SANTA CLARA VALLEY MEDICAL CENTER

Report ID: Z32G11.01, California Department of Public Health

Reported Entity: SANTA CLARA VALLEY MEDICAL CENTER

Issue:

Based on interview and record review, the hospital failed to prevent the unauthorized disclosure of patient health information (PHI) for six of 14 sampled patients (3, 5, 7, 9, 11, and 13), when medication labels containing PHI were dispensed to incorrect patients. The failure resulted in the disclosure of PHI of six patients to unauthorized individuals. Findings:1. The California Department of Public Health received a faxed report on 9/18/14, which indicated Patient 3's medication had been incorrectly dispensed to Patient 4. Patient 4's family member returned the medication to the pharmacy on 9/13/14 and exchanged it for Patient 4's correct medication. The label on the medication bottle disclosed Patient 3's name and medication information to Patient 4. A hospital internal investigation revealed a pharmacy staff member had inadvertently dispensed Patient 3's medication to Patient 4. During an interview on 11/3/14 at 1:30 p.m., the ethics and compliance officer (ECO) stated on 9/12/14 Patient 4's family member had picked up Patient 4's medications at a hospital affiliated pharmacy. After arriving home, Patient 4's family member noticed the label on the medication bottle was for Patient 3. Per Patient 4's family member, Patient 4 did not take any of the medication. ECO stated that on 9/13/14, Patient 4's family member returned the bottle of medication to the pharmacy.During an interview on 11/3/14 at 1:45 p.m., the hospital affiliated pharmacy's technician (VPT) stated on 9/13/14 Patient 4's family member came into the pharmacy holding a medication bottle and said "this is not my [family member's] medication we picked up yesterday." VPT stated the label on the bottle indicated the medication bottle belonged to Patient 3.A review of a copy of a letter dated 9/18/14 from the hospital to Patient 3 indicated, on 9/13/14 Patient 3's medication had been dispensed inadvertently to Patient 4's family member, who had returned the medication to the pharmacy. The label on the bottle of medication disclosed Patient 3's name and medication information.A review of a copy of the medication bottle label indicated Patient 3's name, medication name, and instructions for medication use were disclosed.2. The California Department of Public Health received a faxed report on 6/9/14, which indicated, on 6/4/14, Patient 6 brought a medication bottle to a hospital affiliated clinic pharmacy and informed the pharmacy staff he had received Patient 5's medication in the mail. A hospital internal investigation revealed the package sent to Patient 6 had two address labels, the packaging label was for Patient 5 and the mailing label was for Patient 6. Patient 6 did not take any of the medication. The label on the medication bottle disclosed Patient 5's name, medication name, and dosage.During an interview on 10/31/14 at 10:45 a.m., the compliance and privacy officer (CPO) stated on 6/4/14, Patient 6 brought a package into the pharmacy which he had received in the mail. The package had a label with Patient 5's name and address and a mailing label with Patient 6's name, address, and a tracking number. CPO stated the package had been mailed on 6/2/14 and Patient 6 did not open the medication. During an interview on 10/31/14 at 12:40 p.m., the pharmacy technician (PT A) stated on 6/4/14, Patient 6 came into the pharmacy with a package which had Patient 5's address and Patient 6's address. PT A stated Patient 6 had said the medication which had been mailed to him was not his medication and he was waiting for his medication through the mail. PT A stated the medication bottle Patient 6 had given to her had disclosed Patient 5's name, medication name, and directions for taking the medication. A review of a copy of a letter dated 6/9/14 from the hospital to Patient 5 indicated on 6/4/14, Patient 6 had notified the pharmacy he had received Patient 5's medication which disclosed Patient 5's name, address, and medication information.A review of a copy of Patient 5's medication label disclosed Patient 5's name, medication name, and directions for taking the medication.3. The California Department of Public Health received a faxed report on 6/11/14, which indicated on 6/6/14, Patient 8 brought a medication bottle to a hospital affiliated pharmacy and informed the pharmacy staff he had received Patient 7's medication in the mail. A hospital internal investigation indicated the package sent to Patient 8 contained two bottles of the same medication. One of the medication bottles was intended for Patient 7. Patient 7's medication label disclosed the patient's name, medication, and dosing information. The fax report further indicated a pharmacy staff member had inadvertently placed both bottles in the same package which was then mailed to Patient 8.During an interview on 10/31/14 at 12:55 p.m., CPO stated on 6/6/14, Patient 8 had brought a bottle of medication to a hospital affiliated pharmacy which had a label disclosing Patient 7's name and the medication name. CPO stated Patient 8 had received two identical bottles of medication in the same package, one belonging to him and the other belonging to Patient 7. CPO stated a pharmacy staff had placed both bottles in the same package which had been mailed to Patient 8.During an interview on 10/31/14 at 1 p.m., a pharmacist (TP) stated Patient 8 brought the package and the wrong medication bottle to the pharmacy. TP stated the package had Patient 8's correct name and address, but the medication label indicated the medication bottle belonged to Patient 7. TP stated Patient 8 told him the bottle of medication was not his, but the name and address on the shipping package were Patient 8's. TP stated Patient 7 and Patient 8 were prescribed the same medication.A review of a copy of a letter dated 6/11/14, from the hospital to Patient 7 indicated on 6/6/14, Patient 8 received a bottle of medication in the mail with a label which disclosed Patient 7's name, medication, and dosing information. A review of a copy of Patient 7's medication label indicated Patient 7's name, medication name, and dosage information were disclosed.4. The California Department of Public Health received a faxed report on 6/26/14, which indicated on 6/20/14, Patient 10 brought a medication, which belonged to Patient 9, to a hospital affiliated pharmacy. The pharmacy staff confirmed Patient 10 did not take any of the medication. A hospital internal investigation revealed a pharmacy staff member had inadvertently dispensed Patient 9's medication bottle to Patient 10 disclosing Patient 9's name and medication name. During an interview on 10/31/14 at 12 p.m., the assistant pharmacy director (APD) stated Patient 10 was waiting in the pharmacy for his prescription to be filled. APD stated when a staff member called a claim check number (each patient waiting for medication gets a claim check with a sequential number on it) Patient 10 came to the pick up window and said the number was his. The staff member checked Patient 10's identification, but did not match it to the claim check, and inadvertently dispensed the medication belonging to Patient 9. APD stated "Shortly after", Patient 9, having the correct claim check number, came to the pick up window inquiring about his medication, which the computer indicated had already been dispensed. APD stated a pharmacy staff member realized she had dispensed Patient 9's medication to Patient 10. During an interview on 10/31/14 at 12:05 p.m., pharmacy technician B (PT B) stated she was at the pick up window when Patient 10 came to the window. She asked the patient his claim check number, which he said was "12". PT B stated she had told Patient 10 his medication was not ready yet. PT B stated when the medication for claim check "12" was ready, she called out number "12" and the same patient from earlier (Patient 10) came to the window. PT B stated she did not ask to see the claim check, she just scanned the label on the prescription, and when the patient information came up on the computer screen she did not match Patient 10's identification to the computer screen. PT B stated shortly afterward, her coworker, told her Patient 9 actually had claim check number "12". PT B realized she had given Patient 10 the wrong medication. PT B stated the next day Patient 10 brought back the wrong medication to the pharmacy to exchange it for the correct medication.During an interview on 10/31/14 at 12:10 p.m., APD stated PT B should have keyed in Patient 9's medical record number then scanned the medication bottle label. APD stated if it was the wrong patient or medication, the bottle's label would not have scanned.During an interview on 10/31/14 at 12:25 p.m., TP stated Patient 10 realized the medication was not his and returned the wrong medication the following day. TP stated Patient 10 stated the medication was not his, and he wanted his correct medication. TP stated Patient 10 was a regular patient whose medical record number ends in "12", and when PT B called out the claim check number "12" Patient 10 thought PT B was referring to the last two digits of his medical record number.A review of a copy of a letter dated 6/26/14, from the hospital to Patient 9 indicated, on 6/20/14, Patient 10 brought a medication belonging to Patient 9 into the pharmacy. The label on the medication disclosed Patient 9's name, physician, and medication name.A review of a copy of Patient 9's medication label indicated Patient 9's name, medication name, and dosage information were disclosed. 5. The California Department of Public Health received a faxed report on 9/23/14, which indicated on 9/16/14, Patient 12 brought to a hospital affiliated pharmacy a bottle of medication which belonged to Patient 11, and had been dispensed to Patient 12. The label on Patient 11's medication bottle disclosed Patient 11's name and drug name. During an interview on 11/3/14 at 11:55 a.m., a pharmacy supervisor (PS B) stated on 9/16/14 at approximately 9 a.m., Patient 12 came to the pharmacy to pick up her medications and was given two bottles of her medication and inadvertently given one bottle of Patient 11's medication. PS B stated when Patient 12 arrived home and noticed she had a bottle of medication which was not hers, she returned it to the pharmacy. During an interview on 11/3/14 at 12:05 p.m., the pharmacist (SP A) stated she had spoken with Patient 12 who stated she had picked up her medications and had also received a bottle of medication for Patient 11 in error. SP A stated she asked Patient 12 to bring back the wrong medication to the pharmacy, and Patient 12 brought it back that day (9/16/14). During an interview on 11/3/14 at 1:20 p.m., the pharmacist in charge (SP B) stated Patient 12 brought Patient 11's medication bottle to the pharmacy, stated her name and said "here is the medication." SP B stated she counted the pills and all of them were there.A review of a copy of a letter dated 9/23/14, from the hospital to Patient 11 indicated on 9/16/14, Patient 12 had brought a bottle of medication to the pharmacy which disclosed Patient 11's name and medication name. A review of a copy of Patient 11's medication label indicated Patient 11's name, medication, and dosage were disclosed.6. The California Department of Public Health received a faxed report on 8/11/14, which indicated on 8/6/14, Patient 14 notified a hospital affiliated pharmacy she had received medication which belonged to Patient 13. Patient 14 stated she had consumed some of the medication (Losartan, a blood pressure medication), and she returned the medication bottle to the pharmacy once she realized it belonged to Patient 13. A hospital internal investigation revealed staff had inadvertently dispensed medication to Patient 14 which belonged to Patient 13. The label on the medication bottle disclosed Patient 13's name, medication, and dosage. During an interview on 11/3/14 at 11:30 a.m., PS A stated on 5/23/14, Patient 14 received Patient 13's medication and returned the medication to the pharmacy on 8/6/14 for refills of her medication. PS A stated Patient 14 had brought her medicine bottles to be refilled. PS A stated the pharmacy assistant (PA) took each bottle and scanned it into the system to be refilled. PS A stated one of the bottles had Patient 13's name on it. PS A stated Patient 14 did not know to whom the medication bottle belonged but had taken some of the medication. PS A stated Patient 13 had received her correct medication on 5/28/14 by mail. During an interview on 11/3/14 at 12 p.m., PA stated Patient 14 said in May she had picked up the medication bottle at the pharmacy. PA stated the medication bottle belonged to Patient 13, and it still contained some medication. A review of a copy of a letter dated 8/11/14, from the hospital to Patient 13 indicated on 8/6/14 Patient 14 brought a medication bottle to the pharmacy which had disclosed Patient 13's name, medication, and dosage information.A review of a copy of Patient 13's medication label indicated Patient 13's name, medication, and dosage information was disclosed.A review of the hospital's 12/27/13 "Workforce General Obligations Regarding uses & Disclosures of PHI" policy indicated the hospital's workforce members must ensure that all workforce members take reasonable steps to safeguard PHI from any intentional or unintentional disclosure.

Outcome:

Deficiency cited by the California Department of Public Health: Health & Safety Code 1280

Related Reports:

The report containing this deficiency also includes information about 1 other violation. Note that these may be related to the same event: Z32G11.02

2 other violations reported on the same date. Note that other citations may be about the same event: UMGJ11.01, UMGJ11.02