Gundersen La Crescent Clinic

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review, observation, and an interview with laboratory personnel, the laboratory failed to retain all analytic records of activities as specified in 493.1256 (e)(2), specifically records of lot numbers and expiration dates of the stains used by the laboratory each day of use in 2022 and 2023. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed the Technical Consultant (TC) and Testing Personnel 1 (TP1) during a tour of the laboratory at 08:05 a.m. on June 14, 2023. 2. The empty manual differential stain jars and Zeiss AX10 microscope used to perform manual blood smears were observed as present and available for use during the tour of the laboratory. 3. In an interview at 8:09 a.m. on June 14, 2023, TP1 confirmed the lot number and expiration date of the staining material were not getting documented in a way that clearly defined what lot was used for each day of patient testing. TP1 further confirmed that she performed approximately 10-15 manual blood smears per month. 4. A patient who had a manual blood smear performed on January 4, 2022 (MRN XXX249) was reviewed on the day of survey. Records of the lot numbers and expiration of the staining material used could not be found. The laboratory was unable to provide the records at request. 5. In an interview at 10:17 a.m. on June 14, 2023, the TC confirmed the above findings. . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure three of five available blood collection vacutainers used for collection of blood for coagulation testing was not used after the expiration date had been exceeded. Findings are as follows: 1. Three of the five Becton Dickinson Vacutainer Buffered Sodium Citrate, 0.109 M, 3.2% trisodium citrate blood collection tubes with lot number 2228631 and expiration date 05/31/2023 were observed as present and available for use in the patient draw area #1 during the tour. 2. In an interview at 8:05 a.m. on June 14, 2023, the Technical Consultant confirmed the above finding. . D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on review of personnel records and interview with laboratory personnel, the laboratory failed to ensure staff performing moderately complex testing meet the qualification requirements of 493.1423 to perform the functions specified in 493.1425 for the complexity of testing performed. Findings are as follows: Documentation was not provided for one of eight testing personnel showing educational requirements under 493.1423 were met. See D6065. . D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure one of eight testing personnel had the required educational credentials to perform moderate complexity testing. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing and Microscopic Examinations for bacteria, parasites, fungus, and urine sediment as confirmed the Technical Consultant -- 2 of 3 -- (TC) and Testing Personnel 1 (TP1) during a tour of the laboratory at 8:05 a.m. on June 14, 2023. The laboratory performed approximately 7,895 moderate complexity tests annually. 2. Documentation of a high school education was not found for Testing Personnel 7 (TP7) during review of laboratory documents. An Associate degree in Radiography for TP7 was provided. 3. Survey document Form CMS-209, signed by the Laboratory Director (LD) on June 14, 2023, listed TP7 as qualified to perform moderate complexity testing. 4. In an interview at 11:45 a.m. on June 14, 2023, the TC and LD confirmed documentation of a high school education was not present for TP7. The laboratory was given an opportunity to provide the credentials within 2 days of the survey. 5. In an email dated June 15, 2023, received at 3:49 p.m., the LD indicated the diploma or official documentation of high school education had not been received for TP7. -- 3 of 3 --

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 an unacceptable Hematology proficiency testing (PT) result 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 1:50 p.m. on 07/22/21. 2. The laboratory performed PT using the American Proficiency Institute (API) program. 3. The laboratory received an unacceptable Lymphocyte (Lymph) PT result for 1 of 5 PT challenges completed for the 2019 Hematology 3rd event. See below. API 2019 Hematology 3rd event Sample Test Lab result API range HSY-08 Lymph 37.1 22.0-28.3 4. Investigation of unacceptable PT results was required as established in the Quality Assurance for Laboratory Testing procedure provided by the laboratory. 5. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 4:15 p.m. on 07/22/21, the LD confirmed the above finding. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step 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 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 reference intervals were consistent between procedure and patient test report. Findings are as follows: 1. The laboratory performed Coagulation testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 1/24/18 at 10:05 a.m. 2. A Roche Coaguchek XS Pro coagulation analyzer was observed as present and available for use during the tour. 3. The reference interval listed in the PT-INR* Whole Blood Using Coaguchek XS Plus or Pro Test System Procedure, located in the on-line Procedure Manual, was not consistent with that included on the patient test report (MRN = 7178049) reviewed on date of survey, 1/24 /18. Analyte Procedure Report INR 0.9 - 1.1 0.8 - 1.1 4. In an interview at 2:15 p.m. on 1/24/18, the LD confirmed the above findings. * PT-INR = Prothrombin Time - International Normalized Ratio . 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 --