Liberty Mountain Pediatrics

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 Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to ensure the Laboratory Director (or designee) signed the PT attestation statements. This was noted for two of the six events reviewed from the date of the last survey, 12-22-2023 through the date of the current survey, 01-08- 2025. The findings include: 1. A review of the 2023-2024 API PT Hematology records revealed the Laboratory Director (or designee) did not sign the attestation statements for the following PT events: a) 2023 Hematology/Coagulation-2nd Event b) 2024 Hematology/Coagulation-2nd Event 2. The PM and TP1 confirmed the above findings during the exit conference on 01-08-2025 at 1:46 PM. 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 American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to document the PT evaluation review for one of the six 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 -- events reviewed from 2023-2024. The findings include: 1. A review of the API PT records revealed no documentation of the PT performace review from the Laboratory Director, or designee, for the 2024 Hematology/Coagulation-3rd Event. 2. The PM and TP1 confirmed the above findings during the exit conference on 01-08-2025 at 1: 46 PM. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a lack of Hematology calibration records, the Horiba Hematology User Manual, and an interview with Practice Manager (PM) and Testing Personnel 1 (TP1), the laboratory failed to ensure the Hematology analyzer was calibrated per the manufacturer's instructions. No calibration documentation was available for review from the date of the last survey, 12-22-2022, through the date of the current survey, 01-08-2025. The findings include: 1. A review of Hematology calibration records revealed Horiba Micros 60X had no calibration performed and documented from 2022 -2025. 2. A review of the Horiba ABX Micros 60 Hematology Analyzer User Manual, under the Quality Assurance, 2.1 General Recommendations for Calibration revealed, "The calibration on Horiba Medical instruments is an exceptional procedure, which must be carried out particularly in case of certain technical interventions ..." 3. 2. The PM and TP1 confirmed the above findings during the exit conference on 01-08-2025 at 1:46 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 a review of the personnel records and an interview with the Practice Manager (PM) and Testing Personnel 1 (TP1), the Technical Consultant (TC) failed to ensure three of the three Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) had competency assessments which included the six minimal regulatory requirements. The surveyor noted six of the six requirements were missing from the annual and semi-annual competencies. The findings include: 1. A review of -- 2 of 3 -- the 2023-2024 personnel records revealed the TP competency assessment for Hematology specialty had no documentation of six of the six minimal regulatory requirements. The surveyor noted the six missing requirements are 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. The PM and TP1 confirmed the above findings during the exit conference on 01-08-2025 at 1:46 PM. -- 3 of 3 --

Summary Statement of Deficiencies D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel # 1, the Technical Consultant failed to evaluate and document the performance of individuals at least annually after the first year of performing Complete Blood Count (CBC). This was noted on three of four employees for 2019 and 2020. The findings include: 1. A review of personnel evaluation records revealed the annual performance was not evaluated or documented for Testing Personnel #1, #2, and #3 for 2019 and 2020. Testing Personnel #1's semiannual evaluation was performed on 06/24/2019, Testing Personnel #2's semiannual evaluation was performed on 05/22/2019, and Testing Personnel #3's semiannual evaluation was performed on 06/24/2019. For Testing Personnel #1, #2, and #3, after semiannual evaluations, no annual evaluations were performed until 03/24/2021 (Testing Personnel #2) and 03/26/2021 (Testing Personnel #1 and #3). 2. During an interview on 04/14/2021 at 09:30 AM, Testing Personnel #1 confirmed annual evaluations for Testing Personnel #1, #2 and #3 were not evaluated or documented for Complete Blood Count (CBC) for 2019 and 2020. 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 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the policies and procedures and an interview with Testing Personnel #1, the surveyor determined the Laboratory Director failed to sign her review and approval of the Horiba ABX Micros 60 Hematology Analyzer Daily Guide in use by the testing personnel for the performance of CBC's (Complete Blood Counts) before patient testing began on 11/1/2018. The findings include: 1. A review of the laboratory policy and procedure manual in "Section 2-CBC" revealed the statement, "See Horiba Hematology Analyzer Daily Guide". 2. A review of the Horiba ABX Micros 60 Hematology Daily Guide revealed no evidence (as indicated by a signature and date) of the Laboratory Director's review and approval of the procedures used by the testing personnel. A review of Hematology records revealed patient CBC testing began on 11/1/2018. 3. During an interview on 2/14/2019 at 11: 10 AM, Testing Personnel #1 reviewed the manuals with the surveyor, and confirmed the above noted findings. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic 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 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)