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Post-Inspection If a CLIA inspector has just walked out your door or you’ve just received the Statement of Deficiencies from your recent inspection, read on.At the end of the inspection process, you were given a verbal summary of findings. You need this document, you haven’t a policy to cover that situation, you didn’t implement these parts of your QA plan… Begin working to correct problem areas immediately, while the inspection is still fresh in your mind and your notes are still intelligible. When the SOD arrives a week or two later, you’ll be ready. The SOD is a computer-generated document that details the findings of your inspection in the form of citations. Each citation is identified by a prefix or D-tag and consists of a quotation from the Code of Federal Regulations (deficiency), followed by findings that illustrate noncompliance (evidence). Citations are divided into three levels of seriousness: standard, conditional, and immediate jeopardy. A standard level deficiency is relatively minor and does not impact quality of care. A condition level is more serious, affecting the quality of services provided. Immediate jeopardy is a situation that has caused or is likely to cause harm, injury, or death to individuals served by the laboratory. The language used in citations is concise, specific, and includes phrases like “the laboratory failed to document…” and “the director failed to ensure…” Since the SOD is printed in a narrow column format, a single deficiency may require more than one page. Just a few standard deficiencies may result in a SOD of considerable length, striking fear into the hearts of uninitiated laboratory directors and staff. Each citation in the SOD requires a response called a Plan of Correction, in which you describe your plan for correcting your “failures” to comply. Remember to address your corrective action to the deficiency, not to the specific evidence beneath. You will be asked to provide a date of expected completion. Immediate and serious deficiencies must be corrected within 23 days. Laboratories with condition level deficiencies that are not immediate and serious are given 45 days. Labs with only standard level deficiencies have a year to correct. If you began working as the inspector walked out the door, many of the corrections may be in place when the SOD arrives. In these cases, use the date on which each correction was effective. If you are still in the correction process, estimate your completion date based on the level of seriousness and your staff’s workload and ability to get the task done. You may be asked to provide proof of compliance, in the form of a newly written procedure or temperature or quality control record. Knapp·Frazer Consulting is available to write and help implement your Plan of Correction or to simply answer questions about your citations and the correction process. |
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This article may be republished in its entirety on your web site or in your newsletter under the following two conditions: 1) Include the following statement at the beginning or end of the article. "Republished with permission of the author, Margaret A Knapp MT(ASCP) CLS, of Knapp·Frazer Consulting. www.knapp-frazer.com ~ 707.539.6621" 2) Send copy of your publication or URL to Knapp·Frazer Consulting at time of republication. |
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