Philip C Bosch Md

Summary Statement of Deficiencies D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records related to quality control documentation and an interview with laboratory personnel (LP) on 6/16/2022 between 8:30 and a.m. and 10:30 a.m, it was determined that control organism testing for antimicrobial sensitivity testing was not being done on each day of use. Findings include: 1. On 6/16/22, an inspection was conducted between 8:30 a.m and 10:30 a.m. 2. This laboratory does culture and sensitivity testing for urine specimens, to include Kirby Bauer zone sizing for antimicrobial resistance testing. Testing is done for 7 antibiotic zone discs. 3. During a review of the quality control records, it was noted that control organisms were not being utilized on each day of testing to check the effectiveness of the procedure. 4. According to the CMS 116 volumes submitted, there are approximately 1,400 culture tests done annually (assumes each had a Kirby Bauer test). 5. The laboratory director recognized the above findings. 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 D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control (QC) records and interview with the laboratory director, it was determined that the laboratory failed to routinely have control procedures that monitor the accuracy and precision of the complete analytic process, and failed to monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. The findings included: a. The laboratory is a physician office laboratory (POL), specialized in urology. b. The laboratory performed direct susceptibility urine culture for sensitivity to the following antibiotics, Ampicilline, Ciprofloxacin, Gentamycin, Nitrofurantoin, Tetracyclin, and SXT for a positive growth based on colony count for urine culture in blood agar (BA) media. c. Interview with the laboratory director for the direct urine sensitivity testing quality control records, the laboratory failed to maintain proper quality control activity records. d. For direct susceptibility testing, the laboratory must establish its own size ranges for zones of inhibition with QC organisms. 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 -- 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 review of the laboratory's direct susceptibility for urine culture patient test result reports and its worksheets, and interview with the laboratory director and the personnel, it was determined that the laboratory failed to effectively monitor and quality assess to ensure the accuracy of the urine culture testing and the results transcribed from worksheets to NexGen, an electronic medical record (EMR) system. The findings included: a. The laboratory is a physician office laboratory (POL), specialized in urology. b. The laboratory performed direct susceptibility urine culture for sensitivity to the following antibiotics, Ampicilline, Ciprofloxacin, Gentamycin, Nitrofurantoin, Tetracyclin, and SXT for a positive growth based on colony count for urine culture in blood agar (BA) media. c. Review of 6 patient final test reports printed out from EMR and its worksheets, Patient Acct#0347 reported on 08/08/2019 indicated a missing disk of Gentamycin in the process of this patient sample testing. d. The laboratory personnel mistakenly entered a 100 colony count for a 80 colony count from the worksheet to EMR for the patient Acct# 1912 reported date of 07/25/2019. e. The laboratory failed to quality assess and document for the activities and failed to take