Ravensong Clinical Laboratory Llc

Summary Statement of Deficiencies D0000 Amended on April 21, 2025. An announced CLIA initial survey was conducted at Ravensong Clinical Laboratory LLC on February 26, 2025 to March 31, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5400 - Analytical System - 493.1250 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to have a complete "Validation" before testing 282 patients since 10/07/2024 for the following assays: Streamline PCR Wound pathogen panel, Streamline PCR UTI (Urinary Tract Infection) pathogen panel, and Streamline PCR Respiratory (RPP) pathogen panel (See D5423). D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a 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 -- test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to have a complete "Validation" before testing 282 patients since 10/07/2024 for the following assays: Streamline PCR Wound pathogen panel, Streamline PCR UTI (Urinary Tract Infection) pathogen panel, and Streamline PCR Respiratory (RPP) pathogen panel. Finding Included: Review of Food and Drug Administration (FDA) Classification website revealed the following tests were not listed on the website: Streamline PCR Wound pathogen panel, Streamline PCR UTI (Urinary Tract Infection) pathogen panel, and Streamline PCR Respiratory (RPP) pathogen panel. Review of Wound panel qPCR Validation report signed by the Laboratory Director on 09/28/2024, revealed the laboratory changed the threshold values after they ran all the samples without a validated basis to show that changing the threshold values would not affect results, failed to show concentration of interfering substances, failed to show volumes pipetted per well, and failed to demonstrate the stability of each target for the following pathogens: Acinetobacter baumannii Bacteroides fragilis Candida albicans Candida dubliniensis Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Citrobacter braakii/freundii Citrobacter koseri Enterobacter cloacae Enterococcus spp. Escherichia coli Klebsiella aerogenes K. oxotyca /michiganensis -lactamase (blaKPC) -lactamase (CTX-M-Group 1) Metallo-- lactamase (blaNDM) Fluoroquinolones Klebsiella pneumoniae Morganella morganii Mycoplasma genitalium Mycoplasma hominis Prevotella bivia Proteus mirabilis Pseudomonas aeruginosa Serratia narcoses Staphylococcus aurous Staphylococcus epidemics Staphylococcus saprophytic Streptococcus glaciate (Group B) Streptococcus apogees (Group A) Surrealism surrealistic Ethicality/Bacilli (Mecca) Sulfonamides Tormentor Review of UTI panel qPCR Validation report signed by the Laboratory Director on 09/28/2024, revealed the laboratory changed the threshold values after they ran all the samples without a validated basis to show that changing the threshold values would not affect results, failed to show concentration of interfering substances, failed to show volumes pipetted per well, and failed to demonstrate the stability of each target for the following pathogens: Acinetobacter baumannii Bacteroides fragilis Candida albicans Candida dubliniensis Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Citrobacter braakii /freundii Citrobacter koseri Enterobacter cloacae Enterococcus spp. Escherichia coli Klebsiella aerogenes K. oxotyca/michiganensis -lactamase (blaKPC) - lactamase (CTX-M-Group 1) Metallo--lactamase (blaNDM) Fluoroquinolones Klebsiella pneumoniae Morganella morganii Mycoplasma genitalium Mycoplasma hominis Prevotella bivia Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Staphylococcus saprophyticus Streptococcus agalactiae (Group B) Streptococcus pyogenes (Group A) Ureaplasma urealyticum Methicillin/Oxacillin (mecA) Sulfonamides Trimethoprim Review of RPP panel qPCR Validation report signed by the Laboratory Director on 10/09/2024, revealed the laboratory changed the threshold values after they ran all the samples without a validated basis to show that changing the threshold values would not affect results, failed to show concentration of interfering substances, -- 2 of 3 -- failed to show volumes pipetted per well, and failed to demonstrate the stability of each target for the following pathogens: Influenza A virus Influenza B virus Human metapneumovirus A Human metapneumovirus B Enterovirus Rhinovirus Adenovirus Bocavirus and Epstein Barr virus duplex SARS-CoV-2 Respiratory Syncytial virus and Coronavirus HKU1 duplex Coronavirus OC43 and Coronavirus NL63 duplex Coronavirus 229E mecA Parainfluenza virus 1 Parainfluenza virus 3 Parainfluenza virus 2 and Parainfluenza virus 4 duplex Streptococcus pneumoniae Streptococcus pyogenes and Mycoplasma pneumoniae duplex Bordetella pertussis Haemophilus influenzae Moraxella catarrhalis Staphylococcus aureus and Chlamydophila pneumoniae duplex Acinetobacter baumannii Enterobacter cloacae Klebsiella aerogenes Klebsiella pneumoniae Legionella pneumophila Proteus mirabilis Pseudomonas aeruginosa Staphylococcus epidermidis During an interview on 03/12 /2025 at 12:34 PM, the Laboratory Consultant confirmed the following patient tests were run after the incomplete validation: A. 191 Patients had been tested with Streamline PCR UTI pathogen panel. B. 82 Patients had been tested with Streamline PCR RPP pathogen panel. C. 60 Patients had been tested with Streamline PCR wound panel. On 03/31/2025 at 9:36 AM, the Laboratory Consultant acknowledged patient testing started on 10/07/2024 for Streamline PCR UTI pathogen panel and Streamline PCR Wound pathogen panel. The Laboratory Consultant also confirmed patient testing started on 10/09/2024 for Streamline PCR RPP pathogen panel. -- 3 of 3 --