Search Privacy Violations, Breaches and Complaints
This database was last updated in December 2015 ago and should only be used as a historical snapshot. More recent data on breaches affecting 500 or more people is available at the U.S. Department of Health and Human Services’ Breach Portal.
SANTA CLARA VALLEY MEDICAL CENTER
Cited by the California Department of Public Health for a violation of California’s Health and Safety Code relating to medical privacy during an inspection that began on July 25, 2014. Also cited in 90 other reports.
Report ID: DHZ011.01, California Department of Public Health
Reported Entity: SANTA CLARA VALLEY MEDICAL CENTER
Issue:
Based on interview and record review, the hospital failed to protect the patient rights for confidential treatment for one of two sampled patients (1), when a surgical equipment representative (Rep) was in an operating room (OR) without the patient's consent. This failure resulted in an unauthorized individual entering an OR during a surgical procedure. Findings:The California Department of Public Health received a faxed report on 6/5/13, which indicated on 5/30/13, during Patient 1's surgery a Rep entered the OR without Patient 1's consent. A staff member informed Rep Patient 1 had not consented to Rep being in the OR during the procedure. Rep was in the OR for approximately five minutes before leaving.During an interview on 7/25/14 at 9:55 a.m., the compliance and privacy officer (CPO) stated on 5/30/13, she was informed by an OR staff Rep had entered the OR without Patient 1's prior consent. CPO stated a consent is usually filled out every time a representative is present in the OR. She then stated an OR staff member had asked Rep to leave, since Patient 1 had not given consent.During an interview on 7/25/14 at 1:15 p.m., the OR assistant nurse manager (ANM) stated if a representative was needed during a procedure, the surgeon would obtain a patient consent prior to the procedure. ANM further stated, if it was an emergency surgery, Rep would have been allowed in the OR only while Rep's tool or implant was being used, but the surgeon would still have to fill out the consent form and check the box indicating it was an emergency surgery.A review of a copy of a letter sent on 6/5/13, from the hospital to Patient 1, indicated Patient 1's medical information had been disclosed on 5/30/13, when a representative had entered the OR, during Patient 1's surgical procedure, without Patient 1's consent. A review of a copy of the hospital's 3/2008 "Visitors to Observe Surgery" policy indicated a visitor is any individual, not directly related to the clinical performance of the surgical procedure. Company Representatives are considered visitors. The policy further indicated a visitor is not allowed to observe surgery unless there is express patient permission and OR management approval. Patient signature is required unless the surgery is urgent or emergent and the reason for visitor observation is documented by the surgeon on the "Request for Permission to Observe in Surgery" form.
Outcome:
Deficiency cited by the California Department of Public Health: Patients' Rights