Summary:
Summary Statement of Deficiencies D0000 A complaint survey was performed on March 13, 2018. Care Rite, PLLC 44D2077868 was not in compliance with 42 CFR Part 492, Requirements for Laboratories; with conditions cited at 42 CFR 493.801 Enrollment and testing of samples. Laboratory A is Care Rite PLLC 44D2036174 located at 1445 Hwy 51 ByPass, Suite A, Dyersburg, TN 38024. Laboratory B is Care Rite PLLC 44D2077868 located at 521 Hwy 51, North Suite A, Ripley, TN 38063. Laboratory A sent to Laboratory B the American Proficiency Testing (API) 2017 event 3 complete blood count (CBC) proficiency testing (PT) samples on November 27, 2017 prior to the December 1, 2017 result due date. Laboratory B performed the API 2017 event 3 PT samples on November 28, 2017, but did not share the results with Laboratory A. Laboratory B was not enrolled in proficiency testing during the 2017 event 3 and wanted to use Laboratory A's PT samples as quality assessment. Laboratory B did not share their results with Laboratory A. Laboratory A reported their own CBC PT results to API on November 20, 2017. Laboratory B did not notify Centers for Medicare and Medicaid (CMS) of the receipt of the PT samples. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This CONDITION is not met as evidenced by: The laboratory failed to notify CMS the receipt of the PT samples from Laboratory A. (Refer to D2013) D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the quality assessment (QA) records, the