Mobile Bay Ob/Gyn

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Policies and Procedure Manual, and an interview with the Technical Consultant (TC), the laboratory failed to establish a policy to monitor and assess competency of physicians who performed Provider Performed Microscopy (PPM). This was noted from the date of the last survey, 09-20-2022, to the date of the current survey, 01-15-2025. The findings include: 1. A review of the Policies and Procedures Manual revealed a lack of policy to monitor and assess the competency of physicians who performed PPM and were responsible in reporting PPM patient results. 2. During the exit conference on 01-15-2025 at 2:45 PM, the TC confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records, and an interview with the Technical Consultant (TC), the Laboratory failed to implement a mechanism to verify the accuracy of the Provider Performed Microscopy (PPM) on the Urine Sediments 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 -- PT, a non-regulated test. The surveyor noted the laboratory failed two out of the three consecutive events from 2022-2023. The findings include: 1. A review of the AAB- MLE PT records revealed the laboratory evaluation scores were 50 percent on the PPM-Urine Sediments PT for the following events: a) 2022 MLE M3 b) 2023 MLE M1 2. A further review of the laboratory's PT Failure log revealed the TC's

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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the surveyor determined the laboratory failed to successfully participate in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for Events #1 and #3, 2021, and Event #1, 2022. These failures result in a non-initial unsuccessful PT participation. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the surveyor determined the laboratory failed to successfully participate in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for Events #1 and #3, 2021, and Event #1, 2022. These analyte failures resulted in a non-initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following for RBC and HCT: a) 0 % for Event #1, 2021. b) 60 % Event #3, 2021. c) 40% Event #1, 2022. 2. The surveyor confirmed the above noted findings with a review of the detailed PT evaluations from MLE. 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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the laboratory director failed to ensure the testing personnel successfully participated in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for Events #1 and #3, 2021, and Event #1, 2022. These analyte failures for three events resulted in an non-initial unsuccessful PT participation. The findings include: Refer to 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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, the laboratory director failed to ensure the testing personnel successfully participated in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for Events #1 and #3, 2021, and Event #1, 2022. These analyte failures for three events resulted in an non-initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored the following for RBC -- 2 of 3 -- and HCT: a) 0 % for Event #1, 2021. b) 60 % Event #3, 2021. c) 40% Event #1, 2022. 2. The surveyor confirmed the above noted findings with a review of the detailed PT evaluations from MLE. -- 3 of 3 --

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 a review of CMS (Centers for Medicare and Medicaid Services) CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, and a review of the Recertification Notes from 4/06/2021, the surveyor determined the laboratory failed to successfully participate in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for two of three consecutive testing events (Event #1 and #3, 2021). These failures result in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored zero percent (%) for all analytes of the CBC (Complete Blood Count) for Event #1, 2021, due to a "Failure to Participate," and 60 % for the RBC 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 -- and Hematocrit for Event #3, 2021. 2. The surveyor confirmed the above noted findings with a review of the detailed PT evaluations from MLE. 3. The surveyor conducted a recertification survey on 4/7/2021 and noted the laboratory received a "Failure to Participate" for Event #1, 2021, due to illness of staff. None performed the PT testing, prior to the submission deadline. The laboratory performed a self- evaluation. The laboratory staff stated they notified MLE via email. Additionally, CLIA has no record the laboratory ceased patient testing during this time. Note: In the event the laboratory ceases patient testing for a time, it is not required to perform the PT. However, the lab is responsible and must notify the PT provider as well as the CLIA State Agency. . D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS CASPER reports and MLE (Medical Laboratory Evaluation) Proficiency Testing (PT) evaluations, and a review of the Recertification Notes from 4/06/2021, the surveyor determined the laboratory failed to satisfactorily perform in PT testing for RBC (Red Blood Cell Count) and HCT (Hematocrit) for two of three consecutive testing events (Event #1 and #3, 2021). These failures result in an initial unsuccessful PT participation. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2016 - 2018 API (American Proficiency Institute) proficiency testing (PT) records, personnel records, and an interview with the Technical Consultant, the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely performed moderate complexity Hematology testing on patients. This was noted on six of six surveys reviewed. The findings include: 1. A review of API attestation statements revealed Testing Personnel (TP) #1 had performed all the testing on the surveys performed from 6/15/2016 to 2/16 /2018 (the most current survey). None of the PT testing had been performed by TP #2. 2. A review of the personnel files revealed TP #2 was full time, and had been qualified to perform moderate complexity Hematology testing since the previous survey (on 4/29/2016). 3. During an interview on 5/15/2018 at 1:05 PM, the Technical Consultant was asked if the laboratory had rotated the Hematology proficiency testing among all personnel who routinely performed patient CBC (Complete Blood Count) testing. The Technical Consultant confirmed TP #2 had performed CBC testing on patients, however TP #1 had performed all the proficiency testing in the last two years. SURVEYOR:Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor 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 --