New England Dermatology, Pc

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure proficiency testing (PT) material is tested in the same manner as patient samples. Findings include: 1. Record review on 2/28/2025 of the laboratory's American Association of Bioanalysts Medical Laboratory Evaluation, Provider Performed Microscopy, PT records, 'Provider Potassium Hydroxide (KOH)/Scabies Proficiency Testing' Forms revealed: a. 2025 Event 1 - All samples were tested by 16 different testing personnel (TP) b. 2024 Event 3 - All samples were was tested by 14 different TP. c. 2024 Event 2 - All samples were tested by 17 different TP. d. 2024 Event 1 - All samples were tested by 16 different TP. e. 2023 Event 3 - All samples were tested by 16 different TP. f. 2023 Event 2 - All samples were tested by 15 different TP. g. 2023 Event 3 - All samples were tested by 16 different TP. 2. Staff interview on 2/28/2025 at 10:00 AM with the Clinical Manager for General Dermatology confirmed more than one TP looks at the photomicrographs and writes their results on the form noted in #1 above. 3. The laboratory performs 776 tests annually in the specialty of Microbiology. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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 -- (e)(11) 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 record review and staff interview, the laboratory director (LD) failed to ensure new testing personnel (TP) received training prior to testing patient samples. Findings include: 1. Record review on 2/28/2025 of the laboratory's CMS for 209, signed by the LD on 2/28/2025 revealed: a. One new TP performing Grossing, GTP1. b. Two new TP performing Potassium Hydroxide (KOH) and Scabies testing, KSTP1 and KSTP2. 2. Record review on 2/28/2025 of the laboratory's employee records revealed: a. GTP1 hired on 3/6/2024 did not have documented training before testing patient samples. b. KSTP1 hired on 1/15/2024 did not have documented training before testing patient samples c. KSTP2 hired on 3/18/2024 did not have documented training before testing patient samples. 3. Record review on 2/28/2025 of the KOH /Scabies laboratory's 'Training Checklist' procedure signed by the LD on 6/8/2023 revealed, "NEDLC laboratory requires PPM testing personnel should receive adequate training before they perform testing and reporting patient results for Potassium Hydroxide KOH examination." 4. Record review on 2/28/2025 of the MOHS laboratory procedure manual (MPM) revealed the MPM did not have a procedure to train new grossing testing personnel. 5. Staff interview on 2/28/2025 at 12:00 PM with the Clinical Manager for General Dermatology and the MOHS Clinical Supervisor confirmed the above new testing personnel did not have documented training before testing patient samples. 6. The laboratory performs 776 tests annually in the specialty of Microbiology and 13,628 tests annually in the specialty of Histopathology. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and staff interview the Technical Supervisor failed to ensure testing personnel (TP) received annual competency assessment. Findings include: 1. Record review on 2/28/2025 of the laboratory's employee competency records revealed 2 of 13 KOH/Scabies TP did not have documented competency assessment in 2023 or 2024. 2. Staff interview on 2/28/2025 at 10:00 AM with the Clinical Manager for General Dermatology confirmed the above testing personnel did not have documented competency assessment in 2023 or 2024. 3. The laboratory performs 776 tests annually in the specialty of Microbiology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . 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 procedure manual review and interview, the laboratory director failed to approve, sign, and date laboratory procedures as evidenced by the following: a) A review of the clinical laboratory procedure manual for Physician Performed Microscopy Procedures (PPMP) revealed that the current laboratory director had not reviewed and approved the laboratory policy and procedure manual. b) The Director of Operations confirmed in an interview on 2/7/23 at 11:38 a.m. that documentation was not available to verify that the current laboratory director had reviewed and approved of laboratory procedures. c) Based on the lack of procedure review by the laboratory director there was no assurance that laboratory personnel were following established policies and procedures (refer to D6175). The laboratory performs approximately 374 PPMP procedures annually. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with 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 -- each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document a control slide of known reactivity with each patient slide or group of patient slides when special staining was performed as evidenced by the following: a) A review of fifteen (15) histopathology skin slide final reports was performed for slide examinations performed between 1/14/22 and 1/19/23. b) The review revealed that for two (2) of the fifteen (15) patient reports special and immunostains were performed on the following slide specimens: 1. Case number NED22-11074 - Melan A immunostain and Fontana Mason and Iron special stains - reported on 10/19/22. 2. Case number NED22-12916 - Brown and Benn special stain - reported on 12/6/22. c) There was no documentation in the facility's record system of the reactions of the control slide with each immunostain or special stain for slides prepared at a reference laboratory and read at this laboratory site. d) The Director of Operations confirmed in an interview on 2/7/23 at 12:15 p.m. that the results of the immunostain control portion of patient slides were being reviewed by the doctors and the reference lab where the slides were prepared but the results of the control slide exams were not being documented in the laboratory's record system. The laboratory performs approximately 14,863 histopathology slide exams annually. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on record and procedure review and interview, laboratory personnel failed to follow the laboratory's procedures for test reporting as evidenced by the following: a) A review of the laboratory's procedure for Physician Performed Microscopy Procedures (PPMP) for reporting indicated that results are reported either positive or negative. 2) A review of six (6) patient charts for Potassium Hydroxide (KOH) procedures performed between 3/16/22 and 12/30/22 revealed that for two (2) of the six (6) results reported the results were documented as "+/-" in the patient's electronic medical records (medical records 20244 and 132098 for KOH exams performed on 5 /30/22 and 12/30/22 respectively). c) The Director of Operations indicated in an interview on 2/7/23 at 11:55 a.m. that the +/- entries indicated that the results were equivocal (no definitive result) and that the patient would be treated as if the results were positive. However, this type of reporting was not indicated in the laboratory's procedure manual. The laboratory performs approximately 374 PPMP procedures annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing review and interview, the laboratory failed to properly document the handling of proficiency testing samples as evidenced by the following: a) The laboratory is enrolled in a Physician Performed Microscopy Procedure (PPMP) module through the American Association of Bioanalysts (AAB). A review of proficiency testing records for calendar years 2019 and 2020 (6 testing events) revealed the fact that the program report forms and the attestation statements provided by the proficiency testing program were not maintained for five (5) of the six (6) proficiency testing events reviewed (testing events 1, 2, 3 for 2019 and testing events 1 and 3 for 2020). In addition a copy of the program reports for each testing event was not available for three (3) of six (6) testing events (testing event 3 for 2019 and testing events 2 and 3 for 2020). b) The executive director interviewed on 4/9/21 at 11:20 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 -- AM confirmed that the program report forms and the attestation statements for the above events were not completed by the laboratory director and the laboratory technologist. . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing review and interview, the laboratory failed to retain all proficiency testing records for at least 2 years as evidenced by the following: a) The laboratory is enrolled in a Physician Performed Microscopy Procedure (PPMP) module through the American Association of Bioanalysts (AAB). A review of proficiency testing records for calendar years 2019 and 2020 (6 testing events) revealed the fact that the final PT report issued, by the PT service, evaluating the submitted test results was not available for three (3) of six (6) testing events (testing event 3 for 2019 and testing events 2 and 3 for 2020). b) The executive director interviewed on 4/9/21 at 11:20 AM confirmed that the final PT reports were not available. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview, the laboratory failed to maintain documenation to verify that a review and evaluation of PT results was performed as specified in subpart H of this part as evidenced by the following: a) The laboratory is enrolled in a Physician Performed Microscopy Procedure (PPMP) module through the American Association of Bioanalysts (AAB). A review of proficiency testing records for calendar years 2019 and 2020 (6 testing events) revealed the fact that the laboratory failed to document a review of three (3) of three (3) proficiency testing reports. The other three (3) reports were not available in the record to review. b) The executive director interviewed on 4/9/21 at 10:00 AM confirmed that the proficiency testing reports had not been signed off as being reviewed by the technical supervisor. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review interview and interview, the technical supervisor failed to evaluate and document the performance of individuals responsible for high -- 2 of 3 -- complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: a) Review of the CMS 209 Laboratory Personnel Report on 4/9/21 revealed that there was one (1) new histotechnician hired and performing tissue inking since the last CLIA recertification survey on 11/30/18. b) Review of personnel competencies for calendar years 2019 and 2020 revealed that there was no documentation of semiannual competency evaluations for the one (1) new histotechnician who had been working for over a year. c) Histotechnician number 2 confirmed in an interview on 4/9/21 at 11:45 AM that no semiannual competency evaluations had been performed on the one (1) new histotechnician. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Dermatology, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 record review and interview, the laboratory failed to verify at least twice annually procedures it performs that are not included in subpart I of this part as evidenced by the following: Potassium Hydroxide (KOH) and wet prep examinations: a) The laboratory director interviewed on 11/30/18 at 12:10 PM indicated that the laboratory was enrolled in the American Association of Bioanalysts (AAB) proficiency testing program to cover the performance of KOH and wet preps. b) No documentation could be provided at the time of the survey to confirm the laboratory's enrollment in the proficiency testing program. MOHS slide examinations: a) The laboratory's policy for MOHS slide case reviews is to have five cases reviewed two times per year for each MOHS surgeon b) A review of skin slide case reviews for calendar years 2016, 2017 and 2018 revealed that for 2017 and 2018 one (1) of two (2) MOHS surgeons only had case reviews performed once during the year. For 2017 the case review had been performed on 2/28/17 and for 2018 on 11/14/18. c) The histotechnician interviewed on 11/30/18 at 11:55 AM confirmed that one of the MOHS surgeons had not had case reviews performed twice annually for the years indicated. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation and record review, the laboratory failed to ensure laboratory reagents were not used when they had exceeded their expiration date. The findings include: During a tour of the laboratory on 11/30/18 at 10:40 AM the surveyor observed the following expired item in the laboratory area where Physician Performed Microscopy Procedures (PPMP) are performed: 1. One (1) bottle of Wright Giemsa stain lot number K14B31, expiration date 11/17; There were no in-date reagents available in the laboratory. Based on this evidence the accuracy and reliability of microscopic examinations utilizing this stain could not be assured. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually as evidenced by the following: a) Findings revealed that the technical consultant failed to evaluate the competency, at least annually, of seventeen (17) out of seventeen (17) mid-level practitioners performing provider performed microcopy procedures (PPMP) (potassium hydroxide (KOH) and wet preps) for calendar years 2017 and 2018. b) This was confirmed through an interview with the technical consultant on 11/30/18 at 12:00 PM. 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 an interview, the laboratory director failed to ensure that documentation was maintained to verify that newly hired personnel were appropriately trained for the type and complexity of the services offered as evidenced by the following: a) One (1) new histotechnician had been hired since the last CLIA survey performed. The histotechnician performs high complexity inking and grossing of tissues. There was no documentation maintained to verify that she had received training in all aspects of the laboratory operation prior to performing high complexity procedures. b) Interview on 11/30/18 at 12:05 PM with the main histotechnician, responsible for training, -- 2 of 3 -- confirmed that there was no documentation maintained of the new histotechnician's initial training. -- 3 of 3 --