A Woman's Choice Of Greensboro, Inc

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, observation, and interview with TP (testing personnel) #1 on 3/27/24, the laboratory failed to update the procedure manual with instructions for the urine hCG (human chorionic gonadotropin) kits currently in use in the laboratory. Findings: Review of the laboratory's policies and procedures revealed manufacturer's instructions for the "hCG 2IU Test Disk" and the "Rapid Response Human Chorionic Gonadotropin hCG Test Cassette (Urine)". During a tour of the laboratory at approximately 11:50 a.m., the surveyor observed "Henry Schein One Step+ hCG Urine Cassette Test" and "dBest One Step Rapid Test" kits in the laboratory, available for use." Manufacturer's instructions for these tests were not included in the laboratory's procedure manual. During interview at approximately 12:00 p.m., TP #1 confirmed the laboratory currently uses Henry Schein One Step+ hCG Urine Cassette Test and dBest One Step Rapid Test. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 4 -- Based on review of the laboratory's procedure manual and interview with TP #1 on 3 /27/24, the laboratory's policies and procedures were not signed and dated by the current laboratory director. Review of the laboratory's procedure manual revealed a coversheet which stated "... Lab Director will review and sign the Policy and Procedure Manual yearly or as new Policies are put in place throughout the year." Review of the laboratory's procedure manual revealed the policies and procedures were signed by the previous laboratory director, but had not been signed and dated by the current lab director. During interview at approximately 9:45 a.m., TP #1 confirmed that the current laboratory director had not signed and dated the laboratory's policies and procedures. This deficiency was cited on the previous survey 7/9/21. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2022, 2023, and 2024 Rh(D) logs, and interview with TP #1 on 3/27/24, the laboratory failed to document the results of Rh(D) quality control testing for 24 days of patient testing from 2/15/24-3/27/24 when approximately 120 patients were tested. Findings: Review of the laboratory's "POLICY & PROCEDURE FOR QUALITY ASSURANCE" revealed "... 1. Everyday controls will be done and written on lab sheets before the start of every clinic (Rh positive and negative *documented in slot 1 and 2* ...". Review of the 2023 and 2024 Rh(D) logs revealed the laboratory discontinued patient Rh(D) testing 10/21/23. Patient Rh(D) testing resumed 2/15/24. Review of Rh(D) logs from 2/15/24 - 3/27/24 revealed the laboratory documented the lot number and expiration date for Rh(D) positive and negative controls on each log, but failed to document the results obtained. Approximately 120 patients were tested on 24 days of testing when quality control results were not documented. During interview at approximately 12:30 p.m., TP #1 stated they tested positive and negative Rh(D) controls each day that patients were tested. She stated they had updated the logs, and she confirmed the Rh(D) quality control results were not documented on the logs. This deficiency was cited on the previous survey 7/9/21. . D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory -- 2 of 4 -- director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of policies and procedures, review of quality assessment records, review of personnel records, and review of quality control records 3/27/24, the laboratory director failed to ensure the laboratory's quality assessment program was effective at identifying and correcting problems and preventing recurrence. Findings: Review of the laboratory's POLICY & PROCEDURE FOR QUALITY ASSURANCE" revealed "... 4. At the end of each month the Director of Patient Services will complete quality assurance checklist and

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the clinic manager 7/9/21, the laboratory failed to ensure that all procedures were approved by the current laboratory director. Review of the laboratory's procedure manual revealed the procedures were not signed and dated by the current laboratory director. During the exit interview at approximately 4:05 p.m., the clinic manager confirmed that the laboratory's procedures had not been signed by the current laboratory director. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. 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 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of the laboratory's policies and procedures, and random review of 2019, 2020, and 2021 daily logs 7/9/21, the laboratory failed to perform and document a positive and a negative control each day of patient testing for Rh(D). The QUOTIENT "BLOOD GROUPING REAGENT Anti-D blend ALBAclone" product insert states "... QUALITY CONTROL Quality control of reagents is essential and should be performed on each day of use and in accordance with local, state and federal regulations. ..." The "Protocol for Administering Rh Test" procedure states "... A control must be done daily before performing this test. This is achieved by testing cells known to be negative and positive for the relevant antigen. Test reagent by using confirmed Positive and Negative blood specimens. ..." The "Rh Testing Policy & Procedure" states "... Testing Anti-D is a daily process. Make sure after testing the Anti-D with the controls, results are placed on lab sheet before clinic begins. ..." Random review of the Rh(D) daily logs revealed the laboratory failed to perform and document positive and negative controls each day that patients were tested. Examples: 1. 2 of 20 days in December 2019 (12/26, 12/30) positive and negative controls not documented - 21 patients tested. 2. 4 of 22 days in January 2020 (1/4, 1/6, 1/7, 1/10) positive and negative controls not documented - 51 patients tested. 3. 1 of 21 days in February 2020 (2/13) positve control not documented - 11 patients tested. 4. 1 of 22 days of testing in March 2021 (3/27) positive and negative controls not documented - 8 patients tested. This deficiency was cited on the previous survey 7/12/18. D5785

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and review of 2016, 2017, and 2018 API (American Proficiency Institute) proficiency testing records 7/12/18, the laboratory failed to retain all proficiency testing records for at least two years. The laboratory's "PROFICIENCY TESTING" policy states "... Employees will do the testing as they would on a daily basis Lab director will sign Place a copy of package insert of proficiency testing will be placed in the lab book ..." Review of 2016, 2017, and 2018 API proficiency testing records revealed the laboratory did not have the following records available for review during the survey: a. the signed attestation statement for the 2017 1st event; b. the signed attestation statement and the report form used to record proficiency testing results for the 2018 1st event. 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)