WK 5 - REGULATION, ACCREDITATION & LEGISLATION

1983: PERSPECTIVE PAYMENT SYSTEM

- For MediCare patients who establish based on Diagnosis Related Groups (DRG).

- Hospitals are paid a fixed amount per DRG

1984: DEFICIT REDUCTION ACT

- Established out-patient laboratory fee to schedule control cost.

DEFRA

1988: CLINICAL LABORATORY IMPROVEMENT ACT OF 1988

- All laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards.

CLIA

1989: PHYSICIAN SELF-REFERRAL BAN

- Prevents the physician from referring MediCare patients to self-owned laboratories.

65 YRS OR OLDER, WITH DISABILITIES, PATIENT WITH END STAGE RENAL DISEASE

MediCare patients are:

1990: THREE-DAY RULE

- Payment for any laboratory testing done within

three calendar days before admission as in-

patient will not be reimbursed.

1992: OCCUPATIONAL EXPOSURE TO BLOOD BORNE PATHOGENS

- Establish OSHA guidelines to limit unnecessary exposure to biological hazards.

OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS

- Establish OSHA exposure to limit unnecessary exposure to hazardous chemicals.

1996: HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT

- Law that protects patients from inappropriate

dispersion of personal information.

- Access to protected health information (PHI).

HIPAA

1977: OFFICE OF INSPECTOR GENERAL COMPLIANCE GUIDELINES

• Help the laboratories to develop programs that

promote high ethical and lawful conduct.

• Billing Practices – fraud abuse

OIG

AUG. 24, 1998 - RESPONSE TO CMS & ABUSE OF PAYMENT

- Physicians must know how to select the most

appropriate test/s needed and should avoid the “shotgun” approach to test ordering practices.

SHOTGUN

mag-oorder ng mga test na hindi naman kailangan ng pasyente.

SERUM

OGGT & FBS, what specimen?

ETHYLENEDIAMINETETRAACETIC ACID

HBA1C

ORAL GLUCOSE TOLERANCE TEST

OGTT

FASTING BLOOD SUGAR

FBS

2001: CMS NATIONAL COVERAGE DETERMINATIONS

- Replace most local medical review policies

which are used to determine whether laboratory

tests are medically necessary and reimbursable.

2003: HAZARDOUS MATERIAL REGULATIONS

- Deals with shipment of blood and other

potentially biohazardous products.

2007: HI-TECH ACT

- Contains incentives related to adoption of health

care information technology & electronic health

records (EHR).

- Provides patients the access to their PHI of

which the access provided within 30 days of the

requests.

CENTERS FOR DISEASE CONTROL AND PREVENTION

CDC

- Under of DOH and Human Services

- For Public Health Safety

CENTERS FOR MEDICARE AND MEDICAID SERVICES

CMS

- Largest healthcare medical programs in the US.

• MediCare

• Medic Aid – for low-income individuals.

ENVIRONMENTAL PROTECTION AGENCY

- Enforces standards for disposal of hazardous

lab materials.

• Formalin

• Xylene

• Potential Carcinogens

EQUAL EMPLOYMENT OPPORTUNITY COMMISSION

- It deals with fair employment practices.

FOOD AND DRU ADMINISTRATION

- Part of HHS

- Regulates and manufactures of biologics and

medical device and test kits.

- The largest organization for laboratory

professionals and offers certification for various

specialties.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

HHS

- Oversees CMS, OIG, & FDA

NUCLEAR REGULATORY COMMISSION

NRC

- Enforces federal guidelines for the proper use of

non-military nuclear facilities.

NATIONAL INSTITUTE IF DRUG ABUSE

NIDA

- Performing and maintaining quality control for

drug abuse testing.

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION

NARA

• Provides database and access to the federal

register.

• Federal Register – Lab and regulations

are published.

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH

NIOSH

- Part of HHS

- Provides research, information, education, and

training in the field of occupational safety and

health.

- Allows recommendations, not enforcing.

NATONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

NIST

- Under ng Commerce Department

- Contributed to the development of many

healthcare products.

OFFICE OF INSPECTOR GENERAL

OIG

- Part of Health and Human Services

- Responsible for auditing, inspecting, and

identifying fraud and abuse in CMS programs.

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

OSHA

- Under ng Department of Labor

- Develops and enforces workplace standard to

protect employee’s safety and health.

DEPARTMENT OF HOMELAND SECURITY

DHS

- Identifies, regulate, and may inspect high risk

chemical facilities and radiation sources that

may be risk of terrorism.

AMERICAN ASSOCIATION OF BLOOD BANK

AABB

- A peer professional group that offers a blood

bank accreditation.

AMERICAN SOCIETY FOR CLINICAL PATHOLOGY

ASCP

- The largest organization for laboratory

professionals and offers certification for various

specialties.

COLLEGE OF AMERICAN PATHOLOGIST

CAP

- Offers the largest proficiency program in the US

CLINICAL AND LABORATORY STANDARDS INSTITUTE

CLSI

- Develops standardized criteria regarding laboratory practices.

COMMISSION ON OFFICE LABORATORY ACCREDITATION

COLA

- Non-profit organization that provide assistance to

physician office laboratory.

THE JOINT COMMISSION

- Laboratory that is under government that had

been designated by the DOH to provide special

function and services for specific disease.

• Confirmatory

• Training

• Research

• EQAS (External Quality Assurance

Services)

• Validate test kits and reagents

LUNG CENTER OF THE PHILIPPINES

LCP

NRL: Clinical Chemistry

NATIONAL KIDNEY TRANSPLANT INSTITUTE

NKTI

NRL: Hematology, Immunohematology, Immunopathology, Anatomical Pathology

EAST AVENUE MEDICAL CENTER

EAMC

NRL: Drug Testing, Water Microbiology

SAN LORENZO HOSPITAL

SLH

NRL: STD / AIDS Central Cooperative Laboratory (SACCL)

RESEARCH INSTITUTE FOR TROPICAL MEDICINE

RITM

NRL:

Microbiology (Bacteria)

Parasitology (Parasites)

Mycology (Fungi)

Virology (Virus)