Corrective Action, continued

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The page below is a sample from the LabCE course Inspection Preparation, Process, and Corrective Action. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Corrective Action, continued

Once citations or items requiring a response and/or correction are submitted by the inspectors, the laboratory will be required to do the following:

  1. Address each of the items requiring action or correction.
  2. Formulate a schedule for performing each of the items requiring action or correction.
  3. Complete a written response to each item noted in the final report. This written response is the Plan of Correction (POC).
  4. Format the POC as per the guidance of the inspecting agency.
  5. CMS 2567 form may be utilized to provide the list of deficiencies and will be utilized to provide the POC to the inspector. Refer to the attached sample form.
  6. CMS requires a response be received within 10 calendar days from the date on the summary report. The POC may not extend beyond 45 days on the summary report.
  7. Accreditation agencies will utilize a different format for POC. The instructions for documenting the items will be specific for each agency and format provided.
  8. The response inclusive of a timeline will be forwarded to the inspecting agency by the required deadline.
  9. All corrective action steps will be completed as per the timeline and any require follow up documentation forwarded to the inspecting agency by the established deadline for submission.
  10. If the deadline cannot be observed, the laboratory should request an extension of the deadline to accommodate the delay.
When utilizing the CMS 2567 form, each item will be tagged with the designated requirement. The tag will be noted in the far-left column (ID Prefix Tag). Detailed explanation of the requirement and deficiency will be described in the adjacent column. (Summary Statement of Deficiencies). The response will be made in the third (ID Prefix Tag) and fourth columns. The ID tag will be provided in the third column. A description of the corrective action and timeline for completion will be described in the fourth column (Plan of Correction).
Agencies not utilizing the CMS 2567 will provide guidance for submission of POC. Follow the instructions for using the format provided. Submit as per the agency instructions.