West End Womens Medical Group

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on May 24, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the 2021 American Proficiency Institute (API) Rh Slide Test proficiency testing (PT) attestation forms and an interview with the laboratory manager, the director failed to sign the attestation forms documenting the routine integration of PT samples into the workload. Findings include: 1. Review of the 2021 API Rh Slide Test PT attestation forms revealed that the director failed to sign the attestation form from the third PT event of 2021. 2. An interview with the laboratory manager on May 24, 2023 at approximately 11:00 AM confirmed these findings. The laboratory performs approximately 100 immunohematology tests per year. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 observation and an interview with the laboratory manager, the laboratory failed to ensure that control materials were discarded by their expiration dates. Findings include: 1. Observation of the control materials available for use in the laboratory revealed that Rh positive and negative controls with an expiration date of 5 /14/2023 were available for use. 2. The laboratory manager confirmed these findings and indicated the laboratory's procedure was to discard the controls 90 days after collection, in an interview on May 24, 2023, at approximately 11:30 AM. The laboratory performs approximately 100 immunohematology tests annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 2/02/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of federal database CASPER Report 155D, American Proficiency Institute (API) proficiency testing (PT) evaluation forms, and review of the 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 -- laboratory's records during the on-site survey on 2/02/2021, the laboratory did not successfully participate in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the second and third testing events of 2020 with a score of 60% and 80%, respectively, resulted in unsuccessful proficiency testing performance for D (Rho) typing. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for D (Rho) typing in the second and third testing events of 2020. Refer to D2162. 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 review of federal database CASPER Report 155D, American Proficiency Institute (API) proficiency testing (PT) evaluation forms, and review of the laboratory's records during the on-site survey on 2/02/2021, the laboratory did not successfully perform in a proficiency testing program. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the second and third testing events of 2020 with a score of 60% and 80%, respectively, resulted in unsuccessful proficiency testing performance for D (Rho) typing. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for D (Rho) typing in the second and third testing events of 2020 with scores of 60% and 80%, respectively. 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 review of federal database CASPER Report 155D, American Proficiency Institute (API) proficiency testing (PT) evaluation forms, and review of the laboratory's records during the on-site survey on 2/02/2021, Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1407. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 review of federal database CASPER Report 155D, American Proficiency Institute (API) proficiency testing (PT) evaluation forms, and review of the laboratory's records during the on-site survey on 2/02/2021, the laboratory director failed to ensure that proficiency testing samples were tested as required. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for D (Rho) typing in the second and third testing events of 2020. CASPER Report 155D, API PT evaluation forms and laboratory records reported a score of 60% for the second testing event of 2020 and a score of 80% for the third testing event of 2020. -- 3 of 3 --