Phlebotomy ch 38

What does CLIA stand for

Clinical Laboratory Improvement Amendments

CLIA was designed to

Set safety policies and procedures that protect patients

CLIAs intent

To protect the public health by regulating lab tests

CLIAs regulations are based on

The complexity of the tests, they affect all aspects of the lab.
More complex test = more stringent rules

CLIAs regulations specify

Type of test performed
Personnel involved in testing
Quality control

Quality control

Measures used to monitor the processing of lab specimens:
Proper use
Expiration dates
Indications for precision & accuracy of analytic process


Provider-Performed Microscopy Procedure
Microscopic examinations the require the expertise of a physician or mid-level provider that is qualified in microscopic examinations

Quality assurance

Process to provide accurate, complete, and consistent health care documentation in a timely manner. Making an effort to resolve inconsistencies, inaccuracies, risk management issues, and other problems

Congress passed CLIA '88 to establish

Quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of pt test results regardless of where the test was performed


Any facility that performs tests on specimens derived from humans for the purpose of providing info on the diagnosis, prevention, or treatment of the disease/impairment/assessment of health

CLIA is ___ funded

Costs of administrating the program must be covered by the regulated facility

Who is responsible for CLIA test categorization


Who is responsible for deciding which tests fall under which categories


Who implements CLIA


Steps in enrolling in CLIA

Register- complete application
Pay fees
Be surveyed
Become certified

CLIAs fees are based on

Certificate requested by lab (waived, etc)
Annual volume and types of tests performed

Waived and PPMP labs may apply for certificate ___ because _____

They are not subject to routine inspections

Labs that have to be routinely inspected

Labs performing moderate-high complexity testing
Can be surveyed by CMS or private organization

If waived tests only are performed, the lab needs what certificate/survey

Certificate of Waiver (COW)

If PPMP tests are performed, the lab needs what certificate/survey

Certificate of PPMP

If moderate complexity tests are performed, the lab needs what certificate/survey

Certificate of registration
CLIA survey
Certificate of compliance

If high complexity tests are performed, the lab needs what certificate/survey

Certificate of registration
Survey by an accrediting agency
Certificate of accreditation

Categories of testing

Moderate complexity (PPMP)
High complexity

Waived tests

Simple, unvarying, require minimum judgement/interpretation
Test errors are minimal hazard to pt
Lowest percentage of tests performed

PPMP tests

Moderate complexity test
Added as a subcategory

Criteria used to categorize moderate and high complexity tests

Degree of operator intervention needed
Degree of knowledge/experience needed by operator
Degree of maintenance/troubleshooting needed to perform test

MAs perform ___ tests


Certificate of Waiver (COW)

Certificate given to labs to perform only waived tests

Certificate of PPMP

Certificate given to lab so that the provider/mil-level practitioner/dentist performs only PPMP procedures of the moderate complexity tests
Lab can also perform waived tests

Certificate of registration

Certificate given to lab so they they can perform moderate and high complexity tests until entity is surveyed to be in compliance with CLIA regulations

Certificate of compliance

Certificate given to labs after passing inspection and found to be in compliance with all CLIA regulations

Certificate of accreditation

Certificate given to labs if lab is accredited by an organization approved by CMS

All certificates require renewal every

2 years

If a lab is certified, the must ______ within _____ if it changes the type of tests it performs

Notify CMS
6 months

Examples of an infraction

Failure to enroll with CMS
nonparticipating in proficiency testing
Failure to return the proficiency testing results

Examples of a penalty

Denial or revocation of certificate
Score of zero on proficiency test (80% min)

If a lab receives an infraction or penalty ____ payments may be suspended or terminated

Medicare and Medicaid

Newly regulated labs will not be subject to penalties during first round of inspection cycle unless

Inadequacies pose immediate danger to patients

Law mandates quality assurance and quality control for

Non waived tests

CMS form 116

Collects lab's information regarding their operation
Needed to: evaluate fees, determine baseline data, update existing data, fulfill legal requirements
Information obtained from application will be used by the surveyor if there is an on-site inspection

Quality assurance guidelines

Labs are required to establish policies and procedures that: assess test quality, identify problems and correct them, ensure precise/dependable/punctual reporting of test results, maintain competent staff
If complaint is filed, an investigation must be do

Quality control guidelines

Labs are require to have adequate supplies and equipment to perform tests
Procedures manual available in testing area
Documentation of maintenance for: instruments, equipment, and test systems

Personal standards guidelines

The law lists specific qualifications and responsibilities of those performing non waived tests
Personnel must report tests results accurately
High complexity tests must be done by technologist or technician (except cytology)

Unannounced inspection guidelines

Moderate-high complexity categories have unannounced inspections by DHHS
Waive test labs must prove that tests are being done according to manufacture instructions
Inspections can involve: interviewing employees, observation of performing tests, data anal

The law requires/specifies/mandates:

(1) All labs are required to register with CLIA
(2) Regulations apply to all labs
(3) Regulations are specific to the complexity of the test
(4) Labs must obtain a certificate to perform tests
(5) Certificates must be renewed every 2 years
(6) A lab must

To be categorized as a PPMP, the procedure must meet all criteria:

(1) Exams must be done by one of the following practitioners: provider, mid-level practitioner, or dentist
(2) Procedure is of moderate complexity
(3) Primary instrument used is a microscope
(4) Specimen is liable. Any delay in testing process may comprom

To be categorized as a lab that performs waived tests all criteria must be met:

(1) Tests must be simple lab exams/procedures cleared by the FDA for home use. Methods of used are simple and accurate so errors are negligible or pose no harm to patient.
(2) Tests are on CLIAs waived test list
(3) Manufacturer's instructions for test ar

Procedures required by CLIA to be performed in quality-control protocol for automated hematology instruments

- Calibration- regularly scheduled intervals
- Control sample testing- 2 levels tested each day equipment is used (before pt sample is used) Results must fall within 2 standard deviations of expected mean value
- Proficiency testing- reference lab must be

CLIA must be ___ supporting


MA's responsibilities when it comes to tests in labs

- competently performing tests
- maintaining personal records
- compiling a procedures manual on how to perform every test done (reviewed every year)
- documentation
- be knowledgable and comply with the law
- be prepared for CLIA inspections
- keep up wi

OSHA regulations intentions

To ensure employers have a safe and healthy work environments for all employees

OSHA standards that have the greatest impact

- Occupational Exposure to Hazardous Chemicals
- Bloodborne Pathogen Standard

OSHA published Occupational Exposure to Hazardous Chemicals in effort to

reduce the number of chemically related illnesses and injuries in the workplace

Standard of Occupational Exposure to Hazardous Chemicals

- Intention: heightens employee awareness of risks linked with chemical dangers
- Serves: improve work practices through employee training and identification of hazardous chemicals
- Requires employees to use PPE to protect themselves from harmful chemica

Chemical Hygiene Plan (CHP)

- Core of OSHA safety standard on hazardous chemicals
- Written plan that specifies the training and info requirements of the standard
- Control measures: fumed hoods, glove boes, etc
- Designates chemical hygiene or safety officer
- Provisions for housek

Primary goals employers must accomplish to be in compliance with OSHAs standard of chemical exposure

- Mandatory inventory, list of all chemicals considered hazardous. Documentation of: quality of chemicals stored per month or year. if substance is gas, liquid, or solid. the manufactures's name and address. chemical hazard classification
- MSDA manual- d

Chemical warning label: Blue

health hazard

Chemical warning label: red

flammability hazard

Chemical warning label: yellow

reactivity or instability hazard

Chemical warning label: white

special hazard, use PPE

Scale of chemical warning labels

0 - 4
0 being not hazardous
4 being the most hazardous

Requirements for CHP

- Employers must have a written operational plan relevant to the safety and health of employees
- Available written instructions on the use of PPE
- Fume/biohazard hoods are regularly checked
- Training sessions must be held for employees about their righ

MAs can be exposed to hazardous chemicals through

skin contact

Do students have to follow OSHA safety procedures?


Are students fall under the OSHA guidelines?

they are not considered employees

What do you do when a chemical spills on skin

flush with water immediately and continue for 5 minutes
refer to MSDS sheet

What do you do when chemicals get in eyes

eyes are flushed for 15 minutes
refer to MSDS sheet

Chemicals that can produce toxic fumes should be handled

under a fume hood

Cumulative trauma disorders

injuries involving the musculoskeletal or nervous system
Result of long-term, repetitive work actions
Ex: carpal tunnel syndrome, trigger finger

A major part of infection control is

medical asepsis

Standard Precautions were issued by


CLIA '88 was made law to regulate

laboratory tests performed on specimens taken from the human body

The core of the OSHA safety standard for chemical exposure is

the chemical hygiene plan

The agency that requires employers to ensure employee safety concerning exposure to potentially harmful substances is:


Successful laboratory programs include

orientation, periodic drills, and consistent enforcement of policy

CLIA regulations specify all the following except

the methods used in testing

The agency charged with implementing CLIA is


How many categories of testing are there in CLIA


Which is not an approved provider for PPMP

a medical assistant

MAs perform most of their test in which CLIA category


The standard published by OSHA to prevent cumulative trauma disorders is

Ergonomic Hazards

MSDS do contain

flammability fo the chemical

Reagents and materials used for waived testing generally

are prepackaged
are premeasured
require no special handling