The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MERCY MEDICAL CENTER REDDING 2175 ROSALINE AVE, CLAIRMONT HGTS REDDING, CA 96001 Feb. 18, 2011
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, interview, and record review, the facility failed to ensure one of 30 sampled patients and one unsampled patient's medications in multi-dose vials were labeled with the date they were opened. This failure could result in the administration of medication that had become contaminated and result in an infection. (Patients 22 and 50)

Findings:

On 2/14/11 at 9:10 am and 10:26 am respectively, Patients 50 and 22's medication drawers were observed to contain opened multi-use vials of labetalol (for high blood pressure) that did not have a date when they were opened or when they would expire.

On 2/15/11, the facility policy, titled, Management of Medications, revised 8/10, read, "At a minimum, all medications must be labeled with a 28-date expiration date for multi-dose vials from the date of opening or puncture.."

On 2/14/11 at 9:10 am, Administrative Nurse J acknowledged Patients 22 and 50 labetalol vials should be dated with an expiration date when opened.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0188
Based on interview and record review, the facility failed to ensure that one of 30 sampled patients had documentation of the patient's response to restraint interventions. This failure had the potential for a patient to suffer physical and psychological harm due to restraint use. (Patient 22)

Findings:

On 2/17/10, Patient 22's record indicated that he was admitted for sepsis (an infection of the blood) on 2/13/11. Patient 22 was placed in bilateral wrist restraints because he was pulling on his tubes and trying to climb out of bed. There was no evidence of a nurse monitoring his response to the restraints and the needs for continued use of the restraints on 2/13/10.

On 2/17/11, the facility policy, titled, Restraints/Use of, revised 3/10, indicated that adults in restraints must be monitored every two hours with the documentation of the patient's care needs, safety risks, signs of injury and a restraint removal assessment.

On 2/17/11 at 7:50 am, Administrative Nurse W reviewed the record and acknowledged that the restraint flow sheet which contains the required assessments for patients in restraints was not present in Patient 22's record.
VIOLATION: MEDICAL STAFF Tag No: A0044
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure that medical staff requirements for the countersignature for verbal orders was met for seven of 30 sampled patients. This failure had the potential for medical errors to occur to transcription errors and lack of oversight by a qualified professional. (Patients 21, 26, 27, 28, 29, 31 and 32)

Findings:

On 2/16/11, the facility's Medical Staff Bylaws, dated 12/10, read, "Telephone/verbal orders shall be countersigned, dated and timed by the prescriber, or another physician if the prescriber is not available, within forty-eight (48) hours."

On 2/14 through 2/17/11, Patients's records were reviewed. These records contained verbal orders for medications that were not countersigned within 48 hours (2 days), as follows:
a. On 2/16/11, Patient 21's medication ordered on [DATE] was not signed, three days later;
b. On 2/16/10, Patient 26's medications ordered on [DATE] were not signed until 8/11/10, 11 days later;
c. On 2/16/11, Patient 27's medications ordered on [DATE] for a cardiac catheterization (x-ray of the blood vessel) were not signed, and orders for insulin that were not signed until 10/5/10, 23 days later;
d. On 2/16/11, Patient 28's medications ordered on [DATE] were not signed until 7/26/10, 12 days later; and
e. On 2/16/11, Patient 29 had six medication orders from 2/5 through 2/22/10 that were not signed until 2/26/10, four (4) to 21 days later.
f. Patient 31 had medications ordered on [DATE] and not signed until 3/2/10, five days later;
g. Patient 32 had medications ordered on 2/23 and 2/24/10 and not signed until 3/3/10, seven to eight days later.

On 2/17/11 at 1:55 pm, Admin Staff H acknowledged that the facility was aware that there was a problem with the timeliness of verbal order signatures but had not implemented an action plan to correct the problem.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observation, interview, and record review, the facility failed to ensure one of 30 sampled patients' right to privacy was honored when Patient 22's dressing change was viewed from the hallway. This failure could result in the patient feeling humiliated and an unauthorized access to the patient's medical information.

Findings:

On 2/14/11 at 10:26 am, Patient 22 was observed from the hallway outside his room. Two people were in the process of changing dressings to Patient 22's right lower leg. The curtain was not pulled to provide privacy during the dressing change.

On 2/14/10, the facility policy, titled, Patient Rights and Responsibilities, last revised on 8/10, indicated that examination and treatment were confidential and should be conducted discreetly.

On 2/15/11 at 7:30 am, Registered Nurse I acknowledged that the curtain was not pulled during the dressing change and should have been pulled to protect Patient 22's privacy during the dressing change.
VIOLATION: QAPI Tag No: A0263
Based on observation, interviews and document reviews, the Quality Assessment and Performance Improvement Department failed to develop, implement, and maintain an effective, ongoing, facility-wide quality assessment and performance improvement program as evidenced by:

1. The facility quality assurance program failed to identify and reduce medication errors when the quality program failed to communicate medication related events to the medication error program (aka Medication Error Reduction Plan) in order to reduce medication errors (see A266, A500).

2. The facility quality assurance program failed to identify and reduce medication errors when the facility pharmacy failed to provide Heparin, a High Alert medication, in the smallest ready-to-administer form (see A266, A500).

3. The facility quality assurance program failed to separate Heparin, a High Alert medication, from floor stock in accordance to facility policy (see A266, A500).

4. The facility failed to ensure that the causes of a patient death was analyzed in a thorough, credible, and timely manner to identify possible root causes. (see A287)

5. The facility failed to ensure that preventative actions taken in response to an adverse event involving an overdose of lidocaine (a local anesthetic and used to treat irregular heart beat) to Patient 1 were implemented throughout the hospital. (see A288)

6. The facility failed to ensure that after identifying actions for improvement that they measure the success of the actions they had taken after an adverse event involving Patient 1. (see 290)

The cumulative effects of these systemic problems resulted in the failure to maintain an effective facility-wide quality program in accordance with the statutorily-mandated Conditions of Participation.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interviews and document reviews, the hospital failed to identify and reduce medical errors as evidence by:

1. The hospital quality assurance department failed to identify and reduce medication errors when the quality program failed to communicate medication related events to the medication error program (Medication Error Reduction Plan) in order to reduce medication errors.
2. The hospital quality assurance program failed to identify and reduce medication errors when the hospital pharmacy failed to provide Heparin, a High Alert medication, in the smallest ready-to-administer form.
3. The hospital quality assurance program failed to separate Heparin, a High Alert medication, from floor stock in accordance to hospital policy.

Findings:

1. A review of Patient 1's clinical record indicated Patient 1 was [AGE] years old and had a history of [DIAGNOSES REDACTED] (heart muscle disease). On 05/20/10 at 1:21 pm Patient 1 had a procedure for placement of an inplantable Cardioverter defibrillator pace maker (medical device which controls abnormal heart rates). Before the procedure Patient 1 was in no apparent distress and had a normal heart beat.

A review of the discharge summary dictated 05/26/10 indicated " date of death : 05/22/10 ... The patient was undergoing elective pacemaker implantation ...Code Blue was called overhead ...The patient was promptly intubated and resuscitated in the usual fashion requiring less than 10 minutes before return of spontaneous circulation. The procedure was completed and the patient was transferred to the Intensive Care Unit necessitating pressors, inotropes and invasive mechanical ventilation for support ...The patient ...had clinical seizures. EEG was performed and confirmed this ...I discussed with the family his ...probable prognosis. He [family member] told me the patient would not desire continued ...therapies ...the focus of care be switched to comfort measures only so that he may be allowed to die a natural death which he did shortly after extubation. "

A review of the clinical record for Patient 1's procedural summary in the entitled section Medication Summary indicated the total dosages of medications that were used throughout the artificial pacemaker procedure:
Versed 5 mg
Fentanyl 100 mcg
Lidocaine 2000 mg

According to Lexicomp Online, a nationally recognized medication information resource, Patient 1's Versed and Fentanyl doses were within recommended dosage ranges. The Lidocaine dose was 6-7 times higher then the recommended maximum dose of 300 mg.

Document medical staff summary of "Investigation" furnished on 02/17/11 at 11:45 am indicated "Case again deemed as care not acceptable based on conscious sedation and lidocaine/epinephrine administration. It was the opinion of the anesthesiologists that this may have been a preventable death in that the patient likely received excessive medications overall."

During an interview on 02/16/11 at 11:27 am the Pharmacy Staff D stated that Pharmacy was primarily responsible for running the Med Error Program (aka Medication Error Reduction Plan). He also stated that the primary purpose of the Med Error Program was to reduce medication errors throughout the hospital.

In an interview on 02/16/11 at 2:40 pm the Pharmacy Staff D stated that the Med Error Program did not receive information from the Quality Department until approximately 5 months after the Patient 1's medication error. He also stated that 9 months after the medication error the medication error had not been reviewed by the Med Error Program. There were no current plans to review Patient 1's medication error.

During an interview on 02/16/11 at 11:27 am Pharmacy Staff D stated the Med Error Program relied on the Quality Department to report all medication related events. When he received the events the Med Error Committee (Medication Safety Committee) would review the events for medication errors, and then develop a plan to reduce medication errors in the hospital.

In an interview on 02/15/11 at 10:34 am Administrative Staff H stated that hospital staff would report events and then the Quality Department would triage all the medication related events to Pharmacy Staff D.

A review of a computerized event log indicated a list of reported events from hospital staff. The following events were reported on 08/01/10:
*Patient was on Integrilin and Heparin drips (both blood thinners). Following this patient complained of headache, X-ray computer tomography scan (medical scan) of head showed intra-cerebral bleed (bleeding in brain). A short time later patient was declared dead.
*Pressure ulcer (skin breakdown)

A review of a computerized event log indicated a list of reported events from hospital staff. The following events were reported on 08/02/10:
*Patient Controlled Analgesia (PCA) flow sheet for one patient was found in the chart of another patient
*Discharge orders for one patient was found in the chart of another patient

During an interview on 02/17/11 at 10:24 am and 12:04 pm Pharmacy Staff D stated the events reported in the computerized event log on 08/01/10 and 08/02/10 were not reported to him or the Med Error Committee. He also stated Integrilin and Heparin could have been the cause for intra-cerebral bleeding, and that pressure ulcers could be caused by long term steroid use and could be medication related. He said that PCA flow sheet and discharge orders found in the wrong chart also could contribute to medication errors.

In an interview on 02/17/11 at 8:55 am Administrative Staff B stated the Quality Department was not aware of the issues relating to not communicating medication related events to Pharmacy and the Med Error Program. She also stated that she was not aware of any discussions regarding the Med Error Program not reviewing all medication related events for medication errors.

2. According to the Institute for Safe Medication Practices, a nationally recognized medication safety resource, and the American Society of Health System Pharmacists (ASHP), a nationally recognized professional organization, High-alert medications should have special safeguards such as storing in ready-to-administer doses. Manipulation of medications before administration should be minimized.

On 02/15/11 at 2:35 pm in the Interventional Radiology (IR) Department, Heparin 1000 u/ml 30 ml bulk vials were being used for a scheduled procedure. There were several Heparin 30 ml bulk vials in the cabinet.

During an interview on 02/15/11 at 2:35 pm Nurse A stated that on average a procedure will use about 10-12 ml of the Heparin 1000 u/ml (this would be 1 vial of Heparin 10 ml with 1-2 ml of overfill). He acknowledged that a total 30 ml bulk vial of Heparin would not be used during a procedure. He said the 10 ml Heparin vials would suffice.

A review of the IR medication order form dated 1/12/11, indicated that Heparin 1000 u/ml 30 ml, one box of 25 was ordered on [DATE]. 18 bulk vials (calculated as 25-7) of 30 ml Heparin was used for over 1 month in the IR for procedures. On average approximately 3 times what was needed per procedure.

In an interview on 02/17/11 at 8:55 am Administrative Staff B stated the Quality Department was not aware that the 30 ml bulk vials of Heparin were being stored in the IR cabinet as floor stock. Bulk vials of Heparin would increase the potential for medication errors.

3. According to the hospital policy dated 08/17/10 entitled Management of Medications indicated "All therapeutic heparin products are stored separated and identified as separate stock with high-alert stickers. "

On 02/16/11 at 11:00 am in the IR Department it was observed Heparin 1000 unit/ml 10 ml vials stored as floor stock in a cabinet. The Heparin vials were stored together with other medications in the cabinet. The Heparin vials were not stored separately from other medications.

In an interview on 02/17/11 at 8:55 am Administrative Staff B stated the Quality Department was not aware that Heparin was stored with other medications in the IR cabinet as floor stock. Separating Heparin from regular floor stock would help prevent and reduce medication errors.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure that the causes of Patient 1's death was analyzed in a thorough, credible, and timely manner to identify possible root causes. This failure failed to identify a medication error involved lidocaine (a local anesthetic and used to treat irregular heart beat) that went unaddressed for several months. This failure had the potential to result in other patients' harm from a similar error. (Patients 1) See A500 for further information.

Findings:

1. Patient 1's record indicated that he was admitted on [DATE] for insertion of an automated implantable cardioverter-defibrillator (AICD - a device implanted in the chest that sends an electrical charge to the heart when it beats too fast or quivers) in the cardiac catheterization (cath) lab. Patient 1 had a drop in the oxygen saturation in his blood during the procedure and life saving measures (a code for cardiac arrest) were instituted. The physician completed the procedure and transferred Patient 1 to the intensive care unit where he expired two days later.
On 2/15/11 at 2:30 pm, Administrative (Admin) Staff A, B, and C from the Quality Department were interviewed regarding the analysis of the cause of Patient 1's death. Admin Staff C stated Patient 1 was admitted with [DIAGNOSIS REDACTED] (reduced heart pumping action) and left systolic dysfunction (the inability of the heart chamber to fill with blood completely). Admin Staff C stated that there was no reason to believe that Patient 1 would have an cardic arrest (no heart beat) during the procedure. Admin Staff C reported that cardiac cath lab staff said Patient 1 was talking and responding fine until shortly before Patient 1's heart stopped beating.

Admin Staff B explained that Patient 1's case was reviewed because it triggered three different events requiring review: an arrest during a procedure with sedation; a death following a cardiac cath; and a complaint from staff regarding the the code team responsiveness. Admin Staff B stated that a root cause analysis (a process to identify possible causes of an event and process/systems improvements) for Patient 1's event was conducted on 6/17/10 and identified several areas for improvement. Admin Staff C stated Patient 1's case was referred for physician peer review at the same time and there were no indications that an expedited review was required.
Admin Staff A stated the Quality Department staff were concerned about understanding the cause of death and requested that Physicians E and X review the case to assist in determining the cause of death in addition to the other reviews.
Admin Staff B stated that, on 9/21/10, the facility was directed by an anonymous person to include looking at the dosage amount of lidocaine used to anesthetize the chest during the AICD insertion because of a similar situation at another hospital that was related to a patient's death. Admin Nurse B further stated the case was referred back to medical staff for further review.
Patient 1's record contained a nursing record of the AICD insertion procedure which indicated that 50 milliliters (ml) of lidocaine 2% (percent) with EPI (epinephrine - also known as adrenaline, used to increase heart rate) was recorded as given in two different injections (100 ml total) to Patient 1, completed at 1:30 pm and 1:32 pm just prior to his arrest at 1:50 pm. Next to this recording was a notation that stated, "Yes, 100 ml EPI/LIDO (lidocaine)."

Patient 1's procedural summary in the entitled section Medication Summary indicated the total dosages of medications that were used throughout the artificial pacemaker procedure which included Lidocaine 2000 mg (100 ml of 2% Lidocaine).

According to Lexicomp Online, a nationally recognized medication information resource indicated the recommended dosages for Lidocaine anesthesia (local injectable) maximum: 4.5 mg/kg/dose not to exceed 300 mg; do not repeat within 2 hours. Patient 1's lidocaine dose was 6-7 times higher then the recommended maximum dose of 300 mg.

On 2/15/10 at 3 pm, Admin Staff B was asked about why the lidocaine overdose was not found earlier even though there was the unusual notation on Patient 1's procedure record, "Yes, 100 ml EPI/LIDO (lidocaine)." She stated that no one noticed it. She further stated it was determined not to be a sentinel event so it did not trigger an expedited review. She further explained that the review had been focused on the medications used during conscious sedation (drugs used to reduce irritability and aggitation during an invasive procedure) as a possible cause of death. She confirmed that a pharmacist was not part of the root cause analysis even though Patient 1's event was considered (at that time) to be related to the administration of medication for conscious sedation. Admin Staff A, B, and C stated they all reviewed the case and did not clue into the lidocaine problem. Admin Staff B stated she had not read every word of the nurse report of the AICD insertion. When asked how many people reviewed the case prior to the anonymous tip, Admin Staff A produced a list that indicated 13 people directly reviewed the record and 30 other people reviewed the case in meeting forums. Pharmacist D did not review the case until 10/29/10, five months later.

On 2/15/10, the facility policy, titled, Sentinel Event Management, revised 2/09, defined a sentinel event as an unexpected occurrence involving death or serious physical or psychological injury, or risk thereof. The policy further gave an example of a sentinel event that would require review as, "An unanticipated death...., not related to the natural course of a patient's illness or underlying condition."

The policy further defines the characteristics of a thorough and credible root cause analysis (RCA) as:
a. "To be thorough , the RCA must include:
- a determination of the human and other factors most directly associated with the sentinel event, and the process(es) and systems related to its occurrence;
- analysis of the underlying systems and processes through a series of "Why?" questions to determine where redesign might reduce risk;
- inquiry into all areas appropriate to the specific type of event as described in the current edition of "Minimum Scope of Review of Root Cause Analysis";
- identification of risk points and their potential contributions to this type of event;
- a determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist.
b. To be credible, the RCA must:
- include participation by the leadership of the organization and by the individuals most closely involved in the processes and systems under review;
- be internally consistent, i.e., not contradict itself or leave obvious questions unanswered;
- provide an explanation for all findings of "not applicable" or "no problem;" and
- include consideration of any relevant literature.

The "Minimum Scope of Review of Root Cause Analysis" attachment to the above policy indicated that detailed inquiry into physical assessment process, availability of information, physical environment, and medication management are required in case of procedural complication and medication error. Admin Staff B confirmed the RCA did not include all of the above items. Admin Staff B acknowledged that a pharmacist did not attend the RCA.

On 2/15/10 at 2 pm, Admin Staff B stated the staff involved in the root cause analysis were two members from the Quality Department, the temporary Cardiac Cath Department manager, an internal medicine physician, and a cardiovascular technician. She also confirmed that neither a physician or nurse skilled in procedures done in the cardiac cath lab participated in the RCA.

Therefore, the facility failed to identify the death of Patient 1 as a sentinel event, failed to review Patient 1's record in enough detail to identify irregularities, failed to conduct a root cause analysis that was thorough in evaluating all of the intersecting processes and systems, and failed to conduct an RCA that was credible by including key cardiac cath lab and pharmacy personnel.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review, the facility failed to ensure that preventative actions taken in response to an adverse event involving an overdose of lidocaine (a local anesthetic and used to treat irregular heart beat) administered to Patient 1 were implemented throughout the hospital. This failure had the potential to result in additional patients receiving overdoses of lidocaine in other departments of the facility. See A500 for further information.

Findings:

On 2/15/11, the facility policy, titled, Event Reporting and Management, indicates events are reported to facilitate the analysis of healthcare errors, and the evaluation and development of action plans to prevent future or similar events from occurring.

On 2/15/11 at 2:30 pm, Administrative (Admin) Nurse C and Q were interviewed regarding the actions taken in the cardiac catheterization (cath) lab as a result of their evaluation of Patient 1's adverse event, on 5/20/10, in which lidocaine was administered to Patient 1, in an amount that exceeded the recommended maximum dose, which lead to signs and symptoms of lidocaine toxicity and was a significant contributing factor to Patient 1's subsequent death on 5/22/10. Admin Q reported that several preventative actions were taken, including:
- improved draping of the patient during the procedure;
- improved timing of medication administration used for conscious sedation (an altered state of consciousness that minimizes pain through the use of pain relievers and sedatives);
- improvements in the communication and documentation of medications administered during the procedure; and
- the use of end-tidal carbon dioxide monitoring (exhaled carbon dioxide) for patients with pacemaker (device to assist in regulating the heart beat) insertion or an ASA score of 4 (a American Society of Anesthesiologists score that identifies the patients most at risk during sedation and anesthesia.)

On 2/17/11 at 8:55 am, Admin Staff A and C were interviewed regarding the Quality Department's evaluation of potential adverse trends in relation to Patient 1's adverse event. Admin Nurse A was asked if any of the preventative actions identified above were evaluated for use in other departments of the facility and she replied, "No." Admin Nurse C stated that she spoke informally to the interventional radiology (IR) department regarding their use of lidocaine during procedures. Admin Nurse C stated she did not have any written records assessing the IR department's risk or any medical record reviews to assess the IR current lidocaine usage patterns. Admin Nurse C acknowledged that other departments in the facility that used lidocaine were not assessed to their usage patterns. When asked if a review was done of other similar drugs to lidocaine were assessed for their usage pattern, Admin Nurse C stated, "No." Admin A confirmed that no policies were changed or created as a part of their response to Patient 1's adverse event.

On 2/17/10 at 1:10 pm, when asked if a message warning the nurse of the weight-based maximum limit for lidocaine was programmed into the automated medication dispensing cabinet system, Admin A confirmed it had not.

On 2/15/11, the facility policy, titled, Performance Improvement Plan, revised 12/10, indicated that one of the functions of the Quality Department was to report one-time occurrences of significant adverse outcomes and potential adverse trends to the Quality Assessment and Improvement Committee and appropriate leaders.

On 2/17/10, the Quality Assessment and Improvement Committee minutes did not contain evidence that actions taken to improve services in the cardiac cath lab had been considered for other departments of the facility or that trends related to lidocaine usage were evaluated other than for cardiac cath lab patients.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review, the facility failed to ensure that after identifying actions for improvement that they measure the success of the actions they had taken. This failure has the potential for medical errors and adverse events to persist due to unsuccessful actions and a lack of accountability for evaluation of those actions. See A287 and A500 for further information.

Findings:

1. On 2/15/11, the facility policy, titled, Performance Improvement Plan, revised 12/10, indicated, "Collaborative and specific indicators of key processes are designed, measured and assessed by all appropriate departments/services and disciplines of the facility in an effort to improve patient safety and organizational performance. These indicators are objective, measurable, based on current knowledge and experience, and are structures to produce statistically valid, data driven, performance measures of care provided. The mechanism also provides for evaluation of improvements and stability of improvements over time.... The Quality Department ... attends medical staff, nursing staff, and other clinical staff's quality meetings or Medical Center performance improvement activities as requested to support identification of conclusions, recommendations, actions, and follow-up monitoring and evaluation activities."

On 2/15/11 at 2:30 pm, Administrative (Admin) C and Q were interviewed regarding the actions taken in the cardiac catheterization (cath) lab as a result of their evaluation of Patient 1's adverse event, on 5/20/10, in which lidocaine was administered to Patient 1 in an amount that exceeded the recommended maximum dose which lead to signs and symptoms of lidocaine toxicity and was a significant contributing factor to Patient 1's subsequent death on 5/22/10. Admin Q reported that several preventative actions were taken, including:
- development of a weight-based maximum dose chart for lidocaine administration;
- improved draping of the patient during the procedure;
- improved timing of medication administration used for conscious sedation (an altered state of consciousness that minimizes pain through the use of pain relievers and sedatives);
- improvements in the communication and documentation of medications administered during the procedure; and
- the use of end-tidal carbon dioxide monitoring (exhaled carbon dioxide) for patients with pacemaker (device to assist in regulating the heart beat) insertion or an ASA score of 4 (a score that identifies the patients most at risk during sedation and anesthesia)
When asked how Admin Nurse Q would know if the actions taken were successful, she reported that she has done spot checks to see if personnel were implementing the actions identified in response to Patient 1's event. Admin Q confirmed that she did not have any quality indicators she measured as part of her quality plan or any written evidence that the actions taken were successful.

On 2/17/11 at 8:55 am, Admin Nurse A and C were asked if any new quality indicators were developed to evaluate the success of the actions the facility had taken to prevent a similar occurrence as Patient 1's adverse event, they responded, "No."
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the facility failed to ensure that after identifying actions for improvement that they measure the success of the actions they had taken. This failure has the potential for medical errors and adverse events to persist due to unsuccessful actions and a lack of accountability for evaluation of those actions. See A287 and A500 for further information.

Findings:

1. On 2/15/11, the facility policy, titled, Performance Improvement Plan, revised 12/10, indicated, "Collaborative and specific indicators of key processes are designed, measured and assessed by all appropriate departments/services and disciplines of the facility in an effort to improve patient safety and organizational performance. These indicators are objective, measurable, based on current knowledge and experience, and are structures to produce statistically valid, data driven, performance measures of care provided. The mechanism also provides for evaluation of improvements and stability of improvements over time.... The Quality Department ... attends medical staff, nursing staff, and other clinical staff's quality meetings or Medical Center performance improvement activities as requested to support identification of conclusions, recommendations, actions, and follow-up monitoring and evaluation activities."

On 2/15/11 at 2:30 pm, Administrative (Admin) C and Q were interviewed regarding the actions taken in the cardiac catheterization (cath) lab as a result of their evaluation of Patient 1's adverse event, on 5/20/10, in which lidocaine was administered to Patient 1 in an amount that exceeded the recommended maximum dose which lead to signs and symptoms of lidocaine toxicity and was a significant contributing factor to Patient 1's subsequent death on 5/22/10. Admin Q reported that several preventative actions were taken, including:
- development of a weight-based maximum dose chart for lidocaine administration;
- improved draping of the patient during the procedure;
- improved timing of medication administration used for conscious sedation (an altered state of consciousness that minimizes pain through the use of pain relievers and sedatives);
- improvements in the communication and documentation of medications administered during the procedure; and
- the use of end-tidal carbon dioxide monitoring (exhaled carbon dioxide) for patients with pacemaker (device to assist in regulating the heart beat) insertion or an ASA score of 4 (a score that identifies the patients most at risk during sedation and anesthesia)
When asked how Admin Nurse Q would know if the actions taken were successful, she reported that she has done spot checks to see if personnel were implementing the actions identified in response to Patient 1's event. Admin Q confirmed that she did not have any quality indicators she measured as part of her quality plan or any written evidence that the actions taken were successful.

On 2/17/11 at 8:55 am, Admin Nurse A and C were asked if any new quality indicators were developed to evaluate the success of the actions the facility had taken to prevent a similar occurrence as Patient 1's adverse event, they responded, "No."
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
Based on medical record review, document review and staff interview, for one medical record (Patient 1) of fifteen surgical medical records reviewed, the medical staff failed to enforce sections of the medical staff bylaws, rules and regulations that required each surgical patient "have a complete H&P [history and physical examination]" and "an interval note [a brief H&P that detailed changes since the complete H&P had been performed]... prior to surgery."

Findings:

On 2/15/11 the electronic medical record of Patient 1 was reviewed and was noted to lack a complete medical history and physical examination. The record also did not have an interval note (a progress note updating changes that had taken place since the H&P was performed). Patient 1 was admitted as an outpatient to the facility's cardiac catheterization laboratory on 5/19/10 for surgical placement of an internal cardiac pacemaker and defibrillator (a device that send signals to the heart to keep the heart rate regular and shocks the heart if it begins to have ineffective contractions.) Patient 1 was admitted to the hospital after having an intraoperative complication. Two days later, Patient 1 died .

On 2/14/11 the medical staff bylaws and rules and regulations were obtained and reviewed. Article III of bylaws states in part, "The attending physician shall be responsible for the preparation of a complete medical record for his/her patient. This shall include a history and physical..." The rules and regulations stated in part, on page 3, section 2.A.2), "Patients going to surgery must have a complete H&P or its equivalent within 30 days of surgery and an interval note or progress note recorded ... prior to surgery." "The interval note should compliment the original H&P and specify any changes to the original document/findings (vital systems, organs or areas of the body that will be having procedure or surgery, pertinent negatives, etc.) This note must be dated and timed to correspond with the time there review of the patient occurred."

On 2/16/11 at 11:45 am, the facility's Medical Director (Admin. Staff E) was interviewed. During this discussion, Admin Staff E acknowledged that contrary to requirements in the medical staff bylaws, rules and regulations, Patient 1 had surgery performed without a properly recorded complete H&P and interval note. Admin Staff E also listed several other necessary pre-surgical documents that were missing from Patient 1's record. These included: 1) a proper informed consent, 2) an American Society of Anesthesiologist (ASA) score (a risk assessment prior to anesthesia and surgery), 3) proper documentation that the surgery was needed and 4) any pre-surgical laboratory studies. He further acknowledged that in the cardiac catheterization laboratory there wasn't a functioning mechanism to prevent patients from having surgery without a pre-surgical review of the chart to assure it contained all of the necessary documents that were required before surgery.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review of 30 sampled patients, the facility failed to administer drugs as ordered by the physician and within accepted standards of practice as evidenced by:

1. For Patient 44, there was a failure to follow physician's orders when staff gave him medication and fluids after he was ordered to have nothing by mouth, to clarify physician's orders, to document the correct route of medication administration, and to complete an accurate medication reconciliation between the physician orders and the Medication Administration Records (MARs).

2. For Patient 34, there was a failure to complete an accurate medication reconciliation between the physician orders and the MARs.

3. For Patient 40, there was a failure to complete an accurate medication reconciliation between the physician orders and the MARs and document the correct route of medication administration.

4. For Patient 43, there was a failure to administer medication in a timely manner.

5. For Patient 41, there was a failure to complete an accurate medication reconciliation between the physician orders and the MARs, document the correct route of medication administration, and clarify a physician's medication order.

6. For Patient 21, there was a failure to administer medication in a timely manner.

The above referenced medication issues caused or had the potential to cause medication errors resulting in significant injury and or death.

Findings:

1. Patient 44 was a [AGE] year old developmentally delayed patient admitted to the facility on [DATE] with diagnoses that included [DIAGNOSES REDACTED].

Patient 44 had prior swallow studies (tests to determine if a patient is at risk for choking on food and/or fluids) conducted by a speech/language pathologist at the facility on 8/16/10 and 8/24/10. As a result of these tests Patient 44 was determined to be at risk for aspiration (choking/inhaling on food and/or fluids) and was a "silent aspirator".

During an interview on 1/12/11 at 2:15 pm, Speech/language Pathologist L reviewed the above swallow studies. She explained that silent aspiration meant that when the patient eats or drinks, the food or fluids go into the lungs and there are no outward symptoms such as coughing or tearing.

Patient 44 was hosptalized on [DATE] at which time his physician noted that if he was not made NPO (nothing by mouth) and a PEG tube inserted he would continue to develop aspiration pneumonia which at some point would be fatal. Subsequently, Patient 44 had a PEG tube inserted and was discharged back to the ICF on 9/20/10 and made NPO with all medications to be given per the PEG tube.

At the time of Patient 44's admission on 12/19/10, the physician medication reconciliation order sheet was completed and listed all the medications Patient 44 had taken at the ICF. The route of all medications listed was "via PEG tube" and this form was signed by the physician and faxed to the pharmacy. The MARs that were printed by the pharmacy listed all except one of the medications to be given by mouth (po) instead of PEG tube as ordered by the physician.

The facility's policy titled, Medication Reconciliation, dated 9/16/10, read as follows: the physician medication reconciliation order form is faxed to pharmacy where a pharmacist reviews it. The ordering physician will be contacted for any clarification needed.

During an interview on 1/6/11 at 11:30 am, Pharmacy Staff D stated that a pharmacist would review the physician medication reconciliation sheet and control the information placed on the MARs. He stated that the route was entered as po by the pharmacist when it should have been via PEG tube.

There was a physician's order written on 12/20/10 at 8:30 am that read as follows: allow all po meds to be given by PEG. The MARs that were printed the following day on 12/21/10 and thereafter continued to list the route of the medications as po instead of via PEG tube.

During an interview on 1/6/11 at 11:30 am, Pharmacy Staff D stated that after the MD order on 12/20/10, the subsequent MARs should have been changed to reflect the route as PEG for all medications. He stated that there was a 24 hour chart check done by the RN and if any corrections were indicated, the nurse should have faxed the MAR to pharmacy where the pharmacist would review the physician's order and the MAR. He confirmed that the pharmacy had not received any MARs to be corrected from the nursing staff. During a later interview on 1/12/11 at 2 pm, Pharmacy Staff D stated that the pharmacist who reviewed the order missed it due to human error.

The facility's policy titled, Management of Medications, dated 8/17/10, read as follows: The daily MAR is delivered to each nursing unit after midnight. It is checked for accuracy/completeness and signed by the night RN. Any discrepancies are reported to pharmacy for resolution.

During an interview on 2/8/11 at 2:20 pm, Administrative (Admin) Staff F stated it was the responsibility of the night shift nurse to check the MARs and the physician orders and if the route was incorrect, the nurse should have found the physician's order that specified the route and fax it, along with the incorrect MAR, to the pharmacy to alert them of the error. She stated that on some days the MARs reflected po and on other days some of the nurses had lined out po and wrote PEG.
On 2/15/11, the facility policy, titled, Management of Medications, dated 8/17/10, indicated that if a medication order is incomplete or unclear, the individual who wrote the order shall be contacted, and the order clarified accordingly. The policy further indicated clarification of orders were documented on the order sheet as a "clarification", timed, dated, and signed by the individual receiving the clarification.

The MARs from 12/19 - 12/28/10 were printed with med route as "po" on all medications except one. "PEG" was handwritten next to the "po" on the MARs for 12/21, 12/22, and 12/27. The MARs for 12/28 had the "po" crossed out and "PEG" written as the route for all the medications. During an interview on 1/5/11 at 3:10 pm, Administrative Staff B confirmed that the route should have been clarified on the MARs.

There was a physician's order on 12/19/10 for ice chips followed by an order for clear liquids on 12/21/10, then an order on 12/22/10 to make Patient 44 NPO.

During an interview on 1/6/11 at 3:10 pm Registered Nurse M stated that the physician changed the diet order from NPO to clear liquids for Patient 44 on the day shift on 12/21/10, so she gave him juice, jello and water. She stated she had no reason to question this order.

During an interview on 1/6/11 at 3:30 pm, Registered Nurse (RN) N stated that she had given Patient 44 liquid medications and fluids on the night shift on 12/21/10. She then received a call from a nurse from the ICF where Patient 44 had previously resided who told her that Patient 44 was an aspiration risk and had to be NPO. RN N left a note for the next shift and a subsequent physician's order was written on 12/22/10 that made Patient 44 NPO.

During an interview on 1/5/11 at 3:10 pm, Administrative Staff B stated that records of past admission were readily accessible via the computer for hospital staff including physicians.

Even though past records including prior swallow studies were available, it took three days after admission before facility staff and physicians recognized that Patient 44 was an aspiration risk and needed to be made NPO.

During an interview on 1/6/11, a nurse and an administrative staff member from the ICF where Patient 44 resided prior to admission, stated that while visiting Patient 40 on 12/28/10, they saw a cup of water with a bendable straw on the bedside table.

Interviews were conducted on 1/6 and 1/12/11, with the nurses who cared for Patient 44 from the beginning of the day shift on 12/27, until the time of his death at 5:40 am on 12/29/10. All the nurses denied giving Patient 44 any water and stated that they crushed all medications, mixed them with water then gave them through the PEG tube.

However, during postmortem care, staff from the ICF found a pill in Patient 44's bed. This pill was examined on 1/6/11 and again on 2/2/11, and found to be a medication Patient 44 had received during his hospitalization . The letters and numbers on the pill found by the ICF staff were clearly visible and were identical to a pill from the facility's pharmacy that was provided for comparison by Administrative Staff B on 1/19/11.

Patient 44's physician listed aspiration as the cause of death in his death summary report dictated on 12/29/10. An autopsy report listed the cause of death as undetermined.

2. A review of Patient 34's record disclosed that he was an [AGE] year old admitted on [DATE] and was discharged to another facility on 1/24/11 with a diagnosis of [DIAGNOSES REDACTED]. A PEG tube was inserted on 1/20/11. The MARs from 1/20 through 1/24/11 listed the route of medications as po and medications were charted as being given po.

The facility's policy titled, Medication Reconciliation, dated 9/16/10, read as follows: the physician medication reconciliation order form is faxed to pharmacy where a pharmacist reviews it. The ordering physician will be contacted for any clarification needed.

The facility's policy titled, Management of Medications, dated 8/17/10, read as follows: The daily MAR is delivered to each nursing unit after midnight. It is checked for accuracy/completeness and signed by the night RN. Any discrepancies are reported to pharmacy for resolution.

During an interview on 2/17/11 at 3:30 pm, Pharmacy Staff D had no explanation for the MAR inconsistencies.

During an interview on 2/17/11 at 3:40 pm, Administrative Staff F stated that all the nurses reported that the medications were given via the PEG tube even though the meds were documented as being given po.

3. A review of Patient 40's record disclosed a verbal order dated 2/14/11 at 8:06 pm, for Klonopin one milligram three times per day as needed for anxiety. The MARs for the following day did not include this order.

The facility's policy titled, Management of Medications, dated 8/17/10, read as follows: The daily MAR is delivered to each nursing unit after midnight. It is checked for accuracy/completeness and signed by the night RN. Any discrepancies are reported to pharmacy for resolution.

During an interview on 2/16/11 at 2:10 pm, Administrative Staff G stated the night nurse should have
caught this when she reviewed the MARs and physician orders.

4. A review of Patient 43's record disclosed a verbal order from the physician written by a pharmacist on 2/13/11 at 5:15 pm, for Vancomycin (antibiotic) 500 milligrams (mg) intravenously now. The medication was signed as being given at 10 pm.

The facility's policy titled Management of Medications, dated 8/17/10, read as follows: stat or now medications shall be administered within 30 minutes of the order.

During an interview on 2/17/11 at 10:35 am, Administrative Staff F stated she had talked to the day and night shift nurses about the reason for the late administration of the medication. Both nurses confirmed that the order was not there during the change of shift ending at 7:15 pm. The order was located around 7:30 to 8 pm then the nurse called the pharmacist to send the medication.

During an interview on 2/17/11 at 3:30 pm, Pharmacy Staff D stated that there was a delay in placing the order in the chart but there was not a delay in getting the medication to the unit and the medication was on the unit when the nurse called for it.




5. On 2/16/11, Patient 41's record indicated he was admitted on [DATE] for metabolic [DIAGNOSES REDACTED] (damage to the brain due to lack of glucose, oxygen or other metabolic agent). Patient 41 had a PEG tube in place upon admission.
Patient 41's record contained a physician's order for Coumadin (a blood thinner) 5 mg po (by mouth) tonight. A review of Patient 41's MAR revealed the rest of Patient 41's medications were ordered to be given via the PEG tube. Patient 41's MAR indicated that the 2/2/11 dose of Coumadin was administered by mouth by Registered Nurse (RN) K .
Patient 41's record had a record of a swallowing evaluation done earlier the same day, 2/2/11, which indicated that Patient 41 must remain on strict NPO (nothing by mouth) to prevent inhaling food and liquids into his lungs.
On 2/17/11, RN K recalled Patient 41 and stated she gave Patient 41's Coumadin via the PEG tube even though it was ordered by mouth. RN K stated she did not "pick up" on the fact that the order was to be given by mouth. RN K further acknowledged she documented she gave the Coumadin my mouth instead of by PEG tube. When questioned as how she should have handled it, she stated that she should have changed the physician's order to PEG tube instead of by mouth.
On 2/15/11, the facility policy, titled, Management of Medications, revised 8/10, indicated that if a medication order is incomplete or unclear, the individual who wrote the order shall be contacted, and the order clarified accordingly. The policy further indicated clarification of orders were documented on the order sheet as a "clarification," timed, dated, and signed by the individual receiving the clarification.
On 2/17/11 at 9:50 am, Admin Nurse A acknowledged that RN K should have contacted the physician who wrote the Coumadin order and clarified whether it should be given by mouth or by PEG tube and documented the clarification order. Admin Nurse A further stated RN K should correctly document the route for the Coumadin administration on the MAR.
6. On 2/17/11, Patient 21's record contained a physician's order, dated 2/13/11 at 1:10 pm, for Vancomyin 1 gram intravenously now. The medication was signed as being given at 6 pm, over 4 hours later.

On 2/17/11 at 11:45 am, Admin Nurse W reviewed Patient 21's record was unable to explain why the Vancomycin was not administered timely. Admin Nurse W stated the record was noted by the nurses at 2 pm and again at 3 pm.

On 2/17/11 at 2:37 pm, Pharmacy Staff D confirmed the pharmacy took one hour to process the above order and acknowledged the order was not given timely. Pharmacy Staff D stated he did not have a quality indicator in place to determine the timeliness of medications ordered now or as soon as possible (STAT).
VIOLATION: VERBAL ORDERS AUTHENTICATED BASED ON LAW Tag No: A0457
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure verbal orders were countersigned within 48 hours for seven of 30 sampled patients. This failure has the potential for an undetected medication error to persist throughout the patient stay. (Patients 21, 26, 27, 28, 29, 31, and 32)

Findings:

On 2/16/11, the facility's Medical Staff Bylaws, dated 12/10, read, "Telephone/verbal orders shall be countersigned, dated and timed by the prescriber, or another physician if the prescriber is not available, within forty-eight (48) hours."

On 2/14 through 2/17/11, Patients 21, 26, 27, 28, 29, 31 and 32's records were reviewed. These records contained verbal orders for medications that were not countersigned within 48 hours (two days), as follows:
a. On 2/16/11, Patient 21's medication ordered on [DATE] was not signed, three days later;
b. On 2/16/10, Patient 26's medications ordered on [DATE] were not signed until 8/11/10, 11 days later;
c. On 2/16/11, Patient 27's medications ordered on [DATE] for a cath lab procedure were not signed, and orders for insulin that were not signed until 10/5/10, 23 days later;
d. On 2/16/11, Patient 28's medications ordered on [DATE] were not signed until 7/26/10, 12 days later;
e. On 2/16/11, Patient 29 had six medication orders from 2/5 through 2/22/10 that were not signed until 2/26/10, four (4) to 21 days later.
f. Patient 31 had medications ordered on [DATE] and not signed until 3/2/10, five days later; and
g. Patient 32 had medications ordered on 2/23 and 2/24/10 and not signed until 3/3/10, seven to eight days later.

On 2/17/11 at 1:55 pm, Administrative Staff H acknowledged that the facility was aware that there was a problem with the timeliness of verbal order signatures but had not implemented an action plan to correct the problem.
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure that 11 of 11 sampled patients that had a procedure in the cardiac catheterization (cath) lab had an accurate record of the amount of lidocaine (used for numbing and irregular heart rhythms) used during the cardiac procedure by routinely assigning a staff member the responsibility of medication documentation when he was unable to determine, either verbally or by observation, the exact amount of medication given to the patients by the physicians. This failure had the potential to to cause medical errors due to a lack of important medical information. (Patients 1, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33)
Findings:
1. A review of Patient 1's record disclosed that he was a [AGE] year old admitted on [DATE] for an insertion of a pacemaker and automatic internal cardiac defibrillator (used to control heartbeat and rhythm), a procedure that was performed in the cardiac cath lab. According to the medication events which were documented by Licensed Staff (LS) O, Patient 1 received 2% Lidocaine (local anesthetic) with Epinephrine (adrenaline which increases heartrate) subcutaneously (given under the skin) 50 milliliters (ml) given by the physician at 1:30 pm and repeated at 1:32 pm.

During an interview on 10/21/10 at 3:35 pm, LS O stated that in this case, one of his responsibilities included documentation of the events, including medications, in chronological order. LS O confirmed that he documented that the physician gave two 50 ml doses of Lidocaine even though he was unable to observe, from where he was located in the room, if the physician gave that entire amount. LS O stated that the physician and other staff members did not verbally state how much medication had been given to Patient 1 by the physician.

During an interview on 11/29/10 at 2:15 pm, Administrative (Admin) Staff P confirmed that as of the date of the procedure, the staff member assigned to document the amount of medication given by the physician, could not always see how much medication the physician had given. She stated there was no way to know exactly how much Lidocaine Patient 1 had received.
2. On 2/16/11, Patient 30's record indicated she was admitted on [DATE] for a pacemaker (used to control heart beat) insertion. Patient 30's record contained a procedure note that indicated the left chest region was anesthetized with lidocaine. Patient 30's record further contained a nursing record of the procedure which had no record of lidocaine being administered.
During an interview on 2/16/11 at 10:35 am, Admin Staff Q stated that it was not the standard of practice for the nurses to document the exact amount of medication the physician gave but rather it was the physician's responsibility.
On 2/16/11 at 12:40 pm, Admin Nurse A acknowledged Patient 30's record did not contain the amount of Lidocaine administered in the physician's procedure notes and that the physician should have documented the amount of medication he used during the procedures.
3. On 2/14 through 2/17/11, Patients 24 through 29, 31, 32, and 33's records were reviewed. All of these records contained physician procedure notes for procedures conducted in the cardiac catheterization laboratory which indicated lidocaine was used to anesthetize the site but did not include the specific amount of lidocaine administered by the physician in the procedure note. The medication records contained documentation by the nurses of the amounts of Lidocaine used by the physician.
During an interview on 2/16/11 at 10:35 am, Admin Staff Q stated that it was not the standard of practice for the nurses to document the exact amount of medication the physician gave but rather it was the physician's responsibility.
On 2/16/11 at 12:40 pm, Admin Nurse A acknowledged Patients 24, through 29, 31, 32, and 33's records did not contain the amount of lidocaine administered in the physician's procedure notes and that the physicians should have documented the amount of medication they used during the procedures.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interviews and document reviews the facility failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The facility pharmaceutical services failed to evaluate a lidocaine toxicity medication error which resulted in death in order to reduce similar medication errors within the facility (see A500, A266).

2. The facility pharmaceutical services failed to evaluate medication related events as medication errors in order to reduce medication errors within the facility (see A500, A266).

3. The facility pharmacy failed to provide Heparin, a High Alert medication, in the smallest ready-to-administer form in accordance to standards of practice (see A500, A266).

4. The facility pharmacy failed to separate Heparin, a High Alert medication, from floor stock in accordance to facility policy (see A500, A266).

5. The facility Pharmacists failed to review all non-emergent medication orders prior administration in the Emergency Department (see A500, A266).

6. The facility failed to ensure a medication refrigerator was checked per facility procedure to assure the proper storage of medications requiring refrigeration (see 491).

7. The facility failed to ensure one of 30 sampled patients and one unsampled patient's medications in multi-dose vials were labeled with the date they were opened (see 505).

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on interview and record review, the facility failed to ensure a medication refrigerator was checked per facility procedure to assure the proper storage of medications requiring refrigeration. This failure has the potential for medications to become unstable when not refrigerated which can cause adverse drug reactions.

Findings:

On 2/14/11 at 11 am, the medication refrigerator log in the neonatal intensive care unit indicated two of 13 days without monitoring of the temperature, 2/3 and 2/12/11. The log contained instructions to read and record the temperature daily.

On 2/14/11 at 11 am, Administrative Nurse L acknowledged that the refrigerator temperature should be checked daily and two days in the last 13 had been missed.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and document review the hospital failed to provide medication patient safety in accordance with standards of practice as evidence by:
1. The hospital pharmaceutical services failed to evaluate a lidocaine toxicity medication error which resulted in death, in order to reduce similar medication errors within the hospital.
2. The hospital pharmaceutical services failed to evaluate medication related events as medication errors in order to reduce medication errors within the hospital.
3. The hospital pharmacy failed to provide Heparin, a High Alert medication, in the smallest ready-to-administer form in accordance to standards of practice.
4. The hospital pharmacy failed to separate Heparin, a High Alert medication, from floor stock in accordance to hospital policy.
5. The hospital Pharmacists failed to review all non-emergent medication orders prior to their administration in the Emergency Department.

Findings:

1. A review of Patient 1's clinical record indicated Patient 1 was [AGE] years old and had a history of [DIAGNOSES REDACTED] (heart muscle disease). On 05/20/10 @ 1:21 pm Patient 1 had a procedure for placement of an artificial pace maker (medical device to control heart rate). Before the procedure Patient 1 was in no apparent distress and had a normal heart beat. During the procedure the following medications were administered as indicated by the times:
1:21 pm Versed 1mg IV -for pain/sedation while patient remains awake
1:24 pm Versed 2mg IV
1:24 pm Fentanyl 50 mcg IV - for pain/sedation while patient remains awake
1:28 pm Versed 1mg IV
1:28 pm Fentanyl 50 mcg IV
1:30 pm lidocaine 2% with Epinephrine 50ml SC -local anesthesia
1:31 pm Versed 1mg IV
1:32 pm lidocaine 2% with Epinephrine 50ml SC
1:46 pm Romazicon 0.4 mg -used for Versed overdose
1:46 pm Narcan 0.4mg/ml unknown amount -used for Fentanyl overdose
1:50 pm Code Blue-Patient 1 required immediate resuscitation from cardiac arrest

A review of the discharge summary, dictated 05/26/10, indicated, "date of death : 05/22/10 ... The patient was undergoing elective pacemaker implantation ...Code Blue was called overhead ...The patient was promptly intubated and resuscitated in the usual fashion requiring less than 10 minutes before return of spontaneous circulation. The procedure was completed and the patient was transferred to the Intensive Care Unit necessitating pressors, inotropes and invasive mechanical ventilation for support ...The patient ...had clinical seizures. EEG was performed and confirmed this ...I discussed with the family his ...probable prognosis. He [family member] told me the patient would not desire continued ...therapies ...the focus of care be switched to comfort measures only so that he may be allowed to die a natural death which he did shortly after extubation. "

According to Lexicomp Online, a nationally recognized medication information resource indicated the recommended dosages for the following medications:
*Versed for conscious sedation: 0.5-2 mg slow I.V. over at least 2 minutes; slowly titrate to effect by repeating doses every 2-3 minutes if needed; usual total dose: 2.5-5 mg.
*Fentanyl adjunct to regional anesthesia: Doses and dosage intervals should be titrated to pain relief/prevention. Monitor vital signs routinely. Slow I.V.: 25-100 mcg/dose over 1-2 minutes.
*Lidocaine anesthesia, local injectable: maximum: 4.5 mg/kg/dose not to exceed 300 mg; do not repeat within 2 hours.

A review of the clinical record for Patient 1's procedural summary in the entitled section, Medication Summary, indicated the total dosages of medications that were used throughout the artificial pacemaker procedure:
Versed 5mg
Fentanyl 100mcg
lidocaine 2000 mg

The Versed and Fentanyl doses were within recommended dosage ranges. The lidocaine dose was 6-7 times higher then the recommended maximum dose of 300mg.

According to Lexicomp Online indicated for Lidocaine toxicity, "morbidity and mortality is significant when it does occur. Signs and symptoms of [DIAGNOSES REDACTED]. "

According to the hospital policy, dated 08/17/10, titled, Management of Medications, indicated, "A medication error is defined as a preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is under the control of the health care professional or patient."

Document medical staff summary of "Investigation," furnished on 02/17/11 at 11:45 am, indicated, "Case again deemed as care not acceptable based on conscious sedation and lidocaine/epinephrine administration. It was the opinion of the anesthesiologists that this may have been a preventable death in that the patient likely received excessive medications overall."

According to the American Society of Health System Pharmacists, a nationally recognized professional organization, in the document entitled ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals indicates in the section Medication errors, "Pharmacists, with physicians and other appropriate hospital personnel, shall establish policies and procedures with respect to medication error prevention and reporting. Ongoing monitoring and review of medication errors with corresponding appropriate action should be maintained."

According to the California Code of Regulations under Health and Safety Code Section 1339.63 stipulated, "every general acute care hospital ...shall adopt a formal plan [aka Medication Error Reduction Plan] to eliminate or substantially reduce medication-related errors ...Each facility's plan shall ...identify weaknesses or deficiencies that could contribute to errors in the administration of medication ...Include a multidisciplinary process, including health care professionals responsible for pharmaceuticals, nursing, medical, and administration, 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."

During an interview on 02/16/11 at 11:27 am the Pharmacy Staff D stated that Pharmacy was primarily responsible for running the Med Error Program (aka Medication Error Reduction Plan). He also stated that the primary purpose of the Med Error Program was to reduce medication errors throughout the hospital.

In an interview on 02/16/11 at 2:40 pm the Pharmacy Staff D stated that the Med Error Program did not receive information from Risk Management until approximately 5 months after the Patient 1's medication error. He also stated that 9 months after the medication error the medication error had not been reviewed by the Med Error Program. There were no current plans to review Patient 1's medication error.

The hospital did not provide documentation of the Med Error Program minutes indicating that Patient 1's medication error was discussed.

A review of Patient 51's clinical record indicated Patient 51 had an artificial pacemaker procedure on 10/07/10. The procedural summary in the entitled section Medication Summary indicated that 800 mg of Lidocaine was used throughout the artificial pacemaker procedure. The dose was 2-3 times higher then the maximum recommended dose of 300 mg of Lidocaine.

For Patient 51 there were excessive doses of lidocaine being administered 4 ? months after Patient 1's medication error which resulted in lidocaine toxicity and death. The hospital Med Error Program had not reviewed and evaluated Patient 1's medication error and did not have a plan to reduce similar medication errors within the hospital.

2. According to the National Coordinating Council Medication Error Reporting website, a nationally recognized medication error reporting and information resource, medication errors are defined as, "Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

During an interview on 02/16/11 at 11:27 am Pharmacy Staff D stated the Med Error Program relied on the Risk Management department to report all medication related events. When he received the events the Med Error Committee (Medication Safety Committee) would review the events for medication errors, and then develop a plan to reduce medication errors in the hospital.

In an interview on 02/15/11 at 10:34 am, Administrative Staff R, from the QI/Risk Management Department, stated that hospital staff would report events and then she would triage all the medication related events to Pharmacy Staff D.

A review of a computerized event log indicated a list of reported events from hospital staff. The following events were reported on 08/01/10:
*Patient was Integrilin and Heparin drips (both blood thinners). Following this patient complained of headache, X-ray computer tomography scan (medical scan) of head showed intra-cerebral bleed (bleeding in brain). A short time later patient was declared dead.
*Pressure ulcer (skin breakdown)

A review of a computerized event log indicated a list of reported events from hospital staff. The following events were reported on 08/02/10:
*Patient Controlled Analgesia (PCA) flow sheet were found in the wrong chart
*Discharge orders were found in the wrong chart

During an interview on 02/17/11 at 10:24 am and 12:04 pm, Pharmacy Staff D stated the events reported on 08/01/10 and 08/02/10 were not reported to him or the Med Error Committee. He also stated Integrilin and Heparin could have been the cause for intra-cerebral bleeding, and that pressure ulcers could be caused by long term steroid use and could be medication related. He said that PCA flow sheet and discharge orders found in the wrong chart also could contribute to medication errors.

An interview on 02/15/11 at 10:34 am, Administrative Staff R stated that the events reported on 08/01/10 and 08/02/10 were not reported to Pharmacy Staff D and the Med Error Committee.

The hospital did not provide documentation that the Med Error program had received and reviewed the reported events on 08/01/10 and 08/02/10.

3. According to the Institute for Safe Medication Practices (ISMP), a nationally recognized medication safety resource, in the entitled document ISMP's List of High-Alert Medications indicates "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies like ...limiting access to high-alert medications ...standardizing the ordering, storage, preparation, and administration of these products ..." Heparin was listed as a High-Alert Medication.

According to the American Society of Health System Pharmacists (ASHP), a nationally recognized professional organization, in the entitled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals indicates " Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration (e.g., withdrawal of doses from multidose containers, labeling containers) by final users should be minimized. "

On 02/15/11 at 2:35 pm in the Interventional Radiology (IR) Department Heparin 1000 u/ml 30 ml bulk vials were being used for a scheduled procedure. There were several Heparin 30ml bulk vials in the cabinet.

During an interview on 02/15/11 at 2:35 pm, Registered Nurse U stated that on average a procedure will use about 10-12 ml of the Heparin 1000 u/ml (this would be 1 vial of Heparin 10ml with 1-2 ml of overfill). He acknowledged that a total 30ml bulk vial of Heparin would not be used during a procedure. He said that the Heparin 10ml vials would be enough.

In an interview on 02/16/11 at 9:20 am, the Pharmacy Staff D stated he was not aware that the 30ml bulk vials of Heparin was being stored in the IR cabinet as floor stock. He also stated that he found a total of 7 vials of the 30ml bulk heparin. He said that a box of 25 vials of 30ml Heparin were ordered and stored in the IR cabinet for a month. He also said that they should not have been order in the bulk vial 30ml but should have been ordered as 10ml vials. He acknowledged that bulk vials of Heparin would increase the potential for medication errors and removing the bulk vials would help prevent errors from occurring.

A review of the IR medication order form, dated 1/12/11, indicated that Heparin 1000u/ml 30 ml 1 box of 25 was ordered on [DATE].

Eighteen (18) bulk vials (calculated as 25 minus 7) of 30ml Heparin was used for over 1 month in the IR for procedures. If one 30ml vials was used, this would have been aproximately 3 times what was needed per procedure.

4. According to the American Society of Health System Pharmacists (ASHP), a nationally recognized professional organization, in the entitled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals indicated, "Floor stock. Floor stocks of medications generally shall be limited to medications for emergency use and routinely used safe items (e.g., mouthwash, antiseptic solutions). The potential for medication errors and adverse effects must be considered for every medication allowed as floor stock. "

According to the hospital policy, dated 08/17/10, titled, Management of Medications, indicated, "All therapeutic heparin products are stored separated and identified as separate stock with high-alert stickers. "

On 02/16/11 at 11:00 am in the IR Department, Heparin 1000 unit/ml 10ml vials stored as floor stock in a cabinet were observed. The Heparin vials were stored together with other medications in the cabinet. The Heparin vials were not stored separately from other medication.

In an interview on 02/16/11 at 11:27 am the Pharmacy Staff D stated he was not aware that heparin was stored with other medications in the IR cabinet as floor stock. He did not know why the heparin was stored in this way. He acknowledged the importance of separating Heparin from regular floor stock in order to help prevent medication errors.

5. According to the American Society of Health System Pharmacists (ASHP in the entitled document ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals indicated, "Medication orders. All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional. "

According to the hospital policy, titled, Management of Medications, indicated, "A pharmacist reviews each prescription or medication order again the medication profile of a patient (or other relevant information) prior to administration of the first dose. "

During an interview on 02/15/11 at 3:13 pm Administrative Staff V stated that he was the head of the emergency department (ED) and he was not aware that all medication orders must be reviewed by a pharmacist before the first dose except in emergency situations. He acknowledged that there were medications that were not being reviewed by a pharmacist.

In an interview 02/16/11 at 10:08 am, Registered Nurse K stated that 3/4 of the medications in the MedSelect were not used for emergency situations. The MedSelect is a medication dispensing machine that nurses would take medications out for patients without a pharmacist reviewing the medication orders. She also stated the majority of medications were not critical or urgently needed for patients in the ED.

A review of the MedSelect Inventory Summary indicated the total number of medications found in the MedSelect. There were approximately 250 different types of medications with an average quantity of 10 doses. In total there were approximately 2,500 doses of medications.

The hospital did not provide evidence that Pharmacists were reviewing the medication orders prior to the administration of non emergent medications in the ED.