Maryland Skin Cancer Specialists

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the procedure, review of proficiency testing (PT) records, and email communication with the office manager (OM), the laboratory failed to ensure PT histopathology slides were reviewed at least twice annually. Findings: 1. The "Proficiency Testing Program" procedure stated "Annually, the tech or Risk Manager will send two cases containing the original slides, label it with only the surgical case number, and send it out for a microscopic examination by a Board Certified Pathologist ...Upon receipt of the pathology report from the Pathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician." 2. Paperwork for four cases each of frozen biopsies and Mohs surgeries for 2022 was present in the quality assurance binder. 3. The paperwork did not include a diagnosis from the reviewing pathologist. 4. In an email received on 12/06/2023 at 3:56 PM, the OM confirmed that the slides for the 2022 PT review were pulled, but never submitted for review from a 2nd pathologist and would be sent out for review in 12/2023. 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: 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 -- Based on review of the Laboratory Personnel Report (CMS-209), review of testing personnel (TP) credentials, and interview with the TP and office manager (OM), TP#3 did not meet the qualification requirements to perform high-complexity testing (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 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 -- 2 of 3 -- 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 the Laboratory Personnel Report (CMS-209), review of testing personnel (TP) credentials, and interview with the TP and office manager (OM), TP#3 did not meet the qualification requirements to perform high-complexity testing. Findings: 1. The CMS-209 listed 4 TP. 2. TP#3 stated that they performed grossing and inking of Mohs surgery specimens. 3. During the onsite survey on 12/04/2023 at 2:45 PM, the OM confirmed that TP#3 was not qualified to perform high-complexity testing. -- 3 of 3 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient final reports and interview with the office manager, the final test report did not include the unique identifier assigned to the patient specimen by the laboratory and used throughout the testing process. Findings: 1. During the survey four patient charts were pulled to review the final report with the patients test results. Four of the four that were reviewed did not include the unique identifier/case number of the patient sample used during the testing process. 2. During the exit interview on 06/11/2019 at 11:45 AM the office manager confirmed that unique identifier/case number was not included on the final report. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the procedure manual, review of the quality control (QC) stain records and interview with the office manager, the laboratory director (LD) failed to ensure that the travel histotech who filled in when the routine testing person was unavailable had the proper education and training needed to perform high complexity testing. Findings: 1. The QC stain records for June 2019 through July 2017 were reviewed. 2. The records showed that on the following dates the regular histotech was not working in the laboratory: 08/30/17, 09/01/17, 11/17/17, 01/09/18, 02/09/18, 11/07 /18, 11/14/18, and 11/21/18. The records included the initials of five different histotechnologists. 3. When interviewed the laboratory manager stated that they contacted a company that provided traveling histotechnologists as needed. The company did not provide documentation showing that each of the five histotechnologists met the minimum qualifications of an associate degree in a laboratory science so that they could perform high complexity testing. 4. Review of the evaluation records for the testing personnel showed that there were no documentation showing that each of the five traveling histotechnologists received initial training that included review of the procedure manual; duties and responsibilities; maintenance, and orientation of the laboratory equipment. 5. During the exit interview on 06/11/2019 at 11:45 AM the office manager confirmed that the LD did not ensure that the traveling histotechnologists met the minimum qualifications of an associate degree in a laboratory science and provide initial training to ensure that the histotechnologists were capable of performing the testing per the specifics in the procedure manual for their laboratory. D6178 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(4) Each individual performing high complexity testing must follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance. This STANDARD is not met as evidenced by: Based on observation, review of the daily maintenance records and interview with the testing person, the testing person did not follow the laboratory's procedures for documenting the temperature of the cryostat that was being used each day of testing. Findings: 1. The laboratory has two cryostat available for use in the laboratory. The daily worksheets for May and June 2019 showed that the temperature of one cryostat is recorded each day of testing. 2. When interviewed the testing person stated that sometimes she may be using both of the cryostats but only records the temperature of one of the cryostats. 3. The testing person confirmed that she did not record the identity and temperature of both cryostats when both were in use. 4. During the exit interview on 06/11/2019 at 11:45 AM the testing person confirmed that the daily worksheets did not include the identity and temperature of both cryostats when both were in use. -- 2 of 2 --