CLINICAL LABORATORY LAW (terminology, etc)

Clinical Laboratory

The facility where tests are done on specimens taken from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases.

ownership
function
institutional character
service capability

CLASSIFICATIONS OF LAB

Government clinical laboratories and Private clinical laboratories

(2) Ownership

Government clinical laboratories

Operated and maintained, partially or wholly, by national government, LGU, or any other political unit or any department, division, board or agency.

Private clinical laboratories

Owned, established, and operated by an individual, corporation, association, or organization.

Clinical and Anatomical Pathology

(2) Function of Clinical Laboratory

clinical pathology

- Clinical chemistry, Hematology, Immunohematology
- Microbiology, Immunology, Clinical microscopy
- Histopathology, Cytology, Toxicology, Endocrinology
- Molecular biology, Cytogenetics
- Therapeutic drug monitoring Other similar discipline

anatomical pathology

- Autopsy, Surgical pathology, Immunohistopathology
- Forensic pathology, Molecular pathology, Cytology

free-standing
institution-based

(2) institutional character

institution-based

operate with premises and as part of an institution

free-standing

Those that are not part of any institution

general and special clinical laboratory

(2) categories - service capability

general clinical laboratory

offer basic & routine lab examinations

primary, secondary, tertiary category and limited service capability

(4) categories - service capability -
general clinical laboratory

PRIMARY CATEGORY

- Routine hematology
- QL platelet determination
- Routine UA & FA
- Blood typing (hospi-based)

SECONDARY CATEGORY

- Routine CC
- QN platelet determination
- Cross-match (hospi-based)
- Gram staining (hospi-based)
- KOH (for hospital-based)

TERTIARY CATEGORY

- Special chemistry
- Special hema, including coagulation procedures
- Immunology
- Microbiology
- C&S
o Aerobic & anaerobic (for hospital-based)
o Aerobic & anaerobic (for hospital-based)

LIMITED SERVICE CAPABILITY

- (for institution- based only)
- Provide laboratory tests required for particular service in institutions such as, but not limited to, dialysis centers and social hygiene clinic

Special clinical laboratories

offer highly specialized lab services that are usually not provided by a general clinical laboratory

- Assisted reproduction technology
- Molecular and cellular technology
- Molecular biology, Molecular pathology
- Forensic pathology, Anatomic pathology

Special clinical laboratories

pre-analytical, analytical and post-analytical

COVERAGE OF THE TOTAL TESTING PROCESS IN A LAB

pre-analytical

handles specimen collection & handling

analytical

encompasses testing procedures, instrumentation & equipment, reagents, QC, personnel, and facilities

post-analytical

process that deals with reporting the results and disposal of the waste products

primary, secondary, tertiary clinical laboratory

DEPARTMENT MEMORANDUM NO. 148, SERIES OF 2003

primary - must have minimum technical working area of at least 10 (TEN) square meters
secondary - must have minimum technical working area of at least 20 (TWENTY) square meters
tertiary - must have minimum technical working area of at least 60 (SIXTY) square meters

DEPARTMENT MEMORANDUM NO. 148, SERIES OF 2003

primary -
secondary-
tertiary -

License to Operation (LTO)

document issued by DOH to an individual, agency, partnership, or a corporation that operates clinical laboratory upon compliance with the requirements set forth by the law

Any person, firm, or corporation operating and maintaining clinical lab shall register and secure a license annually with the HFSRB.

TAKE NOTE!

PHYSICIAN'S OFFICE LABORATORY (POL)

Individual doctor's office/clinic wherein lab exams are performed.

*Examinations done are permitted as long as they are used for monitoring.

As a rule, a license is not required for a POL except when it undertakes any or all of the following activities:
- Issue official laboratory results.
- Perform more than monitoring examinations.
- Provide services to individuals other than physician's own px

TAKE NOTE!

MOBILE CLINICAL LABORATORY

specialized facility that moves from one testing unit's site to another or has a temporary testing location

MOBILE CLINICAL LABORATORY

licensed as part of main clinical laboratory and permitted to collect specimens only

MOBILE CLINICAL LABORATORY

allowed to operate w/in a 100-km radius from its main lab only. required to secure Remote Collection Permit for clinical laboratory or RCP-CL from the DOH

POINT OF CARE TESTING (POCT)

- activity conducted in hospital must be under the management and supervision of licensed clinical laboratory of respective hospital.

- may be used for screening patients, preliminary diagnostic testing for emergency treatment, and monitoring of status of patients under treatment such as blood glucose levels for diabetics, electrolytes, oxygen saturation, coagulation status

pathologist

- Heads & manages every clinical lab and all general laboratories, whether government or private, institution -based or freestanding.

- Certified either as a clinical pathologist, an anatomic pathologist, or both by the Philippine Board of Pathology.

pathologist

Has direct supervision and control over other laboratory professionals such as RMTS and MLTs

One-Stop-Shop Licensure System

governs the renewal of hospital-based clinical lab

October 1 to November 30

Non-hospital-based clinical laboratories must renew LTO from _____________ of the current year

HFSRB or CHD director or his/her authorized representative

shall inspect and monitor clinical laboratories through visits to laboratory at any reasonable time

National Reference Laboratory (NRL)

Laboratories in government hospitals that have been designated by DOH to provide special functions and services for specific disease areas.
- Confirmatory testing, Surveillance
- Resolution of conflicting results between or among labs
- Training, Research, Implementation of EQAS
- Evaluation of diagnostic kits & reagents

Philippine National Heart Center (PNHC)
National Kidney and Transplant Institute (NKTI)
Lung Center of the Philippines (LCP)
STD/AIDS Cooperative Central Lab (SACCL)/ San Lazaro Hospital
Research Institute for Tropical Medicine (RITM)
East Avenue Med Center

NRLs IN THE PHILIPPINES - RECOGNIZED BY THE DOH DEPARTMENT CIRCULAR NO. 2013- 0435

Philippine National Heart Center (PNHC)

Anatomic pathology for cardiac diseases

National Kidney and Transplant Institute (NKTI)

- Hematology, coagulation tests
- immunohema, immunopatho
- anatomic pathology for renal diseases, & automated UA

Lung Center of the Philippines (LCP)

CC, anatomic pathology for pulmonary diseases

STD/AIDS Cooperative Central Lab (SACCL)/ San Lazaro Hospital

Screening & confirmatory tests for HIV, syphilis, hepatitis B & C

Research Institute for Tropical Medicine (RITM)

- Dengue, flu, TB and other mycobacteria,
- malaria and other parasites, bacterial enteric diseases, measles and other exanthems
- enterovirus, antimicrobial resistance, emerging and re-emerging infections
- confirmatory test for blood donors & blood unit
- rabies, Japanese encephalitis, and pathogens causing meningitis & meningoencephalitis

East Avenue Med Center

- Screening and confirmatory drug tests
- water testing potability, analytical toxicology
- methemoglobin, hgb, & sulfhemoglobin

All laboratory REPORTS on various examinations of specimens shall bear name and signature of
- pathologist who shall be accountable for reliability of results
- RMT who performed the examination

TAKE NOTE!

laboratory request

consultation of requesting physician to pathologist

lab report

consultation report of pathologist to requesting physician clinical laboratories must have provisions for reporting results of routine and STAT lab examinations, including critical values that would impact patient care

outsourcing

sending a specimen to another laboratory

outsourcing

- allowed only when the laboratory test required is not part of the service capability of referring clinical laboratory
- when it is part of contingency plan in case of equipment breakdown, as stipulated by DOH Circular No. 2018- 0130
- Once outsourced, referring laboratory is prohibited from transferring the result of the outside laboratory to its own form. It will just issue the official result bearing the name of the outside laboratory

- Not less than one month but not more than one year,
- or by a fine of not less than one thousand pesos nor more than five thousand pesos,
- or both such fine and imprisonment, at the discretion of the court.

sions. Any person, firm, or corporation who violates any provisions of R.A. No. 4688 or rules issued by the Secretary of Health shall be punished with imprisonment for?

HFSRB or CHD Director or his/her authorized representative

shall investigate complaint and verify if the laboratory concerned or any of its personnel is accountable for an alleged violation

CHD Director or his/her authorized representative

After investigation, shall suspend, cancel, or revoke for a determined period of time the LTO of licensees who are found violating the provision of R.A. 4688 or its implementing rules, without prejudice to taking the case to judicial authority for criminal action.