Anne Arundel Dermatology, Pa

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: Based on direct observation, review of manufacturer's instructions, laboratory environmental records, and staff interview, determined the laboratory failed to document humidity for the Thermo Scientific Cryostat and Thermo Scientific Linistat Linear Stainer for 37 of 37 days. The findings include: 1. Observation of the MOHS processing room at 10:00 am on 12.08.2023 revealed a Thermo Scientific Cryostat (S#42243) and a Thermo Scientific Linistat Linear Stainer (S#LS5656A1907) in use for patient testing. 2. Review of the instrument instruction manual and operator guide revealed the following: ~ Thermo Scientific Cryostat HM525 Instruction Manual (V 387 779) stated, "Operating conditions: +5C up to +35C (at a max. rel. humidity of 60%)." ~ Linistat Linear Stainer Operator Guide (A79810100 Issue 5) stated, "Relative humidity Max. 80% RH up to 31 C decreasing linearity to 50%RH at 40C ." 3. Review of laboratory environmental records revealed no documentation of humidity monitoring in the MOHS processing room for the following dates: ~in 2022=01.21.2022, 02.04.2022, 03.04.2022, 03.18.2022, 04.01.2022, 04.29.2022, 05.27.2022, 06.10.2022, 07.08.2022, 07.22.2022, 08.05.2022, 09.16.2022, 09.30.2022, 10.28.2022, 12.09.2022 ~in 2023=01.06.2023, 01.20.2023, 02.03.2023, 02.17.2023, 03.03.2023, 03.17.2023, 03.31.2023, 04.14.2023, 04.28.2023, 05.12.2023, 06.23.2023, 07.21.2023, 08.04.2023, 08.18.2023, 09.01.2023, 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 -- 09.15.2023, 09.29.2023, 10.13.2023, 10.27.2023, 11.10.2023, 12.08.2023 4. Interview with the processing tech at approximately 11:00 am on 12.08.2023 confirmed the laboratory failed to document humidity for 37 of 37 days. Word Key: C = degrees Celsius RH = Relative Humidity MOHS= micrographically oriented histograph surgery D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Citation 1: Based on review of the laboratory's Hematoxylin and Eosin (H&E) stain control slide log, procedure manual, and staff interview, determined the laboratory failed to define the predicted characteristics of the H&E stain in 2022 thru the survey date of 12.08.2023. The findings include: 1. Review of the laboratory's H&E stain control slide logs, revealed no documentation of the predicted characteristics of the H&E stain quality for 2022 thru the survey date of 12.08.2023. 2. Review of the laboratory's procedure manual revealed no definition of predictable characteristics of the H&E stain quality. 3. Interview with the laboratory's processing tech at 11:00 am on 12.08.2023 confirmed the predicted characteristics of the H&E stain quality had not been documented and/or defined for 2022 thru the survey date of 12.08.2023. Citation 2: Based on review of the laboratory's Hematoxylin and Eosin (H&E) stain control slide log and staff interview, determined the laboratory failed to document H&E stain quality by the performing provider from January 2022 thru December 2022. The findings include: 1. Review of the laboratory's H&E stain control slide logs, revealed no documentation of stain quality by the performing provider for January 2022 thru December 2022. 2. Interview with the laboratory's processing tech at 11:00 am on 12.08.2023 confirmed the H&E stain quality had not been documented by the performing provider for January 2022 thru December 2022. Citation 3: Based on observation of the laboratory, review of patient test reports, review of slide control logs, and staff interview, determined the laboratory failed to document hematoxylin and eosin (H&E) stain quality assessments for 2 of 37 days in 2022 and 2023. The findings include: 1. Observation of the laboratory at 10:00 am on 12.08.2023 revealed processing and staining of tissue using hematoxylin and eosin (H&E) stains. 2. Review of randomly selected patient test reports/dates revealed patient histopathology cases reported as follows: A.I. DOB=11.26.78--reported on 07.22.2022 J.B. DOB=07. 25.44--reported on 07.22.2022 J.V. DOB=07.10.57--reported on 07.22.2022 A.S. DOB=04.01.40--reported on 07.22.2022 J.H. DOB=06.03.46--reported on 05.12.2023 E.B. DOB=05.12.47--reported on 05.12.2023 J.W. DOB=05.08.41--reported on 05.12.2023 W.W. DOB=12.23.45--reported on 05.12.2023 N.W. DOB=01.02.44-- reported on 05.12.2023 D.A. DOB=02.15.53--reported on 05.12.2023 3. Review of the laboratory's H&E stain control slide logs, revealed no documentation of stain quality for 07.22.2022 or 05.12.2023. 4. Interview with the processing tech at 11:00 am on 12.08.2023 confirmed the H&E stain quality had not been documented for 2 of 37 days in 2022 and 2023. D6079 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), Aspen Web 116, CMS form 209, and interview with the laboratory's CLIA coordinator, the laboratory director failed to ensure compliance with 493.51 which requires notification to HHS or designee of changes in director and/or technical supervisor be communicated within 30 days of the change when the laboratory director and technical supervisor changed in February 2022 and did not notify the State Agency. The findings include: 1. Review of the Form CMS-116 submitted as part of the survey process revealed the name of a laboratory director that was different from the name of the laboratory director as listed in the Aspen Web 116 database. 2. Review of the Form CMS-116 submitted as part of the survey process revealed the name of a laboratory director that was different from the name of the laboratory director as listed on the CMS Form 209. 3. Interview via email with the laboratory's CLIA coordinator at 11:00 am on 12.08.2023 confirmed the laboratory director failed to ensure the State Agency was notified of the change in laboratory director within 30 days of the change in February of 2022. -- 3 of 3 --

Summary Statement of Deficiencies 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 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 -- 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 review of personnel records, procedure manual, and interview with the clinical supervisor and testing person number two listed on the Centers for Medicare and Medicaid Services Personnel Report (CMS-209), the laboratory failed to meet the high-complexity testing requirements for inking of tissue removed during MOHS procedures during 2019 through October 8, 2021. The findings include: 1. Review of the personnel records revealed the following: a.-Personnel competency records for 2019, 2020 and 2021 listed the duties of grossing and inking of tissue for testing persons number two and three. b.- Personnel education documents revealed the following: -Testing personnel number two listed on CMS-209 revealed high school diploma and Certified Medical Assistant (CMA) certificate. -Testing personnel number three listed on CMS- 209 revealed Associates degree in Environmental Health with no confirmation of required 24 hours of Science. 2. Review of the laboratory procedure manual revealed the following: - under section KDG MOHS Histo-technician job description responsibilities:"3. Follow procedures for preparation of tissue dissection and marking of tissue." - under Processing Tissue: "4. Ink tissue according to procedure." 3. Interview with the site supervisor and testing person number two on October 13, 2021 at approximately 2:30 pm confirmed that testing personnel number two and testing personnel number three listed on the CMS-209 perform inking of tissue removed during MOHS procedure during 2019 through October 8, 2021. ==================================== -- 2 of 2 --