Gregory Herbich Md

Summary Statement of Deficiencies D2043 MYCOLOGY CFR(s): 493.827(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of American Association of Bioanalysts (AAB) proficiency testing records and an interview with the laboratory director on 5/22/2024 at 12:15 PM, the laboratory failed to return its Nonchemistry M1 2024 Dernatophyte Culture results within the time frame specified by the program resulting in a score of 0 for the testing event. The laboratory director stated that culture results for Specimens 1, 2, 3, 4, and 5 were not available for reporting by the program deadline. The laboratory performed 18 dermatophyte cultures annually. 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 a review of three of three 2023 AAB Nonchemistry Dermatophyte Culture and KOH slides proficiency testing program evaluations and an interview with the laboratory director on 5/22/2024 at 12:15 PM, the laboratory failed to review and evaluate its proficiency testing performance. The laboratory performed 18 dermatophyte cultures annually. The findings include: 1. The laboratory reported an incorrect response for Specimen 4 in the 2023 AAB Nonchemistry M1 dermatophyte 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 -- culture testing event. The intended response was Trichophyton rubrum (Dermatophytes present). The laboratory reported Negative (Dermatophytes absent). 2. The laboratory reported incorrect responses for Specimen 6 and Specimen 10 in the 2023 AAB Nonchemistry M2 dermatophyte culture testing event. The intended response for Specimen 6 was Negative (Dermatophytes absent). The laboratory reported Positive (Dermatophytes present). The intended response for Specimen 10 was Trichophyton verrucosum (Dermatophytes present). The laboratory reported Negative (Dermatophytes absent). 3. The laboratory reported an incorrect response for Specimen 12 in the 2023 AAB Nonchemistry M3 KOH testing event. The intended response was Positive. The laboratory reported Negative. 4. The laboratory director stated the laboratory failed to return its AAB Nonchemistry M1 2024 Dernatophyte Culture results for Specimens 1, 2, 3, 4, and 5 within the time frame specified by the program resulting in a score of 0 for the testing event. 5. The laboratory director stated proficiency testing program evaluation activities to include

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 a review of Potassium Hydroxide (KOH) examination and Hardy Diagnostics Dermatophyte Test Medium (DTM) culture records, and an interview with the Laboratory Director on 11/22/2022 at 11:45 a.m., the laboratory failed to twice annually verify the accuracy of its KOH and DTM testing. The laboratory performs approximately 21 KOH examinations and DTM cultures annually. The findings included: a. The laboratory verified the accuracy of its KOH and DTM testing once in 2020, once in 2021 and once in 2022 with the Laboratory Director of another CLIA certified dermatology laboratory. Accuracy records consisted only of the Laboratory Director's initials and a review date. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, direct observation and interview with the laboratory director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- on 11/22/2022, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in CFR 493.1289 for the mycology subspecialty testing it performed. The findings included: a. The laboratory failed to verify at least twice annually the accuracy of its KOH examinations and DTM culture testing. See D5217. b. The laboratory failed to follow Hardy Diagnostics DTM Instructions for Use Procedure instructions. See D5413. c. The laboratory failed to follow Hardy Diagnostics DTM Instructions for Use User Quality Control instructions. This is a repeat deficiency cited during the 04/17/2018 and 01/06/2021 surveys. See D5477. d. The laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in its analytic systems. This is a repeat deficiency cited during the 04/17 /2018 and 01/06/2021 surveys. See D5791. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of Hardy Diagnostics DTM culture records and direct observation of patient testing on 11/22/2022 at 11:15 a.m., the laboratory failed to follow Hardy Diagnostics DTM Instructions for Use, Procedure instructions to incubate inoculated patient media at room temperature (15-30 degrees C). The findings included: a. A patient DTM culture observed incubating on top of a file cabinet in the office records section revealed that laboratory failed to monitor and document room temperatures. b. Office staff stated during an interview on 11/22/2022 at 11:25 a.m. that daily room temperatures were not taken. 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 a review of the DTM Fungal Culture Quality Control log and an interview with the Laboratory Director on 11/22/2022 at 11:40 a.m., the laboratory failed to follow the Hardy Diagnostics DTM Instructions for Use, User Quality Control instructions to check 6 of 6 lots of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response. -- 2 of 4 -- The findings included: a. The laboratory failed to demonstrate inhibition or a negative reaction for DTM media lot #s L27471865, L2747329, L27485694, L27491191, L27494925, and L27507335 used between 03/27/2021 and 11/22/2022. b. The laboratory failed to perform quality control on DTM media lot # L2747329 before its 2 /28/2021 expiration date. * This is a repeat deficiency. The laboratory was cited for this deficiency during its 04/17/2018 survey and 01/06/2021 survey. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the DTM Fungal Culture Quality Control log and an interview with the Laboratory Director on 11/22/2022 at 11:40 a.m., the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in CFR 493.1251 through 493.1283. See D5477. * This is a repeat deficiency. The laboratory was cited for this deficiency in its 04/17/2018 survey and 01/06/2021 survey. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a record review of the Hardy Diagnostics DTM test system and an interview with the Laboratory Director on 11/22/2022 at 11:40 a.m., the Laboratory Director failed to ensure that the quality control program was established and maintained to assure the quality of laboratory services provided. See D5791. *This is a repeat deficiency. The laboratory was cited for this deficiency in its 04/17/2018 survey and 01/06/2021 survey. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and direct observation on 11/22/2022, and an interview with the Laboratory Director on 11/22/2022 at 11:45 a.m., the Laboratory Director failed to ensure that the quality assessment program is established and maintained to identify failures in quality as they occur. The Laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately and proficiently and for assuring compliance with the applicable regulations. See D5217 and D5413. -- 4 of 4 --

Summary Statement of Deficiencies 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 a review of Dermatophyte Test Medium (DTM) records and an interview with the Laboratory Director on 01/06/2021 at 09:30 a.m., the laboratory failed to 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 document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. The findings include: a. The laboratory used DTM media to culture patient specimens to detect the presence of dermatophyte fungi. DTM media Lot# 1723313 was used to test 7 patients from 01/18/2018 to 02/26/2018. DTM media Lot# 1725712 was used to test 8 patients from 03/07/2018 to 05/22/2018. DTM media Lot# 1806609 was used to test 17 patients from 08/13/2018 to 02/20 /2019. DTM media Lot# 1901010 was used to test 6 patients from 03/13/2019 to 01/02 /2020. DTM media Lot# L27445884 was used to test 3 patients from 12/14/2019 to 02 /14/2020. DTM media Lot# L27461475 was used to test 5 patients from 08/21/2020 to 11/12/2020. Documentation that these six lot numbers had been checked to support the growth of dermatophyte fungi and produce the red pigment as a biochemical response was not available for review at the time of the survey. b. DTM media Lot #s 1723313, 1725712, 1806609, 1901010, L27445884 and L27461475 were used to test 46 patient specimens from 01/18/2018 to 11/12/2020. Documentation that the 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 -- physical properties of the media had been checked for deterioration upon receipt was not available for review at the time of the survey. c. This is a repeat deficiency. The laboratory's 06/08/2018

Summary Statement of Deficiencies 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 review of Dermatophyte Test Medium (DTM) records and interview with the laboratory director on 4/17/18, the laboratory failed to 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 document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. Findings included: a. The laboratory used DTM media to culture patient specimens and detect the presence of dermatophyte fungi. DTM media Lot# 1612512 was used to test 10 patients from 8/30/16 to 11/29/16. DTM media Lot# 172331 was used to test 9 patient specimens from 11/25/17 to 2/26/18. There was no record at the time of the survey that these two lot numbers had been checked to support the growth of dermatophyte fungi and produce the red pigment as a biochemical response. b. DTM media Lot numbers 1723313, 171214, 1628707, 1620018, and 1612512 were used to test 69 patients specimens from 5/12/16 to 2/26 /18. There was no documentation that the physical properties of the media had been checked for deterioration upon receipt by the laboratory. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of Dermatophyte Test Medium records and interview with the laboratory director on 4/17/18, the laboratory failed to establish and follow written written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct identified in the analytic systems specified in 493.1251 through 493.1283. Findings included: The laboratory did not have written polices and procedures to ensure that each lot number of DTM was tested for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. See D5477. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of Dermatophyte Test Medium records and interview with the laboratory director on 4/17/18, the laboratory director failed to ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. Findings included: The laboratory failed to 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 document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. See D5477. -- 2 of 2 --