Summary:
Summary Statement of Deficiencies D0000 A validation survey was performed at Raazi Clinical Laboratory LLC on March 23, 2026. Raazi Clinical Laboratory LLC was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of proficiency testing samples; D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; 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 a review of the laboratory's policies, the laboratory's proficiency testing (PT) records, patient test records, and staff interview, the laboratory failed to enroll in Bacteriology proficiency testing for the detection of four of twenty-five pathogens included in the laboratory's molecular diagnostic wound panel in 2025. Findings include: 1. A review of the laboratory's policy titled 'Proficiency Testing Policy' revealed the following: "This laboratory will subscribe to a CMS-CLIA approved Proficiency Testing (PT) program provider, such as CAP, AAB, API, or other approved providers, for molecular diagnostic testing when available." 2. A review of the laboratory's proficiency testing records revealed the laboratory failed to enroll in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- PT in 2025 for the detection of the following pathogens: - Clostridium novy - Clostridium septicum - Enterobacter aerogenes - Kingella kingae 3. A review of the laboratory's patient test records revealed the laboratory tested 62 patient molecular diagnostic wound panels in 2025, that included the four pathogens listed above. 4. In an interview on 3/23/26 at 11:00 a.m. in the office, after review of the records, the laboratory director confirmed the above findings. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's records, and staff interview, the laboratory failed to document completion of one of two split sample assessments in 2025 for confirmatory toxicology testing using the LC-MS/MS method. Findings include: 1. A review of the laboratory's policy titled 'Split Analysis: GH Lab' revealed the following: "Compare five samples results with a reference lab to determine the % error (% Difference) of analytes under investigation. The acceptable % error for each individual analyte within each sample is 30%." 2. A review of the laboratory's Split Analysis records for 2025 revealed the laboratory performed two assessments with GH Lab (GHL) on the following dates: - August 2025 - December 2025 3. Further review of the Split Analysis records revealed the laboratory documented the same LC-MS/MS results for the following analytes tested at GHL for August and December: a) Sample 02 - Desmethyltapentadol result: 58.94 - Naltrexone result: 33.39 - Naloxone result: 35.28 - Norhydrocodone result: 59.34 - Ritalinic Acid result: 63.26 - Desmethylcitalopram result: 121.73 - Desmethylvenlafaxine result: 25.95 - Zolpidem Carboxylic acid result: 76.76 - Cotinine result: 57.27 b) Sample 03 - Desmethyltapentadol result: 101.85 - Naltrexone result: 56.76 - Naloxone result: 64.11 - Norhydrocodone result: 117.75 - Ritalinic Acid result: 108.51 - Desmethylcitalopram result: 213.84 - Desmethylvenlafaxine result: 47.1 - Zolpidem Carboxylic acid result: 143.82 - Cotinine result: 105.17 c) Sample 04 - Desmethyltapentadol result: 137.82 - Norhydrocodone result: 144.5 - Ritalinic Acid result: 144.93 - Desmethylcitalopram result: 289.59 - Desmethylvenlafaxine result: 65.41 - Cotinine result: 151.57 d) Sample 05 - Desmethyltapentadol result: 189.06 - Naltrexone result: 124.04 - Norhydrocodone result: 221.23 - Ritalinic Acid result: 206.91 - Desmethylcitalopram result: 376 - Desmethylvenlafaxine result: 89.4 - Cotinine result: 210.36 e) Sample 06 - Desmethyltapentadol result: 253.14 - Naltrexone result: 182.65 - Norhydrocodone result: 306.98 - Ritalinic Acid result: 279.43 - Desmethylcitalopram result: 576.02 - Desmethylvenlafaxine result: 122.84 - Cotinine result: 304.4 4. In an interview on 3/23/26 at 11:40 a.m. in the office, after review of the records, the technical supervisor (as identified on the CMS-209) confirmed the results from GHL were not entered on the Split Analysis spreadsheet for the December assessment, stating the % error calculations were not accurate and assessed for acceptability. Key: LC-MS/MS = Liquid Chromatography-Mass Spectrometry/Mass Spectrometry D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) -- 2 of 6 -- (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's American Proficiency Institute (API) proficiency testing records, and staff interview, the laboratory failed to document performance of a self-evaluation of analytes that were 'not graded' by the proficiency testing program for two of three Microbiology proficiency testing events in 2025. Findings include: 1. A review of the laboratory's policy titled 'Proficiency Testing Policy' revealed the following: "When the result received is 'ungraded' or 'educational challenge', evaluate the result against the participant summary report to determine the laboratory's performance and document