Vibrant Health Family Clinics-Ellsworth

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: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the Hematocrit analyte in the Specialty of Hematology for events 2019-1 and 2019-2. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and Wisconsin State Laboratory of Hygiene (WSLH) PT records, the laboratory failed to achieve satisfactory performance in PT for the Hematocrit analyte in the Specialty of Hematology for events 2019-1 and 2019-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two consecutive PT events for the Hematocrit analyte in the Specialty of Hematology- Event 2019-1, score 40% and Event 2019-2, score 0%. 2. Surveyor review of the WSLH PT evaluation reports on August 21, 2019 confirmed the failed 2019 PT scores for the Hematocrit analyte. This results in a failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events which is unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies 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: Item 1 Based on surveyor comparison of reference (normal) ranges shown in the hematology procedure with those on patient test reports, and interview with the technical consultant, reference (normal) ranges available on patient reports are not consistent with the approved ranges in the procedure. Findings include: 1. Comparison of the reference (normal) ranges shown in the Coulter ACT Diff 2 hematology procedure with those on patient reports from the Coulter ACT Diff 2 printouts show that reference ranges available on patient reports are not consistent with the approved reference ranges in the procedure. White Blood Cell (WBC) count: cmm (per cubic millimeter) Procedure: Female 4.3-11.0 per cmm Printed Patient Report: 4.5-11.0 per cmm Mean Corpuscular Hemoglobin (MCH): pg (picograms) Procedure: Male and Female 25-33 pg Printed Patient Report: Male and Female 26-33 pg 2. Interview with the technical consultant on April 3, 2019 at 3:30 PM confirms the reference ranges provided on printed reports for the evaluation of test results are not consistent with those approved in the laboratory's procedure. Item 2 Based on surveyor review of the Electronic Medical Record (EMR) and interview with the technical consultant, the reference (normal) ranges are not available on the electronic patient test report or electronic laboratory flowsheet. Findings include: 1. Review of the transcribed results for a Complete Blood Count (CBC) into the Cerner EMR show that reference (normal) ranges are not available on the electronic patient test report. 2. Review of the "Lab Flowsheet" in the Cerner EMR show that cumulative CBC results fail to indicate the reference (normal) ranges on the flowsheet. 3. Interview with the technical consultant on April 3, 2019 at 3:45 PM confirms the reference (normal) 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 -- ranges are not available on the electronic patient test report or electronic laboratory flowsheet. -- 2 of 2 --