Arkansas Dermatology

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: Through review of the CMS 209 form, personnel records, and interview conducted on 5/9/2023 it was determined that the competency of the testing personnel was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of personnel files for two of five testing personnel revealed that the annual evaluation of the competency of the testing personnel (number six on the CMS 209 form) was documented only once dated January 4, 2021, testing personnel (number seven the CMS 209 form) was documented only once dated March 9, 2021, and no other documentation of testing personnel competency was presented. B) Upon request, the laboratory was unable to provide other competency evaluations of the testing personnel (number six and seven on the CMS 209 form) after the evaluation identified above. C) In an interview on 5/9/2023 at 11:15 a.m. the testing personnel (number five on the CMS 209 form) said that no other competency evaluations were present and available. 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. 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 -- (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: Through observations made during a tour of the laboratory, review of manufacturer's instruction manual, review of the laboratory's temperature and humidity records and interviews with staff, it was determined the laboratory temperature and humidity was not monitored with the manufacturer's requirement for operating temperature and humidity for the laboratory's Avantik QS11 Cryostat. Survey findings include: A) During a tour of the laboratory on 5/9/2023 at 11:13 a.m., two Avantik QS11 Cryostat instruments were in an adjacent room next to the main laboratory with a closable door. B) Review of the manufacturer's instruction manual for the Avantik QS11 Cryostat revealed operating conditions: +5C up to +35C (at a max. rel. humidity of 60%). C) Review of the laboratory's room temperature and humidity log for Cryostat room for 2022 revealed days recorded of laboratory operation were forty-four. Temperature and humidity recorded in the Cryostat room zero out of forty-four. D) Review of the laboratory's room temperature and humidity log for Cryostat room for 2023 revealed days recorded of laboratory operation were nineteen. Temperature and humidity recorded in the Cryostat room zero out of nineteen. E) In an interview on 5/9 /23 at 11:13 a.m. the laboratory staff member (# 5 on the CMS 209 form) confirmed that the temperature and humidity requirement for Avantik QS11 Cryostat was not recorded. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of the CMS-209 form presented at the time of the survey, a review of personnel records for eight personnel listed on the form CMS-209, and through interviews with laboratory staff, it was determined five of eight testing personnel failed to have written authorization to perform testing without direct supervision. Survey findings include: A. Through a review of the CMS- 209 form, it was determined laboratory personnel # 4, # 5, # 6, # 7, and # 8, were designated as testing personnel. B. A review of personnel records for eight personnel listed on the form CMS-209 revealed that five of eight failed to have written authorization to perform testing without direct supervision. Laboratory personnel # 4, # 5, # 6, # 7, and # 8, did not have a written authorization to perform testing without direct supervision. C. In an interview at 11:13 a.m. on 5/9/2023, laboratory personnel # 5 (listed on the form CMS- 209) confirmed that the laboratory did not have documented authorization for testing for employees performing testing. -- 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: . Through a review of the personnel file for employee #4 (as listed on the form CMS- 209), lack of documentation, and interviews with staff, it was determined that laboratory testing personnel lacked documentation of appropriate education to qualify as High Complexity testing personnel. As cited at: D6171 - one of one testing personnel, performing grossing, failed to meet the education qualifications to perform High Complexity Testing. 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 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 -- 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: Through a review of the form CMS-209 Laboratory Personnel Report (CLIA), a review of personnel records for employee #4 (as listed on the form CMS-209) and through interviews with laboratory staff, it was determined the laboratory failed to have documentation that one of one testing personnel met the education qualifications to perform grossing (High Complexity Testing): Survey Findings follow: A. Through a review of the form CMS-209 Laboratory Personnel Report (CLIA), it was determined that employee #4 was designated as a high complexity testing personnel in the specialty of Histopathology. B. In an interview, at 9:55 a.m., laboratory employee #6 (as listed on the form CMS-209) stated that employee #4 performs grossing of histopathology specimens, which is a high complexity test. C. During a review of personnel records for laboratory employee #4, it was revealed the documentation of -- 2 of 3 -- education for this employee was a BA in English, which does not meet the qualifications for high complexity testing personnel. D. In an interview at 9:55 a.m., laboratory employee #6 confirmed the only education documentation in the file for employee #4 was the BA in English. -- 3 of 3 --