Lake Regional Health System - Eldon Clinic

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 hematology proficiency testing (PT) records for 2018/2019 and interview with the laboratory director, the laboratory failed to ensure one of seven full- time testing personnel participated in the PT process who routinely perform patient testing. Findings: 1. No documentation was available to show testing personnel # 7 participated in hematology PT for 2018 and 2019. 2. Interview on January 28, 2020 at 11:45 AM, the laboratory director confirmed the laboratory failed to include all personnel who routinely perform patient testing, in the PT process. 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 written hematology procedure manual and quality control (QC) records for April 2019 and interview with the laboratory director, the laboratory failed to follow the manual for

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 review of 2018 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2130, unsatisfactory PT performance for the hematocrit analyte for three consecutive testing events 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 review of hematology proficiency testing (PT) results for 2018 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the hematocrit analyte in three consecutive PT events. Findings: 1. The laboratory obtained an unsatisfactory score of 40 percent for the hematocrit analyte in the first PT event of 2018. 2. The laboratory obtained an unsatisfactory score of 60 percent for the hematocrit analyte in the second PT event of 2018. 3. The laboratory obtained an unsatisfactory score of 40 percent for the hematocrit analyte in the third PT event of 2018. 4. Phone interview with the technical consultant on December 26, 2018 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for the hematocrit analyte. -- 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: Based on review of 2018 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the technical consultant, the laboratory failed to successfully participate in PT. See D-tag 2130, unsatisfactory PT performance for the hematocrit analyte for two consecutive testing events 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 review of hematology proficiency testing (PT) results for 2018 and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance for the hematocrit analyte in two consecutive PT events. Findings: 1. The laboratory obtained an unsatisfactory score of 40 percent for the hematocrit analyte in the first PT event of 2018. 2. The laboratory obtained an unsatisfactory score of 60 percent for the hematocrit analyte in the second PT event of 2018. 3. Phone interview with the technical consultant on July 23, 2018 at 1:45 PM confirmed the laboratory failed to achieve satisfactory performance for the hematocrit analyte. -- 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: Based on review of complete blood counts (CBC) normal values on patient test reports and CBC normal values included in the approved procedure manual, the laboratory failed to ensure pertinent normal values, as determined by the laboratory, were available for interpretation of the test results. Findings: 1. Review of CBC normal values included on patient test reports generated by the laboratory information system (LIS) showed the laboratory reports a single set of normal values for all patient age groups and genders for CBC analytes. 2. Review of CBC normal values included in the approved procedure manual showed multiple age groups and gender specific patient normal values for CBC analytes. 3. Interview with the technical consultant on January 30, 2017 at 11:00 AM confirmed age and gender specific CBC normal values included in the approved procedure manual differ from normal values on patient CBC test reports. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent 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 -- characteristics of the method; This STANDARD is not met as evidenced by: Based on review of hematology verification procedures and interview with the technical consultant, the laboratory did not have documentation to show the director reviewed and approved verification procedures for the hematology analyzer (complete blood counts/ CBC) before patient testing started September 5, 2017. Findings: 1. The laboratory did not have documentation to show the director reviewed and approved verification procedures to determine the accuracy, precision, reportable range and reference range performance characteristics for the AcTdiff hematology analyzer # 14608 before patient testing started September 5, 2017. 2. Interview with technical consultant on January 30, 2018 at 11:00 AM confirmed no documentation to show the director approved the verification procedures for the hematology analyzer. Interview with testing personnel #1 on January 30, 2018 at 11:00 AM revealed the laboratory performed 12 to 15 patient CBCs per month on hematology analyzer # 14608. -- 2 of 2 --