Harry J Hurley Md Pc Laboratory

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 lack of documentation and interview with the laboratory director (LD), the laboratory failed to ensure that the verification of accuracy for parasitology microscopic examinations was performed at least twice annually, as required for tests not included in subpart I for 2 of 2 years from 10/05/2023 to the date of the survey. Findings include: 1. On the day of the survey, 10/30/2025 at 11:30 am, the laboratory could not provide documentation that the verification of accuracy for scabies microscopic examinations were performed twice annually for 2 of 2 years from 10/05 /2023 to 10/30/2025. 2. The laboratory performed 1 scabies examine in 2025. 3. The LD confirmed the findings above on 10/05/2023 at 12:00 pm. ***Repeat deficiency*** D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Accu3003 microscope used to perform histopathology microscopic slides from 10/05/2023 to 10/30/2025. Findings include: 1. The laboratory's Safety & Maintenance policy stated the following: working temperature: 0-40 degrees Celsius; maximum 85 % relative humidity 2. On the day of the survey, 10/30/2025, the laboratory failed to provide documentation for the monitoring of room temperature and humidity to ensure operating conditions were met for the following instruments used to perform histopathology microscopic examinations from10/05/2023 to 10/30/2025: - 1 of 1 Accu3003 microscope 3. The laboratory performed 1207 histopathology slide examination in 2024 (CMS 116, estimated annual volume, dated 09/27/2025). 4. The LD confirmed the above findings on 10/30/2025 at 09:30am. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Academy of Family Physicians (AAFP) proficiency testing (PT) records and interview with the laboratory director (LD), the LD/designee and testing personnel (TP) failed to sign 4 of 4 AAFP PT attestation statement documents for parasitology and mycology testing performed in 2021 and 2022. Findings Include: 1. On the day of the survey, 10/05/2023 at 10:00 am, review of the AAFP PT records revealed that the following 4 of 4 AAFP PT attestation statements reviewed were not signed by the LD/designee or TP for parasitology and mycology testing performed in 2021 and 2022: - AAFP-PT 2021-C - AAFP-PT 2022-A - AAFP- PT 2022-B - AAFP-PT 2022-C 2. During an interview, 10/05/2023 at 10:30 am, the LD stated that the office staff submitting the PT results to AAFP would sign the names of the TP and LD for them on the attestation sheets. 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 laboratory director (LD), the laboratory failed to ensure that the verification of accuracy for histopathology, 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 -- mycology, and parasitology microscopic examinations were performed at least twice annually, as required for tests not included in subpart I from 01/14/2022 to the date of the survey. Findings include: 1. On the day of the survey, 10/05/2023 at 11:30 am, the laboratory could not provide documentation that the verification of accuracy for histopathology microscopic examinations were performed at least twice annually from 01/14/2022 to 10/05/2023. 2. The laboratory could not provide documentation for the verification of accuracy for Potassium Hydroxide (KOH) and scabies microscopic examinations performed from 01/01/2023 to 10/05/2023. 3. The laboratory could not provide a procedure for performing verification of accuracy for KOH, scabies and histopathology examinations. 4. The LD confirmed the findings above on 10/05/2023 at 12:00 pm. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 review of laboratory quality control records and interview with the Laboratory Director at the time of the survey (11:30 07/25/2019), the laboratory failed to document all quality control procedures performed, for histopathology slides read between 2018 and 2019. Findings include: 1. 13 patients had histopathology slides read on site between 04/02/2018 and 06/21/2019. 2. Review of the Laboratory stain log revealed no documentation of quality control for histopathology slides read between 2018 and 2019. 3. During the survey (12:15 07/25/2019), the Laboratory Director confirmed the above findings. 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 --