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Based on interviews and examination of administrative documents, the hospital failed to develop the institutional plan and budget under the direction of the governing body and by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution.

Findings:

On 1/6/10 at 1:20 p.m. staff 1 was interviewed about the hospital's overall institutional plan. Staff 1 said neither the budget nor the overall operational plan was developed under the direction of the governing body (Governing Board). She said neither were approved by the Governing Board. On 1/7/09 at 2:20 p.m. staff 1 said the governing body does some assessment of needs for the budget and has started doing strategic planning. However, staff 1 said the Governing Board was currently not developing the institution's operational plan and operating budget.

Staff 1 was asked to provide evidence from the minutes of the Governing Board to demonstrate that it was involved in the preparation of the overal institutional plan including the budget. She was unable to provide documentation which affirmed that the overall institutional plan was developed under the direction of the Governing Board. Examination of minutes of meetings of the Governing Board for 2009 also did not show evidence of the development of the overall operational plan and budget.

On 1/6/10, at 11:30 AM, during review of Patient 400's medical chart, the following was noted:

There was a preprinted physician order form called, "Adult Sliding Scale Insulin Coverage" that was completed by a physician on 12/24/09 at 12 PM for insulin coverage per sliding scale with blood glucose to be checked four times a day before meals and at bedtime; and,

There was a form called, "Blood Glucose Monitoring" used by the nurses for recording the date, time, finger stick glucose, dose of insulin given, and nurse initial. There were documentation of blood sugar checks on 12/25/09 for 9 AM and 9 PM. However, there were no documentation of blood sugar checks on 12/25/09 for before lunch and dinner. Also, on 12/26/09 at 6 AM finger stick blood glucose resulted in the reading of 186 milligrams per deciliter for which no dose of insulin was given to the patient. According to the physician order, 4 units of Regular Insulin should have been administered to the patient.

During an interview on 1/7/10, at 3 PM, Staff 8 could not explain the missing finger stick blood glucose checks or why there was no insulin given for blood glucose reading of 186 milligrams per deciliter at 6 AM on 12/26/10.

Based on interview and review of administrative documents, the hospital failed to properly maintain drug storage areas in the hospital in accordance with accepted professional principles including the California Code of Regulations, Title 22, 70263(q)(10).

Findings:

On 1/7/10 at 9:20 a.m., staff 11, a pharmacist, was interviewed regarding required inspections of drug storage areas which were assigned to him. He said he checked drug storage areas in radiology, ultrasound and nuclear medicine. He said he checked only to "see if medications were in the correct places". He did not mention checking for potential problems including outdated/expired medications, opened containers, and storage conditions such as correct temperatures.

Pharmacist inspections of drug storage areas in the 7-burn area of the hospital were conducted on the following dates according to inspection reports provided by staff 5 on 1/7/10: 11/18/09, 9/9/09, 8/5/09, 7/6/09, 6/22/09, 5/20/09, and 4/1/09. Hospital policy and procedures (Outdate Checking in Pharmacy, 13.8.0) under procedure reads, "Every month all inventory items in the main Pharmacy will have their expiration dates checked. Every month items prepackaged by the pharmacy will be checked." The California Code of Regulations, Title 22, 70263(q)(10) requires drugs maintained in the patient care areas to be inspected at least monthly.

Based on interview and review of administrative documents, the hospital failed to properly maintain drug storage areas in the hospital in accordance with accepted professional principles including the California Code of Regulations, Title 22, 70263(q)(10).

Findings:

On 1/7/10 at 9:20 a.m., staff 11, a pharmacist, was interviewed regarding required inspections of drug storage areas which were assigned to him. He said he checked drug storage areas in radiology, ultrasound and nuclear medicine. He said he checked only to "see if medications were in the correct places". He did not mention checking for potential problems including outdated/expired medications, opened containers, and storage conditions such as correct temperatures.

Pharmacist inspections of drug storage areas in the 7-burn area of the hospital were conducted on the following dates according to inspection reports provided by staff 5 on 1/7/10: 11/18/09, 9/9/09, 8/5/09, 7/6/09, 6/22/09, 5/20/09, and 4/1/09. Hospital policy and procedures (Outdate Checking in Pharmacy, 13.8.0) under procedure reads, "Every month all inventory items in the main Pharmacy will have their expiration dates checked. Every month items prepackaged by the pharmacy will be checked." The California Code of Regulations, Title 22, 70263(q)(10) requires drugs maintained in the patient care areas to be inspected at least monthly.

Based on interviews, observations, and reviews of medical and administrative records, the hospital failed to provide for patient safety with regard to medications when:

1. Pharmacists did not review new medication orders when automated drug dispensing cabinets (ADCs) were not profiled.
2. Nurses were allowed to indiscriminately override profiled ADCs. Overrides allowed nurses to administer medications to patients before pharmacists reviewed the orders. Numerous overrides potentially allowed nurses to admininster medications which were not according to prescribers' orders.
3. ADC discrepancies potentially exposed patients to adverse effects attributable to medication errors.
4. Unclear preprinted physicians' orders potentially contributed to adverse drug events for patients.
5. Medication errors were not promptly addressed by the hospital's patient safety committee.
6. Two of two emergency carts did not properly list the contents of medications on the outside cover and were not sealed by a pharmacist as required by the California Code of Regulations. Emergency medication supplies also were not inspected every 30 days as required by the California Code of Regulations, Title 22, 70263(f)(3).



Findings:

1. On 1/5/10 at 9:25 a.m., staff 2 said automated drug dispensing cabinets (ADCs) in the catheter laboratory, post-anesthesia recovery, trauma, and recovery rooms areas were not profiled. Profiled ADCs meant a pharmacist was required to review new medication orders before a nurse could remove the medications from the ADC. Areas which contained ADCs that were not profiled allowed nurses to remove medications before a pharmacist reviewed the order. Pharmacists reviewed new medication orders in order to avoid potentially harmful medication effects to patients such as those attributable to drug-drug interactions, adverse drug reactions, and drug allergies. New medication orders were faxed to the pharmacy for review for ADCs which were profiled. The pharmacist, after reviewing the order, subsequently allowed the nurse, when appropriate, to remove medications by using the computer system linked to the ADCs. ADCs which were not profiled allowed the hospital to avoid the additional safety of a pharmacist review of new medication orders before the medications were administered to patients.

2. Nurses were able to override ADCs which were profiled. Overrides occurred when a nurse removed medication from an ADC before a pharmacist was able to review the patient's new medication order. Overrides also allowed the hospital to avoid the additional safety of a pharmacist review of new medication orders before the medications were administered to patients. Staff 4 on 1/5/10 provided all of the override reports for the period from 12/6/09 through 1/5/10. The reports consisted of 344 pages with one to seven overrides per page. The reports included overrides from the intensive care unit, labor and delivery, neonatal intensive care, 4th, 6th, 7-burn, and obstetrics areas. On 1/5/10 at 9:45 a.m. staff 2 said staff 3, a pharmacy technician, was responsible for following up on all overrides. He said staff 3 ensured that a prescriber's order was written for the medication and delivered a copy of the order to the pharmacy where a pharmacist entered it into the computer system. Staff 4 said a nurse filled out a report on the override and staff 2 said the report was subsequently filed in the pharmacy. On 1/7/10 at 3:45 p.m., staff 2 again said staff 3 followed up on all overrides to ensure that there was a prescriber's order for the medication. Staff 2 said staff 3 would tell the nurse manager and nursing director of the area where the override occurred if there was no order for the medication. Staff 5 said a pharmacist didn't get involved in overrides, "not very often". Staff 5 said, "we need to have more involvement by pharmacists. We need to decrease both discrepancies and overrides".

Hospital policy and procedures for ADC overrides (Overrides for Pyxis Medications, 2.1.10) read, "the purpose of the override function is to allow for quick administration of medications in emergency and stat situations. However, best pharmaceutical practice and JCAHO (Joint Commission on Accreditation of Healthcare Organizations) standards MM4.10 require that all medication orders be reviewed by a pharmacist prior to administration of the drug. There are two allowable exceptions: 1. A physician controls the ordering, dispensing, and administration of the drug ... 2. Emergencies when time does not permit the pharmacist review ..." The procedure also read, "8. Medications removed using the override function will be analyzed by a pharmacist in a reasonable time frame, and audited on a regular basis." Hospital policy and procedure for "Administration of Medications, 0.1.10, under "Processing Drug Orders" read, "F. Stat Drug Orders. Nursing will place a copy of the stat order on the FAX machine, press the pharmacy and send key and the pharmacy will process the order at once. If the drug order is truly an emergency, an over-ride on the PYXIS (ADC) may be made but this process will bypass all the double check systems."

3. Staff 4 provided discrepancy reports for the ADCs for the period from 12/7/09 through 1/5/10. They consisted of 134 pages with one to five medication discrepancies per page. Potential reasons for the discrepancies included drug diversion, an incorrect visual count by a nurse, removing the wrong medication from the ADC, and entering the incorrect amount in the ADC computer. Potential healthcare related problems attributable to ADC drug discrepancies included administering an incorrect medication to a patient and administering an incorrect dose (for example, two pills instead of one) to a patient.

On 1/5/10 at 1:15 p.m., staff 3, a pharmacy technician, said he resolved all controlled substances (for example, narcotic analgesics such as morphine) discrepancies with a nurse and, together with the nurse, both adjusted the count in the computer. Staff 3 said a pharmacist did not get involved in the process but "I usually let a pharmacist know what happened". Staff 3 said he filed a report in the pharmacy. Staff 4 responded, "we need to examine at least on an annual basis controlled substances discrepancies". On 1/7/10 at 3:45 p.m., staff 5 said, "we need to have more involvement by pharmacists. We need to decrease both discrepancies and overrides."

The hospital's policy and procedures relating to ADC discrepancies (Medstation RX Discrepancy Resolution, 2.1.3) did not indicate a pharmacist was required to be involved in the discrepancy resolution process. The California Code of Regulations, Title 22, 70263(c)(1) reads, "The committee [pharmacy and therapeutics committee] shall develop written policies and procedures for the establishment of safe and effective systems for procurement, storage, distribution, dispensing, and use of drugs and chemicals."

4. On 1/5/10 a sample of approximately 20 preprinted physician's orders which included medications were requested from staff 4. On 1/6/10 staff 4 provided 24 preprinted orders which were reviewed in the presence of staff 4 and staff 5. Thirteen of the 24 preprinted physician's orders contained instructions for medications which were unclear. Examples included:

a. "In-patient Stroke Orders, Stroke Physician Orders": Required the nurse to "Titrate oxygen to maintain oxygen saturation equal to or greater than 95 %." The orders did not specify the method for flow rate adjustments for the nurse to follow nor how high the nurse could have increased the flow rate. Too much oxygen was potentially lethal for some patients.
b. "Admission Orders, Dr. Narindar Singh": Required a pharmacist to adjust intravenous doses of doripenem and imipenem (antibiotics). Staff 2 said pharmacists did not have a protocol for adjusting doses for these drugs in the presence of kidney impairment. This preprinted order also required the nurse to determine whether the patient was allergic to penicillin without identifing all of the penicillin drugs. There were boxes for the physician to check which orderd a nurse to titrate (adjust) intravenous doses of vasopresser drugs (to raise the blood pressure) but provided only dosage rate ranges (for example, 5 to 20 micrograms/kilogram/minute). The instructions did not indicate the method for rate changes which included the frequency of rate changes and when to discontinue the increases. Vasopressors were dangerous drugs which require careful dosage adjustments in order to avoid potential life-threatening adverse reactions.
c. "Post Cardiac Intervention Orders": Required a nurse to adjust the dose ("titrate") of intravenously administered nitroglycerin for blood pressure control. The order did not specify the method to be employed by the nurse for rate adjustments.
d. "Anesthesia Perioperative Orders": Required the nurse to adjust sedation with intravenous midazolam or propofol (sedatives) as needed. The orders did not specify how the nurse was to adjust the rates nor the levels of sedation to be achieved.

5. On 1/6/10 at 4:00 p.m., staff 5 was asked about a medication error which was reported on 8/1/09. The medication error was reported by staff 6, a critical care nurse. It occured when a dialysis nurse, staff 7, reported to staff 6 that he administered 10,000 units of heparin (inhibits coagulation of the blood) when he should not have administered the drug. Staff 5 said the medication error was not addressed by the medication safety committee. The medication safety committee was the hospital's multidisciplinary committee which addressed all medication errors in accordance with California Health and Safety Code, 1339.63. The California Health and Safety Code required the hospital's medication multidisciplinary committee "to regularly analyze all identified actual or potential medication-related errors and describe how the analysis will be utilized to change current procedures and systems to reduce medication-related errors." Staff 4 also said the medication safety committee did not review the incident. On 1/7/10 at 9:40 a.m., staff 5 said the medication safety committee did not discuss the heparin medication error at the December, 2009 meeting, although it was on the agenda. Examination of the minutes of the medication safety committee meetings since 8/1/09 (8/26/09 and 12/09 meetings) did not provide evidence that the heparin medication error was reported.

6. On 1/5/10 at 10:45 a.m., the pediatric emergency cart was examined in the emergency department with staff 8 and staff 9. The eighth drawer from the top contained two-1000 milliliters (ml) containers of the intravenous (IV) solutions dextrose (sugar) 5 percent and half-normal saline (salt) and two-250 ml containers of normal saline IV solutions. The list on the outside cover did not identify the quantities of the solutions contained in the cart. Staff 9 said pharmacists did not check drawer eight when they conducted drug storage inspections. Emergency cart number nine contained two-1000 ml containers of normal saline IV solutions, two-250 ml containers of dextrose 5 percent IV solutions, and one container of 250 ml normal saline IV solution. The quantities of each solution were not listed on the outside cover of the cart. Staff 10 on 1/5/10 at 2:30 p.m. said a pharmacy technician locked the medications in the emergency cart before they were distributed to patient care areas. The California Code of Regulations, Title 22, 70263(f)(2) required the emergency drug supply contents to be listed on the outside cover and the container to be sealed by a pharmacist.

On 1/5/10 at 2:30 p.m., staff 2 was asked how often pharmacists inspected emergency drug supplies in the hospital. He responded, "once a month". Examination of emergency cart inspections for 7-burn area showed these inspections were not conducted every 30 days as required by the California Code of Regulations, Title 22, 70263(f)(3). Pharmacist inspections of drug storage areas in the 7-burn area of the hospital were conducted on the following dates according to inspection reports provided by staff 5 on 1/7/10: 11/18/09, 9/9/09, 8/5/09, 7/6/09, 6/22/09, 5/20/09, and 4/1/09.

Based on observation, interview, and document review, the facility failed to ensure drugs were controlled and distributed in accordance with standards of practice consistent with State law by:

1. not having the date of preparation of IV compounded drugs on the label according to State law;
2. allowing access to narcotic pain medications from Pyxis MedStations via override function ahead of next scheduled dose.


Findings:

1. On 1/6/10, at 10:30 AM, during inspection of the IV (intravenous) room for preparation of IV drugs, it was noted that all labels for the sterile compounded drugs prepared in the pharmacy IV room did not contain the date drugs were prepared.

During concurrent interview, Staff 12 stated that some of the labels were printed with the expiration date of 24 hours and these compounded drugs were prepared in the pharmacy and delivered to the nursing station for administration to the patients the same day and that they were thrown away after 24 hours. Staff 12 stated however, from the label it would not be possible for pharmacy and nurse staff to tell when the labels were generated and when the IV drugs were compounded.

In the pharmacy refrigerator 1, it was noted that compounded IV drugs that were not used by the patients and came back had attached labels that only showed expiration date of 24 hours with no prepared date.

Staff 12, during concurrent interview, stated that those drugs should not have remained in the refrigerator and should have been thrown away.

During concurrent interview, Staff 2 acknowledged that it would not be possible to determine when the IV drugs were made and when they needed to be discarded based on the current practice of labeling of compounded IV drugs.

California Business and Professions Code, section 4076, documented the following:

"(a) A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(5) The date of issue..."

2. On 1/6/10, at 11:30 AM, during review of Patient 400's medical chart, the following was noted:

There was a physician order written on 12/25/09, at 12:40 AM for Demerol (drug for pain) 25 mg IV push one time, may repeat once more in 30 minutes if agitation persists; and,

There was documentation on the MAR by the nurse staff indicating two doses of Demerol 25 mg were given at 12:45 AM and 1:15 AM on 12/25/09.

The Pyxis (automated drug dispensing cabinet) transaction report was reviewed on 1/5/10, at 10:30 AM and it was noted that Nurse 200 removed from the Pyxis machine one dose of Demerol 25 mg at 12:41 AM at 12/25/09 and another dose at 12:46 AM at 12/25/09.

During an interview on 1/7/10 at 3 PM, Staff 8 could not explain why Staff 15 removed two doses of Demerol 25 mg one at a time 5 minutes apart and administered the second dose of Demerol approximately 30 minutes after the first dose of Demerol 25 mg was administered to the patient and stated that the nurse should have taken out the dose of Demerol 25 mg at the time it was needed to be administered and not taken out ahead of time.

Based on observation, interview, and document review, the facility failed to ensure unusable drugs were not available for patient use.

Findings:

1. On 1/5/10, at 11:30 AM, during observation of medication storage in the Surgery Department, it was noted that in the anesthesia cart drawer in the Operating Room 3, there was one open injectable vial of Ketalar (ketamine: an anesthetic agent) 200 mg per 20 ml.

During concurrent interview, Staff 2 stated that there was an open date on the vial to indicate when the vial was opened and that the remaining drug was saved and used for the next case since ketamine was packaged in a multi-dose vial.

Inspection of the vial did not indicate that the Ketalar was packaged in a multi-dose vial and could be used multiple times.

Review of the manufacturer's package insert for ketamine did not indicated ketamine was packaged in multi-dose vial.

Website for Pfizer, the manufacturer of Ketalar, had the following published information on Ketalar:

"6.3 Shelf life
3 years
For single use only. Discard any unused product at the end of each operating session.

2. On 1/6/10, at 10:30 AM, during inspection of the IV (intravenous) room for preparation of IV drugs, it was noted that in the refrigerator 2, there was an open injectable vial of Levaquin 500 mg per 20 ml with no open date on the vial.

During concurrent interview, Staff 12 could not determine when the Levaquin vial was used and stated that she did not use it and that it should have been discarded.

During concurrent interview, Staff 13 stated that remaining undiluted Levaquin vial should have been discarded.

During concurrent interview, the Pharmacy Clinical Manager agreed that the remaining vial should have been discarded.

The manufacturer's package insert for Levaquin had the following information:

"Since no preservative or bacteriostatic agent is present in this product, aseptic
technique must be used in preparation of the final intravenous solution. Since the vials
are for single-use only, any unused portion remaining in the vial should be discarded.
When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of
levofloxacin, the full content of the vial should be withdrawn at once using a single entry
procedure, and a second dose should be prepared and stored for subsequent use."


3. On 1/5/10, at 1:20 PM, during review of Patient 401's medical chart, it was noted that there was a physician order on 1/4/10 on the preprinted order sheet called, "Anesthesia Perioperative Orders" for morphine 5 mg IV Push as needed every 5 minutes for severe pain (pain scale 7-10) up to maximum of 20 mg.

Also reviewed was the PACU Record for Patient 401 that documented administration of four doses of morphine 5 mg for pain on 1/4/10 at 5:40 PM for pain level of 8, at 7:50 PM for pain level 7, at 8 PM for pain level of 7, and at 8:15 PM for pain level of 8.

Pyxis MedStation transaction report was reviewed on 1/5/10 at 12 PM. It was noted that Staff 16 removed two single dose vials of 10 mg morphine on 1/4/10 between 7:43 PM and 7:59 PM and no other morphine vials were removed that day for Patient 401.

During an interview on 1/5/10 at 2:15 PM, Staff 17 stated that 10 mg morphine vials were used to administer 2 doses of 5 mg morphine in the PACU. Staff 17 stated that one dose of 5 mg morphine was drawn out from the 10 mg vial of morphine then the rest of the 10 mg vials was kept and saved for the next dose of 5 mg morphine dose and explained that two vials of 10 mg morphine were removed for total of 4 doses of 5mg morphine administered by Staff 16. Staff 17 did not think this practice posed problems.

During concurrent interview, Staff 2 stated that 10 mg morphine vials that were stocked in the Pyxis MedStation were single-dose vials or single unit-of-use and that they were designed to be penetrated by the syringe needle only once after which the vials should have been discarded since no preservatives were present inside the vial to prevent bacterial growth.

Based on interview and document review, the facility failed to ensure a medication error was immediately reported to the prescribing physician and to the hospital-wide quality assurance program.


Findings:

On 1/5/10, at 10 AM, during an interview, Staff 3 stated that the pharmacy performed the audit of activities of the facility's Pyxis MedStation by all authorized users by reviewing daily two reports: Discrepancy Report and Override Report and that separate records for these two reports were kept in binders. Any abnormal discrepancies and override activities were investigated and forwarded to the pertinent authorized user(s) and unit managers/supervisors for further follow-up.

During review of the override report binder, it was noted that the form called, "Override Report to Nursing Unit" dated 9/2/09 was generated by Staff 3 for reasons that there was a Pyxis override for one dose of injectable meperidine (narcotic pain medication) 50 mg in ICU by Nurse 203 for Patient 402 on 8/1/09, at 6:43 PM indicated in the override report dated 9/2/09 and the pharmacy only received an order for injectable meperidine 100 mg and not 50 mg.

Review of physician orders written on 9/1/09 at 4:50 PM, included Demerol (meperidine) 100 mg intramuscularly every 3 hours as needed for pain for Patient 402.

The Override Report to Nursing Unit report initiated by Staff 3 on 9/2/09 was followed up by the ICU manager/supervisor with the following comment:

"Override determined to be inappropriate.
Discussed with nurse on 9/2/09, counseled re: range dosing.
Patient 88 years old. We did not have 100 mg in Pyxis. Received patient complaint of severe pain...I gave only 50 mg. Re-evaluated patient and did not need the additional 50mg."

During interview on 1/7/09, at 2:30 PM, Staff 3 did not provide any documented evidence that this incident was determined to be a medication error that needed to be reported to the physician. Staff 3 also did not provide any documented evidence that this incident was followed up with the hospital's quality assurance program.

During concurrent interview, Staff 2 acknowledged that it was a medication error and should have been forwarded to the hospital's quality assurance and that the pharmacist was not more actively involved in identifying and reporting of medication errors related to the use of Pyxis MedStation. The Pharmacy Clinical Manager did not provide any documented evidence the ordering physician was contacted and informed of the medication error.

During concurrent interview, Staff 19, the QA manager, stated she did not find any evidence this incident was forwarded to her department for tracking of all hospital medication-related errors.