Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was completed on August 11, 2026 with the following standard level deficiencies cited. 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 review of the laboratory's submitted Form Centers for Medicare and Medicaid Services (CMS) 209, written policies and procedures, lack of competency assessment documentation and interview with the Technical Consultant (TC) #1, the laboratory failed to establish and follow written policies and procedures of assessing competency assessments for 4 of 4 TCs. Findings Included: 1) Review of the laboratory's submitted Form CMS 209 revealed 4 TCs in consultant roles. 2) Review of the laboratory's enterprise policy titled 'Sanford Policy Laboratory, Competency Program' revealed instruction for conducting six-element competency components for Testing Personnel (TPs), and not for consultant and/or supervisors. 3) No consultant competencies for the 4 TCs were provided by the laboratory. 4) In an interview on 8 /11/2026 at 2:30 PM, TC#1 confirmed the laboratory did not assess consultant competencies for consultants and/or supervisors, and did not have documentation on file. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, laboratory policy, patient testing records, and interview with the Technical Consultant (TC) #1, according to the Form Centers for Medicare and Medicaid Services (CMS) 209, the laboratory failed to follow manufacturer instructions to ensure Multiplex Vaginal Panels (MVP) testing was not performed on the Cepheid GeneXpert analyzer for patients under the age of 14, for 5 of 562 patients tested from January 1, 2025 to May 31, 2026. Findings Included: 1) During a laboratory tour on 8/11/2026 at 2:34 PM, one Cepheid GeneXpert analyzer (Serial Number 12055) was observed in operation, available for use for MVP testing. 2) Review of the manufacturer's instructions from Cepheid titled 'GeneXpert Power By CEPHEID INNOVATION Xpert Xpress MVP' revealed the following statements: Page 14 of 53 - "MVP test has been evaluated in patients 14 years of age and older (including pregnant women) Page 53 of 53 - "Revision History - Updated age of patients evaluated from 18 years of age to 14 years of age and older. Added limitation that false negative results can occur if level is outside the BV algorithm parameters for a positive result". 3) Review of the laboratory's policy titled 'Sanford Policy Laboratory Cepheid GeneXpert Xpert Xpress MVP' stated the following on page 10 of 11: "16. The Xpert Xpress MVP test performance has been evaluated in patients 14 years of age and older (including pregnant women)." 4) Review of patient testing records from January 1, 2025 to May 31, 2025 revealed the following 5 patients out of 562 MVPs tested, under the age of 14: a. Specimen ID: 98243178, Age: 2 b. Specimen ID: 98805123, Age:6 c. Specimen ID: 99351639, Age: 4 d. Specimen ID: 100667244, Age: 11 e. Specimen ID: 10795717, Age: 13 5) In an interview on 8/11/2026 at 2:40 PM, TC#1 confirmed the findings and stated the laboratory did not have a mechanism to ensure MVP testing was performed on patients above the age of 14 only. 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 direct observation, review of manufacturer's instructions, written policies and procedures, laboratory temperature continuous monitoring logs, and interview with the Technical Consultant (TC) #1, according to the Form Centers for Medicare and Medicaid Services (CMS) 209, the laboratory failed to define temperatures and humidity in accordance with manufacturer instructions for 2 of 2 years. Findings Included: 1) During a laboratory tour on 8/11/2026 at 2:34 PM, the following were observed stored for use or in operation: a. A box of 50 Remel BactiDrop Potassium Hydroxide (10%) ampoules, Lot Number 291777, Manufacturer storage temperature -- 2 of 4 -- requirements 20 to 25 degrees Celsius. b. 1 Abbott Architect c4000 (Serial Number C461846), Manufacturer operating humidity requirements 10-85% relative humidity (non-condensing). c. 1 Sysmex XN-L 430 (Serial Number 12055), Manufacturer operating humidity requirements 10-85% relative humidity (non-condensing). 2) Review of the laboratory's written enterprise policy titled 'Sanford Policy Laboratory, Temperature and Humidity Monitoring' stated the following on page 1: "To ensure that refrigerators, freezers and the laboratory maintain appropriate temperature, humidity and measured and recorded, any out-of-range temperatures and/or humidity and the corresponding