Plan of Correction (PoC)

6132.2 - Plan of Correction (PoC) (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The laboratory enters its planned action to correct the deficiency and the expected completion date opposite the appropriate data tag on Form CMS-2567. Alternatively, the laboratory may enter its disagreement with a finding and may furnish documentation that requirements are met. If a deficiency has been corrected since the survey, the laboratory should indicate this on the form along with the date of correction. The PoC is a “plan” which contains records (documentary materials) that outlines how the laboratory is going to fix the standard-level deficiency(s) therefore, the PoC may have future dates (i.e., after the date of submission). A record includes all recorded information, regardless of form or characteristics, made or received by a federal agency under federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the US Government or because of the informational value of data in them. 44 U.S.C Chapter 33, Section 3301.” All records must be kept the period defined by the federal requirements at DAA-0440-2015-0008, which is 7 years, or by State requirements, if more stringent than federal requirements. There are four elements that are required to be submitted with a PoC. Those four elements are: 1. Documentation describing the corrective actions that have been taken for patients that were identified by the survey and subsequent analysis as having been affected by the deficient practice(s); 2. An explanation as to how the laboratory has identified other patients who may have been affected by the deficient practice(s); 3. A description of the correction(s) that have been put into place and/or the systemic changes that have been made to ensure that the deficient practice does not recur; and 4. A description of how the corrective actions are being monitored to ensure the deficient practice does not recur. All deficiencies may not be corrected at the time the plan of correction is submitted to the SA or CMS, but it must have corrected dates that are within 12 months after the “date survey completed” listed on the Form CMS-2567 and must be reasonable in timeframe and content. The plan must be specific and time frames stated and realistic, stating exactly: • How the deficient practice will be corrected or how it was corrected; • What corrective action(s) have been taken for patients found to have been affected by the deficient practice; • How the laboratory has identified other patients having the potential to be affected by the same deficient practice and what corrective action(s) has been taken; • What measure has been put into place or what systemic changes have been made to ensure that the deficient practice does not recur; and • How the corrective action(s) is being monitored to ensure the deficient practice does not recur. The laboratory director or other authorized official, (i.e. owner, operator and/or laboratory director) must sign and date the Form CMS-2567 on which the laboratory’s PoC is written. If the laboratory director requests additional time to develop the plan, the SA explains that a preliminary PoC must be submitted within 10 days, as precisely as present information permits, and that it may be followed with a more specific plan as early as possible. Also, the SA advises that a future contact or revisit to verify correction of deficiencies will occur only when the laboratory makes an acceptable PoC. After completing the PoC, if the Form CMS-2567 was generated using ASPEN, the SA instructs the laboratory to retain a copy and return the original to CMS/SA within 10 days of receipt. If the response attempts to refute a citation, the SA contacts the laboratory to resolve the disagreement. If not resolved, the laboratory should put its protest in writing in a form suitable for disclosure but must still provide its plan and time frame for correction. If the laboratory corrects a cited deficiency before the completion of the survey, the SA documents the deficiency on the Form CMS-2567 and explains to the laboratory director that when the laboratory receives the Form CMS-2567, it is to indicate the correction as of that date. It is not acceptable, under any circumstances, for a laboratory to allude in any way to another laboratory or to malign an individual on a publicly disclosable Form CMS- 2567. The SA should request an amended PoC from the laboratory.