Brookings Health System

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 12/20/23. Brookings Health System laboratory was found not in compliance with the following requirement: D6126. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisor failed to ensure annual competency assessments included an assessment of problem-solving skills for twelve of fourteen laboratory staff (A, B, C, D, E, F, G, H, I, J, K and L). Findings include: Review of employees' files for laboratory staff revealed: *Laboratory staff A had a competency evaluation performed on 11/29/22 and on 12/6/23. *Laboratory staff B had a competency evaluation performed on 12/28/22. *Laboratory staff C had a competency evaluation performed on 11/29/22 and on 12/5/23. *Laboratory staff D had a competency evaluation performed on 12/28/22. *Laboratory staff E had a competency evaluation performed on 11/29/22 and on 11/28/23. *Laboratory staff F had a competency evaluation performed on 2/8/22 and on 3/20/23. *Laboratory staff G had a competency evaluation performed on 7/23/22 and on 10/28/23. *Laboratory staff H had a competency evaluation performed on 9/29/23. *Laboratory staff I had a competency evaluation performed on 12/28/22. *Laboratory staff J had a competency evaluation performed on 5/19/22 and on 5/16/23. *Laboratory staff K had a competency evaluation performed on 5/24/22 and on 12/18/23. *Laboratory staff L had a competency evaluation performed on 3/30/22, 9/27/22 and on 11/17/23. a. The above competency assessment forms did not include the assessment of problem- solving skills related to the performance of laboratory testing. b. The above competencies had been completed and signed by laboratory staff A (B, C, D, E, F, G, 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 -- H, I, J, K and L) and laboratory staff B and E (A). c. The laboratory director had reviewed and signed the competency assessments. Review on 12/20/23 of the Quality Assessment Program- Competency policy revised on 3/23/12 revealed: *Problem- solving was not included in the competency assessment procedure. *The current laboratory director had not signed the competency policy. Interview on 12/20/23 at 1: 00 p.m. with laboratory staff A revealed she was not aware it was necessary to document the assessment of problem-solving skills on the competency assessments. Interview on 12/20/23 at 3:00 p.m. with the laboratory director revealed she was not aware of the assessment of problem-solving skills that had to be documented on the competency assessments. -- 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 proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful participation for the free triiodothyronine (T3), sodium, and chloride test methods. Unsatisfactory results had been received in two of three PT events (American Proficiency Institute 2023 Chemistry Core 1st Event, 2023 Chemistry Core 2nd Event and 2023 Chemistry Core 3rd Event) resulting in unsuccessful PT participation. Refer to D2087 and D2109. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 3 -- 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 review of the CASPER proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute (API) PT reports and interview with the laboratory supervisor, the laboratory failed to achieve a satisfactory score of 80% or above for the sodium and chloride test methods for two of three events (API 2023 Chemistry Core 1st Event and 2023 Chemistry Core 3rd Event). Findings include: 1. Review of the 10/25/2023 CASPER Unsuccessful PT Report 153D revealed the laboratory received unsatisfactory scores (less than 80%) for the sodium and chloride test methods in each of the two events identified above. Review of the 10/25/2023 CASPER Individual Laboratory Profile PT report 155D and API PT 2023 Chemistry Core 1st and 2023 Chemistry Core 3rd event evaluation reports revealed scores of 20% and 0% for the sodium test method and scores of 0% and 0% for the chloride test method for each event. Review of the individual API sodium and chloride test method scores for the two API PT events revealed: a. 2023 Chemistry Core 1st Event sodium results: *CH-02 was 130, the acceptable range was 120-129 millimoles/liter (mmol /L). *CH-03 was 181, the acceptable range was 170-179 mmol/L. *CH-04 was 145, the acceptable range was 134-143 mmol/L. *CH-05 was 167, the acceptable range was 155-164 mmol/L. 2023 Chemistry Core 1st Event chloride results: *CH-01 was 98, the acceptable range was 87-97 mmol/L. *CH-02 was 98, the acceptable range was 86-97 mmol/L. *CH-03 was 128, the acceptable range was 11-124 mmol/L. *CH- 04 was 106, the acceptable range was 93-104 mmol/L. *CH-05 was 118, the acceptable range was 103-115 mmol/L. b. 2023 Chemistry Core 3rd Event sodium results: *Results were not reported. 2023 Chemistry Core 3rd Event chloride results: *Results were not reported. Interview on 10/25/23 with the laboratory supervisor revealed the laboratory had been aware of the failures. The initial failures had been investigated. It was determined that sodium and chloride samples sat out to long before testing. The second failure was due to the laboratory supervisor being ill and unable to report the results by the deadline. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 review of the CASPER proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute (API) PT reports and interview with the laboratory supervisor, the laboratory failed to achieve a satisfactory score of 80% or above for the free triiodothyronine (T3) test method for two of three events (API 2023 Chemistry Core 2nd Event and 2023 Chemistry Core 3rd Event). Findings include: 1. Review of the 10/25/2023 CASPER Unsuccessful PT Report 153D revealed the laboratory received unsatisfactory scores (less than 80%) for the free T3 test method in each of the two events identified above. Review of the 10/25/2023 CASPER Individual Laboratory Profile PT report 155D and API PT 2023 Chemistry Core 2nd and 2023 Chemistry Core 3rd event evaluation reports revealed scores of 20% and 0% for the free T3 test method for each event. Review of the individual API free T3 test -- 2 of 3 -- method scores for the two API PT events revealed: a. 2023 Chemistry Core 2nd Event free T3 results: *THY-06 was 21.4, the acceptable range was 15.9-20.8 picograms /milliliter (pg/mL). *THY-07 was 7.1, the acceptable range was 4.4-6.8 pg/mL. *THY- 08 was 16.0, the acceptable range was 11.6-15.3 pg/mL. *THY-10 was 11.2, the acceptable range was 7.5-10.7 pg/mL. b. 2023 Chemistry Core 3rd Event free T3 Results: *Results were not reported. Interview on 10/25/23 with the laboratory supervisor revealed the laboratory had been aware of the failures. The initial failures had been investigated. The investigation determined that particular lot number of free T3 reagent produced slightly elevated results compared to previous free T3 reagent lot numbers. The second failure was due to the laboratory supervisor being ill and unable to report the results by the deadline. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 5/10/22. The Brookings Health System laboratory was found not in compliance with the following requirement: D5435. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to calibrate one of one centrifuges (blood bank serofuge) to ensure proper centrifugation and accurate interpretation of the ABO and Rh blood typing test methods. Findings include: 1. Review of the immunohematology maintenance records revealed no documentation the blood bank serofuge had been calibrated to determine the combination of speed and timing to ensure an optimum blood cell dot formation in 2021 or to date in 2022. That test method had been used as part of the ABO and RH blood typing procedures used to determine a patient's blood type. Review of the laboratory's Calibration of Blood Bank Serofuge standard operating procedure, last signed by the laboratory director on 5/2/21 revealed: *"Purpose: The duration of centrifugation will affect agglutination. An inadequate time may result in insufficient packing and false negative results. Excessive centrifugation may cause the red cells to be packed so tightly that pseudoagglutination results or resuspension may be so difficult that weak 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 -- reactions are dispersed." *"Interpretation; The optimal time of centrifugation is that at which the strongest reaction is obtained with positive cells, a clear cut negative reaction is obtained with negative cells..." Review of the annual test volume survey form revealed 973 ABO and 961 Rh blood typing had been performed on patient specimens during 2021. Interview with the laboratory supervisor on 5/10/22 at 1:40 p. m. revealed: *She confirmed the serofuge had been used for centrifuging patient ABO and Rh blood typing specimens. *She confirmed the serofuge had last been calibrated in 2013 when it was first placed into use. *She was unaware the serofuge needed to be calibrated on an annual basis. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 5/3/2021 through 5/4/2021. The Brookings Health System laboratory was found not in compliance with the following requirement: D5435 and D5445 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: D5435 Based on observation, interview, and record review the laboratory failed to retain the results of the daily background checks on the Sysmex XN-1000 analyzer for 15 of 28 months to ensure critical operating characteristics that affected the stability of the analyzer met specific criteria defined by the manufacturer. Findings include: 1. Observation, interview, and demonstration on 5/4/21 at 10:20 a.m. of the Sysmex XN- 1000 hematology analyzer's electronic files revealed: *The laboratory manager was able to pull up a record of the analyzer's electronic files. *The oldest retained daily background check was dated 4/9/20. * Daily background counts prior to 4/9/20 were unavailable. *There was no way to verify if the background counts prior to 4/9/20 had been acceptable. *Increased background counts could lead to inaccurate patient specimen test results. Review of the annual test volume form revealed 10,178 hematology patient test specimens had been reported in 2019. Interview with the 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 -- laboratory manager on 5/4/21 at 10:20 a.m. revealed: *She believed the XN-1000 was installed in late 2018. *She verified daily background counts had not been printed out or maintained. *She believed the Sysmex XN-1000 hematology analyzer's memory was sufficient to maintain the required 2 years of background counts. *No other log or spreadsheet was available to document the daily background test results. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on interview, observation, and record review the laboratory failed to run external quality control (QC) at the manufacturer's minimum required frequency for one of one test test methods (Profile-V Medtox Scan Drugs of Abuse Test System) reviewed. Failure to run QC at the manufacturer's minimum required number and frequency could result in inaccurate patient test results having been reported. Findings include: 1. Observation and review of the laboratory's "Quality Control Plan (QCP) for Kit Testing" at 9:40 a.m. revealed: *The laboratory had developed an individualized quality control plan (IQCP). *The Profile-V Medtox Scan Drugs of Abuse Test System had been included in the laboratory's kit testing IQCP. *The IQCP stated, "External QC: 2 levels will be performed each month and with each new lot and shipment and recorded. 2 levels will be performed if the testing results seem questionable." Review of the Profile-V Medtox Scan Drugs of Abuse Test System manufacturer's package insert at 9:45 a.m. revealed, "You should run external controls routinely or as needed for any of the following reasons: (1) to practice the test with a known control, (2) when you open a new lot of devices, (3) once a week, (4) if you suspect that the reader or test device is not working properly, (5) if you have had a repeated unexpected test result or (6) if you suspect that the test devices have been stored improperly." Review of the annual test volume form revealed: *The test volumes reported were taken from 2019. *The laboratory performed approximately 295 urine drugs of abuse panels in 2019. Interview on 5/4/21 at 9:45 a.m. with the laboratory manager revealed: *She stated she reported the testing volumes for 2019 as the 2020 testing volumes had been skewed lower due to the Corona virus pandemic. *She believed performance of 2 levels of external QC only once a month had been required. *She confirmed the Profile-V Medtox Scan Drugs of Abuse package insert stated QC was required to be performed at a minimum of once a week. -- 2 of 2 --