Laboratory Management Lesson 7 - Licensing of Clinical Laboratories PDF

LABORATORY MANAGEMENT LESSON 7: LICENSING OF CLINICAL and blood processing LABORATORIES laboratories. In order to promote Blood services facility, drug testing...

LABORATORY MANAGEMENT LESSON 7: LICENSING OF CLINICAL and blood processing LABORATORIES laboratories. In order to promote Blood services facility, drug testing public health, it is laboratory, HIV testing laboratory, declared a national policy water testing laboratory to prevent trafficking in BLOOD SERVICE FACILITIES human blood and its (LICENSING) products and derivatives. Before WW II, blood was (before: commercial blood banks, collected and directly sell blood products, not properly administered to patients. screened) With the advent of Republic Act No. 7719 - National anticoagulants, blood could Blood Services Act of 1994 be preserved and stored in blood banks. An act promoting voluntary Voluntary blood donation blood donation, providing for began to be promoted after an adequate supply of safe WW II. blood, regulating blood banks, and providing penalties for violation thereof In order to promote public health, it is hereby declared the policy of the State: I. To promote and encourage CAVEAT IN BLOOD DONATION: voluntary blood donation by ✓ Protect the donor – ensures that the citizenry and to instill it is safe for the donor to donate public consciousness of the ✓ Protect the recipient – ensures principle that blood donation that any risk of transmitted is a humanitarian act. infection or other adverse effect II. To lay down the legal is minimize. principle that the provision of blood for transfusion is a RA 1517 – Blood Banking Law of professional medical service 1956 and not a sale of a An act regulating the commodity: collection, processing III. To provide for adequate, and sale of human safe, affordable and blood, and the equitable distribution of establishment and supply of blood and blood operation of blood banks  LABORATORY MANAGEMENT IV. To inform the public of the procedures and standards for need for voluntary blood the implementation of R.A. donation to curb the hazards 7719 to facilitate compliance caused by the commercial therewith and achieve the sale of blood; objective thereof. V. To teach the benefits and Section 3: SCOPE rationale of voluntary blood These rules shall apply to all donation. hospitals, entities, VI. To mobilize all sectors of the establishments or community to participate in institutions, government mechanisms for voluntary owned and operated or and non-profit collection of private, engaged in blood blood transfusion services in the VII. The DOH is mandated to Philippines, whether full time establish: National Blood or part time, local or foreign. Transfusion Service Network Section 4: DEFINITION OF TERMS in order to rationalize and improve the provision of CHAPER 1 adequate and safe supply of 4. BLOOD/BLOOD PRODUCTS blood Refers to human blood, ADMINISTRATIVE ORDER NO. 09 process or unprocessed and SERIES 1995 (MAY 12, 1995 ; 9 includes blood components, CHAPTERS) its products and derivative " RULES AND REGULATIONS 5. BLOOD TRANSFUSION SERVICES IMPLEMENTING REPUBLIC ACT No. 7719 OTHERWISE KNOWN AS THE A set of activities or functions "NATIONAL BLOOD SERVICES ACT OF related to blood transfusion 1994" such as, but not limited to, motivation and recruitment Section 1: TITLE of donors, blood collection, These rules shall be known as testing and screening of the "Rules and Regulations donor blood, preparation of Implementing Republic Act blood components, storage No. 7719 otherwise known and distribution of blood and as the NATIONAL BLOOD components, inventory SERVICES ACT OF 1994."* control and quality assurance. Section 2: PURPOSE These Rules and regulations 6. BLOOD BANK/CENTER are adopted prescribing the principles, guidelines, A laboratory or institution with the capability to requit  LABORATORY MANAGEMENT and screen blood donors, health to recruit and screen donors collect, process, store, and collect blood. transport and issue blood for 11. BLOOD STATION transfusion and provide information and/or A government or private hospital or a education on blood Philippine National Red Cross chapter transmissible diseases. which has not been licensed as a blood center but has been authorized 7. HOSPITAL BASED BLOOD by the Department to store and issue BANK/CENTER blood and blood products and A blood/bank center which is perform compatibility testing, when located and performing necessary, according to specific blood bank services within regulations in section 40 hereby; the premises of a hospital 12. BLOOD SERVICE FACILITY and which can perform compatibility testing of Any unit, office, institution providing blood. any of the blood transfusion services, which can be a Blood bank/center, a 8. NON-HOSPITAL BASED BLOOD blood collection unit or a blood BANK/CENTER station; A blood/bank center that 13. VOLUNTARY BLOOD DONOR which is not located and not performing blood bank An individual who donated blood on services within the premises one’s own volition or initiative and of a hospital and is not part not induced, directly or indirectly, in of the hospital. any manner whatsoever, by any monetary compensation. 9. COMMERCIAL BLOOD BANK 14. WALKING BLOOD DONOR A blood bank that exists for An individual who has been profit, money or any material screened by history and physical gain earned out of sale of, or examination, found to be fit to exchange for blood or blood donate blood, and included in products which profit, money the list f qualified voluntary or any material gain are not donors referred to section 4, solely used for the operation paragraph (e) of R. A. No. 7719, and maintenance of the who is ready to donate blood blood bank service. when needed in his or her 10. BLOOD COLLECTION UNIT community. An institution or facility duly 15. BLOOD TRANSFUSION authorized by the department of TRANSMISSIBLE DIEASES  LABORATORY MANAGEMENT Disease which may be transmitted through blood transfusion, including, but not limited to, acquired immune deficiency syndrome (AIDS), HEPATITIS b, Hepatitis C, Malaria and syphilis. BLOOD SERVICE FACILITY CHAPTER VI: A unit, agency or institution PHASE-OUT OF COMMERCIAL providing blood products BLOOD BANKS The type of BSF, i.e., Blood Provides option to Station, Blood Collection Unit, commercial blood banks to Hospital Blood Bank and solely clinical laboratories for Blood Center (Regional, the purpose of security of Subnational and National) tenure of personnel “the department shall affect the CATEGORIES OF BLOOD SERVICE phasing-out of all commercial CAPABILITIES (BLOOD SERVICE) blood banks over a period of (2) A. BLOOD CENTER year after the effectivity of R.A. B. BLOOD BANK 7719”. C. BLOOD COLLECTION UNIT CHAPTER VIII D. BLOOD STATION REGULATION OF BLOOD SERVICES A. BLOOD CENTER Provision on blood bank A non-hospital-based blood services including the service facility licensed by facilities, creation of blood the DOH BHFS with the bank centers, categories of following service capabilities: blood bank service 1. Donor capabilities, blood collection recruitment/retention unis, and blood stations. and care of voluntary Provision on new license blood donors. requirements, qualifications 2. Collection of blood of personnel, and recording, (mobile or facility-based) reporting, and from qualified voluntary documentation blood donors. requirements. 3. Processing and provision of blood components. 4. Storage, issuance, transport and distribution of unites of whole blood and/or  LABORATORY MANAGEMENT blood products to g. Issuance, transport hospitals and other and distribution of health facilities. blood/blood products 5. For national and h. Storage of blood subnational and selected products. regional blood centers 2. Non-Hospital-based only: testing of units pf category B when, in addition blood for 5 infectious to those performed under disease markers (anti – the non-hospital-based HIV ½, anti HCV, HBsAg, category A, it is capable of syphilis, malaria) providing, in addition to whole blood, all blood The blood centers shall be classified products components. into Regional, Subnational and 3. Hospital-based category A National whose service capabilities when, in addition to those will be determined by the National performed under the non- Council for blood services (NCBS) hospital-based Category A, it B. BLOOD BANK is capable of performing compatibility-testing. A blood bank/center may either be 4. Hospital-based Category B Hospital-based or Non-hospital – when, in addition to those based and may be licensed as performed under the category A or B when it meets the Hospital-based category A, it minimum required service is capable of providing, in capabilities set fourth hereunder. addition to whole blood, all 1. Blood bank/center shall be blood products and considered non-hospital- components; and of based category A when it can performing investigation of and is performing the ff: transfusion reactions and a. Recruitment of resolution of incompatible voluntary donors cross-matching results. b. Health education and BLOOD CENTER BLOOD BANK counselling LOCATOR c. Donor screening and selection The Philippine Red d. Blood collection Cross maintains a list of e. Basic blood blood centers and blood processing and testing banks in the country. (transfusion- https://redcross.org.ph/g transmissible ive-blood/ infections) f. Provision of whole blood and packed RBC  LABORATORY MANAGEMENT C. BLOOD COLLECTION UNITS 2. Storage, issuance of In coordination with other whole blood and related or appropriate packed red cells agencies, the Blood 3. Compatibility testing Banks/centers shall organize of red cell units, if and establish Blood Collection hospital-based. units (BCU) which is REQUIREMENTS FOR NEW LICENSE authorized to perform the following: A blood bank/center may be 1. Recruitment and granted a license to operate retention of voluntary only if it shall have complied blood donors; with the following minimum 2. Screening and requirements: selection of qualifies 1. Minimum number and voluntary blood qualification of personnel donors a. Category A Hospital based blood 3. Conduct of health bank/center education and The overall supervision counseling services and management shall 4. Collection of blood be under a competent from qualifies physician duly registered voluntary blood by the Professional donors Regulation Commission 5. Transport of blood (PCR) with a valid units collected to certificate of registration blood center for and a valid professional testing, processing license, who has at least and distribution to six (6) months training in hospitals and other blood banking services health facilities. under an institution or agency recognized by the D. BLOOD STATION BRL. A blood service facility duly The blood bank/center authorized by the Department shall have at least one (1) of Health (DOH) Center for Trained medical Health Development (CHD) technologist duly pursuant to A.O. 101- A s. registered by the PRC 2003 with the following with a valid certificate service capabilities: and a valid professional 1. Provision of whole license, who has at least blood and packed one (1) year on-the-job red cells training or experience in  LABORATORY MANAGEMENT blood banking services additional requirement under an institution or will not be necessary agency recognized by the C. Category B Hospital Based Blood BRL. Bank/Center b. Category B Non-Hospital-based Blood bank/Center The overall supervision and The minimum personnel management shall be under requirements for a PRC – registered and category A Blood licensed physician with a Banks/Centers( section valid certificate in Clinical or 28[2a)shall also be Anatomical Pathology from required of category B the Philippine Board of Non-Hospital-based Pathology with at least 6 Blood Banks/Centers. months additional training In addition to the in blood banking from a foregoing, the laboratory training institution and blood processing recognized by the BRL, section of the Category B and/or a certificate in Blood Non-hospital Based Banking from the Philippine Blood Bank/Center shall Board of Hematology. be managed by and The Blood Banks/centers in under the direct and this category shall also have regular supervision and one (1) trained medical of a PRC-registered and technologist and one (1) licensed physician other medical technologists certified by the or medical laboratory Philippine Board of technician with the same Pathology in Clinical or qualifications as those Anatomical Pathology required for a Category A with at least 6 months Blood Bank/Center. additional training in blood banking from a BLOOD COLLECTION UNITS training institution 1. All Blood Collection Units recognized by the BRL, shall have at least one PRC- and /or the Philippine registered physician and one Board of Hematology and PRC-registered medical Blood transfusion in technologists, both will valid Blood banking. However, certificate of registration and if the overall supervisor valid professional license. of the blood bank/center Both should have had at least is already a pathologists one (1) month training on trained in blood banking voluntary donor recruitment or a HEMATOLOGIST, this  LABORATORY MANAGEMENT and screening; voluntary Bank/Center which has donor holding and confirmed its recognition of motivation; health the coordination and education and counselling; cooperation arrangements blood collection, handling with the BCU. Such and transport; and confirmation may be management of blood contained in an appropriate collection activities and certificate. problems. Such training shall BLOOD STATIONS be done by an agency duly recognized by the BRL. 1. Blood stations may be 2. A blood collection unit shall located only within hospitals have adequate and proper premises, government or equipment and supplies of private, or within the good quality to be able to premises of the PNRC perform donor recruitment chapters. and screening; health 2. A blood station shall be education and counseling; under the responsibility of a blood collection, handling PRC-registered medical and transport; and technologists with a valid management of any certificate of registration and reactions according to the a valid professional license. BRL standards described in 3. A blood station shall have at SOP Manual on Blood least one properly services (section 38). functioning blood There shall be refrigerator with 24 hours written and readily power supply. available contingency 4. There shall be written and plan for all Blood readily available contingency Collection Units in plan for all blood stations in case of problems case of problems such as such as instrument instrument or equipment or equipment breakdown. breakdown. 5. All blood stations shall have a 3. Blood collection unit may be regular schedule, and a statistic or mobile. Physical written record, or arrangements for both kinds maintenances and service of during collection shall be all equipment and comfortable, clean and instrument used in blood adequate. bank. 4. The blood collection unit 6. Blood shall be issued only to shall be clearly attached to a patient confined within the network of one Blood hospital that houses stations  LABORATORY MANAGEMENT or to hospitals within the Confirmatory test area, unless called for by Refers to the analytical emergency conditions. procedure to identify and 7. The authority to operate a qualify the presence of a Blood station shall be specific drug or metabolite, renewed yearly, signed by which is independent of the the Regional Health Director initial test and which uses a and issued to the agency that different technique and operates the Blood chemical principle from that Bank/Center that will of the screening test in order distribute the blood bags to to ensure reliability and the station, with a copy of accuracy. furnished to the chief of the Ps. If the result is negative in the hospital where the blood screening test, you can release the station is located and the result. If it's presumptively positive medical technologist-in- or suspicious, send it to the charge. confirmatory test. BLOOD TRANSFUSION COMMITTEE Blood bank/centers shall CLASSIFICATION OF DRUG have organized blood SCREENING LABORATORIES: transfusion committees. The names of committee 1. OWNERSHIP members, their a. Government corresponding qualifications b. Private and tasks and functions shall 2. INSTITUTIONAL CHARACTER be submitted upon a. Institution-based application for license. b. Freestanding 3. SERVICE CAPABILITY a. Screening laboratory b. Confirmatory laboratory DRUG TESTING LABORATORIES 1. Classification by Ownership DRUG TESTING 1. Government - operated and maintained, partially or wholly, Screening test by the national government, a Refers to a test to eliminate local government unit negative specimen from (provincial, city or municipal), further consideration and to any other political unit or any identify the presumptively department, division, board or positive specimen that agency thereof requires confirmatory 2. Private - owned, established testing. and operated by any individual,  LABORATORY MANAGEMENT corporation, association or 1. Physical plant organization Screening Confirmatory 2. Classification by Institutional laboratory laboratory Character Shall have at Shall have at 1. Institution Based - a laboratory least 20 square least 60 square meters. The meters. The that operates within the work area must clinical work premises and as part of an be 10 square area must be institution, such as but not meters with 30 square limited to hospital, medical exhaust fan, meters with clinic, school, medical facility for sink and storage exhaust fan, overseas workers and seafarers, cabinet. sink, stock room birthing home, psychiatric and facility, drug rehabilitation instrumentation center room. 2. Freestanding - a laboratory that A laboratory of whatever does not form part of any other category shall have within its institution premises an area which can receive or accommodate at least 5 prospective client/donors at a 3. SERVICE CAPABILITY given time, handwashing facility, c. Screening laboratory – a toilet facility, and stall for the laboratory capable of orderly collection of specimens. performing screening A DOH-licensed hospital or non- test hospital based secondary or tertiary category clinical d. Confirmatory laboratory laboratory, which intends to put – a laboratory capable of up a screening laboratory for performing qualitative drug testing, need not provide an and quantitative additional 20 square meters for examinations of its existing floor area. It shall only dangerous drugs form designate an area for drug testing the specimen. within the clinical laboratory. TECHNICAL REQUIREMENTS FOR 2. Headship of the laboratory LICENSING Screening Confirmatory 1. Physical plant laboratory laboratory 2. Headship of the laboratory Headed by a Headed by a 3. Personnel licensed licensed 4. Laboratory equipment physician with physician certification in certified in clinical clinical pathology or pathology by  LABORATORY MANAGEMENT certification in the Philippine and proper clinical Board of remedial laboratory Pathology with actions to be management at least 2 years taken in training of active response to test conducted by laboratory systems being the DOH experience in out of control analytical limits or quality The maximum toxicology or a control results number of licensed screening chemist with at The laboratory laboratories a least a master’s head shall have physician degree in the overall trained in chemistry, responsibility clinical biochemistry of for the laboratory branch of professional, management chemistry and organizational, can handle is at least 2 years educational and 10, provided of active administrative that they are laboratory activities of the physically experience in drug testing feasible (within analytical facility. 5 kilometer chemistry. radius) to 3. Personnel supervise. The head of the Screening Confirmatory lab shall have laboratory laboratory training and/or Shall have shall have full experience in either a full time licensed the theory and licensed chemists, who practice of the chemist, has successfully procedure used medical completed in laboratories, technologist, extensive and resulting in pharmacist or appropriate his/her chemical training in thorough engineer with chromatography, understanding appropriate spectroscopy, of quality training in and either control screening test medical procedures and procedures for technologist, practices; the dangerous pharmacist or review, drugs. The DOH chemical interpretation, shall recognize engineer with and reporting of the training appropriate test results; the program training in the maintenance of screening test chain of custody procedure for  LABORATORY MANAGEMENT dangerous and drugs. The DOH accepted shall recognize equipme the training nt program. The basic Basic laboratory staff equipme equipment of the nt: - confirmatory - refrigerato laboratory shall laborator r/freezer be required to y oven pass a - proficiency test, analytical which is to be balance established and - administered by refrigerat the NRL. or - freezer -fume Minimum technical requirements hood SERVICE CONFIR SCREENIN - other MATORY G necessar LABORAT LABORATO y ORY RY equipme nt based SCREENI Immuno Immunoas on the NG TEST assay say procedur equipme equipment e used nt or or BFAD BFAD registered- registere drug- d drug testing kit testing of thin 4. Laboratory equipment kit or layer thin layer chromatog IT system requirements for chromat raphy confirmatory laboratory and ography screening laboratory CONFIR Gas MATORY chromat 1. Computer EXAMIN ography 600 MHZ processor ATION – mass 128 MB memory spectrom 4 GB hard disk eter (GC- 56 K modem MS) or 2. Printer some 3. Account with local service such provider (SP) modern  LABORATORY MANAGEMENT check for multiple substances at once. IDTOMIS SYSTEM THC (tetrahydrocannabinol)AND Integrated Drug Testing METH (methamphetamine) (2 Operation or Management PANEL) Information System Certainly! Here's another Common used for screening possible revision: drug test for marijuana and The results of drug tests in all shabu laboratories, including both screening and confirmatory labs, will be monitored by the national and NRL using the IDTOMIS SYSTEM. This is also where you print the drug testing results MULTIPANEL TEST KIT A multipanel test kit is a tool used for testing substances in a single sample. It has multiple sections or "panels," MACHINES FOR CONFIRMATORY each designed to check for a different substance. This is GAS CHROMATOGRAPHY – often used in contexts like MASS SPECTROSCOPY (GC-MS) drug testing, where it allows Used for qualitative and for the simultaneous quantitative analysis pf drugs screening of various drugs and metabolites using just one test. It's a practical and efficient way to  LABORATORY MANAGEMENT HIV TESTING Screening test Refers to initial test performed to determine the presence of antibody and/or antigen against HIV 1 and HIV 2. This test includes but id not limited to A. Enzyme immunoassay (EIA) B. Particle agglutination test (PA) C. Rapid assay Confirmatory/supplemental test Refers to the test performed on samples reactive to the screening test to ensure that the results were true positive, this test includes but is not CHAIN OF CUSTODY limited to The sequential A. Western blot (WB) documentation or trail that B. Line immunoassay accounts for the sequence of (LIA) custody, control, transfer, C. Immunofluorescen analysis, and disposition of ce Assay (IF) physical or electronic D. Polymerase Chain evidence (NIH). Reaction (PCR) *pre and post-test counselling HIV TESTING LABORATORY 1. Physical Plant There shall be a designated area within the clinical laboratory or blood center adequate enough for the conduct of HIV testing. The designated area shall be well- lighted and ventilated, dust free with adequate water supply and provision of an  LABORATORY MANAGEMENT area for decontamination of infectious/contaminated WATER TESTING LABORATORY materials. Further, there shall be a designated area (outside the laboratory) accessible for pre and post-test counseling. A. Work Area for HIV Testing B. Pre and Post – test counselling 2 Personnel The HIV testing laboratory shall have a licensed Medical Technologist with training in HIV Proficiency Testing certified by the NRL- SACCL/SLH. The HIV Proficiency certificate of the Medical Technologist shall be posted in a conspicuous place A. CLASSIFICATION OF LDWA within the laboratory. 1. Classification by Ownership a) Government - operated and 3 Equipment/Supplies maintained, partially or wholly, a) The HIV testing laboratory shall by the national government, a have the appropriate equipment local government unit and necessary supplies for HIV (provincial, city or municipal), testing which include personal any other political unit or any protective devices. department, division, board or agency thereof b) The HIV testing laboratory shall b) Private - owned, established utilize reagents, such as HIV test and operated by any individual, kits, which have been registered corporation, association or with the BAD and with a valid organization Certificate of Product _Registration (CPR). However, for screening of 2. Classification by Institutional blood donors, only BAD registered Character kits shall be used. a) Institution Based - a laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical  LABORATORY MANAGEMENT clinic, school, medical facility for ry overseas workers and seafarers, paramete birthing home, psychiatric rs as facility, drug rehabilitation stated in center the 2017 b) Freestanding - a laboratory that PNSDW namely: does not form part of any other lead, institution nitrate, arsenic, 3. CLASSIFICATION BY SERVICE cadmium CAPABILITY: , color, turbidity, disinfecta CLASSIFIC SERVICE MINIMU nt ATION CAPABILI M residual, TY PARAME pH, total TER dissolved TESTED solids A. Microbiol Detects (TDS) ogical and C Microbiol Offers enumera ogical- services te physioche both coliform mical category organism A and B s (total coliform, Physical Plant thermoto lerant c. The laboratory workspace shall coliforms correlate with the volume and type /E. coli, of analysis to be undertaken and HPC) including provisions for periods of in the peak workload. A non-institution water sample based LDWA shall have the following B. Physio- Detects MINIMUM WORK SPACE requirement chemical and per service capability, excluding quantify support areas such as administrative physical office, storage area, records room, and etc.: chemical character c.1 Classification A - 20 sqm. istics of for sterile room and media at least preparation arca the 9 c.2 Classification B - 50 sqm. mandato For wet chemistry area,  LABORATORY MANAGEMENT ICP/AAS room, Professionals that are allowed Spectrophotometer room, to be an analysts and chemical storage room. microbiology Physio- chemical c.3 Classification C - 70 sqm. Registered Registered for sterile room and media medical chemist preparation area, wet technologist chemistry area, ICP/AAS Registered room, Spectrophotometer Certified chemical room, and chemical storage microbiologists technician room under the Registered supervision Personnel food of a technologist registered LDWA shall be composed of the chemist following personnel with their corresponding qualifications and functions: Minimum equipment for each service a. Headship (Pathologist, Sanitary in the ff: Engineers) The head of the laboratory a. Bacteriological analysis shall be a competent and service experienced professional, 1. Incubator with a specialized skill set 2. Water bath 37oC related to and proportionate 45.5 OC 0.5 to the laboratory category. (If The laboratory head is Escherichia essentially responsible for the E.coli test is operation of entire laboratory, performed) its personnel, functions, and 3. Autoclave data, all of which shall meet 4. pH meter the quality assurance criteria 5. analytical balance and regulatory requirements. 6. colony counter 7. microscope b. Analysts 8. hot plate or stove The NRL-EOHTM trained 9. oven sterilizing analyst involved in the 10. Bunsen burner performance of laboratory 11. Refrigerator procedures must have the appropriate degree and at b. Chemical analysis service least two (2) years experience 1. pH meter in water testing procedures 2. oven sterilizing relevant to the service 3. candle turbidimeter capability of the laboratory. 4. pipette washer  LABORATORY MANAGEMENT 5. spectrophotometer, spectronic 20 or AA 6. magnetic stirrer 7. water bath 8. refrigerator 9. gas chromatographer 10. vacuum filter