Mille Lacs Health System - Isle Clinic

Summary Statement of Deficiencies 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 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 2021. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 1:05 p.m. on 09/07/22. 2. A Sysmex KX-21N hematology analyzer was observed as present and available for use during the tour. 3. Sysmex KX- 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 -- 21N calibration verification was required every six months as indicated in the KX- 21N procedure found in the clinic electronic procedure folder. 4. Calibration verification was performed on 01/07/21 as indicated in laboratory records. Documentation for a second calibration verification performed in 2021 was not found. The laboratory was unable to provide the missing documentation upon request. Calibration Verification Date performed Time elapsed 01/07/21 N/A 01/27/22 385 days 5. In an interview at 3:00 p.m. on 09/07/22, the LD confirmed the above finding. -- 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 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 Laboratory Director (LD) during a tour of the laboratory on 11/19/20, at 8:05 a..m. 2. An ELITech Excyte ESR (*) analyzer was observed as present and available for use during the tour. 3. The ESR reference intervals listed in the Erythrocyte Sedimentation Rate Westergren Method (MINI-VES) procedure, located in the on-line Lab Manual, were not consistent with those included on a patient test report reviewed on date of survey, as indicated below. Patient - adult female, aged 79 yrs, tested on 7/25/19 Sex Procedure Report Females = 0 - 20 mm/Hr 0 - 15 mm/Hr 4. In an interview at 8:45 a.m., on 11/19 /20, the LD confirmed the above finding. (*) ESR = erythrocyte sedimentation rate . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 evaluate an unacceptable proficiency testing (PT) result. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 08/08/18 at 1:00 p.m. 2. The laboratory performed PT using the American Proficiency Institute PT provider. 3. The laboratory received an unacceptable PT result from API in the first event of 2018 for the analyte and sample listed below. Blood Cell Identification Sample ID Lab Result API expected BCI-03 Neut., hyposeg.* Neut., seg.* 4. An evaluation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide an evaluation upon request. 5. In an interview on 08 /08/18 at 2:10 p.m., TP1 confirmed a documented evaluation of the unacceptable result was not performed. * Note Neutrophil, hyposegmented Neutrophil, segmented D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 verify the accuracy of Hematology proficiency testing scores when the proficiency testing (PT) program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 08/08/18 at 1:00 p.m. 2. The laboratory performed PT using the American Proficiency Institute PT provider. 3. A PT result from the first event in 2018 was not graded due to lack of consensus. See below. Sample ID Analyte BCI-01 Blood Cell Identification 4. The API expected results data summary was not present in laboratory records. An evaluation for accuracy of the non-graded result was not found during review of laboratory documents. The laboratory was unable to provide an evaluation of non- graded results upon request. 5. In an interview on 08/08/18 at 2:10 p.m., TP1 confirmed the result had not been evaluated for accuracy. 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 observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between the hematology reference range chart and patient test reports. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 08/08/18 at 1:00 p.m. 2. A Sysmex KX-21N hematology analyzer was observed as present and available for use during the tour. 3. The reference intervals listed in the Reference Ranges and Critical Values chart, effective date 05/2010, located in the Clinic procedure manual was not consistent with those included on 2 of 2 patient test reports reviewed on date of survey. See below. Patient A - adult male tested on 05/01/17 Analyte* Chart Report WBC 4.6-10.2 4.0- 11.0 RBC 4.00-5.80 4.40-5.90 HGB 13.0-17.0 11.7-15.7 HCT 37-50 40.0-53.0 MCV 84-96 78-100 MCH 28-34 27-32 PLT 140-350 150-450 Patient B - adult female tested on 05/01/18 Analyte* Chart Report WBC 4.6-10.2 4.0-11.0 RBC 3.65-5.20 3.80-5.20 HGB 11.0-15.6 11.7-15.7 HCT 33-44.5 35.0-47.0 MCV 81-98 78-100 MCH 27-34 27- 32 MCHC 33-35 32-36 PLT 150-410 150-450 4. In an interview on 08/08/18 at 3:00 p. m., TP1 stated the reference ranges listed on the Reference Range and Critical Values chart were in use in the laboratory and confirmed the reference range discrepancy between the chart and the patient test reports. *Note WBC - White Blood Cells RBC - Red Blood Cells HGB - Hemoglobin HCT - Hematocrit MCV - Mean Corpuscular Volume MCH - Mean Corpuscular Hemoglobin MCHC - Mean Corpuscular Hemoglobin Concentration PLT - Platelets -- 2 of 2 --