Froedtert Community Hospital - New Berlin

Summary Statement of Deficiencies D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures, and interview with the laboratory director, the laboratory had not performed two levels of quality control (QC) testing each eight hours of patient testing in twelve of twelve months since April 2022 when the laboratory started D-dimer testing on the Fastpath analyzer. Findings include: 1. Review of Pathfast maintenance worksheets showed QC testing was performed once per day for the three tests performed on the test system. 2. Review of the 'Pathfast Instrument Testing (Troponin I, NT-pro-BNP, D-dimer)' procedure showed the procedure required two levels of external QC daily for D-dimer testing. The procedure did not include instructions to perform QC testing every eight hours of patient testing. 3. Interview with the laboratory director on April 20, 2023 at 1:00 PM confirmed the laboratory did not perform QC testing each eight hours of patient testing on the Fastpath D-dimer test since starting testing in April 2022. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) 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 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of test records and interview with the laboratory director, the laboratory did not maintain a record system that identified which testing person performed each hematology test on the Sysmex XN-330 analyzer in 2022 and 2023. Findings include: 1. Review of test records showed no paper records of tests performed on the Sysmex XN-330 hematology analyzer. Review of electronic records showed no record of which person performed the CBC tests on the Sysmex XN-330. The laboratory estimated they tested approximately 6000 samples annually with the Sysmex XN-330. 2. Interview with the laboratory director on April 20, 2023 at 2:00 PM confirmed the laboratory did not maintain a record system that included the identity of the testing person who performed hematology testing on the Sysmex XN- 330 analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant, the laboratory did not have a copy of the procedure for the Abbott I-Stat analyzer after discontinuation of the basic metabolic panel (BMP) testing in December 2019. Findings include: 1. Review of laboratory procedures showed no evidence of the Abbott I-Stat BMP procedure. 2. Interview with the technical consultant on June 10, 2021 at 11:20 AM confirmed the laboratory did not have a copy of the Abbott I-Stat BMP procedure after discontinuation of the testing. 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 surveyor review of laboratory records and interview with the technical consultant, the laboratory did not have analytical system records for the Abbott I-Stat analyzer for testing performed in 2019. Findings include: 1. Review of laboratory records for the Abbott I-Stat analyzer revealed no quality control, maintenance and 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 -- calibration records for 2019. 2. Interview with the technical consultant on June 10, 2021 at 11:20 AM confirmed the laboratory did not have analytical system records for the Abbott I-Stat analyzer for testing performed in 2019. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant, the laboratory did not retain the PT records for PT testing performed in 2019. Findings include: 1. Review of API PT records showed no evidence of testing records, signed attestation statements, PT result scores from the provider, and documentation of result review for 2019. 2. Interview with the technical consultant on June 10, 2021 at 10:35 AM confirmed the laboratory did not have PT testing records and documented review of results for PT testing performed in 2019. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant, the laboratory director did not assure compliance with the applicable regulations pertaining to retention requirement at CFR 493.1105. Findings include: 1. Review of laboratory procedures showed no evidence of the Abbott I-Stat BMP procedure. 2. Review of analytical records showed no evidence of quality control, maintenance and calibration records for 2019. 3. Review of proficiency testing (PT) records showed no evidence of testing records, signed attestation statements, PT results and scores from the provider and documentation of result review for PT testing performed in 2019. 4. Interview with the technical consultant on June 10, 2021 at 11: 20 AM confirmed the laboratory director did not assure compliance with the applicable regulations pertaining to retention requirements at CFR 493.1105. -- 2 of 2 --

Summary Statement of Deficiencies D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on surveyor review of transfusion records for patient three and interview with the emergency department manager (staff A), the transfusion service did not document the physician's approval for the transfusion of one unit of uncrossmatched red blood cells as required on the "Certification Record of Blood Transfusion" form. Findings include: 1. Review of the "Certification Record of Blood Transfusion" form for patient three, unit number W036318314340, showed the attending physician's signature is required on the form certifying that the patient's life would be endangered by waiting for routine compatibility studies and accepting all responsibility for the emergency transfusion. The attending physician did not sign the form. The form showed staff transfused the unit to patient one starting at 1:00 AM on December 12, 2018. 2. Interview with the emergency department manager (staff A) on February 28, 2019 at 11:45 AM confirmed the attending physician is required to sign the "Certification Record of Blood Transfusion" form and also confirmed the physician did not sign the form approving transfusion of uncrossmatched blood to patient three. D3017 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(a) Arrangement for services. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. 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 -- This STANDARD is not met as evidenced by: Based on surveyor observation of blood products and interview and email correspondence with the Emergency Department Manager (staff A), the emergency department does not have a transfusion service agreement with the organization that supplies blood components for transfusions in the emergency department. Findings include: 1. Observation of refrigerated storage in the emergency department on February 28, 2019 at 11:35 AM showed two type O negative red cell units available for uncrossmatched transfusion. 2. Interview with the Emergency Department Manager (staff A) on February 28, 2019 at 11:35 AM revealed the emergency department performs transfusions including crossmatched or uncrossmatched red cell, platelet, and thawed fresh frozen plasma units. 3. Email correspondence with the Emergency Department Manager (staff A) on March 12, 2019 at 3:05 PM confirmed the emergency department does not have a current transfusion services agreement with their blood component supplier. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of information in the RALS Data Management System and two patient test reports (patient one and two) in the electronic medical record, and interview with the technical consultant, two of two test reports did not indicate the name and address of the testing laboratory. Findings include: 1. Review of information in the RALS Data Management System revealed test results for two patients that had testing performed at this location on the i-STAT analyzer. This laboratory performed testing on patient one on February 15, 2019 and on patient two on February 19, 2019. 2. The electronic medical record test reports for patient one on February 15, 2019 and patient two on February 19, 2019 identified Community Memorial Hospital Laboratory on Town Hall Road in Menomonee Falls as the testing location on both reports. 3. Interview with the technical consultant on February 28, 2019 at 10:40 AM confirmed this laboratory performed i-STAT testing for patients one and two and confirmed the test reports did not indicate the correct name and address of the testing location. -- 2 of 2 --