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SMQT1
Principles of Documentation
| Term | Definition |
|---|---|
| Principle #1: Laboratory Compliance and Noncompliance | When a laboratory complies with the requirements of the survey conducted, the Form CMS-2567 should say lab is in compliance. If a laboratory is not in compliance with one or more tags then Form CMS-2567 includes citations of noncompliance. |
| Principle #2: Using Plain Language | The deficiency citation is written clearly, objectively and in a manner that is easily understood. The deficiency citation does not include consultation; advice, comments or direction aimed at the surveyed laboratory. |
| Principle #3: Components of a Deficiency Citation | A deficiency citation consists of (A) a regulatory reference, (B) a deficient practice statement and (C) relevant findings. |
| Principle #3: Components of a Deficiency Citation A. Regulatory Reference: | A Regulatory Reference includes the following components: 1) A survey data tag (D-Tag) number, 2) The CFR (Code of Federal Regulations), 3) The language from that regulatory reference which specifies the aspect(s) of the requirement with which the lab |
| Principle #3: Components of a Deficiency Citation B. Deficient Practice Statement (DPS) | The specific action(s), error(s), or lack of action (deficient practice), Outcome(s) to the deficient practice, A description of deficient practice. Identifier of individuals involved. Source of information |
| Principle #3: Components of a Deficiency Citation C. Relevant Facts and Findings | The facts and findings relevant to the deficient practice answer the questions: who, what, where, when, and how. They illustrate the laboratory’s noncompliance with the requirement or regulation. |
| Principle #4: Relevance of Onsite Correction of Findings | During survey, the laboratory corrects the situation that resulted in the deficiency, of “NOT MET” it must written in the right hand column Form CMS-2567. During survey, the lab initiates corrective action that abates finding IJ, turn to Appendix Q. |
| Principle #5: Interpretive Guidelines | The deficiency citation explains how the laboratory fails to comply with the regulatory requirements, not how it fails to comply with the guidelines for the interpretation of those requirements. Guidelines are not regulatory requirements. |
| Principle #6: Citation of State or Local Code Violations | The laboratory’s failure to comply with State or local laws or regulations is not documented in the Form CMS-2567 except when the Federal regulation requires compliance with State or local laws. |
| Principle # 7: Cross-References | The crossreferencing of requirements is an acceptable form of documentation on the Form CMS2567 only when it is applicable and provides additional strength to the linked citations. |
| Principle # 8: Condition Deficiencies | The Condition citation includes deficient practice statements and findings to support the determination of noncompliance with a Condition level requirement. The findings may be incorporated either by cross-references or narrative description |
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