Cedar Creek Pediatric & Adolescent Medicine Pc

Summary Statement of Deficiencies 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 observation of the laboratory, review of the Medonic operator's manual, Medonic calibration records, and staff interviews, the laboratory failed to ensure calibration for the Medonic Complete Blood Count (CBC) instrument every six months as recommended by the manufacturer in 2024. The findings include: 1. An observation of the laboratory on 05.05.2025 at 8:35 a.m. revealed a Medonic CBC instrument, serial #19194, used for patient testing. 2. Review of the Medonic operator's manual revealed the following statement: "Calibrate instrument every 6 months based on manufacturer's recommendations and in accordance with local regulations." 3. A review of the Medonic calibration records revealed no calibration record for August 2024. 4. An interview with the Nurse Manager on 05.05.2025 at 12: 30 p.m. and a follow-up electronic message on 05.13.2025 at 2 p.m. confirmed the above survey findings. D6063 LABORATORY TESTING PERSONNEL 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 -- CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of patient test reports, personnel qualifications, and staff interview, testing person number two (TP2) did not meet the regulatory education requirements for moderately complex testing personnel (Refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS-209), lack of documentation, and staff interview, testing personnel number two (TP2) did not qualify to perform moderately complex patient testing due to a lack of documentation of the highest level of education (one of three new testing personnel since the last survey). The findings include: 1. A review of the CMS-209 form revealed TP2 listed as performing moderately complex patient testing. 2. A review of testing personnel records revealed no documentation of the highest level of education for TP2. 3. An interview with the Lab Liaison on 05.05.2025 at 12: 30 p.m., and a follow-up electronic message on 5.06.2025 at 1:51 p.m. confirmed the above survey 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 review of Proficiency Testing (PT) reports for 2020 and 2021, attestation sheets which lacked testing personnel and director signatures and upon interview with the lead testing person, determined the testing personnel and laboratory director failed to sign attestation sheets. The findings include: 1. Review of PT reports for 2020 and 2021. 2. Review of attestation sheets revealed lack of testing personnel and lab director signature for third event 2020 and first, second, and third events 2021. 3. Interview at approximately 12: 30 p.m. February 14, 2022 with the lead testing person confirmed the PT attestation sheets for 2020 and 2021 lacked testing personnel and director signatures as stated. =================================== D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ==================================== Based on review of Complete Blood Count (CBC) Quality Control (QC) records for November 10, 2020, CBC QC 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 -- not tested until after patient CBC testing and upon interview with the lead testing person, determined the laboratory failed to ensure CBC QC was acceptable before reporting six patient CBC results on 11.10.2020. The findings include: 1. Review of Hematology Complete Blood Count (CBC) quality control records for November 10, 2020. 2. CBC quality control documented at 7:25 p.m. with six patient CBC's documented between 12:19 p.m. and 6:24 p.m. on 11/10/2020. 3. Interview with the lead testing person at approximately 12:30 p.m. on February 14, 2022 confirmed that CBC quality control was not ran prior to six patient CBC's tested and reported on 11 /10/2020. ===================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (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. This STANDARD is not met as evidenced by: =================================== Based on review of employee personnel records for 2020 and 2021 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for Testing Personnel (TP) one and two out of five. The findings include: 1) Review of employee personnel records for 2020 and 2021 did not reveal documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills. 2) An interview with the lead testing person on February 14, 2022 at approximately 12:30 p.m. confirmed TP one and two of five TP evaluated during 2020 and 2021 were not evaluated using the six criteria for competency required by Centers for Medicare and Medicaid (CMS). =================================== -- 2 of 2 --

Summary Statement of Deficiencies 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 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)