Northeast Dermatology Associates

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: Based on record review and staff interview, 1 of 3 new testing personnel who performed gross analysis of tissue specimens did not meet qualification requirements to perform high complexity testing in 2021 and 2022. Refer to tag 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 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 -- 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: Based on record review and staff interview, 1 of 3 new testing personnel who performed gross analysis of tissue specimens did not meet education qualification requirements to perform high complexity testing in 2021 and 2022. Findings include: 1. Review of personnel records on 2/23/2022 revealed 3 new testing personnel (TP) performing gross analysis of tissue specimens. Further review of personnel records revealed 1 (TP A) of 3 new testing personnel obtained an Associates degree in Veterinary Technology and certification as a histotechnician through American Society of Clinical Pathology (ASCP) but did not have any other educational qualifications for high complexity testing. TP A completed training in October 2021. 2. Interview with the General Supervisor (GS) on 2/23/2022 at 9:45 a.m. confirmed the above finding. The laboratory's annual gross analysis volume is 73,051. -- 2 of 2 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have an adequate system in place to ensure mycology test results are sent accurately and reliably to the final report destination. Findings include: 1) Review on 3/12/18 of a final report for Accuderm Acu-DTM mycology testing reported on 2/20/17 revealed the laboratory sent mycology test results via an electronic intramail system to the provider. 2) Interview on 3/12/18 at 10:30 a.m. with testing personnel revealed that final patient mycology test reports could only be accessed and viewed in the laboratory by the testing personnel who sent the intramail report. 3) The laboratory performs 272 Acu- DTM patient tests annually. 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) 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 -- 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 record review and staff interview, the laboratory failed to include the name and location where mycology testing was performed on the final reports. Findings include: 1) Review on 3/12/18 of a final report for Accuderm Acu-DTM mycology testing reported on 2/20/17 revealed the laboratory sent mycology test results via an intramail electronic system to the provider. Further review of this final report revealed that the report did not include the name and address of the laboratory where the Acu- DTM test was performed. 2) Interview on 3/12/18 at 10:30 a.m. with testing personnel confirmed the above finding. 3) The laboratory performs 272 Acu-DTM patient tests annually. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to correct problems identified with mycology test reports from February 2017 to March 2018. Findings include: 1) Review on 3/12/18 of a final report for Accuderm Acu-DTM mycology testing reported on 2/20/18 revealed the laboratory sent mycology test results via an intramail electronic system to the provider. 2) Interview on 3/12/18 at 10:30 a.m. with testing personnel revealed that each mycology test report could only be viewed by the provider the intramail was sent to and the testing personnel who sent it. The testing personnel further revealed that the laboratory began using the current mycology test report in February 2017 and had requested more access to the electronic system so that laboratory personnel can review all patient Acu-DTM test reports. As of this survey date, no additional access or updates to the current reporting process has been made to address the problems the laboratory has identified over the last 13 months. 3) Cross reference deficiency tags D5801 and D5805. -- 2 of 2 --