Middle Creek Medical Center

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 reviews of the Complete Blood Count (CBC) Quality Control (QC) records for the Sysmex XP-300 analyzer, patient records, and an interview with the Technical Consultant (TC), the laboratory utilized expired QC materials prior to patient testing. The surveyor noted the three levels of expired CBC QC were used for two days from September - December 2023, affecting sixteen patients. The findings include: 1. Reviews of the CBC QC and the patient records revealed the laboratory utilized three levels of CBC QC after the expiration dates as follows. A) Sysmex QC Lot 31640710- 712, Expiration 09-20-2023, used on 09-21-2023 before testing ten patients. B) Sysmex QC Lot 32480710-712, Expiration 12-13-2023, used on 12-14-2023 before testing six patients. 2. During the exit conference on 07-31-2025 at 2:37 PM, the TC confirmed the above findings. 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 Hematology Sysmex XP-300 maintenance records, the Sysmex XP-300 Instructions For Use, and an interview with the Technical Consultant, 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 -- the laboratory failed to document the manufacturer's required quarterly maintenance. The surveyor noted maintenance due two out of eight quarters in 2023-2025 were not documented. The findings include: 1. A review of the Sysmex XP-300 Maintenance Hematology log maintenance records revealed no documentation of quarterly (every 3 months) maintenance for the following periods: (A) February 2024 - July 2024 (B) January 2025 - July 2025. 2. A review of the Sysmex XP-300 Instructions For Use in section 12, page 12-12, under Clean SRV, revealed the following instructions, "... When the main power switch is turned ON, and if either the counter value exceeds 4,500, or if 3 months have passed since the last maintenance, a message will appear prompting the operator to perform periodic maintenance (SRV cleaning) ...". 3. During the exit conference on 07-31-2025 at 2:37 PM, the TC confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the Technical Consultant (TC), the TC failed to assess and document the semi-annual competency for two of the eleven Testing Personnel (TP) responsible for moderate complexity testing during the first year of patient testing in 2025. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) revealed the TC failed to perform and document the semi-annual competency assessment for TP9 and TP10 in 2025. 2. The TC confirmed the above findings during the exit conference on 07-31-2025 at 2:37 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the Technical Consultant (TC), the TC failed to assess and document the annual competency for one of the eleven Testing Personnel (TP) responsible for moderate complexity testing from 2024-2025. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) revealed the TC failed to perform and document the annual competency assessment for TP3 from 2024-2025. 2. The TC confirmed the above findings during the exit conference on 07-31-2025 at 2:37 PM. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the Hematology quality control (QC) records for the Sysmex XP- 300, the patient results log, and an interview with Testing Personnel #15, the laboratory failed to ensure at least two levels of quality control were run and acceptable prior to analyzing patient specimens and reporting the results. This was noted one day out of six months reviewed from September 2021 through April 2023. The findings include: 1. A review of the QC records for the Sysmex Hematology analyzer revealed on 09/14/2021 a) Low control was acceptable. b) Normal and High controls were unacceptable for Platelets. 2. A review of the cumulative patient log printed from the instrument revealed 12 patient CBC's (Complete Blood Counts) were performed on 09/14/2021. 3. During an interview on May 24th, 2023 at 1:00 PM, Testing Personnel #15 confirmed QC was outside acceptable ranges for the Normal and High controls on 09/14/2021. 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 CASPER reports and American Proficiency Institute (API) proficiency testing (PT) records, the laboratory failed to successfully participate in two of three testing events (Events #1 and #3, 2022) for Red Blood Cell, Hematocrit and Hemoglobin testing (Hematology). These failures result in an initial unsuccessful PT participation.. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 CASPER reports and American Proficiency Institute (API) proficiency testing (PT) records, the laboratory failed to satisfactorily perform in two of three testing events (Events #1 and #3, 2022) for Red Blood Cell, Hematocrit (HCT) and Hemoglobin (HgB) testing (Hematology). The findings include: 1. The CASPER report #155 indicated the laboratory scored the following: a) Event #1 and #3, 2022 RBC = 60 % b) Event #1 and #3, 2022 HCT = 60 % c) Event #1 and #3, 2022 HgB = 60 % 2. A review of the API PT records confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on reviews of competency evaluations, a review of proficiency testing (PT) records, and an interview with Testing Personnel #6, the Technical Consultant failed to evaluate the competency of all testing personnel, assuring the staff maintained their competency to perform test procedures for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations. This was noted from January 2019 to June 2021 for 5 out of 12 Provider-Performed Microscopy (PPM) Testing Personnel. The findings include: 1. A review of competency evaluations revealed personnel who performed Provider-Performed Microscopy were not evaluated on their competency to perform Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations. a) Testing Personnel #6 was previously qualified for Provider-Performed Microscopy and no annual competency evaluations for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations were documented from January 2020 to June 2021. b) Testing Personnel #8 was new for Provider-Performed Microscopy and no initial training or six month/annual competency evaluations for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations were documented from January 2020 to June 2021. c) Testing Personnel #9 was new for Provider-Performed Microscopy and no initial training or six month/annual competency evaluations for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations were documented from January 2020 to June 2021. d) Testing Personnel #10 was previously qualified for Provider-Performed Microscopy and no annual 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 -- competency evaluations for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations were documented from January 2020 to June 2021. e) Testing Personnel #11 was previously qualified for Provider-Performed Microscopy and no annual competency evaluations for Urine Sediment examinations, Direct Wet Mount Preparations, and Potassium hydroxide (KOH) preparations were documented from January 2020 to June 2021. 2 A review of the 2018 - 2021 API (American Proficiency Institute) Proficiency Testing records revealed the laboratory failed one out of eight of Urine Sediment PT events, one out of eight Vaginal Wet Prep - KOH PT events, and two out of eight Vaginal Wet Prep PT events. a) 2018 Hematology 3rd Event 0% Vaginal Wet Prep -KOH performed by Testing Personnel #6,