Auburn Pediatric And Adult Medicine

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Abbott Cell Dyn Emerald maintenance logs, the Abbott Cell Dyn Emerald Operator's Manual and interviews with the Technical Consultant (TC), Testing Personnel 21 (TP21) and Testing Personnel 22 (TP22), the laboratory failed to ensure weekly maintenance was performed and documented for two of the five months reviewed from 2023 - 2025. The findings include: 1. A review of the Abbott Cell Dyn Emerald analyzer maintenance logs revealed no weekly maintenance documentation for December 2023 and March 2024. 2. A review of the Abbott Cell Dyn Emerald Operator's Manual revealed the manufacturer's requirements in the Preventive Maintenance Schedule, Page 9-11, "...Weekly Maintenance: Bleach or Bleach + Cleaning." 3. During the exit conference with the TC, TP21 and TP22 on 06- 11-2025 at 3:05 PM, the TC confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of the personnel records and interviews with the Technical 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 -- Consultant (TC), Testing Personnel 21 (TP21) and Testing Personnel 22 (TP22), the TC failed to ensure Testing Personnel (TP) performing moderate complexity testing had competency assessments which included all six CLIA minimal regulatory requirements. The surveyor noted one of the six requirements was missing on the semi-annual and annual competencies. The findings include: 1. A review of the 2023- 2025 personnel records for TP listed on the CMS-209 (Laboratory Personnel Report) revealed competency assessments for the Hematology specialty had no documentation on one of the six CLIA minimal regulatory requirements, as follows: (1) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. 2. The TC, TP21 and TP22 confirmed the above findings during the exit conference on 06-11-2025 at 3:05 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the Technical Consultant (TC), the Testing Personnel 21 (TP21) and Testing Personnel 22 (TP22), the TC failed to assess and document the annual competency for one of 24 Testing Personnel (TP) responsible for moderate complexity testing from the date of the last survey, 06-23-2023 to the date of the current survey, 06-11-2025. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) revealed the TC failed to perform and document the annual competency assessment for TP1 from 2023-2025. 2. During the exit conference on 06-11-2025 at 3:05 PM, the TC, TP21 and TP22 confirmed the above 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 the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to ensure the Laboratory Director signed the attestation statements for two of five events in 2021 and 2022. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2021 Hematology 3rd Event. b) 2022 Hematology 2nd Event. 2. During an interview on June 6, 2023, at 11:10 AM, the Technical Consultant confirmed the above findings. 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 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 a review of the installation and validation records for the Emerald Cell-Dyn and an interview with the technical consultant, the surveyor determined the laboratory director failed to review and approve of the validation studies and use of the instrument in the laboratory, prior to beginning patient testing, as evidenced by lack of signature. The laboratory director has a responsibility to review and approve of policies, procedures and validation studies, prior to instruments being used in the laboratory. This affected one of one instrument installed to perform non-waived testing. The findings include: 1. During the tour of the laboratory on May 25, 2021 at 9:15 AM, the technical consultant stated the Emerald Cell-Dyn was used to perform Complete Blood Count (CBC) testing. At 9:47 AM, the technical consultant stated the testing began in October of 2020. 2. The surveyor noted the laboratory director had not signed the installation and validation records for the Emerald, upon review of the carryover, precision, calibration report, quality control testing post-calibration, reportable range study (dated 10/21/2020) and method comparison. The surveyor noted the technical consultant signed (dated 2/21/2021) the first page of the method comparison. 3. On May 25, 2021 at 10:30 AM, the technical consultant reviewed the manual with the validation studies, and confirmed she had signed the first page of the method comparison, not until 2/21/2021 (testing began in October, 2020). 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 2 -- technical consultant stated the signature was representative of her review/approval of the entire validation study. The surveyor asked if the laboratory director had reviewed the validation studies and given approval for use. The technical consultant stated she did not believe the laboratory director had reviewed the validation, and added she believed the laboratory director took the staff's word that it was done. Further, the technical consultant reviewed the manual, and stated she did not see where the laboratory director had signed. -- 2 of 2 --