Summary:
Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 American Association of Bioanalysts records for 2019, laboratory policies and staff interview, it was revealed the laboratory failed to have documentation of the laboratory director signing 2 of 2 attestation statements. Findings include: 1. A review of the laboratory's American Association of Bioanalysts records from 2019 (Chemistry Q1 2019 and Chemistry Q2 2019)revealed the laboratory director failed to documentation of the laboratory director signing the attestation statements. 2. Further review of the American Association of Bioanalysts records from 2019 (Chemistry Q1 2019 and Chemistry Q2 2019) revealed the technical consultant's signature on the following attestations statements: A. Chemistry Q1 2019- Comprehensive Chemistry B. Chemistry Q1 2019- D-Dimer 3. A review of the laboratory's policies revealed the laboratory did not have documentation of the laboratory director delegating the responsibility of signing proficiency testing attestation statements to the technical consultant. 4. An interview with testing person #8 (as listed on the CMS 209 form, signed by the laboratory director on 6/19/19) on 6 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- /19/19 at 10:00 in the nurse's station revealed the attestation statements had not been signed by the laboratory director and the laboratory did not have documentation of the laboratory director delegating the responsibilities to the technical consultant. This confirmed the above findings. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CMS 155 report and the American Association of Bioanalysts proficiency testing records, the laboratory failed to obtain a score of at least 80% for the analytes Albumin and Chloride for Q1 Chemistry 2019 event. Findings include: 1. A review of the CMS 155 report revealed the laboratory received a score of 60% for the American Association of Bioanalysts Q1 Chemistry 2019 event for Albumin and Chloride. 2. A review of the American Association of Bioanalysts Q1 Chemistry 2019 proficiency testing records revealed the following analytes had unsatisfactory scores: Analyte Specimen Reported Value Grading Range Albumin 2 5.9 6 - 7.3 Albumin 4 4.2 4.4 - 5.4 Chloride 3 111 97 - 108 Chloride 4 125 109 - 121 For Albumin and Chloride, 2 of 5 proficiency testing results received an unsatisfactory score resulting in a grade of 60% for each analyte. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the laboratory's personnel records and staff interview, it was revealed that the laboratory failed to have documentation of a competency assessment for 1 of 1 technical consultants. Findings include: 1. A review of the laboratory's personnel records for the technical consultant (as listed on the CMS 209 form signed by the laboratory director on 6/19/19) revealed a form titled "Technical Consultant Competency Evaluation". Further review of the "Technical Consultant Competency Evaluation" form revealed the technical consultant's name was listed at the top of the form, there was a date stamp of 6/1/19, the boxes to the left of the 9 elements of the competency assessment were not checked, and there was no signature or date of review from the laboratory director. 2. The laboratory was asked to provide documentation of the technical consultant's competency assessment. No documentation was provided. 3. A review with the administrative laboratory director on 6/19/19 at 11:15 in the nurse's station confirmed that there was not a competency assessment completed for the technical consultant. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without -- 2 of 14 -- analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on laboratory's American Association of Bioanalysts records for Q1 Chemistry 2019 and staff interview, revealed the laboratory failed to have documentation of verifying the accuracy of analytes that were not graded by the proficiency testing program. Findings include: 1. A review of the American Association of Bionanlysts results for Q1 Chemistry 2019 revealed the following analytes were scored as not graded and had a '?' next to the reported value: A. Alanine Aminotransferase (ALT) specimen 2 B. Partial Pressure of Carbon Dioxide (pCO2) specimen 1 American Association of Bioanalysts defines that "?= This score may not truly evaluate performance for this specimen which was not graded because of lack of participant consensus." 2. A review of the American Association of Bioanalysts results for Q1 Chemistry 2019 revealed the following analytes were scored as not graded and had a '#' next to the reported value: A. Alanine Aminotransferase (ALT) specimen 5 B. Chloride specimen 1 C. Chloride specimen 2 D. Chloride specimen 5 E. Sodium specimen 1 F. Sodium specimen 3 G. Sodium specimen 4 H. Sodium specimen 5 American Association of Bioanalysts defines that "# = This method was not graded due to an insufficient number of peer respondents. No appropriate default grouping was available. The listed range should provide a reasonable guide to your performance. However, exercise caution in evaluating your results." 3. An interview with the Administrative laboratory director on 6/19/19 at 10:40 in the nurse's station revealed the laboratory failed to have documentation verifying the accuracy of the above analytes that were scored as not graded by the proficiency testing program. This confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's records, and staff interview, it was revealed the laboratory failed to monitor and evaluate overall quality and correct identified problems in analytic systems as evidenced by: 1. The laboratory failed to have documentation of a procedure of how to perform