Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) events for 2024 and 2025 and interview with the Laboratory Director (LD), the laboratory failed to ensure all persons performing microscopic urinalysis and potassium hydroxide (KOH) and saline wet mounts participated in the PT events at least once per year. Findings include: 1. Upon review of the PT records for 2024 and 2025, totaling 6 events, the laboratory failed to ensure all persons performing microscopic analysis on urines or other bodily tissues using KOH or saline to perform such tests, participated in PT testing. 2. The laboratory employs four (4) persons who perform saline wet mounts and KOH as well as microscopic urine analysis on patient specimens. 3. Review of the attestation statements made by the testing personnel and signed by the LD, revealed that five (5) out of six (6) of these events for 2024 and 2025 PT events for wet mount and KOH were completed by the same testing personnel (TP #1). One event was performed by TP #2. 4. Two (2) out of four (4) TP had no participation in the PT events for 2024 and 2025. 5. Interview with the Laboratory Director (LD) at 11:30 am confirmed these findings. 6. The laboratory reports performing 1338 microscopic assays annually. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, 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 -- laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) records for urinalysis dipstick analysis for December 2025 and interview with the Laboratory Director (LD), the laboratory failed to ensure that QC was performed by all persons performing urinalysis on patient specimens. Findings include: 1. Upon review of QC records for urinalysis for December 2025, using Bio-Rad controls #1 & #2, lot numbers 79981 exp. 08/01/2026 and 79982 exp. 08/01/2026, it was revealed that one (1) of four (4) testing personnel (TP #1) performed the QC on the urine dipsticks twenty (20) days out of twenty four (24) working days in December 2025. 2. TP #2 performed QC on the urine dipsticks two (2) days out of twenty four (24) days in December 2025. 3. TP #3 performed no QC on the urine dipsticks in December 2025. 4. TP #4 performed QC on the urine dipsticks two (2) days out of twenty four (24) days in December 2025. 5. Interview with the Laboratory Director (LD) at 12:30 pm confirmed these findings. 6. The laboratory reports performing 1261 urinalysis tests annually. -- 2 of 2 --