Neighborhood Health Source Sheridan Clinic

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to investigate unacceptable Hematology proficiency testing (PT) results for 1 analyte in 2019. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:05 a.m., on 01/30/20. 2. The laboratory performed PT using the College of American Pathologists (CAP) program. 3. The laboratory received unacceptable PT results in the CAP FH2-A 2019 Hematology Auto Diff event. See below. Sample Test FH2-02 Granulocyte, Absolute FH2-05 Granulocyte, Absolute 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing Procedure located in the Laboratory Manual. 5. An investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 11: 20 a.m., on 01/30/20, the TC confirmed the above finding. 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: 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 -- . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure a reference interval was consistent between a Hematology procedure and a patient test report. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:05 a.m., on 01/30/20. 2. A Sysmex XP-300 hematology analyzer was observed as present and available for use during the tour. 3. The Hematocrit reference interval for adult females listed in the Complete Blood Count (CBC) on the Sysmex XP-300 Automated Hematology Analyzer procedure was not consistent with those included on patient test reports reviewed on date of survey as indicated below. Adult female, date of birth = 12/31/91, tested on 7/24/19 Adult female, date of birth = 3/6/97, tested on 11/26/19 Analyte Procedure Report Hematocrit 35.5 - 40.0 % 35.0 - 45.0% 4. In an interview at 12:10 p.m., on 01/30/20, the TC confirmed the above finding. . -- 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 a review of proficiency testing reports from the College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing for Cell ID or WBC Differential testing under the specialty of Hematology. Findings are as follows: D2122 - the laboratory failed to obtain a PT score for Cell ID or WBC Differential testing of at least 80 percent in two testing events D2131 - the laboratory failed to achieve satisfactory performance for Cell ID or WBC Differential testing in two of three testing events D2122 HEMATOLOGY 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 -- CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the College of American Pathologists (CAP), , the laboratory failed to obtain a PT score for Cell ID or WBC Differential testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Cell ID or WBC Differential testing was obtained in the following events. - 2017 2nd event: 60% - 2018 1st event: 60% . D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on proficiency testing scores from the College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for Cell ID or WBC Differential in two out of three consecutive testing events, constituting unsuccessful performance for the analyte. Review of results from CAP revealed that the laboratory had unsatisfactory performance for Cell ID or WBC Differential in two out of three consecutive events, leading to unsuccessful performance. Unsatisfactory PT performance of the Cell ID or WBC Differential was obtained in the following events. - 2017 2nd event: 60% - 2018 1st event: 60% . -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to document required Hematology analyzer maintenance. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 01/18/18 at 10:10 a.m. 2. A Beckman Coulter AcT Diff 2 hematology analyzer was observed as present and available for use during the tour of the laboratory. 3. Requirements for daily maintenance of the analyzer were established in the Coulter AcT diff 2 Analyzer Operators Guide provided by the manufacturer. 4. Documentation of daily maintenance was not found during review of laboratory records from January 2016 through January 2018. The laboratory was unable to provide daily maintenance documentation upon request. A Coulter Act*T Diff 2 Preventative Maintenance form was present in laboratory records but was not in use. 5. In an interview on 01/18/18 at 1:00 p.m., the TC confirmed the daily maintenance had not been documented in 2016 and 2017. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to follow an established policy to verify the accuracy of test results manually entered into the electronic patient record. Findings are as follows: 1. The laboratory performed Microscopic Examinations and Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 01/18/18 at 10:10 a.m. The TC indicated the test results were entered manually into the electronic patient record. 2. A requirement for scheduled and non-scheduled quality assurance reviews was established in Section 10 - Quality Assurance of the Laboratory Manual. A blank Laboratory Quality Assurance Form found in laboratory records indicated a 5 chart audit was required annually. 3. Documentation of chart audits from 2016 and 2017 was not found. The laboratory was unable to provide documentation of chart audits for this time period upon request. 4. In an interview on 01/18/18 at 1:40 p.m., the TC confirmed the above finding and stated the laboratory most recently verified the accuracy of manually entered test results in 2015. 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 document review and interview with laboratory personnel, the technical consultant failed to ensure testing personnel were assessed through testing previously analyzed specimens, blind samples, or proficiency testing samples at least annually. Findings are as follows: 1. The laboratory performed Microscopic Examinations and Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 01/18/18 at 10:10 a.m. 2. Requirements to assess testing personnel competency via blind testing using a split sample or proficiency testing sample were established in the Test Personnel, Moderately Complex Laboratory procedure located in the Laboratory Manual. 3. Documentation of blind testing was not included on the Competency Assessment: Analytic for Non-Waived Testing form for Testing Personnel 2 (TP2) as indicated below. Year Test 2016 Microscopic Examinations 2017 Hematology, Microscopic Examinations 4. In an interview on 01/18/18 at 10:50 a.m., Testing Personnel 1 verified TP2 performed Microscopic Examinations and Hematology testing. The TC indicated the blind testing assessment should have been completed for TP2 in 2016 and 2017 and confirmed the assessment was not performed. *This is a repeat finding from the 01/06/16 survey* -- 2 of 2 --