Family Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/23/2022. 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. 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 five of six patient reports. Findings include: (1) On 05/23/2022 at 10:00 am, the technical consultant stated the following: (a) CBC testing was performed on the Medonic M-Series hematology 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 six patient records that had been tested between 02/08/22 through 02/11/2022. For five of six patient records there was no indication the laboratory staff followed their written procedure as follows: (a) Patient reported on 02 /08/2022 at 09:41 am - No evidence the provider reviewed the OM flag; (b) Patient 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 -- reported on 02/09/2022 at 11:27 am - No evidence the provider reviewed the BD flag; (c) Patient reported on 02/09/2022 at 12:00 pm - No evidence the provider reviewed the BD flag; (d) Patient reported on 02/09/2022 at 05:29 pm - No evidence the provider reviewed the TM flag; (e) Patient reported on 02/22/2022 at 09:52 am - No evidence the provider reviewed the OM flag; (3) The surveyor reviewed the findings with the technical consultant who stated on 05/23/22 at 10:47 am that the procedure had not been followed as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/15/2020. 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. 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. 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 for 1 of 4 events. Findings include: (1) On 10/15/2020, the surveyor reviewed 2019 and 2020 Hematology 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 2019 Hematology Event (i) MPV (Mean platelet Volume ) - 3 of 5 results exhibited a negative bias (aa) HSY-13 - SDI of -2.0 (bb) HSY-14 - SDI of -3.0 (cc) HSY-15 - SDI of -2.3 (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 on 10/15/2020 at 10:15 am 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 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 -- 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 3 of 3 patient reports. Findings include: (1) On 10 /15/2020 at 10:30 am, the technical consultant stated to the surveyor: (a) CBC testing was performed on the Medonic M-Series hematology 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 records that had been tested between June 2020 through August 2020. For 3 of 3 patient records there was no indication the laboratory staff followed their written procedure as follows: (a) Patient reported on 06/17/2020 at 09:33 am - No evidence the provider reviewed the BD flag; (b) Patient reported on 07 /13/2020 at 01:06 pm - No evidence the provider reviewed the OM flag; (c) Patient reported on 08/17/2020 at 01:52 pm - No evidence the provider reviewed the OM flag. (3) The surveyor reviewed the findings with the technical consultant who stated on 10/15/2020 at 12:15 pm that the procedure had not been followed as indicated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory failed to ensure materials had not exceeded their expiration date. Findings include: (1) On 10 /15/2020, the surveyor observed the contents of the laboratory drawing room. The following expired materials were observed in the drawing room, which were available for use: (a) 23 BD Vacutainer Serum (red top) blood collection tubes lot #8012615, expiration date 01/31/2020. (2) The surveyor showed the expired materials to the technical consultant who stated on 10/15/2020 at 01:05 pm the expired materials were available for use and stated they should have been discarded once they had expired. 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. -- 2 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 ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On 10/15/2020 at 10:30 am, the technical consultant stated to the surveyor CBC (Complete Blood Count) testing was performed using the Medonic M-Series analyzer; (2) The surveyor reviewed two patient CBC reports - the first report was for an adult male patient with the testing performed on 09/9/2020 at 11:08 am; the second report was for an adult female patient with the testing performed on 10/15/2020 at 10:46 am. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), which were: (a) RBC - 4.10 - 5.50 M/L (3) The surveyor reviewed the findings with the technical consultant, who stated on 10/15/2020 at 12:30 pm the patient reports did not include gender specific reference ranges and indicated above. NOTE: Routinely, female reference intervals for the RBC's are lower than male reference intervals. -- 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. 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, the laboratory failed to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for Cell Identification/White Blood Cell differential. Refer to D2128 and D2130. 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 -- 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, the laboratory failed to achieve successful performance for Cell Identification/White Blood Cell Differential. Findings include: (1) The laboratory failed to achieve satisfactory performance in the Third event in 2018 and the Second event in 2019. Refer to D2130. NOTE: The only acceptable

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. 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)