (HRT). All pertinent documents and records of the appellant shall then be elevated by HFSRB/CHD – RLED to the HRT. The decision of the Head of the HRT, if still contested may be brought on a final appeal to the Secretary of Health, whose decision shall be final and executory.

H. CL with revoked licenses can only re–apply after one year from the date of LTO revocation.

I.  Any person authorized or licensed to conduct clinical laboratory tests, who issues false or fraudulent laboratory test results knowingly, wilfully or through gross negligence shall not be allowed to own, manage, operate, or be an analyst of any DOH–licensed CL.

 

X.    TRANSITORY PROVISIONS

A. All existing licensed shall be given three (3) years to comply with the physical plant requirements from the date of effectivity of this order.

B. All existing licensed CL shall be given two (2) years to fully offer the additional services for each category with corresponding personnel and equipment from the date of effectivity of this order.

C. For New CL, this order shall be immediately applicable.

D. For CL currently headed by Anatomic Pathologists with an associate Clinical Pathologists or Clinical Pathologists heading tertiary CL with Anatomic Pathology services, such as headships shall be retained until his/her eventual retirement, resignation, or replacement. Thereafter, all CL shall be headed by a Pathologist certified in Clinical Pathology by the Board of Pathology of the Philippine Society of Pathologists, except for tertiary CL with anatomic pathology service which shall be headed by a Pathologist certified in both Anatomic and Clinical Pathology.

 

XI.   REPEALING CLAUSE

These rules and regulations shall rescind Administrative Order No. 2007 – 0027 titled “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines,” all administrative order and previous issuances inconsistent thereof.

 

XII. SEPARABILITY

If any provision or part of this order be declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective.

 

XIII. EFFECTIVITY

This order shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) copies to the University of the Philippines Law Center.

FRANCISCO T. DUQUE III, M.D., MSc.

Secretary of Health 

 

TABLE OF ANNEXES Administrative Order No. 2021 – 0037
ANNEX NO.	CONTENT
A	Licensing Standards for Clinical Laboratory
B1	Assessment Tool for Licensing A General Clinical Laboratory
B2	Equipment/Instruments/Glassware/Supplies/Reagents per Area of Activity / Service Capability of General Clinical Laboratory
C	Prohibited Acts in the Operations of Clinical Laboratories
D1	Planning and Design Guidelines for General Clinical Laboratory
D2	Checklist for Review of Floor Plans for General Clinical Laboratory
D3a	Sample Floor Plan for General Clinical Laboratory 1
D3b	Sample Floor Plan for General Clinical Laboratory 2
D3c	Sample Floor Plan for General Clinical Laboratory 3
E	Guidelines in Securing for Remote Collection Permit for Clinical Laboratories
F	Application Form for Certificate of Registration for Research and Teaching Clinical Laboratory

 

ANNEX A

LICENSING STANDARDS FOR CLINICAL LABORATORY

I.     PHYSICAL PLANT

Every Clinical Laboratory (CL) shall have an adequate space for its operation to provide services safely, effectively, and efficiently to clients.

A. The CL shall conform to all applicable local and national regulations for the construction, renovation, maintenance, and repair of CL.

B. The laboratory shall conform to the required space for the conduct of its activities. Personnel, fixtures, equipment, sink, etc. shall also be considered. Minimum area requirements for each are listed in Annex D.

C. There shall be well–ventilated, lighted, clean, safe, and functional areas based on the services provided.

D. There shall be a program of proper maintenance and monitoring of physical plant and facilities.

E. There shall be policy guidelines on laboratory biosafety and biosecurity which includes risk assessment that will serve as the basis of biosafety level required for the specific CL.

F. There shall be an area for confirmatory testing for Rapid HIV Diagnostic Algorithm (CrCL) and Glucose–6–Phosphate Dehydrogenase (G6PD) Deficiency which may be a section, unit, or division integrated in a DOH licensed CL, if applicable.

 

II.    PERSONNEL

Every CL shall have an adequate number of trained personnel, depending on the Workload, to provide safe, effective, and efficient services to clients.

A.   Head of the Laboratory (HOL)

1. The head of the laboratory shall be a competent and experienced professional, with a specialized skill set related to and appropriate to the laboratory category, to ensure that the laboratory staff runs efficiently. The head of the laboratory is essentially responsible for the operation of the entire laboratory, its personnel, functions, and data, all of which shall meet the quality assurance criteria and regulatory requirements.

2. The head of the laboratory shall oversee the operation of the CL and have administrative and technical supervision of the activities including the Mobile Clinical Laboratories (MCL), remote collection activities, and Point Of Care Testing (POCT), if applicable.

3. The head of the laboratory shall supervise the staff in accordance with the standards set by the Philippine Society of Pathologists.

4. The head of the laboratory shall visit once a month and at least twice a week of supervisory calls and/or videoconferencing OR at least once a week physical visit. For hospital–based DOH licensed CL, it shall be once a week physical visit. The visits shall have to be well documented.

5. For Geographically Isolated and Disadvantaged Areas (GIDAs) with no Clinical Pathologists, as certified by the Philippine Society of Pathologists, board certified Anatomic Pathologists or Physicians with complete training in Clinical Laboratory Medicine, Quality Assurance and Laboratory Management, may head one primary DOH licensed CL.

B.    Registered Medical Technologist (RMT)

1. There shall be an adequate number of full–time RMT to conduct the laboratory procedures, including those assigned in MCL. The number of staff shall depend on the workload and the services being provided.

2. There shall be staff development and continuing education program at all levels of organization to upgrade the knowledge, attitude, and skill of staff.

3. There shall be a designated Biosafety and Biosecurity Officer in–charge primarily of the risk assessment of the DOH licensed CL.

C.    Support Staff

1. There shall be an adequate number of support staff such as, but not limited to laboratory technician, laboratory aide, encoders, and receptionists when applicable.

D.   POCT Coordinator – if applicable

1. A Senior Staff form the CL shall be designated as POCT coordinator who shall have the following function, but not limited to:

a. Recommends procedures that will ensure the quality of results of POCT in consultation with the Pathologist.

b. Ensures that POCT machines/device and kits are properly maintained.

c. Supervises the operators of POCT device/machine.

d. Ensures that the operators have appropriate training and checks the competency of the operators regularly.

e. Ensures that Quality Control (QC) is implemented and reviews POCT QC results periodically, depending on the number of tests.

E. POCT Operator – if applicable

1. The designated operator of the POCT device/ machine and testing kits shall have the following functions, but not limited to:

a. Ensures accurate results of POCT.

b. Ensure that POCT machines/device and kits are properly maintained and stored.

c. Run tests on quality control at least once each day or as recommended by the manufacturer.

d. Initially, implements quality assurance program or contact the manufacturer’s Applications Specialist for assistance, when a POCT machine/device is not properly functioning, or the control sample is in out control range.

e. Reports to the supervising CL any untoward incidents or problems concerning POCT.

F. MCL Personnel

1. MCL shall has it own set of personnel, which includes the following but not limited to:

a. Registered Medical Technologist – number will depend on the anticipated workload.

b. Support staff such as, but not limited to, driver and laboratory technician.

 

III.           EQUIPMENT/INSTRUMENTS/REAGENTS/GLASSWARES/SUPPLIES

Every CL shall have an adequate equipment, instruments, reagents, glassware, and supplies which are all in good working condition and sufficient for the operations.

A. There shall be available and operational equipment/machines/devices to provide the laboratory examination that the laboratory is licensed for.

B. There shall be a calibration, preventive maintenance, and repair program for every equipment/machines/instruments/device in the DOH licensed CL.

C. There shall be a contingency plan in case of equipment/machines/devices breakdown and malfunction.

D. There shall be adequate available reagents, glassware, and supplies for the laboratory examinations.

E. There shall be an inventory control of the reagents, glassware, and supplies.

F. The reagents, glassware and supplies shall be properly stored under the required conditions.

G. The machines/devices, reagents and test kits that are used in the CL and MCL as well as POCT shall be approved by the Philippine Food and Drug Administration and validated by the proper government institutions (e.g., National Reference Laboratory).

H. The MCL shall have its own set of functional, and operational equipment, as well as its own set of supplies.

 

IV.   SERVICE DELIVERY

The service provided by the CL shall ensure quality and safety to clients, to its personnel and to the public.

A. All Cl shall ensure that the service being delivered to patients must comply with the standards and other related relevant issuances.

B.  Mobile Clinical Laboratory

1. The collection site/area for MCL shall be located within the same region, at a maximum of one hundred (100) kilometer radius, from the address of the DOH licensed CL.

2. Aside from specimen collection for different tests within the service capability of the main CL, the MCL shall be allowed to perform the following on–site tests which shall be declared in the LTO of the main CL:

a.     Urinalysis

b.     Fecalysis

c.      Pregnancy Test (lateral flow)

d.     Basic Serologic Test using Rapid Test Kits – Dengue, Screening of Hepatitis B, RPR/Syphilis Test, and HIV.

3. Specimen collected for other test, not mentioned above (Section IV.B.2), should be properly handled and transported. Serum blood samples for chemistry testing must be separated within four (4) hours from the time of collection.

           

V.    INFORMATION MANAGEMENT

Every CL shall maintain a system of communication, recording, reporting and releasing of results.

A.   Administrative Policies and Procedures

1. The CL shall have written policies and procedures for the provision of laboratory services, the operation and maintenance of the CL, which includes satellite laboratories, MCL and POCT, and shall include the accountabilities of every personnel working in the laboratory.

2. There shall be documented technical procedures for services provided in each section of the laboratory, including MCL and POCT, which will ensure the quality of laboratory results.

3. There shall be a risk assessment for every section in the CL.

B. Communication and Records Management

1. The CL shall maintain and ensure the confidentiality of all records.

2. There shall be procedures for the receipt and performance of routine and STAT requests for laboratory examinations.

3. There shall be procedures for the reporting of results of routing and STAT laboratory examinations, including critical values that would impact on patient care.

4. All results shall be released in accordance with DOH guidelines.

5. All laboratory reports on various examinations of specimens shall bear the name, PRC registration number, and original signature of the Registered Medical Technologist(s) who performed the laboratory examinations, and the Pathologist who shall be accountable for the reliability of the results.

6. There shall be a policy guideline on the use of digital signature. The use of digital signature for laboratory results shall be permitted only if properly authenticated by the Department of Information and Communication – Philippine National Public Key Infrastructure. The use of digital signature shall also be in accordance with the provisions of the E–Commerce Law.

7. There shall be procedures for the reporting of workload, quality control, inventory control, work schedule and assignments.

8. There shall be procedures for the reporting and analysis of incidents, adverse events, and in handling complaints.

9. The retention of laboratory documents, records, slides, and specimens shall be in accordance with the standards promulgated by the DOH or by competent authorities for such purposes.

10.  The operating hours of the CL shall be known to its clients.

11.  The CL which supervises the POCT shall have a master list of the following, but not limited to:

a.     Name and designation of operators, and,

b.     POCT machines, instruments, and kits.

 

VI.  QUALITY IMPROVEMENT

Every CL shall establish and maintain a system for continuous quality improvement activities.

A. There shall be an Internal Quality Assurance Program which shall include:

1. An Internal Quality Control Program for technical procedures.

2. An Internal Quality Assurance Program for inputs, processes, and outputs.

3. A Continuous Quality Improvement Program covering all aspects of laboratory performance. 

B. The CL shall participate in External Quality Assessment Program (EQAP) that may be administered by a designated NRL or other local and international EQAP approved by the DOH.

C. A periodic assessment shall be conducted by representative from the top management, clinical laboratory, clinical departments, and nursing service, to evaluate the policy of the CL on POCT.

 

VII. REFERRAL OF LABORATORY EXAMINATIONS

Every CL shall ensure that the quality of services provided through an agreement, or its equivalent, to a DOH licensed CL performing the laboratory services needed.

A. The referral laboratory must be a DOH–licensed CL. They shall have a Memorandum of Agreement (MOA) with the referring CL and shall be responsible for the collection, transport, and processing of specimens, and releasing of results.

B. A separate MOA is required when referred tests, which are not within the service capability of the CL, unless the referral is part of the contingency plan.

C. A MOA prescribing the accountabilities of each party, shall be secured when laboratory examinations are referred to and provided by another DOH–licensed CL.

D. Referral of examinations to other DOH–licensed Cl are only permitted in the following circumstances:

1. If the laboratory test to be sent out is not part of the service capability expected for the category of the referring laboratory; and,

2. If referral of laboratory test is part of the contingency plan, in cases of equipment breakdown, of the referring CL, this shall be for a certain limited period only, which shall not last for more than 3 months. This shall be properly documented.

 

VIII. ENVIRONMENTAL MANAGEMENT

Every CL shall ensure that the environment is safe for its patients and staff, including the public.

A. There shall be a program of proper maintenance and monitoring of physical facilities.

B. There shall be procedures for proper disposal of infectious wastes and toxic and hazardous substances in accordance with R.A. 6969, also known as “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990” and other related policy guidelines and/or issuances.

C. There shall be a “No smoking policy” and that the same shall be strictly enforced.

D. There shall be a contingency plan in case of accidents and emergencies.

E. There shall be a policy for biosafety and biosecurity.

F. There shall be policy guidelines on infection prevention and control.  

 

 

ANNEX C

PROHIBITED ACTS IN THE OPERATIONS OF CLINICAL LABORATORIES

Sanctions and penalties will be based on Section IX.B of the Administrative Order

A.   The Clinical Laboratory (CL) may be sanctioned or penalized upon commission of the following prohibited acts and violations:

1. Refusal to allow HFSRB/CHD – RLED authorized personnel to conduct inspection or monitoring visits of the clinical laboratory at any appropriate time.

2. Refusal or non–participation of any CL in an External Quality Assessment Program (EQAP) provided by a designated NRL or other local and international EQAP approved by the DOH.

3. Absence of action to improve the unsatisfactory or failed EQAP administered by a designated NRL or other local and international EQAP approved by the DOH.

4. Demonstrating incompetence or making consistent error in the performance of CL examinations and procedures.

5. Deviation from the standard test procedures including use of expired reagents.

6. Issuance of a laboratory report without the approval of the head of the laboratory.

7. Transferring of laboratory results done by another laboratory to the result form of the referring laboratory.

8. Performing laboratory procedures beyond their authorized service capability; and

9. Giving and receiving any commission, bonus, kickback, or rebate or engaging in any split–free arrangement in any form whatsoever with any facility, physician, organization, agency or person, either directly or indirectly, for patients referred to a CL licensed by the DOH.

10.  Violation of provisions in the Republic Act No. 10173 or the Data Privacy Act of 2021.

B. The DOH LTO will be revoked immediately after commission of the following prohibited acts and violations:

1. Permitting unauthorized or unregistered personnel to perform technical procedures and access to laboratory records/data.

2. Lending or using the name of the DOH–licensed CL or head of the laboratory or Medical Technologist to an unlicensed CL.

3. Unauthorized use of the name and signature of the pathologist and RMT to secure LTO.

4. Issuance of fraudulent laboratory results, or tests not actually done or inaccurate results.

5. Change in the ownership, location, and head of the laboratory of laboratory personnel without informing the HFSRB/CHD – RLED and,

6. Any material false statement in the application of LTO.

C.    Other violations similar or analogous to the above will be sanctioned and penalized accordingly.

 

ANNEX D1

PLANNING AND DESIGN GUIDELINES FOR GENERAL CLINICAL LABORATORY

 

A.   GENERAL CONSIDERATIONS

1. Location. The clinical laboratory shall be situated in an area that is accessible both to clients and staff.

2. Privacy. The design shall also provide appropriate levels of the client audible and visual privacy and dignity throughout the diagnosis process, from specimen collection to the releasing of results.

3. Conformance with Building Laws. The clinical laboratory shall conform to all applicable local and national regulation for the planning and design, construction, renovation, maintenance, and repair of its facilities.

4. Ventilation. Adequate ventilation with the acceptable air changes per hour shall be maintained for each specific area of the clinical laboratory.

5. Spaced required. The clinical laboratory shall have adequate space or area provided for its various space/room requirements to attain the effective and efficient operation of its activities and functions.

5.1  The spaces/areas of the clinical laboratory shall be zoned into the following areas, if applicable, and planned based on the functionality of the space and the activity workflow of the laboratory:

5.1.1       General Administrative Services and Public Areas;

5.1.2       Clinical Working Area;

5.1.3       Support Services Area; 

5.2  The General Administrative and Public Areas shall be comprised of the following spaces:

5.2.1   Business Area, provided with:

5.2.1.2  A Reception Area, for information and business transactions, receiving of specimen and releasing of results. 

5.2.1.3  Sufficient waiting area for clients. 

5.2.2   Collection Area. There shall be a collection area/s for specimen which is located outside the clinical working area.

5.2.3  Toilet Facilities, may be withing the premises of the facility but shall not within the clinical working area, or may be adjacent to the clinical laboratory.

5.2.3.1.1  Conveniently accessible toilet for the public.

5.2.3.1.2  A separate toilet for the staff.

5.3  The Clinical Working Area. The clinical working area shall be sufficient to accommodate its activities and allow for smooth and coordinated workflow. Areas and rooms intended for its sections shall be planned to meet the workload described in the functional program.

5.4  The Support Services Area(s) shall be composed of the following spaces:

5.4.1       Sufficient storage for records and supplies

5.4.2       Sterilization area/room

5.4.3       Waste holding area

5.4.4       Staff pantry

5.4.5       Other spaces for staff such as offices, conference room, lockers and changing room (gender–sensitive) and the like, are optional.

5.5  Business area and support services areas may be optional for One Stop Shop (OSS) Facility, provided it is identified and accessible from the clinical laboratory.

6. Functional and Planning Considerations

6.1  The different areas of the clinical laboratory shall be planned functionally related to each other to attain efficient workflow.

6.2  The clinical laboratory shall have space allocated for the performance of its work, and is designed to ensure the quality, safety and efficiency of the service provided to the user and the health, safety and comfort of laboratory personnel, patients, and visitors. The laboratory shall evaluate and determine the sufficiency and adequacy of the space allocate for the performance of the work to accommodate its activities and allow for smooth and coordinated workflow.

6.3  There shall be sufficient and appropriate storage spaces and conditions provided for laboratory specimens, documents, records, manuals, equipment, reagents, supplies, slides, and tissues blocks.

6.4  The clinical working area shall be sufficient to accommodate its activities and allow for smooth and coordinated workflow. Areas and rooms intended for its sections shall be planned to meet the workload described in the functional program. A dedicated room or area for each section of the laboratory shall be provided inside the clinical working area.

 

B.  SPECIFIC TECHNICAL REQUIREMENTS

1. Collection area for blood extraction shall provide space, equipment, and furniture appropriate for its activity performed. The area shall have work counter/tray, space for patient seating, and handwashing stations.

2. Specimen collection toilet for urine and feces shall be equipped with water closet and/or urinal and lavatory. This facility may be located outside the main clinical laboratory, a designated cubicle for specimen collection in a toilet facility, or a dedicated toilet solely for specimen collection.

3. A Pathologist’s area may be provided and shall be located adjacent to or within the clinical working area so that he/she may have easy access to clinical working area of the laboratory. Its location shall permit the Pathologist to observe the clinical working area. It can be a separate room or a cubicle within the clinical working area.

4. Entrance to clinical working area must not be directly located to high traffic areas that might cause unwanted air current drafts which may cause potential damage to equipment and possible contamination of specimen. A hand washing area (with designated dressing area is recommended) at the entry and exit points of the clinical working area is required.

5. Sections of the clinical laboratory shall be provided with stainless steel sink with a depth of at least 8 inches and gooseneck faucet.

6. Each section of the laboratory shall be properly identified in the clinical working area. Separate rooms for both Histopathology and Microbiology section and for molecular pathology, if provided, shall be provided.

7. Provision of toilets and other amenities for staff (e.g., lockers, pantry and changing room) shall be located outside the clinical working are to prevent contamination.

8. Biosafety Cabinets and isolation hoods shall be located so that fluctuations in air supply and exhaust or the operations of equipment do not alter the performance standard of the cabinet/hood.

9. Fire safety. The clinical laboratory shall conform to the applicable provisions of the 2019 Revised Implementing Rules and Regulations (IRR) of Republic Act 9514 or the Fire Code of the Philippines. In addition, there is no more than 23 meters of travel distance to any exit door from any point of the clinical working area.

10.  Corridors. The minimum width for corridor for clinical laboratory shall be at least but not limited to 1.2 meters or four (4) feet. Wider corridors shall be provided taking into consideration of passage of large equipment, movement of people and the activity involved.

11.  Clearances. Adequate clearances intended for working space in the clinical working area shall be provided. Clearance from work counter in the clinical working area from a wall shall be at least 1.2 meters or four (4) feet and 1.52 meters or five (5) feet for a work counter to another work counter to allow passage of staff while others are working. Other consideration shall also be given for adequate clearances, such as size and type of equipment, activity involved, ergonomics and anthropometrics.

12.  Suitable facilities for quick drenching or flushing of the eyes and body parts shall be provided within the clinical laboratory for immediate emergency use. Such unit must be within 30 meters for work access, hands–free eyewash unit with hand wash unit is preferred.

13.  Lighting. All areas be well–lighted by providing appropriate luminaire with no exposed or dangling electrical wires and unwanted glare shall be avoided. Also, convenience outlets shall be provided within the facility.

14.  Ceiling Height. Ceiling Heigh of the clinical laboratory shall conform to the provisions of the National Building Code of the Philippines. The floor–to–ceiling height of rooms containing biosafety cabinet and fume hoods shall be at least 2.6 meters. For rooms containing tall and ceiling–mounted equipment, the ceiling shall be of sufficient height to accommodate the equipment and/or fixtures.

15.  Plumbing. Continuous and sufficient supply of water shall be always made available in both working and hand washing areas. Piping systems shall be kept concealed as possible yet should be located where they be easily accessible for service and repairs with a minimum of disruption of normal laboratory services.

16.  Ventilation. Artificial Air Conditioning shall be provided in the clinical working area to attain required HVAC requirements (i.e., exhaust fan, fume hood, air conditioning). Exhaust fan shall be provided in the clinical working area and its sections as a minimum requirement, with dedicated exhaust fan for rooms in the Microbiology and Histopathology sections.

Exhaust in the clinical working area shall be directed to the outside and air from clinical working area must not be recirculated within the facility. Directional airflow in the laboratory is recommended, wherein air should move from clean to less clean areas, with specific exceptions, based on the functional program of the laboratory and its sections.

There should be a sufficient air exchanges in the clinical working area, depending on the use and contents of the space.

17.  Space. Adequate area should be provided for the people, activity, furniture, equipment, and utility.

SPACE	AREA IN SQUARE METER
GENERAL ADMINISTRATIVE AND PUBLIC AREAS
Business Area
Reception Area	5.02 m2/staff
Waiting Area	0.65 m2/person
Collection Area
Extraction Area (for blood)	6 m2/chair or couch
Specimen Collection Toilet            (for stool and urine)	1.67 m2
Public Toilet	3.06 m2
Staff Toilet	1.67 m2
Pathologist Area	5.02 m2/staff
SUPPORT SERVICES AREA
Storage Area for Supply and Records	4.65 m2 or 1.2 m2/storage unit
Sterilization Unit/Room	4.65 m2
Waste Holding Area	4.65 m2
Staff Pantry	1.4 m2/person
Conference Room (Optional)	1.4 m2/person

18.  Material Specification

18.1  Walls and partition. All walls of the Clinical Laboratory in general shall be structurally sound, safe, and sturdy with minimum fire–resistant rating as prescribed by the Fire Code of the Philippines for this type of occupancy. Wall finish shall be with impervious, smooth, less terminations, and easy to clean.

Interior wall or partitions and walls of the clinical working area and its sections shall be constructed from floor to ceiling.

Cubicle curtains and draperies if used for the clinical laboratory shall be non– combustible or flame–retardant.

18.2  Flooring. Floors in general shall be made of durable and shall be readily cleanable and wear resistant. Floor subject to traffic while wet (i.e., entrance porch, toilet facilities) shall have a non–slip surface. Floors in the clinical working area shall be seamless and self–coving to a height of 6 inches (152.4 mm) towards the wall.

18.3  Work counters. Work counters shall be provided with finish that does not support bacterial growth, durable, non–porous, smooth, and easy to clean, stain and dirt resistant, preferably seamless finish. Sink or lavatory, preferably stainless steel with faucet, preferably gooseneck, with adequate supply of water shall be provided. The width of the work counter shall be at least 600 mm (750 mm or 30 inches is preferred).

Backsplash or wainscoting shall be provided in the work counter, preferably with the same material with the countertop finish or its equivalent with at least 400 mm high.

18.4  Windows. Windows and openings shall follow the requirements of Rule VII of the National Building Code of the Philippines. If operable window is utilized in the clinical working area, it should be fitted with arthropod–proof screens.

18.5  Doors. The minimum clear opening for the main door/s of the clinical laboratory and the clinical working area and exit doors shall be at least 900mm. There shall also be at least one door with a minimum width of 900mm for rooms/sections housing large instruments and equipment. No doors in the clinical working area shall be less than 800mm. The main door of the clinical laboratory and doors to the clinical working area shall have appropriate fire ratings, and preferably be self-closing.

18.6  Carpeting, fabrics, wood, and other similar finishes shall be avoided.

19.  Additional Requirements

The clinical laboratory shall provide for additional requirements depending on the type of pathogens handled in the facility and biosafety level required based on the conducted risk assessment, in adherence with the requirements of laboratory biosafety and biosecurity.

 

ANNEX E

GUIDELINES IN SECURING FOR REMOTE COLLECTION PERMIT FOR CLINICAL LABORATORIES

1. Only DOH–licensed Clinical Laboratories (CL) without mobile clinical laboratory (MCL) shall be required to apply for Remote Collection Permit – CL (RCP – CL).

2. Remote collection can only be done in the following non–clinical laboratory settings such as but not limited to:

2.1.Schools

2.2.Offices

2.3.Churches

2.4.Other areas used for community–based activities.

3. The remote collection facility should have a proper area for specimen collection (e.g., clean toilet for urine and stool collection).

4. Only employed Registered Medical Technologists (RMTs) of the applicant’s CL shall be allowed to collect blood samples/specimens.

5. The activity at the remoted collection facility shall only last for four (4) to six (6) hours.

6. No testing at the remote collection facility shall only last for four (4) to six (6) hours.

7. Specimen should be properly handled and transported.

a. Samples for routine urinalysis and routine fecalysis shall be stored at refrigerated temperature within one (1) hour from the time of collection.

b. The serum from blood samples for chemistry must be separated within four (4) hours from the time collection.

8. The remote collection facility shall be located within the same region, at a maximum of one hundred (100) kilometer radius, from the address of DOH licensed CL.

9. RCP – CL shall be secured from the DOH at least seven (7) working days prior to the scheduled activity.

10.  RCP – CL shall be secured from the DOH regulatory office in accordance with DOH guidelines.

11.  RCP – CL shall be signed by the Director IV of HRSRB or Center for Health Development (CHD), or his designate.

12.  The following are the documentary requirements:

a. Letter of request, signed by the Head of Clinical Laboratory, to conduct remote collection with the following information:

·       Name of the Facility with DOH – LTO number

·       Address of facility

·       Date of collection

·       Time of collection

·       Venue

·       Estimated number of clients

·       Specimen to be collected. 

b. Notarized Memorandum of Agreement or contract between the contracting parties.

c. Technical or operational procedures for remote collection including specimen handling and transportation.

d. List of laboratory supplies/equipment to be used during remote collection including the transport materials.

13.  A remote collection permit fee of Php 500.00 for each site shall be collected from the clinical laboratory.

14.  The RCP – CL shall be valid only up to the date of collection. In case of failure to conduct the collection at the specified date, the laboratory shall inform the HFSRB or CHD – Regulation, Licensing and Enforcement Division (CHD – RLED) in writing, at least within 48 hours before the scheduled date of remote collection and shall be informed of the new schedule which should be within the validity period. Otherwise, another RCP – CL shall be secured.

15.  A copy of the RCP – CL shall be posted in conspicuous area of the remote collection facility.

16.  The clinical laboratory shall maintain records of all remote collection performed.

17.  The HFSRB or CHD – RLED may inspect the remote collection site prior to the issuance of the permit or monitor during the actual collection.

18.  In case of failure to conduct the collection at the specified date, the laboratory shall inform the HFSRB or CHD – RLED in writing, at least within 48 hours before the scheduled date of remote collection and shall be informed of the new schedule which should be within the validity period. Otherwise, RCP – CL shall be secured.

19.  Home service blood collection shall be exempted from securing RCP – CL provided, that it is upon the patient’s doctor request, and the area of collection must be within (1) hour travel time, under normal circumstances, from the licensed clinical laboratory. To ensure proper specimen collection and handling, provision nos. 4, 5, 7.1 and 8 of these guidelines should be followed.

20.  Violations of the guidelines stated herein, and related policies of laws shall be the basis for suspension/revocation of the RCP – CL and the LTO of the main clinical laboratory.