Federal law setting lab standards; classifies tests by complexity
CLIA
CMS document permitting offices to perform simple, low‑risk tests
Certificate of Waiver
Program that evaluates overall accuracy, effectiveness, and validity of lab services
Quality Assurance (QA)
Routine checks on instruments, reagents, and personnel technique
Quality Control (QC)
Document describing hazards and handling of each chemical
SDS (Safety Data Sheet)
Worldwide format for chemical labels & pictograms
Globally Harmonized System (GHS)
Puncture‑resistant, red‑lined receptacle located at point of use
Sharps container
Highest‑power microscope objective; requires a sparing drop of oil
Oil-Immersion Lens
Waived (simple), moderately complex (includes provider‑performed microscopy), highly complex (specialty labs). Complexity is based on how difficult the procedure is to perform and interpret. This describes:
Testing levels
Centers for Medicare & Medicaid Services (CMS) oversees CLIA enforcement; COLA and OSHA also inspect POLs for quality and safety.
administration
Waived‑level tests may be billed to both Medicare and Medicaid when the office holds a current certificate of waiver.
Billing
Applications for waivers and higher‑level certificates are filed through CMS.
Certificates
Evaluate effectiveness of patient care, ensure accuracy and validity of test results—never to guarantee positiveresults.
QA Goals
Monitor instruments, reagents, and staff technique; patient reactions are not a QC component.
QC Checks
Wear gloves, face and eye protection; absorb and discard materials in biohazard bags; disinfect with a 10 % bleach solution.
Spill Response
Must be accessible, near point of use, and locked when contents reach the fill line.
Sharps Containers
Dispose of contaminated items in red‑lined containers marked with the biohazard symbol. Refrigerators for specimens must display “Not for Storage of Food or Medications.”
Biohazard Waste
Wipe with disinfectant after each use to prevent disease transmission
Eyepieces
Use lens tissue paper—never paper towels or compressed air.
Ocular Lens Cleaning
Apply a very sparing amount of oil; clean lens immediately afterward.
Oil- Immersion Technique
High‑power field magnifies ~40×; oil‑immersion provides the greatest detail.
Power Objectives
Keep loosely wrapped when not in use; do not leave plugged in or dangling.
Cord Storage
Provide handling, storage, and first‑aid information for every chemical in the POL.
Safety Sata Sheets (SDS)
Standardized pictograms identify hazards such as corrosion, flame‑over‑circle (oxidizers), skull & crossbones (toxicity). An unexploded‑bomb icon is not a listed hazard symbol.
GHS Labels
