Appleton Area Health

Summary Statement of Deficiencies D0000 The Appleton Area Health laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey completed on April 9, 2026. The following standard-level deficiencies were cited: 493.1253 Establishment and verification of performance specifications 493.1256 Control procedures 493.1291 Test report . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to complete one of five required Performance Verification (PV) activities for one of five newly implemented Chemistry analytes prior to reporting patient test results in 2025. Findings are as follows: 1. The laboratory performed Venous Blood Gas (VBG) testing under the Chemistry specialty as confirmed by the General Supervisor (GS) during a tour of the laboratory at 12:30 p.m. on 4/8/26. 2. A Siemens EPOC Blood Gas Analysis device was observed as present and available for use VBG testing on patient samples during the tour. The laboratory implemented VBG testing using the EPOC device for the following analytes on 7/28/25. pH, Venous PCO2, Venous PO2, Venous Base Excess, Venous Bicarbonate, Venous 3. PV documentation found in the New Test Implementation 2024 + 2025 binder 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 -- provided by the laboratory included accuracy, precision, and linearity verification data for all analytes. Reference range verification documentation was not found for PO2. 4. In an interview at 1:58 p.m. on 4/9/26, the GS confirmed the above findings and indicated the laboratory performed 14 VBG tests on patient samples in 2025. . D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to evaluate stain for intended reactivity each day of use for one of ten days of patient testing in August 2024. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed by the General Supervisor (GS) during a tour of the laboratory at 12:30 p.m. on 4/8/26. 2. Easy III Quick Stain reagents and an Olympus CH30 microscope used to perform manual differentials were observed as present and available for use during the tour. 3. Testing personnel were required to perform and document stain quality and initial a Daily Maintenance Log each day of patient testing as defined in the Easy III Quick Stain For Hematology procedure found in the Hematology & Coagulation Procedure Manual provided by the laboratory on the date of survey. 4. Hematology manual differential smear testing was performed on a single patient sample on 8/3/24, reviewed on the date of survey. Documentation of acceptable stain reactivity was not found for this day of patient testing. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 11:15 a.m. on 4 /9/26, the GS confirmed the above findings and stated the laboratory did not document stain quality on the day the patient test was performed. . D5807 TEST REPORT CFR(s): 493.1291(d) (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 the laboratory personnel, the laboratory failed to ensure one of five pertinent Chemistry reference intervals were included on a patient test report in 2025. Findings are as follows: 1. A Siemens EPOC Blood Analysis device was observed as present and available for use for Venous Blood Gas (VBG) testing on patient samples under the Chemistry specialty as confirmed by the General Supervisor (GS) during a tour of the laboratory at 12:30 p.m. on 4/8/26. 2. A reference interval for PO2 was not included on a patient test report from 10/31/25 reviewed on the date of survey. See below: Patient Test Report from 10/31/25 Analyte Reference Interval pH, Venous 7.32 - 7.45 pH PCO2, Venous 38.0 - 48.0 mm Hg PO2, Venous ---- Base Excess, Venous -2.0 - 3.0 mmol/L Bicarbonate, Venous 22.0 - 29.0 mmol/L 3. A reference interval for PO2 was not established in the Performance Verification activites performed prior to -- 2 of 3 -- implementation of the EPOC device. See D5421. 4. In an interview at 1:58 p.m. on 4/9 /26, the GS confirmed the above findings and indicated the laboratory performed 14 VBG tests on patient samples since implementing the EPOC Blood Gas Analysis device on 7/28/25. . -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(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: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure one of one Individualized Quality Control Plans (IQCP) developed in 2020 was approved, signed, and dated by the laboratory director prior to implementation. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by Technical Consultant (TC) during a tour of the laboratory at 8: 10 a.m. on 06/22/22. 2. An Cepheid GeneXpert was observed as present and available for use during the tour of the laboratory. The laboratory performed the SARS-CoV-2, Flu A, Flu B and RSV Combination Test (4-Plex) with this analyzer beginning in December 2020 as indicated in the 4-Plex performance verification documentation and confirmed by the TC during the tour. 3. An IQCP dated 11/20/20 was found in laboratory records. 4. The laboratory director's approval signature and date were not included in the IQCP document. 5. The laboratory provided approximately 1100 Microbiology results to patients annually as indicated on the Form CMS-116 provided by the laboratory on date of survey, 06/22/22. 6. In an interview at 12:15 p.m. on 06/22 /22, the TC confirmed the above finding. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) 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 -- Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for 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 and document calibrations with the frequency indicated in procedure and established by the manufacturer for one of one new Chemistry analyte implemented in 2021 . Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on at 8:10 a.m. on 06/22/22. 2. An Alfa Wassermann ACE Axcel Chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory implemented Phosphorous (PHOS) testing on this analyzer in August 2021 as indicated in the PHOS performance verification (PV) records. The Laboratory Director approved the PV on 08/16/21. 3. The Alfa Wassermann Ace Inorganic Phosphorus procedure, located in the Ongoing New Assays - Starting Dec 2020 manual, established PHOS calibration performance frequency as every 20 days. The manufacturer's package insert indicated PHOS calibration was required every 20 days. 4. The laboratory failed to perform PHOS calibration every 20 days from September 2021 through date of survey, 06/22/22. Laboratory records from September through November 2021 indicated PHOS calibration was performed every 30 days. Testing Personnel TP5 indicated the analyzer software for PHOS calibration was set at every 30 days. 5. In an interview at 3:45 p.m. on 06/22/22, the TC confirmed the above finding. 6. In an email received at 9:49 a.m. on 06/23/22, the TC indicated 9 patient specimens received PHOS testing from testing implementation to date of survey, 06/22/22. . D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document alarm system function checks for the blood storage refrigerator in 2021 with the frequency defined by the laboratory. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on at 8:10 a.m. on 06/22/22. 2. The laboratory stored blood products in a designated refrigerator. The blood storage refrigerator had a temperature alarm system. 3. Monthly, quarterly, weekend, and holiday blood product storage alarm check requirements were established on the Blood Bank temperature log. The alarm check requirements were listed as follows: Monthly - during a day shift Quarterly - during a night shift in -- 2 of 3 -- March, June, September, and December Weekend - first weekend in January Holiday - Labor Day 4. Blood product storage alarm checks were not performed on seven of eighteen required occasions in 2021 as indicated on the Blood Bank temperature log. See below. February Monthly March Quarterly July Monthly September Monthly, Quarterly December Monthly, Quarterly 5. The laboratory provided approximately 100 Immunohematology results to patients annually as indicated on the Form CMS- 116 provided by the laboratory on date of survey, 06/22/22. 6. In an interview at 5:00 p.m. on 06/22/22, the TC confirmed the above finding. . D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory director failed to ensure initial training on two new analyzers was documented for four of nine testing personnel in 2020 and one of seven testing personnel in 2021. Findings are as follows: 1. The laboratory performed Microbiology and Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 8:10 a.m. on 06/22/22. 2. The laboratory implemented testing on two new analyzers, the Cepheid GeneXpert System in December 2020 and the Beckman Coulter DxH 520 Hematology analyzer in December 2021, as indicated in laboratory records. 3. Training documents for the two new analyzers were not found during review of personnel records for the following testing personnel (TP): GeneXpert TP1 TP2 TP4 TP5 DxH 520 TP4 The laboratory was unable to provide the missing training documents upon request. 4. The laboratory provided approximately 1100 Microbiology results and approximately 10,000 Hematology results to patients annually as indicated on the Form CMS-116 provided by the laboratory on date of survey, 06/22/22. 5. In an interview at 12:10 p.m. on 06/22/22, the TC confirmed the above finding. -- 3 of 3 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to ensure 6 of 6 testing personnel were evaluated for test procedure competency in all specialties in 2018 and 2019. Findings are as follows: 1. The laboratory performed Chemistry and Hematology testing as confirmed by General Supervisor during a tour of the laboratory at 8:05 a.m. on 11/19/20. 2. A MedToxScan Profile V chemistry analyzer, a Tosoh A1A-360 chemistry analyzer, and a Hemetek ESR STAT Plus hematology analyzer were observed as present and available for use during the tour. 3. Competency assessments for testing performed on the above analyzers were not included in the Appleton Area Health Services Laboratory Technical Competency evaluation forms completed in 2018 and 2019 for 6 of 6 testing personnel. 4. The laboratory was unable to provide the missing evaluations upon request. 5. In an interview at 10:25 a.m. on 11/19/20, the Technical Consultant 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 --