Summary:
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 the surveyor's review of the laboratory's policies and procedures, lack of safety procedure, and an interview with office manager (OM); the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to provide a written safety policy and procedure that accurately reflects the existing systems. 2. The OM affirmed by interview on May 14, 2025, at approximately 4:25p.m., that the laboratory lacked a written safety policy and procedures based on the laboratory's risk assessment. 3. According to the laboratory's testing volume declaration submitted at the time of survey, 106 test samples were processed and reported for Mycology, Parasitology, and Dermatopathology. 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 the surveyor's review of the laboratory's policy and procedure, proficiency testing records, eight (8) randomly selected patient records for Mycology and Parasitology, and an interview with the office manager (OM); it was determined that 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 -- the laboratory failed to verify the accuracy of any test or procedure performed at least twice annually for the years 2021, 2022, 2023, and 2024. The findings include: 1. The laboratory's policy and procedure for proficiency testing was limited to only performing peer review for Dermatopathology. Thus, the regulation requirement for proficiency testing for Mycology and Parasitology was not met for all providers for the years 2021, 2022, 2023, and 2024. 2. All 8 patient records reviewed, covering from October 18, 2021 to October 17, 2024 were performed by various providers affiliated with the laboratory and had no records of any proficiency testing. 3. The OM affirmed by interview on May 14, 2025, at approximately 3:00 p.m., that the laboratory only performed proficiency testing for Dermatopathology as mentioned in statement #1. 4. The laboratory's testing declaration form submitted at the time of the survey stated that 6 tests for Mycology and Parasitology were performed and reported during the time when proficiency testing was missed to be performed for all the providers. The reliability and accuracy of patient reporting cannot be assured. D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, six (6) Dermatopathology patient records, preventive maintenance (PM) logs, and an interview with the office manager (OM), it was determined that the laboratory failed to correctly document patient information upon its occurrence. The findings include: 1. One out of 6 patient records reviewed for Dermatopathology was initially recorded in the patient log sheet under March 27, 2022. All logs for cryostat PM, temperature, stain PM, visit note, Mohs surgery note, and patient slides were recorded under March 21, 2022. 2. Patient slides are labeled by the histology technologist (HT) for identifiers that included case number, patient's name, site/location of sample, date of service/examination, and stage-block number. However, for Patient 23-027, examined on March 27, 2022, there were inconsistent labeling, making identification difficult. 3. The OM checked the schedule and affirmed by interview on May 14, 2025 at approximately, 4:10 p.m., that the Mohs surgery date of schedule was under March 27, 2022 and none were examined on March 21, 2022. No