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Medical Testing Site (MTS) Proficiency Testing (PT)
PERFORMANCE REQUIREMENTS
Number of Challenges: The PT programs are required to provide a minimum of 5
samples per testing event, with 3 testing events per year.
Minimum acceptable score for satisfactory participation:
- Microbiology, General Immunology; Syphilis Serology; Routine Chemistry; Endocrinology;
Toxicology; and Hematology:
- 80% overall testing event score for all specialties
- 80% for each analyte
- 100% for HIV testing
- Immunohematology:
- 100% for each analyte and overall testing event score for ABO group and
D(Rho) typing
- 100% overall testing event score for Compatibility testing
- 80% overall testing event score for Unexpected Antibody Detection and Antibody
Identification
UNSATISFACTORY PERFORMANCE:
- Unsatisfactory analyte score;
- Unsatisfactory PT event or overall score for a specialty or subspecialty;
- Failure to participate in a testing event; or
- Failure to return PT results within specified timeframe.
UNSUCCESSFUL PARTICIPATION:
Failure to achieve satisfactory performance (overall testing event score or analyte
score, where applicable) for 2 consecutive testing events or 2 out of 3 consecutive
events.
ACTIONS TO BE TAKEN BY LQA AND MTS FOR UNSUCCESSFUL PARTICIPATION:
- LQA will send the MTS a certified letter identifying the problem and stating that the
laboratory may choose to discontinue patient testing for the identified test, specialty or
subspecialty or follow a directed plan of correction (options listed in the letter).
- The MTS shall notify LQA, in writing, within 15 days of receipt of the notice, of the
decision to discontinue testing patient specimens for the identified test, subspecialty or
specialty or to agree to a directed plan of correction. If a laboratory fails to respond
within fifteen days, LQA will notify the laboratory by letter, or by phone, that its
response is overdue. When the response is received, LQA will review the response and, if
acceptable, notify the laboratory that its request has been accepted. If the plan is
unacceptable, LQA will contact the laboratory to discuss obtaining an acceptable response.
If no response is received within 5 days of the receipt of the letter/phone call,
appropriate disciplinary action will be initiated
- If the MTS chooses to discontinue patient testing for the identified test, the director
may petition for re-instatement after satisfactory performance in 2 successive events.
- The department shall notify the MTS in writing, within 15 days of receipt of the
petition, of its decision related to re-instatement.
DIRECTED PLAN OF CORRECTION:
If a laboratory has failed 2 consecutive testing events or 2 out of 3 consecutive
events of PT, LQA may give the laboratory options rather than require it to discontinue
patient testing. These options may be any one or a combination of the following:
- Undertake appropriate training for the testing personnel involved;
- Employ technical assistance necessary to correct PT problem; or
- Perform special studies such as:
- Testing 10 or more patient specimens from its reference laboratory; or
- Obtaining and analyzing additional PT material from a PT agency.
NOTE: For special studies, the laboratory must submit the results and a statistical
analysis of the results to LQA. LQA will review the data to determine if the laboratory
has performed satisfactorily on the special study.
When LQA determines that the MTS has successfully completed its directed plan of
correction, a letter will be sent stating that LQA accepts the results and the laboratory
may continue testing patient specimens for the analyte(s). The letter will also inform the
laboratory that if it receives an unsatisfactory grade on either of the next 2 sets of PT,
it will have to discontinue testing until it passes 2 consecutive sets of PT.
If a laboratory fails to respond within fifteen days, LQA will notify the laboratory by
letter that its response is overdue. If no response is received within 5 days of the
receipt of the letter, appropriate disciplinary action will be initiated.
A laboratory may be offered a directed plan of correction only once for an analyte(s).
If there is a failure in either of the next 2 events for the same analyte, the MTS will be
required to discontinue patient testing until it successfully passes 2 consecutive sets of
PT for that analyte.
If it is discovered during an on-site survey that a laboratory has not enrolled in an
approved PT program, a deficiency will be written. The only acceptable plan of correction
(POC) is immediate enrollment in PT with proof of enrollment sent along with the
POC
DISCIPLINARY ACTION
If a laboratory refuses to voluntarily discontinue testing patient specimens when
it has been notified to do so, or does not respond in writing to the notification, LQA
will begin enforcement action.
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