Flashcards in CLIA '88 Deck (55):
What does CLIA stand for?
Clinical Laboratory Improvement Amendments
What does Subpart M in CLIA '88 cover?
What does Subpart H in CLIA '88 cover?
Participation in Proficiency Testing
What does Subpart T in CLIA '88 cover?
What does Subpart K in CLIA '88 cover?
Quality Systems for Non-Waived Tests
What changes have to reported to CMS within 30 days?
Director or Technical Supervisor
What changes have to be reported to CMS within 6 months?
1. performing a test not included in your certification specialty
2. any deletions or changes in tests in a specialty or sub-specialty included on the certification of compliance.
Name the three categories of tests described by CLIA '88?
1. waived tests
2. tests of moderate complexity
3. tests of high complexity
What type of CLIA issued certificate is required for laboratories performing tests of moderate or high complexity as an initial certificate before the lab applies for the next level of certificate?
Certificate of Registration
What type of CLIA issued certificate is required for laboratories performing waived tests only?
Certificate of Waiver
What type of CLIA issued certificate is required for laboratories performing PPM tests only?
Certificate for PPM procedures
What type of CLIA issued certificate is given to laboratories that meet all requirements?
Certificate of Compliance
What CLIA issued certificate replaces the Certificate of Registration?
Certificate of Compliance
What CLIA issued certificate suggests that your laboratory will be inspected by State CMA inspectors?
Certificate of Compliance
If your laboratory has a Certificate of Compliance, who is likely to inspect your laboratory?
State CMA inspectors
What CLIA issued certificate states your laboratory meets the standards of private non-profit accreditation programs?
Certificate of Accreditation
What two CLIA issued certificates are essentially the same, but just recognize two different inspection methods?
Certificate of Compliance (state CMA) and Certificate of Accreditation (private HHS approved accreditation programs)
How long is a CLIA issued certificate valid?
For waived testing, test system instructions must be written at what level?
no higher than 7th grade
Provider Performed Microscopy
Name a few examples of PPM procedures. (9)
1. wet mounts (vaginal, cervical, skin)
2. potassium hydroxide (KOH) preparations
4. fern test
5. post-coital direct
7. fecal leukocyte exam
8. semen analysis
9. nasal smears for eosinophils
Successful participation in PT is considered what percentage passing?
The subspecialties that require 100% passing results on PT include what two groups in immunohematology?
1. ABO grouping and Rho typing
2. Compatibility Testing
What four specialties are defined for PT testing?
2. Diagnostic immunology
What are the three subspecialties of chemistry?
1. routine chemistry
What are the two subspecialties of diagnostic immunology?
1. syphilis serology
2. general immunology
What are the five subspecialties of microbiology?
For almost all subspecialty PT challenges, what is the number of samples per testing event?
5 per testing event
How many times a year should one receive a PT challenge?
3 times a year
Failure to return PT results is considered what type of performance?
an unsatisfactory performance with a score of 0 (failure)
Under Pathology, what is the annual testing structure for cytology?
90% passing on a 10 slide test
If one fails the cytology PT, what is the next step?
The next PT must be rescheduled within 45 days, 90% passing on a 10-slide set.
What happens with the cytology PT if the 10 slide test is failed twice?
documented remedial training and education in the area of failure, reexamination of slides must be documented, and a third tests of 20 slides must be scheduled. passing rate is 90%.
What is the passing rate required in cytology on the 3rd try 20 slide test?
What happens in the cytology PT if the individual fails the 3rd attempt (20 slide test)?
35 hours of documented remedial training and education followed by repeating the 20 slide test with a 90% passing score
As part of Subpart K (Quality Systems), what must the laboratory have in place for complaint investigation?
A documentation system for all complaints and problems received by the laboratory. Documentation must also exist of any investigations or corrective actions, when necessary.
As part of Subpart K (Quality Systems), what must the laboratory do to establish systems assessment?
Lab must establish and follow written policies and procedures for ongoing mechanisms to monitor, assess, and when indicated, correct problems identified. A review of effectiveness of corrective actions. Document all general laboratory systems assessment activities.
What is the proper laboratory procedure when an oral request for a test is received?
Oral tests are permitted only if they are followed by a written authorization within 30 days.
How long is the laboratory required to keep records of the test requisitions?
minimum of 2 years
In a procedure manual, is it appropriate to use a textbook or part of a textbook in lieu of a written procedure?
no; textbooks may be used to supplement the procedure, but cannot serve as a replacement for a written procedure
How long is the laboratory required to store discontinued procedures?
minimum of 2 years - not stored with active procedures
Should both discontinued and current procedures be stored together?
Discontinued procedures should be filed separately from active procedures
What signature is required on all new procedures and all modifications of procedures?
The laboratory director
What four components are required for every method validation or verification?
1. accuracy and precision
2. analytical sensitivity/specificity
3. reportable range of patient test results
4. reference range of normal values
What must the laboratory have for every piece of equipment in use in the laboratory?
a maintenance protocol, documentation of performed maintenance, documented function checks
Prior to what date are laboratories not required to establish performance characteristics of moderate or high complexity testing?
April 24, 2003
Every how many months are you required to perform instrument calibration at a minimum?
What other four instances would warrant an instrument calibration?
1. lot change in reagents
2. PM or part replacement
3. a shift or trend in control results
4. the lab schedules more frequent calibration
Reportable range controls for quantitative assays require how many levels?
1. not detected
2. LOW, which should be near the lower limit
3. HIGH, which should be near the upper limit
What controls are required for a qualitative assay?
Positive and Negative
What type of testing is used to determine the mean and standard deviation of either calibrator or control material?
What big change happened within CLIA in October of 2014?
CLIA allows HIPAA covered entities to provide results to patients
According to HIPAA Privacy Rule, if a patient requests a result, when should they be delivered?
Within 30 days of patient request
What records should be retained when there is an error in reporting?
The problem should be documented (e.g. PI form), and records should be maintained in duplicate of the original and corrected reports.