University Of Central Missouri Health Care Center

Summary Statement of Deficiencies 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 review of the Quantimetrix Dipper Urinalysis Dipstick quality control (QC) package insert, observation of the Quantimetrix Dipper Urinalysis Dipstick QC vials, review of patient results and interview with the technical consultant (TC), the laboratory failed to document open and expiration dates on urinalysis QC. Findings: 1. Review of the Quantimetrix Dipper Urinalysis Dipstick QC package insert states "After initial use, each tube of control is stable for 3 months or 20 dipstick immersions, whichever occurs first". 2. Observation of opened Quantimetrix Dipper Urinalysis Dipstick QC vials lot # 256321 and 256322 showed no open and expiration dates on QC vials. 3. Review of patient results showed the laboratory performed approximately 148 urinalysis tests from January 1,2026 to date May 11, 2026. 3. Interview with the TC on May 11, 2026 at 2:00 PM confirmed the laboratory failed to document open and expiration dates on urinalysis QC. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on microscope maintenance and interview with the technical consultant the laboratory failed to establish maintenance protocol for the microscope. Findings: 1. Review of microscope showed no documentation of maintenance for 2018 to date November 19, 2019. 2. Interview with the technical consultant on November 19, 2019 at 11:00 AM confirmed the laboratory failed to establish maintenance protocol for the microscope. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD 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 2 -- Based on review of quality control (QC) procedures and interview with the technical consultant, the laboratory failed to perform a positive and negative control each day of testing for moderately complex human chorionic gonadotropin(HCG) kit testing. Findings: 1. Review of QC procedures for HCG kit testing showed the laboratory allowed usage of serum or urine for HCG. This changed the kits from waived complexity to moderate complexity. Review of the QC documentation revealed the laboratory failed to perform a positive and negative external control each day of testing. 2. Interview with the technical consultant on November 19, 2019 at 11:00 AM confirmed, the laboratory did not test a positive and negative control each day of serum HCG testing. -- 2 of 2 --