Associated Dermatologists, Pc

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of initial training documentation for one out of one testing personnel and interview with the facility personnel, the laboratory director failed to ensure that all testing personnel receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. No initial training documentation was presented for review for one out of one testing personnel who began grossing patients' specimens on August 21, 2022, in the subspecialty of Histopathology. 2. The facility personnel interviewed on August 25, 2023 at 1:40 PM confirmed the laboratory failed to have documentation of initial training for the testing personnel indicated above. 3. The laboratory's reported annual test volume for the subspecialty of Histopathology is 12,000. 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. 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 -- This CONDITION is not met as evidenced by: The Condition of Testing Personnel was found to be not met based on education verification documentation presented during the survey for one out of two testing personnel who failed to meet the required education qualifications for individuals performing high complexity testing. See D6171 for findings. 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 -- 2 of 3 -- 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 education documentation presented for review for one out of two testing personnel (TP-2) who perform the gross examination on patient specimens and interview with the facility personnel, TP-2 failed to meet the required education qualifications to perform high complexity testing. Findings include: 1. The laboratory performs grossing and biopsy interpretations under the subspecialty of Histopathology, with a reported annual test volume of 12,000. 2. The CMS-209, Laboratory Personnel form submitted for review during the survey indicated two testing personnel who perform the gross examination on patient specimens: TP-1 began patient testing on August 1, 2022 and TP-2 began patient testing on February 1, 2021. 3. No documentation was presented for review during the survey to indicate TP- 2 met the required education qualifications under 493.1489 in the CLIA regulations for Testing Personnel who perform high complexity testing. 4. The facility personnel interviewed on 8/25/2023 at 1:30 PM confirmed that the testing personnel stated above lacked the appropriate education documentation for the complexity of testing performed by the laboratory. -- 3 of 3 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy manual and Mohs log, review of patient slides and interview with the facility personnel, the laboratory failed to follow established procedures to ensure positive identification of patient's dermatopathology specimens. Findings include: 1. The laboratory performs Mohs testing under the sub- specialty of histopathology, with an approximate annual test volume of 400. It is the practice of the laboratory to assign a unique accession number to each patient specimen. The accession number is included on the Mohs log, the patient slide(s) and the patient test report. 2. The laboratory's established policy titled, "Test Procedures" listed under section 7.1 states, "Write the patient's last name, accession number, and the number of specimen pieces on the slide before placing the sections on the slide to ensure the identity of the patient". 3. The Mohs slides reviewed during the survey for patient E.O., tested on 6/09/2017, failed to include the accession number (T17-117)on the slides. 4. The facility personnel confirmed that the Mohs slides from the patient indicated above failed to include the accession number per laboratory policy. 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess employee competency. Findings include: 1. The laboratory began grossing patient specimens in July 2017. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of individuals who perform the gross evaluation on histopathology specimens. 3. The facility personnel confirmed that the laboratory did not have a policy established to assess the competency of testing personnel who perform the gross evaluation on histopathology specimens. 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 review of the laboratory's Mohs procedure manual presented during the survey and interview with the facility personnel, the laboratory failed to have the Mohs procedure manual approved, signed, and dated by the current laboratory director. Findings include: 1. The Mohs procedure manual presented for review during the survey conducted on July 19, 2018 failed to include the approval, signature and date of the current laboratory director. 2. The individual listed as Laboratory Director on the CMS-209, Laboratory Personnel Form submitted during the survey was assigned the position of Laboratory Director on 5/02/2017, according to the CMS Database. 3. The facility personnel acknowledged that the Mohs procedure manual was not signed and dated by the current laboratory director at the time of the survey. 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: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of staining materials used for patient testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory processes and interprets histopathology slides from patient specimens with an approximate annual test volume of 14,500. The laboratory began this form of testing in July 2017 and performs the Hematoxylin and Eosin (H&E) stain on each specimen in addition to the following special stains, if requested: PAS, Trichrome, Fite's, Colloidal Iron, Fontana Masson, Iron, Gram Stain, and Congo Red. 2. No documentation of the H & E stain acceptability was presented for review for case number AD17-000937 from 08/31/2017. 3. No documentation of the PAS and -- 2 of 3 -- Colloidal Iron stain acceptability was presented for review for case number AD17- 000937 from 08/31/2017. 4. The facility personnel confirmed that the laboratory failed to document the H & E and special stain acceptability each day of use on the date indicated above. -- 3 of 3 --