All Womens Health Center Of Sarasota Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at All Womens Health Center of Sarasota Inc on 04/18/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a written policies and procedures that ensured positive identification of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results for 2 of 2 years (2022-2023). Findings included: 1. The Specimen Collection and Handling policy stated specimens were to be labeled but not what information was needed to ensure integrity of specimen. 2. Review of patient logs for 10/2022, 2/2023, and 7/2023 revealed only patient names used for labeling. Testing Personnel #1 confirmed on 4/18/2024 at 3:25 PM only patient names were used for identification. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document results of control materials for Bovine Albumin Quality Control used for detecting Rhesus (Rh) antibodies in 10/2022 for 4 (10/06/2022, 10/12/2022 , 10/14/2022, and 10/26/2022) out of 5 days (10/06/2022, 10/12/2022 , 10/14/2022, 10/20/22, and 10/26/2022) of testing. Findings included: 1. Review of patient testing logs for 10/2022 documented patient testing was performed 10/06/2022, 10/12/2022 , 10/14/2022, 10/20/22, and 10 /26/2022. The Bovine Albumin results failed to be documented for 10/06/2022 with 6 patients reported, 10/12/2022 with 13 patients reported , 10/14/2022 with 9 patients reported, and 10/26/2022 with 12 patients reported. 2. Testing Personnel #1 on 4/18 /2024 at 3:25 PM confirmed the Bovine Albumin Quality Control was not documented on the listed dates when patient testing was performed in 10/2022. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at All Women's Health Center of Sarasota Inc. on 02/28/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 Analytic Systems 493.1250 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 record review and interview with the Administrator the laboratory failed to perform competency assessment for 3 out of 3 Testing Personnel. Findings Included: Review of the CMS 209 (signed and dated by the Laboratory Director on 02/26/2020) revealed that there were 3 Testing Personnel. Testing Person #A started 10/2018, Testing Person #B started 03/2019, and Testing Person #C started 02/2019. Review of Personnel files revealed no competency assessments for Testing Person #A, #B, or #C. Interview on 02/28/2020 at 2:15 PM with the Administrator confirmed that no competency assessments were performed on the Testing Personnel. 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 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 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Administrator the laboratory failed to perform preventative maintenance on the Rh view box since 03/22/2018 (See D5429). D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the Administrator the laboratory failed to perform preventative maintenance on the Rh view box since 03/22/2018. This is a repeat deficiency from the recertification survey conducted 02/22/2018. Findings Included: Review of the preventative maintenance for the Rh view box revealed that the last time it was performed was 03/22/2018. The preventative maintenance was due 03/2019. Interview on 02/28/2019 at 1:00 PM with the Administrator confirmed that the preventative maintenance had not been performed. Review of the

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 record review and interview with the Laboratory Manager, the laboratory failed to rotate proficiency testing to include all testing personnel who perform patient testing for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of the Testing Personnel sheet revealed that 4 people performed patient testing (Testing Person #A, B, C, and D). Review of American Proficiency Institute (API) proficiency testing attestation statements revealed that Testing Person #A performed proficiency testing 5 (1st, 2nd, 3rd 2016 and 1st and 2nd 2017) out of 6 (1st, 2nd, 3rd testing events in 2016 and 2017) testing events and Testing Person #C performed testing for testing event 3 in 2017. During an interview on 02/22/18 at 10:00 AM the Laboratory Manager confirmed that proficiency testing was not rotated among all staff who performed patient testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Manager, the laboratory 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 -- failed to perform preventative maintenance on the Rh view box for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of laboratory preventative maintenance revealed no preventative maintenance documentation for the Rh view box. During an interview on 02/22/18 at 10:40 AM the Laboratory Manager confirmed that there had been no preventative maintenance performed on the Rh view box. -- 2 of 2 --