Pcg Molecular Llc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of enrollment documentation and an interview with the lab director, the laboratory failed to enroll in proficiency testing (PT) program for testing the SARS- CoV-2 assay. Findings include: 1. Due to the lack of enrollment documentation, when requested, the lab was unable to verify the enrollment in a PT program. 2. Interview with the lab director in his office on 2/10/21 at approximately 3:00 PM, confirmed the lab had not enrolled in a PT program at the time of the survey. 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 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) initial survey was completed on December 17, 2020. The laboratory was found not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780 resulting in immediate jeopardy. The following deficiencies were cited: 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 surveyor observation and an interview with the Laboratory Director (LD), the laboratory failed to provide a flammables cabinet, shower station and eyewash for immediate emergency use within the laboratory area. The findings include: 1. The laboratory failed to have a shower station and eyewash available in the laboratory to ensure safety measures of any person's eyes or body that may be exposed to injurious corrosive materials, for quick drenching or flushing for immediate emergency use. A tour of the laboratory confirmed a shower station and eye wash was absent from the laboratory area. 2. The laboratory is using flammable reagents for RNA extractions and storing the reagents in the fume hood. The laboratory does not have a flammables cabinet to safely store the flammable reagents. 3. The LD confirmed on 12/17/2020, at 11:45 AM, in the laboratory, that a shower station, eye wash and flammables cabinet has been absent from the laboratory from September 2020 through December 2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the procedure manual and interview with the testing personnel (TP), determined that the laboratory failed to establish a written policy that assess employee competency for all laboratory procedures performed in the laboratory from September 2020 to December 2020. The findings include: 1. The laboratory failed to have a written policy and procedure to assess competency based on the position responsibilities on an initial, semi-annual, and annual bases. 2. An initial competency was not performed for any of the testing personnel prior to patient testing from September 2020 through December 2020. 3. An interview with the Laboratory Director on 12/17/2020 at 2:30 PM, in the office, confirmed that the laboratory did not have a written policy for assessing employee competency for all test performed in the laboratory. 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 review of the laboratory proficiency test (PT) records and interview with the Laboratory Director (LD), the laboratory failed to ensure that at least twice annually the laboratory verified the accuracy of BioCode SARS-CoV-2 assay and unregulated analytes. The findings include: 1. Review of the laboratory's records revealed that there was no documentation of peer review or internal proficiency testing (PT) performed twice annually for the BioCode SARS-CoV-2 assay for unregulated analytes. 2. The laboratory does not have a policy indicating how PT for unregulated analytes is assessed. 3. The LD confirmed on 12/17/2020, at 1:30 PM, in the office, that the laboratory has not performed PT twice annually for the BioCode SARS-CoV- 2 assay or unregulated analytes from September 2020 through December 2020. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of