South Peninsula Hospital

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of patient and quality control result log sheets and an interview with the technical supervisor, the laboratory did not include positive and negative control materials each day patients were tested using the Sure-Vue Mono test kit beginning in May 2024. 1. A review of patient results and quality control records from May 17, 2024 through December 11, 2024 revealed the laboratory failed to perform positive and negative controls for 32 out of 35 days of patient testing. 2. An interview conducted on 12/11/2024 at 2:00 PM with the technical supervisor confirmed positive and negative controls were not performed each day of patient testing. 3. The log sheets show 38 patients tested during from 5/17/24 through 12/11/24. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of South Peninsula Hospital Laboratory Blood Bank Specimen Labeling and Acceptability Procedure (BB-018), transfusion records, and interview with the laboratory manager, the laboratory did not follow its procedure for collecting and labeling blood bank specimens by not applying the blood bank identification band to the patient and affixing the corresponding label to the specimen at the time of collection. Findings include: 1.Policy BB-018 Procedure states: a."1.: The patient must be positively identified at the time of collection." b."1.c: Use of the Securline Identification armband is mandatory for all recipients of red blood products, FFP, and platelets. c."5. The Blood Bank specimen is good for 3 days, ending at midnight of day 3." 2. The laboratory received an order for a Type and Screen, and crossmatch for Patient #694077 (for 2 units of packed red blood cells (PRBC), for transfusion on 8/8 /2022 at 13:38 pm. 3. Upon receipt of the blood bank order received at 13:38, Patient #694077 was not redrawn for transfusion work up at the time the patient was banded with the blood bank Securline identification armband as directed in the laboratories Policy BB-018 Procedure. 4. The laboratory used the routine draw blood specimen collected at 06:00 am on 08/08/2022, and re-labeled the routine 06:00 am blood specimen with the corresponding Securline blood bank identification label (#2113 CFR) and performed the requested ABO type, screen and crossmatch. 5. The laboratory manager confirmed these findings by interview on 8/25/22 at 14:00. 6. The laboratory reports performing 2526 immunohematology tests annually. 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 --

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 an off-site desk review of the laboratory's 2021 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, it was determined that the laboratory failed to successfully participate in PT. See D-Tag 2096, unsatisfactory performance for the same analyte in two out of three consecutive Routine chemistry PT events. Refer to D 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review, the laboratory's graded PT results from the Wisconsin State Laboratory of Hygiene (WSLH) and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for Total Bilirubin in two out of three consecutive testing events. Findings: 1. The laboratory is subscribed to the Wisconsin State Laboratory of Hygiene (WSLH) for chemistry proficiency testing. 2. The laboratory received the following scores for Total Bilirubin: 2021 second testing event = 60% 2021 third testing event = 80% -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) results and technical supervisor interview, the laboratory failed to document the acceptability of PT results when these results were not evaluated or scored by the PT provider for all non-scored analytes in the 2020 Hematology and Microbiology surveys. Findings include: 1. The laboratory subscribes to the Wisconsin State Laboratory of Hygiene for proficiency testing. 2. In the 2020-1 Hematology survey, the following sample was not scored and did not have documented review for acceptability: a. 2020-HemeReg1: Cell Identification (XIE-7) 3. In the Microbiology surveys, the following samples were not scored and did not have documented review for acceptability: a. 2020-BactiReg1: Susceptibility (MC-5), BioFire FilmArray GI Panel (EP-1, EP-2), and BioFire FilmArray ME Panel (MEP-1, MEP-2, MEP-3, MEP-4, MEP-5) b. 2020-BactiReg2: Susceptibility (MC-14), BioFire FilmArray ME Panel (MEP-6, MEP-7, MEP-8, MEP-9, MEP-10) c. 2020-Bacti- Reg3: Susceptibility (MC-22, MC-23), BioFire FilmArray ME Panel (MEP-11, MEP- 12, MEP-13, MEP-14, MEP-15) 4. The technical supervisor confirmed these finding on 4/20/2021 at 12:30 pm. 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 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 interviews with the laboratory technical supervisor and review of the laboratory's verification of the Siemens EPOC, the laboratory failed to assess precision prior to testing patients. Findings include: 1. The verification for the Siemens EPOC was completed on 3/1/2020 and did not include documentation of precision for blood gas (pH, pCO2, pO2), Sodium, Potassium, Ionized Calcium, Chloride, Glucose, Lactate, Creatinine, and Hematocrit. 2. The laboratory performs approximately 320 blood gas analyses and 35 point of care chemistry panels annually. 3. The technical supervisor confirmed these findings on 4/20/2021 at 12:30 pm. -- 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 review of proficiency testing records, the laboratory unsuccessfully participated in proficiency testing (PT) for Yeast Identification in the the subspecialty of Mycology. D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing performance for Yeast Identification in the subspecialty of Mycology in two out of three testing events. Findings: 1. The laboratory is subscribed to the Wisconsin Laboratory of Hygiene (WSLH) proficiency testing program for Mycology. 2. The laboratory received the following scores: 2019 Third Testing Event = 40% 2020 Second Testing Event = 60% -- 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 review of proficiency testing records, the laboratory unsuccessfully participated in proficiency testing (PT) for the specialty of Bacteriology and Immunohematology Antibody Identification. See D2028, 2191 D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing performance for the specialty of Bacteriology in two out of three testing events. Findings: 1. The laboratory subscribes to the College of American Pathologists (CAP) proficiency testing program for Bacteriology. 2. The laboratory received the following scores: 2017 Third Testing Event = 79% 2018 First Testing Event = 66% D2191 ANTIBODY IDENTIFICATION CFR(s): 493.865(f) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory failed to achieve satisfactory proficiency testing performance for the analyte Antibody Identification in two out of three testing events. Findings: 1. The laboratory subscribes to the College of American Pathologists (CAP) proficiency testing program for Antibody Identification. 2. The laboratory received the following scores: 2017 Third Testing Event = 0% 2018 First Testing Event = 0% -- 2 of 2 --