Clinical Laboratory Licensing Standards PDF

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 th...

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 headone 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 1.67 m2 (for stool and urine) 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.