AO 2021-0037 comparison with previous AO in 2007.pptx

Comparison of previous AO 2007 to current AO 2021

1. Orientation on the Administrative Order No. 2021-0037 “New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines”

2. RATIONALE By virtue of Republic Act No. 4688 s. 1966, “An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty forthe 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 mandated 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. 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and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines,” may have become outdated.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 procedures with the requirements of AO 2020- 0047 titled “Rules and Regulations Governing the Licensure of Primary Care Facilities in the Philippines.” The necessity to review the current AO 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. 11223 or the Universal Health Care Act which is to guarantee access to quality and affordable health products, devices, facilities and services.

3. SUBJECT ADMINISTRATIVE ORDER No. 2021-0037 New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

4. OBJECTIVE ADMINISTRATIVE ORDER No. 2021-0037 To ensure accountability of the laboratory on generation of accurate, precise and reliable laboratory results in a timely manner through continuous compliance

5. SCOPE ADMINISTRATIVE ORDER No. 2021-0037 This AO shall apply to all individuals, agencies, partnerships or corporations, private or government-owned

6. GENERAL GUIDELINES All CL shall secure DOH-LTO prior to its operation and must comply with the minimum regulatory standards and requirements at all times. The DOH-LTO shall be secured from the DOH regulatory office in accordance with DOH guidelines. Only DOH-licensed institution-based CL may have a SCL which shall be located within the premises of the regulated health facility. A DOH-licensed CL may have MCL services as listed in Section IV of Annex A, provided, they adhere to the standard testing protocols. 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 ), proviged that the additional services have been approved and indicated as add-on services in the DOH-LTO of the CL.

7. GENERAL GUIDELINES Unit/Section of health facilities performing diagnostic CL tests 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. 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. 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. CLs that are operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH-HFSRB.

8. GENERAL GUIDELINES 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. All CLs shall make their prices for laboratory services accessible to the public as mandated by the UHC law and related DOH issuances. 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. At the CHD, the Director IV, shall approve the issuance ofthe DOH-LTO of the CL. 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 supplementsto this Order.

9. GENERAL GUIDELINES The CL shall be compliant with the prescribed standards and requirements (Annex A), Assessment Tool for Licensing Clinical Laboratories (Annex Bl and B2) and other relevant laws and issuances. These standards shall also apply to MCL and SCL . 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 a violation of, or failure to comply with any of the terms and conditions and provisions of these rules and regulations.

10. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2021-0037 BY OWNERSHIP GOVERNMENT PRIVATE

11. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY FUNCTION CLINICAL PATHOLOGY ANATOMIC PATHOLOGY CLINICAL PATHOLOGY ANATOMIC PATHOLOGY MOLECULAR PATHOLOGY

12. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2021-0037 BY INSTITUTIONAL CHARACTER INSTITUTION-BASED NON-INSTITUTION- BASED

13. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY GENERAL CLINICAL LABORATORY Primary Secondary Tertiary Limited Service 2. SPECIAL CLINICAL LABORATORY CLINICAL LABORATORY FOR CLINICAL AND PATHOLOGY Primary Secondary Tertiary Limited Service 2. CLINICAL LABORATORY FOR ANATOMIC PATHOLOGY only 3. CLINICAL LABORATORY FOR MOLECULAR PATHOLOGY only

14. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY (Clinical Laboratory and Anatomic Pathology) Primary Provides the following minimum service capabilities: Routine Hematology [Complete Blood Count — includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction ( Hematocrit ), Leucocyte Number Concentration (White Blood Cell or WBC Count) and Leucocyte Type Number Fraction (Differential Count) Complete Blood Count Qualitative Platelet Determination - Quantitative Platelet Count

15. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY (Clinical Laboratory and Anatomic Pathology) Primary Provides the following minimum service capabilities: Blood Typing — for hospital based Clinical Microscopy: Routine Urinalysis Routine Fecalysis Forward and reverse ABO grouping and Rh typing (tube method) Clinical Microscopy: Urinalysis Fecalysis Fecal Occult Blood Test, Pregnancy test (rapid test kits) Wet smear for Trichomonas

16. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY (Clinical Laboratory and Anatomic Pathology) Primary Optional: -Serology: Dengue, HBsAg , Syphilis; HIV Screening test TB (DSSM) Serology: Dengue, HBsAg , Syphilis; HIV Screening test TB (DSSM) or Nucleic Acid amplification test for government Additional: - Chemistry:FBS /RBS, OGTT, Lipid Profile (Cholesterol, Triglycerides, HDL, LDL), Creatinine , BUN, Uric acid

17. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY(Clinical Laboratory and Anatomic Pathology) Secondary Primary category laboratory + Routine Clinical Chemistry includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, Blood Total Cholesterol Concentration Quantitative Platelet Determination Cross Matching — for hospital based Gram Staining — for hospital based KOH — for hospital based Primary category laboratory plus Serum electrolytes ( Sodium,Potassium , Chloride), ALT AST Hematology : For hospital-based: coagulation studies ( PT,aPTT ) Microbiology: Gram Stain KOH Anatomic: Pap smear

18. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY (Clinical Laboratory and Anatomic Pathology) Tertiary Provides the minimum service capabilities of a secondary category laboratory plus the following: Special Chemistry Immunology Microbiology — culture and sensitivity • aerobic and anaerobic (for hospital based) • aerobic or anaerobic (for non-hospital based) - Special Hematology, including coagulation procedures Provides the minimum service capabilities of a secondary category laboratory plus: Other Clinical Chemistry Examinations; Hospital-based: ABG Any machine-based serological and immunological testing such as, but not limited to: tumor markers, thyroid function tests and hepatitis profile Microbiology — culture and sensitivity - aerobic and anaerobic - Anatomic: For hospital-based: Cytology and Histopathology

19. CLASSIFICATION OF CLINICAL LABORATORIES CLASSIFICATION ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 BY SERVICE CAPABILITY (Clinical Laboratory and Anatomic Pathology) Limited-Service Capability - (For institution-based only) Provides the laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics Provides one (1) or two (2) specialized tests that are not classified under Anatomic or Molecular Pathology: Hormones, Trace metals, tumor markers, allergy panel *DOH-based Program Laboratory DOH Program related tests: Kato Katz, Malarial smear, Filaria smear, Slit skin smear, RPR

20. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 1. PTC N/A Required 2. ISSUANCE OF LTO/COR All non hospital/hospital based clinical laboratories (LTO) All non hospital/hospital based clinical laboratories (LTO); clinical laboratories for research and teaching purposes (COR) 3. VALIDITY LTO: 1 YEAR LTO: 1 YEAR COR: 3 YEARS

21. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 4. VIOLATIONS 1. Refusal or nonparticipation 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; 2. . Issuance of a laboratory report without the approval of the head of the laboratory 3. Permitting unauthorized or unregistered personnel to perform technical procedures 4. Demonstrating incompetence or making consistent errors in the performance of CL examinations and procedures; 5. Deviation from the standard test procedures including use of expired reagents 6. Reporting or releasing erroneous results 7. Lending or using the name of the DOH-licensed CL or the head of the laboratory or medical technologist to an unlicensed CL Refusal to allow HFSRB/CHD-RLED authorized personnel to conduct inspection or monitoring visits of the clinical laboratory at any appropriate time; Refusal or nonparticipation 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; 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; Demonstrating incompetence or making consistent errors in the performance of CL examinations and procedures; Deviation from the standard test procedures including use of expired reagents;

22. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 4. VIOLATIONS 8. Unauthorized use of the name and signature of the pathologist and medical technologist to secure LTO 9. Reporting a test result for a clinical specimen even if the test was not actually performed 10. Transferring of laboratory results done by another laboratory to the result form of the referring laboratory 11. Performing or reporting tests in a specialty or subspecialty in which the laboratory is not licensed 12. Giving and receiving any commission, bonus, kickback or rebate or engaging in any split-fee 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 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-fee 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.

23. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 4. VIOLATIONS B. The DOH_LTO will be revoked immediately after commission of the following prohibited acts and violations: Permitting unauthorized or unregistered personnel to perform technical procedures and access to laboratory records/data; Lending or using the name of the DOH-licensed CL or the head of the laboratory or medical technologist to an unlicensed CL; Unauthorized use of the name and signature of the pathologist and RMT to secure LTO; Issuance of fraudulent laboratory results, or tests not actually done or inaccurate results; Change in the ownership, location, and head of the laboratory or laboratory personnel without informing the HFSRB/CHD-RLED; and, Any material false statement in the application of LTO.

24. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 4. SANCTIONS (for non hospital-based) CL without DOH LTO: subject to imprisonment for not less than 1 month or fine of not les than Php 1,000.00 and not more than Php 5,000.00 or both at the discretion of the court. 1 st offense: stern warning 2 nd offense: Php 30,000.00 3 rd offense: Php 50,000.00 4 th offense: Revocation of DOH-LTO (Re-apply after 1 year) A CL without DOH PTC and corresponding DOH LTO shall be issued CDO with administrative penalty of Php 50, 000.00 5. COMPLAINTS The BHF/CHD Director/authorized representative shall conduct an investigation to verify if the concerned laboratory is accountable for the alleged violation. The CHD Director, after the investigation shall suspend,cancel , revoke the LTO for a determined period of time who are found violating the provisions of R.A 4688. In case of complaints, the CL, upon receipt of such by 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 to the cl during the investigation depending on the seriousness of violation.

25. PROCEDURAL GUIDELINES ADMINISTRATIVE ORDER No. 2021-0037 TRANSITORY PROVISIONS 1. COMPLIANCE TO PHYSICAL PLANT: 3 YEARS 2. COMPLIANCE TO ADDITIONAL SERVICES AND PERSONNEL/EQUIPMENT: 2 YEARS 3. For CL currently headed by Anatomic Pathologists with an associate Clinical Pathologist or Clinical Pathologists heading tertiary CL with Anatomic Pathology services, such headships shall be retained until his/her eventual retirement, resignation or replacement

26. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 License to operate/ accreditation Certificate and other documents •Valid licenses/Certificates posted in a conspicuous area visible to client •Compilation of Clinical Laboratory AOs, Report of Inspection/Monitoring •Copy of lab floor layout •Notarized MOA with clinicians for inst.-based laboratory (if applicable) Document Review • Compilation of Clinical Laboratory AOs, Reports of Inspection/Monitoring   PTC is required Institution Based – a laboratory that operates within the premises and operates as part of a DOH licensed health facility. Policy on Management Review •Conduct of regular staff meetings held at least twice a year or as needed. •Documented minutes of meeting (reflecting the date, time, attendance, agenda and action taken signed by head of laboratory) shall be present and properly filed up Document Review • Written policy on management review • Compilation of documented minutes of meeting reflecting the date, time, attendance, agenda, and action taken signed and approved by head of laboratory • Supporting documents for evaluation and monitoring of activities such as records, logbooks, checklist of supplies, inspection report, purchasing or procurement and acceptance of supplies, etc .

27. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 Adequate number of qualified personnel with documented training and experience to conduct the laboratory procedures performed. •List of Personnel with designation (other functions or special assignments ) •Area of assignments indicated in the posted work schedule signed and approved by head of laboratory •Proof of attendance •Proof of qualifications: Updated copy of 201 File: Resume PRC ID and Certificate PSP Board Certificate (Head) Notarized Employment contract Training Certificates Annual Health status (Latest Medical Certificate) Copy of Authority to practice certificate signed by the head of the Government facility, if applicable Document Review • List of Personnel with designation • Area of assignments indicated in the posted work schedule signed and approved by head of laboratory Proof of attendance Proof of qualifications (please refer to specific personnel) • Authority to practice signed by the head of the government facility, if applicable (A.O. # 92 s. 2003) There is a policy whenever there is an increase in workload , there shall be a corresponding increase in the number of personnel Workload ratio per shift (8 hours) 1:50 – manual method 1:50 – semi automated method 1:100 – fully automated method *If 70% of services are performed in an automated method , facility is considered as fully automated

28. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 Adequate number of qualified personnel with documented training and experience to conduct the laboratory procedures performed. Cont.. Document Review • There is a policy on hiring or designating additional personnel

29. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 Qualification of the Head of Laboratory   CP/AP Clinical Laboratory (Primary, Secondary, Tertiary) – Certified Clinical Pathologist (CP) Anatomic Laboratory – Certified Anatomic Pathologist (AP) Molecular Laboratory (Immunohematology, Infectious) – Certified Clinical Pathologist (CP) B. Registered Medical Technologist (RMT )   Generalized assignment Document Review Proof of qualifications: • Updated resume • PRC certificate and valid PRC ID • Relevant training certificates • Notarized employment contract • Annual medical certificate At least 1 competent RMT per assigned area Document Review Proof of qualifications: • Updated resume • PRC certificate and valid PRC ID • Relevant training certificates • Notarized employment contract • Annual medical certificate • Proof of immunization (Hepatitis B and Influenza)

30. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 There is policy on the implementation of National Database of Human Resource for Health Information System (NDHRIS)   N/A Document Review • Proof of submission of data to NDHRHIS (still awaiting for the policy direction from MIS) Each personnel shall have a record of updated 201 files   Document Review • Updated 201 files of all laboratory personnel Document Review • Updated 201 files of all laboratory personnel

31. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 The Head of the Laboratory shall have the overall supervision on technical procedures as well as on the administrative   Documented proof of Supervisory visit at least once a month or as needed. Proof of qualifications: • Updated resume • PRC certificate and valid PRC ID • PSP Board Certificate • Notarized employment contract • Relevant training certificates Annual medical certificate Document Review • Proof of supervisory visits at least once a week for physical visit OR once a month physical visit with at least twice a week of supervisory calls and/or video conferencing • For HOL of hospital-based clinical laboratory: supervisory physical visits of at least once a week Proof of qualifications: • Updated resume • PRC certificate and valid PRC ID • PSP Board Certificate • Certificate of Good Standing from PSP • Notarized employment contract • Relevant training certificates (e.g., Molecular Pathology) • Annual medical certificate and proof of immunization (Hepatitis B and Influenza)

32. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 RMT staff with designated assignments, as applicable:   •Valid HIV-trained RMT for lab with HIV Services (Required full time RMT for OFW facility)   •Certificate of training on DSSM for lab with AFB services   •Certificate of Training on Bacteriology (Tertiary category) Additional proof of trainings rHlVda - Certificate of proficiency (SACCL) AFB microscopy - Certificate of training on DSSM (NTRL ) Bacteriology - Certificate of training in bacteriology (RITM and other RITM recognized institutions) Malaria smear - Certificate of training in malaria smear (RITM) Others C. Biosafety and Biosecurity Officer (May be designated by the HOL)   N/A Document Review • PRC certificate and valid PRC ID (RMT) • Certificate of training in Biosafety and Biosecurity (RITM and/or UP-NTCBB)

33. ASSESSMENT TOOL Staffing Pattern for RMT Analysts ADMINISTRATIVE ORDER No. 2007-0027

34. ASSESSMENT TOOL Staffing Pattern for RMT Analysts ADMINISTRATIVE ORDER No. 2021-0037

35. ASSESSMENT TOOL Staffing Pattern for RMT Analysts AO 2007-0027 AO 2021-0037

36. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 Policy guidelines on laboratory biosafety and biosecurity •Documented procedure/ process on laboratory biosafety and biosecurity •Good Laboratory Practice that includes use of PPE and other precautionary measures Document Review • Written protocols on laboratory biosafety and biosecurity • Good Laboratory Practice that includes use of Personal Protective Equipment and other precautionary measures • Local risk assessment reviewed at least annually Adequate supply of properly stored and inventoried reagents and supplies for the laboratory examinations to be provided. •Certificate of Product Registration and evaluation of National Reference Labs.(NRL), Food & Drug Administration (FDA) etc.(If applicable) Certificate of Product Registration from FDA including the reagents, supplies, and equipment used for POCT and MCL

37. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 Administrative policies & procedures for provision of laboratory services and for the operation and maintenance of the laboratory •Documented policies, protocols, procedures signed and approved by the head of laboratory •Guidelines in the operation and maintenance of the laboratory including policy on security of supplies, specimens and confidentiality of records •Documented policies, protocols, procedures signed and approved by the head of laboratory •Guidelines in the operation and maintenance of the laboratory including policy on security of supplies, specimens and confidentiality of records Laboratory services and corresponding prices are accessible to the public ( DC 2021-0216 ) Technical procedures of services provided in each section are available •Documented technical procedures provided in each section • Documented policies, protocols, and guidelines in the operation and maintenance of the laboratory Procedures for reporting of results of routine and STAT laboratory examinations •Documented procedures for reporting of results of routine and STAT laboratory examinations. Documented procedures for reporting of results of routine and STAT laboratory examinations. Documented procedures for the validation of laboratory results prior to reporting

38. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 All laboratory reports on various examinations of specimens shall bear the name of the pathologist or designated associate who shall be responsible for the reliability of the results. The reports shall bear the name of the registered medical technologist(s) who performed the examinations and duly signed by that person(s). Electronic signatures will be permitted in accordance to the E- commerce law.   •Laboratory report forms bearing the name of the head or associate and facsimile signature with PRC ID No . •Laboratory reports bearing the name of RMT and original signature with PRC ID No. who performed the examinations •Updated records of result (logbooks/ electronically stored data with back up) including entry, releasing & endorsement records Policy for Laboratory Information System (LIS) (if available) Laboratory report forms bearing the name of the head or associate and facsimile signature with PRC ID No. • Laboratory reports bearing the name of RMT and original signature with PRC ID No. who performed the examinations •Updated records of result (logbooks/ electronically stored data with back up) including entry, releasing & endorsement records Policy for Laboratory Information System (LIS) (if available) There is a policy guideline on the use of authenticated electronic/digital signature that is in accordance with the E- commerce law • Documented policy for Laboratory Information System, if available

39. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 The retention of records of the laboratory shall follow standards promulgated by the Department of Health •Documented procedure for the retention of records which follows standards promulgated by the Department of Health Documented procedure for the retention of records which follows standards promulgated by the Department of Health Compiled laboratory tests results, whether logbook or electronically stored Policy on referral and outsourcing of examinations. •Documented Procedures on referral and outsourcing of examinations to other licensed clinical laboratory •Records of outsourced examinations •MOA, DOH license or its equivalent on referral of laboratory services to outside duly licensed laboratory Documented Procedures on referral and outsourcing of examinations to other licensed clinical laboratory •Records of outsourced examinations •MOA, DOH license or its equivalent on referral of laboratory services to outside duly licensed laboratory DOH-LTO of referral testing laboratory

40. RETENTION OF RECORDS

41. RETENTION OF RECORDS

42. RETENTION OF RECORDS

43. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 There is a policy on POCT   Document Review • Documented list of POCT operators, machines, instruments and kits • Documented procedure on the conduct of periodic assessment by representatives from the top management, clinical laboratory, clinical department and nursing service, to evaluate the policy of the clinical laboratory on POCT There is a policy on Mobile Clinical Laboratory   Document Review • Documented Procedures on Collection of specimens Processing of specimens • Land Transportation Office Registration (proof of ownership) • File of Memorandum of Agreement between the clinical laboratory and the facility where the mobile activity is conducted

44. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 SPECIMEN COLLECTION BLOOD EXTRACTION   Slides Alcohol 70% Cottons Capillary Tubes Labeling Materials Tourniquet Lancet Test Tubes Sterile Medical tape Syringe(any gauge 21,22,23) Slides Alcohol 70% Cottons Capillary Tubes Labeling Materials Tourniquet Lancet Test Tubes Sterile Medical tape Syringe(any gauge 21,22,23) PUNCTURE PROOF SHARPS CONTAINER

45. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 SPECIMEN COLLECTION OTHER BODY FLUIDS   Specimen container w/ cover or Screw Cap (50mL) Applicator Stick Plastic calibrated loop and other necessary materials Sterile Screw Cap Specimen Container Sterile Swab Specimen container w/ cover or Screw Cap (50mL) Applicator Stick Plastic calibrated loop and other necessary materials, if applicable Sterile Screw Cap Specimen Container, if applicable OTHER EQUIPMENT Non- Mercurial Thermometer: (Room and storage refrigerator) Refrigerator Non- Mercurial Thermometer: (Room and storage refrigerator) Refrigerator (samples/reagents) Fire Extinguisher (Class B) Spill Kits

46. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL MICROSCOPY URINALYSIS   EQUIPMENT/INSTRUMENTS (MANUAL) Clinical Centrifuge (2,000 rpm)¹ Microscope (Binocular Compound) REAGENTS 4 - parameter strips 10 - parameter strips EQUIPMENT/INSTRUMENTS (AUTOMATED) Strip Reader REAGENTS 10 Parameters Control Low Normal High EQUIPMENT/INSTRUMENTS (MANUAL) Clinical Centrifuge (2,000 rpm)¹ Microscope (Binocular Compound) REAGENTS 4 - parameter strips 10 - parameter strips EQUIPMENT/INSTRUMENTS (AUTOMATED) Strip Reader Urine Analyzer REAGENTS Controls Normal Pathologic

47. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL MICROSCOPY URINALYSIS   SUPPLIES Slides Test tubes(10ml)¹ Cover Slips Test Tube Rack Applicator sticks SUPPLIES Slides Test tubes(10ml)¹ Cover Slips Test Tube Rack Applicator sticks

48. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL MICROSCOPY STOOL ANALYSIS   EQUIPMENT/INSTRUMENTS (MANUAL) Microscope (Binocular Compound) REAGENTS Normal Saline Solution Lugol’s Iodine SUPPLIES Slides Test tubes(10ml)¹ Cover Slips Test Tube Rack Applicator sticks EQUIPMENT/INSTRUMENTS (MANUAL) Microscope (Binocular Compound) REAGENTS Normal Saline Solution Lugol’s Iodine SUPPLIES Slides Test tubes(10ml)¹ Cover Slips Test Tube Rack Applicator sticks PREGNANCY TEST Pregnancy Test Kit Pregnancy Test Kit

49. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL MICROSCOPY FECAL OCCULT BLOOD Occult Blood Test Kit (Optional ) Occult Blood Test Kit SPECIAL TESTS For DOH identified endemic areas only(e.g., Kato Katz, Schistosomiasis , Malaria smear, Filaria smear, slit-skin smear, rapid plasma regain for syphilis) Indicate the test

50. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY (MANUAL) HEMOGLOBIN EQUIPMENT/INSTRUMENTS Spectrophotometer or its equivalent REAGENTS Hemoglobin Reagent ( Cyanmet Hemoglobin) Standard SUPPLIES Cuvettes / test tubes Sahli / micro pipette EQUIPMENT/INSTRUMENTS Spectrophotometer or its equivalent REAGENTS Hemoglobin Reagent ( Cyanmet Hemoglobin) Standard SUPPLIES Cuvettes / test tubes Sahli / micro pipette

51. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY (MANUAL) HEMATOCRIT EQUIPMENT/INSTRUMENTS Hematocrit Centrifuge Hematocrit Reader SUPPLIES Capillary Tube Sealer EQUIPMENT/INSTRUMENTS Hematocrit Centrifuge Hematocrit Reader SUPPLIES Capillary Tube Sealer DIFFERENTIAL COUNT EQUIPMENT/INSTRUMENTS Differential Counter Slides Staining Glasses Microscope REAGENTS Hematology Staining Kit Oil immersion EQUIPMENT/INSTRUMENTS Differential Counter Slides Staining Glasses Microscope REAGENTS Hematology Staining Kit Oil immersion

52. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY (MANUAL) RBC, WBC, PLATELET COUNT EQUIPMENT/INSTRUMENTS Pipette Shaker Tally Counter Microscope RBC / micro pipette Hemacytometer w/ Cover Slips WBC / micro pipette Petri Dish (as applicable) REAGENTS RBC Diluent WBC Diluent Platelet Diluent EQUIPMENT/INSTRUMENTS Pipette Shaker Tally Counter Microscope RBC / micro pipette Hemacytometer w/ Cover Slips WBC / micro pipette Petri Dish (as applicable) REAGENTS RBC Diluent WBC Diluent Platelet Diluent

53. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY (AUTOMATED) COMPLETE BLOOD COUNT EQUIPMENT/INSTRUMENTS Hematology Analyzer REAGENTS Diluents Lyse Cleanse Solution Controls Low Normal High Other Reagents EQUIPMENT/INSTRUMENTS Hematology Analyzer REAGENTS Diluents Lyse Cleanse Solution Controls Low Normal High Other Reagents

54. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY BLOOD GROUPING (TUBE METHOD) EQUIPMENT/INSTRUMENTS Serofuge or its equivalent REAGENTS Blood Typing Sera FORWARD AND REVERSE ABO GROUPING AND Rh (D) TYPING (TUBE METHOD) EQUIPMENT/INSTRUMENTS Serofuge or its equivalent Test Tubes METHODS Manual Semi Automated Machine Automated REAGENTS Blood Typing Sera Normal Saline Solution Gel-type based blood typing reagents

55. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY CROSS MATCHING (HOSPITAL BASED) EQUIPMENT/INSTRUMENTS Water bath or its equivalent REAGENTS Anti- Human Globulin Enhancement solution(LISS) Normal Saline Soln . EQUIPMENT/INSTRUMENTS Water bath or its equivalent REAGENTS Anti- Human Globulin Enhancement solution(LISS) Normal Saline Soln.

56. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 HEMATOLOGY COAGULATION EQUIPMENT/INSTRUMENTS Calibrated Pipettes Coagulation Machine REAGENTS Coagulation Reagents Controls FOR HOSPITAL-BASED EQUIPMENT/INSTRUMENTS Calibrated Pipettes Coagulation Machine Cuvettes or its equivalent REAGENTS Coagulation Reagents Controls

57. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL CHEMISTRY ROUTINE TESTS (SECONDARY & TERTIARY) Blood Glucose, Total Cholesterol, Blood Uric Acid, Blood Creatinine , Blood Urea Nitrogen TERTIARY (Optional for Secondary) Other Special Tests: Liver Profile Lipid Profile & Other Body Fluids ROUTINE TESTS (PRIMARY) Blood Glucose (FBS,RBS,OGTT), Total Cholesterol, Triglycerides, HDL Blood Uric Acid, Blood Creatinine , Blood Urea Nitrogen ADDITIONAL SERVICE FOR SECONDARY CATEGORY ROUTINE TESTS (PRIMARY) PLUS ELECTOLYTES (Na, K, Cl ), ALT, AST ADDITIONAL SERVICE FOR TERTIARY CATEGORY PRIMARY PLUS SECONDARY TESTS PLUS OTHER CLINICAL CHEMISTRY EXAMINATIONS ARTERIAL BLOOD GAS (FOR HOSP.-BASED)

58. ASSESSMENT TOOL ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL CHEMISTRY ROUTINE TESTS (SECONDARY & TERTIARY) EQUIPMENT/INSTRUMENTS Spectrophotometer or its equivalent Calibrated Pipettes Clinical Centrifuge Water Bath or equivalent Timer Refrigerator REAGENTS Controls (Normal & Pathologic) Glucose Total Cholesterol Uric Acid Creatinine BUN ROUTINE TESTS (PRIMARY) EQUIPMENT/INSTRUMENTS Spectrophotometer or its equivalent Calibrated Pipettes Clinical Centrifuge Water Bath or equivalent Timer Refrigerator REAGENTS Distilled Water Standard/Calibrator Controls (Normal & Pathologic) Glucose Total Cholesterol Uric Acid Creatinine BUN Triglycerides HDL Oral Glucose Tolerance Drink

59. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL CHEMISTRY ELECTOLYTES (Na, K, Cl), ALT, AST OPTIONAL FOR SECONDARY CATEGORY ADDITIONAL SERVICE FOR SECONDARY CATEGORY EQUIPMENT/INSTRUMENTS Manual or Automated Analyzer REAGENTS Standard/Calibrator Controls (Normal & Pathologic) Na K Cl ALT AST

60. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL CHEMISTRY OTHER CLINICAL CHEMISTRY EXAMINATIONS TERTIARY (OPTIONAL FOR SECONDARY) ADDITIONAL SERVICE FOR TERTIARY CATEGORY EQUIPMENT/INSTRUMENTS Manual or Automated Analyzer REAGENTS Standard/Calibrator Controls (Normal & Pathologic) Test Reagents ARTERIAL BLOOD GAS (HOSPITAL-BASED) ADDITIONAL SERVICE FOR TERTIARY CATEGORY EQUIPMENT/INSTRUMENTS Manual or Automated Analyzer REAGENTS Standard/Calibrator Controls (Normal & Pathologic) Test Reagents

61. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 CLINICAL CHEMISTRY GLASSWARES/SUPPLIES Cuvettes Test tubes Glass Pipettes Pipette & Pipette tips Test Tubes Rack GLASSWARES/SUPPLIES Cuvettes Test tubes Glass Pipettes Pipette & Pipette tips Test Tubes Rack

62. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 IMMUNOLOGY/SEROLOGY (TERTIARY OPTIONAL FOR SECONDARY) RPR/Syphilis Test ASO Titer CRP Hepatitis Profile HBsAg & others Others: HIV Test (OFW) EQUIPMENT/INSTRUMENTS Clinical Centrifuge Microscope/ agglutination viewer Micro plate/ Strip System Bead System ELISA and Washer Set Water Bath at 37 0C REAGENTS Indicate Test Kits or Reagents BASIC SEROLOGIC TESTING using Rapid Test Kits (Dengue, Hepatitis B, Syphilis, HIV RAPID TEST KITS Dengue Syphilis Hepatitis B (Screening) HIV (Screening) EQUIPMENT/INSTRUMENTS Cuvettes Test Tubes Test Tubes Rack Glass Pipettes Pipettes and Pipette Tips Microscope or agglutination viewer REAGENTS Standard/Calibrator (if applicable) Controls (Normal & Pathologic) if appliable Other Test Reagents (if applicable)

63. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 IMMUNOLOGY/SEROLOGY MACHINE BASED SEROLOGICAL AND IMMUNOLOGICAL TESTING (TERTIARY OPTIONAL FOR SECONDARY) Hepatitis Profile HBsAg & others EQUIPMENT/INSTRUMENTS Micro plate/ Strip System Bead System ELISA and Washer Set Water Bath at 37 0C REAGENTS Indicate Test Kits or Reagents ADDITIONAL SERVICE FOR TERTIARY CATEGORY Tumor Markers, Thyroid Function, Hepatitis Profile EQUIPMENT/INSTRUMENTS Automated Analyzer Manual Spectrophotometer or its equivalent REAGENTS Standard/Calibrator Controls (Normal & Pathologic) Distilled Water Tumor Markers Thyroid Function Hepatitis Profile

64. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY Gram Stain KOH (TERTIARY OPTIONAL FOR SECONDARY) EQUIPMENT/INSTRUMENTS Microscope with Oil- immersion objective Staining Rack Bunsen Burner Timer REAGENTS Gram’s stain Kit 10% KOH GLASSWARES/SUPPLIES Slides Loop Applicator Sticks Forceps Cover Slips ADDITIONAL SERVICE FOR SECONDARY CATEGORY GLASSWARES/SUPPLIES Centrifuge Refrigerator REAGENTS 10% KOH Gram’s Stain Kit

65. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) Acid-Fast Bacilli Stain EQUIPMENT/INSTRUMENTS Isolation Hood with exhaust fan (Improvised) (optional for tertiary laboratory) REAGENTS Acid-Fast Bacilli Stain Kit GLASSWARES/SUPPLIES Slides Loop Applicator Sticks Forceps Cover Slips TB DIRECT SPUTUM SMEAR MICROSCOPY for Government Facilities EQUIPMENT/INSTRUMENTS Microscope (Binocular Compound) Staining Rack Bunsen Burner or Electric Loop Incinerator Isolation Hood with Exhaust Fan (improvised) Timer Slides Cover Slips Inoculating Loops Applicator Sticks Forceps REAGENTS Acid Fast Bacilli Stain Kit

66. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) CULTURE AND SENSITIVITY EQUIPMENT/INSTRUMENTS Incubator Drying Oven Autoclave Refrigerator Centrifuge Bunsen Burner or Electric /Loop Incinerator Weighing Scale Biosafety cabinet (Class II Type A with certification) Water Bath Candle Jar Caliper/Ruler Table Lamp Electric/Gas Stove Laboratory Thermometer Calibrated Inoculating Loops Timer Colorimeter Forceps ADDITIONAL SERVICE FOR TERTIARY CATEGORY EQUIPMENT/INSTRUMENTS Incubator Drying Oven Autoclave Refrigerator (with freezer) Weighing Scale Biosafety cabinet (Class II Type A with certification) Candle Jar Caliper/Ruler Table Lamp Electric/Gas Stove Laboratory Thermometer Calibrated Inoculating Loops Water Bath Sterile Swab Automated System /Blood Automated Card System (indicate the name of the machine)

67. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) CULTURE AND SENSITIVITY GLASSWARES/SUPPLIES Graduated Cylinder Beaker Petri dish Swabs Applicator Sticks Loop Glass Pipettes GLASSWARES/SUPPLIES Graduated Cylinder Beaker Erlenmeyer flask Petridish Glass Pipettes

68. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) CULTURE AND SENSITIVITY CULTURE MEDIA/REAGENTS BHI BAP MAC CAP GBA BCA SSA TCBS MHA TSB SFB APW Thio broth TSA MHA w/ 5% sheep Blood CULTURE MEDIA/REAGENTS BHI BAP MAC CAP GBA BCA SSA TCBS MHA TSB SFB APW Thio broth TSA MHA w/ 5% sheep Blood

69. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) CULTURE AND SENSITIVITY CULTURE MEDIA/REAGENTS Biochemical Reaction (Conventional Method/ Commercially Prepared) Sensitivity Disk/ Antimicrobial Disk Mac Farland Standard (0.5) Control Strains (ATCC) Pseudomonas aeroginosa Staphylococcus aureus Escherichia coli CULTURE MEDIA/REAGENTS Biochemical Reaction (Conventional Method/ Commercially Prepared) Sensitivity Disk/ Antimicrobial Disk Mac Farland Standard (0.5) Control Strains (ATCC) Pseudomonas aeroginosa Staphylococcus aureus Escherichia coli

70. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MICROBIOLOGY (TERTIARY) NUCLEIC ACID AMPLIFICATION TEST (NAAT) for Government Facilities N/A EQUIPMENT/INSTRUMENTS NAAT for TB REAGENTS Test Kits for NAAT

71. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 ANATOMIC PATHOLOGY PAP’S SMEAR FOR SECONDARY CATEGORY EQUIPMENT/INSTRUMENTS Microscope (Binocular Compound) Timer Slides Cover Slips Adhesive or its equivalent Forceps Staining Glasses REAGENTS Papanicolaou Stain

72. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 ANATOMIC PATHOLOGY (HOSPITAL BASED) -TERTIARY Surgical Pathology Cytology EQUIPMENT/INSTRUMENTS Microtome Paraffin Oven Tissue Processor REAGENTS Formalin Hematoxylin & Eosin Xylene Alcohol (50%, 70%, 80% 90%, 100%) Paraffin wax Xylene Chloroform Benzene Carbon tetrachloride Toluene GLASSWARES/SUPPLIES Slides Staining Glasses ADDITIONAL SERVICE FOR TERTIARY CATEGORY EQUIPMENT/INSTRUMENTS Microtome Paraffin Oven Automatic Tissue Processor Manual Technique Water Bath REAGENTS Formalin Hematoxylin & Eosin Stain Xylene Alcohol (50%, 70%, 80% 90%, 100%) Paraffin wax Chloroform Benzene Carbon tetrachloride Toluene

73. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 ANATOMIC PATHOLOGY (HOSPITAL BASED) -TERTIARY FROZEN SECTION (IF APPLICABLE) EQUIPMENT/INSTRUMENTS Cryostat Block-holder Staining Glasses REAGENTS Alcohols (70%, 80%,90%) Isopentane H & E stain EQUIPMENT/INSTRUMENTS Cryostat Block-holder Staining Glasses REAGENTS Alcohols (70%, 80%,90%) Isopentane H & E stain AUTOPSY (IF APPLICABLE) EQUIPMENT/INSTRUMENTS Ruler Autopsy Table Bone Saw Scalpel Scissors Rib Shears Toothed Forceps Weighing Scale

74. ANNEX A ADMINISTRATIVE ORDER No. 2007-0027 ADMINISTRATIVE ORDER No. 2021-0037 MOLECULAR PATHOLOGY INDICATE SERVICES EQUIPMENT/INSTRUMENTS Clinical Centrifuge Refrigerator PCR Other Machines/Equipment/Supplies REAGENTS Distilled Water Standard/Calibrator Controls (Normal & Pathologic) Test Reagents

75. ASSESSMENT TOOL DOH-HFSRB-QOP01-CLG-AT