Summary:
Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an announced CLIA validation survey at SUNNYVIEW HOSPITAL AND REHABILITATION CENTER on July 10, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to not be in compliance with all condition-level CLIA requirements. The following condition and standard level deficiencies were found during CLIA exempt-state validation survey performed on July 10, 2024. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Test (PT) records and an interview with the laboratory supervisor, the laboratory failed to rotate proficiency testing for the i-STAT between 54 out of 55 testing personal from 2022 to 2024. Findings Include: 1. On the day of survey, July 10, 2024 at 2:45 pm, review of the API PT records for testing performed on the Abbott i-STAT revealed, 1 out of 55 nurses performed all testing events from 2022 to 2024. 2. The laboratory could not provide documentation for PT being rotated among the other 54 out of 55 testing personnel performing tests on the Abbott i-STAT. 3. The laboratory supervisor confirmed the findings above on July 10, 2024 at 3:00 pm. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 review of competency assessment records, the competency assessment procedure and interview with the laboratory supervisor, the laboratory failed to establish a competency assessment procedure to assess technical supervisors (TS) for their supervisory roles performed from July 2022 to July 2024. Findings Include: 1. On the day of survey, July 10, 2024, review of the competency assessment procedure revealed, the procedure did not include the assessment for TS and their supervisory roles performed in the laboratory from July 2022 to July 2024. 2. On Form CMS 209, there are two TS listed who have not undergone competency assessments for their supervisory roles in the laboratory. 3. The laboratory supervisor confirmed the findings above on July 10, 2024 at 9:30 am. 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 laboratory records and interview with the laboratory supervisor, the laboratory failed to meet analytic systems requirements in 493.1251 through 493.1283 for the laboratory and point of care testing performed from July 2022 to July 2024. Refer to: D5401, D5403, D5429, and D5447. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the laboratory supervisor, the laboratory failed to establish a policy / procedure for the Sysmex XN- 550 complete blood count (CBC) analyzer from July 2022 to July 2024. 1. On the day of survey, July 10, 2024 at 2:15 pm, review of the laboratory procedures revealed, the laboratory procedures binder did not include a procedure for the Sysmex XN-550 CBC analyzer. 2. Per Form CMS 116, an estimated 67,594 hematology tests are performed annually. 3. The laboratory supervisor confirmed the finding above on July 10, 2024 at 2:30, as the procedure could neither be found in the binder onsite or in the laboratory's computer system. -- 2 of 7 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)