Central Valley Medical Center

Summary Statement of Deficiencies D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review of Proficiency Testing (PT) documentation and interview with the Technical Supervisor (TS), the laboratory failed to document remedial action for unsatisfactory PT Event 3 in 2024 for PCO2 testing. The laboratory performs approximately 300 blood gas chemistry tests annually. Findings include: 1. Based on record review of College of American Pathologists (CAP) PT documentation, the laboratory failed to document remedial action for the unsatisfactory 2024 Event 3 for PCO2 blood gas testing. 2. Interview with TS on 3/3/2025 at approximately 1:15 p.m. confirmed that remedial action was not documented for the failed PT Event 3 in 2024 for PCO2 blood gas testing. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. 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 -- This STANDARD is not met as evidenced by: Based on review of competency documentation and interview with the Technical Supervisor (TS), the laboratory failed to evaluate competency for KOH testing for 9 out of 9 Testing Personnel (TP) . Findings include: 1. A laboratory record review revealed lack of competency documentation for KOH testing since the last survey on 7 /31/2023 for 9 out of 9 TP. 2. Interview with TS on 3/3/2025 at approximately 1:00 p. m. confirmed that the lab failed to document competency for KOH testing for 9 out of 9 TP. -- 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 a review of Quality Assurance (QA) documentation for the Quidel Triage meter (Triage) and an interview with the Laboratory Manager, it was determined that the laboratory failed to have a system that twice a year evaluates and defines the relationship between the test results of their two Quidel Triage Meters for the D- Dimer test. The laboratory performs approximately 1200 D-Dimer tests annually. Finding include: 1. A review of QA documentation for the Triage at approximately 3: 30 PM on 7/31/23 showed an initial validation comparison study performed between 10/15/22 - 10/24/22 for the laboratory's two Triage meters. 2. At the time on survey, no other documentation was available to show comparison testing between the laboratory's two Triage meters from 10/24/22 - 07/31/23. 3. In an interview with the Laboratory manager at approximately 3:40 PM on 7/31/23, it was confirmed that the laboratory failed to have a system that twice a year evaluates and defines the relationship between the test results of their two Quidel Triage Meters for the D- Dimer test. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on quality control records review, lack of documentation, and interview with staff the laboratory failed to retain quality control records for at least 2 years for at least, but not limited, to 5 of 5 chemistry tests reviewed performed on the Cobas e 601 and c 501 instruments. The instruments test and report approximately 44 tests. Findings include: 1. Quality control records review failed to include quality control records for patient testing performed on 05/03/2017 for digoxin testing for patient 4911 and for tests performed on 03/23/2017 for Magnesium, Phosphorous, Cholesterol, and Triglyceride tests for patient 408223. 2. In an interview conducted on 08/07/2018 at approximately 10:30 A.M., staff stated the laboratory failed to back up all quality control data using the instruments and daily data storage drive uploads. Staff stated the data had been deleted from the instrument and was not stored on the external storage drive for quality control data requested for testing performed on 05/03 /2017 or 03/23/2017. 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 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 -- 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: Based on Individualized Quality Control Plan (IQCP) review, manufacturer's package inserts review, and interview with the laboratory manager, the laboratory failed to ensure the quality control plan included the number and type of quality control materials were stated for 7 of 7 IQCPs reviewed. Findings include: 1. IQCPs reviewed included the statement in the quality control plan that the "manufacturer's quality control instruction is minimum number and frequency required". 2. In the qualitative tests manufacturer's package inserts reviewed, the manufacturers failed to state the quality control include a positive and a negative control. 3. In an interview with staff on 08/07/2018 at approximately 12:30 P.M. staff stated the IQCP quality control plan did not include the requirement to perform a positive and a negative control for Fetal Fibronectin, Amnisure, MedTox, C. difficile toxin, Binax now RSV, Quidel hCG serum pregnancy tests, and Quidel Strep A Quick Vue tests. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control materials observed and interview with the laboratory manager, the laboratory failed to ensure they used serum pregnancy controls of the same matrix as patient specimens for approximately 750 tests per year for 2 of 2 years of testing reviewed, from August 2016 to August 2018. Findings include: 1. Quality control materials observed on 08/06/2018 at approximately 10:00 A.M. for pregnancy tests were of a urine matrix. 2. In an interview with the laboratory manager on 08/06 /2018 at approximately 10:00 A.M., the manager stated the laboratory did not have different controls to verify the accuracy of serum pregnancy (human chorionic gonadotrophin) testing. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on personnel qualification records review and interview with personnel and the laboratory manager, one of nine high complexity testing personnel failed to qualify as a high complexity test person performing Immunohematology compatibility and Bacteriology identification and susceptibility testing. (See D6171) -- 2 of 4 -- D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet -- 3 of 4 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on personnel qualification records review and interview with testing personnel and the laboratory manager, 1 of 9 high complexity testing personnel failed to qualify to perform Immunohematology and Bacteriology high complexity tests. Findings include: 1. Testing personnel qualification records review failed to include at least 6 semester hours of required Chemistry courses. 2. In an interview with the testing person and the laboratory manager on 08/08/2018 at approximately 9:30 A.M., the testing person stated the testing person's credentials did not meet the minimum of 6 semester hours of Chemistry courses to qualify as a high complexity testing person. -- 4 of 4 --