A Womans World Medical Center Inc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 2, 2024. A Woman's World Medical Center clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the laboratory logs, and interview, the laboratory failed to report the temperature of the refrigerator and the Rh (Rhesus) typing box each day of testing from 12/16/2023 to 12/30/2023. Findings: During a tour of the laboratory on 04/03 /2024, the Anti-D for Rh factor typing was in the refrigerator. The Daily Temperature Log noted the "Refrigerator Temp. Range 36 - 45 degrees" Fahrenheit and "Rh Box Temp. Range 45 - 50 degrees." Review of "Daily Temperature " showed the last temperature taken of the refrigerator and Rh typing box for 2023 was on 12/13/2023. Review of the Daily Laboratory Log showed 10 patients on 12/16/2023, 14 patients on 12/18/2023, 11 patients on 12/23/2023 and 14 patients on 12/30/2023 were tested for Rh. On 04/02/2024 at 10:45 AM, the Laboratory Owner acknowledged the temperatures for the refrigerator and the Rh Typing Box were not recorded. 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 D0000 Recertification survey was conducted on November 5, 2019. A Womans World Medical Center Inc. was not in compliance with 42 CFR 493, requirements for clinical laboratories. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and staff interview, the Technical Consultant failed to provide technical oversight of the laboratory. Findings: Cross Reference D6054. Based on record review and staff interview, the laboratory failed to document annual competency assessment on two out of two testing personnel from 11/05/17 to 11/05 /19 (A & B). This is a repeat deficiency from the survey conducted on 11/29/17. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document annual competency assessment on two out of two testing personnel from 11/05/17 to 11/05 /19 (A & B). This is a repeat deficiency from the survey conducted on 11/29/17. 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 -- Findings: Review of the competency records showed that the laboratory failed to have documentation of annual competency assessments for two out of two testing personnel from 11/05/17 to 11/05/19. During an interview on 11/05/19 at 2:25 PM, the President/Owner stated she had not done any competency assessments on the testing personnel since 2017. -- 2 of 2 --