Warner Orthopedics & Wellness

Summary Statement of Deficiencies D0000 An Initial survey was performed on August 2, 2023 at Warner Orthopedics Wellness, LLC, CLIA ID # 19D2264786. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory personnel, the laboratory failed to ensure laboratory supplies were not used beyond their expiration date. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the following expired supplies: - Thirteen (13) Copan e-swabs, lot N2004800, expiration date April 30, 2023 2. In interview on August 2, 2023 at 10:01 a.m., the Technical Supervisor confirmed the supplies identified above were expired. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(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 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: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: I. Based on observation; review of the laboratory's test menu, policy and procedure menu, and performance verification studies; as well as interview with laboratory personnel, the laboratory failed to establish specimen stability for nail pathogen testing on the QuantStudio analyzer. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the laboratory utilized the QuantStudio analyzer for nail pathogen testing. 2. Review of the laboratory's test menu revealed the laboratory utilized the QuantStudio analyzer for the following nail pathogen testing: Alternaria species; Aspergillus species (fumigatus, niger, terreus, versicolor); Candida albicans; Candida dubliniensis; Candida glabrata; Candida krusei; Candida lusitaniae; Candida parapsilosis; Candida tropicalis; Curvularia lunata; Epidermophyton floccosum; Fusarium solani; Microsporum audouinii; Microsporum canis; Microsporum gypseum; Microsporum nanum; Pichia onychis; Trichophyton species (interdigitale, mentagrophytes, rubrum, soudanense); Trichophyton violaceum, tonsurans; Trichophyton beigelii, mucoides; Pseudomonas aeruginosa; Staphylococcus aureus; and Sarcoptes scabiei. 3. Review of the laboratory's policy "Specimen Collection & Handling (Nail/Fungal)" revealed the following instructions for storage of nail samples: - The specimen is stored at room temperature until receipt at the lab and then refrigerated once received. The sample is stable for 72 hours at room temperature or 5 days at 2-8 degrees Celsius. - If testing will be delayed for >72 hours specimens should be transferred and stored at -20 degrees Celsius for up to 2 months (60 days). 3. Review of the laboratory's validation records revealed the laboratory did not perform a stability study for nail pathogen testing. 4. In interview on August 2, 2023 at 1:50 p.m., the Technical Supervisor confirmed the laboratory did not perform stability studies for nail pathogen testing when performing validation of the QuantStudio analyzer. II. Based on observation; review of the laboratory's test menu, policy and procedure menu, manufacturer's package insert, and performance verification studies; as well as interview with laboratory personnel, the laboratory failed to establish specimen stability for wound pathogen and antibiotic resistance testing on the QuantStudio analyzer. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the laboratory utilized the QuantStudio analyzer for wound pathogen testing. 2. Review of the laboratory's test menu revealed the laboratory utilized the QuantStudio analyzer for the following wound pathogen and antibiotic resistance testing: Acinetobacter baumannii; Bacteroides fragilis; Citrobacter species (C. freundii, C. koseri); Enterobacter species; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Morganella morganii; Proteus species (P. vulgaris, P. mirabilis); Pseudomonas aeruginosa; Staphylococcus species (S. epidermidis, S. haemolyticus, S. saprophyticus, S. lugdunensis); Streptococcus pyogenes; blaKPC; blaVIM, blaNDM; blaCTX-M; mecA, ermA, ermB, ermC; qnrA; tetM, vanA, vanB; and blaOXA. 3. Review of the laboratory's policy "Specimen Collection & Handling (Wound)" revealed the recommended collection device for wound specimens was the BD eSwab in liquid amies. 4. Further review of the laboratory's policy "Specimen Collection & Handling (Wound)" revealed the following instructions for storage of wound samples: - The specimen is stored at room temperature until receipt at the lab and then refrigerated once received. The sample is stable for 72 hours at room temperature or 5 days at 2-8 degrees Celsius. - If testing will be delayed for >72 hours specimens should be transferred and stored at -20 degrees Celsius for up to 2 weeks (14 days). 5. Review of the manufacturer's package insert for the eSwab revealed "To -- 2 of 5 -- maintain optimum organism viability, transport specimens collected using ESwab directly to the laboratory, preferably within 2 hours of collection. If immediate delivery or process is delayed, then specimens should be refrigerated at 4-8 degrees Celsius or stored at room temperature (20-25 degrees Celsius) and processed within 48 hours except for Neisseria gonorrhoeae cultures, which should be processed within 24 hours." 6. Review of the laboratory's validation records revealed the laboratory did not perform a stability study for wound pathogen and antibiotic resistance testing. 7. In interview on August 2, 2023 at 1:50 p.m., the Technical Supervisor confirmed the laboratory did not perform stability studies for wound pathogen and antibiotic resistance testing when performing validation of the QuantStudio analyzer. III. Based on observation, review of the laboratory's performance verification studies, and interview with laboratory personnel, the laboratory failed to evaluate the accuracy studies performed for nail pathogen testing on the QuantStudio analyzer. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the laboratory utilized the QuantStudio analyzer for nail pathogen testing. 2. Review of the laboratory's validation records for nail pathogen testing revealed IV. Based on observation, review of the laboratory's performance verification studies, and interview with laboratory personnel, the laboratory failed to evaluate the accuracy studies performed for wound pathogen and antibiotic resistance testing on the QuantStudio analyzer. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the laboratory utilized the QuantStudio analyzer for wound pathogen testing. 2. Review of the laboratory's validation records for wound pathogen testing revealed D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records and the laboratory's policy and procedure manual, as well as interview with laboratory personnel, the laboratory failed to ensure the monthly maintenance on the QuantStudio was performed as required by the laboratory for five (5) of nine (9) months reviewed. Findings: 1. Observation by surveyors during the laboratory tour on August 2, 2023 at 9:50 a.m. revealed the laboratory utilized the QuantStudio analyzer for microbiology testing. 2. Review of the laboratory's QuantStudio maintenance logs and policy "QuantStudio Systems Maintenance" revealed the laboratory was to perform the following monthly tasks: - Perform Background Calibration - Perform Instrument Self-Test - Run disc clean-up and defragmentation 3. Further review of the maintenance logs revealed the laboratory did not perform monthly maintenance for the following months: - November 2022 - December 2022 - January 2023 - March 2023 - May 2023 4. In interview on August 2, 2023 at 11:50 a.m., the Technical Supervisor stated the instrument was down from February 15, 2023 through March 20, 2023. She confirmed the maintenance was not performed for the months identified above. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to -- 3 of 5 -- determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the laboratory's