Adam S Plotkin Md Pa D/B/A

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory had subsequent unsuccessful performance in proficiency testing for the specialty of mycology. Refer to D2046. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on October 18, 2018 at 10:00 AM, showed that the laboratory had unsatisfactory testing scores in the specialty of mycology for three testing events out of five testing events in 2017 and 2018. 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 -- D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing for the specialty of mycology. Findings include: On October 18, 2108 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for three out of five testing events in 2017 and 2018. Due to the laboratory's third failure, the laboratory had a subsequent unsuccessful participation in proficiency testing. Event #1, 2017 Mycology-60% Event #3, 2017 Mycology-60% Event #2, 2018 Mycology-60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of mycology. Findings include: On October 18, 2018, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the specialty, mycology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2046. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of mycology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on October 18, 2018 on or about 10:00 AM -- 2 of 3 -- showed that the laboratory received unsatisfactory proficiency testing scores for three out of three out of five testing events in 2017 and 2018. Due to the laboratory's third failure, the laboratory had a subsequent unsuccessful participation in proficiency testing. The test scores are shown below. Event #1, 2017 Mycology-60 % Event #3, 2017 Mycology-60 % Event #2, 2018 Mycology-60 % -- 3 of 3 --

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 record review and interview with laboratory personnel, the laboratory did not verify the accuracy of Mohs surgery slides twice annually. Findings include: Review of Mohs surgery proficiency testing records for the past two years on 09/20 /18 revealed that there was no documentation to indicate that proficiency testing had been performed in 2017. The laboratory consultant confirmed at 11:25 a.m. on 09/20 /18 that proficiency testing for 2017 could not be located. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation of control procedures having been performed on each new batch of media used for mycology cultures. Findings include: Review of mycology records om 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 -- 09/20/18 revealed that there was no documentation of quality control organisms being used to check each batch of media for its ability support growth and produce the correct biochemical response. The laboratory consultant confirmed that documentation had not been located at 12:19 p.m. on 09/20/18. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the Mohs technologist had received training for the testing that she performed. Findings include: Review of personnel records on 09/20/18 revealed that there was no training documentation for the Mohs technologist that started testing in July, 2017. The laboratory condultant confimed at 11:25 a.m. on 09 /20/18 that the only documentation was the competency that was performed in September, 2018. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with laboratory personnel, the technical consultant did not ensure that the Mohs technologist had been envaluated semiannually during her first year. Findings include: Review of personel records on 09 /20/18 revealed that the technologist that started employment there on 07/24/17 did not have a competency evaluation until 09/18. The laboratory consultant confirmed at 11:25 a.m. on 09/20/18 that the technologist started working there in July of 2017 and the only competency that was performed was in September of 2018. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017, the laboratory did not have successful performance in proficiency testing for the subspecialty of mycology. Refer to D2046. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on February 19, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, dermatophyte identification for two out of three testing events in 2017. D2046 MYCOLOGY 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 -- CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the subspecialty of mycology. Findings include: On February 19, 2018, on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, dermatophyte identification, as shown below. Event #1, 2017 dermatophyte identification-60% Event #3, 2017 dermatophyte identification-60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of mycology. Findings include: On February 19, 2018, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, dermatophyte identification, in the subspecialty of mycology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2046. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the subspecialty of mycology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on February 19, 2018 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores -- 2 of 3 -- as shown below. Event #1, 2017 dermatophyte identification-60% Event #3, 2017 dermatophyte identification-60% -- 3 of 3 --