Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 14, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. An immediate jeopardy situation was identified due to the laboratory's inability to demonstrate compliance in the speciality of Hematology , specifically the laboratory's inability to employ qualified testing personnel and a qualified technical consultant, lack of oversight by the laboratory director and the laboratory's continued non- compliance demonstrated by repeat deficiencies. A cease testing letter was submitted by the laboratory director at the summation discussion. 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 testing (PT) records from the American Proficiency Institute (API) and staff interview, the laboratory failed to retain documentation signed by the testing personnel (TP) and laboratory director (LD) attesting to routine integration of samples into the patient workload. Findings include: 1. Review of 2016, 2017 & 2018 attestation statements for PT from API in the speciality of hematology for complete blood counts (CBC) revealed no documentation of attestation statements for the 3rd event of 2017 and the 1st event of 2018 . 2. Interview with the office manager, testing personnel # 3, (see CMS 209) on August 14, 2018 at 1 pm in the office assigned to the surveyor confirmed attestation statements for the events listed above are not available at the time of the survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 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 2018 PT records from API and staff interview, the laboratory failed to document each step to the testing and reporting of PT samples and failed to retain documentation for a minimum of two years from the date of the PT event. Findings include: 1. Review of 2018 event 1 API PT records revealed instrument printouts, raw data, attestation statement and testing records are not available for review. 2. Interview with the testing personnel # 3 (see CMS 209) on August 14, 2018 at 1 pm in the office assigned to the surveyor confirmed testing records for the 1st event of 2018 are not available for the surveyor. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation during a tour of the laboratory and staff interview, the laboratory failed to comply with rules governing storage of non-biohazard material in an area designated for biohazard material. Findings include: 1. Observation by the surveyor during a tour of the laboratory revealed injectable vaccines and insulin stored in the refrigerator that had a biohazard sign posted on the outside door. Control material used in laborortory testing which contains blood was also stored in this refrigerator. 2. Interview with the testing personnel # 3 (see CMS 209) on August 14, 2018 at 11 am in the laboratory confirmed injectable vaccines and insulin used to treat patients are stored in the refrigerator designated for biohazard storage. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of records to review, documentation of -- 2 of 12 -- repeat deficiencies and staff interview, the laboratory failed to meet testing requirements in the speciality of Hematology for testing of complete blood counts (CBC) on the Emerald Cell Dyn hematology analyzer. Findings include: Refer to D 5429 & D 5439 Note: These are repeat deficiencies and were also cited at the October 2014 survey. This condition contributed to the Immediate Jeopardy determination. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records, lack of quality assessment activity and staff interview, the laboratory failed to monitor and evaluate the overall quality of the laboratory and failed to correct identified problems. Note: This condition level deficiency contributed to the Immediate Jeopardy determination. Finding include: Refer to D 5211, D 5221 and D 5291 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 2017 and 2018 PT records from API and staff interview the laboratory failed to document review of PT evaluations for testing performed in the speciality of hematology. NOTE: This is a repeat deficiency. It was cited at both the 2014 and 2016 surveys and contributed to Immediate jeopardy determination.. Findings include: 1. Review of PT records for event 3 of 2017 revealed no API evaluation is available and and no documentation showing the laboratory reviewed results. 2. Review of PT records for event 1 of 2018 revealed no documentation showing the laboratory reviewed results.. 3. Interview with testing personnel # 3 (see CMS 209) on August 14, 2018 at 1 pm in the office assigned to the surveyor confirmed PT records listed above are not available. 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 CMS CASPER 0096D report, lack of PT records from event 3 of 2017 and event 1 of 2018 and staff interview, the laboratory failed to document