Uc Health Dept Of Dermatology

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 record review and an interview with the Clinical Operations Manager (COM), the Laboratory Director (LD) failed to ensure policies and procedures were approved, signed and dated before use. This deficient practice had the potential to affect 1,175 patients tested under the subspecialty of Histopathology from 09/11/2023 to 12/13/2023. Findings Include: 1. Review of the Form CMS-209 approved on 12/13 /2023 by the current LD listed the new/current LD since the previous inspection. 2. The COM stated the new LD had assumed the role on 09/11/2023. . 3. Review of the laboratory's "Manual Review" page provided on the date of inspection, revealed an LD approval signature and date of 12/12/2023. 4. On 12/12/2023 at 1:30 PM the COM confirmed policies and procedures were not approved, signed and dated by the new LD before use. 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 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: The laboratory failed to ensure an individual, performing high complexity testing, met the qualification requirements of 493.1489 to perform the functions specified in 493.1495 for the testing procedures performed. Findings Include: 1. The laboratory failed to ensure TP#1 met the education requirements, as specified in subpart M for high complexity testing procedures performed. (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 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 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 -- 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 record review and an interview with the manager, the laboratory failed to ensure Testing Personnel (TP#1), met the high complexity TP qualification requirements for inking and grossing procedures. This deficient practice had the potential to affect all patients tested under the subspecialty of histopathology. Findings Include: 1. Review of the laboratory's CMS-209 form, approved and signed by the Laboratory Director on 12/18/2019, found TP#1 listed and certified by the Laboratory Director to perform high complexity test procedures. 2. Review of the policy and procedure manual titled "CLIA Mohs Manual" section titled "Histologic Job Description" found the following statement: "Responsibilities ...2. Process tissue for frozen sectioning. This includes inking and sectioning tissue (grossing), mount and cut tissue..." 3. Review of education documentation revealed TP#1 possessed a high school diploma from June 1983. The laboratory was unable to provide other education -- 2 of 3 -- or training documents required. 4. TP#1 confirmed they were performing high complexity grossing procedures. The interview occurred 12/18/2019 at 2:30 PM. -- 3 of 3 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory records and an interview with the Testing Personnel (TP), the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. Findings Include: 1. Review of "Laboratory Standard Operating Procedure" manual found no mention of preanalytic quality assessment policy and procedures. 2. The Surveyor requested the laboratory's preanalytic quality assessment policy and procedures on the date of inspection. The TP confirmed on 02/05/2018 at 10:40 AM, the laboratory did not have a preanalytic quality assessment policy and procedure and was unable to provide the requested documentation on the date of inspection. 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 record review and an interview with Testing Personnel (TP), the laboratory 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 -- failed to follow written policies and procedures and document all activities of the daily quality control for H&E reagents. Findings Include: 1. Review of the laboratory's "Laboratory Standard Operating Procedure LSOP-Mohs-020" policy and procedure provided on the date of the inspection, revealed the following statements: "Linear Stainer and manual staining requires multiple changes of solutions throughout the day in order for the slide staining to be optimal." "...The hematoxylin and eosin shall be replaced with fresh reagent on Mondays. The hematoxylin must be filtered each morning prior to staining." "...The Toluidine Blue and H&E stains are monitored on the daily QC/QA sheet." 2. The surveyor requested the daily QC/QA sheet for the reagent changes during 2016, 2017 and 2018 from the TP. 2. The TP confirmed the laboratory did not have daily QC/QA sheets and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/05/2018 at 10:30 AM. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, record review, and an interview with Testing Personnel (TP), the laboratory failed to establish and document a maintenance protocol that ensured microscope performance which was necessary for accurate and reliable test results and test result reporting. Findings Include: 1. Direct observation of the histopathology laboratory on the date of the inspection revealed an Olympus BX-40 microscope utilized for histopathology slide, tissue, and stain quality prior to sending the case for interpretation. 2. Review of the laboratory's policies and procedures did not find any mention of daily/as needed microscope maintenance procedures. 3. The Surveyor requested the laboratory's microscope maintenance policy and procedure and 2015, 2016, and 2017 daily/as needed microscope maintenance documentation from the TP. The TP stated the laboratory had not established a microscope maintenance policy and procedure, had not documented internal daily/as needed microscope maintenance activities in 2015, 2016, and 2017, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/05/2018 at 11:05 AM. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on record review and an interview with Testing Personnel (TP), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems. Findings Include: 1. Review of the laboratory's "Laboratory Standard Operating Procedure" policy and procedure provided on the date of the inspection, found no mention of an ongoing review process for analytic laboratory functions. 2. The Surveyor requested the laboratory's 2016, 2017, and 2018 analytic systems quality assessment documentation from the TP. The TP confirmed the laboratory did not have any quality assessment policy and procedures established, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02/05/2018 at 10:30 AM. 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 record review and an interview with Testing Personnel (TP), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the postanalytic systems. Findings Include: 1. Review of the laboratory's "Laboratory Standard Operating Procedure", manual provided on the date of the inspection, found no mention of an ongoing review process for postanalytic laboratory processes. A 2016 "QA Record Keeping" document for review of patient reports was found, however no documentation for 2017 and 2018 was found. 2. The Surveyor requested the laboratory's quality assessment policy and procedure to include the postanalytic systems and 2017 and 2018 postanalytic quality assessment documentation from the TP. The TP confirmed the laboratory did not have any other quality assessment policy and procedures established and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 02 /05/2018 at 11:01 AM. -- 3 of 3 --