Summary:
Summary Statement of Deficiencies 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 surveyor review of proficiency testing (PT) records for the 202 and 2022, surveyor review of the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by testing personnel (TP) #1 at 11:00 p.m. on 11/17 /22, the laboratory failed to allow TP who routinely perform CBC testing on the patient samples to participate in proficiency testing events for 2021 and 2022. Findings include: 1. Review of proficiency records since the last survey on 3/25/21, revealed the 2nd and 3rd events for 2021, all 3 events for 2022 were all performed by TP #1. 2. In an interview with TP #1 at 11:00 p.m. on 11/17/22 confirmed that CBC testing on patient samples is routinely performed by all testing personnel (TP #1 through #3) as listed on the CMS-209. 3. TP #2 nor TP#3 did not participate in the proficiency testing events for CBC in the 2nd and 3rd events of 2021 or either of the events for 2022. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of laboratory testing records from 04/01/2021 through 11/16/2022 and interview with TP #1 at 12:00 p.m. on 11/16/2022, the technical consultant (TC) listed on the CMS (Centers for Medicare & Medicaid Services) 209 personnel form had not documented as reviewed all laboratory records. Findings Include: 1. The surveyor reviewed temperature records and quality control records from 01/02/2022 through 11/16/2022. 2. The technical consultant failed to document review of the following: a. Temperature logs (room, humidity and refrigerator) from 01/02/2022 through 11/16/2022. b. Henry Schein Combo serum pregnancy test quality control (QC) from 01/02/2022 through 11/11/2022. 2. TP #1 in an interview at 12:00 p.m. on 11/16/2022 confirmed there was no documented review of these records by the TC. -- 2 of 2 --