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 surveyors' observation, lack of safety policies and procedures, and interviews with the nursing supervisor (NS) and office manager (OM); it was determined that the laboratory lacked an eyewash station in the testing area as well as an evacuation route. The laboratory failed to observe safety procedures to ensure protection from physical, chemical, and biohazardous materials. The findings included: 1. During the laboratory tour conducted on April 26, 2024, at approximately 1:30 p.m. the surveyors observed that the laboratory's hand shower spray hose on the sink does not satisfy the requirement for an eyewash station in the area where histopathology samples are prepared. 2. Upon review of the policies and procedures manual of the laboratory, it was observed that no safety policies and procedures were found at the time of the survey. 3. The NS affirmed there was no other eyewash station in the laboratory aside from the hand shower spray hose in the processing area and is unaware of any policies and procedures for safety. 4. Both NS and OM affirmed that there was no evacuation route posted anywhere in the laboratory. 5. Based on the laboratory's annual testing volume declaration signed by the laboratory director on April 25, 2024, the laboratory processed and reported approximately 2,000 samples for dermatopathology and Mohs collectively. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the 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 -- date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on the written policies and procedures manual for retention and storage applicable to histopathology and Mohs, review of ten (10) randomly chosen dermatopathology test records, and interview with the nursing supervisor (NS); the laboratory failed to have a written policy for Mohs and dermatopathology documentation and slide retention. The findings included: 1. Based on the day of survey conducted on April 26, 2024, at approximately 12:00 p.m., a written policy for retention of documents for two years was found but lacked the information for retention period for slides. 2. The NS affirmed by interview on April 26, 2024, at approximately 12:00 p.m. that the laboratory had an incomplete policy for documents retention for Mohs and histopathology slides. 3. The laboratory declared on April 26, 2024, that 2,000 tests are performed annually for Mohs and dermatopathology. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the surveyors' review of ten (10) randomly selected patient records for Mohs and histopathology, interviews with the nursing supervisor (NS) and office manager (OM) on April 26, 2024 at approximately 12:30 p. m., the laboratory failed to correctly match the document of their slide accession number / Mohs case number to the final report. The findings included: 1. The surveyors reviewed a total of ten (10) randomly selected patient records that consisted of five (5) records for Mohs and five (5) for histopathology records from June 7, 2022 to February 9, 2024. One (1) out of five (5) records for Mohs was discrepant as Mohs case number was missing on the slide presented at the time of survey. 2. Four (4) out of five (5) Mohs patient records were discrepant as Mohs case number assigned to the patients were different from the assessment notes and final report recorded in the patient's chart. 3. No Quality Control staining slide was found for five (5) out (5) histopathology patient records reviewed at the time of the survey. 4. Based on an e-mail response from the OM, she affirmed that the discrepancy in statements 1 and 2 above were due to the automatic assignment of the Electronic Health Record (EHR) without their knowledge. No