Summary:
Summary Statement of Deficiencies D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure confidentiality of patient information throughout all phases of the total testing process. Findings include: 1. On 11/07/18 at 10:00 AM, the surveyor was given a tour of the laboratory. The laboratory was located in a corner within the same space as of 4 Path laboratory. A box which contained patients' records was stored on the floor beneath a desk with a computer that Medical Diagnostic Laboratories LLC used for accessioning . There was no lock on the box where patient's records were stored. 2. On 11/07/18 at 10:30 AM, testing personnel confirmed the surveyor's findings. 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 review of laboratory records and test reports, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified 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 -- problems for its mycology testing. Findings include: 1. Review of laboratory records revealed that the laboratory failed to establish performance specifications for it PCR testing for the detection of fungi. See D5423 2. There was no documentation to show that the laboratory took