Phlebotomy book- Chapter 15 Flashcards
CLIA 88 ID 3 levels of complexity for-
medical lab tests
Provider-performed microscopy was added to CLIA 88 in 1997 as a-
subcategory of moderate complexity tests
high complexity tests require- (3)
-close attention to detail
-specialized training & substantial experience
-interpretation & troubleshooting skills
high complexity tests involve-
manual manipulation of complex equipment & reagents
Examples of high complexity tests- (3)
-Manual DNA extraction procedures
-Special staining procedures
-Complex analyzers that require detailed setup or operator interaction
moderate complexity tests require- (4)
-formal training
-little manual manipulation
-may require direct supervision
-personnel required to have proper training & experience
ex of moderate complexity tests-
Tests that involve running simple automated instruments
Provider-performed microscopy procedures are a subcategory of-
moderate complexity testing that allows healthcare providers to perform certain tests only for their own patients
ex of provider performed microscopy procedures- (9)
-Direct wet mounts.
-Potassium hydroxide (K O H) preparations.
-Pinworm examinations.
-Fern tests.
-Post-coital qualitative tests
-Urine sediment examinations
-Nasal smears for granulocyte
-Fecal leukocyte examinations
-Qualitative semen evaluation
Waived tests-
FDA-approved laboratory tests that are minimally complicated and pose little risk of harm to the patient
Examples of waived tests- (6)
-Blood glucose levels by glucose monitoring devices cleared by the FDA specifically for home use
-Erythrocyte sedimentation rate
-Fecal occult blood
-Spun microhematocrit
-Urine chemical testing
-Urine pregnancy tests
Erythrocyte sedimentation rate-
non-automated
Spun microhematocrit-
manual procedure for determining hematocrit that requires only a small amount of blood
urine pregnancy tests- (2)
-visual color comparison tests
-the testing of urine for the presence of human chorionic gonadotropin, indicating pregnancy
waived tests require-
less training than higher complexity tests, on-the-job training possible
all medical labs must comply with-
CLIA 88
A Certificate of Accreditation (COA) is awarded to laboratories that perform-
moderate & high complexity testing & meet the standards of a private not-for-profit accreditation program. These labs must be surveyed every other year.
A Certificate of Compliance (COC) is awarded to laboratories that perform-
moderate & high complexity testing after inspectors find that the lab is in compliance with all applicable CLIA requirements. These labs must also be surveyed every other year.
A Certificate of Registration (COR) is granted to laboratories that have- (2)
-applied for either COA or COC
-enables the lab to perform moderate & high complexity testing until it has been inspected & verified to meet all requirements for COA or COC.
A Certificate for Provider-Performed Microscopy Procedures is granted to labs at facilities where-
physicians, mid-level practitioners, or dentists perform only certain microscopy procedures.
The Clinical Laboratory Improvement Advisory Committee (CLIAC) has made several recommendations for-
good practice in a Certificate of Waiver laboratory.
A Certificate of Waiver must be granted before-
a laboratory can perform waived tests. These labs must submit to random inspections & investigation if indicated.
ESR-
Rate at which RBCs settle in whole blood.
SOP post-exam guidelines- (3)
-Report test results to the physician in a timely manner.
-Follow package insert recommendations for follow-up or confirmatory testing.
-Follow OSHA regulations for disposing of biohazardous waste.
Standard operating procedure (SOP) requires the person performing waived testing to follow-
designated steps during all phases of the testing process (pre-examination, examination, post-examination)
waived testing regulations- (9)
-Follow federal, state, and local regulations.
-Perform waived tests only.
-Follow manufacturer instructions.
-Do not modify instructions.
-Allow random inspections.
-Establish lab safety plan that follows OSHA guidelines.
-Have a designated area with adequate space & conditions.
-Have enough personnel & train them appropriately.
-Have written documentation of each test performed.
Facilities that perform waived lab tests must have a designated person-
usually a physician or experienced lab supervisor that is responsible for lab supervision. All personnel must follow the guidelines, regulations, & requirements
SOP pre-examination guidelines- (6)
-Confirm written test orders.
-Establish procedure for patient ID.
-Give pre-test instructions and determine whether patients followed them.
-Collect specimens according to package insert instructions.
-Label specimens appropriately.
-Never use expired reagents or test kits
SOP examination guidelines- (6)
-Perform quality control testing.
-Correct problems discovered during QC testing before testing patient samples.
-Establish policy for control testing frequency.
-Follow test-timing recommendations.
-Interpret test results as directed.
-Record test results according to office policy
To help ensure the quality of testing, Certificate of Waiver laboratories are also required to participate in-
quality assurance/assessment programs for each test they perform.