Pediatric Associates Of Mobile

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a lack of Calibration-Verification (C-V) records for the Reichert Unistat Bilirubinometer analyzer and an interview with the Technical Consultant (TC) /Testing Personnel 1 (TP1), the laboratory failed to perform C-V procedures at least every six months as per manufacturer's requirement. The surveyor noted no documentation of two of the two possible C-Vs due after the Bilirubin testing was started on 04-16-2025. The findings include: 1. A review of the C-V records for the Reichert Unistat Bilirubinometer analyzer revealed no documentation the C-V performance when it was due October 2025 and April 2026 after the Bilirubin testing was started on 04-16-2025. 2. A review of the Reichert Unistat Bilirubinometer 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 -- manual revealed the following manufacturer's requirement on page 12, Section 6.0 Calibration, 6.1 Calibration Frequency, "The Reichert Unistat Bilirubinometer requires calibration...at least at six-month intervals, ..." 3. TC/TP1 confirmed the above findings during the exit conferenec on 08-05-2026 at 1:23 PM. 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 reviews of the personnel records and interview with the Technical Consultant (TC)/Testing Personnel 1 (TP1), 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 six of the six requirements were missing from the annual competencies completed in 2025- 2026. The findings include: 1. A review of the 2025-2026 personnel records for TP listed on the CMS-209 (Laboratory Personnel Report) revealed competency assessments for the Hematology and Chemistry specialties had no documentation of the six CLIA minimal regulatory requirements, as follows: (1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. (2) Monitoring the recording and reporting of test results. (3) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (4) Direct observation of performance of instrument maintenance and function checks. (5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (6) Assessment of problem-solving skills. 2. TC/TP1 confirmed the above findings during the exit conference on 08-05- 2026 at 1:23 PM. -- 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 API (American Proficiency Institute) Proficiency Testing (PT) records, and an interview with the Technical Consultant (TC) who is also the Testing Personnel (TP), the laboratory failed to ensure proficiency testing samples were rotated among all personnel who performed moderate complexity patient testing. This was noted on four out of seven Hematology events reviewed from 2022 to 2024. The findings include: 1. A review of API attestation statements revealed TP had performed the following Hematology PT events: a) 2023 Hematology 1st Event b) 2023 Hematology 2nd Event c) 2023 Hematology 3rd Event d) 2024 Hematology 1st Event 2. During an interview on 11-21-2024 at 1252 PM, TC confirmed the above findings. 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 Consultatnt (TC), the Testing 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 -- Personnel (TP) and the Laboratory Director (LD) (or Designee) failed to sign the PT attestation statements for the specialty in Hematology. This was noted in two of the seven events reviewed from 2022 to 2024. The findings include: 1. A review of the API PT records revealed no signature by the TP or LD on attestation statements for the following surveys: a) 2022 Hematology 3rd Event was missing TP signature. b) 2024 Hematology 2nd Event was missing LD and TP signatures. 2. During an interview on 11-21-2024 at 12:52 PM, the TC confirmed the above findings. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the Policies and Procedures and an interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to establish and maintain a Quality Assurance Program (QAP) to assure the quality of laboratory services provided. This was noted from the implementation of the Policy and Procedure Manual on 7-11-2022, to the date of the current survey, 11-21-2024. The findings include: 1. A review of Policies and Procedures revealed no evidence of a QAP established and maintained for the laboratory patient testing services from 2022 to 2024. 2. During an interview on 11-21-2024 at 12:52 PM, the TC confirmed the above findings. 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 the personnel records and an interview with Technical Consultant (TC), the TC failed to evaluate semi-annual competencies for Testing Personnel (TP) performing moderate complexity testing from 2022 to 2024. This was noted for four out of four testing personnel listed on the CMS-209 (Laboratory Personnel Report) submitted on the current survey date of 11-21-2024. The findings include: 1. A review of the personnel records revealed no evidence of evaluation by the Technical Consultant for the semi-annual competencies for four of the four TP listed on the current CMS-209 (Laboratory Personnel Report). 2.During an interview on 11-21-2024, at 10:30 AM, TC confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the -- 2 of 3 -- performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with Technical Consultant (TC), the TC failed to evaluate annual competencies for Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) and performing moderate complexity testing. The surveyor noted four out of four TP previously qualified since the date of the last survey, 6-9-2022 to the date of the current survey, 11-21-2024. The findings include: 1. A review of the personnel records revealed no evidence of evaluation by the Technical Consultant for annual competency assessments for four out of four TP listed on the CMS-209 (Laboratory Personnel Report). 2. During an interview on 11-21-2024, at 10:30 AM, TC confirmed the above findings. -- 3 of 3 --