Cell Diagnostics Inc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Total Cholesterol for the second event of 2021 (Q2-2021). The finding included: 1. Based on review of PT records for the Q2-2021 AAB reported the following unsatisfactory scores for Total Cholesterol Event Score 20.0: Sample Reported Grading Range 6 72 74-90 7 105 107-131 8 156 156-191 9 138 139- 170 10 177 181-221 2. Based on the laboratory testing declaration submitted at the time of the survey on October 19, 2021 the laboratory analyzed and reported approximately 49,700 Routine Chemistry tests for each year during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed on 10/19 /2021 at approximately 11;30 a.m. that the laboratory received the above unsatisfactory proficiency testing scores. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on laboratory technical supervisor interviews, proficiency test reports Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- documents for Routine Chemistry, and policies and procedures record review on October 19, 2021; the laboratory director failed to ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. See D2087. -- 2 of 2 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on request, and the lack of the laboratory's Turn Around Time (TAT) policy and procedure, and interview with the technical supervisor, and testing personnel, the laboratory failed to establish, follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. The findings included: a. The laboratory has no documentation to show that a policy and procedure for the TAT has been established, and written. b. The following patient test results were reported on varies days: Date of Test Order: Date Reported: Receipt: 6/22/2018 GI Panel 6/24/2018 7/11 /2018 Respiratory Panel 7/18/2018 9/21/2018 GI Panel & Respiratory Panel 9/27 /2018 Note: Gastrointestinal (GI) Panel includes: Campylobacter, Clostridium Difficile Toxins A/B, Plesiomonas Shigelloides, Salmonella, Vibrio, Vibrio Cholerae, Yersinia Enterocolitica, Enteroaggregative E. Coli, Enteropathogenic E. Coli, Shiga- Like Toxin Pro E. Coli, E. Coli 0157, Shigella/Enteroinvasive E. Coli, Cryptosporidium, Cyclospora Cayetanensis, Entamoeba Histolytica, Giardia Lamblia, Adenovirus F 40/41, Astrovirus, Norovirus Gl/Gll, Rotavirus A, and Sapovirus. Respiratory Panel Includes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Matapneumovirus, Human Rhinovirus /Enterovirus, Influenza A H2009, Influenza A H3, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Bordetella Parapertussis, Chlamydia peumoniae and Mycoplasma Pneumonia. c. The technical supervisor, confirmed (12/6//2018, 1600) that the laboratory has not established, written TAT policy and procedure. Based on 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 2 -- organisms and viruses included in the GI and Respiratory Panels, the TAT is essential in reporting the results in a timely manner. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on request and the lack of the laboratory's policy and procedure for Turn Around Time (TAT), and interview with the technical supervisor and testing personnel, it was determined that the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. See D 5891. -- 2 of 2 --