Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 17, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with laboratory testing personnel, the laboratory testing personnel (TP) failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the 2016 - 2017 AAB (American Association od Bioanalytics) PT records revealed the TP did not sign the 2017 events 1,2, or 3 attestation statements. 2. An interview with TP # 2 (CMS 209 form) on 4/17/18 at approximately 11 AM in the employee breakroom, confirmed the TP did not sign the aforementioned attestation forms. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient reports and an interview with testing personnel (TP), the laboratory failed to include all required components on the facility's result reports. Findings include: 1. Review of 3 (three) patient reports performed at the facility revealed the reports did not include the name/location of the testing facility. 2. Interviews with TP #2 (CMS 209 form) and the lab coordinator on 4/17/18 at approximately 10:45 AM in the employee breakroom, confirmed the lack of required information. -- 2 of 2 --