State Operations Manual (Pub. 100-07), Ch. 6 § 6130.3

Citing Condition-Level Deficiencies

Last amended: 2020Year: 2020Length: 192 wordsOfficial source
6130.3 - Citing Condition-Level Deficiencies (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) When the deficient practice is of such a serious nature that correction is a condition for allowing the laboratory to continue with patient testing, cite the most appropriate condition and document the finding using the format in the Principles of Documentation. As stated in the Principles of Documentation, the laboratory must correct all standard-level deficiencies that are used to support the condition-level noncompliance finding before the laboratory can be found back in compliance with the condition. Options within Subpart K • Specialty and Subspecialty conditions--Use these conditions when serious deficiencies are identified within the specialty or subspecialty. D5002 - D5042. • General Laboratory Systems--Use this condition when serious deficiencies are identified within general laboratory systems. D5200. • Preanalytic--Use this condition when serious deficiencies are identified within the preanalytic phase of testing. D5300. • Analytic--Use this condition when serious deficiencies are identified within the analytic phase of testing. D5400. • Postanalytic--Use this condition when serious deficiencies are identified within the postanalytic phase of testing. D5800. NOTE: A serious deficiency is based on the nature and extent of the deficient practice.
State Operations Manual (Pub. 100-07), Ch. 6 § 6130.3: Citing Condition-Level Deficiencies | Justis AI