Gundersen Boscobel Area Hospital And Clinics

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory policies, competence assessment records, and the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form 209), and interview with the Ancillary Services Manager (Staff A), the laboratory did not follow their procedures for competence assessment for three of four staff members identified as technical consultants (TC), technical supervisors (TS) or general supervisors (GS). 1. Review of the Technical Consultant or Technical Supervisor and General Supervisor sections of the policy, "Objectives and Organization - Pathology and Laboratory Medicine, Lab - 0175", showed "Competency will be assessed annually using the form Technical Consultant / Technical Supervisor / General Supervisor Assessment, Lab-0135.18". 2. Review of competence assessment records revealed the director completed an assessment of Staff A in their performance of the responsibilities delegated as a TC, TS, and GS and signed the assessment on January 26, 2026. No other records were available for evaluation of other personnel with these delegated responsibilities including Staff B, C and D. 3. Review of the CMS Form 209 submitted for this survey showed the director delegated: Staff B with GS responsibilities for high complexity testing, TC responsibilities in bacteriology, mycology, parasitology, immunology, chemistry, and hematology and TS responsibilities in bacteriology and hematology. Staff C with TC and TS responsibilities in immunohematology, and Staff D with TC responsibilities in Chemistry. 4. Interview with Staff A on June 30, 2026, at 12:45 PM confirmed the director did not complete annual competence assessments for each of the staff members assigned TC, TS, and GS responsibilities. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 surveyor review of laboratory procedures, proficiency testing (PT) and other laboratory records, and interview with the Ancillary Services Manager (Staff A), the laboratory did not perform twice annual accuracy evaluations for fluid white blood cell (WBC) differentials in two of the last two years. Findings include: 1. Review of the procedure, 'Body Fluid Analysis - Affiliate, Lab - 8760' showed in the section, 'Differentials done on site (Boscobel and St. Joseph's)', "If WBC count is >200, prepare slide for differential. Stain and count per manual differential procedure if a differential is requested to be performed on site." 2. Review of PT records from 2024 through 2026 showed no results for fluid differentials. 3. Review of laboratory records from 2025 through 2026 showed no evidence the laboratory used an alternate method to evaluate fluid differential accuracy. 4. Interview with Staff A on June 30, 2026, at 2: 05 PM confirmed the laboratory would perform a fluid differential when the WBC count was greater than 200 and confirmed the laboratory did not verify the accuracy of the fluid differential procedure twice annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of laboratory records and procedures and interview with the Ancillary Services Manager (Staff A), the laboratory director did not approve, sign, and date one of one new procedure for performing High Sensitivity Troponin I test on the i-STAT analyzer before the laboratory placed the testing into use. Findings include: 1. Review of the performance verification records for the High Sensitivity Troponin I test on the i-STAT showed the laboratory implemented the test on November 18, 2025. 2. Review of the procedure, 'High Sensitivity Troponin I using the Abbott i-STAT, Lab-8650', origination date March 24, 2026, showed the laboratory director approved the procedure on March 23, 2026. There was no evidence the laboratory had an earlier version of the procedure. 3. Interview with Staff A on July 1, 2026, at 12:30 PM confirmed the implementation date and procedure approval date, and confirmed the laboratory director failed to approve, sign, and date the new procedure before the laboratory placed the test into use. Item 2: Based on surveyor review of laboratory procedures and interview with the Ancillary Services Manager (Staff A), the laboratory director did not approve, sign, and date one of one procedure for transfusion reactions when the laboratory changed its procedure. Findings include: 1. Review of 'Transfusion Reactions, Lab-3508' showed the laboratory revised the policy February 21, 2025. Further review showed the laboratory director approved an older version of the policy on November 8, 2023. 2. Interview with Staff A on June 30, 2026, at 2:50 PM confirmed the laboratory director did not approve, sign, and date the changes in the procedure. -- 2 of 5 -- D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the Ancillary Services Manager (Staff A) the laboratory did not document the date of initial use on the procedure for one of one new test system placed into use. Findings include: 1. Review of the performance verification records for the High Sensitivity Troponin I test on the i-STAT showed the laboratory implemented the test on November 18, 2025. 2. Review of the procedure, 'High Sensitivity Troponin I using the Abbott i-STAT, Lab-8650', showed no indication of the initial date of use for the test at this laboratory. 3. Interview with Staff A on July 1, 2026, at 12:30 PM confirmed the laboratory implemented the test on November 18, 2025 and confirmed the procedure did not include the initial date of use for the i-STAT High Sensitivity Troponin I test at this laboratory. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) 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 surveyor observation of a phlebotomy collection tray and interview with the Ancillary Services Manager (Staff A), one out of 52 blood sample collection tubes on a phlebotomist's collection tray was expired but available for use. Findings include: 1. Observation of a phlebotomy collection tray on July 1, 2026, at 10:30 AM revealed a red top vacutainer blood sample collection tube with expiration date June 3, 2026, available for use. 2. Interview with Staff A on July 1, 2026, at 1:50 PM confirmed the blood sample collection tube was expired and could have been used for collection. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's individualized quality control plans -- 3 of 5 -- (IQCPs) and interview with the Ancillary Services Manager (Staff A), three of four of the laboratory's IQCPs did not specify the type of controls used. Findings include: 1a. Review of two IQCPs, 'Quality Control Plan Test: MEDTOX Urine Drug Screen' and 'Quality Control Plan Test: Serum Pregnancy (Sure-Vue)', revealed both stated, "Perform two levels of external quality control (one positive and one negative), upon receipt of a new lot number of test kits/shipment and with every 30 days of kit use." Further review showed the IQCPs did not define the type of positive and negative external controls required. 1b. Review of the IQCP, 'Quality Control Plan Test: i- STAT Blood Gases, Creatinine, Chem 8+, HS Troponin I', revealed the plan stated, "Perform two levels of external quality control (Level 1 & 3), upon receipt of a new shipment, new lot number of test kits, and with every 30 days of kit use." Further review showed the IQCP did not define the type of external controls required. 2. Interview with Staff A on July 1, 2026, at 12:20 PM confirmed the IQCPs did not identify the type of external quality controls required for each of the test systems. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Ancillary Services Manager (Staff A), the laboratory director was not on site in the last six months. Two of two documented visits occurred on or before October 13, 2025. Findings include: 1. Review of records documenting onsite visits by the laboratory director showed they performed director responsibilities during two onsite visits to the laboratory in 2025 on April 14 and October 13. The laboratory had no documentation showing the director made an onsite visit after October 13, 2025. 2. Interview with Staff A on July 1, 2026, at 1:20 PM confirmed the director had not been onsite in the last six months. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of humidity records and maintenance logs and interview with the Ancillary Services Manager (Staff A), the director did not ensure the environmental conditions of the laboratory were appropriate for testing performed on the ACL Top coagulation analyzer during three of three months reviewed in 2026. Findings include: 1. Review of the maintenance log, 'ACL TOP 350 Model Maintenance Log' from January 2026 showed personnel noted issues with HemosIL RecombiPlasTin reagent stability and contacted the manufacturer. Personnel noted the laboratory installed a humidifier to address the issue. 2. Review of communication -- 4 of 5 -- from Werfen, the manufacturer of the HemosIL RecombiPlasTin reagent, showed the manufacturer recommended maintaining relative humidity levels from 30% to 60% and stated, "In cases where these conditions cannot be maintained, Werfen recommends that reagents be stoppered and capped in their original vial and stored at 2-8 degrees C (Celsius) when not in use in order to optimize reagent stability". 3. Review of humidity records documented on the 'Daily Temperature Monitoring Log' from February through April 2026 showed the following: Month | number of days humidity measured less than 30% | number of days in the month February | 25 | 28 March | 20 | 31 April | 14 | 30 The log showed the laboratory's acceptable humidity range was less than 80%. 4. Interview with Staff A on July 1, 2026, at 10:30 AM confirmed the environmental conditions identified as appropriate for testing by the manufacturer of the coagulation reagents used on the ACL Top coagulation analyzer were not met after personnel installed the humidifier in the laboratory. Further interview confirmed personnel did not stopper and cap reagents when they were not in use during periods of low humidity. -- 5 of 5 --

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)