Clinical Laboratory Law PDF 2021-0037

CLINICAL LABORATORY LAW REPUBLIC ACT NO. 4688 Presentation by Brylle Kevin Ugay, RMT ADMINISTRATIVE ORDER NO. 2021 - 0037 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines) Clinical laboratory leadership:...

CLINICAL LABORATORY LAW REPUBLIC ACT NO. 4688 Presentation by Brylle Kevin Ugay, RMT ADMINISTRATIVE ORDER NO. 2021 - 0037 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines) Clinical laboratory leadership: ⚬ Managed by a Registered Medical Technologist ⚬ Headed by a Pathologist (Clinical or Anatomical) certified by the Philippine Board of Pathology Medical Technologist staffing: ⚬ Number depends on workload and services provided REPUBLIC ACT NO. 4688 Also known as the Clinical Laboratory Act of 1966, Approved on June 18, 1966. To regulate the operation and maintenance of clinical laboratories and to require their registration with the Department of Health, providing penalty for the violation thereof and other purposes. SECTION 1 Clinical laboratories must register and secure an annual license from the Secretary of Health. SECTION 2 Only a licensed physician qualified in laboratory medicine and authorized by the Secretary of Health can be in charge of a clinical laboratory. Annual renewal of authorization required. Licenses for laboratories require administration by an authorized physician. SECTION 3 The Secretary of Health, through the Bureau of Research and Laboratories, is responsible for enforcing the Act. Authorized to issue rules and regulations necessary for enforcement. SECTION 4 Penalties for violations: Imprisonment: 1 month to 1 year Fine: 1,000 to 5,000 pesos Both fine and imprisonment, at the court's discretion. SECTION 5 Invalid sections of the Act do not affect the validity of the remaining provisions. SECTION 6 Authorization of fifty thousand pesos from the National Treasury to implement the Act. SECTION 7 All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. SECTION 8 The Act takes effect upon approval. Approved, June 18, 1966 ADMINISTRATIVE ORDER NO. 2021 - 0037 I. RATIONALE Focus on regulation to ensure access to quality and affordable health services, especially for the poor. Accurate laboratory results are essential for quality patient care. Republic Act No. 4688 mandates DOH to enforce and update regulations for laboratory performance. Technological advances require updated standards for clinical laboratories. ADMINISTRATIVE ORDER NO. 2021-0037 II. OBJECTIVE Prescribe revised minimum standards for clinical laboratories. III. SCOPE AND COVERAGE Applies to all operators of clinical laboratories in the Philippines. Includes analysis of tissues, fluids, secretions, excretions, etc. Exempts government clinical laboratories performing specific DOH program work. ADMINISTRATIVE ORDER NO. 2007-0027 IV. DEFINITION OF TERMS 1. Applicant: Person intending to operate a clinical laboratory. 2.BHFS: Bureau of Health Facilities and Services. 3.CHD: Center for Health Development. 4.Clinical laboratory: Facility performing tests on human specimens. 5.Critical values: Life-threatening values requiring prompt action. 6.DOH: Department of Health. 7.EQAP: External Quality Assessment Program. 8.Inspection tool: Checklist for evaluating laboratory compliance. 9.Institution: Establishment organized for educational, medical, or charitable purposes. 10.License: Document issued by DOH to operate a clinical laboratory. ADMINISTRATIVE ORDER NO. 2007-0027 IV. DEFINITION OF TERMS 11. Licensee: Entity holding the license. 12. LTO: License to Operate. 13. Mobile Clinical Laboratory: Mobile testing unit with a base laboratory. 14. Monitoring Examinations: Series of tests for treatment guidance. 15. NRL: National Reference Laboratory. 16. POL: Physician’s Office Laboratory. 17. POCT: Point of Care Testing. 18. Routine Tests: Basic tests not requiring immediate release of results. 19. Satellite Testing Site: Testing site under a licensed laboratory. 20. STAT Tests: Urgent tests with immediate results within one hour. ADMINISTRATIVE ORDER NO. 2007-0027 V. General Guidelines 1. All CL shall secure DOH – LTO 2. The DOH – LTO shall be secured from the DOH regulatory office in accordance with DOH guidelines. 3. Only DOH–licensed CL may have a SCL 4. A DOH–licensed CL may have MCL 5. The DOH–licensed CL shall not perform any examinations or testing beyond its authorized service capability. 6. Unit/Section of health facilities performing diagnostic CL 7. The head of the CL shall be a Pathologist certified by a professional organization 8. There shall be an adequate number of competent personnel assigned 9. CLs that are operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH – HFSRB. ADMINISTRATIVE ORDER NO. 2007-0027 V. General Guidelines 10. The DOH designated NRL shall be covered by the license of the CL of the hospital where they are affiliated with. 11. All CLs shall make their prices for laboratory services accessible to the public 12. 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. 13. At the CHD, the Director IV, shall approve the issuance of the DOH – LTO of the CL. 14. In the advent of new technologies or diagnostic platforms that shall affect the current licensing standards for CL 15. The CL shall be compliant with the prescribed standards and requirements 16. The DOH – LTO may be revoked, suspended, or modified in full or in part for any false statement by the applicant ADMINISTRATIVE ORDER NO. 2007-0027 VI. SPECIFIC GUIDELINES CLASSIFICATION OF CLINICAL LABORATORIES A. Ownership: 1. Government 2.Private B. Function: 1. Clinical Pathology: Includes multiple disciplines such as chemistry, hematology, microbiology. 2.Anatomic Pathology: Includes surgical pathology, cytology, autopsy. C. Institutional Character: 1. Institution Based 2.Freestanding ADMINISTRATIVE ORDER NO. 2007-0027 VI. CLASSIFICATION OF CLINICAL LABORATORIES D. Service Capability: 1. General Clinical Laboratory: ⚬ Primary Category: Routine hematology, urinalysis, fecalysis, blood typing. ⚬ Secondary Category: Adds routine clinical chemistry, quantitative platelet determination, cross matching, Gram staining, KOH. ⚬ Tertiary Category: Adds special chemistry, special hematology, immunology, microbiology. ADMINISTRATIVE ORDER NO. 2007-0027 V. CLASSIFICATION OF CLINICAL LABORATORIES 2. Special Clinical Laboratory: Offers highly specialized services not provided by general laboratories. Laboratories can offer additional services if they comply with staffing, equipment, and supply requirements and list these services under their LTO. Limited Service Capability: For institution-based labs like dialysis centers, offering specific required tests. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 1. Permit to Construct 1. A filled-out application form for DOH – PTC 2. A DOH – PTC shall be required for construction of a new CL and for renovation or expansion of existing CL 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).” ADMINISTRATIVE ORDER NO. 2007-0027 VI. PROCEDURAL GUIDELINES 2. LTO (License to Operate) Any person, firm or corporation desiring to establish, operate, and maintain CL shall submit an accomplished application form to HFRSB/CHD – RLED A complete application for DOH – LTO or CL Completely filled out application Form 1 and its attachments Notarized Acknowledgement 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) Accomplished Self–Assessment Tool Health Facility Geographic Form Copy of Official Receipt payment Certificate from NRL – SLH/SACCL for rHIVdaA Confirmatory, if applicable. Certificate from Newborn Screening Reference Center (NSRC), if applicable. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 2. LTO (License to Operate) Upon receipt of the complete application forms, the HFRSB/CHD – RLED representative, in accordance with the current DOH guidelines, 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 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. Submitted complete applications that are not processed within twenty (20) days by the HFRSB/CHD – RLED, Only DOH licensed CL identified by the program and has already secured a certificate of “Certified rHIVda Confirmatory Laboratory (CCL)” from the NRL A DOH – licensed hospital – based tertiary CL, already certified by the NSRC, may apply as G6PD Deficiency confirmatory laboratory to HFRSB. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 2. LTO (License to Operate) 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. 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. 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. Different branch(es) of a CL, even if owned by the same entity shall secure separate DOH – LTO. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 2. LTO (License to Operate) 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.” The DOH – LTO shall be placed in an area that can be readily seen by the public, always. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 3. Certificate of Registration COR is required for research and teaching laboratories. Applicants shall submit an accomplished registration form The applicant shall be required to pay a non–refundable application fee before submission of the requirements as part of complete application. The HFSRB shall evaluate and accept applications based on the due execution of forms and completeness of attachments. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 4. Validity The DOH – LTO is valid for one (1) year. 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. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 5. Fees All fees shall follow the prescribed fees by the DOH. 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. ADMINISTRATIVE ORDER NO. 2007-0027 VII. PROCEDURAL GUIDELINES 6. Monitoring 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. 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. 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. ADMINISTRATIVE ORDER NO. 2007-0027 VIII. ROLES AND RESPONSIBILITIES A. Health Facilities and Services and Regulatory Bureau shall Set standards for the regulation of CL and strictly enforce the provisions of this order. Disseminate regulatory policies, standards, and forms for information and guidelines of the DOH – CHDs. Provide consultation and technical assistance to stakeholders, including regulatory officers from the DOH – CHDs in line with the regulations of CL. Respond promptly to complaints relative to the operation of CL under its jurisdiction. ADMINISTRATIVE ORDER NO. 2007-0027 VIII. ROLES AND RESPONSIBILITIES B. Center for Health Development – Regulatory, Licensing and Enforcement Division Strictly enforce the provision of this Order. Submit quarterly report on Suspension/Revocation/Cease and Desist Order issued on CL not later than the 15th day of the following month after the covered quarter. Provide consultation and technical assistance to stakeholders in line with the regulations of CL. Respond promptly to complaints relative to the operation of CL under its jurisdiction. ADMINISTRATIVE ORDER NO. 2007-0027 VIII. ROLES AND RESPONSIBILITIES C. National Reference Laboratories Provide laboratory reference/referral services for confirmatory testing. Train laboratory personnel and recognize other training institutions. Maintain the National External Quality Assessment Scheme (NEQAS). Perform technical evaluation of reagents and diagnostic kits. ADMINISTRATIVE ORDER NO. 2007-0027 VII. ROLES AND RESPONSIBILITIES D. DOH-licensed Clinical Laboratories Continuously comply with the rules and regulations, licensing standards and requirements for CL, as provided in this Order and related issuances. 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. In times of Pandemic of Public Health Event, be mandated to submit timely reports and data. ADMINISTRATIVE ORDER NO. 2007-0027 IX. VIOLATIONS 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. 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: 1st Offense: Stern Warning 2nd Offense: Thirty thousand pesos (Php 30,000.00) 3rd Offense: Fifty thousand pesos (Php 50,000.00) 4th Offense: Revocation of DOH – LTO 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. 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). ADMINISTRATIVE ORDER NO. 2007-0027 IX. VIOLATIONS Section 4 of Republic Act No. 4688 shall still be impossible aside from the administrative penalty provided in this order. 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. 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. CL with revoked licenses can only re–apply after one year from the date of LTO revocation. 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. ADMINISTRATIVE ORDER NO. 2007-0027 IX. VIOLATIONS Section 4 of Republic Act No. 4688 shall still be impossible aside from the administrative penalty provided in this order. 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. 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. CL with revoked licenses can only re–apply after one year from the date of LTO revocation. 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. ADMINISTRATIVE ORDER NO. 2007-0027 XI. TRANSITORY PROVISIONS All existing licensed shall be given three (3) years to comply with the physical plant requirements from the date of effectivity of this order. 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. For New CL, this order shall be immediately applicable. 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. ADMINISTRATIVE ORDER NO. 2007-0027 XIII. REPEALING CLAUSE XIV. SEPARABILITY CLAUSE XV. EFFECTIVITY This Order shall take effect fifteen (15) days after its approval and publication in the Official Gazette or newspaper of general circulation THANK YOU!