All Common
The Lab must perform and record these for all instruments and equipment following a defined schedule, as least as frequent as specified by the manufacturer.
What is maintenance/function checks?
COM.30600
The Lab must have this in place to manage policies, procedures and forms that are subject to CAP accreditation.
What is a document control system
GEN.20375
This must be reviewed for acceptability before reporting of results.
What is the results of controls?
MOL.34352 QC Confirmation of Acceptability
The histology lab must retain records for the number of..( 3 things)
What is Blocks, slides and Stains
ANP.21350
This is a plan for the laboratory that must include emergency lighting and must cover personnel, patients and visitors, and must address the special needs of persons with disabilities. Routes must be clearly marked.
What is an evacuation plan?
GEN.73900
The laboratory must do this when acceptable temperature ranges are exceeded
What is take Corrective Action?
COM.30800
This must be checked and recorded daily using a calibrated instrument.
Refrigerator and Freezer Temperatures
GEN.41042
This person is qualified as having one of the following:
1. Person who qualifies as a section director/technical supervisor; or
2. Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology with at least four years of experience (at least one of which is in molecular pathology methods) under a qualified section director
What is a Molecular Pathology General Supervisor
MOL.49655 Molecular Pathology General Supervisor Qualifications
For special Stains these must be verified and recorded as acceptable prior to or concurrent with reporting of patient results
What is positive and negative controls.
ANP.21395
This must be provided and maintained whenever blood and other potentially infectious materials are handled and in circumstances during which exposure is likely to occur.
What is PPE ( gloves, gowns and eye protectors, etc).
GEN.74100
The laboratory's must participate in this type of program according to COM.01300
What is Proficiency Testing( PT) or External Quality Assessment ( EQA)
Cap requires that we have a program in place in which employees can earn these throughout the year
GEN.54200
What is Continuing Education credits?
This is available, when appropriate, and is certified at least annually to ensure that filters function properly and that airflow rates meet specifications.
What is a biological Safety Cabinet?
MOL.54570
There must be a written procedure to prevent this of specimens in the histology laboratory.
What is cross contamination
ANP.21397
These are posted both at the entry door and throughout each laboratory. Additionally, are affixed to any refrigerator, freezer, incubator, or other equipment that is located in a hallway or other type of open access or passage area and is used for storing/holding clinical specimens or other potentially infectious materials
What is Biohazard labels?
This is must be implemented in each section of the laboratory and ensure Quality throughout the pre-analytic, analytic and post-analytical phases of testing.
What is the Quality Management System?
Personnel Records require many components such as this item that must be signed by the employee and details responsibilities.
What is Job Description?
GEN.54400
Prior to clinical use of each modified FDA cleared/approved test and laboratory-developed test (LDT), the Lab must perform this.
What is a validation study?
MOL.31130
A qualified pathologist must do this prior to reporting the results.
What is selects or confirms the appropriate areas for analysis?
ANPO.23027 Areas for Analysis
This must be adequate plumbed or self-contained and tested regularly.
What is eye wash stations?
This must be done twice a year if more than one nonwaived instrument is used for a given analyte.
What is Comparability of Instruments and Methods
COM.04250
This job title in the lab or above must assess competency.
What is General Supervisor?
GEN.55500
Discrepancies between the molecular pathology laboratories final results, other laboratory, findings, and the clinical presentation are...
What is investigated and recorded, along with any
necessary corrective action.
MOL.49565
Evidence of compliance for this requirement includes: Written procedure defining frequency of changing staining solutions AND QC records for solution changes
What is There is a schedule to change the solutions in automated stainers.
ANP.21360
In order to comply with CAP chemical safety all employees must have access to what specific documents? (3)
1. Current Safety Data Sheets
2. Chemical Hygiene Plan of the laboratory
3. Code of Federal Regulations
GEN.76100