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An act Regulating the Operation and
Maintenance of Clinical Laboratories and
Requiring the Registration of the Same
with the Department of Health
Maintenance of Clinical Laboratories and
Requiring the Registration of the Same
with the Department of Health
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REPUBLIC ACT No. 4688 has how many sections
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REPUBLIC ACT No. 4688
| Question | Answer |
|---|---|
| An act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health | REPUBLIC ACT No. 4688 |
| REPUBLIC ACT No. 4688 has how many sections | 8 |
| vDate of Approval: of REPUBLIC ACT No. 4688 | June 18, 1966 |
| Administrative Order (A.O.) 201 series of 1973 | (October 26, 1973) |
| A.O. 49-B series of 1988 | (October 25, 1988) |
| A.O. 59 series of 2001 | (November 19, 2001) |
| A.O. 2007-0027 | (August 22, 2007) |
| Any person, firm or corporation operating and maintaining a clinical laboratory in which body fluids, tissues, | Section 1 |
| Provided, That government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are extensions government regional or central laboratories | Section 1 |
| It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in laboratory medicine | Section 2 |
| No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, | Section 2 |
| The Secretary of Health, through the Bureau of Research and Laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act | Section 3 |
| Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health | Section 4 |
| If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair, or invalidate the remainder thereof. | Section 5 |
| The sum of fifty thousand pesos, or so much thereof as may be necessary, is hereby authorized to be appropriated, | Section 6 |
| All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed. | Section 7 |
| This Act shall take effect upon its approval. | Section 8 |
| A.O. 201 series of 1973 has how many sections? | 24 sections |
| A.O. 201 series of 1973 Date of Approval: | October 26, 1973 |
| Revised Rules and Regulations Governing the Registration, Operations and Maintenance of Clinical Laboratories in the Philippines | Section 1 (Purpose and Title): |
| Laboratories solely used for academic training and/or for purely research activities are exempted | Section 2 (Scope): |
| Submit to Secretary, through BRL, sworn application with the ff: | Section 3 (Basic License Requirements) |
| An inspector from BRL on will inspect the lab within 60 days, and verify if the requirements have been met | Section 3 (Basic License Requirements) |
| o P100.00 per license payable to BRL o Renewal: within last two months of each year upon payment of P50.00 o Grace Period: 2 months (P10.00 fine) o All gov't labs are exempted from fees | Section 4 (Fees): |
| No lab is permitted to operate without proper license | Section 5: |
| No person is permitted to manage, administer, or supervise a climb unless he/she is an authorized licensed physician qualified in laboratory medicine | Section 6: |
| a. Clinical Laboratories (Clinical Pathology, Anatomical Pathology, Forensic Pathology) | Section 7 (Definition of Terms): |
| Head/Chief/Director/In-charge (licensed and authorized pathologist or physician with training in in lab medicine) | Section 7 (Definition of Terms): |
| Personnel (Associate Pathologist, Pathology Assistant, Medical Technologist, Laboratory Technicians, Laboratory Aides) | Section 7 (Definition of Terms): |
| Equivalents (substitute equipment, supplies and materials) | Section 7 (Definition of Terms): |
| Only written interpretations by Secretary of Health and Justice will be recognized | Section B (Interpretations): |
| Owner or authorized representative must file the application with the use of sworn "Petition to Establish, Operate and Maintain Clinical Laboratory" and physician-signed "Information Sheet" | Section 9 |
| o License is not transferable o Laboratories transferring to a new location or having a change in ownership shall inform in writing the BRL within 15 days after the transfer has been completed | Section 10 (Terms and Conditions of License): |
| o Failure: revocation | Section 10 (Terms and Conditions of License): |
| Pathologists/Associate can only supervise a max of 4 clin lab and/or blood banks contiguously located in a particular area | Section 11 (Requirements for a Clin Lab): |
| Licensed physician can only supervise one laboratory | Section 11 (Requirements for a Clin Lab): |
| Routine Tests, Routine Blood Chemistry, Special Biochemistry and Serology, Bacteriology, Mycology, Parasitology, Anatomic Pathology, Radioisotope Examinations | Minimum Equipment and Apparatuses |
| All laboratory requests shall be considered as consultations between the requesting physician and the pathologist of the laboratory | Section 12 (Reporting) |
| Reports shall not be issued orally, in writing, or in portions without the actual signature of the Pathologist, or his authorized associate or assistants except in emergencies when the results may be released as authorized by the Pathologist | Section 12 (Reporting) |
| All requests and reports shall be kept on file for at least one year provided a duplicate copy is on file for the patient's medical records. | Section 13 (Recording) |
| Records of anatomic and forensic pathology should be kept permanently in the laboratory | Section 13 (Recording) |
| The rate of laboratory fees to be charges by clinical laboratory for examination shall be within the range of the usual fees | Section 14 (Laboratory Fees) |
| Professional services rendered to the patient in the performance of special procedure of examination shall be treated separately and not included in the laboratory fee. | Section 14 (Laboratory Fees) |
| Section 15 (Publicity) | Only the name of the laboratory, address, telephone number of the laboratory, pathologists and assistants and field of work covered by the licensure shall appear on the letterhead and other information media. |
| Section 16 (Exhibition of Certificate of Approval and License and Rules and Regulations) | o The license of the clinical laboratory must be placed in a conspicuous place within the laboratory |
| Section 17 (Expiration) | Each specific license shall expire on the last day of December of the year stated therein, |
| Application for renewal of license shall be filed in accordance with the preceding Section 3 & 4. The Bureau of Research and Laboratories shall process applications for license | Section 18 (Renewal) |
| Secretary of Health or his representative | Section 19 (Inspection): |
| Director of BRL or his representative | Section 20 (Quality Control Test): |
| (Modification and Revocation of Licenses) | Section 21 |
| (Investigation of Charges or Complaint) | Section 22 |
| o Imprisonment for not <1 month, but not >1 year o Fine of not <P1,000.00, but not >P5,000.00 o Or both | Section 23 (Violations) |
| (Effectivity) | Section 24 |
| A.O. 49-B series of 1988 how many sections | 27 |
| A.O. 49-B series of 1988 Date of Approval: | October 25, 1988 |
| Revised Rules and Regulation Governing the registration, operation, and Maintenance of Clinical Laboratories in the Philippines | Section 1 (Title): |
| These rules and regulations are issued to implement R.A. 4688 (Clinical Laboratory Law) consistent with ? | E.O. 119 (Reorganization Act of the Ministry of Health) |
| Section 2 (Authority) | o These rules and regulations are issued to implement R.A. 4688 (Clinical Laboratory Law) consistent with E.O. 119 (Reorganization Act of the Ministry of Health) |
| (Purpose) | Section 3 |
| Exempted = Same as AO 201 s. 1973; and Physicians doing only simple and routine examinations (routine hematology, urinalysis, fecalysis, and gram staining) for their own patients only in their own clinics. | Section 4 (Scope) |
| o DOH through BRL | Section 5 (Regulatory Authority): |
| a) Routine hematology (CBC)- hemoglobin mass concentration, erythrocyte volume fraction (hematocrit), leukocyte number concentration (WBC count) and leukocyte type number fraction (differential count | Primary Category: |
| (a) Services of Primary Category (b) Routine chemistry (c) Blood typing and Cross matching | Secondary Category: |
| (a)Services of Primary and Secondary Category (b) Special chemistry (c) Special hematology (d) Culture and Sensitivity of Bacteria | Tertiary Category: |
| Function: of A.O. 49-B series of 1988 | o Clinical Pathology o Anatomic Pathology o Forensic Pathology |
| Institutional Character | o Hospital Laboratories o Free-Standing Laboratories |
| (Licensing) | Section 7 |
| (Licensing Requirements) | Section 8 |
| (Management of the Clinical Laboratory): o Head, Pathologist | Section 9 |
| (Quality Control Tests) | Section 10 |
| (Reporting) | Section 11 |
| (Recording) | Section 12 |
| (Laboratory Rates) | Section 13 |
| Basic License Requirements) | Section 14 |
| (Application of License) | Section 15 |
| Non- refundable o Renewal shall be done from January to March o Late Renewal (April to May): P100.00 fine o If licensed is not renewed within May, a new license shall be applied for | Section 16 (License Fees) |
| Director of BRL or his representative | Section 17 (Inspection): |
| o by the Undersecretary for Standards & Regulations o 1 year: validity of provisional license for lab with insufficient Pathologists, and Physician-in-charge that is undergoing training | Section 18 (Issuance of License): |
| (Terms and Conditions of License | Section 19 |
| (Certificate of Approval and License and the Rules and Regulations) | Section 20 |
| Expiration | Section 21 |
| o labs for renewal can still operate during the period of application for renewal | Section 22 (Renewal): |
| o published periodically, and made available to any person, agency, or organization for legitimate purposes | Section 23 (Publication of Licensed Laboratories): |
| Modification and Revocation of Licenses) | Section 24 ( |
| o Operating without pathologist, qualified and authorized licensed physician, or registered medical technologist o Change of ownership, location, head without informing BRL | Section 25 (Violations) |
| o Revised Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines | Section 1 (Purpose and Title): |
| These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law consistent with ? | E.O. 102 series 1999: Redirecting the Functions and Operations of the Department of Health. |
| MEDTECH PRAYER | - |
| MT Code of Ethics | - |
| Revised Code of Ethics, what year PAMET Office | March 7, 1997 |
| All labs should be licensed and regulated by the DOH (except government labs doing minimum lab exams | Section 1: |
| licensed physicians should be in-charge of the labs | Section 2 |
| DOH-BRL is the one in-charge with the implementation of this act and to issue rules and regulations | Section 3: |
| punishment for violators (1 month – 1 year imprisonment, 1000-5000 pesos fine) | Section 4 |
| Separability Clause | Section 5 |
| Php 50,000 from the National Treasury are appropriated to carry out this act | Section 6: |
| Repealing Clause | Section 7 |
| Effectivity (May 19, 1966) | Section 8 |
| Physical Facilities- Primary = | 10 sq. m |
| Physical Facilities- Secondary = 20 sq. m. | 20 sq. m. |
| Physical Facilities- Tertiary = | 60 sq. m. |
| issued to labs that have complied with BHFS requirements | License to Operate (LTO) |
| exempted but must register | Teaching/Research Labs |
| must register with BHFS | Special Labs |
| must secure license if they issue official lab report, cater to other patients, and perform tests other than monitoring | Physical Office Lab (POL) |
| must be supervised by licensed laboratory | Point-of-care testing (POCT) |
| ab that moves from testing site to another testing site, but has a base laboratory. Allowed to operate within 100km radius from the main lab | Mobile laboratory: |
| any testing site that performs lab exams under the administrative control of a licensed laboratory, | Satellite testing site: |
| Renewal of license: - Non-hospital based - | October to November (processed not later than 5 days after expiration) |
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