Bmg Family Physicians Group Foundation, Inc

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedures, lack of records, patient test reports, and staff interviews, the laboratory failed to retain all quality control (QC) records for three of nine QC lot numbers reviewed for the Sysmex XS-1000i instruments used to perform complete blood count with automated differential (CBC w/Diff) patient testing in 2024. The findings include: 1. Observation on 04/24/2025 at 10:00 am revealed the primary Sysmex XS-1000i (Serial 74901) instrument in the laboratory and a second Sysmex XS-1000i (Serial 74900) instrument in the nurse laboratory. The laboratory used both instruments for CBC w/Diff patient testing. 2. A review of the laboratory procedure titled "Sysmex XS-1000i Quality Control" in the section "Submission of QC Data" revealed that the laboratory director reviewed instrument printouts used to establish QC ranges and Levy Jennings reports for each QC lot number and Sysmex XS-1000i instrument. 3. A review of the laboratory's QC records for the Sysmex XS-1000i instruments (Serial 74901 and 74900) revealed that the instrument printouts used to establish QC ranges and Levy Jennings reports were not available for QC lot numbers 41760804, 41760805, and 41760805 used from 07/08/2024 through 09/13/2024 on the date of the survey (04/24 /2025). 4. A review of final patient test reports revealed that the laboratory reported CBC w/Diff results for patient 174252522 (Serial 74901) at 8:32 am and patient 174271457 (Serial 74900) at 4:26 pm on 07/24/2024. 5. An interview with the laboratory liaison on 04/24/2025 at 2:30 pm confirmed the survey findings. 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 review of the laboratory's procedure manual, review of patient complete blood count (CBC) results and lack of documentation, and staff interview, the laboratory failed to follow its' own policy for protocol to follow when CBC results were flagged by the instrument for three of three patients with flagged CBC results reviewed from 01/29/24 from the nursing triage instrument (serial # 74900). The findings include: 1. Review of the laboratory procedure titled "Sysmex XS-Series Automated Hematology Analyzer" "Flagging Interpretation Guide" approved by the laboratory director on 10/10/23 revealed the following: WBC and differential results that are flagged with (*) should be allowed to sit for five minutes and then repeated. "If flags do not clear, specimen should be forwarded to reference lab." "Delta Check" "Means there is significant difference between this result and a previous result. Recollect. Allow to sit for 5 minutes. If Delta check does not clear, show the ordering provider before finalization." "Suspect PLT Clumps?" " Recollect sample if capillary sample. If flags do not clear, collect and run venous sample. 2. Review of patient CBC instrument printouts and final patient results from the nurse triage area revealed flagged patient results that were reported without following laboratory protocol as follows: Date 01/29/2024: CBC results for patient ID 1C11786870 with an action message of "Delta Check Failure. Check Sample." CBC results for patient ID 1C11692956 with WBC (White Blood Cell), WBC differential, platelet, and mean platelet volume (MPV) results that were flagged with (*) and a Platelet Message of "PLT Clumps?." Also noted was an action message of "Delta Check Failure. Check 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 -- Sample." CBC results for patient ID 1C11620261 with an Action Message of "Delta Check Failure. Check Sample." There was no evidence that the samples were repeated, recollected, or sent to a reference laboratory before reporting. 4. During an interview on 02/20/24 at 2:00 pm, the laboratory liaison confirmed that three of three patients with flags that were performed and reported on 01/29/24 were not handled according to the laboratory's written protocol. 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)

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 the laboratory's proficiency testing (PT) records and interview with the laboratory liaison, the laboratory director and testing personnel failed to sign five of six PT attestation statements in 2020, 2021, and 2022. The finding include: 1. Review of the laboratory's proficiency testing records revealed the following: Events not signed by testing personnel = 2020 Event B, 2021 Event B, 2021 Event C Events not signed by lab director = 2021 Event A, 2021 Event B, 2021 Event C, 2022 Event A 2. Interview with laboratory liaison on 07.07.2022 at 3:30 pm confirmed that four of six PT events were not signed by the lab director and three of six PT events were not signed by testing personnel. Five of six PT events reviewed for 2020, 2021 and 2022 were not signed by either the testing personnel and/or the laboratory director. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to have a written procedure for use of the Sysmex XS-1000i complete blood count instrument (Refer to D5401), failed to perform twice a year Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- comparison between its' two complete blood instruments (Refer to D5775), failed to follow its' own quality assessment process/procedures (Refer to D5791) and failed to have an effective quality assessment process in place to prevent problems associated with quality control review and failure to perform twice a year comparisons between complete blood count instruments (Refer to D5793). 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 observation of the laboratory, document request, and interview with the laboratory liaison, the laboratory failed to have a written and approved procedure for use of the Sysmex XS-1000i Complete Blood Count (CBC) instrument. The findings include: 1. Observation of the laboratory on 07.07.2022 at 8:30 am revealed two Sysmex XS-1000i CBC instruments in use for patient testing. 2. Document request made on 07.07.2022 at 11:30 am to the laboratory liaison revealed no written and approved procedure for use of the Sysmex XS-1000i was available. 3. Interview with the laboratory liaison on 07.07.2022 at 12:00 pm confirmed no written procedure manual for use of the Sysmex XS-1000i CBC instrument was available. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records and interview with the laboratory liaison, the laboratory failed to compare results of complete blood count (CBC) results between their two Sysmex XS-1000i CBC instruments in 2020, 2021, and 2022. The findings include: 1. Observation of the laboratory on 07.07.2022 at 8:30 am revealed two Sysmex XS-1000i CBC instruments in use for patient testing (serial number 74901 in the main lab and serial number 74900 in the nurse triage area). 2. Review of laboratory records revealed no twice a year comparison between the instruments in 2020, 2021, and 2022. 3. Interview with the laboratory liaison on 07.07.2022 at 11:55 am confirmed the laboratory failed to compare results between CBC instruments twice a year in 2020, 2021, and 2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 2 of 6 -- identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, review of complete blood count (CBC) quality control (QC) records, and interview with the laboratory liaison, the laboratory failed to follow the quality assessment process/procedure in 2020, 2021 and 2022 (12 of 39 lots reviewed for the laboratory instrument and 27 of 39 lots reviewed for the nurse triage instrument.) The findings include: 1. Observation of the laboratory on 07.07.2022 at 8:30 am revealed two Sysmex XS-1000i instruments in use for performing patient testing for CBC (Instrument serial #74901 in the lab area and instrument serial #74900 in the nurse triage area). 2. Review of the laboratory procedure titled "Quality Control" revealed that new QC lot targets are validated over 10 runs and must be reviewed and approved for acceptability by the lab director before use. The policy also states the lab director will review the entire QC packet for each lot to include the package insert for controls, range verification, raw data and levey jennings printouts as well as the peer review report from Sysmex. 3. Review of the laboratory's CBC quality control records revealed the following: Instrument serial number 74901 (Lab Instrument) Note: Level 1 (0804), Level 2 (0805), and Level 3 (0806) per parent lot Lot 0182-No records for validating QC targets, no cumulative data, no review of quality control. In use from 07.20.2020 to 09.18.2020 Lot 0238-No records for validating QC targets. In use on 09.03.2020 Lot 1208-No cumulative data printed, no review of QC data. In use from 08.23.2021 to 10.15.2021 Lot 1264-No records for validating QC targets, no cumulative data, no review of QC data. In use from 10.18.2021 to 12.10.2021. Lot 1320--No cumulative data, no review of QC data. In use from 12.13.2021 to 02.02.2022 Lot 2011--No review of QC data. In use from 01.26.2022 to 04.01.2022 Lot 2067--No review of QC data. In use from 03.23.2022 to 05.27.2022 Instrument serial number 74900 (Nurse Triage Area) Note: Level 1 (0804), Level 2 (0805), and Level 3 (0806) per parent lot Lot 0182--No record of target validation, no cumulative data, no review of QC. In use from 07.20.2020 to 09.18.2020 Lot 0238--No record of target validation. In use on 09.03.2020. Lot 0294--No review of QC data. In use from 11.06.2021 to 01.08.2021. Lot 0350--No cumulative QC data, No review of QC. In use from 12.30.2021 to 03.05.2021. Lot 1040--No cumulative QC data, no review of QC. In use from 03.02.2021 to 04.30.2021. Lot 1208-No cumulative QC data, no review of QC. In use from 08.23.2021 to 10.15.2021. Lot 1264--No cumulative QC data, no review of QC. In use from 10.18.2021 to 12.10.2021 Lot 1320--No cumulative QC data, no review of QC. In use from 12.13.2021 to 02.02.2022 Lot 2011--No lot validation records, no cumulative QC data, No review of QC. In use from 01.26.2022 to 04.01.2022 Lot 2067---No lot validation records, no review of QC. In use from 03.23.2022 to 05.27.2022. 4. Interview with the laboratory liaison on 07.07.2022 at 3:30 pm confirmed the laboratory failed to follow the quality assessment process/procedure for review of CBC QC target limits and QC cumulative data in 2020, 2021 and 2022 for 12 of 39 lots for the laboratory instrument and 27 of 39 lots for the nurse triage instrument. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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: The laboratory failed to maintain satisfactory participation for two consecutive proficiency testing (PT) events for the red blood cell (RBC) analyte, resulting in the first unsuccessful PT occurrence for the RBC analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2019 and 2020 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the red blood cell (RBC) analyte in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the RBC analyte. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the RBC analyte: 2019 event three: 60% 2020 event one: 0% 2) Review of the laboratory's proficiency testing records revealed the following: 2019 event three: Sample numbers SXT-11 and SXT- 12 scored as "Fail," resulting in an overall score of 60% for the RBC analyte. 2020 event one: Sample numbers SXT-1, SXT-2, SXT-3, SXT-4, SXT-5 scored as "Fail-No Results Received," resulting in an overall score of 0% for the RBC analyte, and the first unsuccessful PT occurrence for the RBC analyte. -- 2 of 2 --