Moderately Complex Testing- Initial Training
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Good morning everyone- Our moderately complex testing falls under Washington State Department of Laboratory Quality Assurance. This has been our accrediting body for this testing for 15+ years. Most recently during an inspection a discussion took place around initial training documentation. We are being told by DOH that for initial training documents that the medical director or technical consultant must sign off on individual staffs training documents (or we can choose to have some sort of cover letter on each staffs individual training packet). Has anyone else ran into this and if so which standard outlines that this is an individual sign off by the medical director or technical consultant? We have reviewed the state WACS, the CFRs. talked to other accrediting bodies and their interpretations are different.
We do have an overarching quality assurance policy that outlines the training program, the cadence, who is approved to sign off on training documents, carry out training, etc. but we are being told this isn't good enough because the sign off on the individual training document must be the medical director or technical consultant. We have dug and dug into this to try to find something tht aligns with what DOH is stating (even met with them) but we still arent able to connect the dots on their interpretation. If anyone can share their understanding, cite the regulation specifically, etc. that would be super helpful! At the end of the day, we want to do what is best for patient care, in alignment with standards, etc. but this one has us stumped! Thanks!
We do have an overarching quality assurance policy that outlines the training program, the cadence, who is approved to sign off on training documents, carry out training, etc. but we are being told this isn't good enough because the sign off on the individual training document must be the medical director or technical consultant. We have dug and dug into this to try to find something tht aligns with what DOH is stating (even met with them) but we still arent able to connect the dots on their interpretation. If anyone can share their understanding, cite the regulation specifically, etc. that would be super helpful! At the end of the day, we want to do what is best for patient care, in alignment with standards, etc. but this one has us stumped! Thanks!
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cindy.sorensen@stlukes-stl.com
§493.1407 Standard; Laboratory director responsibilities (e)(11) Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
§493.1407 Standard; Laboratory director responsibilities (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results.
You can have multiple Technical Consultants; are they asking for something more complicated than a list of who fulfills the qualifications of being a Technical Consultant?
Who is responsible for performing the competency assessment?
The Technical Consultant for moderate complexity testing (42 CFR §493.1413(b)(8)) is responsible for performing and documenting competency assessments. The competency assessments may also be performed by other personnel who meet the regulatory qualification requirements for TC for moderate complexity testing.