REPUBLIC ACT NO. 4688 Flashcards
Laban mhiee kaya mo ito T _ T
1
Q
It is an act Regulating the Operation and Maintenance of Clinical Laboratoriesand Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes.
A
REPUBLIC ACT NO. 4688
2
Q
How many sections does RA No. 4688 have?
A
8 sections
3
Q
RA No. 4688 Date of Approval:
A
June 18, 1966
4
Q
4 Implementing Rules and Regulations:
A
✓ 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)
5
Q
DATE OF APPROVAL:
- Administrative Order (A.O.) 201 series of 1973
A
(October 26, 1973)
6
Q
DATE OF APPROVAL:
- A.O. 49-B series of 1988
A
(October 25, 1988)
7
Q
DATE OF APPROVAL:
- A.O. 59 series of 2001
A
(November 19, 2001)
8
Q
DATE OF APPROVAL:
A.O. 2007-0027
A
(August 22, 2007)
9
Q
What section?(4688)
- Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, SHALL REGISTER AND SECURE A LICENSE ANNUALLY AT THE OFFICE OF THE SECRETARY OF HEALTH.
A
SECTION 1
10
Q
What section? (RA 4688)
- 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 of government regional or central laboratories.
A
SECTION 1
11
Q
WHAT SECTION?(RA 4688)
- 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 and AUTHORIZED BY THE SECRETARY OF HEALTH, such authorization to be RENEWED ANNAULLY.
- 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, direction and supervision of an authorized physician, as provided for in the preceding paragraph.
A
SECTION 2
12
Q
WHAT SECTION? (RA No. 4688)
- 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 and SHALL BE AUTHORIZED TO ISSUE SUCH RULES AND REGULATIONS as may be necessary to carry out its provisions.
A
SECTION 3
13
Q
WHAT SECTION? (RA No. 4688)
- Any person, firm or corporation who VIOLATES ANY PROVISION OF THIS ACT or the rules and regulations issued thereunder by the Secretary of Health shall be punished with IMPRISONMENT for not < 1 MONTH BUT NOT > 1 YEAR, or by a fine of NOT < 1,000.00 pesos nor > 5,000.00 pesos, or both such fine and imprisonment, at the discretion of the court.
A
SECTION 4
14
Q
SECTION 4 (RA No. 4688)
* Any person, firm or corporation who VIOLATES ANY PROVISION OF THIS ACT shall be punished with IMPRISONMENT for not ______________________or by a
fine of ___________________ or both such fine and imprisonment, at the discretion of the court.
A
NOT < 1 MONTH but NOT > 1 YEAR
NOT < 1,000.00 pesos nor > 5,000.00 pesos
15
Q
WHAT SECTION? (RA No. 4688)
* 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.
A
SECTION 5
16
Q
WHAT SECTION ? (RA No. 4688)
- The SUM OF FIFTY THOUSAND PESOS (50, 000), 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.
A
SECTION 6
17
Q
WHAT SECTION? (RA No. 4688)
- All Acts or parts of Acts which are INCONSISTENT with the provisions of this
Act are hereby REPEALED.
A
SECTION 7
18
Q
SECTION 7 (RA No. 4688)
* All Acts or parts of Acts which are ___________with the provisions of this
Act are hereby ______________.
A
INCONSISTENT
REPEALED
19
Q
WHAT SECTION? (RA No. 4688)
* This Act shall take effect upon its approval.
A
SECTION 8
20
Q
How many sections does A.O. 201 series of 1973 have?
A
24 sections
21
Q
Date of Approval: October 26, 1973
A
A.O. 201 series of 1973
22
Q
WHAT SECTION? (A.O. 201 series of 1973)
- (Purpose and Title): Revised Rules and Regulations Governing the Registration, Operations and Maintenance of Clinical Laboratories in the Philippines
A
SECTION 1
23
Q
WHAT SECTION? (A.O. 201 series of 1973)
- (Scope): Laboratories solely used for ACADEMIC TRAINING OR FOR PURELY RESEARCH ACTIVITIES ARE EXEMPTED
A
SECTION 2
24
Q
WHAT SECTION? (A.O. 201 series of 1973)
- (Basic License Requirements): SUBMIT TO SECRETARY, THROUGH BRL, SWORN APPLICATION with the ff:
1. Name, citizenship and domicile of the head of the laboratory;
2. Place, municipality and province where it is to be established;
3. Name of establishment
4. Name, citizenship and domicile of the owner
5. Scope and nature of work to be undertaken
6. Statement that applicant has complied with all business requirements
under other existing laws or ordinances that are necessary in
pursuance of the activity for which a license is herein applied for
7. A tax clearance for the preceding year - An inspector from BRL will inspect the lab within 60 days, and verify if the
requirements have been met.
A
SECTION 3: (Basic License Requirements)
25
WHAT SECTION? (A.O. 201 series of 1973)
* (Fees): P100.00 per license payable to BRL
* Renewal: within last TWO MONTHS of each year upon payment of P50.00
* Grace Period: 2 months (P10.00 fine) All government labs are exempted
from fees
SECTION 4
26
WHAT SECTION? (A.O. 201 series of 1973)
* No lab is permitted to operate without proper license
SECTION 5
27
WHAT SECTION? (A.O. 201 series of 1973)
* No person is permitted to manage, administer, or supervise a clin lab unless
he/she is an authorized licensed physician qualified in laboratory medicine
SECTION 6
28
WHAT SECTION? (A.O. 201 series of 1973)
* (Definition of Terms):
a. Clinical Laboratories (Clinical Pathology, Anatomical Pathology, Forensic Pathology)
b. Head/Chief/Director/In-charge (licensed and authorized pathologist or
physician with training in lab medicine)
c. Personnel (Associate Pathologist, Pathology Assistant, Medical Technologist, Laboratory Technicians, Laboratory Aides)
d. Equivalents (substitute equipment, supplies and materials)
SECTION 7
29
WHAT SECTION? (A.O. 201 series of 1973)
* (Interpretations): ONLY WRITTEN INTERPRETATIONS BY SECRETARY OF HEALTH AND JUSTICE will be recognized
SECTION 8
30
WHAT SECTION? (A.O. 201 series of 1973)
* Owner or authorized representative must file the application with the use of
sworn “Petition to Establish, Operate and Maintain a Clinical Laboratory”
and physician-signed “Information Sheet
SECTION 9
31
WHAT SECTION? (A.O. 201 series of 1973)
* (Terms and Conditions of License): License is not transferable
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
* Failure: revocation
SECTION 10
32
WHAT SECTION? (A.O. 201 series of 1973)
* (Requirements for a Clin Lab):
A. PERSONNEL: HEAD and at least ONE medical technologist
> Pathologists/Associate can only supervise a max of 4 clin lab
and/or blood banks contiguously located in a particular area
> Licensed physician can only supervise one laboratory
B. PHYSICAL PLAN :
> Separate from any commercial or non–medical establishment or
residential quarters.
> Working space must correlate capacity of hospital
> Adequate physical provisions
o If needed, sleeping quarters
> Lab space cannot be used as bleeding area or reception rooms for a blood bank
C. MINIMUM EQUIPMENT AND APPARATUSES
> Routine Tests, Routine Blood Chemistry, Special Biochemistry and Serology, Bacteriology, Mycology, Parasitology, Anatomic Pathology, Radioisotope Examinations
SECTION 11 (REQUIREMENTS FOR A CLINICAL LABORATORY)
33
WHAT SECTION? (A.O. 201 series of 1973)
* (Reporting)
-All laboratory requests shall be considered as consultations between the requesting physician and the pathologist of the laboratory.
* Reports shall NOT BE ISSUED ORALLY IN WRITING, or IN PORTIONS WITHOUT THE ACTUAL SIGNATURE ODF THE PATHOLOGIST.
SECTION 12: (REPORTING)
34
WHAT SECTION? (A.O. 201 series of 1973)
* (Recording)
- 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.
* Records of anatomic and forensic pathology should be kept permanently in
the laboratory.
SECTION 13 (RECORDING)
35
WHAT SECTION? (A.O. 201 series of 1973)
* (Laboratory Fees)
- The rate of laboratory fees to be charges by clinical
laboratory for examination shall be within the range of the usual fees prevailing at the time and particular place taking into consideration costs of
production and quality control of various laboratory procedures. 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)
36
WHAT SECTION? (A.O. 201 series of 1973)
* (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.
* No laboratory shall make advertisement on medical pad, fictitious and unproven claim misleading statements and to advocate directly or by any means of subterfuge unreliable and inconclusive laboratory procedures which
may prove detriment to patient care.
SECTION 15: (PUBLICITY)
37
WHAT SECTION? (A.O. 201 series of 1973)
* (Exhibition of Certificate of Approval and License and Rules and Regulations):
The license of the clinical laboratory must be placed in a
conspicuous place within the laboratory. The physician–in–charge must likewise place his or her license and authority together with his certificate of proficiency in the specialty in a prominent place in the laboratory. A copy of the rules and regulations should be readily available for guidance of all staff
and personnel in the laboratory.
SECTION 16: (EXHIBITION OF CERTIFICATE OF APPROVAL AND LICENSE AND RULES AND REGULATIONS
38
WHAT SECTION? (A.O. 201 series of 1973)
* (Expiration): Each specific license shall expire on the last day of DECEMBER of the year stated therein, including the authorization given to the Head, Director or Physician–in–charge of the clinical laboratory.
SECTION 17: (EXPIRATION)
39
WHAT SECTION? (A.O. 201 series of 1973)
* (Renewal): 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 or renewal immediately upon receipt thereof, provided, however, that such clinical laboratory may continue operation during the pendency of the final action of their applications unless otherwise or ordered or advised by the Secretary of Health to cease operation.
SECTION 18: (RENEWAL)
40
WHAT SECTION? (A.O. 201 series of 1973)
* (Inspection): Secretary of Health or his representative
SECTION 19: INSPECTION: SECRETARY OF HEALTH OR HIS REPRESENTATIVE
41
WHAT SECTION? (A.O. 201 series of 1973)
* (Quality Control Test): Director of BRL or his representative
SECTION 20: (QUALITY CONTROL TEST)
42
WHAT SECTION? (A.O. 201 series of 1973)
* (Modification and Revocation of Licenses)
SECTION 21: (MODIFICATION AND REVOCATION OF LICENSES)
43
WHAT SECTION? (A.O. 201 series of 1973)
* (Investigation of Charges or Complaint)
* Upon the filling of a complaint or charges duly sworn by any person interested party or corporation, against a clinical laboratory or any of its personnel to the effect that one or more of such personnel of an approved laboratory have
violated or are violating R.A. no. 4688 or the provisions of these regulations, the Secretary of Health or his duly authorized representatives shall investigate the complaint or charge and verify if the laboratory concerned or any of its
personnel is guilty of the charges. If upon investigations, a person or persons are found violating the provision of R.A. No. 4688 or any of these regulations, the Secretary of Health shall cancel or revoke for a definite or indefinite period of time the license of the laboratory and the authority of the offending person or persons, without prejudice to taking the case to judicial authorities for
criminal action
SECTION 22: (INVESTIGATION OF CHARGES OR COMPLAINT)
44
WHAT SECTION? (A.O. 201 series of 1973)
* (Violations)
o Imprisonment for not less than 1 month and not more than 1 year
o Fine of not P5,000.00
o Or both
SECTION 23: (VIOLATIONS)
45
WHAT SECTION? (A.O. 201 series of 1973)
* (Effectivity)
SECTION 24
46
HOW MANY SECTIONS DOES (A.O 49-B series of 1988) HAVE?
27 SECTIONS
47
A.O 49-B series of 1988 Date of approval:
October 25, 1988
48
WHAT SECTION? (A.O 49-B series of 1988)
* (Title): Revised Rules and Regulation Governing the registration, operation, and Maintenance of Clinical Laboratories in the Philippines
SECTION 1: (TITLE)
49
WHAT SECTION? (A.O 49-B series of 1988)
* (Authority): 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)
50
WHAT SECTION? (A.O 49-B series of 1988)
* (Purpose): These rules and regulations are promulgated to protect the health of the people by preventing the operation of sub–standard, improperly managed and inadequately supported clinical laboratories and by improving
the quality of the performance of clinical laboratory examinations.
SECTION 3: (PURPOSE)
51
WHAT SECTION? (A.O 49-B series of 1988)
* (Scope): 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)
52
WHAT SECTION ? (A.O 49-B series of 1988)
* (Regulatory Authority): DOH through BRL
SECTION 5: (REGULATORY AUTHORITY)
53
WHAT SECTION? (A.O 49-B series of 1988)
* (Classification of Laboratories According To): SERVICE CAPABILITY
> PRIMARY CATEGORY
a) Routine hematology
(b) Routine urinalysis
(c) Routine fecalysis
(d) Gram staining
>SECONDARY CATEGORY
(a) Services of Primary
Category
(b) Routine chemistry
(c) Blood typing and
cross matching
>TERTIARY CATEGORY
(a) Services of Primary
and Secondary
Category
(b) Special chemistry
(c) Special hematology
(d) Culture and
Sensitivity of Bacteria
SECTION 6: (CLASSIFICATION OF LABORATORIES ACCORDING TO SERVICE CAPABILITY)
54
SECTION 6 (A.O 49-B series of 1988)
* (Classification of Laboratories According To): SERVICE CAPABILITY
- Routine hematology
Routine urinalysis
Routine fecalysis
Gram staining
PRIMARY CATEGORY
55
SECTION 6 (A.O 49-B series of 1988)
* (Classification of Laboratories According To): SERVICE CAPABILITY
- (a) Services of Primary
Category
(b) Routine chemistry
(c) Blood typing and
cross matching
SECONDARY CATEGORY
56
SECTION 6 (A.O 49-B series of 1988)
* (Classification of Laboratories According To): SERVICE CAPABILITY
- (a) Services of Primary
and Secondary
Category
(b) Special chemistry
(c) Special hematology
(d) Culture and
Sensitivity of Bacteria
TERTIARY CATEGORY
57
WHAT SECTION? (A.O 49-B series of 1988)
* Function:
o Clinical Pathology:
✓ includes clinical chemistry, hematology, chemistry, microbiology, parasitology, mycology, clinical microscopy, immunology and serology, immunohematology and blood banking, radioisotope analysis and laboratory endocrinology and similar disciplines
o Anatomic Pathology: histopathology
o Forensic Pathology: includes all medico–legal examination
* Institutional Character:
✓ Hospital Laboratories
✓ Free-Standing Laboratories
SECTION 6: (FUNCTIONS)
58
WHAT SECTION? (A.O 49-B series of 1988)
* (Licensing): No clinical laboratory may operate without a proper and valid issued by the BUREAU OF RESEARCH AND LABORATORIES
SECTION 7:(LICENSING)
59
WHAT SECTION? (A.O 49-B series of 1988)
* (Licensing Requirements)
* All clinical laboratories shall be required to demonstrate compliance with the
following Technical Standards as requirements to licensing:
o Proper and competent management by a physician, licensed and duly
registered with the Board of Medicine (PRC), qualified in laboratory
medicine and duly authorized by the Undersecretary of Health for
Standards and Regulation
o Adequate staffing by qualified and trained personnel with at least one
(1) medical technologist registered with the Board of Medical
Technology (PRC) (c) Well ventilated, lighted, clean and safe physical
space sufficient to accommodate its activities
o Necessary equipment, furniture, glassware, reagents and supplies to
undertake the required services
* The BUREAU OF RESEARCH AND LABORATORIES shall evaluate compliance with such technical standards in accordance to minimum requirements for such category of laboratory or additional tests applied for as may be promulgated under these rules and regulations.
SECTION 8: (LICENSING REQUIREMENTS)
60
WHAT SECTION? (A.O 49-B series of 1988)
* (Management of the Clinical Laboratory): Head, Pathologist
SECTION 9: (MANAGEMENT OF THE CLINICAL LABORATORY)
61
WHAT SECTION? (A.O 49-B series of 1988)
* (Quality Control Tests)
- The Director of the Bureau of Research and Laboratories or his representative is hereby authorized to conduct such quality control tests as he deems appropriate or necessary for the administration or these regulations, for the control of operations and as criteria for the renewal of licenses.
SECTION 10: (QUALITY CONTROL TESTS)
62
WHAT SECTION? (A.O 49-B series of 1988)
* (Reporting)
SECTION 11:(REPORTING)
63
WHAT SECTION? (A.O 49-B series of 1988)
* (Recording)
SECTION 12: (RECORDING)
64
WHAT SECTION? (A.O 49-B series of 1988)
* (LABORATORY RATES)
SECTION 13: (LABORATORY RATES)
65
WHAT SECTION? (A.O 49-B series of 1988)
* (Basic License Requirements
SECTION 14: (BASIC LICENSE REQUIREMENTS)
66
WHAT SECTION? (A.O 49-B series of 1988)
* (Application of License)
SECTION 15: (APPLICATION OF LICENSE)
67
WHAT SECTION? (A.O 49-B series of 1988)
* (License Fees): Nonrefundable: A non–refundable fee shall be charged for every application for a license issued to open and operate a clinical laboratory both government and private.
* A non–refundable fee is charged on application for RENEWAL FILED DURING THREE MONTHS OF EACH YEAR
* All fees shall be payable to the Bureau of Research and Laboratories in accordance with the following schedule
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)
68
(A.O 49-B series of 1988)
- SECTION 16: (LICENSE FEES)
For NEW LICENSES
✓ Primary category P 200.00
✓ Secondary category P 300.00
✓ Tertiary category P 500.00
For RENEWAL of licenses
✓ Primary category P 100.00
✓ Secondary category P 150.00
✓ Tertiary category P 250.00
LICENSE FEES
69
(A.O 49-B series of 1988)
- SECTION 16: (LICENSE FEES)
> For NEW LICENSES
✓ Primary category P 200.00
✓ Secondary category P 300.00
✓ Tertiary category P 500.00
70
(A.O 49-B series of 1988)
- SECTION 16: (LICENSE FEES)
> For RENEWAL of licenses
✓ Primary category P 100.00
✓ Secondary category P 150.00
✓ Tertiary category P 250.00
71
WHAT SECTION? (A.O 49-B series of 1988)
* (Inspection): Director of BRL or his representative
SECTION 17: (INSPECTION)
72
WHAT SECTION? (A.O 49-B series of 1988)
* (Terms and Conditions of License)
SECTION 19: (TERMS AND CONDITIONS OF LICENSE)
72
WHAT SECTION? (A.O 49-B series of 1988)
* (Issuance of License): 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)
73
WHAT SECTION? (A.O 49-B series of 1988)
* (Certificate of Approval and License and the Rules and Regulations)
SECTION 20: (CERTIFICATE OF APPROVAL AND LICENSE & THE RULES AND REGULATIONS)
74
WHAT SECTION? (A.O 49-B series of 1988)
* (Renewal): labs for renewal can still operate during the period of application for renewal.
SECTION 22: (RENEWAL)
74
WHAT SECTION? (A.O 49-B series of 1988)
* (Expiration): Each specific license shall expire on the LAST DAY OF DECEMBER of the year stated herein, including the authorization given to the head of the clinical laboratory.
SECTION 21: (EXPIRATION)
75
WHAT SECTION? (A.O 49-B series of 1988)
* (Publication of Licensed Laboratories): published periodically, and made available to any person, agency, or organization for legitimate purposes
SECTION 23: (PUBLICATION OF LICENSED LABORATORIES)
76
WHAT SECTION? (A.O 49-B series of 1988)
* (Modification and Revocation of Licenses)
SECTION 24:( MODIFICATION AND REVOCATION OF LICENSES)
76
WHAT SECTION? (A.O 49-B series of 1988)
* (Violations)
o Operating without pathologist, qualified and authorized licensed
physician, or registered medical technologist
o Change of ownership, location, head without informing BRL
o Refusal to allow inspection during reasonable hours
o Refusal to perform tests on quality control samples
SECTION 25: (VIOLATIONS)
77
WHAT SECTION? (A.O 49-B series of 1988)
* (Investigation of Charges of Complaints)
SECTION 26: (INVESTIGATION OF CHARGES OF COMPLAINTS)
77
HOW MANY SECTIONS DOES A.O 59 series of 2001 HAVE?
13 SECTIONS with ANNEX A (Technical Standards and Minimum
Requirements)
78
WHAT SECTION? (A.O 49-B series of 1988)
* EFFECTIVITY
SECTION 27: (EFFECTIVITY)
78
A.O 59 series of 2001 date of APPROVAL:
November 19, 2001
79
WHAT SECTION? (A.O 59 series of 2001)
* (Purpose and Title): Revised Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
SECTION 1: (PURPOSE AND TITLE) : Revised Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
80
WHAT SECTION? (A.O 59 series of 2001)
* (Authority): 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.
* The Department of Health (DOH), through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall EXERCISE THE REGULATORY FUNCTIONS UNDER THESE AND REGULATIONS .
SECTION 2: (AUTHORITY)
81
WHAT SECTION? (A.O 59 series of 2001)
* (Purpose): These rules and regulations are promulgated to protect and promote the health of the people by ensuring availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards
SECTION 3: PURPOSE
82
WHAT SECTION? (A.O 59 series of 2001)
* (Scope):
o Exempted = GOVERNMENT LABS THAT ARE 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
SECTION 4: (SCOPE)
83
WHAT SECTION? (A.O 59 series of 2001)
* (Classification of Laboratories)
SERVICE CAPABILITY
> PRIMARY CATEGORY
(a) Routine hematology (CBC) – hemoglobin mass concentration, erythrocyte volume fraction (hematocrit)
b) Routine urinalysis
(c) Routine fecalysis
(d) Blood typing – hospital-based
(e) Quantitative platelet determination – hospital based
> SECONDARY CATEGORY
(a) Services of Primary
Category
(b) Routine chemistry
(c) Cross matching
> TERTIARY CATEGORY
(a) Services of Primary
and Secondary
Category
(b) Special chemistry
(c) Special hematology
(d) Immunology and Serology
(b) Routine urinalysis
(c) Routine fecalysis
(d) Blood typing – hospital-based
(e) Quantitative platelet determination – hospital based
(e) Microbiology
* FUNCTION:
o Clinical Pathology:
✓ includes Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic
Drug Monitoring and other similar disciplines.
o Anatomic Pathology:
✓ includes Surgical Pathology, Immunohistopathology, Cytology,
Autopsy and Forensic Pathology.
* Institutional Character:
✓ Hospital Laboratories Non-hospital-based Laboratories
SECTION 5: (CLASSIFICATION OF LABORATORIES)
84
WHAT SECTION? (A.O 59 series of 2001)
SECTION 5: (CLASSIFICATION OF LABORATORIES)
(a) Routine hematology (CBC) – hemoglobin mass concentration, erythrocyte volume fraction (hematocrit)
b) Routine urinalysis
(c) Routine fecalysis
(d) Blood typing – hospital-based
(e) Quantitative platelet determination – hospital based
PRIMARY CATEGORY
85
WHAT SECTION? (A.O 59 series of 2001)
SECTION 5: (CLASSIFICATION OF LABORATORIES)
(a) Services of Primary
Category
(b) Routine chemistry
(c) Cross matching
SECONDARY CATEGORY
86
WHAT SECTION? (A.O 59 series of 2001)
SECTION 5: (CLASSIFICATION OF LABORATORIES)
(a) Services of Primary
and Secondary
Category
(b) Special chemistry
(c) Special hematology
(d) Immunology and
Serology
(b) Routine urinalysis
(c) Routine fecalysis
(d) Blood typing –
hospital-based
(e) Quantitative platelet
determination – hospital
based
(e) Microbiology
TERTIARY CATEGORY
87
WHAT SECTION? (A.O 59 series of 2001)
* (Policies): BHFS-approved permit to construct and design lay-out of a clinical laboratory must be secured prior to submission of an application for a Petition to Operate
SECTION 6: (POLICIES)
88
WHAT SECTION? (A.O 59 series of 2001)
* (Requirements and Procedures for Application of Permit to Construct and License to Operate):
o Each region has different schedule for application of renewal
o Late Renewal (2 months after expiry date): P1,000 FINE
o BHFS/CHD (Center for Health Development) WILL INSPECT THE LAB EVERY 2 YEARS
o An extension laboratory shall have a separate license
SECTION 7: (REQUIREMENTS AND PROCEDURES FOR APPLICATION OR PERMIT TO CONSTRUCT AND LICENSE TO OPERATE)
89
WHAT SECTION? (A.O 59 series of 2001)
* (Violations)
o Similar to AO 49-B s. of 1988
o Gross negligence
o Any act or omission detrimental to the public
o The Provincial, City, and Municipal Health Officers are authorized to
report to the CHD and BHFS any violations
SECTION 8: (VIOLATIONS)
90
WHAT SECTION? (A.O 59 series of 2001)
* (Investigation of Charges of Complaints):
✓ Laboratory closure order issued by DOH shall not be rendered ineffective by any way
SECTION 9: (INVESTIGATION OF CHARAGE OF COMLPAINS)
91
WHAT SECTION? (A.O 59 series of 2001)
* (Modification and Revocation of License)
SECTION 10: (MODIFICATION AND REVOCATION OF LICENSE)
92
WHAT SECTION? (A.O 59 series of 2001)
* (Repealing Clause)
SECTION 11: (REPEALING CLAUSE)
93
WHAT SECTION? (A.O 59 series of 2001)
* (Publication and List of Licensed Clinical Laboratories)
SECTION 12: (PUBLICATION AND LIST OF LICENSED CLINICAL LABORATORIES)
94
WHAT SECTION? (A.O 59 series of 2001)
* (Effectivity)
➢ ANNEX A (Technical Standards and Minimum Requirements)
➢ Staffing:
✓ Pathologist or Physician with 3 months Training;
✓ Sufficient number of RMTs proportional to the workload
✓ Hospital-based: 1 RMT per shift
✓ Staff development and Appropriate Continuing Education Program
➢ Physical Facilities
✓ PRIMARY = 10 sq. m.
✓ SECONDARY = 20 sq. m.
✓ TERTIARY = 60 sq. m.
➢ Equipment/Instruments
➢ Glasswares/Reagents/Supplies:
➢ Waste Managment
➢ Quality Control Program
✓ Internal
✓ External – lab must participate in External Quality Assurance Program
by National Reference Labroatories
➢ Reporting
➢ Recording
➢ Laboratory Fees
SECTION 13: (EFFECTIVITY)
95
HOW MANY SECTIONS DOES A.O. 2007-0027 HAVE?
15 SECTIONS
96
A.O. 2007-0027 DATE OF APPROVAL:
August 22, 2007
97
TITLE: Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
A.O. 2007-0027
98
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
➢ General requirements:
✓ License to Operate (LTO) – issued to labs that have complied with BHFS requirements
✓ Teaching/Research Labs – exempted but must register
✓ Special Labs – must register with BHFS
✓ Physical Office Lab (POL) – must secure license if they issue official lab report, cater to other patients, and perform tests other than monitoring
✓ Point-of-care testing (POCT) – must be supervised by licensed
laboratory
99
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
➢ Specific requirements:
✓ Head – Pathologist
✓ Staff – RMTs
✓ Equipment
✓ Reagent and Supplies
✓ Technical Procedures
✓ QA and QC
✓ Physical Plant
100
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
- lab 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
101
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
- any testing site that performs lab exams under the administrative control of a licensed laboratory, but performed outside the physical confines of the laboratory
Satellite testing site:
102
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
- Renewal of license
✓ Non-hospital based – October to November (processed not later than 5 days after expiration)
✓ Hospital-based – renewed along with the hospital
103
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
> Classification of Lab According to Service Capability
- (a) Routine hematology
(CBC) – hemoglobin mass concentration, erythrocyte volume
fraction (hematocrit), leukocyte number concentration (WBC
count) and leukocyte type number fraction (differential count)
(b) Routine urinalysis
(c) Routine fecalysis
(d) Blood typing – hospital-based
(e) Qualitative platelet determination – hospital based
PRIMARY CATEGORY
104
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
> Classification of Lab According to Service Capability
(a) Services of Primary Category
(b) Routine chemistry
(c) Quantitative Platelet Count
(d) Cross matching – hospital-based
(e) Gram Stain - hospital based
(f) KOH - hospital-based
SECONDARY CATEGORY
105
A.O. 2007-0027 : Revised Rules and Regulation Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
> Classification of Lab According to Service Capability
(a) Services of Primary and Secondary Category
(b) Special chemistry
(c) Special hematology (Coagulation)
(d) Immunology and Serology
TERTIARY CATEGORY
