Jefferson City Medical Group

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of documentation of formaldehyde and xylene monitoring and interviews with the testing personnel (TP) #1 and the laboratory director (LD), the laboratory failed to follow established procedures for shipping of slides and blocks and for formaldehyde and xylene monitoring in 2023 and to date November 6, 2024. Findings: 1. Review of the laboratory procedure "Procedure for Formaldehyde and Xylene Monitoring" states, "The monitor sampling will be performed initially and if results are within PEL, sampling will take place one year after each year that the lab is operating with formaldehyde and/or xylene." 2. Lack of documentation of monitoring for formaldehyde and xylene showed the laboratory failed to follow the established procedure for formaldehyde and xylene monitoring in 2023 and to date November 6, 2024. 3. Review of the laboratory procedure "Slide & Block Shipping" states, "Blocks and slides are to always be shipped in separate boxes due to the nature of delivery. It is the best patient care to separate the blocks and slides to decrease the risk of both blocks and slides to be lost together during shipping." 4. Interview with the testing personnel (TP) #1 on November 6, 2024 at 9:20 AM, TP #1 confirmed she ships slides and blocks together in same box and failed to follow the established procedure for shipping of slides and blocks. 5. Interview with the laboratory director (LD) on November 6, 2024 at 9:45 AM confirmed the laboratory failed to follow established procedures for shipping of slides and blocks and for formaldehyde and xylene monitoring. 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 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 personnel competency testing policy, personnel records for 2017 and 2018 and interview with the laboratory manager, the laboratory failed to follow the written policy for evaluating competency for one of two testing personnel. Findings: 1. The competency testing policy states, "Competency testing is performed within six months of initial training." 2. Review of personnel records revealed testing personnel #2 received initial training on August 18, 2017. Documentation showed the next competency testing for testing personnel #2 was performed on August 13, 2018. 3. Interview with the laboratory manager on August 14, 2018 at 2:30 PM confirmed, the laboratory failed to follow the policy for evaluating the competency of testing personnel within six months of initial training. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory test record system (grossing log), twelve of twelve patient specimens from July 26, 2018 and interview with the laboratory manager, the laboratory failed to have a records system that includes the identity of personnel who performed the histopathology grossing procedures. Findings: 1. Review of the grossing log for July 26, 2018 revealed no documentation to show the identity of personnel performing grossing procedures on each of the twelve patient specimens. 2. Interview with the laboratory manager on August 14, 2018 at 2:30 PM confirmed, the laboratory failed to ensure the records system included the identity of personnel performing the grossing procedures. 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 review of personnel records and interview with the laboratory manager confirmed, one of two testing personnel failed to have academic qualifications required to perform high complexity testing. (Refer to # 6171) 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 -- 2 of 3 -- 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 review of academic credentials and interview with the laboratory manager, the laboratory failed to provide academic credentials to qualify one of two testing personnel performing high complexity testing. Findings: 1. The laboratory could not provide academic credentials to show testing personnel # 1 was qualified to perform high complexity testing. (histopathology grossing procedures) 2. Interview with the laboratory manager on August 15, 2018 at 2:30 PM confirmed, the laboratory could not provide academic credentials necessary to qualify testing personnel #1. -- 3 of 3 --