Bmg Family Physicians Group Foundation, Inc

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 laboratory proficiency testing (PT) records and staff interview, the laboratory director failed to sign the PT attestation statements for five of five events reviewed from 2022 and 2023. The findings include: 1. Review of the laboratory PT records revealed the laboratory director failed to sign the attestation statements for events 2023 Event one Provider Performed Microscopy, 2023 Event two Hematology, 2022 Events one, two, and three for Hematology and Provider Performed Microscopy (five of five events reviewed). 2. Interview on 08/24/2023 at 11:00 am with the laboratory liaison confirmed the laboratory director failed to sign the attestation statements for five of five events in 2022 and 2023. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory's PT records and staff interview, the laboratory failed to retain the Sysmex XS 1000i complete blood count (CBC) instrument printouts for 2022 Hematology event one (one of five events reviewed) for a period of two years. The findings include: 1. Review of the laboratory's PT records for 2022 Event one Hematology revealed the CBC instrument printouts were not retained. 2. Interview on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 08/24/2023 at 11:00 am with the laboratory liaison confirmed the laboratory failed to retain the instrument print outs for 2022 Event one Hematology PT. 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 review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) for moderate and high complexity testing (Form CMS-209), laboratory policy, laboratory personnel records, and staff interview, the laboratory failed to follow their own policy for assessing testing personnel (TP) competency for CBC, potassium hydroxide (KOH), vaginal wet prep, and urine microscopic patient testing for 10 of 11 TP reviewed in 2022 and 2023, and failed to ensure the policy included requirements for demonstrated accuracy/competency prior to performing patient testing as required in Subpart M. The findings include: 1. Review of the Form CMS-209 revealed eleven TP that performed moderately complex patient testing. 2. Review of the laboratory policy titled "Personnel Assessment Policy" revealed competency assessment requirements for TP required six months after hire and annually thereafter that included the required six elements. The policy did not include a requirement for demonstration of accuracy/competency prior to patient testing. 3. Review of the laboratory personnel records revealed the following testing personnel with no documented competency assessments that included the required six elements. TP two and three: No documented initial competency prior to CBC, KOH, Wet prep, or Urine microscopic moderately complex patient testing in 2023. TP four: No documented annual competency that included the required six elements in 2022 and blind testing not included in 2023 for CBC patient testing. TP five, six, seven, 11: No documented initial competency prior to CBC patient testing in 2023. TP eight and nine: No documented initial, semi-annual, or annual competency for CBC patient testing in 2022 and 2023. TP 10: No initial or semi-annual competency for CBC patient testing in 2022 and 2023. 4. Interview on 08/24/2023 at 10:04 am with the laboratory liaison and office manager confirmed the laboratory failed to follow its' own policy for TP competency assessment and failed to have a competency assessment policy that was in compliance with the requirements in subpart M when it did not require demonstration of accuracy/competency prior to patient testing. 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: I. Based on review of final patient test review, laboratory procedure, and staff interview, the laboratory failed to follow the procedure in use for reporting vaginal -- 2 of 4 -- wet prep examination patient results in 2022. The findings include 1. Review of one of two final patient test reports for wet prep revealed reporting of cholesterol crystals for patient 13693296 (resulted on 01/28/2022). 2. Review of the procedure titled "Wet Prep Exam for Vaginitis" revealed the following analytes to be reported: white blood cell, yeast, trichomonas, clue cells, bacteria, and sperm. 3. Interview on 08/24/2023 at 2:00 pm with the laboratory liaison confirmed the laboratory failed to follow its' own procedure for final patient test reporting for wet prep in 2022. II. Based on observation of two laboratory areas, lack of documentation, review of laboratory procedure, and staff interview, the laboratory failed to follow the procedure in use for instrument to instrument comparison of the two Sysmex XS 1000i hematology instruments used for CBC patient testing in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 08/24/2023 at 9:29 am revealed a Sysmex XS 1000i (Serial # 74908) in the main laboratory, with observation of a second Sysmex XS 1000i (Serial # 74907) 12:02 pm in the nursing triage area, in use for performing patient CBC testing. 2. There was no documentation of instrument to instrument comparison in 2021, 2022, or 2023. 3. Review of the laboratory policy titled "Proficiency Test Performance" revealed "For the offices with 2 Sysmex instruments you must run the CBC samples AFTER THE DATA SUBMISSION DEADLINE on the nurses' Sysmex." The instrument printouts are labeled with "Result Comparison" reviewed by the laboratory liaison and laboratory director, and filed in the proficiency test binder. Check lists are to be used to ensure all records are present, signed, and retained. 4. Interview on 08/24/2023 at 2:00 pm with the laboratory liaison confirmed the laboratory failed to follow its' own procedure for instrument to instrument comparison for the two Sysmex XS 1000i hematology instruments used for CBC patient testing in 2021, 2022, and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of control package inserts, and staff interviews, the laboratory failed to label three of three CBC quality control (QC) vials with open date and expiration date on the date of the survey. The findings include: 1. Observation of the laboratory on 08/24/2023 at 9:40 am revealed QC vial lot numbers 32050804, 32050805, and 32050806 in use for performing QC on the Sysmex XS 1000i. The vials were not labeled with either open or corrected expiration dates. 2. Review of the Sysmex e-Check (XS) QC package insert revealed that the controls are stable for 14 days after opening. 3. Interview on 08/24/2023 at 9:43 am with the laboratory liaison, office manager, and testing personnel confirmed the laboratory failed to label QC vials with open dates and corrected expiration dates on the date of the survey. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, random patient test report review, and staff interview, the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for event one in 2023 for the complete blood count (CBC) regulated analytes to include white blood cell (WBC), red blood cell (RBC), platelet (PLT), hemoglobin (Hgb), hematocrit (Hct), and WBC differential (WBC Diff). The findings include: 1. Review of the laboratory PT records revealed there was no documentation of participation for 2023 event one for the regulated analytes WBC, RBC, PLT, Hgb, Hct, and WBC Diff. 2. Review of patient test reports revealed patient reporting for CBC on 02/09/2023 (patient 160505450). 3. Interview on 08/24/2023 at 11:00 am with the laboratory liaison confirmed the laboratory director failed to ensure the laboratory was enrolled in PT for 2023 event one for regulated CBC analytes with patient testing performed. -- 4 of 4 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with testing personnel number seven, the laboratory failed to test proficiency testing samples in the same manner as patient samples in 2018. The findings include: 1) Review of the laboratory's proficiency testing records for microscopy (wet prep, urine microscopy, Potassium Hydroxide (KOH) for 2018 event two revealed the following: Two sets of results for microscopy slide responses in different handwriting. 2) Interview with testing personnel number seven on October 10, 2019 at 1:00 p.m. confirmed the laboratory did not test proficiency testing samples the same as patient samples. The laboratory does not have patient tests for microscopy read by two people. Testing personnel number seven stated that the previous testing personnel had incorrect responses recorded. She stated that when she was sending the results to the PT program she read the slides and corrected them because she knew they were wrong. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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. This STANDARD is not met as evidenced by: Based on review of patient number one test report, the laboratory's complete blood count (CBC) quality control (QC) records and maintenance records, and interview with the laboratory liaison, the laboratory failed to retain CBC quality control limits and background counts in 2018. The findings include: 1) Review of patient number one CBC test report revealed patient testing for CBC on 04.06.2018. 2) Review of the laboratory's QC and maintenance records for CBC for April 2018 revealed the following: QC lot number 8016 in use during April 2018 - no retention of the QC limits in use at the time of patient testing. No retention of the background count for date of patient testing. 3) Interview with the laboratory liaison on October 10, 2019 at 1:00 p.m. confirmed the laboratory failed to retain CBC QC limits for lot 8016 and instrument background count in 2018. 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 review of the laboratory procedure manual, employee personnel records for 2018 and 2019 and interview with the laboratory liaison, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the procedure and competency documentation: 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) Review of the 2018 and 2019 employee personnel records revealed the use of training documents for documenting competency. The training documents did not specify the methods used for assessment of competency. The training documents did not include all six criteria required for competency assessment. 3) Interview on October 10, 2019 at 1:00 p.m. with the laboratory liaison confirmed the testing personnel competency procedure /documentation did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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 -- 2 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the American Academy of Family Physicians (AAFP) proficiency testing attestation statements, the Centers for Medicare and Medicaid (CMS) Laboratory Personnel Report (CMS form 209) and interview with the laboratory liaison the laboratory failed to perform proficiency testing by personnel who routinely perform patient testing in 2016 and 2017. The findings include: 1. Review of the 2016- A, 2016-B, 2016-C, 2017-A, and 2017-B AAFP proficiency testing attestation statements revealed that proficiency testing for all events was performed by testing personnel number one. 2. Review of the CMS form 209 revealed eleven personnel who perform patient testing. 3. Interview with the laboratory liaison on January 5, 2018 at 11:00 am confirmed that other personnel perform patient testing and the laboratory failed to perform proficiency testing by the same personnel who routinely perform patient testing in 2016 and 2017. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of validation data for the Sysmex XS-1000i complete blood count (CBC) instrument and interview with the laboratory liaison, the laboratory failed to verify the manufacturer's normal range in 2016. The findings include: 1. Review of the validation data performed on 5-25-2016 for two Sysmex XS-1000i instruments (serial #s 74907 and 74908) revealed no normal range study. 2. Interview with the laboratory liaison on January 5, 2018 at 1:15 pm confirmed the laboratory uses the Sysmex XS-1000i instruments for patient CBC testing, uses the manufacturer's normal values, and failed to verify the manufacturer's normal values in 2017. 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 between two complete blood count (CBC) instruments twice a year in 2016 and 2017. The findings include: 1. Observation of the laboratory on January 5, 2018 at 9:00 am revealed two Sysmex XS 1000i instruments in use for patient testing, one in the main laboratory and one in the nurse's laboratory area. 2. Review of available laboratory records revealed no studies were present for twice a year comparison between the two Sysmex XS 1000i CBC instruments. 3. Interview with the laboratory liaison on January 5, 2018 at 1:30 pm confirmed the laboratory uses two different Sysmex XS 1000i instruments for patient testing and failed to compare results between the two instruments twice a year in 2016 and 2017. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessment forms and interview with the laboratory liaison, the technical consultant failed to include blind testing as part of competency assessment for eleven of eleven employees in 2016 and 2017. The findings include: 1. Review of the 2016 and 2017 testing personnel competency assessment forms revealed blind testing was not used as part of competency assessment for eleven of eleven employees. 2. Interview with the laboratory liaison on January 5, 2018 at 12:30 confirmed the competency assessment of employees does not include blind testing. -- 2 of 2 --