US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1273: Meet the histopathology requirements: control slides of known reactivity with each special stain and fluorescent and immunohistochemical stain checks each time of use, documented; retention of slides, blocks and tissue remnants until a qualified individual has made the diagnosis; tissue reports signed (or electronically authorised) by a qualified pathologist or an HHS-approved neuromuscular pathology trainee; and recognised disease nomenclature in reports

What does 1273 require?

Fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use as section 493.1256(e)(3) requires, and for every other differential or special stain a control slide of known reactivity must be stained with each patient slide or group of slides and the control reaction documented. Stained slides, specimen blocks and tissue remnants must be retained as section 493.1105 requires, with tissue remnants preserved until the portions submitted for microscopy have been examined and diagnosed by an individual qualified under section 493.1449(b), (f) or (g). An individual who has completed an HHS-approved neuromuscular pathology training program may examine and report neuromuscular pathology. Tissue pathology reports must be signed by a qualified individual, or where a computer report carries an electronic signature it must be authorised by the individual who examined the specimen and made the diagnosis, and reports must use acceptable terminology from a recognised system of disease nomenclature. All control procedures must be documented.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Subpart K: quality system, analytic systems (sections 493.1250 to 493.1289) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.