Oneida Community Health Center

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 surveyor review of laboratory personnel records and policies, and interview with the Laboratory Director, the laboratory did not establish a policy for evaluating the competency of seven of seven personnel performing delegated responsibilities in the Clinical Laboratory Improvement Amendment (CLIA) named positions, clinical consultant (CC) and technical consultant (TC). Findings include: 1a. Review of the laboratory's personnel records revealed the Laboratory Director delegated responsibilities to six individuals in the TC position using the form, "2025 Assignment of Designee/Technical Consultant". The form did not include an assessment of competency for the six individuals. 1b. Review of the laboratory's personnel records revealed no evidence the Laboratory Director delegated responsibilities and evaluated competency of the individual in the CC position. 2. Review of the laboratory's policies revealed the laboratory had a policy for competency evaluation, "Laboratory Staffing and Competency", but there was no evidence the policy defined a process for competency evaluation of individuals in the CC and TC positions, including when competency is assessed after personnel are delegated to the CC and TC positions, and the frequency at which competency is assessed thereafter. 3. Interview with the Laboratory Director on November 19, 2025, at 9:40 AM confirmed the laboratory did not establish written policies that defined a process, including time and frequency, for evaluating the competency of personnel performing delegated responsibilities in the TC and CC positions. D5439 CALIBRATION AND CALIBRATION VERIFICATION 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): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with the Laboratory Director, the laboratory did not perform calibration verification at least once every six months for one of three tests that require calibration verification since the laboratory transitioned all chemistry testing to the QuidelOrtho Vitros 5600 on September 20, 2023. Findings include: 1. Review of calibration verification records showed no evidence the laboratory performed calibration verification at least once every six months for the B12 test on the QuidelOrtho Vitros 5600 analyzer since the laboratory started using the analyzer to perform chemistry testing on September 20, 2023. 2. Interview with the Laboratory Director on November 19, 2025, at 1:15 PM confirmed the laboratory did not perform calibration verification for the B12 test at least once every six months since the laboratory started using the QuidelOrtho Vitros 5600 analyzer to perform chemistry testing on September 20, 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor observation of equipment in the laboratory, review of records and interview with the laboratory director, the laboratory has not evaluated the relationship between the two MedTox Urine Drug Screen analyzers used to test patient samples with Profile V cartridges. The laboratory did not complete four of four evaluations in the last two years. Findings include: 1. Observation of equipment in the laboratory on September 14, 2023, at 10:00 AM revealed two MedTox Urine Drug Screen Analyzers were available for testing. 2. Review of laboratory records showed no evidence of comparison or evaluation twice annually of the relationship of results from the two analyzers. 3. Interview with the laboratory director on September 14, 2023, at 3:45 PM confirmed the laboratory had not evaluated the relationship between test results produced by the two analyzers twice annually in the past two years. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Item 1: Based on surveyor review of the Individualized Quality Control Plan (IQCP), control and patient test records, and interview with a technical consultant, staff A, the laboratory did not meet their stated Quality Control (QC) requirements for testing external controls every thirty days for the Alere Human Immunodeficiency Virus (HIV) Ag/Ab analyte for two of eleven months in 2021. Findings include: 1. Review of the laboratory's IQCP for HIV Ag/Ab testing showed external QC is required every thirty days and with each new lot or shipment of test kits. 2. Review of QC records showed the laboratory performed QC testing on: a. June 3, 2021 and July 28, 2021, with thirty day QC due July 3, 2021. b. September 1, 2021 and October 26, 2021, with thirty day QC due October 1, 2021. 3. Review of patient test records showed the laboratory ran twenty patients between July 3, 2021 and July 27, 2021, with no QC run within thirty days prior to patient testing. Further review of patient test records showed the laboratory ran seventeen patients between October 1, 2021 and October 25, 2021, with no QC run within thirty days prior to patient testing. 4. Interview with staff A on November 30, 2021 at 11:55 AM confirmed the laboratory did not meet their QC requirements for Alere HIV Ag/AB testing for two of eleven months in 2021. Item 2: Based on surveyor review of the Individualized Quality 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 -- Control Plan (IQCP), control and patient test records, and interview with a technical consultant, staff A, the laboratory did not meet their stated Quality Control (QC) requirements for testing external controls every thirty days for the Chlamydia /Gonorrhea polymerase chain reaction (PCR) test for two of eleven months in 2021. Findings include: 1. Review of the laboratory's IQCP for Chlamydia/Gonorrhea testing showed external QC is required every thirty days and with each new lot or shipment of test kits. 2. Review of QC records showed the laboratory performed QC testing on: a. March 10, 2021 and April 13, 2021, 2021, with thirty day QC due April 10, 2021. b. September 10, 2021 and October 25, 2021, with thirty day QC due October 10, 2021. 3. Review of patient test records showed the laboratory ran three patients between April 10, 2021 and April 12, 2021, with no QC run within thirty days prior to patient testing. Further review of patient test records showed the laboratory ran twenty-three patients between October 10, 2021 and October 24, 2021, with no QC run within thirty days prior to patient testing. 4. Interview with staff A on November 30, 2021 at 11:55 AM confirmed the laboratory did not meet their QC requirements for Chlamydia/Gonorrhea PCR testing for two of eleven months in 2021. -- 2 of 2 --