Utica Park Clinic Locust Grove

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/10/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, observation of the laboratory, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for expiration dates of mononucleosis testing kits. Findings include: (1) On 07/10/2024 at 1:45 pm an observation of the laboratory revealed the following expired materials which appeared to be available for use: (a) Three Clarity mononucleosis tests, lot #222D11A, with a manufacturer's expiration date of 12/2023. (2) The findings were reviewed with the technical consultant, who stated on 07/10/2024 at 1:45 pm the test kits had expired and were available for use. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency 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 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure proficiency testing attestation records had been signed by the laboratory director for one of five events reviewed. Findings include: (1) On 7/10 /2024 at 1:50 pm, a review of 2023 and 2024 proficiency testing records identified the following for one of five events: (a) 2023 Hematology - Second Event (i) The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the technical consultant, who stated on 07/10/2024 at 1:50 pm, the attestation statement had not been signed by the laboratory director. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure patient test reports included the facility name, as stated on the CLIA certificate for one of one report reviewed. Findings include: (1) On 07/10 /2024 at 2:00 pm, the technical consultant stated CBC testing was performed using the Medonic M-Series analyzer; (2) A review of a patient report identified the facility name, as stated on the CLIA certificate, was not included on the report: (a) Patient CBC testing resulted on 07/03/2024 (3) The findings were reviewed with the technical consultant , who stated on 07/10/2024 at 2:00 pm, the laboratory name had not been included on the patient test reports. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the -- 2 of 3 -- laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for one of five proficiency testing events reviewed in 2023 and 2024. Findings include: (1) A review of 2023 and 2024 proficiency testing events identified attestation statements had been signed up to three months after the samples had been tested for one of five events reviewed: (a) First Hematology Event 2024 - The sample testing had been completed on 03/15/2024 and the attestation statement had not been signed by the laboratory director until 07/8/2024. (2) The records were reviewed with the laboratory director who stated on 7/10/2024 at 02:00 pm the attestation statements had not been signed timely as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory 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 -- failed to achieve satisfactory performance for two of three testing events for Cell Identification/White Blood Cell differential for %Neutrophils/Granulocytes. Refer to D2128 and D2130. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing Comparative Evaluation obtained from American Proficiency Institute, the laboratory failed to achieve successful performance for Cell Identification/White Blood Cell Differential for %Neutrophils/Granulocytes. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event in 2020 and the first event in 2021. Refer to D2130. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/13/2020. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the testing person failed to sign a proficiency testing attestation statement for 2 of 6 events. Findings include: (1) The surveyor reviewed 2019 and 2020 proficiency testing records and identified the following for 2 of 6 events: (a) First 2020 Hematology /Coagulation Event - The attestation statement had not been signed by the testing person performing the test; (b) Second 2020 Hematology/Coagulation Event - The attestation statement had not been signed by the testing person performing the test. (2) The surveyor reviewed the findings with the technical consultant, who stated to the surveyor on 10/13/2020 at 10:30 am, the attestation statements had not been signed by the person performing the test. 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 -- 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 policy and procedure manual and interview with the technical consultant, the laboratory failed to follow written procedures for CBC (Complete Blood Count) testing for 2 of 3 patient reports. Findings include: (1) On 10 /13/2020 at 10:00 am, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed on the Medonic analyzer; (2) The surveyor reviewed the written procedures titled, "Medonic Flagged Results Policy", which stated, (a) "WBC Differential results may be flagged BD, NM, OM, and TM If the patient sample is flagged the sample is held for 5-10 minutes and the test repeated. If the flags have been removed or are still present in the same location the results are reported. At the physician's discretion the sample may be referred for further testing." (b) "If the sample volume is not sufficient for repeat analysis, another sample can be drawn OR the flagged result may not be reported in LabDaq and, if paper printouts are reviewed by the provider, the flagged results must be blacked out completely." (3) The surveyor reviewed 3 patient reports that had been tested between January 2020 through August 2020. For 2 of 3 patient reports there was no indication the laboratory staff followed their written procedure as follows: (a) Patient tested 07/24/2020 at 09: 19 am - No evidence the provider reviewed the OM flag; (b) Patient tested 08/12/2020 at 11:01 am - No evidence the provider reviewed the OM flag. (3) The surveyor reviewed the findings with the technical consultant who stated on 10/13/2020 at 02:45 pm that the procedure had not been followed as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) On 10/13/2020 at 10:00 am, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed on the Medonic analyzer; (2) The surveyor reviewed the manufacturer's monthly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log which were: (a) Clean the aspiration probes using an alcohol wipe; (b) Fill a cup with 10 ml 2% hypochlorite (Bottle #2 from Boule Cleaning Kit) and one cup with 18 ml diluent. Aspirate the hypochlorite as a pre-dilute sample; (c) Run 2 blank samples by aspirating diluent as a pre-diluted sample; (d) Perform a background check, in pre-dilute mode, to verify all values are within range. (3) Maintenance records were reviewed by the surveyor for 12 months (January 2020 through December 2020). The monthly maintenance had not been documented as -- 2 of 3 -- performed between: (a) 08/10/2020 and 10/30/2020 (4) The surveyor reviewed the records with the technical consultant, who stated on 10/13/2020 at 10:30 am, there was no evidence the above maintenance had been performed as required. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found to be in compliance with standard-level deficiencies cited. 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 records and interview the technical consultant, the technical consultant failed to ensure that persons performing moderate complexity testing had been evaluated semiannually during the first year of testing. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records. The following was identified: (a) Testing Person #3 - The initial training for this person was completed on 09/27/17. There was no evidence that a semiannual evaluation had been performed (due 03/2017); (b) Testing Person #4 - The initial training for this person was completed on 10/25/17. There was no evidence that a semiannual evaluation had been performed (due 04/2017). (2) The surveyor reviewed the records with the technical consultant, who stated there were no records to prove the above persons had been evaluated semiannually. 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 --