Gundersen Boscobel Area Hospital And Clinics

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor observation of the large white freezer, review of temperature logs, and interview with a technical consultant, staff A, the laboratory did not define an acceptable temperature range that was consistent with the manufacturer's acceptable range for the Maine Standards calibration verification material stored in the freezer for twenty-eight days of one hundred fifty-two days from January 1, 2024, through May 31, 2024. Findings include: 1. Observation of eight boxes of Maine Standards Validate calibration verification material used for chemistry analytes in the large white freezer on June 5, at 3:30 PM showed the manufacturer required storage at -10 to -25 degrees Celsius (C). 2. Review of the "Daily Temperature Monitoring Log" from January 1st through May 31, 2024, showed the defined acceptable temperature range for the large white freezer was -20 C or colder. Further review showed the following dates the temperature was colder than -25 C: January: 12, 16-17, 27 February: 25-27 March: 13, 22, 24 April: 7, 11, 19, 25-26, 29 May: 8-11, 13-14, 18, 24, 26-29 3. Interview with the staff A on June 5, 2024, at 3:35 PM confirmed the laboratory's acceptable range for the large white freezer was not consistent with the manufacturer's acceptable range for the Maine Standards Validate calibration verification material. 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 -- 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 survey review of a patient's chemistry test report and laboratory procedures and interview with a technical consultant, staff A, the reference ranges shown on the patient report were not the same as the approved reference ranges for two of six chemistry analytes reviewed. Findings include: 1. Review of the reference range of a chemistry test report from January 23, 2024, in the electronic medical record (EMR) for patient 1 (an adult female) showed the following expected ranges: Analyte /Reference range Sodium /135-146 milli moles/Liter (mmol/L) Potassium /3.4-5.0 mmol/L Chloride /96-108 mmol/L Creatinine /0.51-0.95 milligrams/deciliter (mg/dL) Calcium /8.6-10.0 mg/dL Glucose /70-99 mg/dL 2. Review of the individual chemistry procedures for each analyte showed the approved reference ranges for an adult female are: Analyte /Reference range Sodium /135-146 mmol/L Potassium /3.4- 5.0 mmol/L Chloride /96-108 mmol/L Creatinine /0.6-1.1 mg/dL Calcium /8.5-10.4 mg/dL Glucose /70-99 mg/dL Further review showed the creatinine and calcium reference ranges in the procedure did not match the patient's test report. 3. Interview with staff A on June 6, 2024, at 12:50 PM confirmed the reference range for creatinine and calcium in the procedures were not the same as the test report. This is a repeat deficiency from July 14-15, 2022. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on surveyor review of quality control procedures and interview with the chemistry technical consultants, staff A and staff B (who is the technical leader for chemistry), the technical consultant for chemistry did not ensure parameters set for acceptable level of quality performance were maintained for two of two analytes reviewed. 1. Review of the "Quality Control Criteria for Chemistry" procedure stated: "7) A monthly review of all computer data is conducted by the technical leader. Unrecognized problems and potential problems are discussed, and recommended actions are instituted towards correcting problems or trend, including any clinically significant increases in imprecision." 2. Review of quality control reports for alkaline phosphatase from December 1, 2023, through April 30, 2023, showed the target mean and standard deviation (SD) for Lot number 92951 (level 1) was 111.1 and 5.0 and Lot number 92952 (level 2) was 419.7 and 15.0. Further review showed the target mean and SD were unchanged during this timeframe. 3. Review of quality control reports for alkaline phosphatase showed the following calculated mean and SD for each month were: Lot # 92951 Month / Calculated mean / Calculated SD / Comment -- 2 of 3 -- December / 107.6 / 15.0 January / 109.0 / 1.9 February / 108.2 / 2.4 / 18 of 29 results were below the target mean. March / 107.3 / 2.2 / 26 of 31 results were below the target mean. April / 105.6 / 2.0 / All 30 results were below the target mean. Lot # 92952 Month / Calculated mean / Calculated SD / Comment December / 411.9 / 4.0 / 24 of 31 results were below the target mean. January /409.4 / 3.5 / 29 of 31 results were below the target mean. February / 406.9 / 4.5 / All 29 results were below the target mean. March / 405.4 / 3.7 / All 31 results were below the target mean. April / 401.4 / 4.2 / All 30 results were below the target mean. Further review showed the staff B reviewed the results monthly with no documentation of discussion or recommended action based on trending within the data. 4. Review of quality control reports for amylase from December 1, 2023, through April 30, 2023, showed the target mean and standard deviation (SD) Lot number 92952 (level 2) was 414.3 and 16.0. Further review showed the target mean and SD were unchanged during this timeframe. 5. Review of quality control reports for amylase showed the following calculated mean and SD for each month were: Lot # 92952 Month / Calculated mean / Calculated SD / Comment December / 405.8 / 2.8 / 30 of 31 results were below the target mean. January /408.0 / 6.8 / 29 of 31 results were below the target mean. February / 428.8 / 2.2 / All 29 results were above the target mean. March / 428.1 / 2.1 / All 31 results were above the target mean. April / 427.4 / 2.3 / All 30 results were below the target mean. Further review showed the staff B reviewed the results monthly with no documentation of discussion or recommended action based on trending within the data. 6. Interview with staff A on June 5, 2024, at 2:30 PM confirmed the technical consultant for chemistry did not ensure parameters set for acceptable level of quality performance were maintained. 7. Interview with staff B (the chemistry lead and technical consultant) on June 5, 2024, at 2:50 PM confirmed the technical consultant did not follow the quality control procedure to discuss and recommend actions based on trends in quality control and did not ensure parameters set for acceptable level of quality performance were maintained. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on survey review of immunohematology logs and electronic medical record (EMR) and interview with the general supervisor, testing personnel did not report test results for one of one immunohematology report reviewed. Findings include: 1. Review of the immunohematology log showed patient 2 received emergency release transfused blood on December 23, 2023. Further review showed a type and screen, and unit crossmatches were performed on the patient. 2. Review of the EMR for patient 2 showed no test results for the type and screen and unit crossmatches. 3. Interview with the general supervisor on June 6, 2024, at 12:41 PM confirmed testing personnel did not report test results into the Laboratory Information System (LIS) for the immunohematology report reviewed and the results were not in the patient's chart. -- 3 of 3 --

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 surveyor review of maintenance logs and manufacturer's instructions and interview with the general supervisor, the laboratory had not performed the required two-month maintenance three of nine times and had not performed two of the three required maintenance items every six months on the Roche cobas c 311 analyzer from January 2021 through June 2022. Findings include: 1. Review of the "cobas c 311 analyzer Maintenance Logs" from January 2021 through June 2022 showed replacements of the ISE (ion selective electrode) measuring cartridges for sodium, potassium and chloride were to occur every two months. The records showed the laboratory replaced the electrodes quarterly in February, May, August, and November 2021, and February and May 2022. The logs showed the six-month maintenance tasks included cleaning the water inlet filter and cleaning the cooling fan. The laboratory did not document completion of these two items on any of the reviewed maintenance logs. 2. Review of the manufacturer's instructions for maintenance of the Roche c311 showed replacement of the ISE measuring cartridges must occur at least every two months and cleaning the inlet water filter and cooling fan must occur every six months. 3. Email correspondence with the general supervisor on August 9, 2022 at 2: 27 PM confirmed the laboratory did not change the ISE measuring cartridges on the Roche cobas c 311 every two months and confirmed the laboratory did not clean the water inlet filter or cooling fan every six months as required by the manufacturer. D5807 TEST REPORT CFR(s): 493.1291(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 2 -- 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 surveyor review of procedures, manufacturer's instructions and patient test reports and interview with the general supervisor, the interpretive information for opiates on the patient test report was not accurate on two of two test reports reviewed. Findings include: 1. Review of the "Trauma Drugs of Abuse - Medtox, Lab 8001" procedure showed the internally calibrated threshold for opiates was 100 ng/mL (nanograms per milliliter). 2. Review of the "Medtox Profile V MEDTOXScan Drugs of Abuse Test System Package Insert" showed the cutoff concentration for Opiates was either 100 ng/mL or 2000 ng/mL. 3. Review of test reports for patients one and two showed the cutoff for Opiates was 300 ng/mL. 4. Interview with the general supervisor on July 14, 2022 at 4:15 PM confirmed the cutoff found on the test report was not accurate. -- 2 of 2 --

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 surveyor review of immunoassay calibration verification records and procedures from the Roche Elecsys 411 analyzer and interview with general supervisor, the laboratory did not perform calibration verification analysis that included the maximum reportable range for the Free Thyroxine (FT4) analyte in 2019 and 2020. Findings include: 1. Review of calibration verification records for the Roche Elecsys 411 analyzer showed the laboratory performed calibration verification 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 -- for FT4 with a range of less than 0.101-4.71 ng/dL. 2. Review of the FT4 procedure for the Roche Elecsys 411 analyzer showed the laboratory's reportable range is 0.1- 7.77 ng/dL. 3. Interview with the general supervisor on January 5, 2021 at 9:15 AM, confirmed the laboratory did not perform calibration verification analysis that included the maximum reportable range for the FT4 analyte in 2019 and 2020. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Individualized Quality Control Plan (IQCP) and control and patient test records, and interview with the general supervisor, the laboratory did not meet their stated Quality Control (QC) requirements for testing external controls every thirty days for the serum human chorionic gonadotropin (HCG) analyte for two of twelve months in 2020. Findings include: 1. Review of the laboratory's IQCP for serum HCG testing showed external QC is required every thirty days and with each new lot or shipment of test kits. 2. Review of QC records showed the laboratory performed QC testing on: a. March 4, 2020 and April 19, 2020, with thirty day QC due April 4, 2020. b. November 13, 2020 and December 27, 2020, with thirty day QC due December 13, 2020. 3. Review of patient test records showed the laboratory ran patient 1 on April 12, 2020, with no QC run within thirty days prior to patient testing. Further review of patient test records showed the laboratory ran patient 2 on December 15, 2020 and patient 3 on December 21, 2020, with no QC run within thrity days prior to patient testing. 4. Interview with the general supervisor on January 4, 2021 at 12:45 PM confirmed the laboratory did not meet their QC requirements for serum HCG testing for two of twelve months in 2020. -- 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2019-3 and 2020-2. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) and American Proficiency Institute (API) PT records, the laboratory failed to achieve satisfactory performance in PT for the White Blood Cell (WBC) Differential (Diff) analyte in the Specialty of Hematology for events 2019-3 and 2020-2. Findings include: 1. Review of PT records in the federal CASPER reporting system shows that the laboratory failed two out of three PT events for the WBC Diff analyte in the Specialty of Hematology: Event 2019- 3, score 60% and Event 2020-2, score 0%. 2. Surveyor review of the API PT evaluation reports on September 30, 2020 confirmed the failed PT scores for the WBC Differential analyte. This results in a failure to achieve an overall testing event score of satisfactory performance for two out of three testing events which is unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies 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 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)