Clinical Laboratory Laws q

RA 4688

An act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with DOH, providing penalty for the violation thereof, and for other purposes.

Section 1 (Clinical Lab Laws)

Acquisition of license

anually, office of the secretary of health

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions, and radioactivity from being or animal are analyzed for the determination if the presence of pathologic organisms, process and or conditions in the persons or animals from which they were obtained, shall register and secure a license (when) at the (where)?

Government Hospital Laboratories

- doing routine or minimum laboratory examinations shall be exempt from the provisions of this section (1) if their services are extensions of government, regional or central laboratories.

government, regional or central

Government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section (1) if their services are extensions of - laboratories.

Section 2

Head of the laboratory:
• Licensed physician duly qualified in laboratory medicine
• Authorized by the secretary of Health and to be renewed annually

Licenses physician

Section 2
Head of laboratory:
- duly qualified in laboratory medicine
• Authorized by the Secretary of Health and to be renewed anually

Secretary of Health, annually

Head of the laboratory:
• Licensed physician duly qualified in laboratory medicine
• Authorized by the - and to be renewed -

Physician

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 - .

Secretary of Health

No license 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.

Section 3

Secretary of Health (through the Bureau of Research and Laboratories):
• Shall be charged with the responsibility of strictly enforcing provisions of this Act.
• Shall be authorized to issue roles and regulations as mag be necessary to carry out its provisions.

Charged with the responsibility of strictly enforcing provisions

Secretary of Health (through the Bureau of Research and Laboratories):
• Shall be - of this Act.
• Shall be authorized to issue roles and regulations as mag be necessary to carry out its provisions.

authorized to issue roles and regulations as mag be necessary to carry out its provisions

Secretary of Health (through the Bureau of Research and Laboratories):
• Shall be charged with the responsibility of strictly enforcing provisions of this Act.
• Shall be -.

Section 4

Punishment in cases of violations against the provisions of this Act:
• Imprisonment for not less than 1 month but not more than 1 year or;
• fine of not less than ₱1000 or more than ₱5000
• both fine and imprisonment at discretion of the court

Not less than ₱1000 or more than ₱5000

Punishment in cases of violations against the provisions of this Act:
• Imprisonment for not less than 1 month but not more than 1 year or;
• fine of -
• both fine and imprisonment at discretion of the court

Not less than 1 month or more than 1 year

Punishment in cases of violations against the provisions of this Act:
• Imprisonment for - or;
• fine of not less than ₱1000 or more than ₱5000
• both fine and imprisonment at discretion of the court

Both fine and imprisonment at discretion of the court

Punishment in cases of violations against the provisions of this Act:
• Imprisonment for not less than 1 month but not more than 1 year or;
• fine of not less than ₱1000 or more than ₱5000
• -

Section 6

₱50000: authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effecr the provisions of this Act.

50000

₱ - or so: authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effecr the provisions of this Act.

National treasury

₱50000 or soauthorized to be appropriated, out of any funds in the - not otherwise appropriated, to carry into effecr the provisions of this Act.

Administrative order no. 274 series of 1976

Rules and Regualations Governing Affilation of Medical Technology Schools, Colleges and Universities in Government Hospitals under DOH

Responsibilities of the DOH and Laboratories

• Must be licensed as specified in RA 4688 (approx. 3-4 MTS, 8hr duty)
• Position of medical technologist should be provided for each of the sections of clinical chemistry, clinical microscopy (urinalysis and parasitology), microbiology (bacteriology), hematology, blood banking and serology and histopathology (bacteriology), hematology, blood banking and serology
• Adequate laboratory space
• Sufficient equipment and supplies
• 2 interns at any time in each section
• Must have a training program for MT interns.

Licensed

In responsibilities of DOH and laboratories,
(A school) must be - as specified in RA 4688

Clin. Chem, clin. Micro, microbio, hematology, blood banking and serology, histopathology

In responsibilities of DOH and laboratories,
Position of medical technology should be provided for each of the secrions of -

2

In responsibilities of DOH and laboratories,
There should be how many interns any time in each section?

Specialty society in laboratory medicine

In responsibilities of DOH and laboratories,
(A MT School) must have a training for medical interns. (The requirements are:)
Must be a member of the - ?

Committee on affiliation

In responsibilities of DOH and laboratories,
(A MT School) must have a training for medical interns. (The requirements are:)
• Must be a member of the SSLM
• Training program should also be prepared in coordinatoin with TRAINING OFFICER and must be submitted to the -? with the CONTRACT OF AFFILIATION

Baseline skills and knowledge

In responsibilities of DOH and laboratories,
(A MT School) must have a training for medical interns. (The requirements are:)
• Must be a member of the SSLM
• Training program should also be prepared in coordinatoin with training officer and must be submitted to the affiliation committee with the contract of affiliation
. Objective measure or evaluation of - prior to allowing interns to handle actual specimens

(1) Objectives of training, (2) procedures and methods to be taught, (3) principles of the methods, (4) right work attitude and ethical values, (5) required quota to develop accuracy and precision, (6) objective evaluation of performance in each sectiin, (7) time schedule, (8) lectures seminars and conferences, (9) methodology of training

In the Responsibilities of Department of Health and Laboratories,
Objective measure or evaluation of baseline skills and knowledge prior to allowing interns to handle actual specimens includes:
?

3000

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in clinical chemistry is?

1500

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in clinical microscopy; complete urinalysis is?

1500

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in clinical microscopy; parasitology (direct fecal smear and concentration test or kato thick smear)?

800

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in microbiology; gram staining, acid test staining is?

1000

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in microbiology; isolation and identification of organisms?

1200

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in hematology; peripheral blood study (hemoglobin, white cell count, schilling, hematocrit and res cell morphology or CBC)?

800

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in hematology; sedimentation rate, platelet count, bleeding and clotting time, malarial smears and other tests

900

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in blood banking and serology; blood typing

600

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in blood typing and serology; compelete cross matching?

300

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in blood banking and serology; serology: VDRL (venerial disease research laboratory) -syphilis

300

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in blood banking and serology; serology: Widal Test

500

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in histopathology; hematoxilin and eosin stain HAE

500

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year) in cytology?

Half

In AO 274 S 1976
Minimum number of exams of each section to accomodate interns (per year). Note: For each additional intern, another - of the requirement shall be added.

10

At least 1 member of the professional staff to every group of interns not exceeding - in each section should be provided.

Laboratory instructor

Staff and personnel of the laboratory must be assisted by a - to monitor ATTENDANCE, BEHAVIOR, PERFORMANCE, including guidance in readings and application to the theoretical knowledge

10

No more than - MT Interns shall be allowed to train during the night shift in understaffed hosps. No intern shall be allowed to be assigned without the regular professional staff on duty at all times.

Intern's laboratory fee

- for the laboratory must be spent for laboratory needs utilised exclusively for training and not for payment for furniture or appliances.

director of the hospital

- is responsible for the admission of the number of interns approved by the committee.

Priority

- is given to the interns residing within the area or region of the hospital.

Quarterly

?# reports on the AFFILIATION FEES and BUDGETARY OUTLAY showing the proposed amount for each personnel must be submitted to the SECRETARY OF HEALTH thru the Accreditation Committee together with the report or status of the AFFILIATION PROGRAM

AFFILIATION FEES and BUDGETARY OUTLAY

Quarterly reports on the - showing the proposed amount for each personnel must be submitted to the SECRETARY OF HEALTH thru the Accreditation Committee together with the report or status of the AFFILIATION PROGRAM

SECRETARY OF HEALTH

Quarterly reports on the affiliation fees and budgetary outlay showing the proposed amount for each personnel must be submitted to the - thru the Accreditation Committee together with the report or status of the AFFILIATION PROGRAM

Responsibilities of the affiliating universities, schools, colleges of medical technology

• Requirements before applying for affiliation
• Universities, schools, and colleges shall...

Deped and the board of MT

Requirements before applying for affiliation:
• Approval from?
• Compliance with the provisions of RA 5527 and PD 498

RA 5527 and PD 498

Requirements before applying for affiliation:
• Approval from DepEd and board of MT
• Compliance with the provisions of -

Laboratory instructor

Universities, schools and colleges shall:
Provide a -

Pay or replace

Universities, schools and colleges shall:
- damage, breakage of losses by the MT interns of lab property, equipment or supplies

Theoretical aspect

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

35, first 5 days of the month

Universities, schools and colleges shall:
Pay the hospital amount of ₱- for each intern monthly. Payment is done within the -
(Separate answers by comma.)

6

Universities, schools and colleges shall:
Make request of affiliation - copies for the chief of hosp and must be renewed every school year

Joint responsibilities of affiliating universities, schools, and colleges in mt and the laboratories

• pathologist
• 12 month internship
• monthly conference
• cooperation and harmonious working relations among staff and interns

Pathologist

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

2 mos

12 months internship (division in secs):
Clin chem?

2 mos

12 months internship (division in secs):
Clin micro?

2 mos

12 months internship (division in secs): Microbiology (bacteriology)?

2 mos

12 months internship (division in secs):
Hema?

1 mo

12 months internship (division in secs):
Blood banking and serology?

1 mo

12 months internship (division in secs): histopathology?

8 weeks

12 months internship (division in secs):
The remaining - will be assigned in any secs

Administrative order no. 118-B series of 1992

Rules and regulations governing the accreditation if clinical laboratories for training of mt interns

Establishment, head, owner, valid permit, training program,

Basic accreditation requirements of clinical laboratories for training of interns:
(1) Name of -
(2) Place, municipality, and province
(3) Name, citizenship, home address of the -
(4) name, citizenship, home address of the -
(5) Copy of -
(6) - for mt interns
(7) volume of examinations performed in the previous year for each section

500, 250, 200, 90

Accreditation fees for clinical laboratories for training mt interns:
Initial application -
Renewal -
Penalty - (filed w in - days after expiration)

Director of the Bureau of research and laboratories

Inspection for the acceeditation of clinical laboratories for training mt interns:
- : inspect the premises and facilities

Director of regional, provincial, city and municipal health officers

Inspection for the acceeditation of clinical laboratories for training mt interns:
• Each lab must prepare all the necessary records
• - report to the BRL the existence of unccredited clinical laboratories training MT interns

15

Terms and conditionin the accreditation of clinical lab for training mt interns:
• transfer locations: inform BRL in writing with - days after transfer
• penalty: suspension or revocation of certificate

2

Expirationof accreditation certificate:
• - years after the sate if aoproval (indicated at the upper righr corner)

60

Renewal (AO 118-B series of 1992)
In rules and regulations governing the accreditation of clin lab for training mt interns
- days before expiration

Pathologist/MT, false statement, reasonable time, inspection, annual

Violations in AO 118-B series of 1992
• Training interns without a -
• - in the application
• failure to correct deficiency within-
• Refusal to allow -
• Repeated failure to submit - report

Administrative order no. 59 Series of 2001

Rules and regulation governing the establishment, operation, and maintenance if clinical laboratories in the philippines

Clinical pathology, anatomic pathology; surgical, immunohistopathology, cytology, autopsy, forensic

Classification by function of laboratories

(Separate by commas then ; for subgroups)

Hospital-based, non-hospital-based

Classification of clin lab by institutional character

Primary

Classification of clin lab by service capability:
(Services)
•Routine Hematology
Hemoglobin, hematocrit, wbc count, differnetial count, platelet count (qualitative)
•Routine urinalysis
•Routine fecalysis
•Blood typing
•Quantitative platelets determination

Secondary

Classification of clin lab by service capability:
(Services)
•Routine Primary
•Routine Clinical Chemistry
Blood Glucose
Blood Urea Nitrogen BUN
Blood Uric Acid
Blood Creatinine
Total Cholesterol
-cross-matching

Tertiary

Classification of clin lab by service capability:
(Services)
•Special Chemistry
•Special Hematology (bone marrow)
• Immunology/Serology (HIVE, syphilis, hepa)
• Microbiology

10 sq m

Space of primary clin lab

20 sq m

Space of secondary clin lab

60 sq m

Space of tertiary clin lab

Primary

Equipments/instruments (classification by service capability)

Clin centrifuge
Hemocytometer
Microhematocritcentrifuge
Microscope
Hemoglobinometer
Differential blood cell count

Secondary

Equipments/instruments (classification by service capability)

Refrigerator
Phatometer
Waterbath
Timer
Primary

Tertiary

Equipments/instruments (classification by service capability)

Primary
Secondary
Incubator
Balance, trip/analytical
Serofuge
Autoclave
Drying overn
Biosafety cabinet

Director of bureau of health facilities and services (bhfs), 4, dti/sec

Application for permit to construct
Letter application to ?
- set if site development plans and floor (approved by arch/engr)
- registration (for private labs)

Notarized application form

Application for a new license (to operate) ?

Jan-mar, feb-april, mar-may, april-june, may-july

Application for renewal of license to operate schedule

NCR ?
1, 2, 3, CAR ?
4, 5, 6 ?
7, 8, 9 ?
10, 11, 12, CARAGA, ARMM ?

Non-refundable, cashiers pf BHFS/centers of health development (CHO)

Permit and license fees to construct/operate
• -
• Must be paid to the ?

1000

Penalty for late renewal (license to operate) after 2 months from expiry dat

Director of BHFS/CHO

Inspection & monitoring for license to operate and permit to construct is done by?

Diretor of CHO

Isauance of license to operate is done by?

Non-transferable, separate

Terms and conditions fobapplication of license to operate and permit toncontruct
• -
• extension laboratory has - license?
• license must be displayed in a visible location or area of the laboratory

Mt/pathologist, BHFS/CHO, inspection, gross alliance, public

Violations for application of license to operate and permit to construct

• operation of laboratory withhout a pathologist or medical technologist
• change of ownership, location head of laboratory or personnel without informing the -
• refusal to allow -
• -
• any omission or act detrimental to the -

Secretary of health

- may suspend or revoke the operation of laboratory