Seasons Medical

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 proficiency testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from Wisconsin State Laboratory of Hygiene (WSLH) and the American Proficiency Institute (API) and a telephone interview with the Laboratory Manager on 10/09/2024 at 3:09 PM, the laboratory failed to successfully participate in proficiency testing for the specialty hematology for the analyte Red Blood Cell (RBC) count 2 (two) out of 3 (three) events for 2023 and 2024. Refer to: D2123 and D2130. D2123 HEMATOLOGY 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 -- CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the Wisconsin State Laboratory of Hygiene (WSLH) and an interview with the laboratory manager on 10 /09/24, the laboratory failed to participate in testing for PT event three (3) in 2023 for the specialty of hematology for the analyte Red Blood Cell (RBC) count. The findings include: 1. A review of Report 155D and graded PT results from WSLH identified that the laboratory failed to participate in event three (3) in 2023 for the specialty of hematology for the analyte RBC count Analyte Year Event Score RBC count 2023 3 0% 2. An interview with the laboratory manager on 10/09/2024 at 3:09 PM confirmed the above findings. 3. The laboratory reports performing 2045 RBC counts per year D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 the Centers for Medicare and Medicaid (CMS) Proficiency Testing (PT) data report (Report 155D), graded PT results from the Wisconsin State Laboratory of Hygiene (WSLH) and the American Proficiency Institute (API), and an interview with the laboratory manager on 10/09/24, the laboratory failed to achieve satisfactory performance for two (2) out of three (3) PT events for the analyte Red Blood Cell (RBC) count. The findings include: 1. A review of Report 155D and graded PT results from WSLH and API identified that the laboratory failed to achieve satisfactory performance for events three (3) in 2023 and two (2) in 2024 for the specialty of hematology for the analyte RBC count. PT Provider Analyte Year Event Score WSLH RBC count 2023 3 0% API RBC count 2024 2 60% 2. An interview with the laboratory manager on 10/09/2024 at 3:09 PM confirmed the above findings. 3. The laboratory reports performing 2045 RBC counts per year. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of training documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the laboratory technical consultant (TC) on 9/21/2021, the laboratory failed to establish and follow written policies and procedures to assess testing personnel in accordance with 42 C.F.R. 493.1413(b)(7)(8) for 2020. The findings include: 1. A review of training and competency assessment records identified two (2) of 16 testing personnel listed on the CMS 209 failed to have documentation of annual competency which included the six parameters as listed in 493.1413(b)(8) for 2020. 2. An interview with the TC on 9/21/2021 at 1:45 pm confirmed that there were no competency assessments for two (2) of 16 testing personnel for 2020. 4. The laboratory reports performing 2,277 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on an observation and an interview with the technical consultant, the laboratory failed to observe safety procedures to ensure protection from chemical and biohazardous contamination. Findings: 1. An observation on July 16, 2019, at 3:00 PM, of the laboratory space in the Women's Clinic revealed two large plastic disposable drink containers with straws located on top of the refrigerator next to the counter space containing open urine cup specimens, as well as, yogurt, Coke, and bottled waters and juice in the refrigerator used to store testing reagents for hemoglobin and glucose. 2. An interview with the technical consultant on July 16, 2019, at 3:15 PM, confirmed the laboratory staff failed to observe safety procedures in the laboratory. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the operations manager, the laboratory failed to verify the accuracy of microscopic fungal examinations using potassium hydroxide (KOH) at least twice a year since the last survey on October 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 9 -- 2017. Findings: 1. A record review of laboratory documents revealed the laboratory failed to verify the accuracy of microscopic KOH examinations at least twice a year since the last survey. 2. The laboratory performed approximately 60 KOH examinations in 2018. 3. An interview with the operations manager on July 16, 2019, at 3:15 PM, confirmed the laboratory failed to document the accuracy of KOH examinations at least twice a year. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to monitor and evaluate the overall quality of testing for complete blood counts, pediatric bilirubin, and microscopic fungal examinations and failed to identify and correct problems in the test systems. Refer to D5403, D5413, D5415, D5439, D5481, D5775, D5781, and D5783. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)