Regulation, Accreditation and Legislation

RA 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, and for Other Purposes"

Laboratory Requests and Reports

- Consultation between pathologist and physician - All reports must be signed by the pathologist before releasing

(TJC) The Joint Commission

- Formerly known as Joint Commission on Accreditation of Healthcare Organizations - usually surveys the laboratory as part of an overall health care facility survey - Fulfills licensure requirements in some states and general requirements of many insurers

Limited Service Capability

- Provides lab tests required for a particular service in institutions such as but not limited to dialysis centers and Social Hygiene Clinics - Institution based only

American Association of Blood Banks (AABB)

- peer professional group that offers a blood bank accreditation program that can substitute for a CAP inspection - It has CLIA deemed status

- issue official lab results - perform more than monitoring exams - cate not only the physicians px

A POL is required to secure a clinical lab license if it performs that ff activities:

Instituion

A corporate or establishment organized for an educational, medical, charitable or similar purposes.

Clinical Laboratory

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

Freestanding

A lab that does not form part of any other institution

Special Clinical Laboratory

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

Institution based

A lab that operates w/in the premesis and as part of an institution, such as but not limited to hospital medical clinic, school, medical facility for ofws and seafarer, birthing home, psychiatric facilities, drug rehab center

External Quality Assessment Program

A program where participating laboratories are given unknown samples for analysis. These samples are to be treated as ordinary human specimens for the usual processing and examination. The quality of performance of the laboratory shall be assess through the closeness of its results to the pre-determined value or to the reference value generated by the participating laboratories through peer group analysis.

15 days after its approval

AO No. 2007-0027 shall take effect

Health Insurance Portability and Accountability Act (HIPAA)

Access to PHI is restricted on a "need-to-know" basis as described in an employee's job description/title

CHD Directer or his authorized representative

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

SECTION 7 of RA 4688

All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

Philippine Board of Pathology

All Clinical Lab shall be headed and managed by either Clinical or Anatomic pathologist certified by

1988: Clinical Laboratory Improvement Act of 1988 (CLIA '88)

All laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards based on test complexity

Blood typing

Among the services provided by a Primary category clinical laboratory, what is the test that can only done in a hospital based clinical lab?

- Crossmatching - Gram staining - KOH (Potassium Hydroxide)

Among the services provided by a Secondary category clinical laboratory, what is the test that can only done in a hospital based clinical lab?

False. It MAY or MAY NOT.

An NRL is not a part of a general clinical laboratory.

Indefinite

Anatomic Pathology

SECTION 1 of RA 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: 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.

Satellite Testing Site

Any testing site that performs lab exams under the administrative control of a licensed lab; but performed outside physical confines of that lab

Bureau of Health Facilities and Services

BHFS

Routine tests

Basic, commonly requested tests in the lab, the results of w/c are not required to be released immediately upon completion.

Center for Health Development

CHD

Republic Act 4688

Clinical Laboratory Act of 1966

1 year

Clinical Pathology records are kept

a. Ownership b. Function c. Institutional Character d. Service Capability

Clinical laboratories can be classified by:

Center for Health Development

Conducts the inspection of Clinical Laboratories

BHFS or CHD Directer or their authorized representatives

Conducts the monitoring of Clinical Laboratories

2009: HITECH Act

Contains incentives related to adoption of health care information technology and the electronic health record (EHR)

Department of Homeland Security

DHS

Department of Health

DOH

2003: Hazardous Material Regulations

Deal with shipment of blood and other potentially biohazardous products

1996: Health Insurance Portability and Accountability Act

Directs how health care information is managed - This law protects patients from inappropriate dispersion of personal information

External Quality Assessment Program

EQAP

1983- Prospective Payment System 1984- Deficit Reduction Act 1988- Clinical Improvement Act of 1988 (CLIA '88) 1989- Physician Self-Referral Ban - Ergonomic Safety and Health Program Management 1990- Three Day Rule - Occupational Exposure to Hazardous Chemicals in Laboratories 1992- Occupational Exposure to Blood-Borne Pathogens 1996- Health Insurance Portability and Accountability Act 1997- OIG Compliance Guidelines 2001- CMS National Coverage Determinations 2003- Hazardous Material Regulations 2009- HITECH Act

Enumerate the Laboratory Regulations and their Significance.

(CDC) Centers for Disease Control and Prevention (CMS) Centers for Medicare and Medicaid Services (DOT) Department of Transportation (EPA) Environmental Protection Agency (EEOC) Equal Employment Opportunity Commission (FDA) U.S Food and Drug Administration (HHS) Department of Health and Human Services (NARA) National Archives and Records Administration (NIDA) National Institute on Drug Abuse (NRC) Nuclear Regulatory Commission (NIOSH) National Institute of Occupational Safety and Health (NIH) National Institute of Health (NIST) National Institue of Standards and Technology (OIG) Office of the Inspector General (OSHA) Occupational Safety and Health Administration

Enumerate the Laboratory related Governmental Agencies

(AABB) American Association of Blood Banks (ASCP) AmericanSociety of Clinical Pathology (CAP) College of American Pathologists (CLSI) Clinical and Laboratory Standards Institue (COLA) Commission on Laboratory Accreditation (TJC) The Joint Commission

Enumerate the Laboratory related Non-Governmental Agencies

1989: Ergonomic Safety and Health Program Management Guidelines

Establish OSHA guidelines for employee safety.

1984: Deficit Reduction Act

Established outpatient laboratory fee schedule to control costs

1983: Prospective Payment System

Established payment based on diagnosis-related groups (DRGs) for Medicare patients

1992: Occupational Exposure to Blood-Borne Pathogens

Establishes OSHA guidelines to limit unnecessary exposure to biological hazard

1990: Occupational Exposure to Hazardous Chemicals in Laboratories

Establishes OSHA guidelines to limit unnecessary exposure to hazardous chemicals.

Non-refundable

Fees are _____________ for the initial application, renewal of license

1st day of October until the last day of November

For non-hospital based labs, application of renewal of LTO (complete) during this period shall be granted with discount

1997: OIG Compliance Guidelines

Help laboratories develop programs that promote high ethical and lawful conduct, especially regarding billing practices and fraud and abuse

One-Stop-Shop Licensure System

Hospital based labs are licensed through

Department of Homeland Security

Identifies, regulates, and may inspect high-risk chemical facilities and radiation sources (including blood irradiators) that may be risks for terrorism; may require certification for non-U.S. citizens working in the laboratory.

SECTION 5 of RA 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.

Not less than 1 month but not more than 1 year; Not less than 1000 pesos but not more than 5000 pesos.

In Section 4 of RA 4688, Any person, firm or corporation who violates any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health shall be punished with imprisonment for _____________________________________________, or by a fine of _____________________________________________, or both such fine and imprisonment, at the discretion of the court.

Blood of sheep, rabbit and horse.

In a blood agar plate, what animals blood do they use?

Only 1, either aerobic or anaerobic.

In culture sensitivity, aerobic and anaerobic bacterias are being used. In a hospital based laboratories, both aerobic and anaerobic can be used. What about in free standing laboratories?

Secretary of Health and Bureau of Research and Laboratories

In the Section 3 of RA 4688, they are in-charge 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.

Clinical Pathology

Includes Hematology, immunology, immunohematology, clinical chemistry, microbiology, clinical micrscopy, molecular biology, endocrinology, cytogenetics, toxicology, and Therapeutic Drug Monitoring

Anatomic Pathology

Includes Surgical Pathology, Immunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology

1990: Three-Day Rule

Initiated by CMS ✓ Payment for any laboratory testing done 3 calendar days before admission as an inpatient is not reimbursed because testing is considered to be part of the hospital stay

Notice of Violation

Issued immediately after monitoring of non-compliant clinical laboratories

CHD

Issues the LTO for HIV and water analysis

SECTION 2 of 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 annually. 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.

License to Operate

LTO; also refers to license

(DOT) U.S. Department of Transportation

Laboratory specimens sent to reference laboratories must be packaged per guidelines set by this agency

(ASCP): American Society for Clinical Pathology

Largest organization for laboratory professionals and offers certification for various specialties

American Society of Clinical Pathology (ASCP)

Largest organization for laboratory professionals and offers certification for various specialties

(CAP) College of American Pathologists

Largest proficiency survey program in the United States and has a peer-surveyed laboratory accreditation program that has CLIA deemed status

Lung Center of the Philippines

NRL for Chemistry

East Avenue Medical Center

NRL for Drug Testing and Clinical Microscopy

San Lazaro Hospital

NRL for HIV

National Kidney and Transplant Institute (NKTI)

NRL for Hematology

Rizal Medical Center

NRL for Histopathology

Research Institute for Tropical Medicine

NRL for Microbiology

National reference Laboratory

NRL; A laboratory in a government hospital which had been designated by the DOH to provode special functions and services for specific disease areas.

This order is promulgated to precribe a revised minimum standard for clinical laboratories. This shall also ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety.

Objective of AO No. 2007-0027

Point of Care Testing

POCT; a diagnostic testing at or near the site of px care rather than in a clinical laboratory Ex. Bedise testing, outpx and home care

Physician's Office Laboratory

POL; An individual doctor's office/ clinic wherein lab exams are performed

Critical values

Panic values originally described by Lundberg as "life-threatening" unless something is done promptly and for which some corrective action could be undertaken

(CLSI) Clinical and Laboratory Standards Institute

Peer professional group that develops standardized criteria regarding laboratory practices; accrediting and licensing entities often adopt these as standards (formerly NCCLS)

Laboratory Compliance Program

Physicians must now select the most appropriate tests and avoid the "shotgun" approach to test-ordering practices

1989: Physician Self-Referral Ban

Prevents physicians from referring Medicare patients to self-owned laboratories

(COLA) Commission on Office Laboratory Accreditation

Provide assistance to physician office laboratories (POLs)

Hitech Act

Providing patients access to their PHI access must be provided within 30 days of the request

1. Malaria screening 2. Acid fast bacilli staining 3. Tests for STD 4. Cervical PAP smear

RA 4688 is a law that scopes all clinical laboratories, EXCEPT for government clinical laboratories doing microscopic works only for specific DOH programs such as:

Not later than 5 working days after the expiration data of its license

Renewal of license of clinical lab shall be processed

2001: CMS National Coverage Determinations

Replaced most local medical review policies used to determine whether certain laboratory tests are medically necessary and therefore reimbursable

stat'im

STAT is an abbreviation of _____ which means immediately

48 hours

Serum/CSF/body fluids are kept

False.

T or F? Routine test, do not follow that usual procedures and systems in the lab since its very common.

Monitoring Examinations

Tests done in series on patients as a guide for laboratory

STAT tests

Tests done on urgent cases, the results of w/c shall be released immediately, within 1 hour (30-45 mins) after the procedure.

Annually

The LTO can are inspected

DOH, BHFS

The LTO can be obtained to

1 year

The LTO is valid for

Inspection tool

The checklist used by the regulatory officers during inspection visits to evaluate compliance of the clinical laboratory to the minimum standard and technical requirements

Philippine Society of Pathologists

The head of the lab shall supervise staff in accordance to the standards set by

Licensee

The individual, agency, partnership or corporation to whom the license is issued and to whom rests compliance with this order

- Blood bank donor/receipt records - Blood bank employee signatures/initials - Blood bank patient records - Flow cytometry plots/histogram - FNA slides - Paraffin Blocks/Slides - Reports (Surgical, Cytology, Non-forensic) - Surgical Pathology (Bone Marrow Slides)

These records/specimen(s) are kept for 10 years

Wet tissue

These records/specimen(s) are kept for 2 weeks

- Accession logs - Maintenance/Instrument logs - Clinical Pathology Test records - Quality Control records - Requisitions - Retired Laboratory procedures

These records/specimen(s) are kept for 2 years

Cytogenetic reports/images

These records/specimen(s) are kept for 20 years

Cytogenetic Slides

These records/specimen(s) are kept for 3 years

- Blood bank QC Records - Cytology Slides

These records/specimen(s) are kept for 5 years

- Blood bank deferred records - Anatomic Pathology

These records/specimen(s) are kept indefinitely

Blood/Fluid Smears Microbiology Stained Slides

These records/specimens are kept for 7 DAYS

BHFS or CHD Directer or their authorized representatives

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

SECTION 8 of RA 4688

This Act shall take effect upon its approval.

Administrative Order No. 2007-0027

Through this administrative order, RA 4688 was revised.

50 thousand pesos

Under the SECTION 6 of RA 4688, the sum of __ thousand pesos, 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.

24 hours

Urine are kept for

State Departments of Health

Vary in the extent to which they regulate laboratories. Some states, like New York, license all laboratories and oversee mandatory proficiency testing and laboratory inspection programs; others do neither. New York and Washington, D.C., have Clinical Laboratory Improvement Act "deemed status."

- Drug testing - Clinical Microscopy

What are the 2 Fortes of EAMC?

a. Primary category b. Secondary category c. Tertiary Category d. Limited Service Capability (Institution based only)

What are the 3 categories under General clinical laboratory?

Provision of referral services such as confirmatory testing, surveillance, resolution of conflicting results between or among laboratories, training, researc, implementation of EQAS; evaluation of diagnostic kits and reagents

What are the functions of an NRL?

- Routine hematology (CBC) - Qualitative platelet determination - Routine Clinical Microscopy (Routine Urinalysis and Fecalysis) - Blood Typing

What are the services provided by a Primary category clinical laboratory?

- Routine Clinical Chemistry - Quantitative Platelet determination - Crossmatching - Gram staining - KOH (Potassium Hydroxide) - Primary service capabilities

What are the services provided by a Secondary category clinical laboratory?

- Special hematology - Special Chemistry - Immunology - Microbiology- Culture & Sensitivity

What are the services provided by a Tertiary category clinical laboratory?

1. Clinical Pathology 2. Anatomic Pathology

What are the two classification by Function?

1. Institution Based 2. Free standing

What are the two classification by Institutional Character?

1. Government 2. Private

What are the two classification by Ownership?

1. General clinical laboratory 2. Special clinical laboratory

What are the two classification by Service capability?

June 18, 1966

When did RA 4688 was enacted?

Francisco T. Duque III, MD, MSc

Who is the current Secretary of Health?

Mobile Clinical Laboratory

a laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location. - It shall have a base laboratory

Applicant

a natural or juridical person who intends to operate a clinical laboratory

Government

operated and maintained, partially or wholly, by the national government, LGU and other political unit

Private

owned, established and operated by any individual, corporation, association, or organization

(CDC) Centers for Disease Control and Prevention

provides oversight of public health and safety

License

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

(OSHA) Occupational Safety and Health Administration

▪ Develops and enforces workplace standards to protect employees' safety and health

(NRC) Nuclear Regulatory Commission

▪ Laboratory tests that use radioactive materials (like radioimmunoassays) must adhere to guidelines set by this agency

(NIDA) National Institute on Drug Abuse

▪ Regulates standards for performing and maintaining appropriate quality control for drugs of abuse testing

(NIH) National Institutes of Health

▪ agency of HHS and is a world leader in medical research

(NIST) National Institute of Standards and Technology

▪ developed standards for calibration, weights and measures, and the International System of Units

(CMS) Centers for Medicare and Medicaid Services

▪ formerly known as HCFA ▪ oversees the largest health care program in the United States ▪ sets quality standards and reimbursement rates that apply to the laboratory and are often used by other third- party payers

(HHS): U.S. Department of Health and Human Services

▪ oversees CMS, OIG, and FDA

(EEOC) Equal Employment Opportunity Commission

▪ oversees and enforces Title VIII dealing with fair employment practices related to the Civil Rights Act of 1964 and the Equal Employment Opportunity Act of 1972

(NIOSH) National Institute of Standards and Technology

▪ part of HHS and provides research, information, education, and training in the field of occupational safety and health

(FDA): U.S. Food and Drug Administration

▪ part of HHS and regulates the manufacture of biologics and medical devices and test kits

(NARA) National Archives and Records Administration

▪ provides a number of databases, including access to the Federal Register, where laboratory and other regulations are published

Office of the Inspector General (OIG)

▪ responsible for auditing, inspecting, and identifying fraud and abuse in CMS programs such as laboratory testing

(EPA) Environmental Protection Agency

▪ sets and enforces standards for disposal of hazardous laboratory materials