Bringing transparency to federal inspections
Tag No.: A0405
25052
Based on observation, record and document review, the hospital failed to ensure one of two nurses administering medications to patients documented the exact times the medications were given and used two sources of information to identify patients before administering their medications (RN5). These failures could result in the potential administration of medications to the wrong patient and at a wrong time.
Findings:
1. According to the hospital's policy and procedure entitled, "Patient Identification," nurses and other healthcare providers would verify patient identification using two patient identifiers prior to any procedure, specimen collection, or administration of medication or blood product.
On 7/21/10 at 0917 hours, RN 5 was observed administering morning medications to Patient 23. The medications administered were heparin (blood thinner to prevent blood clots) 5000 units subcutaneously and pantoprazole 20 milligrams orally. RN 5 entered Patient 23's room and started to speak with the patient while preparing the medications to be administered. RN 5 did not check two sources of patient identification before she administered medications to Patient 23. Patient 23 received the above two medications without being properly identified.
2. According to the hospital's policy and procedure entitled, "Medication MGMT: Maintenance & Administration of Medications," under Section L, medications were to be documented at the time they were given.
On 7/21/10 at 0917 hours, RN 5 was observed to prepare and administer morning medications to Patient 23. Medications administered were heparin (blood thinner to prevent blood clots) 5000 units subcutaneously and pantoprazole 20 milligrams orally. The medications were administered at 0927 hours.
Review of the computerized Medication Administration Record (MAR) revealed the medications were documented as given at 0900 hours.
On 7/21/10 at 1515 hours, the Assistant Pharmacy Director (APD) stated scheduled medications administered in the morning were documented as given at 0900 hours whether the medication was given before or after that time. He also stated the computer program only allows for doses to be documented as administered on the hour (ex. 09, 10, 11, etc).
The MAR was a legal document where accuracy was expected. Patient 23's medications were documented as given at 0900 hours when they were actually given at 0927 hours.
25447
Tag No.: A0491
Based on observation, interview, and record review, the facility failed to have a policy and procedure for the monitoring and administration of Aranesp (darbepoetin, a drug used to stimulate the production of red blood cells).
Findings:
A medication pass was observed on 7/22/10 at 0900 hours for Patient 26. Aranesp 100mcg (micrograms) was listed on the MAR to be administered at 0900 hours on 7/22/10. At 0900 hours, when RN 9 attempted to administer the dose, Aranesp had not been supplied by the pharmacy for Patient 26.
On 7/22/10 at 1055 hours, Patient 26's medical record was reviewed. A medication order had been entered by MD 1 on 7/15/10 at 1030 hours. The order indicated, "Aranesp Darbopoetin Alpha/Albumen Syringe 100mcg., IVP (intravenous push), flush with 5ml NS now." An additional order was written as, Aranesp Darbopoetin Alpha/Albumen Syringe 100 mcg IVP, flush with 5 ml NS, to be given every 7 days, dated 7/22/10 at 0900 hours.
RN 9 was interviewed on 7/22/10 at 0900 hours and confirmed that the medication was not available at 0900 hours. The dose was not administered.
On 7/22/10 at 1125 hours, MD 1 changed the 0900 dose for the 7/22/10 of Aranesp 100mcg. to give with dialysis the following day on 7/23/10 at 0900 hours.
On 7/22/10 at 1400 hours, the APD was interviewed. When the policy and procedure for pharmacist monitoring of Aranesp was requested, he stated there was a policy and procedure for holding Aranesp. Aranesp was to be held until the results of the morning hemoglobin (blood test to determine the amount of iron in red blood cells) level was known. The APD further stated that Aranesp had presumably been held by the pharmacist until a hemoglobin level was available.
On 7/22/10 at 1430 hours, the APD stated he looked for the Aranesp P&P but was mistaken. There was no approved hospital P&P to hold the Aranesp.
Tag No.: A0500
25052
Based on observation, interview and record review the hospital failed to:
* Ensure a pharmacist had oversight on all medications dispensed and administered in the emergency department and the out-patient surgical center and the medications were administered safely and appropriately.
* Ensure that a current list of emergency medications stored in the code blue cart (cart used to store medications and devices needed in a medical emergency) were listed on the outside of the cart so staff were aware of the medications available for use.
* Ensure the policy and procedure describing requirements for patient education on discharge medications was accurate and reflected actual nursing care procedures in the hospital.
* Ensure the monthly floor stock inspections performed by the pharmacist indicated the deficiencies found and the inspection form with these deficiencies was reviewed by the director of nursing.
Findings:
1. According to the hospital's policy and procedure entitled, "Medication MGMT: Maintenance and Administration of Medications," under section S, a pharmacist would review all medication orders, unless a physician/provider would control the ordering, preparation, and administration of the medication; or in urgent situations when the resulting delay would harm the patient, including situations in which the patient experienced a sudden change in clinical status.
On 7/20/10 at 1344 hours, while touring the emergency department (ED), the Assistant Pharmacy Director (APD) stated medications were dispensed from Automated Dispensing Cabinets (ADCs). Medications were stored in the ADCs and when there was an order for a medication, the nurse entered her personal code and removed the medication for administration. The APD stated controlled and non-controlled medications were stored (controlled medications are medications that have potential for abuse like narcotics while non-controlled medications do not) in these cabinets. The APD stated there was no mechanism in place to ensure the medications ordered, were the medications removed from the ADC by the nurse and administered to the patient. In the ED, medications were not "profiled" like they were in the rest of the hospital. A "profiled" medication was when the pharmacist reviewed the order to ensure the medication was safe and appropriate to give to the patient before it was administered. In the ED, medications were being administered to patients without a pharmacist review.
On 7/20/10 at 1514 hours, the APD stated pharmacists in the ED did not review medications prior to administration in non urgent situations like they did in other parts of the hospital. There was also no retrospective review of medications administered to determine whether the medications were administered safely and accurately. The APD stated, "We don't look at it."
On 7/21/10 at 1346 hours, while touring the outpatient surgical center, the APD stated the ADCs were set up the same way as they were in the ED. They were not profiled and there was no pharmacist review of medications before they were removed by the nurse and administered to the patient. There was also no retrospective review process being performed. In other areas of the hospital (except the ED and Outpatient Surgical Center), ADCs were "profiled" and medications were reviewed for appropriateness by a pharmacist before the first dose was dispensed, except in emergent or urgent situations.
The American Society of Healthsystem Pharmacist (ASHP) article entitled, "ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices," April 1998, stated that provision should be made for the retrospective review and reconciliation by a pharmacist of orders that were initiated without a pharmacist review and approval.
2. California Code of Regulations, Title 22, Section 70263(f)(2) states the contents of the drug supply in the emergency drug supply container, "Shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."
On 7/21/10 at 1346 hours, review of the code blue cart revealed a list on the outside of the cart entitled, "UCI Medical Center Crash Cart: 3A" which listed the contents in the drawers of the cart but did not include all the emergency medications stored in the cart. RN 3, who was the supervising nurse for the unit, was asked if the list contained everything in the cart. She responded, "yes." Further investigation revealed another list which contained the emergency drug tray contents was scotch taped underneath the first list and out of sight. RN 3 stated she was unaware of this drug tray content list which included medications that were available for use during a medical emergency.
3. On 7/21/10 at 1305 hours, review of the policy and procedure (P&P) entitled, "Medication Management: Discharge Prescription Procedures," showed that upon request, the inpatient pharmacist should assist in the provision of discharge medication patient education.
On 7/22/10 at 0806 hours, the APD stated that nurses provided education on medications to patients being discharged. He added the nurses printed out drug information handouts and provided them to patients on discharge. On 7/22/10 at 1001 hours, the APD produced a P&P entitled, "Patient and Family Education." It stated nurses would provide discharge instructions to patients "when appropriate." The APD was asked what "appropriate" meant and he could not answer.
On 7/22/10 at 1400 hours, RN 4 was asked the procedure for providing education on medications to discharged patients. She stated all patients, including those taking the medications prior to admission, were provided with a handout for every discharge medication.
The hospital's P&P which indicated, "When appropriate," did not reflect the nursing care practice in the hospital of providing education to all patients and for all discharge medications.
4. California Code of Regulations, Title 22, Section 70263(q)(10), states that, "Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist. Any irregularities shall be reported to the director of nursing service and as required by hospital policy."
On 7/22/10 at 1015 hours, during a tour of the outpatient Comprehensive Digestive Disease Center, the monthly floor stock inspection reports were reviewed for the months of April, May and June, 2010. For these three months, there was no documentation noted pertaining to the deficiencies found during the inspection. All that was noted were "Yes" marks in the far right column signifying there were no deficiencies found and all the areas inspected were in compliance with the above regulation.
On 7/22/10 at 1021 hours, RPh 1 stated she performed the monthly inspections for April and May 2010. She stated when she found a medication not in compliance with Title 22, she would remove it and verbally report it to the nursing manager.
No documentation was found on the inspection form of deficiencies and there was no documentation provided to ensure the deficiencies would not be repeated.
The American Society of Healthsystem Pharmacist's (ASHP) article entitled, "ASHP Technical Assistance Bulletin," March 1980, stated monthly audits of all medication storage areas and the results of these audits should be documented in writing.
The hospital failed to document the results of their findings and report it to the director of nursing services for follow up.
25447