CLIA and OSHA Flashcards
Labs that are exempt from CLIA *
Forensic labs, research labs, drug testing labs (NIDA)
CMS Definition: *
Centers for Medicare and Medicaid Services
CMS applies to: *
Laboratories billing medicare and medicaid
Certificate of registration *
Lab’s that are just starting out will get this until they are inspected.
Certificate of compliance *
Required for labs performing moderate of high complexity testing. Given by STATE CMS inspectors after the lab has met requirements for certification.
Certificate of accreditation *
Issued to labs that meet the standards of a private non-profit accreditation program approved by CMS. Issued in lieu of other certificates.
Accreditation agency must be More or Less strict than CLIA*
More
If the lab changes ownership, name, location, director or technical supervisor, they must notify CMS within: *
30 days
If the lab adds, subtracts, or changes test menu, they must notify CMS within: *
6 months
Provider performed microscopy *
Are subject to their own certification, considered moderately complex, are subject to inspection. Must be done in the office on live specimens.
Unsatisfactory PT
Failure to attain a passing score in one testing event, requires corrective action.
Unsuccessful PT
Unsatisfactory performance in two consecutive or two out of three testing events.
Successful Participation in PT
Satisfactory performance is considered 80%
Quality Systems required for non-waived testing. List 7 *
- Confidentiality of PHI
- Competency of personnel and review corrective action.
- Complaint investigations and documentation.
- Communication between lab and physicians, document
- Specimen Identification and integrity
- Evaluate PT performance
- General Lab Systems Assessment, document review
Technical Supervisor (high complexity) must evaluate competency how often? *
On hire (after training), again in 6 months, and annually after that, unless methodology changes.
The Test Requisition must include what 5 components: **
- Patient name or other identifier
- Sex and age or DOB
- Name and address of requestor/ contact
- The test to be performed
- The date and time of collection
Pap samples must also include: *
Date of last menstrual period and whether the patient has had previous abnormal results.
Oral requests for tests are permitted only if: *
The laboratory requests written authorization within 30 days
How long do you have to save test requisition *
2 years
How long do you have to save QC records *
2 years or 5 years for immunohematology
How long do you have to save test records and test reports *
2 years or
5 years for immunohematology and cytology slides
10 years for pathology records
Test records must include: *
- ID of tech performing test
- ID of patient
- Date and time of specimen receipt
- Condition of specimen
- Date and time of testing
The test report must include: *****
- Patient’s name or ID number
- Name and address of the lab
- Report date
- Test performed
- Specimen source
- Result, units, and interpretation
True or False: CLIA labs that are also HIPPA covered entities must provide the patient with a copy of their test report within 30 days of their request? *
True
Reagent label must include: *****
- Identity
- Concentration
- Storage Requirements
- Date made and expiration
- Lot number
PPM Personnel Requirements
- Director
- Testing personnel
Moderate Complexity Personnel Requirements
- Director
- Technical Consultant
- Clinical Consultant
- Testing personnel
