Unit 3.3_ Nature of Clinical Laboratory PDF

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of le...

PRAYER BEFORE CLASS Holy Spirit, Divine Creator, true source of light and fountain of wisdom! Pour forth your brilliance upon my dense intellect, dissipate the darkness which covers me, that of sin and of ignorance. Grant me a penetrating mind to understand, a retentive memory, method and ease of learning, the lucidity to comprehend, and abundant grace in expressing myself. Guide the beginning of my work, direct its progress and bring it to successful completion. This I ask through Jesus Christ, true God, and true man, living and reigning with You and the Father, forever and ever. Amen. Outline PART I PART II General Overview Sections in the Clinical Classification of Clinical Laboratory Laboratories Laboratory Testing Cycle Quality Assurance in the Clinical Laboratory PART III Philippine Regulations on Clinical Laboratories Learning Outcome 1. Explain the roles, functions, and services offered by the different sections of the clinical laboratory and understand the law governing their operations.  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY PHILIPPINE REGULATIONS ON CLINICAL LABORATORIES Nature of the Clinical Laboratory What law regulates the clinical laboratories in the Philippines? Clinical laboratories in the Philippines is governed by: Republic Act 4688 aka Clinical Laboratory Law of 1966 - Approved on June 18, 1966 - Aims to ensure the health of the general public by preventing the operation of substandard laboratories Republic Act No. 4688 Philippine Regulations on Clinical Laboratories - An act that regulates the operation and maintenance of clinical laboratories and requiring registration of the same with the DOH, providing penalty for the violation. Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 1 - Any person, firm or corporation, operating and maintaining clinical laboratory that involves human beings or animals shall register and secure a license annually at the office of the Secretary of Health - Exemption: government hospital laboratories doing routine or minimum laboratory examinations if services are extensions of government regional or central laboratories Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 2 - Licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health shall be the one in-charge of a registered clinical laboratory - Authorization to be renewed annually Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 3 - Secretary of health, through the Bureau of Research and Laboratories shall be responsible for strictly enforcing the provisions of this Act and authorized to issue necessary rules and regulations Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 4 - Any person, firm, or corporation who violates any provision of this Act or rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment no less than one month but not more than one year, and/or by a fine of not less than one thousand pesos nor more than five thousand pesos Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 5 - If any section or part of this Act adjudged to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof Republic Act No. 4688 Philippine Regulations on Clinical Laboratories Section 6 - The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. DOH Administrative Order No. 59 s. 2001 - Rules and regulation governing the establishment, operation and maintenance of clinical laboratories in the Philippines DOH Administrative Order No. 37 s. 2021 - New rules and regulation governing the regulation of clinical laboratories in the Philippines DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories SCOPE: - Apply to all entities performing the activities and functions of clinical laboratories - Do not include government laboratories doing examinations limited to acid fast bacilli microscopy, malaria screening, and cervical cancer screening, provided their services are declared as extension of a licensed government clinical laboratory DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 1. Clinical Pathology 2. Anatomic Pathology DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 1. Clinical Pathology - Hematology, clinical chemistry, microbiology, parasitology, mycology, clinical microscopy, immunology and serology, immunohematology, toxicology and therapeutic drug monitoring, other similar disciplines. DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 2. Anatomic Pathology - Surgical Pathology - Immunohistopathology - Cytology - Autopsy - Forensic pathology DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Primary Category a. Routine Hematology b. Routine Urinalysis c. Routine Fecalysis d. Blood Typing (hospital based) e. Quantitative Platelet Determination (hospital- based) DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 2. Secondary Category a. Routine clinical chemistry b. Crossmatching DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 3. Tertiary Category a. Special chemistry b. Special hematology c. Immunology and serology d. Microbiology DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories POLICIES: 1. Approved permit to construct and design layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a petition to operate 2. Construction should start after plans have been approved and construction permit have been issued by the BHFS 3. Shall operate with a valid license issued by BHFS/CHD DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories POLICIES: 4. Provide effective and efficient laboratory services 5. Provide adequate and appropriate safety practices DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: APPLICATION FOR PERMIT TO CONSTRUCT 1. Letter of application to the director of BHFS 2. Four sets of site development plans and floor plans approved by an architect and/or engineer 3. DTI/SEC registration (for private clinical laboratory) DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: APPLICATION FOR NEW LICENSE - A duly notarized application form “petition to establish, operate and maintain a clinical laboratory” shall be filed by the owner or his duly authorized representative at the BHFS DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: APPLICATION FOR RENEWAL OF LICENSE - A duly notarized application form “application for renewal of license to establish, operate and maintain a clinical laboratory” shall be filed by the owner or his duly authorized representative at the respective CHD DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: APPLICATION FOR RENEWAL REGION SCHEDULE OF LICENSE NCR January - March - Shall be filed within 90 days before the expiry date of the 1,2,3 & CAR February - April license described as follows: 4,5,6 March - May 7,8,9 April - June 10,11,12, CARAGA, ARMM May - July DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: PERMIT AND LICENSE FEES - Non-refundable license fee for application to construct, and for license to operate a government and private clinical laboratory - Non-refundable fee for application for renewal to operate DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: PENALTIES - Within 2 months after expiry date: penalty of Php1,000.00 for late renewal plus the renewal fee for all categories - More than 2 months after expiry date: Php100.00 fine for each month in addition to Php1,000.00 penalty DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: INSPECTION - Each license shall make available to the director of the BHFS/CHD or his duly authorized representative(s) at any reasonable time, the premises and facilities where the laboratory examinations are being performed for inspection - Each license shall make available to the director of the BHFS/CHD or his duly authorized representative(s) all pertinent records DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: INSPECTION - Every 2 years or as necessary DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: MONITORING - Monitored regularly and records shall be made available to determine compliance with rules and regulations - The director of BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time - All clinical laboratories shall make available to the director of BHFS or his duly authorized representative(s) records for monitoring DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: ISSUANCE OF LICENSE - Issued by the director of CHD or his authorized representative, if application is found to be meritorious DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: TERMS AND CONDITION OF LICENSE - Granted upon compliance with the licensing requirements - Non-transferable - Inform the CHD in writing at least 15 days before actual transfer by the owner or authorized representative desiring to transfer a licensed clinical laboratory to another location DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: TERMS AND CONDITION OF LICENSE - Extension laboratory shall have a separate license - Any change affecting the substantial conditions of the license to operate a laboratory shall be reported within 15 days in writing. Failure to do so will cause the revocation of the license. - License must be placed in a conspicuous area within the laboratory DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: VIOLATIONS - License to operate shall be suspended or revoked by the secretary of health upon violation of RA 4688 or the rules and regulations DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: VIOLATIONS - The following are considered as violations: - Operation of a clinical laboratory without a certified pathologist or without a registered medical technologist - Change of ownership, location, head of laboratory or personnel without informing the BHFS/CHD DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: VIOLATIONS - The following are considered as violations: - Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS during reasonable hours - Gross negligence - Any act detrimental to the public DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories REQUIREMENTS AND PROCEDURES FOR APPLICATION OF PERMIT TO CONSTRUCT AND LICENSE TO OPERATE: VIOLATIONS - Provincial, city and municipal health officers are authorized to report to the CHD and BHFS the existence of unlicensed clinical laboratories or any private party performing laboratory examinations without proper license and/or violations to these rules and regulations DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories INVESTIGATION OF CHARGES OR COMPLAINTS: - BHFS/CHD or representative shall suspend, cancel or revoke for a determined period of time the license, as well as the authority of the offending person(s), without prejudice to taking the case to judicial authority for criminal action - Any person operating a clinical laboratory without proper license shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1 year or a fine of not less than Php1,000.00 and not more than Php5,000.00 or both DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories INVESTIGATION OF CHARGES OR COMPLAINTS: - Any clinical laboratory operating without a valid license or whose license has been revoked/cancelled shall be summarily closed upon order issued by BHFS/CHD or authorized representative - Closure order issued by the DOH shall not be rendered ineffective by any restraining order and injunction order issued by any court, tribunal or agencies or instrumentalities  DOH Administrative Order No. 59 s. 2001 Philippine Regulations on Clinical Laboratories MODIFICATION AND REVOCATION OF LICENSE: - License maybe revoked, suspended or modified in full or in part for any material false statement or violation of, or failure to comply with any of the terms and conditions and provisions of these rules and regulations - No license shall be modified, suspended, or revoked unless prior notice has been made and the corresponding investigation conducted except in cases of willful, or repeated violations hereof, where public health interest or safety requires otherwise Annex A Philippine Regulations on Clinical Laboratories Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements I. STAFFING Managed by licensed physician certified by the Philippine Board of Pathology - In areas with no pathologists, a physician with three (3) months training on clinical laboratory medicine, quality control and laboratory management, may manage a primary/secondary category clinical laboratory - Training certification provided by BHFS Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements I. STAFFING Qualified and adequately trained personnel ○ Sufficient number of RMTs proportional to the workload and shall be available at all times during hours of laboratory operations. ○ For hospital based clinical laboratory, at least one RMT per shift to cover the laboratory operation Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements I. STAFFING Staff development and appropriate continuing education program available at all levels of the organization Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements II. PHYSICAL FACILITIES Well ventilated, adequately lighted, clean, and safe Sufficient to accommodate its activities and allow for smooth and coordinated work flow Adequate water supply Minimum area: ○ Primary category - 10 sq.m. ○ Secondary category - 20 sq.m. ○ Tertiary category - 60 sq.m. Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements III. EQUIPMENT/INSTRUMENTS Provisions for sufficient number and types of appropriate equipment/instruments in order to undertake all activities and laboratory examinations Equipment shall comply with safety requirements Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements IV. GLASSWARES/REAGENTS/SUPPLIES All categories of clinical laboratories shall provide adequate and appropriate glassware, reagents and supplies necessary to undertake the required services Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements V. WASTE MANAGEMENT Provisions for adequate and efficient disposal of waste following guidelines of the DOH and local government Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements VI. QUALITY CONTROL PROGRAM Internal Quality Control Program ○ There shall be documented, continuous competency assessment program for all laboratory personnel ○ Program shall provide appropriate and standard laboratory methods, reagents, supplies, and equipment ○ Program for proper maintenance and monitoring for all equipment ○ Provide a provide for the use of quality control reference materials Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements VI. QUALITY CONTROL PROGRAM External Quality Control Program ○ All clinical laboratories shall participate in an External Quality Assurance Program (EQAP) given by designated NRL and/or other recognized reference laboratories ○ Satisfactory performance rating given by a designated NRL shall be one of the criteria for the renewal of license ○ Any refusal to participate in EQAP given by a designated NRL shall be one of the bases for suspension/revocation of the license of the laboratory Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements VII. REPORTING All laboratory reports on various examinations of specimens shall bear the name of the RMT and the Pathologist and duly signed by both No person in the clinical laboratory shall issue a report, orally or in writing, whole or portions thereof without a directive from the Pathologist or his authorized associate to the requesting physician or his authorized representative except in emergency cases when the results may be released as authorized by the Pathologist. Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements VIII. RECORDING Adequate and effective system of recording requests and reports of all specimens submitted and examined Provisions for filing, storage, and accession of all reports All laboratory records shall be kept on file for at least one (1) year ○ Anatomic and forensic pathology records shall be kept permanently in the laboratory Annex A Philippine Regulations on Clinical Laboratories Technical Standards and Minimum Requirements IX. LABORATORY FEES Rates shall be within the range of the usual fees prevailing at the time and the particular place, taking into consideration the cost of testing and quality control of various laboratory procedures Professional services rendered to the patient in the performance of special procedures or examinations shall be charged separately and not included in the laboratory fee/s DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 1. Clinical Pathology - Clinical chemistry, clinical microscopy, toxicology, therapeutic drug monitoring, immunology and serology, hematology and coagulation, bacteriology, parasitology, mycology, virology DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 2. Anatomic Pathology - Surgical pathology - Cytopathology - Immunohistochemical techniques - Autopsies - Forensic pathology DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Function 3. Molecular Pathology - PCR DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Institutional Character 1. Institution-based 2. Non-institution based DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Clinical Laboratory for Clinical and Anatomic Pathology 2. Clinical Laboratory for Anatomic Pathology ONLY 3. Clinical Laboratory for Molecular Pathology ONLY DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Clinical Laboratory for Clinical and Anatomic Pathology Primary Category DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Clinical Laboratory for Clinical and Anatomic Pathology Secondary Category DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Clinical Laboratory for Clinical and Anatomic Pathology Tertiary Category DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Service Capability 1. Clinical Laboratory for Clinical and Anatomic Pathology Limited Category DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories CLASSIFICATION OF LABORATORIES: A. Classification by Ownership 1. Government 2. Private DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 1. PERMIT TO CONSTRUCT Completely filled out application form for DOH-PTC shall be submitted to the DOH regulatory offices DOH-PTC shall be required for construction of new CL and for renovation or expansion of existing CL, including change in ownership and transfer of location Application shall be processed in accordance with the procedural guidelines set forth in AO No. 2016-0043 (Guidelines in the Application for DOH-PTC) DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 2. LICENSE TO OPERATE Any person, firm or corporation desiring to establish, operate, and maintain CL shall submit an accomplished form to HFSRB/CHD-RLED, once it is fully functional Component of complete application for DOH-LTO ○ Application form 1 and its attachments Notarized acknowledgement Any of the following proof of ownership and name of health facility DTI/SEC/CDA registration including articles of incorporation/cooperation and by-laws Accomplished self assessment tool Health facility geographic form DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 2. LICENSE TO OPERATE Upon receipt of complete application forms, the HFSRB/CHD-RLED representative, reviews the application and conducts an on-site assessment of the laboratory to determine full compliance with the standards and technical requirements Upon assessment, if CL is not fully compliant, the HFSRB/CHD-RLED shall provide a written report outlining the laboratory’s deficiencies. The laboratory must with the deficiencies within thirty (30) days. DOH-LTO shall only be issued after HFSRB/CHD-RLED has determined that the laboratory is fully compliant Submitted complete applications that are not processed within twenty (20) days by the HFSRB/CHD-RLED due to force majeure shall automatically be granted the LTO and post-licensing visit shall be scheduled DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 2. LICENSE TO OPERATE DOH-LTO is non-transferable HFSRB/CHD-RLED, shall be notified in writing of any change in management name, ownership, or headship or laboratory personnel. Failure to notify any substantial change in the condition of the laboratory in writing within fifteen (15) days, may be a basis for suspension or revocation of DOH-LTO DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 2. LICENSE TO OPERATE Different branch(es) of a CL, even if owned by the same entity shall secure separate DOH-LTO DOH-LTO shall be placed in an area that can readily be seen by the public at all times DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 3. CERTIFICATE OF REGISTRATION Required for research and teaching laboratories Applicants shall submit an accomplished registration form together with the necessary attachments to HFSRB Pay a non-refundable application fee before submission of requirements HFSRB shall evaluate and accept applicants based on the due execution of forms and completeness of attachments DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 4. VALIDITY DOH-LTO valid for one (1) year COR for CL that is operated and maintained exclusively for research and teaching purposes shall be required to register with the DOH-HFSRB every three (3) years DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories PROCEDURAL GUIDELINES 5. MONITORING HFSRB/CHD-RLED may conduct unannounced on-site visits of licensed CL and registered research and teaching laboratories to monitor and document the continuous compliance of the CL to the set standards If upon monitoring visit, CL is found violating, the HFSRB/CHD-RLED may immediately impose preventive suspension CL that are operated and maintained for research and teaching purposes shall not issue official results DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 1. NON-INSTITUTION BASED CLINICAL LABORATORIES 1st offense: stern warning 2nd offense: Php 30,000 3rd offense: Php 50,000 4th offense: Revocation of DOH-LTO DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 2. INSTITUTION BASED CLINICAL LABORATORIES - Sanctions based on AO No. 2007-0022 - Cease and Desist Order - all hospitals operating without an LTO - Written warning - first violation - Administrative fines - Violations involving basic, ancillary and other facilities required for licensure - Php 30,000: second violation - Php 50,000: third violation DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 2. INSTITUTION BASED CLINICAL LABORATORIES - Sanctions based on AO No. 2007-0022 - Administrative fines - Violations involving basic, ancillary and other facilities that are not required for the licensure - Php 20,000: second violation - Additional 20% of the previous fine for every subsequent violation DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 2. INSTITUTION BASED CLINICAL LABORATORIES - Sanctions based on AO No. 2007-0022 - If fine is not paid within 10 working days after receipt of official note, surcharge of 3% of total fines shall be imposed for each month of delay in payment - LTO shall not be released without full payment DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 2. INSTITUTION BASED CLINICAL LABORATORIES - Sanctions based on AO No. 2007-0022 - Suspension or revocation of license: fourth violation DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 3. Any person who operates CL without DOH-PTC and DOH-LTO shall be issued Cease and Desist Order and shall pay administrative penalty of Php 50,000 4. In case of complaints, CL shall be given due process wherein an investigation shall be conducted. A 60 day-preventive suspension may be given to the CL during investigation depending on the seriousness of the violation 5. Any CL or any of its personnel not amenable with the decision of HFSRB/CHD- RLED may file a notice of appeal to the head of the health regulation team within 10 days after receipt of notice of decision. 6. CL with revoked licenses can only re-apply after 1 year from the date of LTO revocation DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories VIOLATIONS, SANCTIONS, AND APPEAL 7. Any person authorized or licensed to conduct clinical laboratory tests, who issues false laboratory test results knowingly, willfully or through gross negligence, shall not be allowed to own, manage, operate, or be analyst of any DOH-licensed CL. DOH Administrative Order No. 37 s. 2021 Philippine Regulations on Clinical Laboratories READING ASSIGNMENT: Licensing Standards for Clinical Laboratory Formative Assessment 1. When was RA 4688 approved? a. 1966 b. 1988 c. 1968 d. 1996 Formative Assessment 1. When was RA 4688 approved? a. 1966 b. 1988 c. 1968 d. 1996 Formative Assessment 2. What are the potential sanctions for a non-institution-based clinical laboratory that has committed a second violation of regulations based on AO N0. 37 s. 2021? a. Revocation of DOH-LTO b. Php 100,000 c. Php 30,000 d. Php 50,000 Formative Assessment 2. What are the potential sanctions for a non-institution-based clinical laboratory that has committed a second violation of regulations based on AO N0. 37 s. 2021? a. Revocation of DOH-LTO b. Php 100,000 c. Php 30,000 d. Php 50,000 Formative Assessment 3. A document that contains new rules and regulation governing the regulation of clinical laboratories in the Philippines? a. DOH AO No. 59 s. 2001 b. DOH AO No. 37 s. 2021 c. Annex A d. DOH AO No. 1 s. 2024 Formative Assessment 3. A document that contains new rules and regulation governing the regulation of clinical laboratories in the Philippines? a. DOH AO No. 59 s. 2001 b. DOH AO No. 37 s. 2021 c. Annex A d. DOH AO No. 1 s. 2024 Formative Assessment 4. According to AO. No. 37 s. 2021, a clinical laboratory with revoked license can only re-apply. a. After 2 years from the date of LTO revocation b. After 1 year from the date of LTO revocation c. After 1 year from the date of PTC d. Never Formative Assessment 4. According to AO. No. 37 s. 2021, a clinical laboratory with revoked license can only re-apply. a. After 2 years from the date of LTO revocation b. After 1 year from the date of LTO revocation c. After 1 year from the date of PTC d. Never Formative Assessment 5. True or False. Laboratory results should include the name and signature of both the RMT and Pathologist. Formative Assessment 5. True or False. Laboratory results should include the name and signature of both the RMT and Pathologist. Formative Assessment 6. True or False. Anatomic and forensic pathology records shall be kept for at least 1 year in the laboratory Formative Assessment 6. True or False. Anatomic and forensic pathology records shall be kept for at least 1 year in the laboratory References Benitez, P., Dumaoal, O., Estrella, F., Mortel, F., Nava, M. (2019). Principles of Medical Laboratory Science 1. C and E Publishing, Inc. Department of Health Administrative Order No. 2021-0037. New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines. https://hfsrb.doh.gov.ph/wp-content/uploads/2021/06/ao2021-0037-2.pdf.  PRINCIPLES OF MEDICAL TECHNOLOGY PRACTICE 1 NATURE OF THE CLINICAL LABORATORY