RA 4688: The Clinical Laboratory Law of 1966 PDF

RA 4688 THE CLINICAL LABORATORY LAW OF 1966  RA 4688 Also called The Clinical Laboratory Law of 1966 approved on June 18, 1966, and signed by President Ferdinand E. Marcos. RA 4688 is the governing law for all existing clinical laboratories...

RA 4688 THE CLINICAL LABORATORY LAW OF 1966  RA 4688 Also called The Clinical Laboratory Law of 1966 approved on June 18, 1966, and signed by President Ferdinand E. Marcos. RA 4688 is the governing law for all existing clinical laboratories in the Philippines. It embodies policies and guidelines for the proper operation of different types of laboratories. Various administrative and executive orders have been issued to supplement the law governing clinical laboratories: AO 201 s. 1973 AO 290 s. 1976 AO 52 s. 1983 AO 49-B s. 1988 EO 102 s. 1999: Redirecting the Functions and Operations of the DOH. AO 59 s. 2001: Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines. AO 27 s. 2007: Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines. CLASSIFICATION OF CLINICAL LABORATORIES Classification by Ownership Government - operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city, or municipal), any other political unit, or any department, division, board, or agency thereof Private - owned, established, and operated by any individual, corporation, association, or organization Classification By Function Clinical Pathology - includes Clinical Chemistry, Hematology, immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology Therapeutic Drug Monitoring, and other similar disciplines Anatomic Pathology - includes Surgical Pathology, lmmunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology CLASSIFICATION OF CLINICAL LABORATORIES Classification by Institutional Character Institution Based - a laboratory that operates within the premises and as part of an institution, such as but not limited to a hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center Freestanding - A laboratory that operates on its own  ACCORDING TO SERVICE CAPABILITY PRIMARY CATEGORY SECONDARY CATEGORY TERTIARY CATEGORY LABORATORY LABORATORY LABORATORY Routine Clinical Chemistry- Routine Hematology include Blood Glucose Special Chemistry Substance Concentration, (CBC) Special hematology BUN, BUA, Blood Creatine Routine Urinalysis Concentration, Blood Total Serology Routine Fecalysis Cholesterol Concentration, Microbiology Blood Typing (Hospital- Quantitative platelet aerobic and anaerobic determination (for hospital based) based) Cross-matching (hospital- aerobic or anaerobic Qualitative Platelet based) (for non-hospital based) dettermination Gram staining (hospital- based) KOH (hospital-based)  ACCORDING TO SERVICE CAPABILITY PRIMARY CATEGORY SECONDARY CATEGORY TERTIARY CATEGORY LABORATORY LABORATORY LABORATORY 12 employees 12 employees without without Microbiology histhology 8 employees 9 employees for Government 13 employees for Hospital- Facilities based  GUIDELINES General Guidelines 1. The LTO is issued only to clinical laboratories that meet BHFS standards and technical requirements. 2. Laboratories used exclusively for research and teaching are exempt from licensing but must register with the BHFS. 3. Special clinical laboratories, such as those for Assisted Reproduction Technology, Molecular Biology, and Forensic Pathology, must register with the BHFS but do not need an LTO until specific regulations are established. A trained pathologist or licensed physician must head these laboratories.  GUIDELINES 4. NRLs designated by the DOH are covered by the hospital's clinical laboratory license, unless they are independent, in which case they must register with the BHFS and be accredited by recognized bodies. 5. A Physician's Office Laboratory (POL) must obtain a clinical laboratory license if it issues official results, performs more than monitoring examinations, or serves patients beyond the physician's own. 6. Point-of-Care Testing (POCT) in hospitals must be managed and supervised by the hospital's licensed clinical laboratory.  SPECIFIC GUIDELINES 1. STANDARDS a. human Resource b. equipment c. glassware, reagents, and supplies d. administrative policies and procedures e. technical procedure f. quality assurance program g. communication and records h. physical facilities/work environment i. referral pf examination outside of the clinical laboratory  SPECIFIC GUIDELINES 2. LTO The LTO is issued to the licensee and is non-transferable. the license is not valid for any premise/ location other than that which is stipulated therein The LTO issued to a clinical laboratory, unless sooner suspended or revoked, is valid for one year and expires on the date set forth by the CHD, as stipulated on the fade of the license. The LTO issued for non-hospital-based laboratories must include specific details like the laboratory's name, owner/operator, head, service capability, validity period, license number, and location. The LTO issuedmust be prominently displayed within non-hospital-based laboratory premises. Hospital-based laboratories are licensed through the One-Stop-Shop Licensure for Hospitals and do not need a separate LTO. The ability to perform HIV testing and/or drinking water analysis must be indicated on the LTO. A single LTO covers the clinical laboratory and its satellite services within the same compound. Satellite laboratories outside the main laboratory's premises require a separate LTO. Mobile clinical laboratories are licensed as part of the main laboratory and can only collect specimens within a 100 km radius. Significant changes affecting the laboratory's conditions must be reported to the CHD within two weeks in writing. The LTO can be revoked, suspended, or modified for false statements, inspection issues, or non-compliance with regulations.  PROCEDURAL GUIDELINES A. Registration for Special Clinical Laboratories, National Reference Laboratories, Research and Teaching Laboratories 1. Applicants can obtain the Application Form for Registration from the BHFS, CHD, or the DOH website (www.doh.gov.ph). 2. Submit the completed form and necessary attachments to the BHFS or the relevant CHD, along with a non-refundable application fee for a Certificate of Registration. 3. The BHFS will evaluate and accept applications based on the proper completion of forms and the completeness of attachments.  PROCEDURAL GUIDELINES B. Procedures for Application for Initial/ Renewal of LTO 1. Applicants can obtain the application form for LTO from the BHFS, the relevant CHD, or the DOH website (www.doh.gov.ph). 2. Submit the completed form and necessary attachments to the CHD, along with a non-refundable application fee for LTO. 3. The CHD will conduct inspections based on licensing requirements as outlined in the Order and the One-Stop-Shop Licensure System for Hospitals.  PROCEDURAL GUIDELINES C. Renewal of LTO 1. Hospital-based clinical laboratories: Renewal follows the One-Stop-Shop Licensure System for Hospitals. 2. Non-hospital-based clinical laboratories: Renewal applications can be filed from October 1st to November 30th. A discount is available for complete applications filed within this period. 3. Compliant clinical laboratories: Renewal will be processed within five working days after the license expiration date. 4. Automatic cancellation: The LTO will be canceled without notice if the application form and fee are not submitted by the expiration date.  PROCEDURAL GUIDELINES D. Inspection 1. Announced inspections: The CHD will conduct licensure inspections at reasonable times. 2. Accessibility: The licensee must ensure the premises and facilities are accessible for inspection by the CHD Director or authorized representatives. 3. Records availability: The licensee must ensure all pertinent records are available for review by the CHD Director or authorized representatives. 4. Inspection tool: An inspection tool outlining standards, criteria, and technical requirements for LTO issuance will be used.  PROCEDURAL GUIDELINES E. Monitoring 1. Regular monitoring: All clinical laboratories will be monitored regularly. 2. Monitoring visits: The BHFS or CHD Director or authorized representatives will conduct monitoring visits at reasonable times. 3. Records and accessibility: Clinical laboratories must ensure all records, premises, and facilities are available for inspection to determine compliance. 4. Notice of Violation: Issued immediately after identifying non-compliance during monitoring. 5. Quarterly summary of violations: The CHD will submit a quarterly summary of violations to the BHFS, detailing the laboratory's name, location, violation, and actions taken. 6. Reporting by Health Officers: Provincial, City, and Municipal Health Officers must report unlicensed laboratories or any parties performing laboratory examinations without proper licenses to the BHFS/CHD.  SCHEDULE OF FEES 1. A non-refundable fee shall be charged for the initial application/ renewal of license to operate a clinical laboratory, either government or private. 2. All fees/ checks shall be paid to the order of DOH in person or through postal money order. 3. All fees, surcharges and discounts shall follow the current DOH prescribed schedule of fees.  VIOLATIONS Violation of Republic Act 4688 or these rules and regulations and/ or commission of the following acts by personnel operating the clinical laboratory under this authority shall be penalized: a. Refusal to participate in designated proficiency programs. b. Issuing reports not by approved procedures. c. Allowing unauthorized persons to perform technical procedures. d. Demonstrating incompetence or making consistent errors in laboratory work. e. Deviating from standard test procedures, including using expired reagents. f. Reporting/releasing erroneous results. g. Lending or using the name of a licensed laboratory or personnel for an unlicensed lab. h. Unauthorized use of pathologist and medical technologist signatures to secure LTO. i. Reporting test results for unperformed tests. j. Transferring test results from an outside lab to the referring lab's form. k. Performing/reporting tests in unlicensed specialties. l. Engaging in kickbacks or split-fee arrangements for patient referrals.  INVESTIGATION OF COMPLAINTS The BHFS or CHD Director, or their authorized representatives, will investigate complaints to determine if the laboratory or its personnel are responsible for the alleged violation. If violations are found, the CHD Director or their representatives will suspend, cancel, or revoke the LTO of the licensee for a determined period, and may also pursue criminal action through judicial authorities. The CHD may enlist law enforcement agencies to close non-compliant clinical laboratories if necessary.  PENALTY Any person who operates a clinical laboratory without the proper license from the DOH Imprisonment: Minimum of 1 month. Fine: Between Php 1,000.00 and Php 5,000.00. APPEAL The decision of the BHFS/ CHD may be appealed to the Office of the Health Secretary within ten ( 10) days after receipt of the notice of the decision.  REPEALING CLAUSE Provisions from previous issuances that are inconsistent or contrary to the provisions of this Order are hereby rescinded and modified accordingly. SEPARABILITY CLAUSE In the event that any provision or part of this Order be declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective. EFFECTIVITY This Order shall take effect fifteen ( 15) days after its approval and publication in the official gazette or newspaper of general circulation. THANK YOU Presented By : Kyla Genyne Q. Inabore