Selma Doctors Clinic

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(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 review of the Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) and an interview with the Technical Consultant (TC) and Testing Personnel 1 (TP1), the laboratory failed to attain satisfactory scores for the Hematocrit (HCT) and Mean Corpuscular Volume (MCV) testing. The surveyor noted one of the six events from 2023-2025 had unsuccessful performance evaluation. The findings include: 1. A review of the WSLH PT records revealed the laboratory received unsatisfactory scores for the HCT (0%) and MCV (60%) in the 2025 Heme Reg 1 Event. 2. During the exit conference on 09-24-2025 at 1:30 PM, TC and TP1 confirmed the above findings. 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: 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 -- Based on reviews of Hematology Daily Logs, the Medonic M-Series maintenance logs, and by direct observation during the laboratory tour, the laboratory failed to ensure, A) the Room and Refrigerator Temperatures (RRT) and the Humidity were documented each day of patient testing (Refer to D5413), B) the daily Medonic M- Series maintenance was documented (Refer to D5415), C) the new expiration date was documented on the Quality Control vials after opening (Refer to D5429). D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of the Hematology Daily Logs, the patient history testing data and an interview with the Technical Consultant (TC) and the Testing Personnel 1 (TP1), the laboratory failed to document the Room and Refrigerator Temperatures (RRT) and the Humidity each day of patient testing. The surveyor noted no RRT and Humidity readings were recorded for one of the 30 days in November 2024, two of the 31 days in July 2025 and one of the 31 days in August 2025. The findings include: 1) A review of the Hematology Daily Logs and patient history testing data revealed the laboratory had no documentation of the RRT and Humidity for the following days. A) November 27, 2024 had 8 patients testing performed. B) July 2, 2025, and July 30, 2025 had 16 patients testing performed. C) August 29, 2025 had 17 patients testing performed. 2. A further review of the Hematology Daily Logs indicated the following specified ranges: A) Room Temperature of 22-30 degrees Celsius B) Refrigerator Temperature of 2-8 degrees Celsius C) Humidity of 20-60 Percent 3) During exit conference on 09-24-2025 at 1:30 PM, TC and TP1 confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, a review of the Complete Blood Count (CBC) Quality Control (QC) package insert, and an interview with the Testing Consultant (TC) and Testing Personnel 1 (TP1), the laboratory failed to write the new expiration date on the QC vials after opening. The surveyor noted three of three QC vials currently in use were missing the open date stability information, the date opened with the new expiration date. The findings include: 1. During the laboratory tour on 09-24-2025 at -- 2 of 3 -- approximately 8:35 AM the surveyor observed the testing personnel had not recorded the open date stability information on the CBC QC vials, Lot number 22505-31, Expiration 10-14-2025. 2. A review of the Boule QC package insert revealed a 14 day open-tube stability requirement. 4. TC and TP1 confirmed the above findings during the exit conference on 09-24-2025 at 1:30 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Medonic M-Series maintenance logs and User Manual, patient testing records, and an interview with the Technical Consultant (TC) and Testing Personnel 1 (TP1), the laboratory failed to document the daily maintenance procedure prior to patient testing for one of the 31 days in March 2024. The findings include: 1. A review of the Medonic M-Series maintenance logs revealed the laboratory had not documented the daily analyzer maintenance for March 28, 2024. 2. A review of the Medonic M-Series User Manual revealed the following instruction on Section 8.1 page 64, Daily Cleaning Procedure. 3. A review of the patient testing records revealed 15 patients were performed on March 28, 2024. 4. During the exit conference on 09-24-2025 at 1:30PM, the TC and TP1 confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, Testing Personnel failed to sign the attestation statement provided by Wisconsin State Laboratory of Hygiene (WSLH). This was noted for two out of six events reviewed from the date of the last survey, April 20, 2022, to the date of the current survey, October 26, 2023. The findings include: 1. A review of PT records revealed attestation statements with no evidence of signatures by the Testing Personnel for Hematology 3rd Event 2022 or Hematology 2nd Event 2023. 2. During an interview on 10/26/2023 at 11:00 AM, the Technical Consultant confirmed the above findings. 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 a review of the CMS CASPER reports (#153 and #155), API (American Proficiency Institute) proficiency testing records, and telephone interviews with the technical consultant, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Free Thyroxine (Free T4) for two of three consecutive testing events. This affected Events #1 and #3 of 2019. The findings include: 1. A review of the Casper reports revealed the laboratory scored sixty percent (60 %) for the Free T4 on Event #1, 2019 and 0 % for the Free T4 on Event #3. 2. The API proficiency testing evaluation revealed the laboratory scored zero percent for the failure to participate in testing for Chemistry Event #3, 2019 (0 % for Free T4), 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 -- resulting in the failure of two of three consecutive testing events, unsuccessful participation. The laboratory scored 60% for Free T4 for the first Event of 2019. 3. The surveyor contacted the technical consultant via telephone on October 21, 2019 at 12:44 PM to inquire of the proficiency testing failure and unsuccessful participation. The technical consultant stated she was not aware of the last failure but would be in contact with the laboratory to determine the circumstances. 4. On October 22, 2019 at 11:21 AM, via telephone, the technical consultant stated the patient testing had been suspended for routine Chemistry, due to the trained technician being out-of-the office, and the Endocrinology (performed on the Frend) would require further investigation to determine the cause of the Free T4 failure. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the CMS CASPER reports (#153 and #155), API (American Proficiency Institute) proficiency testing records, and telephone interviews with the technical consultant, the surveyor determined the laboratory failed to perform satisfactorily in Free Thyroxine (Free T4) testing for two of three consecutive events. These failures affected Events #1 and #3 of 2019 and resulted in unsuccessful proficiency testing participation for the laboratory. The findings include: 1. Refer to D2016. -- 2 of 2 --