Womens Ob/Gyn Center Of Countryside Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Womens OB/GYN Center of Countryside Inc on 4/29/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 policy 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 - 2024). Findings included: 1. Review of the Specimen Collection and Handling policy revealed specimens were to be labeled. The policy did not include what information was needed to ensure positive identification and the integrity of patients' specimens. 2. Review of patient logs for 12/2022, 7/2023, and 2 /2024 revealed only patient names were used for labeling. 3. Interview with Testing Person #A confirmed on 4/29/2024 at 10:40 AM only patients' names were used for specimen identification, and the policy did not include what information to include to ensure positive identification. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of AAB (American Association of Bioanalysts) proficiency testing and interview with the Office Manager, the laboratory failed to get a 100% on proficiency testing for 1 (3rd testing event 2016) out of 6 testing events (1st, 2nd, 3rd testing event 2016 and 2017) reviewed. Findings Included: Review of AAB proficiency testing revealed that in the 3rd testing event of 2016 the laboratory scored 60% for Rh typing. During an interview on 01/30/18 at 2:00 PM the Office Manager confirmed the proficiency testing failure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --