State Operations Manual (Pub. 100-07), Ch. 6 § 6130.3
Citing Condition-Level Deficiencies
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.