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Based on records reviewed and interviews the Hospital failed to complete a comprehensive review of the delay in diagnosis of Patient #1's human immunodeficiency virus (HIV) disease; failed to launch a laboratory review to determine if any additional HIV cases had not been reported and been referred for appropriate follow-up services; and was unable to define what laboratory findings would constitue a case report.

See citation A-0273

Based on records reviewed and interviews the Hospital failed to initiate a comprehensive investigation for one (Patient #1) of ten patients sampled who received a delayed diagnosis of HIV (human immunodeficiency virus) disease. In addition, the Hospital failed to investigate if other patients had been similarly missed and if the provider's current ordering pattern would capture HIV disease for timely reporting and follow-up.

Patient #1 sought medical treatment for vague symptoms of joint pain and fatigue from the Refugee Health Services Department in February of 2013. Despite Patient #1's HIV-type 1 viral load testing results of 7 million copies (highly positive) Patient #1's Primary Care Physician (PCP) told the patient that the test results were negative. Patient #1 remained undiagnosed until May 2018.

The Surveyors interviewed the Patient Safety Risk Specialist at 10:40 A.M. on 7/25/18. The Patient Safety Risk Specialist said that Patient #1's PCP had left the Medical Center to practice elsewhere in 2015. The Patient Safety Risk Specialist said that in connection with the investigation of Patient #1's case she had spoken with PCP #1 who said because PCP #1 was so certain that Patient #1 would test positive for HIV Disease, PCP #1 purposely did not follow the usual sequence of HIV testing that included an HIV screening test that, if positive, would reflex into an HIV confirmatory test followed by the viral load testing. PCP #1 bypassed this ordering sequence and went directly to HIV #1 and #2 viral load testing. The Patient Safety Risk Specialist said they believe that PCP #1 only reported the HIV-2 negative results to Patient #1. The Patient Safety Risk Specialist said PCP #1 said that that was her ordering pattern and she was surprised by the negative results that returned on Patient #1. The Patient Safety Risk Specialist surmised that because the results of HIV 1 and HIV 2 had been resulted in two different reports (one from the Hospital's Laboratory and one from the Hospital's reference laboratory) PCP #1 had missed the positive report of the HIV-1 report.

The Surveyors interviewed Laboratory Leadership consisting of the Laboratory Quality Representative, the Manager of Clinical Services, the Laboratory Team Leader, the Laboratory Application Manager and the Director of Pathology and Laboratory Medicine at 9:30 A.M. on 7/25/18. The Laboratory Team said Electronic Laboratory Reporting (ELR) began at the Medical Center in October of 2013 (8 months after Patient #1's initial HIV testing). According to the Centers for Disease Control (CDC) the automated messaging of laboratory reports sent to the Public Health Departments was designed to improve timeliness, accuracy and report completeness for numerous reportable conditions. The Laboratory Team said in October of 2013 all positive HIV screening and viral load testing was transmitted to the Public Health Department as required. The Laboratory Team was unable to say if a positive HIV viral load constituted a confirmed case of HIV disease.

The Surveyors interviewed the HIV Team consisting of the Manager of the Infectious Disease Clinic and the Senior Director of the Infectious Disease Clinic and Public Health Program at 12:45 P.M. on 7/25/18. The HIV Team said their program was to oversee the navigation and notification of HIV positive patients. The HIV team said that, when a confirmed case of HIV disease was identified, a representative from the Public Health Department would work with the HIV team to ensure patients were notified and linked to follow-up care. The HIV team said HIV viral load testing is primarily used for management/monitoring of HIV-1-infected individuals and was not sure that a positive viral load constituted a confirmed case of HIV disease. The HIV team was unable to answer as to what laboratory testing established a confirmed case of HIV disease.

The Surveyors reviewed the policy entitled Critical Alert Values dated 1/22/18. The policy indicated that HIV was not a critical value and telephone notification to the ordering clinician was not included in the laboratory process.

The Surveyors interviewed the Executive Director of Quality and Patient Safety at 9:25 A.M. on 7/24/18 and repeatedly throughout the survey. The Executive Director of Quality and Patient Safety said PCP #1 had practiced at the Medical Center from June of 2006 through July of 2015. The Executive Director of Quality and Patient Safety said that the laboratory had not done a look back on PCP #1's cases to ensure no additional cases were found.

The Surveyors reviewed the Preventability Determination Report on 7/25/18. The Corrective Action steps indicated that HIV-1 and HIV-2 test results were now returned on one report instead of two and that Information Technology was working with clinicians to simplify the HIV ordering panels. Education and/or information to the ordering clinicians had not yet been done.

Subsequent to Survey the Surveyors interviewed Laboratorian #1 from the State Laboratory to determine if reporting a positive viral load alone without HIV confirmatory testing would constitute a case report of HIV disease. Laboratorian #1 said that since January 2012 a positive viral load would be sufficient to be considered a case report; however if PCP #1 had ordered HIV viral load testing alone as she had done with Patient #1 were there additional cases that the Medical Center failed to report. The PCP had practiced at the Medical Center beginning in 2006.