Allina Health Apple Valley Clinic

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 samples from 1 of 3 Hematology proficiency testing events in 2019 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology and Urinalysis microscopic examination testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:10 a.m. on 12/16/20. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) proficiency provider. 3. The Testing Proficiency Samples procedure located in the API - Policy and Procedure Manual indicated PT samples would be tested in the same manner as patient specimens. In addition, the PT (API) procedure indicated PT can not be done in duplicate if the laboratory does not perform the patient test in duplicate. 4. Microscopic examination PT for Blood Cell Identification (BCI), Pinworm Preparation (PP), Sperm presence /absence (SPM), Urine Sediment (US), Vaginal Wet Preparation (VA), and Vaginal Wet Preparation KOH (VKP) was completed by multiple testing personnel (TP) before the 2019 first event submission deadline as indicated on documents found in the PT manual. See below. 2019 - 1st event Submission deadline 03/29/19 Samples BCI-01 through BCI-05, PP-11, SPM-01, US-01, VA-01, VKP-01 Tested by Date TP1 03/25/19 Former TP VB 03/25/19 5. In an interview at 12:25 p.m. on 12/16/20, the GS confirmed the above finding. 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 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 Chemistry, Urinalysis and Toxicology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 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 Chemistry, Urinalysis and Toxicology for the events and tests listed below. Event = 2016 - Chemistry / Group 2 - 3rd Event Sample ID = UDS-05 Test = Benzodiazapine Event = 2017 - Chemistry / Core - 1st Event Sample ID = CH- 01 Test = LDL Cholesterol (Calculated) Event = 2017 - Hematology / Coagulation - 1st Event Sample ID = UA-02 Test = Urobilinogen Event = 2017 - Hematology / Coagulation - 2nd Event Sample ID = UA-03 Test = Urobilinogen Event = 2018 - Chemistry / Miscellaneous - 1st Event Sample ID = UDS-02 Test = Opiates 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 11/21/18 at 10:30 a.m., Testing Personnel 9 (TP9) confirmed the above findings. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty 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 -- 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). 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 Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 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 Chemistry for the events and tests listed below. Event = 2016 - Chemistry / Group 2 - 3rd Event Sample ID = CH-13 Test = Free Thyroxine, TSH* Event = 2017 - Chemistry / Core - 1st Event Sample ID = CH-01 Test = Free Thyroxine, Triglycerides 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 11/21/18 at 10:30 a.m., Testing Personnel 9 (TP9) confirmed the above findings. * TSH = thyroid Stimulating Hormone . 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 perform and/or document required maintenance on equipment used for Immunology testing. Findings are as follows: 1. The laboratory performed Immunology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 a.m. 2. Various digital timers were observed as present and available for use during the tour of the lab. 2. A requirement for checking the accuracy of timers was established in the Clock & Timer Quarterly Check procedure, located in the Laboratory Procedure Manual. 4. Documentation of accuracy of timers was not found for the following periods during review of laboratory records: 2016 - Calendar Quarters 3 & 4 2017 - Calendar Quarters 1,2 & 3 The laboratory was unable to provide documentation of this function check upon request. 5. In an interview on 11 /21/18 at 1:30 p.m., Testing Personnel 9 (TP9) confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure quality control (QC) was performed each day of qualitative Immunology patient specimen testing. Findings are as follows: 1. The laboratory performed Serum Qualitative HCG* under the specialty of Immunology as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 a. m. 2. QC performance for Serum Qualitative HCG* was established in the Consult Diagnostics hcG Combo Test Cassette manufacturer Instruction for Use (IFU) found in the QC Log Book. 3. Laboratory records confirmed Serum Qualitative HCG* QC had been performed upon opening of each new kit in the timeframe reviewed: October, 2016 - November, 2018. 4. An Individualized Quality Control Plan (IQCP) for Serum Qualitative HCG* was not found in laboratory records. The laboratory was unable to provide an IQCP upon request. 5. In an interview on 11/21/18 at 2:30 p.m., Testing Personnel 9 (TP9) confirmed the above findings. * HCG = Human chorionic gonadotropin . 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 accurate reference ranges were listed on Urinalysis and Chemistry test reports reviewed during the survey. Findings are as follows: A) Urinalysis 1. The laboratory performed Urinalysis testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 a.m. 2. A Siemens Clinitek Advantus urinalysis analyzer was observed as present and available for use during the tour. 3. The reference ranges found in the Urinalysis Table located in the Laboratory Procedure Manual, and the Urinalysis - Complete UA, Dipstick UA and Microalbumin procedure located in the Cliniteks (Advantus / Status +) Manual, were not consistent with that included on the test report (Male - 60 years, Date of testing = 6 /7/18) reviewed on the date of survey, as follows: Parameter: Table: Procedure: Test Report: pH 5.0 - 8.5 4.6 - 8.0 5.0 - 9.0 Specific --- 1.001 - 1.035 1.001 - 1.030 Gravity WBC / hpf* --- None Given 0 - 4 RBC / hpf* --- None Given 0 Casts / lpf* --- None Given Negative Epithelial / lpf*--- None Given Negative Bacteria / lpf* --- None Given Negative Mucous / lpf* --- None Given Negative 4. In an interview on 11/21 /18 at 2:30 p.m., Testing Personnel 9 (TP9) confirmed the above findings. * hpf = High Power Field * lpf = Low Power Field B) Chemistry 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/21/18 at 8:05 a.m. 2. A Siemens Dimension EXL chemistry analyzer was observed as present and available for use during the tour. 3. The reference ranges found in the Dimension EXL Testing Table located in the Chemistry Procedure Manual, and the Chemistry Reference Range Table located in the Laboratory Procedure Manual, were not consistent with that included on the test report (Female - 58 years, Date of testing = 11/20/18) reviewed on the date of survey, as follows: Parameter: = Glucose Dimension EXL Testing Table = 74 - 106 Chemistry Reference Range Table = 70 - 99 Patient Report = 70 - 110 4. In an interview on 11/21/18 at 2: 30 p.m., Testing Personnel 9 (TP9) confirmed the above findings. . -- 3 of 3 --