Summary:
Summary Statement of Deficiencies D0000 An onsite complaint survey was performed for compliance with 42 CFR Part 493, Requirements for Laboratories. 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 Sysmex XP-300 Analyzer 2021 Hematology proficiency testing (PT) records and staff interview, the laboratory failed to retain copies of American Proficiency Institute (API) PT result evaluations and PT submission documents. Findings include: 1. Record review on 03/16/2022 of CASPER Report D155 revealed scores of 100% for Hematology 2021 Events 1, 2, and 3. 2. Record review of 2021 API PT records on 03/16/2022 revealed no result evaluation documentation for API Hematology 2021 Events 1&3, and no attestation statements for API Hematology 2021 Events 1, 2, and 3. 3. Staff interview on 03/16/2022 with TP1 at 12:30 pm confirmed the findings above. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review of the FREND NanoEN Tek Analyzer User and Maintenance Manual records, lack of documentation, surveyor observation, and staff interview with the laboratory administrator (LA), the laboratory failed to maintain documentation of verification studies for the FREND NanoEN Tek Analyzer. Findings include: 1. Record review on 03/17/2022 of an Excel Spreadsheet, Midland Medical Medicare 84403 84153 84443 82306 1.1.21 to 9.21.21 listings CPT codes and patient testing service dates for Prostate Specific Antigen (PSA), Testosterone, 25-Hydroxyvitamin D (Vit D), and Thyroid Stimulating Hormone (TSH), revealed initial patient service dates of 03/21/2021 for Vit D, 04/15/2021 for PSA, 03/22/2021 for TSH, and 06/01 /2021 for Testosterone. 2. The LA stated during an interview on 03/16/2022 at 11:15 am that the FREND NanoEN Tek Analyzer performance verification studies were performed by the laboratory's technical consultant (TC) prior to patient testing, but the LA was unable to located the performance verification records. The LA further revealed that TC was off site, and she was unable to contact the TC to reveal where the records were located. 3. No performance verification records were found during the survey. 4. Surveyor observation on 03/16/2022 at 12:00 pm confirmed that the FREND NanoEN Tek Analyzer was unplugged, in a storage room, and not operational. 5. The laboratory performed 6 PSA, 56 Vitamin D, 55 TSH, and 1 Testosterone tests on the FREND NanoEN Tek Analyzer in 2021 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 record review of proficiency testing (PT) records for 2021 and staff interview with the laboratory administrator (LA), the laboratory failed to maintain PT testing, submission, and evaluation records for Prostate Specific Antigen (PSA), Testosterone, and 25-Hydroxyvitamin D (Vit D). Findings include: 1. Record review conducted on 03/16/2022 of PT API 2021 Chemistry Core PT records revealed a lack of PT testing, submission, and performance evaluation documentation for API 2021 Chemistry Core Events 1&2, and a lack of testing and performance evaluation for 2021 Chemistry Core Event 3. 2. Staff interview on 03/16/2022 at approximately 12: 45 pm with the LA confirmed the finding above. 3. Interview with the LA on 03/16 /2022 at 11:15 am further revealed that new TC was hired when the laboratory resumed testing operations late 2020 and was responsible for PT performed on the FREND NanoEN Tek Analyzer from January 2021 through November 2021. The LA further revealed that she was unable to contact the TC at this time. 4. Record review of a 01/07/2022 letter to COLA from the Laboratory Director revealed that the laboratory discontinued testing on the FREND NanoEN Tek Analyzer November 15, 2021. 5. The laboratory performed 6 PSA, 56 Vitamin D, 55 TSH, and 1 Testosterone tests on the FREND NanoEN Tek Analyzer in 2021. D5400 ANALYTIC SYSTEMS -- 2 of 8 -- 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 surveyor review of Sysmex XP-300 Automated Hematology Analyzer and NanoEnTek System 2021 records and staff interviews, the laboratory failed to have a FREND NanoEN Tek Analyzer procedure approved, signed and dated by the current laboratory director prior to use (refer to D5407); failed to monitor the correct storage temperature range for Sysmex XP-300 control samples (refer to D5413); failed to perform and document preventive maintenance according to the manufacturer instructions for the year 2021 for the XP-300 Automated Hematology Analyzer and FREND NanoEN Tek Analyzer (refer to D5429); failed to perform and document calibration verification for the Sysmex XP-300 Automated Hematology Analyzer (refer to D5439); failed to retain quality control (QC) Sysmex XP-300 instrument printouts for the year 2021(refer to D5481), and failed to document all