Utica Park Clinic Elliott

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/14/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. 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 review of records, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for performing calibrations for one of one Medonic analyzer. Findings include: (1) On 05 /14/2025 at 10:00 am, the laboratory director stated the laboratory performed CBC (Complete Blood Count) testing on the Medonic M series analyzer; (2) A review of the M series procedure manual, page seven titled, "Calibration" stated calibration should occur at a minimum of every six months; (3) A review of records from October 2023 through the current date identified no documentation to prove 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 -- analyzer had been calibrated between 10/06/2023 and 08/09/2024; (4) Interview with the laboratory director on 05/14/2025 at 10:00 am confirmed there were no records to prove the analyzer had been calibrated as required by the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/06/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director 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, manufacturer's instructions, and interview with the laboratory director, the laboratory failed to follow the manufacturer's storage instructions for one of one case of Sophia 2 SARS Antigen test kits. Findings include: (1) On 06/06/2023 at 10:53 am, the laboratory director stated SARS Antigen testing was performed using the Sophia 2 SARS Antigen test kits; (2) On 06/06/2023 at 12: 56 pm, observation of the storage closet located outside of the laboratory identified one case containing 12 Sophia 2 SARS Antigen test kits, lot #707122. The manufacturer's storage requirement, as stated on the box was 15-35 degrees C (Centigrade); (3) Interview with the laboratory director on 06/06/2023 at 01:05 pm confirmed the temperature of the storage room was not being monitored. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 laboratory director, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director for one of five events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first 2023 Hematology proficiency testing records identified the following for one of five events: (a) Third 2021 Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory director who stated on 06/06/2023 at 02:00 pm, the attestation statement had not been signed by the laboratory director. 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 review of records and interview with the laboratory director, the laboratory failed to take

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/12/2021. 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. 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 and interview with the technical consultant, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 3 of 3 patient specimens. Findings include: (1) On 07/12/2021 at 10:30 am, the technical consultant stated the following to surveyor #2: (a) The laboratory performed COVID-19 Testing using the following instrument: (i) Sofia 2 Flu + SARS Antigen FIA (Fluorescent Immunoassay) - qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2 from direct nasal swabs. (2) Surveyor #2 reviewed the manufacturer's product insert titled, "Sofia 2 Flu + SARS Antigen FIA". Under the section titled, "USING SOFIA 2" the manufacturer stated, "Warning: Results must not be interpreted past 30 minutes after inoculation. Using the Sofia 2 past this time may result in false results"; (3) Surveyor #2 reviewed 3 test reports for patients tested between 06/24/2021 and 07/07/2021 and identified the following: (a) Patient Report #1 -Specimen collection date and time (06/24/2021 at 11: 41 am) was the same as the result date and time (06/24/2021 at 11:41 am); (b) Patient Report #2 - Specimen collection date and time (06/24/2021 at 03:16 pm) was the same as the result date and time (06/24/2021 at 03:16 pm); (c) Patient Report #3 - Specimen collection date and time (07/07/2021 at 11:46 am) was the same as the result date and time (07/07/2021 at 11:46 am). (4) Surveyor #2 was not able to 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 -- determine if the results had been interpreted within the 30 minutes after inoculation since the specimen collection date and time was the same as the result date and time; (5) Surveyor #2 reviewed the records with the technical consultant. The technical consultant stated on 07/12/2021 at 12:50 pm the laboratory could not prove the results had been interpreted within 30 minutes after inoculation as indicated above. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results for 1 of 18 events. Findings include: (1) On 07/12/2021, surveyor #2 reviewed 2019, 2020, and 2021 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Hematology (i) 2020 Third Event - Urine Sediment sample US-06 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded result; (3) Surveyor #2 asked the technical consultant if the result had been documented as evaluated. The technical consultant reviewed the records and stated on 07/12/2021 at 12:45 pm the non-graded result had not been documented as reviewed. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (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 (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (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 review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to perform calibration procedures as required by the manufacturer. Findings include: (1) On 07/12/2021 at 10:25 am, the technical consultant stated to surveyor #2 CBC (Complete Blood Count) testing was performed using the Medonic M-Series analyzer; (2) Surveyor #2 reviewed the manufacturer's instructions, contained in the "Medonic M-Series Users Manual" for performing calibration procedures. The section on page 59 titled, "Section 7: Calibration" stated, "This section describes the step-by-step procedure for calibration -- 2 of 3 -- of the Medonic M-Series. The instrument has been calibrated by Boule prior to shipment. Good laboratory practice, however, requires regular checks and calibration of the measured parameters. It is recommended to calibrate the instrument every 6 months"; (3) Surveyor #2 reviewed records from 10/25/2019 through 04/29/2021. There was no evidence the calibration procedure had been performed between 10/25 /2019 and 10/12/2020; (4) Surveyor #2 reviewed the findings with the technical consultant who stated on 07/12/2021 at 12:50 pm, the calibration procedure had not been performed as indicated above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with the technical consultant, the laboratory failed to provide normal reference intervals for 1 of 1 urine sediment examination test reports. Findings include: (1) On 07/23/2021 at 10:25 am, the technical consultant stated to surveyor #2 Urine Sediment examinations were performed; (2) Surveyor #2 reviewed one Urine Sediment examination report for a patient tested on 05/03/2021 at 03:11 pm. The report did not include a normal reference range for the urine sediment examination; (3) Surveyor #2 reviewed the report with the technical consultant, who stated on 07/12/2021 at 12:52 pm Urine Sediment examination reports did not include a normal reference range as indicated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/02/2019. 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. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy and interview with the technical consultant, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities; (2) The surveyor asked the technical consultant if a written policy to evaluate the technical consultant based on job responsibilities was available. The technical consultant stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Third 2017 Hematology Event (i) Hematocrit - 3 of 5 results exhibited a positive bias (aa) HSY-11 - SDI of 2.2 (bb) HSY-13 - SDI of 2.0 (cc) HSY-15 - SDI of 3.1 (b) First 2018 Hematology Event (i) MCV (Mean Corpuscular Volume) - 5 of 5 results exhibited a positive bias (aa) HSY-01 - SDI of 3.0 (bb) HSY- 02 - SDI of 2.8 (cc) HSY-03 - SDI of 3.0 (dd) HSY-04 - SDI of 3.0 (ee) HSY-04 - SDI of 2.9 (c) Second 2018 Hematology Event (i) MCV (Mean Corpuscular Volume) - 4 of 5 results exhibited a positive bias (aa) HSY-06 - SDI of 2.5 (bb) HSY-07 - SDI of 2.1 (cc) HSY-08 - SDI of 2.3 (dd) HSY-09 - SDI of 2.3 (d) Third 2018 Hematology Event (i) MCHC (Mean Corpuscular Hemoglobin Concentration) - 3 of 5 results exhibited a negative bias (aa) HSY-11 - SDI of - 2.5 (bb) HSY-12 - SDI of - 2.4 (cc) HSY-15 - SDI of - 2.7 (ii) MCV (Mean Corpuscular Volume) - 5 of 5 results exhibited a positive bias (aa) HSY-11 - SDI of 2.1 (bb) HSY-12 - SDI of 2.1 (cc) HSY-13 - SDI of 2.1 (dd) HSY-14 - SDI of 2.1 (ee) HSY-15 - SDI of 2.1 (e) First 2019 Hematology Event (i) Monocytes - 3 of 5 results exhibited a positive bias (aa) HSY-01 - SDI of 2.0 (bb) HSY-02 - SDI of 2.2 (cc) HSY-04 - SDI of 2.5 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the technical consultant, and asked if the biases had been addressed. The technical consultant stated the biases had not been addressed. 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. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor: (a) CBC testing was performed on the Medonic M-Series analyzer; (b) The laboratory tested 3 levels (Low, Normal, High) of Boule Con-Diff Quality Control (QC) materials each day of patient testing. (2) Later during the survey, the surveyor reviewed the written procedure titled, "CBC NEW LOT VERIFICATION" which stated, (a) "3. New lot will be run along side of current lot until 2 to 10 runs of each Low, Normal and High control has been ran." (3) The surveyor reviewed records for 9 control lot numbers. There was no evidence the provided ranges were verified before the lot numbers were put into use for 3 of 9 lot numbers as follows: (a) Low control (lot #21902-21), normal control (lot #21902-22), and high control (lot #21902-23) put into use on 03/26/19. (3) The findings were discussed with the technical consultant who stated the manufacturer's ranges had not been verified before the above lot numbers had been put into use. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 3 -- CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 ensure an analyzer was stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed on the Medonic M-Series analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be maintained within the range of 20- 80% (3) The surveyor reviewed laboratory humidity records from November 2017 through May 2018 and identified the following for 6 of 7 months as follows: (a) November 2017 - 4 of 25 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 1,21,23,27); (b) December 2017 - 17 of 25 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 6,7,8,9,11,12,13,14,15,16,18,23,26,27,28,29,30); (c) January 2018 - 21 of 26 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 3,4,5,6,8,9,10,11,12,13,15,16,17,18,19,23,24,25,26,27,29,30 ); (d) February 2018 - 16 of 24 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 1,2,3,5,6,7,8,9,10,11,12,13,14,17,21,22,26); (e) March 2018 - 12 of 26 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 6,7,8,9,12,13,14,15,20,21,22,24); (f) April 2018 - 13 of 26 humidity readings were documented as "LO" and the surveyor was unable to determine actual humidity (days 1,4,5,6,7,9,10,11,16,17,19,20,21). (4) The surveyor reviewed the records with the technical consultant who stated the laboratory had not documented the actual humidity results as indicated above. Therefore, the surveyor could not determine the humidity had been maintained according to manufacturer's instructions. -- 3 of 3 --