Arkansas Dermatology

Summary Statement of Deficiencies 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: 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 humidity was not monitored with the manufacturer's requirement for the laboratory's The Avantik QS12 Cryostat, Avantik QS11 Cryostat, and Thermo Scientific Cryostat HM525. Survey findings include: A) During a tour of the laboratory on 5/11/23 at 11:49 a.m., The Avantik QS12 Cryostat, Avantil QS11 Cryostat, and Thermo Scientific Cryostat HM525 was observed in the main laboratory. B) Review of the manufacturer's instruction manual for The Avantik QS12 Cryostat, Avantil QS11 Cryostat, and Thermo Scientific Cryostat HM525 revealed condtions of operating requirement "+5C up to +35C (at a max. Relative humidity of 60%)". C) Review of the laboratory's room temperature and humidity log for 2021 revealed days recorded of laboratory operation were 236. Humidity recorded 0 out of 236. D) Review of the laboratory's room temperature and humidity log and for 2022 revealed days recorded of laboratory operation were 247. Humidity recorded 0 out of 247. E) Review of the laboratory's room temperature and humidity log and for 2023 revealed days recorded of laboratory operation were 82. 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 -- Humidity recorded 0 out of 82. F) In an interview on 5/11/23 at 11:49 a.m. the laboratory staff member (# 10 on the CMS 209 form) confirmed that the laboratory failed to monitor humidity. -- 2 of 2 --

Summary Statement of Deficiencies D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: . Through a review of personnel records for three of ten testing personnel, it was determined the laboratory director failed to ensure that testing personnel #7, #8 and #10 ( as listed on CMS form 209) had the appropriate education requirements to perform High Complexity testing, the grossing of tissue specimens. As cited at D 6171. 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 personnel files for ten of ten laboratory testing personnel ( 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- three of ten laboratory testing personnel lacked documentation of appropriate education to qualify as High Complexity testing personnel to perform grossing. 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 -- 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 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 -- 2 of 3 -- the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: . Through a review of CLIA laboratory manual, personnel records, CMS Form 209, lack of documentation as well as interview with staff, it was determined the laboratory failed to have documentation that three of ten testing personnel met the education qualifications to perform grossing (High Complexity Testing): Survey Findings follow: A. A review of CLIA laboratory manual revealed the names of testing personnel #7, #8 and #10 (as listed on form CMS-209) authorized by laboratory director to gross tissue. B. A review of the personnel records for ten of ten testing personnel revealed three of ten testing personnel lack the education requirements to perform High Complexity testing. C. Surveyor requested education documentation for High Complexity testing. Laboratory provided high school diplomas for testing personnel #7, #8, and #10. D . In an interview on 4/15/2021 at 11:30, laboratory testing personnel #6 (as listed on form CMS-209) confirmed the education documentation for testing personnel #7, #8 and #10 as having high school diplomas. -- 3 of 3 --