Transplant Immunology Lab Nw Univ

Summary Statement of Deficiencies D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(g) (d)(3)(v) 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 molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on general supervisor 2 interview and next-generation sequencing (NGS) quality control record review on April 2, 2026 at 09:25 am, the laboratory failed to include two quality control materials at least once a day patient molecular amplification NGS specimens were assayed. Findings included: a. In histocompatibility, the laboratory performed patient specimen HLA typing assays using NGS protocols. b. Although the laboratory included a negative quality control material each day patient NGS HLA typing assays were performed, the laboratory maintained no documentation to indicate that a quality control material with a known HLA typing result was assayed each day patient NGS HLA typing assays were performed. c. The general supervisor 2 confirmed these findings on April 2, 2026 at 09:25 am. d. According to general supervisor 1, the laboratory performed and reported approximately 2,771 patient HLA typing results annually. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) (e)(13) Ensure that policies and procedures are established for monitoring individuals 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 -- who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on general supervisor 1 and laboratory personnel interviews and written laboratory personnel competency policy record review on April 1, 2026 at 09:45 am, the laboratory director, high complexity testing, failed to ensure that written procedures were established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform tests procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings included: a. Although the laboratory maintained documentation to indicate it had met the CLIA regulations at 42 CFR 493.1451 (b)(8) and (9), the laboratory maintained no written protocols detailing the procedures used to conduct laboratory personnel competency activities. b. These findings were confirmed by general supervisor 1 and laboratoroy personnel on April 1, 2026 at 09:45 am. c. According to laboratory documentation, the laboratory performed and reported approximately 37,193 patient tests annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the general supervisor (GS), the laboratory failed to employ individuals who meet the qualification requirements of 493.1489 for testing personnel (TP). Finding: 1. The laboratory failed to ensure laboratory personnel meet the qualification requirements for performing highly complex testing throughout the laboratory. See D6171. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (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 the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS-209), employee files, and an interview with the general supervisor (GS); the laboratory failed to ensure laboratory employees meet the qualification requirements for testing personnel (TP) as defined in 493.1489. Findings: 1. Review of the employees' files and CMS-209 revealed the following: a). The CMS-209 lists 11 TP in the laboratory, b). Of the 11 TP, 2 employees failed to provide evidence that their education requirements meet the criteria for performing highly complex testing. c) These 2 TP (TP-D8 line 14 and TP-VG line 16, both from page 1) need their foreign degrees evaluated for the United States equivalence. 2. All TP were performing Histocompatiblity tests and reporting test results. 3. On a Validation survey conducted -- 2 of 3 -- on 02/27/2018 at 2:00 PM, the laboratory director and GS confirmed the above findings. -- 3 of 3 --