Pa Dermatology Partners - King Of Prussia

Summary Statement of Deficiencies D0000 A recertification survey conducted by the Pennsylvania State Agency on 07/29/2025 found the PA Dermatology Partners - King of Prussia laboratory to be out of compliance with the following condition: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) 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 observation of the laboratory and interview with the Director of Clinical Development (DCD), the laboratory failed to ensure that 3 of 7 tissue marking reagents used for macroscopic histopathology examinations (grossing and inking) were not used beyond their expiration date from 02/28/2025 to date of survey. Findings include: 1) On the day of survey 07/29/2025 at 12:48 pm while touring the laboratory, the surveyor discovered the following 3 of 7 expired tissue marking reagents used for the grossing and inking of histopathology specimens from 02/28 /2025 to 07/29/2025: - 1 opened bottle of Avantik Orange Tissue Marking Dye (expired 02/28/2025) - 1 opened bottle of Avantik Green Tissue Marking Dye (expired 04/30/2025) - 1 opened bottle of Avantik Yellow Tissue Marking Dye (expired 06/30/2025) 2. The DCD confirmed the findings above on 07/29/2025 at 1: 00 pm. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient 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 -- 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) 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 review of patient test reports (Mohs maps) and interview with the Director of Clinical Development (DCD), the laboratory failed to include the address of the location where Mohs microscopic slide examinations were performed on 2 of 2 patient test reports reviewed from 08/22/2023 to the day of survey. Findings Include: 1. On the day of survey, 07/29/2025 at 12:40 pm, review of 2 of 2 patient test reports (Mohs maps) revealed the laboratory failed to ensure the addition of the address of the laboratory where Mohs microscopic slides were examined from 08/22/2023 to 07/29 /2025. 2. The laboratory reported an estimated annual volume of 800 histopathology examinations performed in 2024 (CMS 116, dated 07/28/2025). 3. The DCD confirmed the findings above on 07/29/2025 at 1:00 pm. 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 review of laboratory policy, lack of documentation, and interview with the Director of Clinical Development (DCD), the Laboratory Director failed to provide overall management and direction in accordance with 493.1445 for 18 of 23 months from 08/22/2023 to 07/29/2025. Refer to D6093 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance (QA) policy, lack of documentation, and interview with the Director of Clinical Development (DCD), the Laboratory Director (LD) failed to ensure an established QA program was maintained to ensure the quality of services provided by the laboratory for 18 of 23 months from 08/22/2023 to the date of survey. Findings include: 1. The laboratory's Quality Assurance policy states, "On months when patient testing is being performed in the laboratory, the nurse or Mohs histotechnician, along with the laboratory director, will check off the line items on the Monthly Quality Checklist. The laboratory director will then be responsible for signing off on completed quality assurance checklists." 2. On -- 2 of 3 -- the date of survey, 07/29/2025 at 12:46 pm the laboratory failed to provide documentation of the monthly quality checklist used to perform periodic QA evaluation and assess the laboratory's pre-analytical, analytical, and post-analytical processes for the following 18 of 23 months from 08/22/2023 to 07/29/2025: - January 2024 through December 2024 - January 2025 through June 2025 3. The laboratory performed 800 histopathology examinations in 2024 (CMS 116, estimated annual volume, dated 07/28/2025). 4. The DCD confirmed the findings above on 07/29 /2025 at 1:00 pm. *REPEAT DEFICIENCY -- 3 of 3 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of Mohs surgery diagrams and interview with the Laboratory Manager (LM), the laboratory failed to indicate on 2 of 2 patient Mohs surgery diagrams, the correct address where tests were performed from 09/22/2021 to the day of survey. Findings include: 1. On the day of survey, 08/22/2023 at 10:47 am, review of patient Mohs surgery diagrams (2 of 2 reviewed) revealed that the laboratory did not include the correct address where patient tests were performed. 2. The Mohs surgery diagram stated "2913 Windmill Road, Suite 7, Sinking Spring, PA 19608" when patient tests were performed at "200 Mall Blvd, King of Prussia, PA 19406." 3. The LM confirmed the findings above on 08/22/2023 around 11:05 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the Laboratory Manager (LM), the laboratory failed to perform and document maintenance on 1 of 1 thermometer used for monitoring room temperatures and room humidity from 09/22 /2021 to 08/22/2023. Findings include: 1. On the day of survey, 08/22/2023 at 11:00 am, an observation of the laboratory revealed that the following thermometer used to record room temperatures and room humidity expired on 17 December 2022. -Thomas Scientific - S/N- 200818360. 2. The LM confirmed the findings above on 08/22/2023 around 11:05 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the quality assurance procedure, lack of quality assurance documentation and interview with the Laboratory Manager (LM), the laboratory director (LD) failed to ensure quality assessment (QA) programs were maintained and documented to ensure the quality of services provided by the laboratory from 11/30 /2021 to 01/31/2023. Findings include: 1. The quality assurance procedure states, "Monthly the nurse or tech will check off the Monthly Quality Assurance Checklist." 2. On the day of survey, 08/22/2023 at 10:36 am, the laboratory could not provide documentation of monthly QA activities performed to assess the laboratory's pre- analytic, analytic and post analytic phases of testing from 11/30/2021 to 01/31/2023. 3. The LM confirmed the findings above on 08/22/2023 around 11:05 am. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 a review of quality control (QC) records and interview with Chief Operating Officer (COO), the laboratory did not document Hematoxylin and Eosin (H & E) stain QC monitoring activities for intended reactivity from 06/01/2021 to the day of survey. Findings include: 1. On day of survey 09/22/2021 at 09:55 a.m., The laboratory could not provide QC documentation for staining characteristics for the H&E stain performed from 6/1/2021 to 09/22/2021 2. The COO confirmed the finding above on 09/22/2021 at 10:15 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --