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A copy of the inspection tool for licensure of a general clinical laboratory in the Philippines. This tool may serve as a guide for self-assessment of the facility in preparation for inspection/ monitoring visits.
Revised as of March 31, 2008 Page 1 of 9 INSPECTION TOOL FOR LICENSURE OF A GENERAL CLINICAL LABORATORY Name of Laboratory: _____________________________________________________________________________ Address: ______________________________________________________________________________________ Number & Address Barangay/ Municipality ______________________________________________________________________________________ Province/City Region Contact No./Fax No./E-mail Address: ________________________________________________________________ Application for: Initial Renewal License No: ____________ Date Issued: ____________ Expiry Date: ____________ GENERAL INFORMATION: Name of Owner or Institution: ______________________________________________________________________ Name of Head of Laboratory: ______________________________________________________________________ Classification according to: Ownership: Government Private Institutional Character: Institution-based Free-standing Service Capability: Primary Secondary Tertiary Limited LIST ACTUAL SERVICES OFFERED (include Mobile Lab if any) Instructions: (1) Encircle (+) if item indicated is present, and (-) if item indicated is absent/ present but non-functional. (2) All items with (*) shall be posted in a conspicuously designated area. (3) This tool may serve as a guide for self-assessment of the facility in preparation for inspection/ monitoring visits. Page 2 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS Application Documents Documentary requirements complete AO No. 2007- (+) (-) 0027 Section Certificates valid and required forms duly VII. B. – C. (+) (-) accomplished p. 7 – 8 1. MANAGEMENT REQUIREMENTS 1.1. Management Responsibility The clinical laboratory shall be managed effectively and efficiently and in accordance with its vision, mission, and objectives. 1.1.1. There shall be a continuing program on staff development AO No. 2007- and training. 0027 Section VI. B. 1. (a) v. 184.108.40.206. Proof of training through relevant certificates, memos, p. 5 (+) (-) written reports, budgetary allocations, etc. 1.1.2. There shall be a policy for hiring, orientation and promotion AO No. 2007- for all levels of personnel. 0027 Section VI. B. 1. (a) 220.127.116.11. Documented procedure/ process on hiring, orientation p. 5 (+) (-) and promotion of personnel at all levels 1.1.3. There shall be a policy for discipline, suspension, demotion AO No. 2007- and termination of personnel at all levels. 0027 Section VI. B. 1. (a) 18.104.22.168. Documented procedure/ process on discipline, p. 5 (+) (-) suspension, demotion and termination of personnel at all levels Page 3 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 1.2. Manpower The clinical laboratory shall be organized to provide effective and efficient laboratory services. 1.2.1. The organizational chart shall be clearly structured. AO No. 2007- 0027 Section 22.214.171.124. Organizational chart clearly structured indicating the VI. B. 1. (a) (+) (-) names with pictures and designation, reflecting lines of p. 5 authority, accountability, communication, inter- relationship, hierarchy of functions and flow of referrals 1.2.2. Duties and responsibilities shall be clearly spelled out. 126.96.36.199. Documented duties and responsibilities of all clinical (+) (-) laboratory personnel 1.2.3. The general clinical laboratory shall be headed and managed AO No. 2007- by a Clinical and/ or Anatomic Pathologist certified by the 0027 Section Philippine Board of Pathology (PBP). If the head is certified VI. B. 1. (a) i. – in Anatomic Pathology only, there shall be a consultant iii. p. 5 certified in Clinical Pathology. 188.8.131.52. The clinical laboratory shall be headed and managed (+) (-) by a licensed physician certified by the Philippine Board of Pathology. This shall apply to all general clinical laboratories be they government or private, institution based or freestanding. 184.108.40.206. In laboratories offering Clinical Pathology services only, (+) (-) the head of such laboratory shall be certified in Clinical Pathology or in both Clinical Pathology and Anatomic Pathology. 220.127.116.11. In laboratories offering both Anatomic and Clinical (+) (-) Pathology services, the head shall be certified in both Anatomic and Clinical Pathology; if the head is certified in Clinical Pathology only, he should have an associate in Anatomic Pathology; and if the head is certified in Anatomic Pathology only, he should have an associate in Clinical Pathology. 18.104.22.168. In tertiary clinical laboratories, the head shall undergo (+) (-) additional training in either laboratory management for a period of at least 2 weeks or its equivalent or for health service management for a period of no less than 2 months or its respective equivalent; however, those with masters degree in hospital or health administration or in public health or in business administration with major in health services administration or their equivalent shall be deemed to have complied with this requirement. Page 4 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 22.214.171.124. An anatomic pathologist who has been head of a (+) (-) primary or secondary clinical laboratory or a pathologist who has been head of a tertiary clinical laboratory but has not had laboratory management training as defined in item #126.96.36.199 for a period of at least 5 years at the time of effectivity of this A.O., shall continue to remain in such post up to and until his eventual retirement, resignation, end of term or termination for just cause. Any and all successors must comply with the provisions above; provided however, that this shall not prevent those falling under this provision from again assuming headship of a laboratory if and when the exigencies of the service so require. 188.8.131.52. An anatomic pathologist who currently heads primary or (+) (-) secondary clinical laboratories for a period of less than 5 years at the time of effectivity of this A.O., shall remain as head of such laboratories provided he/ she completes additional training in laboratory management within a period of one year. He/ she is allowed to retain headship of such laboratories in a prescribed geographic area of practice as may be determined by the Philippine Society of Pathologists (PSP). 184.108.40.206. In areas where clinical pathologists are not readily (+) (-) available, as certified by the PSP, the BHFS shall allow the following to handle primary or secondary clinical laboratories in the following order of priority: Board certified anatomic pathologists who have had training in clinical pathology for at least 2 years; Board certified anatomic pathologists who have no training in clinical pathology; Licensed physicians who are not board certified in either clinical or anatomic pathology but who have residency training in clinical pathology for at least 2 years. 220.127.116.11. In areas where pathologists are not readily available, as (+) (-) certified by the PSP, the BHFS shall allow duly licensed physicians who shall have undergone and successfully completed training in clinical laboratory medicine, quality assurance and laboratory management conducted by the BRL, CHD or PSP and jointly certified to with BHFS to head only one hospital clinical laboratory. 18.104.22.168. The head shall assume the technical and administrative (+) (-) supervision and control of the clinical laboratory. Page 5 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 1.2.4. There is an adequate number of qualified staff with AO No. 2007- documented training and experience to conduct the 0027 Section laboratory procedures performed. VI. B. 1. (a) iii. – iv. p. 5 22.214.171.124. The staff shall be supervised by the head of the (+) (-) laboratory. 126.96.36.199. There shall be sufficient number of registered medical (+) (-) technologists proportional to the workload as determined by the head of the lab and shall be available at all times during hours of lab operation. For hospital-based clinical labs, there shall be an adequate number of med techs per shift to cover laboratory operations. 1.3. PHYSICAL FACILITIES/ Work Environment Adequate facility shall be in place for the safe and efficient operation of the clinical laboratory. 1.3.1. The clinical laboratory has adequate space for the conduct AO No. 2007- of its activities. 0027 Section VI. B. 1. (h) ii. 188.8.131.52. Ocular inspection demonstrates adequate space for the p. 6 (+) (-) equipment, furniture, storage of glassware, reagents and supplies and the activities of the laboratory staff 184.108.40.206. Work area accessible to laboratory personnel only and (+) (-) at least 10 square meters exclusive of areas not used for technical work. 1.3.2. The clinical laboratory shall be adequately ventilated, well- AO No. 2007- lighted, clean, safe and functional based on the services it 0027 Section provides. VI. B. 1. (h) iii. p. 6 220.127.116.11. Ocular inspection demonstrates good ventilation, (+) (-) lighting, cleanliness with no risk of physical and chemical hazards 1.3.3. There shall be a program of proper maintenance and AO No. 2007- monitoring of physical plant and facilities. 0027 Section VI. B. 1. (h) iv. 18.104.22.168. Documented program for the proper maintenance and p. 6 (+) (-) monitoring of physical plant and facilities 1.3.4. There shall be a policy on laboratory biosafety and AO No. 2007- biosecurity and for the proper disposal of waste and 0027 Section hazardous/ infectious substances that shall conform to the VI. B. 1. (h) v.- standards set by the DOH. vi. p. 6 22.214.171.124. Documented procedure/ process on laboratory (+) (-) biosafety and biosecurity and for the proper disposal of waste and hazardous/ infectious substances Page 6 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 1.4. EQUIPMENT Adequate equipment shall be in good working order. 1.4.1. There is an adequate number of operational equipment to AO No. 2007- provide the laboratory procedures the laboratory is licensed 0027 Section for. VI. B. 1. (b) i. p. 5 126.96.36.199. Equipment listed available in the laboratory (+) (-) 188.8.131.52. Equipment are operational. (+) (-) 184.108.40.206. Provision for personal protective equipment (+) (-) 1.4.2. There is a program for calibration, preventive maintenance AO No. 2007- and repair for the equipment. 0027 Section VI. B. 1. (b) 220.127.116.11. Record of schedule of calibration and maintenance of ii. p. 5 (+) (-) equipment 18.104.22.168. Record of reports of preventive maintenance and repair (+) (-) 1.4.3. There is a contingency plan in case of equipment AO No. 2007- breakdown. 0027 Section VI. B. 1. (b) 22.214.171.124. Documented contingency plan in case of equipment iii. p. 5 (+) (-) breakdown 1.5. REAGENTS AND SUPPLIES Adequate reagents and supplies shall be in good working order. 1.5.1. There is an adequate supply of properly stored and AO No. 2007- inventoried reagents and supplies for the laboratory 0027 Section examinations to be provided. VI. B. 1. (c) i.- ii. p. 5 126.96.36.199. Quality records of reagents/ supplies, their usage/ (+) (-) consumption and disposal are available 1.5.2. The reagents and supplies are stored under the required AO No. 2007- conditions. There are adequate storage facilities such as 0027 Section refrigerators for perishable reagents and supplies. VI. B. 1. (c) iii. p. 5 188.8.131.52. Temperature monitoring records (+) (-) 1.5.3. There is appropriate storage area/ technique for flammable, AO No. 2007- combustible and hazardous chemicals/ reagents. 0027 Section VI. B. 1. (h) v.- 184.108.40.206. Material Safety Datasheet (MSDS) available for all vi. p. 6 (+) (-) reagents/ supplies and accessible to all personnel at all times Page 7 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 1.6. ADMINSTRATIVE POLICIES AND PROCEDURES Policies and procedures for provision of laboratory services are AO No. 2007- formulated for the laboratory and in each of the sections. 0027 Section VI. B. 1. (d) 1.6.1. Documented and updated policies and procedures for p. 5 (+) (-) provision of laboratory services in the laboratory and in each of the sections 1.6.2. Documented policies, protocols, guidelines in the operation (+) (-) and maintenance of the laboratory 1.6.3. Documented policies and procedures on Point of Care AO No. 2007- (+) (-) Testing, if hospital based 0027 Section VI. A. 6. p. 5 1.7. COMMUNICATION AND RECORDS There shall be a system of communication, reporting and recording of results of examinations. 1.7.1. There are procedures for the receipt and performance of AO No. 2007- routine and STAT requests for laboratory examinations. 0027 Section VI. B. 1. (g) 220.127.116.11. Documented procedures for receipt and performance of i. p. 6 (+) (-) routine and STAT requests for laboratory examinations 1.7.2. There are procedures for reporting of results of routine and AO No. 2007- STAT laboratory examinations. 0027 Section VI. B. 1. (g) 18.104.22.168. Documented procedures for reporting of results of ii. p. 6 (+) (-) routine and STAT laboratory examinations 1.7.3. All laboratory reports on various examinations of specimens AO No. 2007- shall bear the name of the pathologist or designated 0027 Section associate who shall be responsible for the reliability of the VI. B. 1. (g) results. The reports shall bear the name of the registered iii. p. 6 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. 22.214.171.124. Laboratory report forms bearing the name of the head (+) (-) or associate 126.96.36.199. Laboratory reports signed by the medical technologists (+) (-) who performed the examinations 1.7.4. There are procedures for reporting of work load, quality AO No. 2007- control, inventory control, etc. 0027 Section VI. B. 1. (g) 188.8.131.52. Documented procedures for reporting of work load, iv. p. 6 (+) (-) quality control, inventory control, etc 1.7.5. There is a procedure for reporting and analysis of incidents, AO No. 2007- adverse events, etc. 0027 Section VI. B. 1. (g) 184.108.40.206. Documented procedure for reporting and analysis of v. p. 6 (+) (-) incidents, adverse events, etc 1.7.6. The retention of records of the laboratory shall follow AO No. 2007- standards promulgated by the Department of Health and/ or 0027 Section competent professional organizations. VI. B. 1. (g) vi. p. 6 220.127.116.11. Documented procedure for the retention of records (+) (-) which follows standards promulgated by the Department of Health Page 8 of 9 STANDARDS AND REQUIREMENTS REFERENCE FINDINGS 2. TECHNICAL REQUIREMENTS 2.1. TECHNICAL PROCEDURES The laboratory shall use appropriate technical procedures for AO No. 2007- services provided in each section, which will assure the quality of 0027 Section laboratory results. VI. B. 1. (e) p. 6 2.1.1. Technical procedures of services provided in each section are available. 18.104.22.168. Documented technical procedures for services provided (+) (-) in each section 2.2. QUALITY ASSURANCE PROGRAM The laboratory shall practice quality assurance program. 2.2.1. There shall be a policy on Quality Assurance Program and AO No. 2007- Continuous Quality Improvement. 0027 Section VI. B. 1. (f) 22.214.171.124. Documented Internal Quality Assurance Program i. p. 6 (+) (-) including Internal Quality Control and Continuous Quality Improvement 126.96.36.199. Results/ findings of Quality Assurance audits/ (+) (-) assessments 2.2.2. The laboratory shall participate in an External Quality AO No. 2007- Assessment Program (EQAP) administered by the 0027 Section designated National Reference Laboratories (NRL) or other VI. B. 1. (f) EQAP approved by the BHFS-DOH. ii. p. 6 188.8.131.52. Documented procedure in the actual performance of (+) (-) the EQAP activities administered by the NRLs. 184.108.40.206. Certificate of participation of the laboratory in an EQAP (+) (-) administered by the NRLs or by a NEQAP approved by the BHFS-DOH 2.3. REFERRAL OF EXAMINATIONS OUTSIDE OF THE CLINICAL LABORATORY When laboratory examinations are referred to and provided by an AO No. 2007- outside clinical laboratory, the referring clinical laboratory shall 0027 Section obtain assurance of the quality of services provided through an VI. B. 1. (i) agreement or its equivalent with a licensed clinical laboratory p. 6 performing the laboratory services needed. 2.3.1. There shall be a policy on referral and outsourcing of examinations. 220.127.116.11. MOA or its equivalent on referral of laboratory services (+) (-) to outside duly licensed clinical laboratory 18.104.22.168. Documented Procedures on referral and outsourcing of (+) (-) examinations to other licensed clinical laboratories 22.214.171.124. SOPs and records of outsourced examinations (+) (-) Page 9 of 9 Note for presence of other laboratories in the vicinity: If any, indicate the kind of laboratory and provide details. Research Lab Special Clinical Lab Teaching Lab Animal Lab Pulmo Lab, Neurology Lab, etc. Others, specify: _________________________________ Remarks: _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ RESULT: Compliance - Comply with ALL standards and requirements Non-Compliance - Does not comply with ALL standards and requirements Regulatory Officers: _______________________________ ____________________ __________________ Signature over Printed Name Designation Date _______________________________ ____________________ __________________ Signature over Printed Name Designation Date Authorized Representative(s) of the Clinical Laboratory: _______________________________ ____________________ __________________ Signature over Printed Name Designation Date _______________________________ ____________________ __________________ Signature over Printed Name Designation Date
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