SANTA CLARA VALLEY MEDICAL CENTER

Report ID: Z32G11.02, California Department of Public Health

Reported Entity: SANTA CLARA VALLEY MEDICAL CENTER

Issue:

Based on observation, interview and record review, the hospital's affiliated pharmacy failed to correctly dispense prescription medication for seven of 14 sampled patients (2, 4, 6, 8, 10, 12, and 14), when prescription medications were dispensed to seven incorrect patients. The failure resulted in seven patients receiving incorrect medications placing them at risk for the potential of taking medications not prescribed to them, and for approximately two months Patient 14 consuming the incorrect medication and requiring medical follow-up. Findings:1. The California Department of Public Health received a faxed report on 8/27/14, which indicated on 8/21/14, Patient 2 notified a hospital affiliated pharmacy's staff, she had received a package containing Patient 1's medication in the mail, along with a package containing her own medication. A hospital internal investigation concluded pharmacy staff had inadvertently labeled both packages with Patient 2's address label. During an interview on 11/3/14 at 10:15 a.m., the pharmacy assistant director (ADM) stated Patient 2 had received two packages in the mail; one contained her medication and the other package contained two bottles of medication for Patient 1. ADM stated Patient 2 had brought to the pharmacy the package containing Patient 1's medications. ADM stated the package which contained Patient 1's medication had a packaging label with Patient 1's name and address on it, but the shipping label contained Patient 2's name and address on it. During an interview on 11/3/14 at 10:45 a.m., the affiliated pharmacist (MP) stated Patient 2 brought a package into the pharmacy and said she received a package with both her name and Patient 1's name on it so she did not open it. MP stated Patient 2 had received a second package with just one label containing Patient 2's name, so she opened that package. That package contained Patient 2's correct medication. A review of a copy of a letter dated 8/27/14 from the hospital to Patient 1 indicated on 8/21/14, hospital staff were notified Patient 2 had received Patient 1's medications inadvertently. Patient 2 had returned Patient 1's medications to the pharmacy. A review of a copy of the label from the package containing Patient 1's medication, indicated two labels, one containing Patient 1's name and address and a second, larger label which contained Patient 2's name and address along with a tracking bar code.A review of a copy of the labels from the two bottles of medication in the package Patient 2 had brought to the pharmacy indicated both medication bottles, calcitriol (for low calcium) 0.5 mcg (a unit of measure) and levothyroxine (add thyroid hormone to the body) 88 mcg, were intended for Patient 1.2. 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 had returned the medication to the pharmacy on 9/13/14 in exchange for Patient 4's correct medication. A hospital internal investigation indicated 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 medication at a hospital affiliated pharmacy. After arriving home, Patient 4's family member noticed the label on the medication bottle was for Patient 3. As per Patient 4's family member, Patient 4 did not take any of the medication. ECO stated Patient 4's family member brought the bottle of medication to the pharmacy on 9/13/14. 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 medication bottle with the medication, was intended for 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. A review of a copy of the label from the incorrect bottle of medication indicated the medication, sertraline (an antidepressant) 100 mg (a unit of measure), belonged to Patient 3.3. 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 indicated the package containing medications was sent to Patient 6. The package contained two address labels, the packaging label was for Patient 5 and the mailing label was for Patient 6. 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 containing medications into the pharmacy which he had received in the mail. The package had a label with Patient 6's name and address and a label with Patient 5's name, address, and a tracking number. CPO stated the package containing medications for both Patient 5 and Patient 6 had been mailed to Patient 6 on 6/2/14. 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 mail order package which contained a label with Patient 5's name and address and a label with Patient 6's name and address. PT A stated Patient 6 had said the medication in the package which had been mailed to him was not his medication. PT A stated the medication bottle Patient 6 had brought back to the pharmacy belonged to Patient 5, it was not the same medication which Patient 6 had been prescribed. 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.A review of a copy of the label on the incorrect medication Patient 6 received indicated the medication, vitamins A, D, and C with Fluoride 0.25 mg, was for Patient 5.4. 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 for Patient 7 and one for Patient 8. The fax report further indicated a pharmacy staff member had inadvertently placed both medication 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, which was intended for Patient 7, to a hospital affiliated pharmacy. CPO stated Patient 8 had received two identical bottles of cough syrup in the same package, one belonged to him and the other belonged to Patient 7. CPO stated a pharmacy staff had placed both bottles in the same package which was then mailed to Patient 8.During an interview on 10/31/14 at 1 p.m., a pharmacist (TP) stated Patient 8 brought to the pharmacy, a package and a medication bottle he received in the mail. TP stated the package had Patient 8's correct name and address, but the medication bottle was for Patient 7. TP stated Patient 8 had told him the bottle of medication was not his, but the name and address on the package was. TP stated Patient 7 and Patient 8 had been 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 which belonged to Patient 7. A review of a copy of the label from the bottle of incorrect medication, guaifenesin ac (cough medicine) 100/10 mg liquid, indicated the medication belonged to Patient 7.5. The California Department of Public Health received a faxed report on 6/26/14, which indicated on 6/20/14, Patient 10 returned to a hospital affiliated pharmacy medication which belonged to Patient 9. A hospital internal investigation revealed a pharmacy staff member had inadvertently dispensed Patient 9's medication to Patient 10. 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 got a claim check which had 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 with 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., the pharmacy technician B (PT B) stated she was at the pick up window when Patient 10 came up to the window. PT B stated she had 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 her coworker shortly afterward 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 Patient 9's 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, and if it was the wrong patient or medication it 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 for him and returned Patient 9's 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 claim check number 12 Patient 10 thought she was referring to the last two numbers 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 to the pharmacy a medication belonging to Patient 9. The label on the medication indicated it was for Patient 9.A review of a copy of the label from the incorrect bottle of medication, augmentin (antibiotic) 500/125, indicated the medication belonged to Patient 9.6. 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. 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 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 Patient 12 had telephoned the pharmacy and talked with SP A stating she had picked up her medications and also received a bottle of medication for Patient 11 in error. SP A stated she had asked Patient 12 to bring the incorrect medication back 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 came in to the pharmacy with Patient 11's medication bottle, said her name and "here is the medication." SP B stated she had 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 belonged to Patient 11. A review of a copy of the label from the incorrect bottle of medication, glipizide (to lower blood sugar) 5 mg, indicated the medication belonged to Patient 11.7. 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 clinic 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 when she realized it belonged to Patient 13. A hospital internal investigation revealed pharmacy staff had inadvertently dispensed medication to Patient 14 which belonged to Patient 13, as confirmed by the label on the medication bottle. 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 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 the bottles and scanned them 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 medicine. During an interview on 11/3/14 at 12 p.m., PA stated the medication bottle containing Patient 13's medication still had some medicine in it, and Patient 14 had said in May she had picked up the medication bottle at the pharmacy. PA stated the medication bottle had Patient 13's name on it. A review of a copy of a "Progress Notes" from Patient 14's doctor visit dated 8/6/14 indicated Patient 14 had vomiting and dizziness on 8/5/14 when she was walking up stairs and "sat down to avoid fall." Patient 14's family member was called, and when the family member arrived, Patient 14 was found vomiting and feeling dizzy. Patient 14 had been taking an incorrect medication since 5/23/14, Losartan 50 mg once a day which had been mailed to her home and not prescribed by her primary care physician. Patient 14 was to have a follow-up appointment within one week, to check her status after taking all of her medications as advised.A review of Lexicomp Online (a pharmaceutical reference website) indicated some of the possible adverse reactions of Losartan were: orthostatic hypotension (drop in blood pressure upon standing), dizziness, and nausea.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 belonged to Patient 13.A review of a copy of the label from the medication bottle given in error to Patient 14, indicated the medication belonged to Patient 13.During a tour of the mail order pharmacy on 11/3/14, accompanied by CPO, ADM, ECO, PS B, the supervisor of central fill pharmacy, and others, the following was observed: bottles of medication to be mailed were inserted into gray plastic envelopes and a label was affixed with the patient's name and address. These medications were placed into a plastic bin and brought to the postage station. The staff at the postage station scanned the bar code on the envelope which brought up the patient's information on a computer screen. The envelope was weighed and a mailing label printed, which was visually compared to the label already on the envelope and then scanned. If the mailing label did not match the patient information on the screen a warning window popped up on the screen.During an interview on 12/10/14 at 10:15 a.m., the director of pharmacy (DOP) stated the hospital had a large number of prescriptions to fill (approximately 5,000 prescriptions per day). To be able to keep up with the volume and complexity, the pharmacy had to rely on more automation (machines filling the medication bottles and preparing them for mailing) to decrease human errors. DOP stated sometimes the machines were not fast enough. One example was the machines could not print and attach the mailing labels as fast as the prescriptions were being filled, and sometimes the machine would place the wrong mailing label on the package. DOP also stated if a patient's information was on the computer screen too long without use, the screen would lock. The patient's identification would need to be keyed back in to bring up the patient's information again, but sometimes the staff would scan the barcode on the medication bottle (which would bring up the wrong patient) instead of asking again for two forms of identification. DOP stated the pressure and being rushed due to a large volume of patients caused most of the human errors of not requesting two identifiers from patients.A review of a copy of the hospital's 04/2014 policy, "Prescription Pick Up/Pharmacy Beneficiary Signature and Relationship Requirement Log" indicated staff must use at least two patient identifiers at all times to confirm the patient's identity. The barcode on each prescription bottle must be scanned, then confirm pick-up status of each prescription. Have patient sign the signature pad, and confirm their name on the signature pad. Before completing the final transaction, review the signature on the screen versus the patient's name.A review of a copy of the hospital's 01/2014 policy, "Medical Mail-order Shipping Execution/Delivery Confirmation Tracking" indicated double check and match the patient's name on the shipping label and the name on the prescription label before sealing the container. Do not place multiple orders of different patients on the packing table. Complete one order at a time (avoid scanning multiple labels at same time). Label generated at manifest station (2nd label) will be affixed on a side of the 1st label so that the patient's name and address are visible on both. Match the name and address before affixing the 2nd label.

Outcome:

Deficiency cited by the California Department of Public Health: Pharmaceutical Service General Requirements

Related Reports:

The report containing this deficiency also includes information about 1 other violation. Note that these may be related to the same event: Z32G11.01

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