Anniston Care Plus Llc

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on reviews of the validation records for the Medonic M Series (SN48442) Hematology analyzer, patient logs and an interview with the Laboratory Supervisor, the surveyor determined the Laboratory Director failed to document approval of the validation as verification of the manufacturer's performance specifications before patient testing began. The Medonic was used for eight days of patient CBC (Complete Blood Count) testing before the verification data was reviewed/approved by the Laboratory Director. The findings include: 1. A review of the Hematology records revealed validation procedures on the new Medonic M Series were performed on 8/4 /2020, and testing personnel began using the new Medonic for patient testing on 8/5 /2020. However, the Laboratory Director did not review and approve the verification procedures until 8/13/2020. 2. A review of the patient data logs for the Medonic Hematology analyzer revealed 76 patient CBC's were performed from 8/5/2020 through 8/12/2020. 3. During an interview on 3/2/2022 at 4:00 PM, the Laboratory Supervisor confirmed the above noted findings. SURVEYOR ID#32558 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 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the test menu with the staff, a review of the API (American Proficiency Institute) proficiency testing records, and an interview the Laboratory Manager and the Laboratory Supervisor, the surveyor determined the laboratory failed to review and evaluate results for the second miscellaneous Chemistry event of 2018, due to the failure to obtain the results from the proficiency testing provider. This affected one of twenty testing events reviewed by the surveyor. The findings include: 1. During the initial tour of the laboratory on November 13, 2019 at approximately 10: 00 AM, the Laboratory Supervisor stated urine micro-albumin and creatinine were performed on the DCA Vantage and confirmed the tests were moderate-complexity. 2. A review of the API proficiency testing records revealed records for only one event (Chemistry Miscellaneous, #1 2018) for urine creatinine and micro-albumin had been retained by the laboratory. 3. At 12:23 PM on November 13, 2019, the surveyor inquired of the Laboratory Supervisor if the laboratory had particpated in more events for the above mentioned analytes, in 2018. The supervisor reviewed the records and confirmed only the first event was retained; and there was no documentation of the second event of 2018 in the proficiency testing manual. At 12:27 PM, the Laboratory Manager printed the results of the miscellaneous Chemistry Event #2 for creatinine and micro-albumin. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 a review of the API (American Proficiency Institute) proficiency testing records for 2018 -2019, and an interview with the Laboratory Manager and the Laboratory Supervisor, the surveyor determined the laboratory staff failed to document and implement