1 Clinical Laboratory Laws

Clinical Laboratory Law

Republic Act No. 4688 is also known as?

Complete Title of Republic Act No. 4688

An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof

June 18, 1966

Date of Approval of Republic Act No. 4688

annually at the office of Secretary of Health

[4688] Sec 1. 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 pathogenic organisms, processes, and/or conditions in the persons or animals from which they were obtained, shall register and secure a license ____________ at the ______________________.

• Government hospital laboratories

• extensions of government regional or central laboratories

Section 1 - 4688
NOTE: ___________________________ doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are ______________________ _______________________________.

licensed physician duly qualified in laboratory medicine

Section 2 - Head of the Laboratory
Head of the laboratory: ____________

• Secretary of Health

• annually

The licensed physician set as the head of the laboratory must be authorized by the _______ and to be renewed ____________?

• No license

• Secretary of Health

Section 2 - 4688
NOTE: _________________ shall be granted or renewed by the ___________________ for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction, and supervision of an authorized physician.

Secretary of Health (through the Bureau of Research and Laboratories)

• shall be charged with the responsibility of strictly enforcing the provisions of this Act (4688)

• shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions

• imprisonment for not less than 1 month but not more than 1 year, or;

• fine of not less than P1000 nor more than P5000, or;

• both fine and imprisonment, at the discretion of the court.

Punishments in cases of violations against the provisions of RA 4688

• Section 5

• not affect, impair or invalidate

What section of RA 4688 states that any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgement shall _______, ________, or ___________ the remainder thereof.

• P50,000 or so

• National Treasury

Section 6 - 4688
_______________: authorized to be appropriated, out of any funds in the ________________ not otherwise appropriated, to carry into effect the provisions of this Act.

ADMINISTRATIVE ORDER NO. 274 SERIES OF 1976

Rules and Regulations Governing Affiliation of Medical Technology Schools, Colleges and Universities in Government Hospitals under the Department of Health

Must be licensed

Responsibilities of the Department of Health and Laboratories
1. ____________________ as specified in R.A. 4688.

•  Clinical chemistry

• Clinical microscopy (urinalysis and parasitology)

• Microbiology (bacteriology)

• Hematology

• Blood banking and serology

• Histopathology

Responsibilities of the Department of Health and Laboratories (AO 274)- Position of medical technologist that should be provided for each of the sections?

• adequate laboratory space

• sufficient equipment and supplies

Responsibilities of the Department of Health and Laboratories. (AO 274)

There must be adequate ___________ and sufficient ___________ and ____________.

2 interns

There must be ______ number of interns at any time in each section.

True

True or False: A responsibility of the DOH and Laboratories is to have a training program MT for interns.

False – It must be prepared in coordination with the training officer.

True or False: A training program for medical technology interns must be prepared solely by the laboratory manager without coordination with the training officer.

True

True or False: The training program should be submitted to the Committee on Affiliation along with the contract of affiliation.

True

True or False: The training program requires an objective measure or evaluation of the baseline skills and knowledge of interns before they handle actual specimens.

False – The laboratory must be a member of the specialty society.

True or False: It is mandatory for the training program to be conducted by a laboratory that is not a member of the specialty society in laboratory medicine.

Objective measure or evaluation of the baseline skills and knowledge prior to allowing interns to handle actual specimens.

• Objective of training

• Procedures and methods to be taught

• Principles of the methods

• Right work attitudes and ethical values

• Required quota to develop accuracy and precision

• Objective evaluation of performance in each section

• Time schedule

• Lectures, seminars and conferences

• Methodology of training

3000 exams

Minimum number of examinations or samples for Clinical Chemistry section to accommodate interns (per annum):

• Urinalysis- 1500 samples

• Parasitology- 1500 samples

Minimum number of examinations or samples for Clinical Microscopy section to accommodate interns (per annum):

• Gram staining, acid test staining- 800 samples

• Isolation & identification of organisms- 1000 samples

Minimum number of examinations or samples for Microbiology section to accommodate interns (per annum):

• Peripheral blood study- 1200 samples

• Sedimentation rate, platelet count, bleeding and clotting time, malarial smears and other tests- 800 samples

Minimum number of examinations or samples for Hematology section to accommodate interns (per annum):

• Blood typing – 900 tests

• Complete cross-matching – 600 tests

• Serology

  • VDRL – 300 tests

  • Widal Test – 300 tests

Minimum number of examinations or samples for Blood Banking and Serology section to accommodate interns (per annum):

500 tests

Minimum number of examinations or samples for Histopathology & Cytology section to accommodate interns (per annum):

True

True or False: For every 2-10 interns there must be 1 RMT.

• at least 1 member of the professional staff

• not exceeding 10 interns

NOTE: For each additional intern, another half of the requirement shall be added. At least ____________ staff to every group of interns not exceeding ____ in each section should be provided.

• monitor attendance

• behavior

• performance

Staff and personnel of the laboratory must be assisted by a laboratory instructor to __________________, ____________, _______________ including guidance in readings and application to the theoretical knowledge.

10 medical technology interns. 1:10 ratio

No more than ___________________________ shall be allowed to train during the night shift in understaffed hospitals. No intern is to be assigned without the regular professional staff on duty at all times. Ratio?

• Intern’s affiliation fee

• for laboratory needs

______________________ for the laboratory must be spent for __________________ utilized exclusively for training and not for payment of furniture or appliances.

Director of the hospital

______________________ is responsible for the admission of the number of interns approved by the Committee.

within the area or region

Priority is given to interns residing __________ of the hospital.

• affiliation fees and budgetary outlay

• Secretary of Health

Quarterly reports on the ________________ and ________________ showing the proposed amount for each personnel must be submitted to the _______________________________ thru the Accreditation Committee together with the report of the status/or problems of the Affiliation Program.

Responsibilities of the Affiliating Universities/Schools/Colleges of Medical Technology- Requirements before applying for affiliation

• Approval from DepEd and the Board of Medical Technology

• Compliance with the provisions of RA 5527 and PD 498

Responsibilities of the Affiliating Universities/Schools/Colleges of Medical Technology- Universities, schools and colleges shall: ___________

Provide a laboratory instructor

Pay or replace damage, breakage of losses

Universities, schools and colleges shall:______________________________________ by the medical technology interns of laboratory property, equipment or supplies

completed the theoretical aspect

Universities, schools and colleges shall: Make sure that all interns before the start of internship must have_______________________

• 35 pesos, monthly

• first five days of the month

Universities, schools and colleges shall: Pay the hospital amount of _________ for each intern ____________. Payment is done within the ___________________________

• 6 copies

• renewed every school year

Universities, schools and colleges shall: Make a request of affiliation _________________ to the Chief of Hospital and must be ________________________

True or False: Universities, schools and colleges shall see to it that students and instructor are in proper uniforms and provided with a laboratory gown and

3 years

Universities, schools and colleges shall review contracts every?

Pathologist

_________: prepares the training program in coordination with the training officer

2 months

12 month internship: rotation for Clinical Chemistry

2 months

12 month internship: rotation for Clinical Microscopy (Urinalysis and Parasitology)

2 months

12 month internship: rotation for Microbiology (Bacteriology)

2 months

12 month internship: rotation for Hematology

1 month

12 month internship: rotation for Blood Banking and Serology

1 month

12 month internship: rotation for Histopathology

8 weeks

12 month internship: rotation for the remaining ________ will be assigned in any sections

Monthly conference

• Evaluate implementation of the program

• Changes of the program

• Problems of the implementation

• Cooperation

• harmonious working relations

Joint Responsibilities of Affiliating Universities, Schools and Colleges in Medical Technology and the Laboratories:

_______________ and __________________________ among staff and interns

ADMINISTRATIVE ORDER NO. 118-B SERIES NO. OF 1992

Rules and Regulations Governing the Accreditation of Clinical Laboratories for Training of Medical Technology Interns

Basic Accreditation Requirements (AO 118-B)

• Name of establishment

• Place, municipality and province

• Name, citizenship, home address of the head

• Name, citizenship, home address of the owner

• Copy of a valid permit

• Training program for medical technology interns

• Volume of examinations performed in the previous year for each section

• P500

• P250

• P200

Accreditation Fees (AO 118-B):

• Initial application: _______

• Renewal: _______

• Penalty: _______ (filed within 90 days after expiration)

• Director of Bureau of Research and Laboratories

• Director of Regional Health Offices, Provincial, City and Municipal Health Officers

Inspection (AO 118-B):

• __________________________________: inspect the premises and facilities

• Each laboratory must prepare all the necessary records

• ___________________________________: report to the BRL the existence of unaccredited clinical laboratories training medical technology interns

• inform BRL in writing within 15 days after transfer

• suspension or revocation of certificate

Terms and Conditions (AO 118-B):

• Transfer location: ________________________________

• Penalty: ________________________________________

2 years

Expiration of Accreditation Certificate (AO 118-B):________ after the date of approval (indicated at the upper right corner)

60 days

Renewal (AO 118-B): _____________ before expiration

Violation as stated in AO 118-B

• Training interns without a pathologist or medical technologist

• False statement in the application

• Failure to correct deficiencies within a reasonable time

• Refusal to allow inspection

• Repeated failure to submit an annual report

ADMINISTRATIVE ORDER NO. 59 SERIES OF 2001

Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines

Classification of Laboratories based on Function

• Clinical Pathology

• Anatomic Pathology

  • Surgical Pathology

  • Immunohistopathology

  • Cytology

  • Autopsy

  • Forensic Pathology

• Hospital-based laboratory

• Non-hospital based laboratory

Classification by Institutional Character

• ________________________: laboratory that operates within the hospital

• ________________________: laboratory that operates at its own

• Letter of application to the Director of Bureau of Health Facilities and Services (BHFS)

• 4 sets of Site Development Plans and Floor Plans (approved by an architect or engineer)

• DTI/SEC registration (for private laboratories)

Requirements and Procedures for Application of Permit to Construct and License to Operate. Application for permit to construct:

Notarized application form

Requirements and Procedures for Application of Permit to Construct and License to Operate. Application for new license (AO 59): _______________

January to March

Application for renewal of license: Schedule of application for renewal of license for NCR

February to April

Application for renewal of license: Schedule of application for renewal of license for 1,2,3, CAR

March to May

Application for renewal of license: Schedule of application for renewal of license for 4,5,6

April to June

Application for renewal of license: Schedule of application for renewal of license for 7,8,9

May to July

Application for renewal of license: Schedule of application for renewal of license for 10, 11, 12 , CARAGA, ARMM

• Non-refundable

• Must be paid to the cashier of BHFS/ Centers for Health Development (CHD)

Permit and license fees stated in AO 59

• ________________________

• Must be paid to the ________________

P1000

Penalties (AO 59): ________ for late renewal after 2 months from expiry date

Director of BHFS/ CHD

Responsible for Inspection & Monitoring as stated in AO 59

Director of CHD

Responsible for Issuance of License as stated in AO 59

Terms and Conditions as stated in AO 59

• Nontransferable

• Extension laboratory has a separate license

• License must be displayed in a visible location or area of the laboratory

Violations as stated in AO 59

• Operation of laboratory without a pathologist or medical technologist

• Change of ownership, location head of laboratory or personnel without informing the BHFS and/or the CHD

• Refusal to allow inspection

• Gross negligence

• Any act or omission detrimental to the public

Secretary of Health

____________ may suspend or revoke the operation of laboratory

Provincial, City and Municipal Health Officers

___________________: report the existence of unlicensed laboratories

• Internal QC

• External QC

Quality Control (QC)

• ____________: provide appropriate and standard methods, reagents, etc.

• ____________: given by a National Reference Laboratory

Quality Control

• represents the techniques and procedures that monitor per performance characteristics

• a system of techniques to ensure with a specified degree of confidence that the result obtain from each series at analysis is true and correct

detect and repair performance – remove sporadic spikes

Main purpose of Quality Control is to __________________ to the prior chronic level, either by prompt action to restore the status quo or, preferably, by preventing the damage from occurring in the first place

• deals with the causes, sources of errors, mistakes and the procedures used to recognized and minimize errors; part of QA

Purposes/Objectives of QC

• to check for the quality of reagents

• to check for the stability of the machine

• to check for technical (operator) errors

• Intralab QC (Internal QC)

• Interlab QC (External QC)

Kinds of QC

Intralab QC (Internal QC)

• Involves the analysis of control samples together with the patient specimen

• Detects changes in performance between the present operation and the stable operation

• Important for the daily monitoring of accuracy and precision of analytical methods

• Detects both random and systematic errors in a daily basis

• Allows identification of analytic errors within a one – week cycle

Interlab QC (External QC)

• Involves proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical laboratories

• Important in maintaining long – term accuracy of the analytical methods

• Also used to determine state-of-the-art interlaboratory performance

• The College of American Pathologists (CAP) proficiency program is the gold standard for clinical laboratory external QC testing

follow the DOH guidelines

Waste Disposal as stated by AO 59

laboratory files must be kept for at least 1 year

Recording as stated by AO 59