Centracare Melrose

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 two unacceptable Hematology proficiency testing (PT) results out of thirty challenges completed in 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor during a tour of the laboratory at 8:10 a.m. on 11/09/22. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory received one unacceptable Eosinophil % PT result of fifteen Eosinophil % testing challenges completed in 2021 and one unacceptable Monocyte % PT result of fifteen Monocyte % testing challenges completed in 2021 as indicated in API reports. See below. 2021 1st Hematology event Test: Eosinophil % Sample: PNT-01 Laboratory Result: 5.5 API expected range: 1.6-5.4 2021 1st Hematology event Test: Monocyte% Sample: PNT-03 Laboratory Result: 1.8 API expected range: 0.0-1.6 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing Policy located in Policystat, the laboratory's policy management software. 5. 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 10:50 a.m. on 11/09/22, the Technical Supervisor confirmed the above finding. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure two of five reviewed Hematology reportable ranges and two of two Chemistry reportable ranges obtained during two of three performance verification (PV) activities completed in 2021 were adopted by the laboratory. Findings are as follows: The laboratory performed Hematology and Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a. m. on 11/09/22. A. Hematology 1. A Beckman Coulter DxH 690T hematology analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer to perform Complete Blood Count (CBC) testing in August 2021. The CBC included the following regulated analytes: WBC - White Blood Cells RBC - Red Blood Cells HGB - Hemoglobin HCT - Hematocrit PLT - Platelets 3. PV activities on the DxH 690T analyzer were completed in August 2021 as indicated in laboratory records found in the Performance Verification Data Manual, DxH690T and confirmed by the GS during the laboratory tour. 4. The WBC and RBC upper reportable range limits adopted by the laboratory did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents and the Beckman Coulter DxH 600/690T procedure found in Policystat, the laboratory's policy management software. See below. Analyte PV Adopted WBC 0-384.6 0-399.9 RBC 0-7.95 0-8.08 5. In an interview at 3:10 p.m. on 11/09/22, the Technical Supervisor confirmed the above finding. B. Chemistry 1. An Abbott Alinity chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory completed PV activities for Acetaminophen (ACE) and Salicylates (SAL) in December 2021 as indicated in laboratory records found in the Acet/Sali Validation folder. 2. The ACE and SAL upper and/or lower reportable range limits adopted by the laboratory did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents and the Acetaminophen on the Alinity System Plasma/Serum and Salicylate on Alinity System procedures found in Policystat. See below. Analyte PV Adopted ACE 10.3-349.33 17-378 SAL 10.10- 96.80 5-100 3. The laboratory performed 63 ACE and 57 SAL tests on patient samples since the 12/27/21 implementation date as indicated by the laboratory on 11 /09/22 . 4. In an interview at 1:15 p.m. on 11/09/22, the Technical Supervisor confirmed the above finding. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit -- 2 of 3 -- of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform calibration verification on a Hematology analyzer at least once every 6 months in 2022. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor during a tour of the laboratory at 8:10 a.m. on 11/09/22. 2. A Beckman Coulter DxH 690T hematology analyzer was observed as present and available for use during the tour. 3. DxH 690T calibration verification was required every six months as indicated in the Beckman Coulter DxH 600/690T procedure found in the Policystat, the laboratory's policy management software. 4. Calibration verification was performed in August 2021 during installation of the analyzer and in November 2022 as indicated in laboratory records. Documentation for a calibration verification performed in early 2022 was not found. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 3:10 p.m. on 09/07/22, the Technical Supervisor confirmed the above finding and indicated the calibration verification due in February 2022 was not performed. -- 3 of 3 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure microscopic examination proficiency testing was performed consistent with the number of times the laboratory routinely tested patient samples. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) proficiency testing provider. 3. Microscopic examination PT for Blood Cell Identification, Urine Sediment, Fern Test, Sperm presence/absence, Vaginal Wet Preparation and Vaginal Wet Preparation (KOH) from the API 2017 and 2018 events were completed by multiple testing personnel as indicated on Competency Assessment forms. See below where x indicates the testing personnel completed the microscopic examination PT for that event. Event Testing Personnel 1 2 3 4 5 6 2017-1 x x x x x 2017-2 x x x 2017-3 x x x x x 2018-1 x x x x x x 2018-2 x x x x x x 4. In an interview on 09/27/18 at 10:45 a.m., the GS confirmed the PT had been performed by multiple testing personnel prior to the submission date deadline and patient specimens would not routinely be handled in this manner. 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. 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 document review and interview with laboratory personnel, the laboratory failed to evaluate unacceptable proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The laboratory received unacceptable PT results from API in Hematology as listed below. Event Sample Test Lab API result 2018-1 PNT-03 Mono* 1.8 0.0-1.5 2018-2 PNT-06 Mono 5.8 0.0-5.5 4. An evaluation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 09/27/18 at 11:30 a.m., the GS confirmed a documented evaluation of the unacceptable results was not performed. * Note Mono - Monocytes D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Microbiology and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The laboratory received non-graded results from API due to no consensus in Microbiology and Hematology for the events and tests listed below. The Data Summaries from API with the expected results for these tests were not included in the laboratory's records. Event Sample ID Test 2017-2 UA-03 Urobilinogen 2017-2 UR-06 Susceptibility 2018-1 BCI-01 Blood Cell Identification 2018-2 BCI-10 Blood Cell Identification 2018-2 UR-06 Susceptibility 4. An evaluation of the non-graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 09/27/18 at 11:30 a. m., the GS confirmed an evaluation of the non-graded PT results was not performed. 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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of a non-regulated analyte at least twice annually. Findings are as follows: 1. The laboratory performed Tick Identification testing as confirmed by the General Supervisor during a tour of the laboratory on 09/27/18 at 8: 10 a.m. 2. Twice annual verification of accuracy documents for Tick Identification -- 2 of 4 -- were not found during review of laboratory proficiency testing records from 2017 through date of survey, 09/27/18. The laboratory was unable to provide verification of accuracy documents upon request. 3. In an interview on 09/27/18 at 12:50 p.m., the GS confirmed the accuracy of Tick Identification testing had not been verified in 2017 or 2018. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure functions checks for a Chemistry analyzer were performed and documented as required. Findings are as follows: 1. The laboratory performed Chemistry as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a..m. 2. An i-STAT system was observed as present and available for use during the tour. 3. Twice annual verification of the i-STAT thermal probe was required as indicated in the manufacturer's operator's manual provided by the laboratory. 4. The thermal probe check was performed and documented on one occasion, on 05/21/18, in the January 2017 to September 2018 time frame as indicated in laboratory records. Documentation of other maintenance activities performed on 01/13/17, 05/24/17, and 11/23/17 were found but the thermal probe check was not included. 5. In an interview on 09/27/18 at 3:30 p.m., the GS confirmed the above finding. In emails received on 10/04/18 and 10/05/18, the GS indicated the thermal probe checks had been performed but were not documented. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant failed to ensure all Microbiology training for new testing personnel was documented. Findings are as follows: 1. The laboratory performed Trichomonas, Gardnerella vaginalis and yeast testing using the BD Affirm Microbial Identification system under the specialty of Microbiology as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a.m. 2. BD Affirm Microbial Identification system training and initial competency documents for 1 of 1 new testing personnel were not found during review of the laboratory's records. The laboratory was unable to provide the documents upon request. 3. In an interview on 09/27/18 at 9: 00 a.m, the GS confirmed BD Affirm Microbial Identification system training was not documented for the new testing personnel. -- 3 of 4 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to evaluate testing personnel for competency in all moderately complex test procedures performed by the laboratory in 2017. Findings are as follows: 1. The laboratory performed Trichomonas, Gardnerella vaginalis and yeast testing using the BD Affirm Microbial Identification system under the specialty of Microbiology as confirmed by the General Supervisor (GS) during a tour of the laboratory on 09/27/18 at 8:10 a.m. 2. Review of personnel records indicated 5 of 5 testing personnel were not evaluated for competency on the BD Affirm Microbial Identification system in 2017. The laboratory was unable to provide the missing competency assessment documents upon request. 3. In an interview on 09/27/18 at 9: 25 a.m., the GS confirmed the above findings. -- 4 of 4 --