Huggins Hospital

Summary Statement of Deficiencies D0000 Huggins Hospital had a Proficiency Testing (PT) survey performed on 4/3/2025 (offsite) and 4/15/2025 (onsite) for failed PT results. The survey for PT was performed pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at Title 42 CFR 493. 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 record review and staff interview, the laboratory failed to successfully participate in a proficiency testing program for routine chemistry testing in 2024 and 2025. Refer to D2087 and D2096. 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory (lab) failed to attain satisfactory scores of 80% for partial pressure of oxygen (pO2) in proficiency testing (PT) event 2 of 2024 and event 1 of 2025. Findings include: 1. Review on 4/3/2025 of CASPER Report 0155D revealed the following scores for pO2 PT: 2024 Event 2 = 0% 2025 Event 1 = 20% 2. Interview with the Technical Supervisor on 4/15/2025 at 10:30 a.m. confirmed the above scores for pO2. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) 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 record review and staff interview, the laboratory (lab) failed to achieve satisfactory performance for partial pressure of oxygen (pO2) in 2 out of the last 3 proficiency testing (PT) events in 2024 and 2025 resulting in unsuccessful performance. Findings include: 1. Review on 4/3/2025 of CASPER Report 0155D revealed the lab obtained the following unsatisfactory scores for pO2 PT: 2024 Event 2 = 0% 2025 Event 1 = 20% 2. Interview with the Technical Supervisor on 4/15/2025 at 10:30 a.m. confirmed the unsatisfactory scores for pO2 listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to test control material every 8 hours of performing and reporting blood gas analytes (hydrogen concentration, partial pressure of oxygen, partial pressure of carbon dioxide, and oxygen saturation) results for 23 of 24 days patient testing was performed in April and May 2021 Findings include: 1) Review on 5/20/2021 of patient blood gas test records from April and May 2021 revealed 29 patient blood gases had been reported on 24 different days. 2) Review on 5/20/2021 of control records for blood gas testing from April and May 2021 revealed quality control testing was not performed within 8 hours before patient testing on 23 of the 24 days; for 28 out of 29 patients tested and reported during this period. 3) Interview on 5/20/2021 at 9:45 a.m. with a Technical Supervisor (TS) confirmed control testing had not been performed for 28 of the 29 patient blood gas results reported. The TS revealed revealed the blood gas analyzer was a replacement instrument, put into use in April 2021, and had not been programmed to perform the quality control testing automatically each day. 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 D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document that it checked the current batch of MacConkey with Sorbitol (SMAC) for sterility, its ability to support growth and produce biochemical responses used for the determination of sorbitol fermentation and a visual inspection of the batch received in February 2019. Findings include 1) Observation on 3/28/19 at 9:30 AM of the bacteriology storage refrigerator revealed two media plates of SMAC lot 474858. 2) Review on 3/28/19 of the laboratory's "Non-Exempt Media Quality Control 2019" log from January through March 2019 revealed no documentation that the current lot 474858 of SMAC had been visually checked for cracks or signs of deterioration, checked for sterility, checked for its ability to support growth of microorganisms that ferment sorbitol and microorganisms that do not ferment sorbitol. 3) Review on 3/28 /19 of the shipping invoice for SMAC lot 474858 revealed the laboratory received 1 pack (of 10 plates) on 2/20/19. There was no documentation on the invoice of a visual inspection of SMAC media plates. 4) Interview on 3/28/19 at 9:45 AM with the General Supervisor (GS) confirmed the above findings. The GS revealed there is no quality assurance procedure to review the control log to ensure media has been checked prior to it's use. 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 -- 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 record review and staff interview, the laboratory's hematology control procedure failed to include instruction to perform two levels of control testing every 8 hours for nonmanual coagulation test systems in 2018 and 2019. Findings include: 1) Review on 3/28/2019 of the D-Dimer Procedure, last revised 1/18/2018, revealed the manufacturer's instruction to perform two levels of controls upon opening each new reagent cartridge kit. The laboratory did not develop an individualized quality control plan (IQCP) to support the alternative control procedures. 2) Review on 3/28/2019 of D-Dimer control testing from 1/1/19 to 3/28/19 revealed two levels of D-Dimer controls were run within 24 hours of patient testing. 2) Interview on 3/28/2019 at 12: 45 PM with the Technical Supervisor (TS) confirmed the laboratory did not develop an IQCP to support the frequency of D-Dimer control testing outlined in the procedure and revealed the laboratory's practice was to perform control testing more frequent than the procedure required by performing them every 24 hours from patient testing. -- 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 record review and phone interview, the laboratory failed to successfully participate in consecutive proficiency testing (PT) events for subspecialty mycology in 2017. Findings include: 1) Review on 1/11/2018 of CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory obtained unsatisfactory PT scores in the 2nd (60%) and 3rd (60%) Wisconsin State Laboratory of Hygiene (WSLH) PT events in 2017 for the subspecialty mycology. 2) Review on 1/11/2018 of the WSLH PT evaluation records revealed the laboratory obtained unsatisfactory scores for yeast identification within the subspecialty mycology. The laboratory obtained scores of 60% in the 2nd WSLH PT event in 2017 and 60% in the 3rd 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 -- WSLH PT event in 2017 for yeast identification testing. 3) Phone interview on 1/11 /2018 at 11:45 a.m. with the Technical Supervisor confirmed the above findings. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and phone interview, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score for mycology yeast identification in two consecutive events in 2017. Findings include: 1) Review on 1/11 /2018 of CASPER Report 0155D (Individual Laboratory Profile) revealed the laboratory obtained unsatisfactory PT scores in the 2nd and 3rd Wisconsin State Laboratory of Hygiene (WSLH) PT events in 2017 for the subspecialty mycology. 2) Review on 1/11/2018 of the WSLH PT evaluation records revealed the laboratory obtained unsatisfactory scores for yeast identification within the subspecialty mycology. The laboratory obtained scores of 60% in the 2nd WSLH PT event in 2017 and 60% in the 3rd WSLH PT event in 2017 for yeast identification testing. 3) Phone interview on 1/11/2018 at 11:45 a.m. with the Technical Supervisor confirmed the above findings. -- 2 of 2 --