Tanner Memorial Clinic

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 records reviewed and interview with the testing personnel, the laboratory failed to establish a written policy to assess personnel competency for MOHS testing since the last survey on March 28, 2019. Findings include: 1. Review of laboratory policies and procedures revealed the laboratory failed to establish and perform competency assessment for two of two testing personnel. 2. On May 3, 2022 at approximately 2:00 p.m., interview with two of two testing personnel confirmed there was no competency assessment policy established or performed for testing personnel. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 laboratory record reviews and interview with testing personnel, the 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 -- laboratory failed to establish written policies and procedures for monitoring the temperature on the Avantik-QS cryostat since the last survey on March 28, 2019. Findings include: 1. Review of laboratory temperature log sheets revealed no documentation of normal reference ranges for the Avantik-QS cryostat. 2. On May 3, 2022 at approximately 2:30 pm, interview with two of two testing personnel confirmed there was no documentation of a normal temperature reference range on the temperature log sheets for the Avantik-QS cryostat. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on laboratory record reviews and interviews with testing personnel, the laboratory director failed to establish and maintain a quality assessment program to assure the quality of laboratory services provided since the last survey performed on March 28, 2019. Findings include: 1. Review of Hematoxylin and Eosin stain quality control log sheets revealed no review of quality control results was completed by the laboratory director or designee. 2. Review of Hematoxylin and Eosin stain log sheets revealed no records of reagent lot numbers and expiration dates. 3. Interview with two of two testing personnel on May 3, 2022 at approximately 2:35 p.m. confirmed there were no Hematoxylin and Eosin stain lot numbers and expiration dates recorded in the log sheets and no review of quality control was completed by the laboratory director or designee. 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 records and interviews with the testing personnel, the laboratory failed to employee qualified testing personnel that met the educational requirements for high complexity histopathology testing. (refer to 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 -- 2 of 4 -- 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 the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on an interview with the testing personnel, and review of education records, the laboratory failed to employ qualified personnel to perform gross examinations for high complexity histopathology testing since the last survey performed on March 28, 2019. Findings include: 1. Review of education records for one of one testing personnel revealed educational requirements were not met for high complexity grossing examination in histopathology testing. 2. During an interview with both testing personnel on May 4, 2022 at approximately 2:15 p.m. it was confirmed -- 3 of 4 -- personnel did not meet the high complexity educational requirements for grossing histopathology specimens. 3. The laboratory performed approximately 3,040 tests per year. -- 4 of 4 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation and confirmation by staff, the director failed to sign and date as approve the procedure manual for collecting, labeling, processing, reading and reporting histopathology tissue samples. Findings include: 1. The laboratory procedure manuals included 2 manuals for testing biopsy and Mohs micrographic surgery specimens. The director's signature was not present for the comprehensive manual as approval for the processes. The Mohs manual lacked the date the director approved the manual. 2. In an interview conducted on 03/28/2019 at approximately 11:00 A.M. staff confirmed the manuals were missing the signature for the comprehensive manual and dates of approval for both manuals. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 patient test reports review, patient slide review, histpathology log book, and confirmation by staff, the laboratory failed to ensure the patient biopsy specimen slide identification correlated with the specimen results reported for biopsy specimen M18- 1781. The laboratory reported approximately 5000 tests results per year. Findings include: 1. The patient test report reviewed for the specimen logged in to the laboratory on 07/25/2018 as M18-1781 included the slide reviewed was M18-1778. The slide for the specimen was labeled as M18-1781. 2. In an interview with staff on 03/28/2019 at approximately 12:00 Noon, staff confirmed the slide labeled with the patient's name and specimen log book number was not the slide number on the test report. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on patient test report review, lack of documentation and interview with staff, the laboratory failed to establish and follow an ongoing mechanism to monitor, assess and when indicated correct problems identified for patient test reports reviewed from March 2017 to March 2019. The laboratory performed approximately 5000 histopathology cases per year. Findings include: 1. The laboratory failed to establish a post analytic procedure for review of patient test reports to identify errors in the specimen identification. (See D5801) 2. In an interview conducted on 03/28/2019 at approximately 12:15 P.M. the laboratory staff stated the laboratory did not have a process to document a review of patient test reports was performed. The laboratory practice was to dictate results into a report form and electronically sign the dictated report. It could not be determined if the testing person reviewed the dictated report prior to release. -- 2 of 2 --