Concierge Dermatology & Skin Surgery Center

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on the number and severity of the deficiencies cited herein, the Condition: Histopathology was not met. Findings include: 1. The laboratory failed to assess the competency of testing personnel performing tissue specimen grossing and microscopic tissue examinations as part of Mohs surgery. Refer to D5209. 2. The laboratory failed to verify the accuracy of its tissue specimen grossing and microscopic tissue examinations as part of Mohs surgery. Refer to D5217. 3. The laboratory failed to ensure the Hematoxylin and Eosin stain performed with the intended staining characteristics. Refer to D5473. 4. The laboratory failed to follow procedures to perform analytic system quality assessments. Refer to D5791. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to assess the competency of testing personnel performing tissue specimen grossing and microscopic tissue examinations as part of Mohs surgery for 2 (May 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 -- 2019 to May 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Quality Control" policy revealed a section stating, "A minimum of 2 random cases are reviewed yearly by a dermatopathologist or Mohs Surgeon. Discrepancies would be addressed in the patient chart." 2. On 5/13/21 at 12:45 pm, the surveyor requested the laboratory's personnel competency assessments, and they were not made available. 3. An interview on 5/13/21 at 12:45 pm with the Mohs Technician confirmed the laboratory did not have competency assessment documentation available. 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 the Mohs Technician, the laboratory failed to verify the accuracy of its tissue specimen grossing and microscopic tissue examinations as part of Mohs surgery for 2 (May 2019 to May 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Quality Control" policy revealed a section stating, "A minimum of 2 random cases are reviewed yearly by a dermatopathologist or Mohs Surgeon. Discrepancies would be addressed in the patient chart." 2. On 5/13/21 at 12:45 pm, the surveyor requested the laboratory's verification of accuracy documentation and it was not made available. 3. An interview on 5/13/21 at 12:45 pm with the Mohs Technician confirmed the laboratory did not have verification of accuracy documentation available. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Technician, the laboratory failed to ensure the Hematoxylin and Eosin stain performed with the intended staining characteristics for 3 (September, October, and December 2020) of 24 months reviewed. Findings include: 1. A review of the laboratory's "Laboratory Quality Control for Hematoxylin and Eosin" logs revealed the following months lacked documentation of Hematoxylin and Eosin stain performance: a. September 2020 b. October 2020 c. December 2020 2. A review of the laboratory's "Quality Control" policy revealed a section stating, "A control slide will be evaluated each day that a frozen section is prepared. A record of the control slide will be maintained. In this laboratory, this is accomplished by reviewing and recording the staining of a designated slide (QC slides are stored in a container unstained from a previous day's case) each day Mohs is performed. Documented on the Stain Quality Control Log." 3. A review of the laboratory's patient logs revealed 33 patients were tested on days when Hematoxylin and Eosin stain performance had not been documented in the -- 2 of 3 -- months listed above. 4. An interview on 5/13/21 at 12:55 pm with the Mohs Technician confirmed the Hematoxylin and Eosin stain performance documentation was not available for the months listed above. 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 record review and interview with the Mohs Technician, the laboratory failed to follow procedures to perform analytic system quality assessments for 2 (May 2019 to May 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Quality Assurance" policy revealed a section stating, "The Quality Assurance Program involves monitoring the facilities, test methods, equipment, reagents, materials, supplies, procedure manual, method verification, equipment maintenance, calibration and calibration verification, control procedures, remedial actions, and maintenance of quality control records." 2. On 5/13/21 at 1:10 pm, the surveyor requested the laboratory's analytic system quality assessment, and it was not made available. 3. An interview on 5/13/21 at 1:10 pm with the Mohs Technician revealed the laboratory's analytic system quality assessment documentation was not available. -- 3 of 3 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, procedure review, and interview with the office manager, the laboratory failed to keep food and beverages out of the laboratory. Findings include: 1. An observation by the surveyor during the laboratory tour on 5/22/19 at 1:13 pm revealed a box with bagged snacks and juice near the cryostat in the laboratory. 2. A review of the laboratory's "General Laboratory Cleaning and Safety" procedure revealed a section stating, "No food, drink, or cosmetics are allowed in the laboratory." 3. An interview with the office manager on 5/22/19 at 1:13 pm confirmed food and beverage were present in the laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on observation, procedure review, and interview with the office manager, the laboratory failed to follow written procedures for the manual staining process for 7 (November 2018 to May 2019) of 7 months. Findings include: 1. An observation 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 2 -- the surveyor during the laboratory tour on 5/22/19 at 1:13 pm revealed a sheet of paper titled, "Manual Staining Process" with staining instructions by the manual staining station. 2. A review of the laboratory's "Staining H&E Frozen Sections By Hand" procedure revealed discrepancies between the policy and the "Manual Staining Process" guide near the manual staining station. Differences include: a. Water dip rinse 1. Manual Staining Process states "10 dips" 2. Procedure states "10-15 dips" b. Acid Wash 1. Manual Staining Process states "15 dips" 2. Procedure states "15 seconds" c. 100% Alcohol 1. Manual Staining Process states "45 seconds" 2. Procedure states "30 seconds" d. Xylene Substitute 1. The Manual Staining Process has three separate steps: the first for 30 seconds, and the last two each for 15 seconds. 2. The procedure has two steps: Xylene for 30 seconds and the holding tank. 3. During the interview on 5/22/19 at 2:03 pm, the office manager confirmed the two staining procedures contained discreptancies. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview with office manager, the laboratory failed to label the inking reagents used for specimen grossing with the expiration dates for the current lots in use. Findings include: 1. An observation by the surveyor during the laboratory tour on 5/22/19 at 1:13 pm revealed aliquoted inking reagents without expiration dates affixed on the storage containers. 2. A review of the laboratory's " Preparation and Labeling" procedure revealed a section stating, "All reagents are to be labeled with the following information: reagent, dilution, date of preparation, date received and opened, technician, and temperature for storage (if not room temperature)." 3. During the interview on 5/22/19 at 1:13 pm, the office manager confirmed the inking reagents were missing expiration dates on the storage containers. -- 2 of 2 --