Bbh Pcn Gardendale

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD), the laboratory failed to ensure the Laboratory Director (or designee) and the analyst signed the PT attestation statements. The surveyor noted four of the six events reviewed from the date of the last survey, 07-20-2023 through the date of the current survey, 07-22- 2025, were missing the signed attestation documents. The findings include: 1. A review of the 2023-2025 API PT records revealed the Laboratory Director (or designee) and the analyst had not signed the attestation statements for the following PT events. a) 2023 Hematology/Coagulation-Second Event b) 2023 Hematology /Coagulation-Third Event c) 2024 Hematology/Coagulation-Third Event d) 2025 Hematology/Coagulation-First Event 2. The LD confirmed the above findings during the exit conference on 07-22-2025 at 1:00 PM. 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 D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel files and an interview with the Technical Consultant, the Technical Consultant failed to evaluate competency on Testing Personnel at least semi-annually during the first year of patient testing on the Cell Dyn Emerald Hematology analyzer. This was noted for one out of one Testing Personnel listed on the Laboratory Personnel Report (Form CMS-209). The findings include: 1. A review of Personnel files revealed Testing Personnel #1 had initial training for the Cell Dyn Emerald dated 8/8/2022, and an annual competency dated 7/3/2023. There was no semi-annual competency evaluation for Testing Personnel #1 available for review. 2. During an interview on 7/20/2023 at 10:00 AM, the Technical Consultant confirmed the above findings and stated, "I skipped her semi-annual". 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 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 the CMS (Centers for Medicare and Medicaid Services) CASPER reports and a review of the API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in Hematology testing for the Platelet Count for two consecutive testing events, Event #1 and #2, 2021, resulting in an initial unsuccessful proficiency testing failure for the laboratory. The findings include: 1. A review of the CMS CASPER reports revealed the laboratory scored 60 % (percent) for Platelets for Events #1 and 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 -- #2, 2021, resulting in an initial unsuccessful proficiency testing failure for the laboratory. 2. A review of the API proficiency testing evaluations confirmed the above noted findings. 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 the CMS (Centers for Medicare and Medicaid Services) CASPER reports and a review of the API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in Platelet Count testing (Hematology) for two consecutive testing events, Event #1 and #2, 2021, resulting in an initial unsuccessful proficiency testing failure for the laboratory. The findings include: 1. A review of the CMS CASPER reports revealed the laboratory scored 60 % (percent) for Platelets for Events #1 and #2, 2021, resulting in an initial unsuccessful proficiency testing failure for the laboratory. 2. A review of the API proficiency testing evaluations confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of API (American Proficiency Institute) proficiency testing records and an interview with the Laboratory Directory (LD), who also serves as the Technical Consultant, the surveyor determined the laboratory failed to ensure the testing personnel and LD signed the attestation statement for Hematology, Event #2, 2018. This affected one of six proficiency testing events (2017-2018), reviewed by the surveyor. The findings include: 1. A review of the proficiency testing records for 2017 and 2018 revealed the LD nor the testing personnel signed the attestation statement for the Hematology testing, Event #2, 2018. 2. In an interview on 2/12/2019 at 1:45 PM, the surveyor discussed the above noted findings with the Laboratory Director. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing records for 2017 - 2018, and an interview with the Laboratory Director (also serving as the Technical Consultant), the surveyor determined the laboratory failed to implement and document