Laboratory safety, PROFICIENCY TESTING, CLINICAL LABORATORY IMPROVEMENT ACT (CLIA), Compliance issues

As a lab manager, one needs to have a strong understanding of:

PATIENT and EMPLOYEE SAFETY

Hierarchy of Control

is a traditional method used to prevent workplace hazards.

An Important Infection Control Practice

Hand Hygiene

Chemical Hygiene Plan

Defines the policies and procedures for all chemicals used in the laboratory.

Physical Hazards and other Laboratory Associated Hazards

1.Ergonomics
2.Noise
3.Latex
4.UV light exposure
5.Radiation Safety
6.Radioactive Waste
7.Compressed gasses
8.Centrifuges
9.Dry ice
10.Fire prevention and safety

Who is responsible for regulations relating to general workplace safety and protecting the health of U.S. workers

OSHA

What is PT testing?

CLIA approved Proficiency Testing programs allow laboratories to evaluate their performance on a regular basis; usually 2 to 3 times a year. These programs also allow laboratories to improve the accuracy of the patient results they provide.

If proficiency specimens are not commercially available (most commonly seem in molecular testing)

vLaboratories can exchange blind split samples
vBlinded samples are measured or documented by independent means such as chart review

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF __

1996

PT is performed usually

two - three times a year

You __ share results with other laboratories

cannot

Requirements for PT

Must fulfill all standards
Keep Results for at least 2 years, signed by person who completed the PT, and lab director

A laboratory is defined as

any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

Laborites that must be CLIA certified includes

cash only models and insurance model laborites

Analytes that do not have a Proficiency Testing program available must be evaluated at least __ a year

twice

What certificate types are available?

◻Certificate of Waiver

◻Provider Performed Microscopy

◻Certificate of Compliance

◻Certificate of Accreditation

Who needs a CLIA certificate?

Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate.

Certificate of Waiver

These tests have been approved by the FDA for home use and require very little training to perform.

What are Provider Performed Microscopy tests?

Tests performed by a health care provider such as a doctor, physician's assistant, or nurse practitioner. These tests include: microscopic sediment analysis, wet preps, KOH preps, and other microscopic based procedures.

Is proficiency testing required for Provider Performed Microscopy?

No, proficiency testing is not required for Provider Performed Microscopy. However, the quality of the tests performed must be evaluated at least twice a year.

What types of tests are classified under a Certificate of Compliance?

Moderate or high complexity tests

How often must analytes without a Proficiency Testing program be evaluated under a Certificate of Compliance?

At least twice a year

How frequently are facilities with a Certificate of Compliance inspected?

Every two years

What components must be included in the Quality Assurance program of a facility with a Certificate of Compliance?

Quality control, personnel policies, patient test management, and proficiency testing

What is a Certificate of Accreditation?

These certificates have the same standards as the Certificate of Compliance, but are inspected by a CMS-deemed professional organization, not CMS directly.

Who inspects Certificates of Accreditation?

A CMS-deemed professional organization, not CMS directly.

What are the requirements for testing personnel

For tests classified as waived or moderately complex, testing personnel must have at least a high school diploma or G.E.D. and documentation of training before performing tests.

For tests classified as high complexity, testing personnel must have an associate of science degree or higher and documentation of training before performing tests.

How often must all personel be evaluated

within six months of hire and annually after that.

Laboratories need to comply with requirements that pertain to their laboratory in order to maintain

licensure and accreditation

Compliance agencies

◦Centers for Medicare and Medicaid Services (CMS)
◦Occupational Safety and Health Administration (OSHA)
◦Food and Drug Administration (FDA)
◦College of American Pathologists (CAP)
◦Commission on Laboratory Assessment (COLA)
◦American Association of Blood Banks (AABB)

PURPOSE OF ACCREDITATION

To recognize quality
To inform the public that an institution has met minimum standardsTo improve the quality of patient care

Agencies review ____ of the laboratory operation.

all aspects

Identifies deficiencies as phase I or phase II
Two year cycle;

Year 1 self-evaluation
Year 2 on-site inspection
Cycle repeats again

What is a Phase I Deficiency in a CAP Inspection?

Requires a response

What is a Phase II Deficiency in a CAP Inspection?

Requires a response AND documentation that supports that response

AABB

◻Inspection every two years
◻For transfusion services (blood bank) only
◻Inspector is usually a blood banker from another accredited blood service
◻Deficiencies handled the same as CAP

NAACLS (National Accrediting Agency for CLS)

◻It is aaccreditation of educational programs for MLS

◻University/colleges and hospital programs

◻Accreditation can be awarded up to seven years

Clinical and Laboratory Standards Institute (CLSI)

◻CLSI is a World Health Organization Collaborating Center for Clinical Laboratory Standards and Accreditation.