Summary:
Summary Statement of Deficiencies 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 the laboratory's proficiency testing records, and interview with Testing Personnel #1(TP1), the Laboratory Director (LD) and testing personnel failed to sign the vendor's proficiency testing attestation statement for 6 of 6 proficiency testing events participated in from 2016-2017. Record review was from 2016-2017. The findings include: 1. Review of the laboratory's proficiency testing records revealed the LD and Testing Personnel did not sign the vendor's proficiency attestation statement for 2016 Accutest BGAS Blood Gas/Electrolytes Cycle 1, 2 and 3. 2. Review of the laboratory's proficiency testing records revealed the LD and Testing Personnel did not sign the vendor's proficiency attestation statement for 2017 Accutest BGAS Blood Gas/Electrolytes Cycle 1, 2 and 3. 3. On 3/15/18 at approximately 10:45 AM, TP1 confirmed the findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, and interview with Testing Personnel #1(TP1), the laboratory failed to retain the instrument printouts for 6 of 6 proficiency testing events participated in from 2016-2017. Record review was from 2016-2017. The findings include: 1. Review of the laboratory's proficiency testing records revealed the laboratory did not retain the instrument printouts for 2016 Accutest BGAS Blood Gas/Electrolytes Cycles 1, 2, and 3. 2. Review of the laboratory's proficiency testing records revealed the laboratory did not retain the instrument printouts for 2017 Accutest BGAS Blood Gas/Electrolytes Cycles 1, 2, and 3. 2. On 3/15/18 at approximately 10:45 AM, TP1 confirmed the findings. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's policy and procedure manual and interview with Testing Personnel #1 (TP1), the laboratory failed to document the date of initial use of 1 of 1 new instrument procedures (ABL 80 Flex). Record review was from 2016-2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a procedure, "ABL 80 Flex", with no date of initial use. 2. On 3/15 /18 at approximately 11:15 AM, TP1 confirmed the findings. B. Based on review of the laboratory's policy and procedure manual and interview with Testing Personnel #1 (TP1), the laboratory failed to document the date of discontinuance of 1 of 1 retired instrument procedures (ABL 5). Record review was from 2016-2017. The findings include: 1. Review of the laboratory's policy and procedure manual identified a procedure, "ABL 5", with no date of discontinuance. 2. On 3/15/18 at approximately 11:15 AM, TP1 confirmed the findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's Accutest proficiency testing (PT) records and interview with Testing Personnel #1 (TP1), the laboratory failed to review and evaluate PT results for 6 of 6 PT events for 2016-2017. Record review was from 2016 to 2017. The findings include: 1. Review of the laboratory's Accutest PT records revealed the LD did not sign as reviewed the PT results for 2016 BGAS Cycle 1, 2 -- 2 of 10 -- and 3. 2. Review of the laboratory's Accutest PT records revealed the LD did not sign as reviewed the PT results for 2017 BGAS Cycle 1, 2 and 3. 3. On 3/15/18 at approximately 10:45 AM, TP1 confirmed the findings. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's Accutest proficiency testing (PT) records and interview with Testing Personnel #1 (TP1), the laboratory failed to document the