Sedgwick County Health Center

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 direct observation and an interview with the general supervisor (GS), the laboratory failed to replace the Siemens Dade Innovin reagent after it had exceeded the expiration date and approximately 50 PT/INR patient tests had been performed using this reagent. Findings include: 1. An observation of the laboratory's reagents on July 22, 2024, at approximately 12:15 PM, revealed five vials of Siemens Dade Innovin reagent, lot number: 5497941C, expired on: 1/14/2024. 2. An interview with the GS on July 22, 2024, at approximately 12:20 PM, confirmed that the Siemens Dade Innovin reagent had expired and had been used for PT/INR testing for approximately 50 patients. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 review of the laboratory's policies and procedures manual, and an interview 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 -- with the General Supervisor (GS), the laboratory failed to establish a policy or procedure for determining the criteria for whether returned blood is suitable for reissue, and for the visual inspection of red blood cells immediately before distribution since the last survey was conducted on November 5, 2021. The laboratory performs approximately 186 immunohematology tests annually. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a policy or procedure for determining the criteria for whether returned blood is suitable for reissue since the last survey was conducted on November 5, 2021. 2. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a policy or procedure for the visual inspection of red blood cells immediately before distribution since the last survey was conducted on November 5, 2021. 3. The laboratory performs approximately 186 immunohematology tests annually. 4. Based on an interview with the GS on July 22, 2024, at approximately 12:45 PM, confirmed that the laboratory failed to establish a policy or procedure for determining the criteria for whether returned blood is suitable for reissue, and for the visual inspection of red blood cells immediately before distribution. 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 a review of the laboratory's policies and procedures manual, and an interview with the general supervisor (GS), the laboratory failed to document their quarterly alarm check for their temperature monitoring system attached to their blood product storage refrigerator and freezer since the last survey was conducted on November 5, 2021. The laboratory conducts approximately 186 immunohematology tests annually. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, revealed the laboratory failed to follow their policy and procedure for documenting quarterly alarm checks for their temperature monitoring system attached to their blood product storage refrigerator and freezer since the last survey was conducted on November 5, 2021. 2. Based on an interview with the GS on July 22, 2024, at approximately 12:25 PM, confirmed that the laboratory had failed to document their quarterly alarm checks of the temperature monitoring system attached to their blood product storage refrigerator and freezer since the last survey was conducted on November 5, 2021. -- 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Cell ID or WBC Diff for two out of three PT events (event 3 in 2023 and event 1 in 2024). See D2121. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT), and email communication with the laboratory manager, the laboratory failed to achieve a satisfactory score for Cell ID or WBC Diff for event 3 in 2023 and event 1 in 2024. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on May 10, 2024, at 01:18 PM, revealed the API PT results for Cell ID or WBC Diff testing scores for event 3 in 2023 was 0%, and 60% for event 1 in 2024. 2. An email with the laboratory's manager on May 13, 2024, at 02:11 PM, confirmed the laboratory failed to achieve satisfactory test performance for Cell ID or WBC Diff. -- 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 a routine proficiency test desk review of the CMS-155 report for proficiency testing performance and interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for PO2 Blood Gas for two consecutive events (Event 3 in 2022 and Event 1 in 2023). See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing scores from the American Proficiency Institute (API) and email communication with the laboratory manager, the laboratory failed to achieve a satisfactory score of at least 80 percent for PO2 Blood Gas testing performed on Event 3 in 2022 and Event 1 in 2023, resulting in unsuccessful performance. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 04/12/2023, at 9:00 AM, revealed the PO2 Blood Gas testing score for Event 3 in 2022 was 60% and Event 1 in 2023 was 40%. 2. An email communication with the laboratory manager on 04/13/2023, at 10:03 AM, confirmed two consecutive unsuccessful proficiency test scored for PO2 Blood Gas testing due to laboratory errors. -- 2 of 2 --