Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted by the Pennsylvania State Agency on 10/29/2025 found the Ringpfeil Advanced Dermatology Haverford laboratory to be out of compliance with the following condition: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 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 a lack of documentation and interview with Testing Personnel (TP) #2, the laboratory failed to establish and maintain a competency assessment procedure to assess the competency for 1 of 1 technical supervisor (TS), 1 of 1 clinical consultant (CC), and 1 of 1 general supervisor (GS) for their supervisory responsibilities performed in histopathology from 12/12/2023 to 10/29/2025. Findings include: 1. On the day of the survey, 10/29/2025 at 9:50 am, the laboratory failed to provide a competency assessment procedure to assess TS, CC and GS for their supervisory responsibilities. 2. The laboratory could not provide competency assessment records for the 1 of 1 CC (CMS 209 Personnel #2), 1 of 1 TS (CMS 209 Personnel #2) and 1 of 1 GS (CMS 209 Personnel #2) for their supervisory responsibilities performed from 12/12/2023 to 10/29/2025. 3. TP #2 confirmed the findings above on 10/29/2025 at 11: 18 am. Repeat deficiency** D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- 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 Testing Personnel (TP) #2, the laboratory failed to ensure that 4 of 6 reagents used to prepare microscopic dermatopathology slides were not used beyond the expiration dates from 12/12/2023 to date of survey. Findings include: 1. On the day of the survey 10/29/2025 at 8:45 am, observation during the laboratory tour revealed the following 4 of 6 expired reagents used to prepare microscopic dermatopathology slides from 12/12/2023 to 10 /29/2025: - 1 opened set of Avantik tissue marker dye (Lot #156628, expired 8/31 /2024). - 1 opened bottle of Sakura Tissue-Tek OCT Compound (expired 2/28/2025). - 1 opened bottle of Avantik Eosin-Y Cytoplasmic Stain (Lot #164413, expired 1/31 /2025). - 1 opened bottle of Avantik Bluing Reagent (Lot #156132, expired 8/31 /2025). 2. The laboratory performed an estimated 229 dermatopathology microscopic examinations in 2024 (CMS 116, dated 10/29/2025). 3. TP#2 confirmed the findings above on 10/29/2025 at 11:18 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 lack of maintenance records, and interview with Testing Personnel (TP) #2, the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 traceable thermometer/humidity monitor used to ensure acceptable operating temperatures were met in the dermatopathology laboratory from 05/26/2024 to 10/29/2025. Findings include: 1. The laboratory failed to provide documentation of maintenance and function checks for the following 1 of 1 traceable thermometer/humidity monitor used to monitor room temperature and humidity levels in the dermatopathology laboratory from 05/26/2024 to 10/29/2025: - Thomas Scientific traceable thermometer/humidity monitor (S/N 221547861, calibration expiration date 5/26/2024). 2. TP#2 confirmed the above findings on 10/29/2025 at 11: 18 am. 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 Testing Personnel (TP) #2, the Laboratory Director (LD) failed to provide overall management and direction in accordance with 493.1445 for 22 of 22 months from 12 /12/2023 to 10/29/2025. Refer to D6093, D6103, D6106 -- 2 of 4 -- 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: A. Based on review of the laboratory's Quality Assessment Program (QAP) Policy, lack of documentation, and interview with Testing Personnel (TP) #2, the Laboratory Director (LD) failed to ensure an established Quality Assessment (QA) program was maintained to ensure the quality of services provided by the laboratory for 22 of 22 months from 12/12/2023 to the date of survey. Findings include: 1. The laboratory's QAP stated, "Each of the laboratory's quality systems will undergo assessment on a regular basis to maintain and improve laboratory performance and services. This assessment includes the following practices: - All Quality Control (QC) logs for testing procedures, reagents, and equipment will be reviewed [by] the Laboratory Director or an appropriate designated staff member on a MONTHLY basis. - The Laboratory Director or an appropriate, designated staff member will conduct meetings with all relevant staff MONTHLY to communicate the results of