Grace Family Practice Clinic, Pc

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient records and interview with the technical consultant, the laboratory failed to ensure provider orders for performing patient complete blood count with differential (CBC with Diff) for two of four patient reviewed from 2021 and 2022. The findings include: 1. Review of patient records revealed the following: Patient #376- CBC with Diff reported on 09/22/21, no order in the patient chart for CBC with Diff. Patient #2085-CBC with Diff reported on 08/15/22, no order in the patient chart for CBC with Diff. 2. Interview on 11/02/22 at 5 pm with the technical consultant confirmed the laboratory performed patient testing for CBC with Diff in 2021 and 2022 for two of four patient records reviewed without a provider order. 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 final patient complete blood count (CBC) results, the manufacturer procedure manual, patient data logs and interview with the technical consultant, the laboratory failed to follow manufacturer instructions for repeat 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 2 -- when instrument flagged results were present for four of four patient reviewed from 2021 and 2022. The findings include: 1. Review of patient numbers 18028, 376, 2579, and 2085 final CBC report revealed the result for platelet was flagged as AG*. 2. Review of the manufacturer procedure manual in the section for flagged results revealed the following: "When histogram flags are displayed, perform analysis again." 3. Review of patient data logs from the CBC instrument revealed the CBC was not repeated for any of the four patients. 4. Interview with the technical consultant on 11 /02/22 at 5 pm confirmed the laboratory failed to follow the manufacturer instructions for repeat testing of flagged platelet results in 2021 and 2022 for four of four patients reviewed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 observation of the laboratory, review of the manufacturer operating manual, lack of documentation and interview with the technical consultant, the laboratory failed to monitor the humidity in the area where the Sysmex XP 300 complete blood count (CBC) instrument was in operation in 2021 and 2022. The findings include: 1. Observation of the laboratory on 11/02/22 at 1:15 pm revealed the Sysmex XP 300 instrument in use for patient testing for CBC. 2. Review of the manufacturer's operating manual revealed a humidity range of 30% to 85% for operation of the instrument. 3. Review of environmental records from 2021 and 2022 revealed no documentation that the humidity was being monitored. 4. Interview with the technical consultant on 11/02/22 at 5 pm confirmed the laboratory did not monitor the humidity in the area were the Sysmex XP 300 CBC instrument was located in 2021 and 2022. -- 2 of 2 --

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 in two out three events for automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte. (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2019 proficiency testing (PT) records, the laboratory failed to maintain successful participation in two out of three events for the White blood Cell (WBC) differential in 2019 events one and three, resulting in the first unsuccessful PT occurrence for the WBC differential analyte. The findings include: 1) Review of the CMS 155 report revealed the following unsatisfactory WBC differential scores: 2019 event one WBC differential = 67% and 2019 event three WBC differential = 67%. 2) Review of the 2019 event one PT summary report revealed the following: Lymphocyte % scored as fail for sample numbers HD-1, HD- 2, HD-3, HD-4, and HD-5, resulting in an overall automated WBC differential score of 67%. 3) Review of the 2019 event three PT summary report revealed the following: Lymphocyte % scored as fail for sample numbers SYX-11, SYX-13, SYX-14; Mono /Mixed % scored as fail for sample number SYX-11 SYX-14; resulting in an overall automated WBC differential score of 67% and the first unsuccessful PT occurrence for the automated WBC differential analyte. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the 2018 and 2019 proficiency testing (PT) records and interview with testing personnel number one, the laboratory failed to perform and document remedial action for the red blood count, hematocrit and automated differential lymphocyte unacceptable scores. The findings include: 1) Review of the 2018 and 2019 PT records revealed the following unacceptable sample scores with no remedial actions documented: 2018 event two sample number HD-08 for hematocrit; 2018 event three sample number HD-11 for red blood count and hematocrit; and, 2019 event one sample numbers HD-01, HD-02, HD-03, HD-04 and HD-05 for automated differential lymphocyte. 2) Interview on July 3, 2019 at 2:30 p.m. with testing personnel number one confirmed the unacceptable sample numbers were circled with no further remedial action documentation. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with testing personnel number one, 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 testing personnel competency procedure: 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) Interview on July 3, 2019 at 3:00 p.m. with testing personnel number one confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records and interview with testing personnel number one, the laboratory failed to verify the accuracy of the wet prep and potassium hydroxide (KOH) at least twice per year in 2017. The findings include: 1) Review of the 2017 proficiency testing records revealed the 2017 events one, two and three scored 50% each event for the wet prep and KOH analytes, with no further accuracy documented. 2) Interview on July 3, 2019 at 2:45 p.m. with testing personnel number one confirmed the remedial action for the wet prep and KOH failed scores did not include documentation to verify the accuracy in 2017. 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)