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Summary Statement of Deficiencies D0000 The Division of Health Service Regulation (State agency) conducted a proficiency testing desk review survey that was completed on November 20, 2023. As a result of the survey, it was determined that the following Conditions were not met: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2021, 2022, and 2023 API (American Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Proficiency Institute) proficiency testing results 11/20/23, the laboratory failed to achieve satisfactory performance for D (Rho) type and failed to achieve overall testing event scores of satisfactory for ABO/RHO on four out of five testing events, resulting in unsuccessful participation in proficiency testing. Findings: See the deficiencies cited at D2162 and D2163. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2021, 2022, and 2023 API proficiency testing results 11/20/23, the laboratory failed to achieve satisfactory performance for D (Rho) type on four of five testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and desk review of 2021 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the API 2021 Immunology/Immunohematology 3rd event. 2. Desk review of CMS Casper reports 153D and 155D and desk review of 2022 proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the API 2022 Immunology/Immunohematology 1st event. 3. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the API 2023 Immunology/Immunohematology 1st event. 4. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed the laboratory received a score of 80% for D (Rho) type on the API 2023 Immunology/Immunohematology 2nd event. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2021, 2022, and 2023 API proficiency testing results 11/20/23, the laboratory failed to achieve overall satisfactory performance for ABO/RHO on four of five testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper reports 153D and 155D and desk review of 2021 API proficiency testing results revealed the laboratory received an overall test event score of 0% for ABO/RHO on the API 2021 Immunology/Immunohematology 3rd event. 2. Desk review of CMS Casper reports 153D and 155D and desk review of 2022 proficiency testing results revealed the laboratory received an overall test event score of 0% for ABO/RHO on the API 2022 Immunology/Immunohematology 1st event. 3. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed the laboratory received an overall test event score of 0% for ABO -- 2 of 3 -- /RHO on the API 2023 Immunology/Immunohematology 1st event. 4. Desk review of CMS Casper reports 153D and 155D and desk review of 2023 API proficiency testing results revealed the laboratory received an overall test event score of 80% for ABO /RHO on the API 2023 Immunology/Immunohematology 2nd event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2021, 2022, and 2023 API proficiency testing results 11/20/23, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. Findings: See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2021, 2022, and 2023 API proficiency testing results 11/20/23, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: See the deficiencies cited at D2162 and D2163. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the 2018, 2019, 2020, and 2021 API (American Proficiency Institute) PT (proficiency testing)records and absence of documentation 5/5/21, the laboratory failed to maintain all PT records and failed to ensure the director and testing personnel signed the attestation statement. Findings: Review of 2018, 2019, 2020, and 2021 API PT records revealed: 1. The laboratory failed to maintain the PT report forms with graded results for the following events: a. 2018 3rd Immunology /Immunohematology test event; b. 2019 2nd Immunology/Immunohematology test event; c. 2020 3rd Immunology/Immunohematology test event; 2. The laboratory failed to ensure the director and/or testing personnel signed the attestation statements for the following events: d. 2018 2nd Immunology/Immunohematology test event; e. 2019 1st Immunology/Immunohematology test event; f. 2019 3rd Immunology /Immunohematology test event; g. 2020 2nd Immunology/Immunohematology test event (only signed by testing personnel and clinic manager); h. 2020 3rd Immunology /Immunohematology test event (only signed by testing personnel and clinic manager); i. 2021 1st Immunology/Immunohematology test event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 laboratory's procedures, review of manufacturer's instructions, review of laboratory records and the absence of documentation, and interview with the clinic manager 5/5/21, the laboratory failed to monitor and document the conditions required for accurate and reliable test performance. Findings: The laboratory's "Policy and Procedure for Refrigerator and Room Temperature" states, "Refrigerators and Rooms that contain regulated reagents and medications must have the temperature monitored to ensure proper temperatures are kept. A thermometer will be placed inside the lab room, and lab refrigerator that contain medication and reagents... Lab Room temperature range should be between 20 degrees C(Celsius)- 31 degrees C(68 degrees F(Fahrenheit)-87 degrees F)." The laboratory's procedure states an incorrect room temperature range that is not consistent with the manufacturer's instructions dated 4-7-2020 for the RhD testing. The ALBAclone Anti-D blend blood grouping reagent instructions revealed under "Slide technique... incubate the test at 18- 24 degrees C for 5 minutes with occasional mixing...." Review of the laboratory's temperature records revealed Room temperature documentation was not available for Room #1 and Room #2 where RhD slide testing was performed after December 2, 2020 until April 2021. Approximately 1,262 patients were tested during this time- frame. At approximately 12 p.m., the clinic manager stated the room temperatures were recorded for the lab area until the end of 2020 when testing was moved into Room #1 and Room #2. She confirmed room temperatures were not being monitored or documented in Room #1 or Room #2. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of procedures, review of manufacturer's instructions, review of 2018, 2019, 2020, and 2021 Rh(Rhesus) Slide test QC(quality control) and patient testing logs 5/5/21, the laboratory failed to document Rh QC each day patients were tested. Findings: The laboratory's procedure "Quality control for RhD Typing" states, " In -- 2 of 6 -- order to show that testing is in a state of control, and to ensure that reagents are operating as expected, daily quality control should be performed on each reagent. A positive and a negative control should be tested each day of use. To fulfill these requirements, Anti-D reagent will be tested with a known RhD positive sample and a known RhD negative sample once each day, before the testing of patient samples begin." The Anti-D blend ALBAclone manufacturer's 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..." Random review of 2018, 2019, 2020, and 2021 Rh QC and patient logs revealed the laboratory failed to document positive and negative control on 14 days between 1/25/20 and 4/21 /20 when approximately 164 patients were tested and reported: a. 1/25/20 - 21 patients tested; b. 1/28/20 - 12 patients tested; c. 1/29/20 - 6 patients tested; d. 1/30/20 - 3 patients tested; e. 1/31/20 - 14 patients tested; f. 3/10/20 - no positive control - 23 patients tested; g. 3/11/20 - no positive control -11 patients tested; h. 3/12/20 - no positive control - 5 patients tested; i. 3/13/20 - no positive control -7 patients tested; j. 3/14/20 - no positive control - 12 patients tested; k. 3/17/20 - no positive control - 13 patients tested; l. 3/18/20 - no positive control - 15 patients tested; m. 3/19/20 - no positive control - 9 patients tested; n. 4/21/20 - 13 patients tested. D5785

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/27/20, the laboratory failed to successfully participate in proficiency testing for D (Rho) type. See the deficiency cited at D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to achieve satisfactory performance for the same analyte in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/27/20, the laboratory failed to achieve satisfactory performance for D (Rho) type on two consecutive proficiency testing events, resulting in unsuccessful participation. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received a score of 80% for D (Rho) type on the 2019 3rd Immunology /Immunohematology test event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate and received a score of 0% for D (Rho) type on the 2020 1st Immunology /Immunohematology test event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/27/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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 director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 5/27/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received a score of 80% for D (Rho) type on the 2019 3rd Immunology/Immunohematology test event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to -- 2 of 3 -- participate and received a score of 0% for D (Rho) type on the 2020 1st Immunology /Immunohematology test event. -- 3 of 3 --