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
Storage
Handling
Stability
Expiration dates
Indications for precision & accuracy of analytic process
PPMP
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
Laboratory
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
User-fee
Costs of administrating the program must be covered by the regulated facility
Who is responsible for CLIA test categorization
FDA
Who is responsible for deciding which tests fall under which categories
CDC
Who implements CLIA
CMS
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 _____
Directly
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
Waived
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
Waived
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
self
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
injection
inhalation
Do students have to follow OSHA safety procedures?
yes
Are students fall under the OSHA guidelines?
no
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
CDC
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:
OSHA
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
CMS
How many categories of testing are there in CLIA
4
Which is not an approved provider for PPMP
a medical assistant
MAs perform most of their test in which CLIA category
waived
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