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 observations during the survey and an interview with laboratory's director and office manager; the laboratory failed to follow safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to follow their safety policy and procedure to provide protection from physical, chemical, biochemical, and biohazardous materials as needed based on the laboratory's risk assessment. 2. Surveyor's observations during the tour and an interview with the OM indicated that the fire extinguisher was not serviced or checked for proper functioning for the past 4 years. 3. The safety of laboratory personnel and patients could not be assured at this time. 4. The annual testing declaration form submitted at the time of survey stated 920 samples were processed and reported for Dermatopathology, Mycology, and Parasitology during the time when safety concern for all personnel and patients could not be assured. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) (a)(7) Slide, block, and tissue retention-- (a)(7)(i) Slides. (a)(7)(i)(A) Retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). (a)(7)(i)(B) Retain histopathology slides for at least 10 years from the date of examination. (a)(7)(ii) Blocks. Retain pathology specimen blocks for at least 2 years from the date of examination. (a)(7)(iii) Tissue. Preserve 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 -- 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 lack of update of policies and procedures reflecting the current practice, review of randomly selected patient test records, and interview with the office manager; the laboratory failed to provide an approved and signed policy and procedure for retention of documents and storage requirements. Findings include: 1. In reference to the retention requirements in 42 CFR Part 493.1105 (Standard Retention Requirements), the laboratory is herein cited for the deficient practice of lacking an approved and signed retention and storage requirements policy and procedure. 2. The OM stated during an interview on 8/7/2025 at approximately 3:30 p. m., that the laboratory does not have a policy and procedure for record retention and storage for: test results, test procedures, quality system assessment record, and Histopathology slides. 3. Based on the laboratory's testing declaration submitted at the time of the survey, the laboratory performed an estimated 920 patient samples during the time that no retention and storage policy and procedure was implemented. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of a Quality Assurance plan (QA), review of the laboratory's policies and procedures, and interview with the office manager; the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. The findings include: 1. Based on the day survey on August 7, 2025, at approximately 2:30 p.m., no documentation could be retrieved by the laboratory to show that a written QA plan was in place for the years 2023, 2024, and 2025. 2. The OM confirmed by interview on August 7, 2025, at approximately 2:45 p.m., that the laboratory did not establish a QA plan to follow written policies and procedures reflecting the current practice for an ongoing mechanism to monitor and assess records identified in the general laboratory systems. 3. According to the testing declaration submitted on the day of the survey 8/7/2025, signed and dated by the laboratory director, the laboratory performed annually 920 tests and diagnosis without an established, approved, signed and dated written QA plan. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on the lack of laboratory's written policies and procedures for KOH (yeast and fugal elements) and Sarcoptes scabiei (scabies) tests and an interview with the office manager (OM); the laboratory failed to have an established policy and procedure that met 493.1251. The findings include: 1. The surveyors' review of the policies and procedures showed that the laboratory lacked protocols for criteria and examples of micrographs for patient sample testing for KOH and scabies detection and diagnosis. 2. The OM affirmed on August 7, 2025, at approximately 2:30 p.m. that the laboratory lacked written policies and procedures for those tests mentioned in statement #1. 3. Based on the testing volume declaration submitted at the time of survey, the laboratory processed and reported approximately 15 KOH and 5 scabies samples annually for which the laboratory lacked written policies and procedures for KOH and scabies in patients' sample testing and criteria for satisfactory specimens. D5779