Applicable
Clinical Laboratory Safety Regulations
PART
III
College of American Pathologists
(CAP)
This
unit will present information regarding the clinical laboratory’s compliance with
the safety related stands required by the College of American Pathologists
(CAP).
Section
1: What is CAP?
Section
2: CAP’s Safety Regulations
Section
3: How Does CAP Affect BME?
Section
4: Compliance Tips
Section
5: The Most Common CAP Deficiencies.
Section
6: Resources
PART
III, Section 1: What is CAP?
The College of American Pathologists (CAP) Laboratory Accreditation Program began in 1962, inspecting just 10 labs. Today, more than 5500 laboratories participate in the CAP Accreditation Program. There is a good chance that your hospital is CAP accredited and is subject to CAP safety standards.
The
goal of the CAP program is improvement.
It is believed that laboratory improvement will occur through a
combination of voluntary peer review, education, and compliance with
established standards. Accredited labs
participate voluntarily, unlike CLIA, which is a federal requirement.
CAP
inspectors are volunteer inspectors acting as peer reviewers. Both the inspectors and the lab personnel being inspected benefit educationally
in a professional exchange of ideas.
CAP
accreditation is recognized as having “deemed status”, or equivalency, to CLIA
certification and Joint Commission on Accreditation of Healthcare Organizations
(JCAHO).
PART
III, Section 2: CAP’s Safety
Regulations
All accrediting agencies will always refer to the OSHA regulations as a resource for their standards. OSHA regulations are often difficult to interpret. CAP has taken the OSHA rules and their own interpretation of good safe laboratory practice and developed very specific standards and checklist questions to guide laboratories in their quest for a safe work place.
The
CAP will not guarantee that following their guidelines will ensure your
facility will pass an OSHA inspection, but following their guidelines will keep
you close to OSHA compliance. It is
always a good idea to examine your safety program and compare it to the OSHA
standards.
The
current (2000) CAP inspection checklist contains 64 questions related to safety
practices. Of these, 11 have direct
bearing on BME personnel. The checklist
questions are related to:
1) Establishment of safety policies and
procedures. Either your hospital
will have a Safety Manual or the laboratory may have its own Laboratory Safety
Manual. In either care, you are
responsible for following the policies and procedures contained in the
manuals. It is a good idea for the BME
Department to have a copy of the Laboratory Safety Manual if lab safety is not
a part of the hospital’s general safety manual. As part of a good safety program, your training and annual
retraining in safety matters must be documented to demonstrate compliance.
2) Specific policies and procedures for safe
handling of electrical equipment. Policies
and procedures must be documented for the safe handling of electrical
equipment. Special procedures are necessary for high voltage equipment.
Policies must specify that portable patient care electrical equipment (patient
bedside or point-of-care analyzers, glucose meters, blood gas analyzers, etc.)
be inspected by BME:
a)
Before
initial use
b)
After
repair
c)
After
modification
d)
When
a problem is suspected.
3)
Policies and procedures for radiation safety. There is no equipment in the lab that generates radioactive
radiation, but there is minimal use of radioisotopes in some hospital
labs. Your exposure to radioisotopes
will be very small. Exposure to
radioisotopes in the lab may occur when a solution of radioactive material is
accidentally spilled into a radiation detector or analyzer. If you become involved in repairing or
maintaining an analyzer contaminated with radioisotopes, the analyzer should
first be decontaminated according to your hospital’s policy and procedure for
such occurrences. Even if it is not a
spill situation, you should protect yourself with protective gloves and a lab
coat or gown when working on radiation analyzers in the lab.
4)
Policies and procedures for biohazard control and infection control
that are compliance with OSHA’s Standard on the Occupational Exposure to
Bloodborne Pathogens . (3 checklist questions related to this.) The
analyzers in the laboratory have some parts that are in contact with blood,
body fluids, or other potentially infectious materials. That particular section of the analyzer
should be decontaminated by laboratory personnel before BME personnel begin
working on the device. The laboratory
must have procedure in place for this purpose, and the lab personnel should
document the decontamination before repair or maintenance work begins.
5)
Instruction in the proper use of personal protective clothing or
equipment (e.g., gloves, gowns, lab coats, masks, eye protectors, etc.). (2 checklist questions related to this). You are required to have
documented training and retraining that you know how to protect yourself from
common hazards in the workplace. In the
laboratory, biohazard and infection control practices will require you to know
how to protect yourself from blood, body fluids and other potentially
infectious material when working in the laboratory. In general, always place a barrier, such as protective gloves,
lab coat or gown, or eye protectors, between you and anything wet when working
in the laboratory. This will help
prevent an exposure to substances that may be infectious or chemically
hazardous.
All personnel reasonably expected to have direct contact with body fluids, such as BME personnel may when installing, repairing or maintaining lab equipment, must receive education on the following items related to biohazard safety:
· Modes of transmission and prevention of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) and hepatitis C virus (HCV).
· Precautionary measures
· The application of “Universal Precautions” or “Standard Precautions”
6) The Hepatitis B Vaccine. All healthcare workers who are reasonably expected to have contact with blood or other potentially infectious materials must be offered hepatitis B vaccine free of charge. If your BME department regularly installs, maintains and repairs laboratory instruments, you are likely to have some risk of hepatitis B exposure. Consult with your supervisor and employee health department for information on the hepatitis B vaccine program at your facility.
7) Prohibition of smoking, eating, drinking, application of cosmetics and lip balm, and manipulation of contact lenses. These practices are not allowed in the clinical laboratory.
8) Policies and procedures for reporting and documenting all occupational injuries and exposures. Any injury such as a cut, scrape or skin puncture by devices in or on a laboratory analyzer must be reported and documented according to your facility’s policies and procedures. Laboratory instruments may be contaminated with biohazardous materials or hazardous chemicals. Proper treatment and follow-up, if needed, will help prevent illnesses from developing due to such occurrences. Proper work practices, using personal protective equipment, will help reduce injuries when working with laboratory equipment.
SECTION III, Part 3: How Does CAP Affect Biomedical Engineering?
A partnership between the clinical lab and biomedical engineering is necessary to provide good quality patient care. The CAP’s safety requirements acknowledge and accept OSHA’s rules and applies them to protecting laboratory workers. This includes Biomedical Engineering personnel who occasionally do their work in the laboratory or on laboratory equipment that may be taken out of the laboratory. Therefore, it becomes inherent upon the BME Department to accept the CAP regulations are a part of their job responsibilities. Equally, it is inherent upon the laboratory or the administration of the healthcare facility to provide BME with the essential information and training to ensure the CAP requirements are met.
SECTION
III, Part 4: Compliance Tips
CAP safety standards have the same focus as stated in the CLIA ’88 section (Part II, Section 4):
Protecting you, the healthcare worker. Refer back to the CLIA ’88 Part II, Section 4, to remind yourself of the following facts:
· OSHA rules drive the system. CAP’s rules have the OSHA regulations as its guidance for developing standards and checklist questions.
· Employers have responsibility to educate and provide you with the necessary personal protective equipment so you can work safely. Documentation must be available.
· You have responsibilities as an employee to learn and obey your facility’s safety policies and procedures. Remember to protect yourself first before working on laboratory instruments or analyzers. Document all safety illnesses and injuries.
Specifically
for CAP requirements, be sure that you carefully document any installation,
repair and maintenance tasks you perform on laboratory instruments or
analyzers. Good documentation will
include the following:
·
Reason
for BME’s work on the analyzer or instrument (i.e., installation, repair,
routine maintenance, routine ground checks, etc.)
·
Date
and who performed the work
·
If
repair or maintenance was done, verification that the analyzer or instrument
returned to proper operation following BME’s work. This should be done in coordination with appropriate laboratory
personnel.
·
If
repair work was unsuccessful, a plan of action must be written to correct the
problem. This should be done in
coordination with appropriate laboratory personnel.
·
Keep
a copy of such work in the BME Department and also in the laboratory.
PART
III, Section 5: The Most Common CAP
Safety Violations.
Each year, the CAP publishes the most common deficiencies discovered during on-site laboratory inspections. The most recent deficiency information related to BME is:
1.
Failure
to document annual electrical ground checks on laboratory equipment.
2.
Failure
to document annual electrical ground checks of power receptacles.
3.
Failure
to document routine maintenance of laboratory instruments or analyzers.
4.
Failure
to document follow-up actions when repairs were initially unsuccessful.
5.
Failure
to perform and/or document annual safety training or re-training on
OSHA’s Bloodborne Pathogen Rule and other general duty safety regulations, such
as electrical safety.
1) CAP Laboratory General Inspection Checklist, Safety Section; 1998-2000 versions.
2)
Your
facility’s safety policies and procedures.
3)
National
Committee for Clinical Laboratory Standards. Clinical Laboratory Safety;
Approved Guideline GP17-A. Wayne, PA:
NCCLS, 1996.
4)
OSHA
Standard for Bloodborne Pathogens. Code of Federal Regulations (CFR). Title 29,
Part 1910.1030.
5)
National
Committee for Clinical Laboratory Standards.
Protection of Laboratory Workers from Instrument Biohazards and
Infection Disease Transmitted by Blood, Body Fluids, and Tissue; Approved
Guideline M29-A. Wayne, PA. NCCLS, 1997.
6)
Website
of the College of American Pathologists:
www.cap.org