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' observations during the laboratory tour, lack of a laboratory safety plan based on a risk assessment, and interviews with the administrative personnel (AP); the laboratory failed to have and follow a laboratory director-written and approved laboratory safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings included: 1. The laboratory failed to have a written safety plan and procedures based on the laboratory's risk assessment to provide protection from physical, chemical, biochemical, and biohazardous materials as needed. 2. Surveyors observed the following during the laboratory tour: a. There was no evacuation route posted at the laboratory. b. There were no biological or chemical spill kits available in the testing area. c. There was no decontamination log dedicated to the testing area. 3. AP confirmed by interview on September 23, 2026, at approximately 4:00 p.m. that the laboratory did not have a laboratory director-written, approved, signed, and dated safety plan based on a risk assessment and lacked safety items as stated in 2. 4. The safety of laboratory testing personnel could not be assured at this time. 5. The annual testing declaration form signed and dated by the laboratory director submitted at the time of the survey stated 1,010 tests were processed and reported during the time when safety concern for all testing personnel could not be assured. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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 lack of annual peer review documentation, three (3) randomly selected patient records, and interviews with the administrative personnel (AP), the laboratory failed at least twice annually to verify the accuracy of any test or procedure it performs. The findings included: 1. The laboratory began patient testing on January 5th, 2026, but failed to perform at least one peer review for the last nine months that patient diagnosis had taken place. 2. All three (3) randomly selected patient records were from the year 2026, and accuracy of the test cannot be verified at this time. 3. The AP confirmed by interview on September 23, 2026, at approximately 3:15 p.m. that the laboratory failed to conduct at least one peer review covering the testing and diagnosing period from January to September 2026. 4. The laboratory director reported in form CMS-116 on the day of the survey that the laboratory processed and reported 610 histopathology tests annually, for which at least once for the year 2026 peer review was not performed. The laboratory must at least twice annually, verify the accuracy of any test or procedure it performs. 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 surveyors' review of the laboratory's policies & procedures, three (6) randomly selected patients' test records, and interviews with the administrative personnel (AP); the laboratory failed to 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. The findings include: 1. The laboratory failed to present a complete quality assurance plan for the current survey year, as evidenced by: a. The laboratory failed to present a comprehensive quality assurance plan that has been reviewed and approved by the current laboratory director. b. The laboratory failed to present a