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Based on observation, interview and record review, the Governing Body failed to be responsible for the institutional conduct of the hospital as evidenced by:

1. The hospital administration did not take responsibility for the safe and effective operation of the dietary service. Cross Reference A-0057.

2. The hospital's QAPI program failed to identify two high risk and potentially problem prone drugs, droperidol and IV insulin, as priorities for inclusion in the hospital's QAPI program. Cross Reference A-0266

3. The Governing Body did not ensure the quality of services provided by the Medical Staff and failed to prevent physicians' use of droperidol in unauthorized areas and on inappropriate patients; did not ensure physicians performed required evaluations of patients who receiving anesthetic agents; did not ensure a physician formulated complete medication orders for a powerful intravenous sedative; and did not ensure physicians followed hospital policies regarding radiation safety monitoring. Cross Reference A-0338.

4. The Governing Body did not ensure that the nutritional needs of all patients were met, and did not ensure safe food handling, production and storage, and did not ensure that complete diet manuals were available to dietary staff at both campuses. Cross Reference A-0618 and A-0749 #1.

5. The Governing Body did not ensure the protection and promotion of the patients' rights to care in a safe environment that minimized the use of seclusion and restraints. Cross Reference A-0115.

6. The Govening Body did not ensure the privacy and integrity of the medical records; the medical record service was not unified under the direction of an individual or group who provided oversight of all of the components of the medical record; did not ensure that the quality of the open medical record was verified, and did not ensure the content of the medical record described the patients' responses to treatment and progress. Cross Reference A-0432, A-0441, and A-0449.

7. The Governing Body did not ensure the quality of services provided by the contracted dialysis services provider. Cross Reference to A-0083.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on staff interview and administrative document review, the governing body failed to ensure the Chief Executive Officer:

1. Took responsibility for the safe and effective operation of the dietary service. Cross Reference A-0057.

2.Ensured the QAPI program identified two high risk and potentially problem prone drugs, droperidol and IV insulin, as priorities for inclusion in the hospital's QAPI program. Cross Reference A-0266

3. Ensured the nutritional needs of all patients were met, and ensured safe food handling, production and storage, and complete diet manuals were available to dietary staff at both campuses. Cross Reference A-0618 and A-0749 #1.

4. Ensured the protection and promotion of the patients' rights to care in a safe environment that minimized the use of seclusion and restraints. Cross Reference A-0115.

5. Ensured the privacy and integrity of the medical records; ensured the medical record service was unified under the direction of an individual or group who provided oversight of all of the components of the medical record; ensured the quality of the open medical record was verified, and ensured the content of the medical record described the patients' responses to treatment and progress. Cross Reference A-0432, A-0441, and A-0449.

These failures placed patients at risk of food borne illness and compromised patient care.

Findings:

In an interview with the hospital administration represented by the VP (Vice President) of Operations on 6/21/12 at 1315 hours, the VP stated he agreed there were serious and substantial issues regarding the Food and Dietetic Services. The VP of Operations stated he was unaware the organizational structure of the department did not include the registered dietitian providing guidance to the Department Director. The VP of Operations stated he was the individual in administration who was responsible for the Food and Dietetic Department.

The hospital failed to ensure the contracted dialysis service for the Mission Viejo Campus provided service and bacterial testing information of the dialysis fluids used during treatments in two of the four machines used for dialysis in the hospital. This resulted in the potential for bacteria to be present in the machines which could enter the patient's bloodstream during a treatment.

Findings:

The hospital's dialysis service was supplied by a contracted vendor. During a review of the required vendor paperwork, no information was found from the vendor for May, 2012, regarding the service performed on the machines and the bacterial testing of the machines.

On 6/21/12 at 1340 hours, the Surveyor and the Biomedical Manager compared the serial numbers on the four dialysis machines available for patient use to the paperwork supplied by the contracted vendor. Review of the paperwork showed there were no bacterial cultures available for two of the four machines in use. The bacterial cultures were required on a monthly basis to ensure safe patient care.

Based on observation interview, and document review the hospital failed to protect and promote the rights of each patient as evidenced by:

1. Patients reviewed in restraint and seclusion did not receive increased monitoring for the potential risks and adverse responses to the physical restraints and the restraints were not reduced or removed when the unsafe situation ended. Cross Reference A-0154.

2. The hospital's Infection Prevention Coordinator failed to develop an effective system for identifying unsafe food handling practices that involved cool down of potentially hazardous foods, and for identifying that the preventative maintenance system for the ice-machine's lacked a sanitizing component in accordance with manufacturer's guidelines. Cross Reference A-0749 #1b.

3. The confidentiality of the medical record was not ensured for the 15 patients and their infants on the Mother Baby Unit when the paper medical records of the patients were stored in unlocked cabinets in the hallway outside of the patient rooms. Cross Reference A-0441.

The cumulative effect of these systematic practices resulted in the hospital's inability to provide quality health care in a safe environment.

Based on interview and medical record review the hospital failed to ensure the informed consent form was completed per the hospital's P&P for three of the 30 patients reviewed (Patients 2, 3, and 54). For Patient 54 there was no documentation of a witness to the patient's signature for a procedure. For Patient 2 the signature of the witness to the patient's signature was illegible and no title was documented for the signature. For Patients 2 and 3, the consent forms showed the yellow copies intended for the patients were attached to the forms and had not been given to the patients. This could potentially result in patients' not being fully informed of their right to effect their healthcare decision.

Findings:

The hospital's P&P to address Informed Consents dated 7/11, showed the witness to the patient's consent was to sign the consent form and should be an RN. The original form was to be placed in the patient's chart and a copy given to the patient.

1. On 6/21/12 at 1200 hours, a tour of the endoscopy procedure area was conducted. A randomly selected medical record, Patient 54's, was reviewed.

A document titled: Authorization For And Consent to Endoscopy OR Procedures, showed Patient 54 had signed the consent for endoscopy, however, absent on the informed consent was a signature by a RN to serve as a witness to the consent provided by Patient 54.


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2. The medical record for Patient 2 was reviewed on 6/18/12 at 1030 hours, with RN A. Review of the consent form to allow a blood transfusion showed the yellow copy of the consent was to be removed and given to the patient. Review of Patient 2's consent form dated 6/1/12, showed the yellow copies were still attached. The signature of the witness to the patient's signature was illegible and no title was documented for the signature. When asked, RN A was unable to state the name or title of the witness.

3. The medical record for Patient 3 was reviewed on 6/18/12 at 1105 hours, with RN B. Two consent forms dated 6/12/12, were observed in the patient's medical record for separate procedures. The consent forms showed the yellow copies intended for the patient were attached to the forms and had not been given to the patient.

2. The hospital's Infection Prevention Coordinator failed to develop an effective system for identifying unsafe food handling practices that involved cool down of potentially hazardous foods, and for identifying that the preventative maintenance system for the ice-machine's lacked a sanitizing component in accordance with manufacturer's guidelines. Failure to sanitize ice-machines' could potentially place patients at risk of an infection. Cross Reference A-0749.



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Based on observation, interview and record review, the hospital failed to ensure patient care was provided in a safe environment as evidenced by:

1. Review of the medical records for five of the five patients reviewed (Patients 7. 46, 51, 52, and 53) who had been in restraint and seclusion (R&S) during their hospitalization showed documentation the patients were sedated with medications after the restraints were applied. There was no intensification of monitoring for potential risks and adverse response to physical restraints. There was no documentation to show their restraints were reduced or discontinued at the earliest possible time. This could potentially result in unnecessary patient restraint.

2. The hospital's failure to develop an effective system for identifying unsafe food handling practices that involved cool down of potentially hazardous foods and for identifying the preventative maintenance system for the ice-machine's lacked a sanitizing component in accordance with manufacturer's guidelines. These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

3. A staff member did not followed the hospital's P&P for hand hygiene during patient care resulting in the potential for the spread of infection.

Findings:

1. The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period.

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the medical record for Patients 7, 46, 51, 52, and 53 did not show evidence that once the unsafe situation ended, the use of restraint and seclusion was reduced or discontinued. There was no documented evidence to show attempts at restraint reduction were employed while the patients were documented to be quiet or sleeping. There was no consistent monitoring of the patients' food or fluid intake while in restraints. There was no documented justification for the continuation of R&S once the patient was observed to be quiet or sleeping. Cross Reference A-0154 and A-0174


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3. On 6/20/12, at 1015 hours, RN BB attempted to give Patient 29 her morning medications. RN BB was observed at a computer terminal at the nursing station. The RN left the computer terminal and obtained the medications from the cassette before proceeding to enter the patient's room. RN BB failed to perform any hand hygeine prior to passing the medications to the patient. At the completion of the medication pass, RN BB washed her hands. RN BB acknowledged she failed to wash her hands prior to passing medications to Patient 29.

Based on observation, interview and document review, the hospital failed to ensure the confidentiality of the medical record for the 15 patients and their infants on the Mother Baby Unit when the paper medical records of the patients were stored in unlocked cabinets in the hallway outside of the patient rooms. This resulted in the potential for unauthorized access to the patients' confidential information.

Findings:

The hospital's P&P for Information Physical Security dated 1/21/11, showed media, (such as hard copies) that contained a patient's confidential information should be secured in a locked desk, cabinet or room.

The Mother Baby Unit was toured on 6/18/12 at 1500 hours, with the unit's Nurse Manager.

Cabinets that lowered to form a writing table were observed at the entrance of each patient room. Outside a patient room the cabinet was open and two chart binders were observed lying on the table. No staff was observed in the area. The Nurse Manager stated although the patient's records were mostly electronic, paper documents, which might include the physician's history and physical, telephone orders from the physician, lab reports, and consents for procedures, were kept in chart backs for the mother and the baby. The Nurse Manager stated however, the cabinets should not be left open and the charts unattended.

Observation of the next room showed the cabinet was in the closed position but was unlocked. The Nurse Manager stated she was unaware of the need to keep each cabinet locked.

The Director of Health Information Services was interviewed on 6/19/12 at 1030 hours. When asked about the storage of the paper medical records in unlocked cabinets on the Mother Baby Unit, the Director stated any piece of the medical record, if left unattended, should be secured in a locked area.

Based on observation, interview and record review, the hospital failed to provide safe care for five of five patients who had been in restraint and seclusion (R&S) during their hospitalization (Patients 7, 46, 51, 52, and 53). All five patients were placed in physical R&S on the Behavioral Health Medicine Unit (BHU). The patients were restrained in the prone (Face Down) position with restraints applied to each limb and torso limiting free movement. Each patient was sedated with medications after the restraints were applied. There was no documentation of increased monitoring for the potential risks and adverse responses to the physical restraints. There was no documentation the patients received consistent monitoring of their intake of fluids while in restraints. All five patients showed the application of physical restraints was initiated as a result of an immediate threat to staff or patient's safety; however, there was no evidence that once the unsafe situation ended, the use of restraint and seclusion was discontinued. There was no evidence attempts at restraint reduction were initiated when the patient was documented to be quiet or sleeping. There was no documented justification for the continuation of the R&S once the patient was observed to be quiet or sleeping. These failures have the potential for causing physical injury during this period of immobilization and violate the patient's rights.

Findings:

The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the hospital's P&P titled: Seclusion and Restraint-BHM-2011DEC-3,11, showed it was the hospital's philosophy to promote the use of preventative strategies and the use of safe and effective alternatives to restraints and seclusion; to deter the actual use of restraints whenever possible; and to utilize the least restrictive measures. Preservation of a patient's rights, dignity and well-being will be maintained at all times.

The P&P showed the hospital endorses least restrictive measures whenever possible. The P&P showed the psychiatric program will use physical restraints only in extreme cases to protect the patient from injury to self and others. Patients will be restrained in five-point restraint and alternate removing opposite hand/leg until patient does not require restraining. Appropriate attention shall be paid every 15 minutes to a patient in R&S, especially in regard to use of the toilet, regular meals and bathing. A face to face (in person clinical evaluation) assessment for physical and psychological status of the patient will be done within one hour of restraint application. The face to face encounter would be used to determine the need to continue restraints.

On 6/18/12 at 1300 hours, an inspection of the Behavioral Health Unit was conducted.

1. Patient 7 was observed during the inspection in five point (each limb and torso) restraints in the prone position.

Medical record review for Patient 7 began on 6/18/12 at 1400 hours. Patient 7 was placed in R&S on 6/10/12 at 2055 hours, for agitated behavior and threatening staff.

Physician's orders dated 6/10/12 at 2055 hours, showed Patient 7 was to be administered Haldol 10 mg IM (intramuscular injection), Benadryl 50 mg IM, and Ativan 2 mg IM. The Drug Information Handbook for Nursing 2007, pages 375, 603, 753, showed the combination of drugs i.e. Haldol, Ativan and Benadryl are administered for their rapid tranquilizing effect on severely-agitated patients.

Documentation on the Seclusion/Restraint flow sheet dated 6/10/12, showed Patient 7 was asleep from 2215 hours to 2400 hours. There was no documentation to show restraint reduction was attempted during this time frame.

Documentation on the Seclusion/Restraint flow sheet showed Patient 7 was again placed in R&S on 6/17/12, at 2100 hours, for yelling, hitting the front door and being paranoid. Physician's orders dated 6/18/12 at 0950 hours, showed Patient 7 was to be administered Haldol 10 mg IM, Benadryl 50 mg IM, and Ativan 2 mg IM.

Documentation on the seclusion/restraint flow sheet showed Patient 7 was sleeping while in restraints on 6/18/12 at 0400 hours, 1245 hours, and 1300 hours to 1500 hours, with no attempt at restraint reduction during these times. Absent was documentation of Patient 7's clinical response to R&S and justification for continuation. Additionally, there was no documentation of the amount of fluids offered or consumed by Patient 7 while he was in restraints. Patient 7 was in restraint and seclusion for a total of 19 1/2 hours.

2. On 6/18/12 at 1430 hours, a medical record review was conducted for Patient 46. Patient 46 was admitted on a legal hold for danger to self, others and gravely disabled. Patient 46 attempted to strike out at staff and was placed in R&S on 6/4/12 at 1545 hours. Patient 46 was provided emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM. There was no vital sign documentation after administration of the medications

Documentation on the R&S Flow sheet showed Patient 46 was sleeping from 1630 hours to 1700 hours, 1730 to 1800 hours, and 1845 hours to 2000 hours. There was no documented evidence Patient 46 had restraint reduction attempted from 1545 hours to 2100 hours. Absent was documentation of Patient 46's clinical response to R&S and justification for continuation.

3. On 6/18/12 at 1445 hours, a medical record review was conducted for Patient 51. Patient 51 was placed in R&S on 6/14/12 at 1800 hours, for throwing himself against a door.

Documentation showed Patient 51 was in R&S from 1800 hours to 2000 hours, and was asleep from 1830 hours to 1900 hours. There was no documented evidence restraint reduction was attempted during that time. Absent was documentation of Patient 51's clinical response to R&S and justification for continuation.

4. On 6/18/12 at 1500 hours, a medical record review was conducted for Patient 52. Patient 52 was placed in R&S on 6/16/12 at 1535 hours. Documentation dated 6/16/12 at 1645 hours, and at 1730 to 1800 hours, showed Patient 52 was asleep while in R&S. Absent was documentation of Patient 52's clinical response to R&S and justification for continuation.

5. On 6/18/12 at 1515 hours, a medical record review was conducted for Patient 53. Patient 53 was admitted on 6/10/12 at 1630 hours, directly into R&S from the gurney after being transferred from another hospital. Documentation on the legal hold showed Patient 53 was labile, tearful, and unable to follow staff's instruction.

Documentation showed on 6/10/12 at 1645 hours, Patient 53 was administered emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM.

Documentation showed on the Seclusion/Restraint Flow Sheet dated 5/10/12, showed Patient 53 was sleeping from 1700 hours to 2000 hours. Restraints were removed at 2000 hours. There was no evidence of restraint reduction attempts from 1700 hours to 2000 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

Documentation showed on 6/11/12 at 2345 hours, Patient 53 was placed in R&S when she became assaultive towards staff and unable to follow staff's instructions.

Documentation showed tranquilizing medication was administered at 2400 hours, and Patient 53 was documented as being asleep from 2400 hours to 0330 hours. Restraints were removed at 0330 hours. There was no evidence of restraint reduction attempts on 6/11/12, from 2400 hours to 0330 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

On 6/18/12 at 1000 hours, an interview was conducted with RN Z. RN Z was asked how Patient 7 was assessed for restraint reduction. The RN stated Patient 7 was uncooperative and threatening. RN Z was asked about offering of fluids, intake and output, and other assessment requirements for patients in R&S. RN Z stated a Patient Care Technician (PCT) was assigned to observe and monitor Patient 7.

On 6/18/12 at 1500 hours, an interview with staff member PCT 3 was conducted. PCT 3 was asked about the flow sheet he was using to document Patient 7's behaviors and responses while in restraints. PCT 3 explained the check marks on the form showed an activity or interaction that had occurred, or an observation of Patient 7. Under the section fluids/foods, a check mark meant fluids were offered. When asked about the fluid volumes Patient 7 had consumed, the PCT stated he did not document fluid intake volumes.

On 6/18/12 at 1530 hours, an interview was conducted with the Nurse Manager of the Behavioral Medicine Unit. The Nurse Manager was asked about the RNs responsibility for patients placed in R&S. The Nurse Manager stated the RN may activate R&S when a crisis occurred and then call the physician for a R&S order. The Nurse Manager stated RN's were trained to perform the initial face to face evaluation and assessment within an hour upon application of R&S. The Nurse Manager stated RN's documented a unit narrative note on a patient in R&S every eight hours at the end of the shift. The Nurse Manager stated fluid volumes (intake and outputs) were checked, but the volume of fluid was not measured or recorded. The Nurse Manager stated she was not aware of the requirement for R&S to be discontinued as soon as the unsafe situation no longer existed.

Based on observation, interview and record review, the hospital failed to provide safe care for five of five patients who had been in restraint and seclusion (R&S) during their hospitalization (Patients 7, 46, 51, 52, and 53). All five patients were placed in physical R&S on the Behavioral Health Unit (BHU) and each patient was restrained in the prone position (positioned on the abdomen face down). All five patients were physically restrained as a result of an immediate threat to staff or the patient's safety; however, there was no evidence that once the unsafe situation ended, the use of restraint and seclusion was discontinued. There was no documented evidence to show attempts at restraint reduction or discontinuation when the patients were documented as quiet or sleeping. These failures have the potential for causing physical injury during this period of immobilization and violate the patient's rights for unnecessary restraints.


Findings:

The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the hospital's P&P titled: Seclusion and Restraint-BHM-2011DEC-3,11, showed it was the hospital's philosophy to promote the use of preventative strategies and the use of safe and effective alternatives to restraints and seclusion; to deter the actual use of restraints whenever possible; and to utilize the least restrictive measures. Preservation of a patient's rights, dignity and well-being will be maintained at all times.

The P&P showed the hospital endorses least restrictive measures whenever possible. The P&P showed the psychiatric program will use physical restraints only in extreme cases to protect the patient from injury to self and others. Patients will be restrained in five-point restraint and alternate removing opposite hand/leg until patient does not require restraining. Appropriate attention shall be paid every 15 minutes to a patient in R&S, especially in regard to use of the toilet, regular meals and bathing. A face to face (in person clinical evaluation) assessment for physical and psychological status of the patient will be done within one hour of restraint application. The face to face encounter would be used to determine the need to continue restraints.

On 6/18/12 at 1300 hours, an inspection of the Behavioral Health Unit was conducted.

1. Patient 7 was observed during the inspection in five point (each limb and torso) restraints in the prone position.

Medical record review for Patient 7 began on 6/18/12 at 1400 hours. Patient 7 was placed in R&S on 6/10/12 at 2055 hours, for agitated behavior and threatening staff. Physician's orders dated 6/10/12 at 2055 hours, showed Patient 7 was to be administered Haldol 10 mg IM (intramuscular injection), Benadryl 50 mg IM, and Ativan 2 mg IM. The Drug Information Handbook for Nursing 2007, pages 375, 603, 753, showed the combination of drugs i.e. Haldol, Ativan and Benadryl are administered for their rapid tranquilizing effect on severely-agitated patients.

Documentation on the Seclusion/Restraint flow sheet dated 6/10/12 showed Patient 7 was asleep from 2215 hours to 2400 hours. There was no documentation to show restraint reduction was attempted during this time frame.

Documentation on the Seclusion/Restraint flow sheet showed Patient 7 was again placed in R&S on 6/17/12, at 2100 hours, for yelling, hitting the front door and being paranoid. Physician's orders dated 6/18/12 at 0950 hours, showed Patient 7 was to be administered Haldol 10 mg IM, Benadryl 50 mg IM, and Ativan 2 mg IM.

Documentation on the seclusion/restraint flow sheet showed Patient 7 was sleeping while in restraints on 6/18/12 at 0400 hours, 1245 hours, and 1300 hours to 1500 hours, with no attempt at restraint reduction during these times. Absent was documentation of Patient 7's clinical response to R&S and justification for continuation. Patient 7 was in restraint and seclusion for a total of 19 1/2 hours.

2. On 6/18/12 at 1430 hours, a medical record review was conducted for Patient 46. Patient 46 was admitted on a legal hold for danger to self, others and gravely disabled. Patient 46 attempted to strike out at staff and was placed in R&S on 6/4/12 at 1545 hours.

Patient 46 was provided emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM. Documentation showed on the R&S Flow sheet showed Patient 46 was sleeping from 1630 hours to 1700 hours, 1730 to 1800 hours, and 1845 hours to 2000 hours. There was no documented evidence Patient 46 had restraint reduction attempted from 1545 hours to 2100 hours. Absent was documentation of Patient 46's clinical response to R&S and justification for continuation.

3. On 6/18/12 at 1445 hours, a medical record review was conducted for Patient 51. Patient 51 was placed in R&S on 6/14/12 at 1800 hours, for throwing himself against a door. Documentation showed Patient 51 was in R&S from 1800 hours to 2000 hours, and was asleep from 1830 hours to 1900 hours. There was no documented evidence restraint reduction was applied during that time. Absent was documentation of Patient 51's clinical response to R&S and justification for continuation.

4. On 6/18/12 at 1500 hours, a medical record review was conducted for Patient 52. Patient 52 was placed in R&S on 6/16/12 at 1535 hours. Documentation dated 6/16/12 at 1645 hours, and at 1730 to 1800 hours, showed Patient 52 was asleep while in R&S. Absent was documentation of Patient 52's clinical response to R&S and justification for continuation.

5. On 6/18/12 at 1515 hours, a medical record review was conducted for Patient 53. Patient 53 was admitted on 6/10/12 at 1630 hours, directly into R&S from the gurney after being transferred from another hospital. Documentation on the legal hold showed Patient 53 was labile, tearful, and unable to follow staff's instruction.

Documentation showed on 6/10/12 at 1645 hours, Patient 53 was administered emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM.

Documentation showed on the Seclusion/Restraint Flow Sheet dated 5/10/12, showed Patient 53 was sleeping from 1700 hours to 2000 hours. Restraints were removed at 2000 hours. There was no evidence of restraint reduction attempts from 1700 hours to 2000 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

Documentation showed on 6/11/12 at 2345 hours, Patient 53 was placed in R&S when she became assaultive towards staff and unable to follow staff's instructions. Documentation showed tranquilizing medication was administered at 2400 hours, and Patient 53 was documented to being asleep from 2400 hours to 0330 hours. Restraints were removed at 0330 hours. There was no evidence of restraint reduction attempts on 6/11/12, from 2400 hours to 0330 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

On 6/18/12 at 1000 hours, an interview was conducted with RN Z. RN Z was asked how Patient 7 was assessed for restraint reduction. The RN stated Patient 7 was uncooperative and threatening. RN Z was asked about offering of fluids, intake and output, and other assessment requirements for patients in R&S. RN Z stated a Patient Care Technician (PCT) was assigned to observe and monitor Patient 7. RN Z stated she makes her patient notes based on the assessments performed by the PCT assigned to watch the patient.

On 6/18/12 at 1500 hours, an interview with staff member PCT 3 was conducted. PCT 3 was asked about the Seclusion/Restraint flow sheet he was using to document Patient 7's behaviors and responses while in restraints. PCT 3 explained the check marks on the form showed an activity or interaction had occurred, or an observation was made of Patient 7. A section on the flow sheet titled: OBSERVATION showed a box was to be checked if the patient demonstrated psychotic behavior. When asked, PCT 3 was unable to verbalize a definition of psychotic behavior.

On 6/18/12 at 1530 hours, an interview was conducted with the Nurse Manager of the Behavioral Medicine Unit. The Nurse Manager was asked about the RNs responsibility for patients placed in R&S. The Nurse Manager stated the RN may activate R&S when a crisis occurred and then call the physician for a R&S order. The Nurse Manager stated RN's were trained to perform the initial face to face evaluation and assessment within an hour upon application of R&S. The Nurse Manager stated RN's documented a unit narrative note on a patient in R&S every 8 hours at the end of the shift. The Nurse Manager stated she was not aware of the requirement for R&S to be discontinued as soon as the unsafe situation no longer existed.

Based on interview, medical record review and review of P&P, the hospital failed to ensure the QAPI program involved all hospital departments and services and focused on indicators related to improve health outcomes and the prevention and reduction of medical errors.

Findings:

1. The QAPI program in the hospital failed to have an effective program to identify two high risk and potentially problem prone drugs, droperidol and IV insulin, as priorities for inclusion in the hospital's QAPI program. Cross Reference A-0500 #1.

2. The hospital's Governing Body failed to ensure sufficient Pharmacist personnel to properly review medication orders, monitor the use of medications, and control drug distribution, and to identify, analyze and correct medication errors to improve patient safety. Cross Reference A-0493.

3. The QAPI program failed to have an ongoing program to address the complexity and scope of Nutrition Care Services which resulted in failure to identify issues in safe food handling practices, food storage and sanitation. Cross Reference A-0620, A-0749 #1a.

4. The QAPI program failed to address the lack of organization and oversight of the dietary department. Cross Reference A-0619.

5 . The QAPI program failed to ensure patient nutritional needs were met. Cross Reference A-0395, A-0467, A-0621, and A-0631.

6. The QAPI program did not have a system in place to measure, analyze and track the quality of medical record documentation processes in the open and closed medial record. Cross Reference to A-0353, A-0457, A-0952, and A-1005.

7. The QAPI program did not ensure the patient's right for freedom from unnecessary restraint. Cross Reference A-0154 and A-0174

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on record review and staff interview, the hospital's Collaborative Practice Council failed to provide an ongoing monitoring and evaluation of the newly implemented IV Insulin protocol in the ICU. This failure placed patients receiving an IV insulin drip at risk of harm or death due to unclear directions of the IV insulin protocol.

Findings:

On 6/20/12, review of the hospital's Collaborative Practice Council's P&P showed the council involved Pharmacy, Nursing and Medical Staff. Pharmacy provided the leadership and was responsible for all medications throughout the hospital.

Per review of the Nursing Performance Improvement Plan, the primary goal was the ongoing improvement of the delivery, quality, efficiency and outcome of patient care and services. The goal would be accomplished through systematic examination of information provided through ongoing monitoring, evaluation and improvement activities. All of these performance activities would be done in accordance with standards of professional health care practices, regulatory and licensing agencies at same time supporting the overall mission and strategic plans of the hospital.

The Nursing Review process of the performance improvement plan was described as setting improvement aims that would be measurable within the patient population. Measures would be established to determine if a specific change actually led to an improvement. The organization would therefore identify changes that would most likely result in improvement. The testing of the changes was then diagrammed into the acronym of PDSA - plan, do, study, act. The change should be planned, then tried, the results observed, and then action taken on what was learned; however, the process which the hospital used for action-oriented learning was not evident when the IV insulin protocol was changed in ICU.

Review of three patient records (Patients 21, 22, and 28) in the ICU revealed there were two different IV insulin protocols in use. Random interviews among the ICU staff on how to follow the directions provided by the protocols revealed conflicting results.

Per interview with RNP 2 and the CICU Clinical Specialist on 6/20/12 at 1118 hours, the old insulin protocol form, dated 3/18/10, was changed approximately on 11/11. The new protocol was approved by different committees on 12/11 before it was implemented on 1/12. The training of the nurses occurred approximately during 11/11, but RNP 2 and the Clinical Specialist stated they did not document the training. When asked if the effectiveness of the new insulin protocol had been reviewed, RNP 2 stated "pitfalls were noted following the new IV insulin protocol, warranting one to one teaching among the nursing staff on one or two occasions." When asked if the insulin protocol changes were monitored by Pharmacy or Nursing, RNP 2 and the Clinical Specialist stated they were unaware of any monitoring that existed.

Further interview of the Pharmacy Clinical Manager on 6/20/12 at 1400 hours, revealed old insulin protocol forms, dated 3/2010, remained in physicians' offices and were being faxed to the Pharmacy department with patient's orders. The old protocol was not identified by other pharmacists as an outdated insulin protocol.

On 6/20/12 at 1627 hours, hospital administration was notified of the surveyor team's concerns regarding the health and safety of ICU patients receiving IV insulin. The team discussed the implementation of a protocol change with no documented inservice training of nursing, the lack of ongoing monitoring on the effectiveness of the protocol, and the lack of action taken despite identification of the insulin protocol flaws.

By 6/21/12 at 1100 hours, the team met with the Collaborative Council to discuss their corrective action plan on the IV insulin drip for ICU realizing the immediacy of the concern.

Based on medical record reviews and interviews, the hospital failed to ensure the QAPI program in the hospital included a program to identify and reduce medical errors the use of two high-risk medications, droperidol and IV insulin which can cause serious harm to patients. The hospital placed patients in an unsafe environment by not identifying the improper administration of these two drugs.

Findings:

1. The hospital failed to ensure the use of the medication droperidol was monitored to ensure use of the medication was appropriate per the hospital's P&P and the FDA guidelines. (Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates that droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.)

Improper use of droperidol was identified for six of the seven patients (Patients 37, 38, 39, 40, 41 and 42) reviewed with orders for the medication. There was no ongoing program of monitoring by the hospital of the use of droperidol.

Droperidol was identified as being administered improperly during a State survey conducted on 3/24/10. The Plan of Correction (POC) from the hospital showed the hospital would remove droperidol from the hospital's formulary and the drug would not be available for use.

Despite the hospital's POC to make droperidol unavailable for use, a hospital P&P/protocol dated March 2012, identified that droperidol would be permitted to be used within certain parameters; however, review of the medical records for Patients 37, 38, 39, 40, 41 and 42 on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3 showed physicians continued to administer droperidol improperly outside the protocol parameters.

At the conclusion of the record review, RNP 1, RPH 2 and RPH 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42. RPH 3 stated droperidol was not supposed to be available in the L&D OR. When asked, RPH 3 confirmed Pharmaceutical Services had not monitored the use of droperidol when the drug was again made available for use. There was no documented evidence to show the use of droperidol had been identified and included in the QAPI program to reduce medical errors.

During a meeting with hospital administration on 6/21/12 starting at 1800 hours, MD E stated anesthesiologists in the OR had wanted droperidol available for use. The Medical Staff had not doubted the anesthesiologists would use the drug within the parameters of the protocol developed in March 2012. At that time the Medical Staff persuaded the hospital to make droperidol available within the parameters of the protocol; however, the drug was not to be available or used in the L&D OR. As was discovered, not only was the drug in the L&D OR, but contrary to hospital policy, anesthesiologists administered the drug without identifying the patient's QT interval. Cross Reference A-0500 #1.

2. The hospital failed to ensure errors in the use of intravenous (IV) insulin for patients in the critical care units were identified and further monitoring was conducted to reduce medication errors. (Insulin is a high-alert medication which lowers blood sugar (BS). Improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.

Insulin medication errors were identified for three of the three patients reviewed with orders for IV insulin using the Intensive Insulin Drip Order form on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours (Patients 21, 22, and 54). RPH 3 stated the Pharmacists did not monitor the administration of intravenous insulin.

At a meeting with RNP 2 and RN T on 6/20/12 starting at 1120 hours, they stated they had found instances of high BS in cardiac surgery patient on IV insulin and had reviewed the insulin administration for those patients. In each case it was noted the RN had not administered the IV insulin per the guidelines of the IIDO. RNP 2 and RN T stated they had counseled these nurses on a one on one basis. However, there was no documentation to show such training had occurred. Moreover, RNP 2 and RN T stated they did not know if the insulin errors were more widespread. They were unable to state their findings had been shared with the Pharmacy staff. There was no evidence provided to show anyone in the hospital was aware of the intravenous insulin administration errors. Cross Reference A-0500 #2.

The Director was asked the procedure for the authentication of physician's telephone or verbal orders. The Director explained when a physician was in the hospital he/she entered a patient's orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign queue (an electronic system) to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.


26881


Based on interview and record review, the hospital failed to ensure the quality assurance program to measure, analyze and track the quality of medical record documentation processes in the open record as evidenced by:

1. Errors were found in the open medical records for two of three open recovery room records reviewed (Patients 10 and 59) which contained inaccurate post anesthesia assessments. Cross Reference to A 1005.

2. One of three open recovery room records contained a history and physical which had not been authenticated and there was no update to the history and physical on the day of surgery. (Patient 10). Cross Reference to A 0952.

3. Two of two open records reviewed of patients receiving Propofol (a powerful intravenous sedative) had incomplete medication orders (Patients 20 and 54). Cross Refence to A 0353.

4. Verbal and/or telephone physician's orders for patient care were not authenticated by a physician's signature as correct within 48 hours for three patients (Patients 25, 48,49). Cross Reference to A 0457.

These failures created the risk of substandard medical records and substandard healthcare for all patients using the hospital.

Findings:

The hospital policy, Plan for Improving Organization Performance (revised 9/2011), read in part, "Department Directors and Managers are responsible for quality care/service within their scope and include, but are not limited to: ongoing quality control activities and monitoring of trends within the area of service, as appropriate. Trends are further measured and assessed resulting in identification of opportunities for improvement within the department and in conjunction with other departments."

During an interview with the Director of Health Information Services on 6/19/12 at 1045 hours, she stated the medical records staff examined the closed records after the patient was discharged, but not open records. The Director stated she had oversight over the Medi-Tech portion of the electronic record, but not other portions of the medical record. The Director stated portions of the medical record were completed in other departments, and those departments were to provide oversight of the accuracy and completeness of those portions of the medical record, including labor and delivery, the operating room record, the cardiac catheterization laboratory, and cardiology.

The Director stated she had received no feedback from those departments regarding difficulties with completing their portions of the medical records. The Director stated members of the Quality department reviewed the closed medical record, but did not examine the open medical record.

Based on administrative and dietary staff and dietary department document review, the hospital failed to have an ongoing QAPI program that addressed the complexity and scope of Nutrition Care Services which resulted in failure to identify issues in safe food handling practices and food storage and sanitation, all of which could result in food borne illness.

Findings:

During the survey of the hospital, from 6/18 - 6/21/12, deficient practices were observed related to:

1. Safe and sanitary food services operation. Cross Reference A-0620 and A-0749 #1 and #2.

2. Lack of organization and oversight of the dietary department. Cross Reference A-0619.

3. Ensuring patient nutritional needs were met. Cross Reference A-0395, A- 0467, A-0621, and A-0631.

The Nutrition Care Department covered food service and patient nutrition care on both the Mission Viejo and Laguna Beach Campuses with a total licensed patient beds of 552, with meals and patient care in the behavioral unit, chemical dependency and medical areas.

In an interview on 6/21/12 at 1100 hours, the the Director of Quality Outcome stated the review of the Nutrition Care Services Department's quality program as reported to the Quality Committee was the same quality program that had been developed and reported quarterly for the past six years. The Director of Quality Outcome acknowledged the quality program for the Nutrition Care Department for both the Mission Viejo and Laguna Beach Campuses, was not working well. The Director stated the hospital's quality improvement program had focused on patient care and not on the dietary or food service aspects of the Nutrition Care Department. The Director confirmed the Nutrition Care Services activities at this time did not show opportunities for improvement, rather were primarily monitoring activities.

An interview with the FSD on 6/21/11 at 0905 hours, and concurrent review of performance indicators for 2011, revealed the dietary department was submitting data on multiple processes (including kitchen refrigerators, patient refrigerators, food temperatures, dishroom temperatures, and sanitation check lists) within the department. The FSD acknowledged all of the indicators of the department were meeting departmental set thresholds at mostly 100 percent. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of safe food handling systems within the department including staff practices of handwashing and maintaining clean environment.
In addition, other nutrition related areas such as patient weight monitoring and nutrition care on the chemical dependency and behavioral health units did not have any quality improvement performance improvement programs.

Based on interviews and document reviews, the hospital failed to identify two high risk and potentially problem prone drugs, droperidol and IV insulin, as priorities for inclusion in the hospital's QAPI program. The improper administration of these high risk drugs had the potential to result in serious adverse events for patients.

Findings:

1. The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads: "Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic-used to treat N&V.) A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, droperidol should NOT be given."

The medical records for Patients 37, 38, 39, 40, 41 and 42 were reviewed on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3. Patient 37 and 38 records showed QT intervals GREATER than the maximum identified in the hospital's droperidol protocol and in the FDA BBW.

Thus, the physicians in the ED did not comply with hospital protocol or with the FDA BBW and placed patients in a potentially adverse situation.

Patients 39, 40, 41 and 42 each received droperidol in the L&D OR during a Cesarean Section. (a surgical procedure during which one or more incisions (cuts) is made into the mother's abdomen and uterus to deliver one or more babies.

Contrary to hospital protocol and contrary to the FDA BBW, there is no evidence the QT intervals for Patients 39, 40, 41 and 42 in the L&D OR were measured. With no QT interval measurement, there could be no determination if the administration of droperidol placed these patients in potentially serious adverse circumstance.

RNP 1, RPH 2 and 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42 and acknowledged there was no evidence anyone in the hospital was aware of the errors. RPH 3 acknowledged that Pharmaceutical Services did not monitor the use of droperidol.

2. The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive intravenous insulin using the Intensive Insulin Drip Orders (IIDO) form. Insulin is a high-alert medication which lowers blood sugar (BS). Improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death."

For Patient 21 - There were eight instances where insulin was administered in error to Patient 21, seven instances where insulin was administered in error to Patient 22, and five instances where insulin was administered in error to Patient 54. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

RPH 3 stated that Pharmacists did not monitor the administration of intravenous insulin. Data provided by RPH 3 showed that between January and June 2012, there were 56 patients that received intravenous insulin.

At a meeting with RNP 2 and RN T on 6/20/12 starting at 1120 hours, they stated they had found instances of high BS in cardiac surgery patients on IV insulin. The RNs stated they had reviewed the insulin administration for those patients. In each case it was noted the RN had not administered the IV insulin per the guidelines of the IIDO. RNP 2 and RN T stated they had counseled these nurses on a one on one basis. However, there was no documentation to show such training had occurred. Moreover, RNP 2 and RN T stated they did not know the insulin errors were more widespread. They were unable to state their findings had been shared with the Pharmacy staff. There was no evidence provided to show anyone in the hospital was aware of the intravenous insulin administration errors. Cross Reference to A 0500 #2.

Based on interviews and document reviews, the hospital's Governing Body failed to ensure adequate resources were allocated and sufficient numbers of Pharmacist and/or other personnel were available to properly review medication orders, monitor the use of medications, control drug distribution and to identify, analyze and correct medication errors to improve patient safety. This resulted in high-risk drug errors not identified, medication distribution not controlled, medication errors vastly underreported, wrong and unlabeled medications found in patient cassettes on the units, and large numbers of medication doses administered in the ED not reviewed. The lack of properly assessing drug use, identifying weaknesses in the drug use system and controlling the distribution of medications potentially placed patients at risk for an adverse event.

Findings:

1. Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates that droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death).

The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads:"Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic.) A baseline ECG (Electrocardiogram) within prior 48 hours is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QT interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, Droperidol should NOT be given."

On 6/20/12 starting at 1325 hours, seven patient records were reviewed with RNP 1, RPH 2 and RPH 3. Two of the seven patients reviewed (Patients 37 and 38) were found to have received doses of droperidol although their QT intervals were GREATER than 450 msec.

Four of the seven patients reviewed (Patients 39, 40, 41 and 42) received droperidol in the L&D OR. There was no evidence the QT intervals for these patients were measured. The findings were confirmed by RNP 1, RPH 2 and RPH 3. RPH 3 stated Pharmacists were not able to monitor the use of droperidol as they did not have enough time to do so. RPH 3 further stated droperidol was not supposed to be stocked in the L&D OR. Thus, there was no pharmacy monitoring or controlling the distribution of a high-risk drug.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. Patients 21, 22 and 54 were found to have received a total of 20 wrong doses of intravenous insulin. (Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death." The findings were confirmed by RNP 1 and RPH 2. RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.


3. The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."

Data provided by RPH 2 identified there were 336 medication errors reported in 2010, and 399 errors reported in 2011, for both the Mission Viejo and Laguna Beach Campuses. Data provided by RNP 1 identified there was a total of 92,000 patient days in 2010 and 94,000 in 2011.

Thus, according to the research performed by the IOM, the hospital should be reporting, on average, about 93,000 errors per year (the average patient days for 2010 and 2011) or more than 200 times the number of errors actually reported (93,000/400).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from three hospitals between October 1 and October 31, 2004, were reviewed using the Institute for Healthcare Improvement's Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:
a) 38% of identified adverse events were medication errors.
b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.

The data from both hospital campuses also showed there were about 23,000 discharges in 2010 and 2011. According to the HA study, the hospital should be reporting about 122,000 (5.3 x 23,000) errors per year. This is about 300 times the number actually reported (122,000/400).

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011" identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

During an interview with RPH 1, RPH 2 and RPH 3 on 6/21/12 starting at 1425 hours, they stated they knew the hospital was underreporting medication errors but had to first focus on priorities such as the more serious errors and the entering physician orders.

4. Data provided by RPH 1 identified:

a. There are approximately 14,000 patients seen at the Mission Viejo Campus ED.

b. Approximately 30,000 doses of medication were removed from the automated dispensing cabinets (ADC's) in the Mission Viejo ED and administered to patients each quarter (3 months).

c. 100 Mission Viejo ED patient records were reviewed each quarter for the appropriate use of medications.

Thus, less than 1% of the 14,000 patient records (100/14,000) and less than 1% (214/30,000) of the 30,000 doses were reviewed to ensure medication use in the ED was appropriate and safe. During an interview with RPH 1 on 6/21/12 starting at 1425 hours, it was stated there was not enough time to audit more patient records.

5. A review of patient cassettes located on 3 E and 3 W of the Mission Viejo Campus revealed three of the cassettes contained medications either unlabeled or not ordered for that patient. An additional two cassettes contained medications; however, there were no patients assigned to those cassettes. This was confirmed by RPH 2, RN N and RN M.

6. Work volume versus Pharmacist hours for April 2012, was provided by RPH 1. Ten full time Pharmacist's work volumes per time period were analyzed. The analysis showed Pharmacists entered orders, reviewed medication orders, provided consultations and answered questions in between 0.86 and 1.9 minutes per order.

The American Society for Health-Systems Pharmacists (ASHP), the internationally recognized professional society which establishes standards of practice for pharmacists practicing in hospitals in its Standard III: Optimizing Medication Therapy reads: " Medication-therapy monitoring includes an assessment of:

a. The therapeutic appropriateness of the patient's medication regimen.

b. Therapeutic duplication in the patient's medication regimen.

c. The appropriateness of the route and method of administration of the medication.

d. The degree of patient compliance with the prescribed medication regimen.

e. Medication-medication, medication-food, medication-laboratory test, and medication-disease interactions.

f. Clinical and pharmacokinetic laboratory data to evaluate the efficacy of medication therapy and to anticipate toxicity and adverse effects.

g. Physical signs and clinical symptoms relevant to the patient's medication therapy."
Given the aforementioned professional practice tasks needed to evaluate a physician's order, it does not appear possible for it all to occur in an average of 1 and 1/2 minutes.

During an interview with RPH 5 on 6/21/12 at 1130 hours, he stated he spent 90% of his time just entering orders and had not much time to visit the patient care area or review medical records.

During an interview RPH 6, RPH 7 and RPH 8 on 6/21/12 starting at 1440 hours, they stated they spent 80% of their time just entering and reviewing orders. They stated they had little time to review patient care areas or medical records. RPH 1, RPH 2 and RPH 3, who were present during the interview, acknowledged the pharmacist's statements.

Based on observation, interview and record review, the Medical Staff of the hospital failed to be accountable to the Governing Body for the quality of care provided to the patients as evidenced by:

1. Droperidol, a medication with the known risk of producing life threatening cardiac arrhythmias was administered to six patients without necessary screening and monitoring activities being performed to minimize the risk to the patients. Cross reference to A 0353 #1 and A 0500 #1.

2. Two physicians, MD A and MD G, performed post-anesthesia assessments documented at incorrect times and inaccurate condition data in the medical record for seven of the 58 post-anesthesia records reviewed, creating the risk of a poor post-anesthesia outcome for those patients. Cross Reference to A 1005 #1.

3. Physicians failed to perform and document post-anesthesia assessments for 19 of the 58 patient post-anesthesia records reviewed, creating the risk of a poor post-anesthesia outcome for those patients. Cross Reference to A 1005 #2.

4. Two physicians, MD B and MD C, performed surgical procedures using radiation emitting equipment and did not wear radiation safety badges as per hospital P&P. Cross Reference to A 0353 #3 and A 0538.

5. For one physician, MD B, the physician was reappointed to the medical staff without a specific recommendation for reappointment documented by the department chairperson. Cross Reference to A 0341.

6. One physician, MD H, did not sign a pre-operative history and physical and did not complete a day-of-surgery update prior to performing surgery. Cross Reference to A 0952.

The cumulative result of these systemic problems resulted in the Medical Staff's failure to ensure high quality healthcare was provided to all patients receiving care in the facility.

Based on interview and record review, the reappointment process of the medical staff did not show documentation one physician (MD B) was recommended for reappointment by the chair of the department prior to reappointment, creating the risk of substandard care by MD B.

Findings:

The Medical Staff Bylaws (approved 4/19/12), read in part, "The responsibilities of the medical staff are to: ...Recommend to the governing body action with respect to appointments, reappointments, staff category and department assignments, clinical privileges, and corrective action."

During a review of the credential file of MD B on 6/19/12 at 1110 hours, the file contained a reappointment evaluation sheet completed prior to the March, 2012 reappointment. The bottom of the form contained three check off boxes next to three choices regarding reappointment, including recommended, and not recommended. None of the boxes were checked. The form was signed by the department chair.

During a concurrent interview with the Manager of Medical Staff Affairs, she stated one of the statements regarding recommending or not recommending reappointment of the physician should have been marked by the chairperson who signed the form.

Based on interview and record review, medical staff members administered droperidol (an intravenous medication that carries the risk of life-threatening irregular heart rhythms) to six patients (Patients 37, 38, 39, 40, 41 and 42) outside the required parameters or without performing required screening and monitoring to minimize the risks; a physician provided incomplete orders for propofol (a powerful intravenous sedative) for two patients (Patients 20 and 54), creating the risk of a poor health outcome; and two physicians (MD B and MD C) performed surgery using radiation emitting equipment without wearing radiation safety badges, contrary to facility policy, creating the risk of a radiation safety hazard.

Findings:

1. The Medical Staff Bylaws (approved 4/19/12) read in part, "Each member of the medical staff shall: ...Strictly abide by the Medical Staff Bylaws, Rules and Regulations and Medical staff Policies and by all other reasonable and lawful standards, policies and rules of the hospital ...

Droperidol was identified as being administered improperly by hospital medical staff during a State survey conducted on 3/24/10. The POC from the hospital showed the hospital would remove droperidol from the hospital's formulary and the drug would not be available for use.

The hospital's P&P protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads: "Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate droperidol is a second or third line antiemetic. A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, droperidol should NOT be given."

Despite the hospital's POC to make droperidol unavailable for use, the protocol described above, dated March 2012, identified droperidol would be permitted to be used within certain parameters. However, review of medical records showed physicians continued to administer droperidol improperly outside the protocol parameters. Cross Reference A-0500 #1.

2. The Medical Staff P&P Medical Record Documentation dated 2/12, read in part, "Medication orders shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the ordering physician. A practitioner's orders must be written clearly, legibly and completely."

a. Patient 20 was observed on 6/19/12 at 1000 hours. The patient was in the CICU and there was a bottle of milky white fluid labeled propofol suspended from the bedside IV pole.

The EMR orders by MD I, dated 6/16/12, for propofol for Patient 20 were reviewed and read, propofol drip 10 mg/ml, usual infusion rate: 10-50 mCg/kg/min, Max infusion rate: 100 mCg/kg/min. There was no starting dose, no titration instructions and no target sedation level specified for the medication. There were no clarifying orders seen.

The orders in the paper medical record for Patient 20 were also reviewed and did not contain any handwritten orders regarding propofol.

The Nurse Manager for the CICU was interviewed on 6/19/12 at 1005 hours. The Nurse Manager reviewed the propofol orders for Patient 20 and stated the sedation level desired should have been specified by the physician in the order.

RN K was interviewed on 6/19/12 at 1010 hours and confirmed there was no handwritten order or clarification of the propofol order for Patient 20.

RN L, who was caring for Patient 20, was interviewed on 6/19/12 at 1015 hours. RN L stated she usually expected titration parameters and would contact the physician if the titration parameters were not in the medication orders. RN L stated she was not aware if the physician was contacted for clarification of the incomplete propofol order.

b. The medical record of Patient 54 was reviewed on 6/20/12. The record included a 6/16/12 handwritten order by MD I for "Diprivan drip for sedation". There was no initial dose specified, titration rate, or description of the level of sedation desired.

During an interview with RN T on 6/20/12 at 1000 hours, she reviewed the medical record and stated that she did not see the starting dose or nursing titration parameters on the propofol orders. The RN stated she did not see any clarifying contact with the physician regarding the propofol sedation goal.

During an interview with RN U on 6/20/12 at 1015 hours, she stated she was the nurse caring for Patient 54. RN U stated propofol orders were initiated by MD I after the patient was intubated (given a breathing tube). The RN stated she recalled calling the physician for clarification of the dosing, but confirmed she had not written down the clarifying orders. RN U stated the level of propofol had been adjusted up and down since the initiation on 6/16/12, by herself and other nurses, but without any specific titration orders being documented.

3. The hospital's P&P, Radiation Monitoring of Personnel revised 6/08, read in part, "(Hospital name) will supply appropriate personnel monitoring badges/devices to and shall require use of monitoring devices by each individual who works in a controlled area where exposure to radiation is possible."

a. During a tour of the Mission Viejo Campus near the surgical suite on 6/18/12 at 1045 hours, the radiation safety badges and badge readout log dated 5/9/12 were reviewed.

During a concurrent interview with the Interim Manager of Surgical Services, and RN J, they were asked to name physicians who performed surgical services in the hospital using fluoroscopy (a technique using radiation). The name of MD C was provided.

RN J reviewed the radiation safety badge log and viewed the badges, and stated that there was no badge for MD C, and that his name did not appear on the log. RN J stated the badges were supplied by the radiology department and it was the hospital's policy for the physicians to wear the badges. RN J stated a physician would be reported if providing services using radiation while not wearing a badge.

During a review of the credential file for MD C on 6/19/12, the file indicated the physician was an active medical staff member who had been providing services in the hospital since 2004. MD C's fluoroscopy license had been renewed and was to expire in 2014.

b. During a tour of the surgery area at the Laguna Beach Campus on 6/18/12 at 1500 hours, the surgical schedule from 6/15/12, was reviewed. A surgery by MD B utilizing a C-arm (also called a fluoroscopy unit-equipment that emits radiation) was on the schedule. Review of the physician radiation safety badges showed there were only three physician radiation safety badges. No radiation safety badge was seen for MD B.

During interviews with the Nurse Manager of Surgical Services Laguna Beach Campus on 6/18/12 at 1500 and 1550 hours, she stated she thought radiation safety badges were being kept by the physicians. The Nurse Manager stated she thought the use of the radiation safety badges was being left up to the physicians.

During an interview with the RT Supervisor Laguna Beach Campus on 6/18/12 at 1550 hours, he stated he did not have the most current radiation badge log, but was not aware of any physicians being recently added to the badge log. The RT Supervisor reviewed the badge logs from from the year 2011, and stated he did not see MD B listed on the logs. The RT Supervisor stated everyone operating within the fluoroscopy unit should have a badge.

During a review of the credential file for MD B on 6/19/12, the file indicated the physician was an active medical staff member who had been providing services in the hospital since 1992. MD B's fluoroscopy license had been renewed and was to expire in 2013.

The Manager of Medical Staff Affairs was interviewed on 6/19/12 and stated she was not sure of the process for providing radiation safety badges to medical staff members.

Based on interview and record review, the hospital failed to ensure one of 116 sampled patients (Patient 56) at the Laguna Beach Campus received diabetic education either by nursing or by a Diabetic Educator per the nursing referral from the nursing admission assessment. This could potentially result in the patient's inability to manage their care after discharge.

Findings:

According to the hospital's document entitled Professional Education Department; Plan for the Provision of Patient Care FY 12 (ADM-2012JAN-TX.2.3), "Diabetic education is provided to patients when a physician order is written for a diabetic educator consult. These educators will usually see the patient with 24 hours of the time the order was received by the Professional Education Department..."

On 6/20/12 at 1055 hours, Patient 56's medical record was reviewed. Patient 56 was admitted to the hospital on 6/6/12. According to Patient 56's Admission Nutrition Screen, which was part of the nursing admission process completed on 6/7/12, Patient 56 had a High Risk Admission Diagnosis of Diabetes-Diabetic ketoacidosis (DKA-a dangerous complication of diabetes mellitus in which the chemical balance of the body becomes far too acidic). The nurse completing the screening correctly identified the patient's diagnosis. According to the directions on the Admission Nutrition Screen in Patient 56's electronic medical record a referral would be generated to the Dietitian and Diabetic Educator.

In an interview with RN W on 6/20/12 at 1135 hours, RN W stated the Diabetic Educator did not come to see patients at the Laguna Beach Campus. RN W stated nursing staff was responsible for providing diabetic education to patients at the Laguna Beach Campus. RN W reviewed Patient 56's medical record and was unable to locate documentation to show diabetic education had been provided to Patient 56 or to family members as was assessed by nursing as appropriate at the time of admission. According to RN W, discharge planning had already been ordered for the patient on 6/20/12.

On 6/21/12 at 1150 hours, the Diabetic Educator confirmed she did receive referrals automatically from the nursing admission screen when one of the four criteria diagnoses were identified for a patient, from both the Mission Viejo Campus and the Laguna Beach Campus. However, the Diabetic Educator verified she only provided diabetic education to those patients at the Mission Viejo Campus, even though she did receive referrals for patients at the Laguna Beach Campus. The Diabetic Educator stated, "It has always been that way." The Diabetic Educator stated, "I think a referral is the same as a physician's order."

During the same interview, the Director of Clinical Education was asked why the nursing referral to a Diabetic Educator was honored for patients at the Mission Viejo Campus but not at the Laguna Beach Campus. The Director stated that was the way it had always been.

On 6/21/12 at 1400 hours, RN P reviewed Patient 56's nursing admission screen and confirmed that by checking the Diabetes-DKA box nursing did make a referral to the Diabetic Educator. RN P stated that she had not been aware that a Diabetic Educator was not educating the patients at Laguna Beach Campus once a nursing referral was received. RN P stated the Diabetic Educator should have been providing that service.

Per interview with RNP 2 and the CICU Clinical Specialist on 6/20/12 at 1118 hours, the previous IIDO form, dated 3/18/10, was updated approximately on 11/11. The new IIDO protocol was approved by different committees on 12/11, before it was implemented on 1/12. The training of the nurses occured approximately in 11/11, but RNP 2 and the CICU Clinical Specialist stated they did not document the training. When asked if the effectiveness of the new insulin protocol had been reviewed, RNP 2 stated "pitfalls were noted following the new IV insulin protocol, warranting one to one teaching among the nursing staff on one or two occassions." However, no documentation of the one to one training was provided.



27873


Based on interviews and medical record reviews, the hospital failed to ensure the RNs were competent in using the hospital Insulin Intensive Drip Orders (IIDO) for three of three patients reviewed (Patients 21, 22 and 54). (Insulin is a high-alert medication which lowers blood sugar (BS). The danger in not following the IIDO is that in an attempt to control high BS, improper doses of insulin can cause hypoglycemia (severely low BS).The recognized dangerous side effect of insulin is hypoglycemia. Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.")

Findings:

The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive IV insulin using the IIDO form.


a. For Patient 21 - There were eight instances where IV insulin was administered in error. For example, at 0006 hours on 5/30/12, Patient 21's BS was 431. The documented insulin rate was 6 units per hour. According to the IIDO, since the BS did not decline by 60, the dosing algorithm (which identified the rate) should have moved over to the next higher level. This did not occur. The documented rate of 6 units per hour should have been 9 units per hour per the algorithm. About one hour later at 0053 hours, Patient 21's BS was 386. Again, the BS did not decrease by 60 so the dosing algorithm should have been moved again to the next higher level. This did not occur. The documented rate of 12 units per hour should have been 15 units per hour per the algorithm.

b. For Patient 22 - There were seven instances where IV insulin was administered in error. For example, at 2000 hours on 6/16/12, Patient 22's BS was 278. Since the BS did not decline by 60 (the BS at 1900 hours was 317), the dosing algorithm should have been moved to the next higher level. Instead, the RN kept the dose at the same algorithm and documented a rate of 9 units per hour. According to the IIOD algorithm, the insulin rate should have been 15.5 units per hour.

c. For Patient 54 - There were five instances where IV insulin was administered in error. For example, at 0200 on 6/18/12, Patient 54's BS was 330, an increase of 44 over the measurement at 0100. Again, the IIDO called for a move to the next higher algorithm which should have been F. However, since algorithm F had no values, the RN should have called the MD to determine what rate was to be administered. There was no documented evidence to show the RN called the MD. The RN continued to use the wrong algorithm for the next four hourly doses. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

2 a. Patient 20 was observed on 6/19/12 at 1000 hours. The patient was in the CICU and there was a bottle of milky white fluid labeled propofol suspended from the bedside IV pole.

The EMR orders by MD I, dated 6/16/12, for propofol for Patient 20 were reviewed and read, propofol drip 10 mg/ml, usual infusion rate: 10-50 mCg/kg/min, Max infusion rate: 100 mCg/kg/min. There was no starting dose, no titration instructions and no target sedation level specified for the medication. There were no clarifying orders seen.

The orders in the paper medical record for Patient 20 were also reviewed and did not contain any handwritten orders regarding propofol.

The Nurse Manager for the CICU was interviewed on 6/19/12 at 1005 hours. The Nurse Manager reviewed the propofol orders for Patient 20 and stated the sedation level desired should have been specified by the physician in the order.

RN K was interviewed on 6/19/12 at 1010 hours and confirmed there was no handwritten order or clarification of the propofol order for Patient 20.

RN L, who was caring for Patient 20, was interviewed on 6/19/12 at 1015 hours. RN L stated she usually expected titration parameters and would contact the physician if the titration parameters were not in the medication orders. RN L stated she was not aware of the physician being contacted for clarification of the incomplete propofol order.

b. The medical record of Patient 54 was reviewed on 6/20/12. The record included a 6/16/12 handwritten order by MD I for "Diprivan drip for sedation". There was no initial dose specified, titration rate, or description of the level of sedation desired.

During an interview with RN T on 6/20/12 at 1000 hours, she reviewed the medical record and stated that she did not see the starting dose or nursing titration parameters on the propofol orders. The RN stated she did not see any clarifying contact with the physician regarding the propofol sedation goal.

During an interview with RN U on 6/20/12 at 1015 hours, she stated she was the nurse caring for Patient 54. RN U stated propofol orders were initiated by MD I after the patient was intubated (given a breathing tube). The RN stated she recalled calling the physician for clarification of the dosing, but confirmed she had not written down the clarifying orders. RN U stated the level of propofol had been adjusted up and down since the initiation on 6/16/12, by herself and other nurses, but without any specific titration orders being documented.

In an interview with the Pharmacy Clinical Manager on 6/19/12 at 1435 hours, he stated that the hospital previously used the paper order form for propofol which provided titration guidance from which the physician could select. The Pharmacy Clinical Manager stated the titration guidance from in the paper order set had not been made a part of the EMR order set.

A blank hospital order set, Pain, Sedation, Agitation Orders (dated 11/10) was reviewed and included a pre-printed page of sedation target score descriptions and dosing warnings, along with spaces for the physician to indicate the starting dose, titration rate, and sedation score target.

The medical record of Patient 54 was further reviewed and showed documentation four nurses caring for Patient 54 had titrated propofol for an intravenous intake amount between 10.4 and 17.1 ml between 6/16/12 and 6/19/12, without any physician orders specifying titration parameters or rates.

3. During an observation on 6/20/12 at 1255 hours in the recovery area at the Laguna Beach Campus, the medical record of Patient 61 was reviewed. The record contained notations of Dilaudid (a powerful pain reliever), being administered eight times in the recovery room, and Oxycodone (a powerful pain reliever) one tab being administered twice in the recovery room. However, there was no physician's order on the record for those medications.

During a concurrent interview with the Nurse Manager of Surgical Services, she confirmed there was no order on the medical record for the pain relievers administered to Patient 61. The Nurse Manager stated the nurse had not yet recorded the verbal order he received for the medications. When asked about the actual dose of the Oxycodone tablets given, the Nurse Manager conferred with the nurse and stated it must have been 5 mg, as that what was the dose available in the ADC.



27873


Based on interviews and record reviews the hospital failed to ensure RN's:

1. Administered intravenous (IV) insulin according to physician's orders for three of three patients reviewed (Patients 21, 22 and 54). (Insulin is a high-alert medication which lowers blood sugar (BS). The danger in not following the IIDO is that in an attempt to control high BS, improper doses of insulin can cause hypoglycemia (severely low BS).The recognized dangerous side effect of insulin is hypoglycemia. Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.")

2. Administered propofol (also known as Diprivan, a powerful intravenous sedative) to two patients (Patients 20 and 54), with initial dose and titration goal orders from the physician, resulting in the risk of medication dosing errors and a poor health outcome.

3. Did not administer medications for one patient (Patient 59), without a medication order for the medications on the record in the recovery room , creating the risk of a medication administration error and a poor health outcome for that patient.

Findings:

1. The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive intravenous (IV) insulin using the intense insulin drip orders (IIDO) form.

a. For Patient 21 - There were eight instances where IV insulin was administered in error. For example, at 0006 hours on 5/30/12, Patient 21's BS was 431. The documented insulin rate was 6 units per hour. According to the IIDO, since the BS did not decline by 60, the dosing algorithm (which identified the rate) should have moved over to the next higher level. This did not occur. The documented rate of 6 units per hour should have been 9 units per hour per the algorithm. About one hour later at 0053 hours, Patient 21's BS was 386. Again, the BS did not decrease by 60 so the dosing algorithm should have been moved again to the next higher level. This did not occur. The documented rate of 12 units per hour should have been 15 units per hour per the algorithm.

b. For Patient 22 - There were seven instances where IV insulin was administered in error. For example, at 2000 hours on 6/16/12, Patient 22's BS was 278. Since the BS did not decline by 60 (the BS at 1900 hours was 317), the dosing algorithm should have been moved to the next higher level. Instead, the RN kept the dose at the same algorithm and documented a rate of 9 units per hour. According to the IIOD algorithm, the insulin rate should have been 15.5 units per hour.

c. For Patient 54 - There were five instances where IV insulin was administered in error. For example, at 0200 on 6/18/12, Patient 54's BS was 330, an increase of 44 over the measurement at 0100. Again, the IIDO called for a move to the next higher algorithm which should have been F. However, since algorithm F had no values, the RN should have called the MD to determine what rate was to be administered. There was no documented evidence to show the RN called the MD. The RN continued to use the wrong algorithm for the next four hourly doses. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

Administering the wrong doses of intravenous insulin placed patients in a potentially serious adverse situation.

Based on interview and record review, the hospital failed to ensure the medical record service had administrative responsibility for the entire medical record as evidenced by:

Findings:

1. The hospital failed to ensure the medical record service was organized with processes in place to maintain complete oversight of the electronic and paper medical record during a patient's stay in the hospital. Cross Reference A-0432.

2. The hospital failed to ensure the P&P to prevent unauthorized persons from gaining physical access to the medical record was implemented on the Mother Baby Unit. Cross Reference A-0441.

3. The hospital failed to ensure the medical records were accurately written, that post-anesthesia evaluations were conducted and documented to ensure recovery from anesthesia. This inaccuracy created the risk of poor health outcomes for patients who did not have documented post-anesthesia evaluations. Cross Reference A-0449 #1 and #2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and medical record review the hospital failed to ensure the medical record service was organized with processes in place to maintain complete oversight of the electronic and paper medical record during a patient's stay in the hospital. This resulted in the potential for physician's dictated reports and telephone orders not to be reviewed as correct and electronically signed in a timely manner to promote safe patient care.

Findings:


Review of the hospital's P&P Physician Orders, Critical Results and Consultations, last reviewed 1/06, showed the prescriber must countersign verbal and telephone orders within 48 hours.

The medical record for Patient 2 was reviewed with RN A and the Nurse Manager on 6/18/12 at 1030 hours, on the 3 W unit of the Mission Viejo Campus. Review of the paper record showed the physician had given nine different telephone orders for the care and treatment of the patient to the nurse by telephone on 6/15/12. Although there appeared to be a signature next to the nurse's signature, it was unclear if the physician had cosigned the telephone orders. There was no date and no time documented next to that signature.

RN A was asked how she would know if the physician had electronically signed the order within the required 48 hours. RN A stated she did not know how to access the electronic record for that information. The Nurse Manager stated she also was unsure of the procedure but would follow up to obtain the information.

The Director of Health Information Services was interviewed on 6/19/12 at 1030 hours. The Director explained when a physician was in the hospital he/she entered patient orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign queue to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.

The Director stated oversight of the open record, while the patient was in the hospital, would be done on a unit basis. When informed the nursing staff was unaware of how to access the information to confirm the telephone orders were signed within the 48 timeframe, the Director stated she did not know the nurses did not have that information.

On 6/19/12 at 1120 hours, the Nurse Manager for the 3 W unit was interviewed. When asked if the unit's nursing staff had any oversight of the electronic medical records for the patients to confirm telephone orders were signed timely by physicians, the Nurse Manager stated, no.

In a follow up interview with the Director of Health Information Services on 6/20/12 at 0950 hours, the Director stated the only involvement her department had in the open patient record was to monitor if the physician's H&Ps and the surgical operative reports were dictated and transcribed within 24 hours. When asked if there was any follow up to ensure these reports, as well as other physician dictated reports, were reviewed and signed by the physicians as correct with in 48 hours, the Director stated there was not.

Based on interview and medical record review the hospital failed to ensure the accuracy of the electronic medical record for one of 116 sampled patients (Patient 2) when telephone orders from the physician were incorrectly entered into the record as written orders resulting in the physician not being electronically flagged to review and sign the orders as correct within 48 hours. This could potentially result in a treatment or medication error.

Findings:

The medical record for Patient 2 was reviewed with RN A and the Nurse Manager on 6/18/12 at 1030 hours, on the 3 W unit of the Mission Viejo Campus. Review of the paper record showed the physician had given nine different telephone orders for the care and treatment of the patient to the nurse by telephone on 6/15/12. Although there appeared to be a signature next to the nurse's signature, it was unclear if the physician had cosigned the telephone orders. There was no date and no time documented next to that signature.

RN A was asked how she would know if the physician had electronically signed the order within the required 48 hours. RN A stated she did not know how to access the electronic record for that information.
The Nurse Manager stated she also was unsure of the procedure but would follow up to obtain the information.

On 6/19/12 at 1120 hours, the Nurse Manager for the 3 W unit was interviewed. The Nurse manager stated upon investigation the telephone orders dated 6/15/12, for Patient 2 were found to have been entered incorrectly into the patient's electronic record. The unit secretary had entered the orders not as telephone orders but as written orders, therefore the physician had not been flagged of the need to sign the orders electronically.

When asked if the unit's nursing staff had any oversight of the electronic medical records for the patients to confirm telephone orders were signed timely by physicians, the Nurse Manager stated, no.

Based on observation, interview and document review, the hospital failed to ensure the P&P to prevent unauthorized persons from gaining physical access to the medical record was implemented on the Mother Baby Unit. The paper medical records for 15 patients and their infants were observed stored in unlocked cabinets in the hallway outside of the patient rooms.

Findings:

The hospital's P&P for Information Physical Security dated 1/21/11, showed media, (such as hard copies) that contained a patient's confidential information should be secured in a locked desk, cabinet or room.

The Mother Baby Unit was toured on 6/18/12 at 1500 hours, with the unit's Nurse Manager.

Cabinets that lowered to form a writing table were observed at the entrance of each patient room. Outside a patient room the cabinet was open and two chart binders were observed lying on the table. No staff was observed in the area. The Nurse Manager stated although the patient's records were mostly electronic, paper documents, which might include the physician's history and physical, telephone orders from the physician, lab reports, and consents for procedures, were kept in chart backs for the mother and the baby. The Nurse Manager stated however, the cabinets should not be left open and the charts unattended.

Observation of the next room showed the cabinet was in the closed position but was unlocked. The Nurse Manger stated she was unaware of the need to keep each cabinet locked.

The Director of Health Information Services was interviewed on 6/19/12 at 1030 hours. When asked about the storage of the paper medical records on the Mother Baby Unit in unlocked cabinets, the Director stated any piece of the medical record, if left unattended, should be secured in a locked area. The Director stated she was unaware the records were not locked and secured.

Based on observation, interview and record review, the hospital failed to ensure:

1. The medical records reflected the response of the patient to treatments administered because the hospital failed to ensure the accuracy of the documented post-anesthesia evaluation for seven of 58 patients (Patients 10, 59, 60, 91, 112, 115 and 116), whose post-anesthesia data was reviewed.

2. Post-anesthesia evaluations were conducted and documented to ensure recovery from anesthesia for 19 of 58 post-anesthesia records reviewed (Patients 64, 67, 71, 76, 79, 81, 84, 87, 89, 93, 98, 100, 102, 105, 107, 109, 111, 113, and 114).

These failures potentially created the risk of poor health outcomes for patients who did not have documented post-anesthesia evaluations.

Findings:

The hospital's P&P, Analgesia and Anesthesia Policy effective January 18, 2012, read in part, "A post-anesthesia evaluation must be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services. The evaluation must be completed and documented by any practitioner who is qualified to administer anesthesia as noted in this section of the policy. The evaluation may not begin until the patient is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation (e.g., answers questions appropriately, perform simple tasks, etc.)."

1 a. During an observation in the pre-operative area on 6/20/12 at 1010 hours, the area was being used as a recovery area because of equipment re configuration underway in the PACU. Patient 10 was observed being wheeled into the area on a gurney from the surgical suite and the operating room staff provided the recovery nurse, RN H with a report of the patient's condition before the operating room staff, including MD A, left the room. The patient was observed to be deeply sedated, nonverbal, unmoving, and with eyes closed.

At 1024 hours on 6/18/12, after continuous observation of Patient 10 being asleep in the recovery area, the anesthesia record portion of the medical record was reviewed. The record contained a post-anesthesia note from MD A timed for 1042 hours, which read that the patient was awake.

During an interview with RN H at 1024 hours on 6/18/12, she stated Patient 10 had not awakened since arriving in the recovery area, and was still sleeping.

During an interview with MD A at 1025 hours on 6/18/12, he stated he must have misinterpreted the time and written the wrong time on the medical record of Patient 10.

b. During a review of 56 medical records of surgery patients from 6/13 through 6/15/12, the time of the post-anesthesia notes written by 16 different physicians was compared to the electronic time stamp in the electronic medical records system. For 5 of the 56 patients (Patients 60, 91, 112, 115 and 116), the time of the post-anesthesia note in the record had been changed to a time later than it was actually written.

The Business Operations Manager of Perioperative Services was interviewed on 6/19/12 at 1110 hours. The Manager stated the electronic medical record for surgical records provided automatic time stamps for each entry made, but the writer could change the time that was automatically input. The Manager stated he was unsure how the times were changed.

During an interview with MD F, an anesthesiologist, on 6/21/12 at 1505 hours, he stated the only explanation he could offer was the physicians did not understand the new medical record system which had been in place since February, 2012.

2. During a review of 56 medical records of surgery patients from 6/13/12 through 6/15/12, the anesthesia records, written by 16 different physicians, were reviewed. Nineteen of the 56 records reviewed (Patients 64, 67, 71, 76, 79, 81, 84, 87, 89, 93, 98, 100, 102, 105, 107, 109, 111, 113, and 114), contained no post-anesthesia note from an anesthesia provider. The records with no post-anesthesia note included records from surgeries involving general anesthesia.

MD F, an anesthesiologist, was interviewed on 6/21/12 at 1505 hours. MD F reviewed the 6/13/12, anesthesia record of Patient 60. MD F stated he had provided the anesthesia for the patient. MD F confirmed there was no post-anesthesia note on the record and the patient had received general anesthesia.

During an interview with the Director of Quality/Outcomes on 6/22/12 at 1250 hours, she stated the quality department was no longer doing open medical record reviews.

3. The recovery room record of Patient 59 was reviewed in the Laguna Beach Campus recovery room on 6/20/12 beginning at 1245 hours.

The Anesthesia Record for Patient 59 showed the surgery ended at 1119 hours on 6/20/12. Post-operatively the patient received 13 doses of pain medication from 1135 hours until 1255 hours. Review of the Pain Management form showed the patients's pain was still rated as 6 out of 10. There was no physician's order on the medical record for 10 of the 13 doses of pain medication administered. Cross Reference to A 0405 #2.

There was no documentation on 6/20/12 at 1255 hours that a physician had come to evaluate the patient post-operatively.

The record contained a pre-printed form, Pre-Anesthesia Orders/Post-Anesthesia Evaluation. The sections of the form for "Recommended Anesthesia Orders" and "Post-Sedation Procedure Evaluation" had been completed. The form was signed by a physician at 0818 hours on 6/20/12. The "Post-Sedation Procedure Evaluation" section of the form had boxes which were checked off by the physician to indicate: vital signs were stable; the patient was awake and alert; respirations/saturations and ability to deep breath/cough effectively, the airway reflex was present and the oxygen saturation on room air was more than the pre-op value; there were no anesthesia complications; nausea was minimal; pain was controlled; and post-op hydration was normal. There was a pre-printed statement, "I have examined the patient prior to discharge, and find the patient stable for discharge" followed by the signature of the physician at 0818 hours (prior to the start of surgery).

In an interview with RN CC on 6/20/12 at 1245 hours, the RN stated the "Post-Sedation Procedure Evaluation" was completed and signed by the physician prior to the surgery.

Based on medical record review and interview, the hospital failed to ensure verbal and/or telephone physician orders for patient care were authenticated by physician signature as correct within 48 hours for three of 116 sampled patients (Patients 25, 48, and 49). When verbal or telephone orders were not reviewed and signed by a physician as correct in a timely manner there was the potential for transcription error and risk to patient safety.

Findings:

Review of the hospital's P&P Physician Orders, Critical Results and Consultations, last reviewed 1/06, showed the prescriber must countersign verbal and telephone orders within 48 hours.

The Director of Health Information Services was interviewed on 6/19/12 at 1030 hours. The Director explained when a physician was in the hospital he/she entered a patient's orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign que to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.

1. The closed medical record for Patient 48 was reviewed on 6/20/12 at 1330 hours with the Clinical Informatics Consultant. An order change for Zofran (anti-nausea medication) was entered into the electronic record by a pharmacist on 5/29/12 at 1156 hours. The order was not electronically signed by the physician until 6/2/12 at 2352 hours (four days later).

2. The closed medical record for Patient 49 was reviewed on 6/20/12 at 1335 hours with the Clinical Informatics Consultant. A telephone order for IV potassium was entered into the electronic record on 5/29/12 at 1954 hours. The order was not signed electronically by the physician until 6/6/12 at 0000 hours (eight days later).


27157


3. On 6/19/12 at 1057 hours, Patient 25's medical record was reviewed. Review of the physician's orders showed a telephone order dated 6/10/12, for Boost TID orally (nutrition supplement three times a day) by a nurse.

On 6/19/12 at 1152 hours, RN P reviewed Patient 25's paper medical record and electronic medical record. The RN stated the telephone order for the Boost Enlive supplement was the order entered as it was the hospital's approved substitute for Boost. RN P stated the order had not been signed and authenticated by the practitioner responsible for the care of the patient.

Further review of Patient 25's electronic medical record showed RD 2 had entered a telephone order for a Jevity 1 Cal Enteral Feed on 6/16/12.

On 6/19/12 at 1154 hours, RN P reviewed Patient 25's electronic medical record. The RN verified the physician had not authenticated the telephone order for the enteral feeding. According to RN P, the medical staff by-laws indicated that telephone orders required the physician's authentication within 48 hours.

Based on interview, hospital document and medical record review, the hospital failed to ensure the informed consent form was complete with witness signature and title for two patients (Patients 2 and 54) of 30 informed consents reviewed. This resulted in an incomplete consent.

Findings:

The hospital's P&P to address Informed Consents dated 7/11, showed the witness to the patient's consent was to sign the consent form and should be a RN.

1. The medical record for Patient 2 was reviewed on 6/18/12 at 1030 hours with RN A. Review of the consent form to allow a blood transfusion dated 6/1/12, showed the signature of the witness to the patient's signature was illegible and no title was documented for the signature. When asked, RN A was unable to state the name or title of the witness.


2. On 6/21/12 at 1200 hours, a tour of the endoscopy procedure area was conducted. A randomly selected medical record for Patient 54 was reviewed.

A document titled: Authorization For And Consent to Endoscopy OR Procedures, showed Patient 54 had signed the consent for endoscopy, however, absent on the informed consent was a signature by a RN to serve as a witness to the consent provided by Patient 54.

Based on staff interview and medical record review, the hospital failed to ensure patient weights were obtained in a timely manner and documented in the medical record which could jeopardize Patient 44's continuing medical care, nutrition care planning, and patient education.

Findings:

Patient 44 was admitted to the Chemical Dependency unit on 5/22/12. Admission weight was and height were documented.

Review of the nutrition assessments dated 6/1, 6/5, and 6/8/12, did not show a current weight.

During an interview with RD 1 and RN S on 6/20/12 at 1230 hours, RD 1 stated patients were not weighed after admission, even for long term hospitalization. RN S stated the nurses assessed the patient's weight change by observation and if the patient was eating.

The hospital did not have a policy to ensure a patient's weight was monitored during hospitalization.

Based on observation, medical record review, and P&P review, the hospital failed to ensure that pharmaceutical services carried out its full and complete oversight to meet the needs of patients in the hospital.

Findings:

1. On 6/20/12 at 1627 hours, the hospital administration was notified of Immediate Jeopardy (IJ) to the health and safety of hospital patients due to the use of droperidol by physicians for patients contrary to the FDA BBW and hospital's P&P. Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicated the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicated droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart. A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.

For Patients 37 and 38, droperidol was administered in the ED, although contraindicated due to measured QT intervals. For Patients 39, 40, 41 and 42, droperidol was administered in the L&D OR with no documented evidence of a measurement of the patients QT interval, contrary to hospital policy.

On 6/21/12 at 1825 hours, the hospital's written plan of action to abate the IJ was accepted by the survey team. The plan of correction stated droperidol would immediately be removed from the hospital's formulary and removed from stock in the OR, ED and the L&D OR. MD E provided a copy of an e-mail sent to all physicians informing them droperidol would no longer be used in the hospital. After confirmation of the POC by the survey team through observation and staff interview the Immediate Jeopardy was abated at 1825 hours on 6/21/12. Cross Reference A-0500 #1.

2. Three patients were found to have received a total of 20 wrong doses of intravenous insulin. Cross Reference A-0405 #1.

3. Medications, including high-risk medications, contained in six patient cassettes on the 3rd floor nursing units were not properly labeled, were stored in the wrong patient cassette (drawer) and were not removed when there was no longer a physician's order for their use. Cross Reference A-0491 #1 and #2.

4. The hospital failed to follow their P&P to resolve ADC controlled substance discrepancies. Cross Reference A-0509.
5. Nursing staff administered propofol (also known as Diprivan, a powerful intravenous sedative) without obtaining initial dose and titration goal orders from the physician. Cross Reference A-0405 #2.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

4. On 6/18/12 at 1000 hours, a inspection/tour of the Acute Rehabilitation Unit (ARU) was conducted. Antibiotic ointments in a open plastic tray were found stored on an unlabeled shelf next an open container labeled "Used Batteries."

On 6/18/12 at 1020 hours, an interview with the ARU Charge Nurse (RN W) was conducted. RN W stated the medications should not be stored in this area.







23015

3. Review of the hospital's P&P titled "Medication Administration" (Code CPC-201MAR-1.M.3.1) showed "Verbal/telephone orders are to be written down when received and repeated back to the physician for confirmation."
On 6/18/12 at 1115 hours, a tour of the Mission Viejo Campus 3 West Oncology/Medical Unit took place with the Medication Safety Officer. A random selection of patient charts showed three of three patients records reviewed (Patients 17, 18 and 19) contained written telephone orders that did not indicate the telephone order was read back to the physician. The Medication Safety Officer stated that all telephone orders "must have read back."


27873


Based on interviews and observations the hospital's pharmacy failed to ensure:

1. Medications on the 3rd floor nursing units, including high-risk medications, were contained in six patient cassettes that were properly labeled, medications were stored in the right patient cassette (drawer)

2. Medications were removed when there was no longer physician's order for their use.

3. The P&P for telephone and verbal orders to be read back to the prescriber was implemented.

4. Medications were stored separately from other items on the Acute Rehabilitation Unit. This could potentially result in a medication error.


Findings:

1. Nursing unit 3 E on the Mission Viejo Campus was visited on 6/18/12 starting at 0850 hours, with RPH 2. The medication cart was opened revealing patient cassette drawers.
* Note: The room numbers have been altered to protect patient privacy.

a. The drawer for Room A Bed 2 was reviewed with RN N. The drawer contained 2 vials of Lovenox. Lovenox is a special form of heparin which is administered either intramuscularly or subcutaneously to thin the blood. It is a high-risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA) strongest warning. The Lovenox vials were not labeled with a patient's name or directions for use. RN N, who was caring for the patient in Room A, stated the patient had no order for Lovenox. Thus a high-risk medication with no patient label was sitting in a drawer for a patient who had no order for the drug creating an unsafe situation.

b. The drawer for room Room B Bed 1 was reviewed with RN U. The drawer contained 1 vial of Humulog insulin and 1 vial of Humulin R insulin. Neither vial was labeled with a patient's name or directions for use. RN U, caring for the patient in 367-1 said there was an order for Humulog for that patient but not for Humulin R. Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death." Thus, 2 different dosages of insulin, a high-alert medication, were sitting in a drawer for a patient with no patient label; one was ordered for the patient the other was not, creating the potential for a serious adverse event.

2. Nursing unit 3 W on the Mission Viejo Campus was visited on 6/18/21 starting at 0945 hours with RPH 2. The medication cart was opened revealing patient drawers.

c. The drawer for room Room C Bed 2 was reviewed with RN Q. The drawer contained the following medications, all with no patient name or directions for use: Lactulose (an osmotic laxative), Docusate (a stool softener), Furosemide (a diuretic which is used to increase urination), Celebrex (an anti-inflammatory drug used to relieve pain. It is a high-risk medication that contains a Black Box Warning (BBW) and senna (a stimulant laxative). According to RN Q, there was no patient assigned to room Room C Bed 2. So, unlabeled and unauthorized medications were sitting in a drawer assigned to a bed with no patient in the bed creating another opportunity for a potential adverse event.

d. The drawer for room Room D Bed 1 was reviewed with RN V. The drawer contained promethazine. Promethazine is both an anti-emetic (to relieve nausea and vomiting) and an antihistamine (to relieve allergic symptoms). Promethazine is also a high-risk drug with a Black Box Warning (BBW). RN V, who was caring for the patient in Room D Bed 1, stated the patient was no longer on promethazine, it had been discontinued the day before. Yet the high-risk medication was still available for use which created another potential adverse event.

e. The drawer for room Room E Bed 1 was reviewed with RN M. The drawer contained Megace. Megace is a drug used to treat breast and endometrial cancer. Lexicomp, a nationally recognized drug information source identifies Megace as a hazardous agent which is to be used with "appropriate precautions for handling and disposal". RN M stated the patient in Room E Bed 1 had no physician's order for Megace. RN M stated it was for a previous patient who had been discharged. So, we have yet another opportunity for a patient to receive unauthorized medication which is considered hazardous.

f. The drawer for room Room F Bed 1 was reviewed with RN M. The drawer contained Humulin R insulin which was not labeled with a patient's name or directions for use. According to RN M, who was caring for the patient in Room F Bed 1, there was no physician's order for Humulin R insulin. As described in the visit to 3 E, under (b) above, insulin is a high-risk drug that could result in serious patient harm.

RPH 2 stated that pharmacy was not aware the above referenced medications were stored in the patient drawers.

Based on interviews and record reviews the hospital failed to ensure there were a sufficient number of Pharmacists to review medication orders, monitor drug use, control drug distribution and to identify, analyze and correct medication errors to improve patient safety. This resulted in high-risk drug errors not identified, medication distribution not controlled, medication errors were vastly underreported, wrong and unlabeled medications were in patient cassettes (drawers), and large numbers of medication doses administered in the ED were not reviewed. The lack of a proper assessment of drug use, identification of weaknesses in the drug use system, and controlling the distribution of medications placed patients at risk for an adverse event

Findings:

1. Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.)

The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations "reads: "indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic.) A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, Droperidol should NOT be given."

On 6/20/12 starting at 1325 hours, seven patient records were reviewed with RNP 1, RPH 2 and RPH 3. Two of the seven patients reviewed (Patients 37 and 38) were found to have received doses of droperidol although their QT intervals were GREATER than 450 msec.

Four of the seven patients reviewed (Patients 39, 40, 41 and 42) received droperidol in the L&D OR. There was no evidence the QT intervals for these patients were measured. Thus, droperidol was administered to Patients 39, 40, 41 and 42 improperly and contrary to the hospital protocol and the FDA BBW. The findings were confirmed by RNP 1, RPH 2 and RPH 3. RPH 3 stated Pharmacists were not able to monitor the use of droperidol as they did not have enough time to do so. RPH 3 further stated droperidol was not supposed to be stocked in the L&D OR. Thus, there was no pharmacy monitoring or controlling the distribution of a high-risk drug. Cross Reference to A 0353.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. The patients were found to have received a total of 20 wrong doses of intravenous insulin. Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death."

The findings were confirmed by RNP 1 and RPH 2. RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.

3. The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."

Data provided by RPH 2 identified there were 336 medication errors reported in 2010, and 399 errors reported in 2011, for both the Mission Viejo and Laguna Beach Campuses. Data provided by RNP 1 identified there were a total of 92,000 patient days in 2010 and 94,000 in 2011.

Thus, according to the research performed by the IOM, the hospital should be reporting, on average, about 93,000 errors per year (the average patient days for 2010 and 2011) or more than 200 times the number of errors actually reported (93,000/400).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from three hospitals between October 1 and October 31, 2004, were reviewed using the Institute for Healthcare Improvement's Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:

a) 38% of identified adverse events were medication errors.

b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.

The hospital's data also showed there was a yearly average of about 23,000 discharges in 2010 and 2011. According to the HA study, the hospital should be reporting about 122,000 (5.3 x 23,000) errors per year rather than the 400 per year actually reported. So, according to the HA study, the hospital should be reporting more than 300 times the number of errors actually reported.

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011" identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

During an interview with RPH 1, RPH 2 and RPH 3 on 6/21/12 starting at 1425 hours, they stated they knew the hospital was underreporting medication errors but they had to focus on priorities first such as entering physician orders into the pharmacy system.

4. Data provided by RPH 1 identified:

a.There were approximately 14,000 patients seen in the Mission Viejo ED;

b. Approximately 30,000 doses are removed from the automated dispensing cabinets (ADC's) in the Mission Viejo ED and administered to patients each quarter (3 months).

During an interview with RPH 1 on 6/21/12 starting at 1425 hours, she stated she reviewed 100 Mission Viejo ED patient records (which yielded 214 doses (30,000 doses/14,000 records)) each quarter for the appropriate use of medications. 100 records and 214 doses represented 7-tenths of 1% (0.7%) of the 14,000 patient records and 30,000 doses administered. Thus, more than 99% of the medication doses removed and administered to patients in the Mission Viejo ED were never reviewed by a Pharmacist. When advised the number of records and doses reviewed was a very small percentage of the total, RPH 1 stated there was not enough time to audit more patient records.

5. A review of patient drawers located on 3 E and 3 W of the Mission Viejo Campus revealed:

a.Three drawers contained medications that were not labeled.

b. Three drawers contained medications that were not ordered for that patient.

c. Two drawers contained medications that were discontinued.

d.One drawer contained five unlabeled medications for which there was no patient, since there was no patient assigned to that room.

This was confirmed by RPH 2, RN N and RN M. RPH 2 further stated the pharmacy was not aware of the improperly stored medications found in the reviewed drawers.

6. Work volume versus Pharmacist hours for April 2012, was provided by RPH 1. Ten full time Pharmacists' work volumes per time period were analyzed. The analysis showed Pharmacists entered orders, reviewed medication orders, provided consultations and answered questions between 0.86 and 1.9 minutes per order. This was confirmed by RPH 1 on 6/21/12 starting at 1440 hours.

The American Society for Health-Systems Pharmacists (ASHP), the internationally recognized professional society for establishing standards of practice for pharmacists practicing in hospitals in its Standard III: Optimizing Medication Therapy reads:
" Medication-therapy monitoring includes an assessment of:
a. The therapeutic appropriateness of the patient's medication regimen.
b. Therapeutic duplication in the patient's medication regimen.
c. The appropriateness of the route and method of administration of the medication.
d. The degree of patient compliance with the prescribed medication regimen.
e. Medication-medication, medication-food, medication-laboratory test, and medication-disease interactions.
f. Clinical and pharmacokinetic laboratory data to evaluate the efficacy of medication therapy and to anticipate toxicity and adverse effects.
g. Physical signs and clinical symptoms relevant to the patient's medication therapy."

Given the aforementioned ASHP standard assessments needed to evaluate a physician's order, it does not appear possible for it all to occur in an average of 1 and 1/2 minutes.

During an interview with RPH 5 on 6/21/12 at 1130 hours, he stated he spent 90% of his time just entering orders and did not have much time to visit the patient care area or review medical records.

During an interview RPH 6, RPH 7 and RPH 8 on 6/21/12 starting at 1440 hours, they stated they spent 80% of their time just entering and reviewing orders. They stated they had little time to review patient care areas or medical records. RPH 1, RPH 2 and RPH 3 who were present during the interview, acknowledged the pharmacist's statements.

5. Malignant Hyperthermia (MH) is an inherited muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis. " (http://www.mhaus.org/patients-and-families/#.T6rWblI2cTY ).

During a tour of the pre-operative and post-operative areas of the Laguna Beach Campus on 6/19/12 at 1115 hours, an observation of the Malignant Hyperthermia Drug Box took place with the Manager of Pharmacy Operations, Laguna Beach. This drug box contained only one liter of sterile water for injection. Sterile water is used to reconstitute Dantrolene©, a medication used to treat MH. Thirty-six vials of Dantrolene© were available: each vial of Dantrolene© requires 60 milliliters of sterile water for reconstitution into a usable, injectable solution. Therefore, over 2 liters of sterile water would be needed to reconstitute this entire supply of Dantrolene© in an emergent MH crisis. There was no pharmacist on site after hours as the Laguna Beach Campus pharmacy was not a 24 hour pharmacy and was serviced by the Mission Viejo Campus after hours.

In addition, a tour of the OR at the Laguna Beach Campus took place on 6/19/12 at 1530 hours with Nurse Manager Surgical Services, Laguna Beach. Observation of a medication refrigerator revealed no Sodium Chloride 0.9% Solution (Normal Saline or NS) was available in a chilled state for use during an MH emergency. "A minimum of 3,000 milliliters of refrigerated cold saline solution for IV cooling" is recommended by the Malignant Hyperthermia Association of the United States (MHAUS). ().

The Nurse Manager stated this refrigerator was recently defrosted and there was a failure to place the 0.9% Sodium Chloride solution back into the refrigerator.

In addition, the Association of periOperative Registered Nurses (AORN) also provides recommendations about the treatment, necessary supplies and medications used in an MH emergency which generally parallel or refer to MHAUS. Supplies as referenced by these organizations were not found located in a central location (such as a dedicated MH Cart as referenced in the above MHAUS documents) - only an emergency box containing the medications was available.

A review of the hospital's Clinical Guideline titled " Malignant Hyperthermia (MH), Management of " (latest review/revision date provided: 11/2009), failed to indicate supplies and cold 0.9% sodium chloride solution (as recommended by MHAUS/AORN) be available for immediate use during an MH emergent situation.




27873


Based on interview and medical record reviews the hospital failed to:

1. For Droperidal: Maintain its Plan Of Correction (POC) for the improper administration of droperidol, cited during a State survey in March 2010. Ensure Pharmaceutical Services monitored the safe use of droperidol for six of the seven patients reviewed (Patients 37, 38, 39, 40, 41 and 42) per hospital P&P and FDA warnings. Ensure Pharmaceutical Services safely distributed droperidol and made certain droperidol was not available in the L&D OR.These failures placed patients at immediate risk for irregular heart rates and/or rhythms and sudden death.

2. Monitor the safe use of the Intensive Insulin Drip Orders (IIDO) protocol.

3. Ensure Medications on the 3rd floor nursing units, including high-risk medications, were contained in patient cassettes that were properly labeled, medications were stored in the right patient cassette (drawer) and the medications were removed when there was no longer physician's order for their use.

4. Identify, analyze and correct medication errors to improve patient safety.

5. To provide certain fluids and supplies that constitute a fully stocked Malignant Hyperthermia Medication (MH)/Supply Cart.

The lack of properly assessing drug use, identifying weaknesses in the drug use system and controlling the distribution of medications placed patients at risk for an adverse event.

Findings:

1. Droperidol was identified as being administered improperly during a State survey conducted on 3/24/10. The POC from the hospital showed the hospital would remove droperidol from the hospital's formulary and the drug would not be available for use.

Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicated the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicated droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart. A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.

For Patients 37 and 38, droperidol was administered in the ED, although contraindicated due to measured QT intervals. For Patients 39, 40, 41 and 42, droperidol was administered in the L&D OR with no documented evidence of a measurement of the patients QT interval, contrary to hospital policy.

The hospital's P&P protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads: "Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate droperidol is a second or third line antiemetic). A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, droperidol should NOT be given."

Despite the hospital's POC to make droperidol unavailable for use, the protocol described above, dated March 2012, identified that droperidol would be permitted to be used within certain parameters. However, review of medical records showed physicians continued to administer droperidol improperly outside the protocol parameters.

The medical records for Patients 37, 38, 39, 40, 41, and 42 were reviewed on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3.

a. Review of Patients 37 and 38's medical records showed QT intervals GREATER than the maximum identified in the hospital's droperidol protocol and in the BBW when administered by physicians in the ED.

Patient 37 is a 43 year old male. His record revealed droperidol was administered on 5/25/12 in the ED at 1330 hours. Documentation showed a QT interval of 467.

Patient 38 is a 62 year old female. Her record revealed droperidol was administered on 5/25/12 at 1546 hours, in the ED. Documentation showed a QT interval of 462.

b. Patients 39, 40, 41, and 42 each received droperidol in the L&D OR during Cesarean Section ( a surgical procedure during which one or more incisions (cuts) is made into the mother's abdomen and uterus to deliver one or more babies).

Patient 39 received droperidol on 5/26/12 at 2016 hours. There was no documentation in the record a QT was measured.

Patient 40 received droperidol on 5/26/12 at 0925 hours. There was no documentation in the record a QT was measured. There was no documentation in the record a QT was measured.

Patient 42 received droperidol on 6/1/12 at 1361 hours. There was no documentation in the record a QT was measured.

Contrary to hospital protocol and contrary to the FDA BBW there was no documented evidence the QT intervals for Patients 39, 40, 41, and 42 in the L&D OR were measured. With no QT interval measurement, there could be no determination if the administration of droperidol placed these patients in a potentially serious adverse position.

At the conclusion of the record review, RNP, RPH 2 and RPH 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42. RPH 3 stated droperidol was not supposed to be available in the L&D OR confirming Pharmaceutical Services did not control the distribution of droperidol. When asked, RPH 3 confirmed Pharmaceutical Services had not monitored the use of droperidol when the drug was again made available for use.

On 6/20/12 at 1627 hours, the hospital administration was notified of Immediate Jeopardy (IJ) to the health and safety of hospital patients due to the use of droperidol by physicians for patients contrary to the FDA BBW and hospital's P&P.

During a meeting with hospital administration on 6/21/12 starting at 1800 hours, MD E stated anesthesiologists in the OR had wanted droperidol available for use. The Medical Staff had not doubted the anesthesiologists would use the drug within the parameters of the protocol developed in March 2012. At that time the Medical Staff persuaded the hospital to make droperidol available within the parameters of the protocol; however, the drug was not to be available or used in the L&D OR.

On 6/21/12 at 1825 hours, the hospital's written plan of action to abate the IJ was accepted by the survey team. The plan of correction stated droperidol would immediately be removed from the hospital's formulary and removed from stock in the OR, ED and the L&D OR. MD E provided a copy of an e-mail sent to all physicians informing them droperidol would no longer be used in the hospital. After confirmation of the POC by the survey team through observation and staff interview the Immediate Jeopardy was abated at 1825 hours on 6/21/12.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. Patients 21, 22 and 54 were found to have received a total of 20 wrong doses of intravenous insulin. (Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death." The findings were confirmed by RNP 1 and RPH 2. RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.

3. Nursing unit 3 E on the Mission Viejo Campus was visited on 6/18/12 starting at 0850 hours, with RPH 2. The medication cart was opened revealing patient cassette drawers.

a.The drawer for Room A Bed 2 was reviewed with RN N. The drawer contained 2 vials of Lovenox. Lovenox is a special form of heparin which is administered either intramuscularly or subcutaneously to thin the blood. It is a high-risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA) strongest warning. The Lovenox vials were not labeled with a patient's name or directions for use. RN N, who was caring for the patient in Room A Bed 2, stated the patient had no order for Lovenox. Thus a high-risk medication with no patient label was sitting in a drawer for a patient who had no order for the drug creating an unsafe situation.

b.The drawer for Room B Bed 1 was reviewed with RN U. The drawer contained 1 vial of Humulog insulin and 1 vial of Humulin R insulin. Neither vial was labeled with a patient's name or directions for use. RN U, caring for the patient in Room B Bed 1 said there was an order for Humulog for that patient but not for Humulin R. Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS).

Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death."

Thus, two different dosages of insulin, a high-alert medication, were sitting in a drawer for a patient with no patient label; one was ordered for the patient the other was not, creating the potential for a serious adverse event.

Nursing unit 3 W on the Mission Viejo Campus was visited on 6/18/21 starting at 0945 hours with RPH 2. The medication cart was opened revealing patient drawers.

c. The drawer for Room C Bed 2 was reviewed with RN Q. The drawer contained the following medications, all with no patient name or directions for use: Lactulose (an osmotic laxative), Docusate (a stool softener), Furosemide (a diuretic which is used to increase urination), Celebrex (an anti-inflammatory drug used to relieve pain. It is a high-risk medication that contains a Black Box Warning (BBW) and senna (a stimulant laxative). According to RN Q, there was no patient assigned to room Room C Bed 2. So, unlabeled and unauthorized medications were sitting in a drawer assigned to a bed with no patient in the bed creating another opportunity for a potential adverse event.

d. The drawer for Room D Bed 1 was reviewed with RN V. The drawer contained promethazine. Promethazine is both an anti-emetic (to relieve nausea and vomiting) and an antihistamine (to relieve allergic symptoms). Promethazine is also a high-risk drug with a Black Box Warning (BBW). RN V, who was caring for the patient in Room D Bed 1, stated the patient was no longer on promethazine, it had been discontinued the day before. Yet the high-risk medication was still available for use which created another potential adverse event.

e. The drawer for room Room E Bed 1 was reviewed with RN M. The drawer contained Megace. Megace is a drug used to treat breast and endometrial cancer. Lexicomp, a nationally recognized drug information source identifies Megace as a hazardous agent which is to be used with "appropriate precautions for handling and disposal". RN M stated the patient in Room E Bed 1 had no physician's order for Megace. RN M stated it was for a previous patient who had been discharged. So, we have yet another opportunity for a patient to receive unauthorized medication which is considered hazardous.

f. The drawer for Room F Bed 1 was reviewed with RN M. The drawer contained Humulin R insulin which was not labeled with a patient's name or directions for use. According to RN M, who was caring for the patient in Room F Bed 1, there was no physician's order for Humulin R insulin. As described in the visit to 3 E, under (b) above, insulin is a high-risk drug that could result in serious patient harm.

RPH 2 stated that pharmacy was not aware the above referenced medications were stored in the patient drawers.


4. The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."

Data provided by RPH 2 identified there were 336 medication errors reported in 2010, and 399 errors reported in 2011, for both the Mission Viejo and Laguna Beach Campuses. Data provided by RNP 1 identified there were a total of 92,000 patient days in 2010 and 94,000 in 2011.

Thus, according to the research performed by the IOM, the hospital should be reporting, on average, about 93,000 errors per year (the average patient days for 2010 and 2011) or more than 200 times the number of errors actually reported (93,000/400).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from three hospitals between October 1 and October 31, 2004, were reviewed using the Institute for Healthcare Improvement's Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:
a) 38% of identified adverse events were medication errors.
b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.

The hospital's data also showed there was a yearly average of about 23,000 discharges in 2010 and 2011. According to the HA study, the hospital should be reporting about 122,000 (5.3 x 23,000) errors per year rather than the 400 per year actually reported. So, according to the HA study, the hospital should be reporting more than 300 times the number of errors actually reported.

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011" identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

During an interview with RPH 1, RPH 2 and RPH 3 on 6/21/12 starting at 1425 hours, they stated they knew the hospital was underreporting medication errors but they had to focus on priorities first such as entering physician orders.

Based on observation at the Mission Viejo campus, interview and document review, the hospital failed to follow their P&Ps for the storage and labeling of medications.
Findings:
A review of the hospital's P&P titled "Medication, Labeling and Storage" Code CPC-2011JUN-1.M.3.9 showed drugs shall be labeled only by persons legally authorized to prescribe or dispense, or under the supervision of a pharmacist.

A review of the hospital's P&P titled "Pyxis Medstation" Code CPC-2012MAR-1.M.3.14 showed selected floor stock will be placed in each Pyxis Medstation (ADC) in accordance with the medications normally used on that unit; the nurse will follow Medstation procedures for removing items from the unit, and any medication removed from the medstation, but not administered to the patient, must be returned to the Medstation as soon as possible.

During a tour of the Endoscopy Suite on 6/18/12 at 1445 hours, a bag containing a 10 ml syringe of normal saline, a 1 mg/ml vial of epinephrine (a drug used as a heart stimulant or to treat allergic reactions), and a needle was observed in a cabinet. The attached label, included the above ingredients and also stated one alcohol wipe was stored in this kit but was not available. The attached label did not include a preparation date and time or the initials of the pharmacist who checked or prepared the bag.
During an interview with the Pharmacy Clinical Manager on 6/18/12 at 1510, he stated the kit should have been in the ADC and it should have been signed or initialed by a pharmacist who checked or prepared the bag.
There was no indication or evidence presented by the facility that this bag was labeled by a person authorized to prescribe or dispense or under the supervision of a pharmacist.
There was no indication that the storage of this medication bag was permissible outside of the automated dispensing cabinet.

Based on observation and interview, the hospital failed to ensure an unmonitored cart containing medications used for epidural anesthesia on the L&D unit was kept locked to prevent access by unauthorized individuals.

Findings:

The hospital's P&P Medication Labeling and Storage, last revised date 6/11, showed drugs shall be accessible only to authorized personnel designated by the hospital in accordance with state and federal regulations.

The L&D Unit was toured on 6/18/12 at 1415 hours, with RN D. Located in the hallway outside of a patient room was a cart labeled "Epidural Cart."

No other staff was observed in the area. The drawers of the cart were not locked.

When inspected, the Epidural cart contained multiple vials of lidocaine, bupivacaine, (anesthetic medications used for peripheral nerve blocks) and epinephrine, (drug used as a heart stimulant or to treat an allergic reaction), syringes and needles.

When asked, RN D stated the cart was used by the anesthesiologist and should be kept locked.

Based on observation and staff interview, expired medication vials and biologicals were found available for patient use in the OR and the ED of the Mission Viejo Campus. Patient use of outdated medications and biologicals offered no assurance of its maximum efficacy.

Findings:

A. On 6/18/12 at 0930 hours, during the initial tour of the ED accompanied by OA 1, more than a dozen vials of expired sterile water, dated 3/12, were found inside the unit's wound dressing cart available for patient use. Inside the unit's pediatric crash cart, a box of expired glucometer strips to test blood sugar level was also found.




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B. During a tour of OR 1 on 6/18/12 at 1125 hours, a clear plastic box secured with a plastic lock and containing medications was seen. A label on the side of the box indicated the next medication to expire was lidocaine, expiration date 10/1/12. However, through the clear plastic cover of the box was seen a cardboard box of Epinephrine 1:10,000, 1 ml, with the expiration date of 6/1/12.

During a concurrent interview with RN J, she confirmed the expiration date on the epinephrine box.

Based on interviews and medical record reviews, Pharmacists failed to identify and report medication errors for the administration of:

* Droperidol - (Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates that droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.)

* Intravenous (IV) insulin - (Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.")

The improper administration of droperidol and IV insulin which were not identified and were, therefore, NOT reported to the prescribing physician or to the hospital quality assurance program.

Findings:

1. On 6/20/12 starting at 1325 hours, seven patient records were reviewed with RNP 1, RPH 2 and RPH 3. Two of the seven patients reviewed (Patients 37 and 38) were found to have received doses of droperidol although their QT intervals were GREATER than 450 msec.

Four of the seven patients reviewed (Patients 39, 40, 41 and 42) received droperidol in the L&D OR. There was no evidence the QT intervals for these patients were measured. The findings were confirmed by RNP 1, RPH 2 and RPH 3. RPH 3 stated Pharmacists were not able to monitor the use of droperidol as they did not have enough time to do so.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. Patients 21, 22 and 54 were found to have received a total of 20 wrong doses of intravenous insulin. The findings were confirmed by RNP 1 and RPH 2.

RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.

Based on interview and document review, the hospital failed to follow their P&P to resolve controlled substance discrepancies at the Mission Viejo Campus. This could potentially result in diversion of controlled substances.

Findings:

A review of the hospital's P&P titled Pyxis Medstation (Code CPC-2012MAR-1.M.3.14) showed the nurse would follow Medstation procedures for removing items from the unit and enter the inventory count when accessing a controlled substance. The off-going charge nurse would verify there were no count discrepancies noted on the Pyxis (ADC) screen. A discrepancy icon would be prominently displayed on the Pyxis screen if there was a discrepancy in that cabinet. The pharmacist would review all narcotic discrepancies daily. If a discrepancy was unclear or incomplete, the charge nurse would be notified immediately for clarification. All unresolved discrepancies must be reported using established department procedures. In addition, the department manager and the Director of Pharmacy must be notified. "AT THE END OF EACH SHIFT THE CHARGE NURSE WILL VERIFY THAT ALL DISCREPANCY REPORTING HAS BEEN COMPLETED" by running a discrepancy Report. Information regarding any discrepancies that had not been resolved shall be forwarded to the Nurse Manager.

Six months of ADC Discrepancy Monitoring Reports were requested for review of controlled substance accountability (November, 2011 through April, 2012) at both the Mission Viejo Campus and the Laguna Beach Campus. There were no unresolved discrepancies noted at the Laguna Beach campus. At the Mission Viejo Campus, 260 of 463 discrepancies (58.1%) were not resolved accurately based on the reports provided.

Based on observation, interview and record review, the hospital failed to ensure that one piece of radiologic equipment, the Laguna Beach Campus B operating room fluoroscopy unit, was subjected to routine periodic inspection, creating the risk of malfunctioning and a substandard health outcome to surgical patients needing fluoroscopy studies.

Findings:

The hospital policy, Periodic Maintenance Program (revision date 2/2012), read in part, "Periodic Maintenance shall be scheduled as follows: Devices classified as having average or minimal maintenance requirements shall be scheduled for annual inspections. Devices classified as having extensive maintenance requirements shall be scheduled for semi-annual inspections."

During a tour of OR 5 on 6/18/12 at 1550 hours, observation of the C-arm fluoroscopy unit labeled OEC9800 Plus GE did not show a maintenance sticker attached.

The RT Supervisor was interviewed on 6/18/12 at 1605 hours. The Supervisor stated he did not know when maintenance was last performed on the machine.

The Asset Record for the 9800 C-arm was reviewed on 6/19/12. Preventive maintenance was performed on the unit 12/11/09, 5/28/10, 11/23/10, and 5/7/11, but not in 2012. The document indicated preventive maintenance was due by 5/16/2012.

Based on observation, interview and record review, the facility failed to ensure that medical staff who were exposed to radiation were monitored for radiation exposure per facility policy, creating the risk of unsafe radiation exposure.

Findings:

The hospital's P&P, Radiation Monitoring of Personnel revised 6/08, read in part, "(Hospital name) will supply appropriate personnel monitoring badges/devices to and shall require use of monitoring devices by each individual who works in a controlled area where exposure to radiation is possible."

a. During a tour of the Mission Viejo Campus near the surgical suite on 6/18/12 at 1045 hours, the radiation safety badges and badge readout log dated 5/9/12 were reviewed.

During a concurrent interview with the Interim Manager of Surgical Services and RN J, they were asked to name physicians who performed surgical services in the hospital using fluoroscopy (a technique using radiation). The name of MD C was provided.

RN J reviewed the radiation safety badge log and viewed the badges, and stated that there was no badge for MD C, and that his name did not appear on the log. RN J stated the badges were supplied by the radiology department and it was the hospital's policy for the physicians to wear the badges. RN J stated a physician would be reported if providing services using radiation while not wearing a badge.

During a review of the credential file for MD C on 6/19/12, the file indicated the physician was an active medical staff member who had been providing services in the hospital since 2004. MD C's fluoroscopy license had been renewed and was to expire in 2014.

b. During a tour of the surgery area at the Laguna Beach Campus on 6/18/12 at 1500 hours, the surgical schedule from 6/15/12, was reviewed. A surgery by MD B utilizing a C-arm (also called a fluoroscopy unit-equipment that emits radiation) was on the schedule. Review of the physician radiation safety badges showed there were only three physician radiation safety badges. No radiation safety badge was seen for MD B.

During interviews with the Nurse Manager of Surgical Services Laguna Beach Campus on 6/18/12 at 1500 and 1550 hours, she stated she thought radiation safety badges were being kept by the physicians. The Nurse Manager stated she thought the use of the radiation safety badges was being left up to the physicians.

During an interview with the RT Supervisor Laguna Beach Campus on 6/18/12 at 1550 hours, he stated he did not have the most current radiation badge log, but was not aware of any physicians being recently added to the badge log. The RT Supervisor reviewed the badge logs from from the year 2011, and stated he did not see MD B listed on the logs. The RT Supervisor stated everyone operating within the fluoroscopy unit should have a badge.

During a review of the credential file for MD B on 6/19/12, the file indicated the physician was an active medical staff member who had been providing services in the hospital since 1992. MD B's fluoroscopy license had been renewed and was to expire in 2013.

The Manager of Medical Staff Affairs was interviewed on 6/19/12 and stated she was not sure of the process for providing radiation safety badges to medical staff members.

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department. Cross Reference to A-0619, A-0620, and A-0749 #1a and b.
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2. Ensure the nutritional needs of patients were met as evidenced by the lack of portion size availability during meal service, the nutrition analysis of menus not consistent with the therapeutic diet orders, nutrition analysis based on established recipes while staff use convenience food items. Cross Reference A-0630.

3. Develop performance improvement activities that reflected the scope and nature of the services and identified opportunities for improvement. Cross Reference A-0276.

4. Ensure safe and effective food storage/production practices. Cross Reference A-0749 #1.

5. Ensure that the current, approved Diet Manual was accessible on the hospital units at the Laguna Campus and included the different types of therapeutic diets routinely ordered at the hospital. Cross Reference A-0631.

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioners orders and acceptable standards of practice.

Based on food storage, production and service observations, dietary staff interview, and dietary document review, the hospital failed to ensure that the specific food and dietetic services organization requirements were met. The lack of organization and oversight of the dietary department resulted in deficient practice in multiple areas related to food safety, service, sanitation and storage.

Findings:

During several interviews with the Food and Dietetic Service Director (FSD) from 6/18-6/21/12, there were observations made that reflected lack of oversight of food service operations. During the interviews conducted with the FSD, she indicated that while she bore the ultimate responsibility of foodservice operations, she managed the day to day foodservice operations through the use of an Assistant Director of Nutrition Services (who had primary oversight responsibilities at the Laguna Campus) and a Clinical Nutrition Manager. The FSD was qualified to serve in the role of FSD based on a four-year degree in Home Economics, but acknowledged that she was not a Registered Dietitian (RD).

The position description of the Assistant Director of Nutrition Services showed the following: "Supervises staff assigned to non-patient food services, Managing Chef, Assistant Chef, and Food Production staff." However, the Nutrition Care Assistants and the RD at the Laguna Campus also reported to the Assistant Director of Nutrition Services.

On 6/21/12 at 1430 hours, review of the Personnel File of the Assistant Director of Nutrition Services, showed that, while he had multiple years of foodservice experience, he did not possess the qualifications per the State requirements to independently provide oversight of the food service department at the Laguna Campus, nor did he possess the competencies in nutritional care to appropriately supervise the RD and Nutrition Care Assistants.

The position description of the Clinical Nutrition Manager (CNM) showed no expectation of the CNM (who is an RD) to provide day to day oversight and guidance to the dietary department as related to foodservice and sanitation operations.

The RD also acknowledged in an interview on 6/21/12 at 0905 hours, that she provided input into policy development and menus and interacted with the Chef at the Mission Campus, but provided limited oversight of foodservice operations and staff at the Laguna Campus.

The dietary department's organizational chart also did not place the CNM in a position where she would provide oversight of foodservice operations, only clinical services.

As a result of this management organizational structure, the FSD was not fully aware of the issues that affected safe food handling practices, disaster food supplies, meal service and patient care.

For example, although there was a cool down procedure at the hospital, there was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. Food storage practices identified during the survey process revealed deficient practices such as storing raw fish directly above ready to serve food products. Trayline was being served three times a day at the Laguna Campus with the absence of portion size guidance to staff, disaster food supplies for pureed diets were expired, available diet manuals at the Laguna Campus were not current and were not consistent with the approved diet manuals, etc. Cross Reference A-0749 #1 and #2, A-0620, A-0630, and A-0631.

Based on food storage and food production and service observations, dietary staff interview, and dietary document review, the hospital failed to ensure the Food and Dietetic Service Director developed and monitored written procedures according to standards of practice for operational processes at the hospital's Mission Viejo and Laguna Beach Campuses. Failure to develop and monitor standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

The hospital failed to ensure food intended as part of the hospital's disaster plan was maintained at appropriate temperatures at all times at the Laguna Beach Campus and at the Mission Viejo Campus that the emergency food was not expired. Failure to maintain disaster foods at the correct temperatures and to ensure that food items were not expired may result in lack of availability of an adequate food supply in the event of a disaster, compromising the medical status of patients.

Findings

1. During several interviews with the Food and Dietetic Service Director (FSD) from 6/18 to 6/21/12, there were observations made that reflected lack of oversight of food service operations. During the interviews conducted with the FSD, she indicated that while she bore the ultimate responsibility of foodservice operations, she managed the day to day foodservice operations through the use of an Assistant Director of Nutrition Services (who had primary oversight responsibilities at the Laguna Campus) and a Clinical Nutrition Manager.
As a result of this management organizational structure, the FSD was not fully aware of the issues that affected safe food handling practices. For example, although there was a cool down procedure at the facility, there was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. Food storage practices identified during the survey process revealed deficient practices such as storing raw fish directly above ready to serve food products. Cross Reference A-0749 #1.

During random review of selected departmental policies and procedures related to identified deficient practices in dietetic services, it was noted policies did not consistently provide sufficient procedural guidance that reflected current standards of practice or the department had not developed procedural guidance for all functions.

a. There was no procedure that provided comprehensive guidance to staff on the proper washing of produce (specifically items such as cantaloupes that can be considered potentially hazardous foods).

b. There was no documented monitoring of safe cool down of potentially hazardous foods.

c. The position description of the Clinical Nutrition Manager did not include the State Regulatory Requirement of oversight of dietary operations.

d. The position description of the Assistant Director of Nutrition Services showed the following: "Supervises staff assigned to non-patient food services, Managing Chef, Assistant Chef, and Food production staff. However, the Nutrition Care Assistants and the Registered Dietitian at the Laguna Campus also reported to the Assistant Director of Nutrition Services. Cross Reference A-0619.
In an interview with the FSD on 6/21/11 at 0905 hours, performance indicators for 2011 were reviewed. Documentation showed the dietary department was submitting data on multiple processes within the department. Cross Reference A-0276.

The FSD acknowledged that all of the indicators of the department were meeting departmental set thresholds. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of safe food handling systems within the department including staff practices of hand washing and maintaining clean environment.

2. On 6/19/12 at starting at 1020 hours, at the Laguna Beach Campus food service the following were observed with concurrent staff interviews:

a. The Assistant Director of Operations stated the facility used a product for washing and reducing pathogens in fruit and vegetables.

Cook 3 stated during the observation that all fruit and vegetables were soaked for 10 minutes in the antimicrobial fruit and vegetable wash before they were pealed or prepared for service. Cook 3 stated all fruits including cantaloupe were just soaked. He stated there was no brushing to remove dirt or debris in the netting of the exterior of the cantaloupe.

Review of the manufacturer's literature on 6/19/12 at 1130 hours, showed the antimicrobial wash directions for a soak-wash procedure stated to "agitate and brush produce as needed."

Review of the FDA Food Code 2009 showed raw fruits and vegetables should be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready to eat form.

The facility practice did not adequately clean the cantaloupe or other membranous or ground grown vegetable to ensure imbedded dirt and debris was removed to prevent growth of microorganisms from the surface of the vegetables and fruit prior to cutting and preparing for service.

3. Starting on 6/18/12 at 0900 hours, at the Mission Viejo Campus food service the following were observed with concurrent staff interviews:

a. The cooling down of potentially hazardous foods (foods that require time/temperature control for safety to limit pathogenic microorganism growth or toxin formation) had not been done in accordance with the hospital's policy and procedure. Cross Reference to A-0749 #1.

b. The 3-compartment sink (wash and sanitize food service equipment) temperature taken by the Executive Chef of the wash compartment was 90.8 degrees F. The Executive Chef stated, "It should be 110 degrees F."

The hospital's policy and procedure entitled Warewashing (last revised 3/09) indicated, "Purpose: To maintain safe infection control standards, all utensils used for eating, drinking and in the preparation and serving of food and drink shall be cleaned and disinfected or discarded after each use..., Three-Compartment Sink Dish Washing Procedure; ...The "wash water shall be 110 degrees F."

Wash solution temperature that is less than 110 degrees F may inhibit removal of organic matter, such as animal fats, and the performance of the detergent may be adversely affected. (FDA Food Code 2009)

4. During the lunch tray line (patient meal tray assembly), there was a reach-in refrigerator with five thawed, 4 fluid ounce cartons of "health shake." The individually packaged health shakes contained manufacturer's guidelines that indicated, "Use within 14 days of thawing."

The Director of Food Service and the Retail Manager both stated the health shakes were not dated as to when they were thawed to ensure they were used within the manufacturer's recommended shelf-life

5. The walk-in freezer contained one six pound frozen, sealed and unopened beef tenderloin, undated. The Director of Food Service and the Retail Manager both stated they could not determine how long the frozen meat had been in the freezer since it was taken out of its packaging box that had contained the label with the date.

The Director of Food Service and the Retail Manager acknowledged that without a date on the frozen meat, dietary staff would be unable to ensure that it was used within the hospital's policy and procedure for storage of frozen foods to ensure food quality.

6. The dry food storage room contained seven nutritional supplements, designed for patients with kidney disease, that contained an expiration date by the manufacturer of "6/1/12." The Director of Food Service and the Retail Manager stated they did not know what that date meant.

On 6/21/12 at 1350 hours, the Clinical Nutrition Manager stated the date of 6/1/12, that was on the nutritional supplements was a discard date. The Clinical Nutrition Manager acknowledged the expired nutritional supplements should not have been available to dietary staff to provide for patient use.

6. On 6/19/12 at 1325 hours, observation of the disaster food supply at the Laguna Beach Campus showed eight cases of peaches baby food with an expiration date of 3/23/11; three cases of chicken and gravy baby food with an expiration date of 9/30/11; a case of baby rice cereal with an expiration date of January 2011; and a case of Enfamil Infant formula with an expiration date of 9/1/11.

On 6/19/12 at 1330 hours, in an interview with the Dietary Management staff member present during the observation, he confirmed the expired items were intended for patients who were prescribed pureed diets. The Dietary Management staff member stated the food should have been discarded.

On 6/19/12 at 1335 hours, review of the hospital's P&P titled "Disaster Meal Plan," showed the baby food items were intended to be served to patients prescribed pureed diets as follows: Rice Cereal, Chicken, Carrots, Peaches and Infant Formula. Four of the five food items intended for the pureed diets were expired.

7. On 6/21/12 starting at 1130 hours, the Director of Nutrition Care Services stated the hospital's disaster food at Mission Viejo Campus consisted of self-heating meals stored in the back of the Mission Viejo hospital in a metal storage conex structure (large metal storage container). The Director stated the conex had a thermometer but there was no documentation of the temperature inside the storage container.

Review of the manufacturer's directions gave sustained storage temperatures ranging from 60 degrees F to 120 degrees F coordinated to the estimated shelf life for each temperature range. The Director of Nutrition Care stated they planned the storage at 80 degrees F and based the shelf life on this temperature.

Based on medical record review and staff interview the hospital failed to ensure qualified dietitians supervised the nutritional aspects of patient care for three of three patients reviewed (Patients 24, 43, and 44) when nutrition information required for accurate and complete nutritional assessment was not included. Patients' therapeutic cardiac or renal diet orders were not met in accordance with orders of the practitioner responsible for the care of the patient. Failure to implement a physician's therapeutic diet order had the potential to compromise patient's medical status. This failure put patients at risk of jeopardizing patient medical care.

Findings:

1. Patient 43 was admitted 6/6/12, with diagnoses of diabetes mellitus with diabetic ketoacidosis (a dangerous complication of diabetes mellitus in which the chemical balance of the body becomes far too acidic) and dehydration.
Review of the nutrition assessment for Patient 43 dated 6/11, 6/14, and 6/18/12, showed a current weight of 155.0 pounds. Review of the admission nursing screen dated 6/7/12, showed the admission weight was 155.0 pounds by scale.
Review of the Care Activity Assessment showed the patient's weight by scale on:
6/8/12 161.0 pounds
6/9/12 163.7 pounds,
6/10/12 169.8 pounds
6/11/12 160.9 pounds
6/12/12 161.4 pounds
6/13/12 146.2 pounds
6/14/12 158.3 pounds
6/15/12 157.0 pounds
6/16/12 148.8 pounds
6/17/12 151.1 pounds
6/18/12 147.2 pounds

Review of the nutrition assessments dated 6/11, 6/14, and 6/18/12, all showed the patient's current weight as 155.0 pounds. The assessments also showed the patient as having IV fluids and 1800 calorie ADA (American Diabetic Association) diet.
During an interview with RD 1 on 6/ 20/12 at 1040 hours, the RD stated he did not monitor the weights taken on the unit and did not use the current weights in the nutrition assessment. RD 1 acknowledged that patient weight and weight changes over time were important aspects of a complete nutrition assessment

2. Patient 44 was admitted to the hospital on 5/22/12. He had sore throat on admission and was treated with antibiotics. On 5/31/12, the history and physical identified a diagnosis of thrush (oral yeast infection). Symptoms included mouth pain and difficulty swallowing. Records show the Thrush was treated for a week until approximately 6/7/12.

Review of the nutrition assessments for Patient 44 dated 6/1, 6/5, and 6/8/12, did not show documentation of, or an assessment of the diagnosis of thrush, or an assessment of food tolerance or intolerance.

On 6/20/12 starting at 1230 hours, RN S stated each morning the RN would assess the patient's food intake and would refer any concerns to the RD or the physician. RN S stated Patient 44 was eating and was being treated for oral thrush. The RN stated the patient was not referred to the RD for assessment. RN S stated she would bring nutritional concerns to the RD or physician after she assessed the patient and thought there was a problem to refer.

3. According to the hospital's P&P entitled Diet Manual, Mission (last reviewed 4/2011), showed "The Nutritional Care Services Department provides accurate diet modifications as prescribed by the physician in accordance with the approved Diet Manual."

On 6/18/12 at 1600 hours, Patient 24's medical record was reviewed at the Mission Viejo Campus. Patient 24 was admitted to the Mission Viejo Campus on 5/31/12, with diagnoses that included end-stage renal (kidney) disease on peritoneal dialysis (a filtering technique that uses the patient's own body tissues inside the abdominal cavity as a filter due to lack of functioning by the kidneys).

On 5/31/12, Patient 24 was prescribed a renal diet (a therapeutic diet for kidney disease) according to the physician's order.

On 6/18/12 at 1650 hours, the Clinical Nutrition Manager stated the hospital had defined a Renal diet order to be 80 grams protein, 2 grams sodium, 2 grams potassium, 1.5 grams phosphorus/day in accordance with the hospital's policy entitled Diet Orders and Changes (last reviewed 12/11).

On 6/18/12 at 1655 hours, the Clinical Nutrition Manager showed the nutrient analysis that was conducted for the patient menus that were provided for a renal diet order. The menu nutrient analysis indicated the menus on a weekly average provided 82.775 grams of protein, 4.427 grams of sodium, 2.27 grams of potassium, and 1.05 grams of phosphorus. The nutrient analysis was dated 4/23/12, and was signed by the Clinical Nutrition Manager.

On 6/19/12, the Clinical Nutrition Manager stated she re-ran the nutrient analysis of the patient menus that were provided for a therapeutic renal diet because she had determined some of the items entered into the nutrient data base were inaccurate. The revised nutrient analysis that was conducted on the original renal menus indicated, "71.645 grams of protein, 2.38 grams of sodium, 1.94 grams of potassium, and .70 grams of phosphorus." The Clinical Nutrition Manager acknowledged that the nutrient analysis remained too high in sodium, and under in the protein requirement for the hospital approved therapeutic renal diet order.

On 6/18/12, during the same interview with the Clinical Nutrition Manager, she stated the hospital approved cardiac diet was defined as 50 grams of fat per day, 300 mg of cholesterol and 2 grams sodium per day.

On 6/18/12, the Clinical Nutrition Manager provided the nutrient analysis for the patient menus with a therapeutic cardiac diet order. The analysis results were that the weekly average of the cardiac patient menus provided 61.349 grams of fat, 562.993 mg of cholesterol, and 4.779 g of sodium per day. The nutrient analysis was signed on 4/23/12, by the Clinical Nutrition Manager.

On 6/19/12, the Clinical Nutrition Manager stated that the above nutrient analysis used incorrect data entry nutrition items for the eggs. The Clinical Nutrition Manager stated she corrected the issue and had a revised cardiac menu nutrient analysis. The revised nutrient analysis indicated the cardiac menus provide a weekly average of 48 grams of fat, 369.998 mg of cholesterol, and 2.379 grams of sodium per day. The cardiac menu provided to patients with a therapeutic cardiac diet order was not in accordance with the therapeutic cardiac diet order prescribed by the practitioner.

According to the hospital's policy and procedure entitled Diet Manual, Mission (last reviewed 4/2011), "The Nutritional Care Services Department provides accurate diet modifications as prescribed by the physician in accordance with the approved Diet Manual."

Based on observation, dietary staff interview and record review, the hospital failed to ensure the competency of a cook responsible for working with the grill and deep fat fryer at the Laguna Beach Campus, as related to emergency response in the event of a fire in the cooking area. Failure to ensure staff competency in this task had the potential to result in an uncontrolled fire that may spread to other parts of the hospital and endanger the lives of staff, patients and visitors.

Findings:

On 6/19/12 at 1100 hours, while FSW 4 was utilizing the grill in the kitchen at the Laguna Beach Campus, the employee was asked what he would do in the event of a fire in the grill or the adjoining deep fat fryer area. The employee stated he would dial 777 on the phone mounted on the wall, utilize the available extinguisher and evacuate. When asked about the nozzles noted above the grill, FSW 4 stated they were sprinklers that came on automatically in the case of a fire.

On 6/19/12 at 1110 hours, in an interview with the Assistant Facilities Director regarding the nozzles above the grill, he stated the nozzles were part of the fire suppression system, designed to dispense a chemical to douse a fire in the grill area. The Assistant Director stated the fire suppression system was activated by pulling the ring located next to the walk in freezer on the left side of the kitchen. The Assistant Director stated the system did not automatically activate. The Assistant Director pointed to a sign above the mounted fire extinguisher that read, "First activate cooking hood fire system before using this extinguisher." The Assistant Director further stated the emergency number that should be dialed was 711 and not 777.

On 6/21/12 at 1430 hours, review of FSW 4's personnel file showed he received orientation on 10/6/09, with performance validation related to emergency codes and procedures. There was no other evidence of documented training provided to FSW 4 related to emergency response for a fire on the grill in the kitchen area where the employee worked on a daily basis.

Based on clinical record review and staff interview, the hospital failed to ensure one patient (Patient 45) was appropriately screened by the Nutrition Care Assistant and two patients (Patients 12 and 45) had nutritional assessments completed by the Registered Dietitian (RD) that were comprehensive in nature. This could potentially result in the hospital failing to meet the nutritional needs of the patients.

Findings:

1. On 6/20/12 at 1230 hours, review of the hospital policy titled "Nutrition Assessment of Patients" showed that one of the criteria for referral to the RD was unintentional weight loss of more than 10% in the past 6 months.

On 6/20/12 at 1300 hours, review of the medical record for Patient 45 showed Physician's Orders dated 6/4/12, indicating the patient's age, admission date, and height and weight. The History and Physical dated 6/4/12, and the internal medicine consultation note dated 6/5/12, indicated the patient was diabetic and claimed to have lost 30 pounds in the last 6 months due to diabetes, and had multiple co-morbidities.

On 6/4/12, the patient's diet was prescribed as a 1800 calorie diabetic and adjusted to a 1500 calorie diabetic diet on 6/12/12. On 6/16/12, physician's notes indicated to increase fluids (not high in sugar).

Daily nursing notes showed the patient was non-compliant with diet, consumed up to seven popsicles a day, was confused and wandered around.

Review of the Nutrition Care Assistant 1's nutrition screen dated 6/4/12, showed the patient's Ideal Body Weight was documented as 0 pounds and the weight change section was documented as, "No Weight Change." The patient was not referred to the RD for follow-up.

On 6/20/12 at 1320 hours, in an interview with RD 1, he stated he was not sure why the nutrition screen did not contain ideal body weight information but suspected the height and weight were not available at the time the nutrition screen was completed. There was no other nutrition screen for Patient 45 located in the medical record.

On 6/21/12 at 1355 hours, in an interview with the Clinical Nutrition Manager, she acknowledged that the Nutrition Screen was incomplete and the Nutrition Care Assistant should have followed up, or flagged the screen for follow-up, by another member of the Nutrition Care Services team in the absence of pertinent information to ensure a complete and accurate screen was completed.

Further review of the Patient 45's medical record showed that RD 1 completed the nutritional assessments for the patient on 6/11/12 and 6/18/12. There was no mention of the patient's reported 30 pound weight loss and whether it was desirable or not. There was no mention of the patient's non-compliance with diet or the physician's order to push fluids. There was no documentation of the nutrition care department's ability to provide sugar free popsicles that would help provide a form of fluids to the patient without compromising blood sugar levels since the patient was a diabetic. There was no documentation of the patient's "confusion" and whether it could possibly be related to the patient's diagnosis which was the primary reason for admission.

On 6/20/12 at 1320 hours, in an interview with RD 1, he acknowledged he did not reflect the patient's reported weight loss in his assessment. A history of the patient's weight was obtained and showed that the patient weight in October, 2011, so the weight loss was close to 13 pounds versus 30, but there was still no indication whether it was a desirable weight loss or not. RD 1 acknowledged that the patient's compliance and fluid status were not reflected in his assessments. RD 1 stated he did not follow-up on the patients confused.

On 6/20/12 at 1230 hours, review of the hospital policy titled "Nutrition Assessment of Patients" showed the following: "The Dietitian or Diet Tech gathers information including screening data, pertinent labs, medications, medical history and physical, and progress notes from the patient's chart. The Dietitian or Diet Tech communicates with members of the Multidisciplinary Patient Care Team to complete the assessment, determine appropriate intervention and make recommendations."

2. On 6/20/12 at 1040 hours, review of the medical record for Patient 12 showed the patient was admitted on 6/14/12, with kidney failure and diarrhea for six days related to Clostridium Difficile (bacterial) infection. An interview was conducted with Patient 12 at 1000 hours. The patient stated he had been a diabetic for many years and was aware of the diabetic diet restrictions. The patient stated he was now on dialysis but was not aware of any dietary or food restrictions that were necessary based on his condition. Patient 12 stated that he thought he should be drinking about a gallon (3840 cc) of fluids per day.

Review of the nutrition assessment completed by RD 1 on 6/15/12, showed the Patient 12's fluid needs were not assessed and were instead deferred to the physician since the patient was on hemodialysis.

Review of the intake and output record for Patient 12 showed the following:
6/16/12: Intake 1050, Output 0
6/17/12: Intake 1350, Output 200
6/18/12: Intake 690, Output 0
6/19/12: Intake 1260, Output 2000

It was also noted that the patient was dialyzed on 6/17/12 and 6/19/12 with an additional dialysis session scheduled on 6/20/12.

Review of RD 1's follow-up nutritional assessment dated 6/19/12, showed no evaluation of the patient's intake and output status and whether the patient's current fluid intake was appropriate. RD 1 could not provide additional information regarding the adequacy of the patient's fluid intake.

Based on observation, staff interview and diet manual review, the hospital failed to ensure:

1. A current diet manual was accessible on the hospital units at the Laguna Beach Campus and included the different types of therapeutic diets routinely ordered at the hospital. Deficient practice related to this requirement may result in patients not receiving therapeutic diets as prescribed by the physician.

2. An approved diet manual at the Mission Viejo Campus contained hospital specific guidance on a hospital approved renal, cardiac, and diabetic therapeutic diet orders. A non-customized diet manual which did not reflect how the hospital prepared and implemented physicians' diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order.

Findings:

1. On 6/20/12 at 1140 hours, RD 1 was asked about the availability of a Diet Manual on the ICU unit at the Laguna Beach Campus. RD 1 stated the diet manual was available online and it was the 2009 Edition of the Food and Nutrition Services Diet Manual. When asked how staff would access the diet manual in the event the computer system was down, RD 1 stated there was a hard copy at the nursing station. Review of the hard copy of the Diet Manual on the ICU unit showed it was the 6 th Edition American Dietetic Association Diet Manual published in the year 2000, and not the 2009 Edition of the Food and Nutrition Services Diet Manual.

On 6/20/12 at 1145 hours, RN X was interviewed regarding how to access the diet manual on the Medical Surgical unit. RN X appeared confused about what a diet manual was. When explained to her that it was a resource document for patient nutritional intake, diets and possible educational material, RN X stated it would be a manual in the room used by staff for computer documentation in the medical record. RN X indicated she was aware of the availability of the diet manual online. Review of the hard copy diet manual on the Medical Surgical unit also showed it was the 6 th Edition American Dietetic Association Diet Manual published in the year 2000, and not the 2009 Edition of the Food and Nutrition Services Diet Manual.

On 6/20/12 at 1235 hours, review of the availability of a hard copy diet manual on the Chemical Dependency Unit also showed it was the 6 th Edition American Dietetic Association Diet Manual published in the year 2000, and not the 2009 Edition of the Food and Nutrition Services Diet Manual.

RD 1 was asked to access the Diet Manual online. Upon inspection of the online document, it was difficult to discern which edition date of the diet manual. In addition, review of the diets outlined in the diet manual utilized by the hospital showed the manual did include the different types of therapeutic diets routinely ordered at the hospital.

On 6/21/12 at 1230 hours, review of the hospital's P&P titled, "Diet Manual, Mission," showed the following: "The Diet Manual shall serve as a guide for menu preparation and for ordering therapeutic diets."

On 6/21/12 at 1355 hours, in an interview with Dietary Staff Management members, they acknowledged the outdated Diet Manuals on the clinical units at the Laguna Beach Campus. In addition, Staff confirmed the diet manual was not specific as to the therapeutic diets routinely ordered (i.e. Renal diet). Staff stated those specifics were delineated in a separate policy and procedure that was not part of the diet manual provided online for staff access.


2. On 6/18/12 at 1600 hours, Patient 24's medical record was reviewed at the Mission Viejo Campus. Patient 24 was admitted to the hospital on 5/31/12, with diagnoses that included end-stage renal (kidney) disease on peritoneal dialysis (a filtering technique that used the patient's own body tissues inside the abdominal cavity as a filter due to lack of functioning by the kidneys).

On 5/31/12, Patient 24 was prescribed a renal diet (a therapeutic diet for kidney disease) according to the physician's order.

On 6/18/12 at 1625 hours, RD 2 was asked to utilize the hospital's approved diet manual to demonstrate the hospital approved guidance for a "renal diet." When RD 2 accessed the on-line diet manual she stated there were general guidelines for a renal diet but no specific definition of how the hospital implemented a renal diet order.

On 6/18/12 at 1650 hours, the Clinical Nutrition Manager stated that the hospital had defined a "Renal" diet order to be 80 grams protein, 2 grams sodium, 2 grams potassium, and 1.5 grams phosphorus/day in accordance with the hospital's policy entitled Diet Orders and Changes (last reviewed 12/11).

The Clinical Nutrition Manager was asked to utilize the hospital approved diet manual to indicate the hospital's approved definition and implementation of a cardiac diet for a patient. The Clinical Nutrition Manager first reviewed the Diet Orders and Changes P&P for "Cardiac," which indicated a cardiac diet would be interpreted as "Low Fat, Low Cholesterol, 2 gram sodium/day. "When asked what low fat and low cholesterol meant to the physicians prescribing the therapeutic diet orders via approval of the diet manual, she stated, "50 grams of fat per day, see it's under the fat restricted column if no fat grams is specified." When asked what the hospital approved diet manual indicated a cardiac diet would be, the Clinical Nutrition Manager stated, "No greater than 30% of calories from fat, no more than 300 mg of cholesterol per day, and no more than 2 gm sodium per day." The directions provided on how to implement a patient meal tray for a patient on a therapeutic cardiac diet could vary depending on the diet manual's version of the cardiac diet versus the hospital's policy.

The Clinical Nutrition Manager stated that the hospital's approved diet manual was not specific to the hospital's "Diabetic" diet order, and was not able to be used as guidance to implementing a patient's diabetic diet order. The Clinical Nutrition Manager stated the diabetic diet order would be interpreted as an 1800 calorie, 5 carbohydrates per meal per day, and was not clear in the hospital's approved diet manual. The Clinical Nutrition Manager verified the hospital's Diet Orders and Changes defined a "Diabetic" diet as "Diabetic food choices." The information that a "Diabetic" diet was interpreted by dietary staff as 1800 calories and 5 carbohydrates per meal per day was limited to the food and nutrition department.

The Clinical Nutrition Manager acknowledged the hospital's on-line diet manual, or paper copy diet manual at the Mission Viejo Campus was not comprehensive and hospital specific to ensure clear communication on routinely prescribed therapeutic diet orders, and therefore not readily available to all medical and nursing staff.

The hospital's policy and procedure entitled Diet Manual, Mission indicated, "Purpose: ...The Diet Manual explains and outlines the diets available and the methods for ordering patients meals; Diet Modifications 1.1 The Nutritional Care Services Department provides accurate diet modifications as prescribed by the physician in accordance with the approved Diet Manual. 1.2 The consistent provision of meals which provide for the nutritional requirements of all patients is only possible with agreed upon definitions of what is appropriate for each disease condition, taking into account the unique circumstances of each patient,...The diet manual is available on line to all practitioners on the Mission Short Cuts/Clinical Diet Manual."

4. On 6/19/12 starting at 1020 hours, at the at the Laguna Beach Campus food service site,
the condenser grills in the produce and dairy walk-in refrigerator were observed to be covered with black debris.

The Assistant Director of Operations reached up and brushed loose debris from the grill and dispersed it into the produce on the shelves. The Assistant Director confirmed the condenser grills were dirty and should be cleaned. He stated the food service staff were to notify the engineering staff to clean as needed. The Assistant Director further stated environmental and food service rounds were conducted each week and the dirty condensers had not been identified.


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On 6/18/12 at 1100 hours, a tour and inspection of the Acute Rehabilitation Unit (ARU) was conducted. The Program Director and the Charge Nurse were in accompaniment. A large, gas cylinder confined to a metal rack on wheels was observed in the activity/therapy room.

The Program Director was asked to demonstrate the volume of gas in the cylinder. The Director made several attempts to turn the gas on but failed to do so. The Director concluded the gas cylinder must have a faulty regulator. When asked if the gas cylinder was ever used, the Director stated it was used when patients required a respiratory care treatment.

Inspection of the oxygen cylinder showed no maintenance sticker. The Program Director did not know the maintenance schedule for the oxygen regulator.

On 6/18/12 at 1115 hours, an interview was conducted with RT 1 who was assigned to the ARU. RT 1 stated the tank was utilized for patients during treatments while in the therapy room. RT 1 stated he did not know the maintenance schedule for oxygen cylinder regulators.


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3. On 6/18/12, an initial tour of the Mission Viejo Campus ED trauma area was conducted accompanied by OA 1. The following was observed:


a. A rusty metal container containing 12 E-tank oxygen cylinders was found stored against the wall. The wheels of the container, including the handle, were noted to be rusty which would prevent a thorough cleaning of its surfaces.


b The portable x-ray film holder that was rolled from one trauma bed to another was noted to have a rusty body, surface, and arms. The original light khaki paint on the equipment had become rusty brown with chipped edges.


c. A fiberoptic scope used for difficult airway intubation (process of inserting a breathing tube to a patient's trachea) was noted to be hanging on the trauma area wall beside a "difficult airway cart." The scope did not have an indicator to show when it was last maintained and cleaned. There was no maintenance log presented to show when the scope was last used.


On 6/18/12 at 1100 hours, the ED Nurse Manager acknowledged it was not a good idea to keep rusty equipment in an area where staff needed a sterile field for invasive procedures.

When interviewed on 6/18/12 at 1105 hours, the Respiratory Therapist Manager was unable to state when the fiberoptic scope was last used or maintained.

4. On 6/19/12 at 1015 hours, during the initial tour of the ICU of the Laguna Beach Campus accompanied by the Nurse Manager, the unit refrigerator used for patients was found in need of defrosting to maximize its efficiency.

The ICU Nurse Manager acknowledged the finding as soon as the amount of ice accumulated inside the refrigerator was observed.


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Based on observation, the hospital failed to ensure equipment and supplies were maintained in an acceptable level of safety and quality to assure dependable equipment function for patient care.

Findings:

1. The hospital policy, Periodic Maintenance Program (revision date 2/2012), read in part, "Periodic Maintenance shall be scheduled as follows: Devices classified as having average or minimal maintenance requirements shall be scheduled for annual inspections. Devices classified as having extensive maintenance requirements shall be scheduled for semi-annual inspections."

On 6/18/12 at 1100 hours, the Mission Viejo Campus OR was toured. In OR Rooms 1 and 2 the following was found:

a. Radios for staff use were observed in both rooms. There were no biomedical stickers (stickers applied to show the medical equipment was safe, functional and properly configured) on the radios.

b. In Room 1, the Stryker cart (video cart used to accommodate medical imaging video equipment for multiple specialty procedures in the operating room), the printer, and the Pneumo Sure (machine used during surgical procedure) did not have a biomedical sticker.

c. The Tram Rac (containing monitors used during surgical procedures) in Room 2 showed the biomedical check had been due 1/12.

d. The monitor on an anesthesia cart showed the biomedical check had been due 5/12.



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5. The 3 E unit at the Mission Viejo Campus was toured with RN B on 6/18/12 at 1055 hours. A blanket warmer in a room off of the hallway was observed at a temperature of 132 degrees F. Review of the temperature log for the warmer showed instructions for the temperature to not exceed 120 degrees F. Further review of the log showed the warmer's temperature had not been checked and documented since 5/12/12. RN B stated the temperature should be checked daily.


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2. During a tour of the Laguna Beach Campus OR 5 on 6/18/12 at 1550 hours, a pharmaceutical catheterization kit marked expired 10/10, was observed on a shelf.

During a concurrent interview with the Nurse Manager Surgical Services, she confirmed the catheter was beyond its expiration date.

Based on observation, interview, and document review, the hospital failed to ensure a sanitary environment and an active program to prevent the spread of infection as evidenced by:

1. The hospital failed to identify unsafe food handling practices involving improper cool down of potentially hazardous foods on both campuses of the hospital. Cross Reference to A-0749 #1 a.

2. Failure to have a preventative maintenance and sanitizing system for the ice-machines. Cross Reference to A-0749 #1 b.

3. Failed to remove outdated supplies from patient care areas.

4. Staff were unaware of correct glucometer cleaning practices.

5. Staff were unaware of correct use of a quality assurance marker used to assure sterility of surgical instruments.

6. Sterile packages in the Laguna Beach Campus ED were not marked with the date, sterilization indicator and initial of the technician who stocked the packages.

7. The Mission Campus ED had storage of sterilized plastic packs of equipment and supplies by the trauma beds that were not labeled with stickers indicating the stock date, the expiration date and the technician's initial.

8. The "difficult airway cart" contained a fast track laryngeal mask airway (LMA) with its sterile packaging ripped open

9. A wound cart contained unwrapped disposable scissors and forceps ready for patient use.

10. An instrument for eye examination that magnifies the ocular surface was stored in a patient's bathroom.

11. Failed to ensure, on the Mission Viejo Campus, the surgical recovery area was clean and, on the Mission Viejo Campus and Laguna Beach Campus, the surgical operating rooms were maintained to ensure cleanliness.

12. Staff failed to wash their hands after patient care.

13. A commercially prepared drink containing a measured amount of glucose used specifically for patients to ingest as a test for diabetes, was stored along with human tissue, blood, and urine specimens in the laboratory of the Mission Viejo Campus.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview and record review, the hospital's Infection Prevention Coordinator failed to develop an effective system for:

1. Identifying unsafe food handling practices that involved cool down of potentially hazardous foods and for identifying that the preventative maintenance system for the ice-machine's on the Mission Viejo Campus lacked a sanitizing component in accordance with manufacturer's guidelines. Failure to sanitize ice-machines' could potentially place patients at risk of an infection.

2. On the Laguna Campus identifying proper hand hygiene was done in the Dietary Department and identifying unsafe food handling practices that involved cool down of potentially hazardous foods which could potentially result in a food borne illness.

3. Ensuring staff were aware of correct glucometer cleaning practices which could potentially result in cross contamination.

4. Ensuring the correct use of a quality assurance marker was used to assure sterility of surgical instruments which created the increased risk of infection for all patients using the facility.

5. Ensuring sterile packages in the Laguna Beach Campus ED were marked with the date, sterilization indicator and initial of the technician who stocked the packages and on the Mission Campus ED ensuring storage of sterilized plastic packs of equipment and supplies by the trauma beds were labeled with stickers indicating the stock date, the expiration date and the technician's initial; the "difficult airway cart" did not contain a fast track laryngeal mask airway (LMA) with its sterile packaging ripped open; a wound cart did not contain unwrapped disposable scissors and forceps ready for patient use which increased the risk of using contaminated equipment and supplies.

6. Ensuring an instrument for eye examination that magnifies the ocular surface was not stored in a patient's bathroom which could result in contamination of the instrument.

7. Ensuring on the Mission Viejo Campus the surgical recovery area was clean and on the Mission Viejo Campus and Laguna Beach Campus the surgical operating rooms were maintained to ensure cleanliness.

8. Ensuring staff washed hands prior to and following patient care.

9. Ensuring a glucose drink, a commercially prepared drink containing a measured amount of glucose used specifically for patients to ingest as a test for diabetes, was not stored along with human tissue, blood, and urine specimens in the laboratory of the Mission Viejo Campus.

Findings:

1. Mission Viejo Campus:

a. According to the hospital's P&P entitled Temperature Requirements, last revised 3/09, "Whenever food has been prepared so that it becomes potentially hazardous, or is potentially hazardous, or is potentially hazardous food that has been heated, it shall be rapidly cooled if not held at or above 135 degrees F. After heating or hot holding, potentially hazardous food shall be cooled rapidly according to the following: *From 135 degrees F to 70 degrees F within 2 hours. (Note: The time for cooling begins when the temperature drops below 135 degrees F.) * From 70 degrees F to 41 degrees F or below within 4 hours. (Note: This allows a total cumulative cooling time of 6 hours.)

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to food borne illness. The initial 2-hour cool is a critical element of this cooling process. (FDA Food Code Annexes, 2009).

On 6/18/12 at 1033 hours, in the walk-in freezer was a large container of frozen cooked meatloaf with a label that indicated, "6/6/12, Use by 9/6/12." According to the Retail Manager the meatloaf was cooked on site on 6/6/12.

On 6/18/12 at 1088 hours, the hospital's Critical Control Point - Cooling log was reviewed. There was no logged entry documented to show the meatloaf cooked on 6/6/12, was cooled down to ensure food safety.

At that time, FSW 5 stated he had cooked the meatloaf on 6/6/12, and did not log the cool down of the meatloaf.

The Director of Food Service stated she had not directed dietary staff to log all the potentially hazardous foods that were cooled down "because we have this process down so tightly."

The Critical Control Point - Cooling log, dated from 7/8/12 - 6/16/12, was reviewed. According to the log, on 6/8/12, chicken noodle soup started the cool down process at a temperature of 210 degrees F and reached 81 degrees F two hours after the initial cool down period began.

FSW 5 stated he had completed the logged entry for the chicken noodle soup on 6/8/12. FSW 5 stated when the soup was 81 degrees F, two hours after the initial cool down began, he placed the food item on ice and placed it in the walk-in refrigerator to continue to cool down. The Director of Food Service, the Executive Chef, and the Clinical Nutrition Manger, Registered Dietitian who was present for the interview, reviewed the cool down log for that food item. All staff verified that continuing to cool down the item was their cool down practice. None of the staff present recognized a problem with that system.

According to the directions located at the top of the cooling log, "Foods not used for immediate service must be cooled from 140 degrees F to 70 degrees F within 2 hours.."

During the same interview, FSW 5 stated he did not always have time to check the 2 hour temperature at 2 hours because he would be too busy with another task at that time.

On 6/18/12 at 1132, in a reach-in refrigerator was a full pan of cooked pasta and a full pan of cooked rice that were prepared on site the day before. FSW 6 stated he had cooled down the items but he never logged the cool down of pasta or rice on the cooling down log.

The Director of Food Service acknowledged the dietary staff was not cooling down potentially hazardous food in accordance with the directions located on the cooling log. The Director of Food Service stated, "I guess we were really focusing on the 6 hour temperature, thinking that was the important one."

The Director of Food Services stated the hospital's Infection Prevention Coordinator did rounding of the kitchen with her at least on a quarterly basis.

Review of the last three documented rounds of the Infection Prevention Coordinator indicated "Cooling: potentially hazardous foods (TCS) to observe food cooled from 140 degrees F to 70 degrees F within 2 hours and 70 degrees F to 41 degrees F within 4 hours and test food and check records..." were all checked "yes" as having been in compliance with hospital policy.

The Infection Prevention Coordinator failed to ensure that there was an effective system in place to ensure that a method of food service which involved a high risk, high volume and problem prone method of cooking which involved cool down would have a system to monitor and proactively prevent a potential for food borne illness with medically compromised patients. The cooling log completed by dietary staff log had reflected that the cooling down of potentially hazardous foods had not been done in accordance with the directions on the log. In addition, the Director of Food Services trained the dietary staff that they did not have to log the cool down of the meat entrees that were cooked to be served on other days thus inhibiting an effective monitoring system to identify unsafe food handling practices.

b. On 6/18/12 at 1215 hours, a white paper towel was swiped along the inside of the ice-machine along the rim of the ice-machine chute. The Retail Manager acknowledged that the towel then had a brown discoloration. The top part of the ice-machine had brown furry substances that clung to the outside vent. The Director of Food Services stated due to the air flow and vents in the kitchen that they had a hard time keeping that area clean.

On 6/18/12 at 1513 hours, Facilities Staff 6 stated he was one of the persons responsible for cleaning the inside of the ice-making apparatus of the ice machines in the kitchen the nourishment rooms on the patient floors. Facilities Staff 6 stated the only product used in the top part of the ice-making apparatus was a nickel safe ice-machine cleaner. Facilities Staff 6 verified there were no other products used to maintain the ice-making apparatus.

On the inside panel of the top-part of the ice-machine located in the kitchen, the manufacturer's guidelines indicated that the ice-making apparatus had a cleaning step and after the cleaning step had a sanitizing component.

On 6/18/12 at 1517 hours, the Assistant Director of Facilities verified for the ice-machine in the kitchen, and for the ice-machines located in the nourishment rooms on patient floors, the ice-machines were cleaned with the nickel safe ice-machine cleaner. The ice-machine's manufacturer's guidelines were discussed with the Assistant Director of Facilities at that time and he acknowledged the ice-machines in the kitchen and hospital wide were not being sanitized. The ice-machine's in the nourishment rooms on patient floors were a different manufacturer from the ice-machine in the kitchen, but they also required a sanitizing component per their manufacturer's guidelines.

A review of a document entitled Weekly Food Safety & Sanitation Audit, used by the hospital's Infection Prevention Coordinator to inspect the ice-machine in the kitchen was limited to the following criteria; "Ice machine scoop(s) stored in dedicated container outside of machine. Dedicated ice carriers stored off the floor and upside down/covered."
The Infection Prevention Coordinator did not have an effective method in place which would have identified the hospital's ice-machines were not being sanitized potentially placing the medically compromised patients at risk for an infection.

2. Laguna Beach Campus

The following were observed on 6/19/12 beginning at 1020 hours:

a. Review of the hand washing policy dated July 2, 2011 stated hand washing in food preparation was the most important measure available to control transmission of organisms and was to promote strict sanitary conditions and to minimize the risk of food contamination. The policy directed staff for the proper method of hand washing was to turn off the water using paper towel instead of bare hands.

FSW 3 demonstrated hand washing practice and used his clean hands to turn off the water.

FSW 3 confirmed he did not follow the correct practice to decontaminate his hands when he touched the handles after washing his hands.

Review of FSW 3's personnel file on 6/21/12 at 1315 hours, showed a completed competency dated 7/21/11, for food safety procedures and included hand washing hygiene simulation.

b. Cook 3 was observed throwing away a piece of plastic covering in a trash can that had a lid in place. Cook 3 juggled the lid open with his forearms and uniform sleeve. He disposed of the plastic wrap and then immediately commenced to tear another piece of plastic wrap and covered a sandwich.

When asked, Cook 3 stated he should have washed his hands after touching the trash can. Cook 3 stated all of the kitchen trash cans were covered. He stated the staff practice was to open the trash cans and then wash their hands after disposing of the trash. Cook 3 could not state why the trash cans were covered during production times but stated it was always a challenge to dispose of trash in a sanitary manner.

The Assistant Director stated on 6/20/21 at 1000 hours, there was no policy to direct staff to ensure the trash cans were maintained accessible during production and acknowledged this was a problem but had not initiated a remedy.

c. The walk in refrigerator contained enchilada sauce, dill sauce, and two pans of rice pilaf dated from 6/17 and 6/18/12. The Assistant Director Operations stated these products were leftover from the tray line. The Assistant Director was not able to confirm the cool down practice when the hot food was placed into the walk in refrigerator. On 6/20/12 at approximately 1400 hours, there was no documentation of the cool down of the products from the tray line.

Review of the hospital's P&P, showed to ensure cooked patient foods were cooled according to established HACCP (hazard analysis critical control point) guidelines, appropriate records were kept of patient food production, the food in ice bath or blast chilled and temperatures were recorded.

Hazard Analysis and Critical Control Point (HACCP) is a systematic approach to identifying, evaluating, and controlling food safety hazards. Food safety hazards are biological, chemical, or physical agents that are reasonably likely to cause illness or injury in the absence of their control. Because a HACCP program is designed to ensure that hazards are prevented, eliminated, or reduced to an acceptable level before a food reaches the consumer, it embodies the preventive nature of "active managerial control."

In an interview on 6/21/12 starting at 1000 hours, the infection control staff RN Y stated she participated in sanitation rounds on the Mission Viejo Campus kitchen but not at the Laguna Beach Campus kitchen. RN Y stated she relied on the food service staff regarding the infection control practices in the kitchen and had reviewed a food safety book. RN Y confirmed she was not familiar with the FDA Food Code 2009, or HACCP procedures specific for the food service operations.

d. In the #6 Walk-In Refrigerator, there was a pan of pasta labeled with a sticker indicating a "Use By" date of 6/18/12. In the same refrigerator, there was an opened Sour Cream container labeled with a "Use By" date of 6/14/12, and an unopened container of Sour Cream imprinted with a manufacturer "Best By" date of 6/15/12. In an interview with the Supervisor of Foodservices present at the time of the observation, he stated all of the aforementioned items should be discarded.
Also in the #6 Walk-In Refrigerator, a pan of raw salmon was observed stored directly above ready to dispense containers of lemonade and iced tea. In an interview with the Assistant Director of Foodservices present at the time of the observation, he stated the raw salmon should be stored below any ready to consume product and storing it above the lemonade and iced tea was a staff oversight. It was standard of practice to ensure that foods would be protected from cross-contamination by separating raw animal foods during storage from ready to eat food.
e. An opened bottle of Sweet and Sour Sauce labeled with a "Use By" date of 5/30/12 was observed stored on the spice shelf . The manufacturer instructions imprinted on the bottle read, "Refrigerate After Opening." The bottle had been opened a year prior. The Assistant Director of Foodservice present at the time of the observations confirmed the bottle should have been refrigerated once opened and should have been discarded.
f. On 6/19/12 at 1325 hours, observation of the disaster food supply at the Laguna Beach Campus showed eight cases of peaches baby food with an expiration date of 3/23/11, three cases of chicken and gravy baby food with an expiration date of 9/30/11, a case of baby rice cereal with an expiration date of January 2011, and a case of Enfamil Infant formula with an expiration date of 9/1/11.
On 6/19/12 at 1330 hours, in an interview with the Dietary Management staff member present during the observation, he confirmed the expired items were intended for patients who were prescribed pureed diets and stated they should have been discarded.
Review of the hospital policy titled, "Purchasing and Receiving Procedures" showed the following guideline under "Emergency Supplies": All expiration dates shall be tracked and expired foods removed."
g. On 6/19/12 at 1340 hours, inspection of the Dry Food Storage area showed two #10 cans of tomatillos stored on the can rack intended for daily food circulation. One of the cans had dents to the top and bottom rims and the other can had a deep dent to the side of the can. In an interview with the Assistant Director of Food Services present at the time of the observation, he acknowledged the cans should have been removed and placed in the designated dented can container.


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9. On 6/20/12, a review of the hospital's P&P titled: Eating, Drinking, Smoking, Safety Code-LAB- 1993-2.1.5, All Laboratory Personnel, showed food may never be stored in any refrigerator where chemicals, reagents, or patient specimens are stored.

On 6/20/12 at 1000 hours, an inspection of the hospital laboratory was conducted with Lab Assistant III and the Coordinator/Chemistry Section. A refrigerator was inspected and found to have a eight ounce bottle of flavored glucose drink laying on its side on the upper rack of the door (a commercially prepared drink containing a measured amount of glucose used specifically for patients to ingest as a test for diabetes).

Contained on the same rack with the glucose drink were human tissue, blood, and urine specimens that were prepared for sending out to an outside testing laboratory.

The Coordinator/Chemistry Section stated food items or any items for human consumption were to be stored in any of the specimen refrigerators.






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5. On 6/20/12, review of the hospital's P&P on Standards for Sterile Storage, effective date 3/2000, Text no. 9 stated, "All hospital sterilized items must be carefully inspected before placed into a storage area. All items must contain name of contents; quality control load and lot number; sterilization date; sterility assurance label; sterilization indicator and the initials of the technician.

a. On 6/19/12 at 1015 hours, during an initial tour of the Laguna Beach Campus ED, accompanied by ED Nurse Manager 2, three sterile packages were observed with no date, no sterilization indicator and no initial of the technician who stocked the packages. The labels of the packages showed the contents were: a tracheotomy tray (a set of sterilize instruments to cut/open the windpipe to make emergency airway); cut-down tray (a set of sterile equipment to surgically expose major blood vessels for direct cannulation to gain intravenous access); and a burn pack (essential first aid kit for chemical, electrical and fire burns). The ED Nurse Manager inspected the packages for additional labeling but found none. She then decided to return the packages to central supply for resterilization.

b. During the initial tour of the Mission Viejo Campus ED on 6/18/12, the storage bins by the trauma beds contained three sterile plastic packs with a white sticker dated 6/12/12. There were no other labels attached. The next bin observed contained two intubation trays with green stickers indicating the stock date, the expiration date and the technician's initial.

On 6/18/12 at 1100 hours, ED Nurse Manager 1 was asked about the hospital's standard way of labeling sterilize packages. She was not able to confirm which was the proper way.

c. On 6/18/12 at 1130 hours, the difficult airway cart in the Mission Viejo Campus ED was inspected. A fast track laryngeal mask airway (LMA) was found with its sterile packaging ripped open. In an interview with the SPD Supervisor on 6/20/12 at 0919 hours, she stated the P&P of sterilize packaging and showed sterilize packs should have a red sticker indicating "sterile unless package opened or damaged. Check before use." The SPD Supervisor added there was no expiration date on the sterility of packaged items as long as their covers were visually intact. Ripped plastic containers should be returned to SPD for resterilization and repackaging.

d. On 6/18/12 at 1120 hours, the wound cart in the Mission Viejo Campus ED was inspected with OA 1. Six disposable scissors and two disposable mosquito forceps were found stored unwrapped in one of the drawers ready for patient use. ED Nurse Manager 1 acknowledged the staff should not be using used disposable equipment from one patient to another.

6. On 6/18/12 at 1000 hours, during a tour of the Mission Viejo Campus ED, accompanied by OA1, a biomicroscope or slit lamp eye meter (an instrument for eye examination that magnifies the ocular surface) covered by a pillow case was found stored in a patient bathroom. ED Nurse Manager 1 acknowledged the possibility of contamination the eye instrument if the bathroom was used by an ED patient.


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7. Mission Viejo Campus

The hospital's P&P Cleaning of Operative Procedure Areas last revised 1/12, showed the policy seeks to minimize any hazard of contamination within the suite due to dust, blood, body fluids or body tissues. In between cases staff were to spot clean any visible or gross soil from walls/ ceilings or other surfaces. Daily terminal cleaning included cleaning of the table pads, any soiling on frames, casters, etc., x-ray view boxes, exteriors of video carts, equipment carts and weekly the vent grills were to be cleaned.

a. On 6/18/12 at 0950 hours, observation was initiated in the surgical recovery area. At the initiation of the observation there were no patients in the recovery area. However, during the observation, an RN entered the area and began preparing two areas to receive patients from the operating rooms. The following was found:

*Dust on top of all the monitoring and other equipment mounted on the wall and on top of the rails above the counters.
* Standing water was observed on the top of a small cabinet. Next to the cabinet a large area was observed with rust, dirt and debris on the flooring. During a concurrent interview with PCT 2, he stated they had just finished removing an ice machine from atop the cabinet and a blanket warmer off the floor of that area.

At 1000 hours, an interview was done with the Executive Director, Ancillary and Support Services and RN X (Infection Prevention). RN X stated all remodel plans were submitted to the infection control committee for approval so they could determine how to protect the patients. RN X stated the committee was not aware of the equipment removal.

The Executive Director, Ancillary and Support Services confirmed the equipment removal had not been submitted to the committee. The decision to remove the equipment was just made the morning before. On 6/19/12 at 0930 hours, during an interview with the Infection Prevention Coordinator, Nursing Services, she stated the infection prevention committee should have been notified about the moving of the equipment.

On 6/18/12 at 1010 hours, during an interview with Environmental Services Supervisor regarding the dust found on top of all the monitors and equipment mounted on the wall and the rails, he stated the scheduled high cleaning for the surgical recovery area was two times a week.

b. On 6/18/12 at 1100 hours, observation of OR rooms 1 and 2 was initiated. The following infection control issues were found:
* Penetrations and cracks in the flooring and dirt in the grooves where the flooring seams had been repaired.
* Dust and dirt on bases of machines.
* Dust on the top shelves of the intubation, anesthesia and medication carts.
* Paint chipped off fronts of drawers on anesthesia carts exposing the metal underneath.
* Rusted areas on anesthesia carts and on the wheels of IV poles, metal tables, suction carts, and containers used to hold the linen bags.
*The moisture resistant covers on mattresses and arm boards were not intact.
* Tears in the moisture resistant covers on chairs and stools exposing the porous material underneath making them difficult to disinfect.
* Rust on the bases of the operating tables.
* The operating table in OR room 1 had a painted wooden board under the mattress which had been taped to table on one side with duct tape. There were chipped areas around the edge of the board exposing the porous wood.
*Paint chipped off door frames, missing caulk and cracks around edges of built-in storage cabinets.
* On the front of an x-ray viewing screen and on the wall near the screen in OR room 2 were spots of what looked like blood.
* By the entry door in OR room 2 was a 2" x 3" area where the outer layer of plaster was missing exposing the porous material underneath.
* Dust and debris under the towels on top of the carts.
* Under the scrub sink in the hallway outside the catheterization laboratory (a procedural area) there was rust, dirt and debris on the floor, and a black substance in the grout.
* Radios in the OR rooms with the antenna wires taped to the walls.

c. During observation of the hallway in the surgical area at 1150 hours, a large blood testing machine was observed on a table. Next to the table was a sharps container (holds used needles and other sharp instruments) mounted on the wall. There were blood spots on front of the machine, the sharps container and on the floor near the machine. The wooden shelf above the machine had chipped areas in the paint exposing the porous wood.

d. On 6/19/12 at 1130 hours, an observation of units 3 E and 3 W was conducted. The following was found:
* Medication carts had a container attached to the sides of the carts where used medication vials and wasted medications were placed. The containers were in a locked holder attached to the cart. The tops of these holders contained dirt and debris.
* At 1149 hours, PCT 1 was observed inside an isolation room wearing PPE and entering information into the computer. After completion of the patient's treatment, PCT 1 removed the PPE and left the isolation room. PCT 1 did not wash her hands prior to leaving the isolation room.

Hospital Policy Isolation: Contact Precautions EPI-2010JUL-4.I.1.2-CHM, last revised 7/10, showed gloves were to be removed before leaving the patient's environment and hand hygiene performed immediately.

* At 1150 hours, an opened box of treatment gloves was observed sitting on the side of a sink in the hallway. PCT 1 came to this sink after leaving the isolation room to wash her hands. After washing her hands, she removed the box of gloves from the side of the sink and placed them on the isolation cart outside the room she had just left.
* There was a brown discoloration in the grout on the top of the sink back splashes near the paper towel dispensers on the sinks on the third floor.

Laguna Beach Campus

a. On 6/18/12 at 1420 hours, an observation was done of the six surgical rooms. The following was observed:
*Dust in the air vents.
* Gaps between the edges of the vents and the walls around the vents.
* Missing areas of laminate on all the wooden doors into the operating rooms and sub-sterile rooms exposing the porous wood underneath. Chipped paint on door frames.
* Areas of missing grout at door frames and penetrations in the walls.
* Penetrations in the flooring.
* Dust and debris around the tops of sharps container holders on the medication carts and in the metal shelves below the sharps containers.
* Chips in wall tiles.
* Rusted wheels and areas on equipment carts, stands, tables and the bottom of the operating tables.
* Mattress covers on the operating tables not intact.
* The covering on the edge of the door leading from the pre-operative area back to the operating rooms was missing exposing the porous wood.
* OR room 5 had missing areas of paint on the overhead lights and exposed areas were rusty.

b. On 6/20/12 at 1110 hours, the patient shower across from room 325 was observed. There was rust on the bottom of the shower and a black substance in the caulk on the inside edge of the shower from the shower base up.

The disinfection of exposed porous materials and rusted areas cannot be guaranteed as these areas will absorb the disinfectants not allowing them to be in contact with the areas for the required amount of time.

c. The temperature log on the irrigation solution warmer showed irrigation solutions must be less than 104 degrees Fahrenheit. The log sheet also showed the temperatures were to be recorded daily. Review of the sheet showed no temperatures were documented on 6/3, 6/9 and 6/17/12. "No cases" was entered in the line after these dates. On 6/8/12 the irrigation temperature was 109 degrees F and the action taken was "turned down." On 6/12/12 the temperature was 104 degrees F and the action taken was "turned down." On 6/6, 6/7,6/11, 6/13, 6/14, 6/15, and 6/18/12 the temperature was also documented as 104 F for the irrigation solution and no documented action was taken. On 6/16/12, the temperature was 105 degrees F and there was no documentation of action taken. There were no follow up temperatures documented to show if the actions taken were effective.


23015


8. On 6/20/12, a medication pass with RN BB was observed. RN BB withdrew medications for Patient 29 at 0900 hours. Patient 29 was only slightly responsive. RN BB decided the patient could not safely take the medications at this time and the medications were returned to the patient's locked medication cassette.

At 1015 hours, RN BB again attempted to give Patient 29 her morning medications. RN BB was observed at a computer terminal at the nursing station. The RN left the computer terminal and obtained the medications from the cassette before proceeding to enter the patient's room. RN BB failed to perform any hand washing or use alcohol based gel prior to passing the medications to the patient. At the completion of the medication pass, RN BB washed her hands. RN BB acknowledged she failed to wash her hands prior to passing medications to Patient 29.

On June 20 at 1130 hours, a review of the Hospital Policy titled "Hand Hygiene" was reviewed. The policy stated "... Indications for handwashing or hand antisepsis: ... 2.3 Before donning gloves ...2.7 After contact with inanimate objects in the immediate vicinity of the patient ... 2.8 After removing gloves. "Failure to follow the hand hygiene policy potentially increased the chances of infection transmission."


26881


3. The hospital's P&P, Blood Glucose Monitoring with Sure Step Flexs Whole Blood Glucose Meter (effective 11/2006) read in part, "The meter must be cleaned daily with bleach wipes prior to QC (quality control) performance. To satisfy 2010 CDC Guidelines on cleaning Bedside Glucose Meters between patients wipe the inside of a Test strip holder with an alcohol wipe before each Bedside Glucose on a new patient."

During a tour of the Mission Viejo Campus surgical recovery room on 6/18/12 at 0945 hours, with RN I, she demonstrated how she would use the glucometer for a patient and replaced it in its storage spot without cleaning it.

In a concurrent interview with RN I, when asked about cleaning of the glucometer, RN I stated that she did not clean it. RN I stated the glucometer was maintained and cleaned weekly by the laboratory department.

4. The hospital's P&P, Biological and Air Removal Testing--Steam Sterilizers, revised 3/12, read in part, "place a non-processed attest Rapid Readout biological indicator (a vial containing bacteria, used to check how well the sterilizer can kill bacteria) from the same manufacturer, date and lot as the test control into the incubator and allow it to remain there until the media in the ampoule turns yellow, indicating positive microbial growth."

The manufacturer's directions for use of biological indicators for checking the quality of sterile processing were reviewed. The directions read in part, "It is a good practice to continue incubation of the positive control biological indicator for a visual pH color change each day a processed biological indicator is incubated."

During a tour of the Mission Viejo Campus sterile processing department on 6/21/12 at 0840 hours, the Supervisor of Sterile Processing explained the use of the biological indicators to ensure sterility of processed surgical instruments. The Supervisor stated the hospital used three hour rapid readout biologic test vials which contained bacteria. The test vials would change color from purple to yellow if there was any growth of bacteria. The Supervisor stated a biological test vial was run with the loads to ensure sterility. A control vial from the same lot was used daily to ensure that the biologic test vial that had been run through the sterilizer contained bacteria. The Supervisor stated the unsterilized control vial was placed in the incubator at the same time as the test vial that was sent through the sterilizer.

The biologic test vial and the control vials run the mornings of 6/20/12 and 6/21/12 were observed. All of the vials were still purple.

In a continuing interview with the Supervisor of Sterile Processing, she was unable to sta

Based on observation, interview and record review, surgical scrub sinks on the Mission Viejo Campus were not all located in visual range of a clock to time surgical scrubs. This created the potential for an increased risk of infection for patients receiving surgical services from staff not able to time their surgical scrubs. In addition, the laryngeal mask airways (LMAs--a type of breathing tube used for sedated patients during surgery) were not removed from use after a year, per manufacturer's guidelines, creating the risk of a poor health outcome for patients on whom LMAs were used.

Findings:

1. Review of the hospital's P&P, Surgical Scrub and Hand Drying Procedure, effective 4/12, showed the direction, "Scrub times should be followed according to the scrub agent manufacturer's written directions."

Review of the hospital's P&P, Antiseptics, Disinfectants and Handwashing Agents, effective 4/12, showed the surgical scrub chemical required a timed scrub.

During a tour of the surgical suite on 6/18/12 at 1030 hours, the scrub sink located outside of the electrophysiology study room was not in visible range of a clock.

The scrub sinks by OR 1 were observed at 6/18/12 at 1135 hours, and were not in visible range of a clock.

During a concurrent interview with the Interim Director of Surgical Services, she was unable to explain how surgeons could time a surgical scrub at the sinks.

2. The manufacturer's warranty for the respiratory equipment in use in the hospital was reviewed and read in part, "The above LMA airways are reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from the date of purchase (whichever is earlier)..."

During tours of the operating rooms on 6/18/12, observation showed the OR cabinets contained more than 30 clear sterile packets containing LMAs.

In an interview with the Supervisor of Sterile Processing on 6/21/12 at 0940 hours, she stated LMA use was tracked and logged.

Review of the LMA logs on 6/21/12 at 0940 hours showed reprocessing of the LMAs was tracked up to 40 times; however many of the LMAs had been in use since at least 2007. For example, LMA SECDO7070414 was used from 11/16/07, and was last used 2/12/12.

During a concurrent interview with the Supervisor of Sterile Processing, she stated they did not discard the LMAs after one year, but continued to use them until they had been used 40 times.

Based on interview and record review, the hospital failed to ensure a history and physical examination had been completed, updated and signed prior to surgery for Patient 10. This resulted in the potential for an increased risk of a poor surgical outcome for the patient due to the possibility of unrecognized medical conditions.

Findings:

The Medical Staff P&P, Medical Records dated 2/2012, read in part, "A medical record is considered complete when all reports are transcribed and authenticated, and all other physician entries in the medical record are authenticated. If a history and physical examination was performed within 30 days prior to the patient's admission or readmission to the hospital, a durable, legible copy of the report may be used in the patient's record provided any changes what may have occurred and the patient's current medical status are recorded at the time of admission, or within 24 hours after admission, and prior to surgery or a procedure requiring anesthesia or deep sedation as an interval note."

During a tour of the recovery room on 6/18/12 at 1010 hours, the medical record of Patient 10, who was recovering from surgery, was reviewed. The record included a history and physical examination dictated on 6/13/12, but was not signed by the physician. The last page of the history and physical contained a stamp that had been applied to the page which read, "History and physical is current. Physical assessment done prior to procedure," along with spaces for MD signature, date and time. However, the spaces for signature, date and time were blank.

In a concurrent interview with the Outcomes Analyst, she confirmed the history and physical had not been signed by the physician and the day-of-surgery update was also not completed.

Based on observation, interview and record review, the hospital failed to ensure the anesthesia service was well organized and responsible for the anesthesia administered in the hospital as evidenced by:

1. The post anesthesia evaluations for six of 58 post anesthesia patients reviewed were entered into the medical record as having been written at a time in the future, compared to the computer-documented time to show the time entered. The anesthesiologists reported the six patients had recovered from anesthesia; however, the patients actually had just emerged from the operating room. Cross Reference A-1005.

2. The post anesthesia evaluations were not found in the medical record for 19 of 58 anesthesia records reviewed. Cross Reference A-1005.

3. For one patient (Patient 59), the post-anesthesia evaluation documentation was completed prior to the start of surgery Cross Reference A-1005.

The cumulative effect of these failings meant the anesthesia service failed to minimize the risks to the patients of anesthesia performed in the hospital.

Based on interview and record review, the hospital failed to ensure the accuracy of the documented post-anesthesia evaluation for seven of the 58 patients whose post-anesthesia data was reviewed (Patients 10, 59, 60, 91, 112, 115 and 116). For 19 of the 58 post-anesthesia records reviewed, there was no documentation found in the medical record to show the post-anesthesia evaluations were conducted to ensure recovery from anesthesia
(Patients 64, 67, 71, 76, 79, 81, 84, 87, 89, 93, 98, 100, 102, 105, 107, 109, 111, 113, and 114). This created the potential for the risk of a poor post-anesthesia health outcome for the patients without accurate post-anesthesia evaluations.

Findings:

The hospital's P&P, Analgesia and Anesthesia Policy effective January 18, 2012, read in part, "A post-anesthesia evaluation must be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia services. The evaluation must be completed and documented by any practitioner who is qualified to administer anesthesia as noted in this section of the policy. The evaluation may not begin until the patient is sufficiently recovered from the acute administration of the anesthesia so as to participate in the evaluation (e.g., answers questions appropriately, perform simple tasks, etc.)."

1. During an observation in the Mission Viejo Campus pre-operative area on 6/20/12 at 1010 hours, the area was being used as a recovery area because of equipment re configuration underway in the PACU. Patient 10 was observed being wheeled into the area on a gurney from the surgical suite and the operating room staff provided the recovery nurse, RN H with a report of the patient's condition before the operating room staff, including MD A, left the room. The patient was observed to be deeply sedated, nonverbal, unmoving, and with eyes closed.

At 1024 hours on 6/18/12, after continuous observation of Patient 10 being asleep in the recovery area, the anesthesia record portion of the medical record was reviewed. The record contained a post-anesthesia note from MD A timed for 1042 hours, which read that the patient was "awake and lucid, no pain or n/v" (nausea or vomiting).

During an interview with RN H at 1024 hours on 6/18/12, who was caring for Patient 10, she stated Patient 10 had not awakened since arriving in the recovery area, and was still sleeping.

During an interview with MD A at 1025 hours on 6/18/12, he stated that he must have misinterpreted the time and written the wrong time on the medical record of Patient 10.

During a review of the post-anesthesia notes and electronic medical record time stamp data for 56 medical records of surgery patients from 6/13/12 through 6/15/12, the time of the post-anesthesia notes written by 16 different physicians were compared to the electronic time stamp in the electronic medical records system. For four of the 56 patients (Patients 60, 91, 112, and 115), and for one patient (Patient 116) for whom only the data, but no record was provided, the time of the post-anesthesia note in the record had been changed to a time later than it when it was actually written, once by MD A, and four times by MD G. The times for the post-anesthesia evaluations recorded in those records were all at a later time than the actual times the notes were written by 16, 20, 29, 10, and 21 minutes, respectively.

The Business Operations Manager of Perioperative Services was interviewed on 6/19/12 at 1110 hours. The Manager stated the electronic medical record for surgical records provided automatic time stamps for each entry made, but the writer could change the time that was automatically input. The Manager stated he was unsure how the times were changed.

During an interview with MD F, an anesthesiologist, on 6/21/12 at 1505 hours, he stated the only explanation he could offer was the physicians did not understand the new medical record system which had been in place since February, 2012.

2. During a review of 56 medical records of surgery patients from 6/13/12 through 6/15/12, the anesthesia records, written by 16 different physicians, were reviewed. Nineteen of the 56 records reviewed (Patients 64, 67, 71, 76, 79, 81, 84, 87, 89, 93, 98, 100, 102, 105, 107, 109, 111, 113, and 114), contained no post-anesthesia note from an anesthesia provider. The records with no post-anesthesia note included records from surgeries involving general anesthesia.

For Patient 79, recovery room nursing notes indicated post-operatively, the patient was hypoxemic (low oxygen in the blood). There was no documentation of a post-anesthesia evaluation by an anesthesiologist.

For Patient 109, recovery room nursing notes indicated post-operatively the patient experienced hypoxemia and refractory pain, but neither had documentation of a post-anesthesia evaluation by an anesthesiologist.

MD F, an anesthesiologist, was interviewed on 6/21/12 at 1505 hours. MD F reviewed the 6/13/12, anesthesia record of Patient 60. MD F stated he had provided the anesthesia care for this patient. MD F confirmed there was no post-anesthesia note on the record and the patient had received general anesthesia. MD F stated there were two methods by which the anesthesiologists were notified of patient readiness for a post-anesthesia evaluation. Either the recovery room nurse would contact the anesthesiologist and state the patient was ready for the evaluation, or when the anesthesiologist was in the recovery room between cases, he would ask the recovery room nurses if there were any patients ready for a post-anesthesia evaluation. MD F stated he provided the evaluations for the patients who were ready, whether or not they were his anesthesia patients. MD F stated he believed that other anesthesiologists were providing post-anesthesia evaluations for some of his patients as well. MD F stated Patient 60 "fell through the cracks" in the hospital's system for post anesthesia evaluation.

During an interview with RN I, a charge nurse for the recovery area, she stated patients were discharged from the recovery area when the nurses found that they met certain criteria. RN I stated both the anesthesiologists and the surgeons wrote discharge orders.

3. The recovery room record of Patient 59 was reviewed on 6/20/12 at 1245 hours, in the Laguna Beach Campus recovery room. The record contained a pre-printed form, Pre-Anesthesia Orders/Post-Anesthesia Evaluation. The sections of the form for "Recommended Anesthesia Orders" and "Post-Sedation Procedure Evaluation" had been completed. The form was signed by a physician at 0818 hours on 6/20/12. The "Post-Sedation Procedure Evaluation" section of the form had boxes which were checked off by the physician to indicate: vital signs were stable; the patient was awake and alert; respirations/saturations and ability to deep breath/cough effectively, the airway reflex was present and the oxygen saturation on room air was more than the pre-op value; there were no anesthesia complications; nausea was minimal; pain was controlled; and post-op hydration was normal. There was a pre-printed statement, "I have examined the patient prior to discharge, and find the patient stable for discharge" followed by the signature of the physician at 0818 hours (prior to the start of surgery).

The Anesthesia Record for Patient 59 showed the surgery ended at 1119 hours on 6/20/12. Post-operatively the patient received 13 doses of pain medication from 1135 hours until 1255 hours. Review of the Pain Management form showed the patient's pain was still rated as 6 out of 10. There was no physician's order on the medical record for 10 of the 13 doses of pain medication administered. Cross Reference to A 0405 #2.

There was no documentation on 6/20/12 at 1255 hours that a physician had come to evaluate the patient post-operatively.

In an interview with RN CC on 6/20/12 at 1245 hours, the RN stated the "Post-Sedation Procedure Evaluation" was completed and was signed by the physician prior to the surgery.

Based on interview and medical record review the hospital failed to ensure the informed consent form was completed per the hospital's P&P for three of the 30 patients reviewed (Patients 2, 3, and 54). For Patient 54 there was no documentation of a witness to the patient's signature for a procedure. For Patient 2 the signature of the witness to the patient's signature was illegible and no title was documented for the signature. For Patients 2 and 3, the consent forms showed the yellow copies intended for the patients were attached to the forms and had not been given to the patients. This could potentially result in patients' not being fully informed of their right to effect their healthcare decision.

Findings:

The hospital's P&P to address Informed Consents dated 7/11, showed the witness to the patient's consent was to sign the consent form and should be an RN. The original form was to be placed in the patient's chart and a copy given to the patient.

1. On 6/21/12 at 1200 hours, a tour of the endoscopy procedure area was conducted. A randomly selected medical record, Patient 54's, was reviewed.

A document titled: Authorization For And Consent to Endoscopy OR Procedures, showed Patient 54 had signed the consent for endoscopy, however, absent on the informed consent was a signature by a RN to serve as a witness to the consent provided by Patient 54.


25720


2. The medical record for Patient 2 was reviewed on 6/18/12 at 1030 hours, with RN A. Review of the consent form to allow a blood transfusion showed the yellow copy of the consent was to be removed and given to the patient. Review of Patient 2's consent form dated 6/1/12, showed the yellow copies were still attached. The signature of the witness to the patient's signature was illegible and no title was documented for the signature. When asked, RN A was unable to state the name or title of the witness.

3. The medical record for Patient 3 was reviewed on 6/18/12 at 1105 hours, with RN B. Two consent forms dated 6/12/12, were observed in the patient's medical record for separate procedures. The consent forms showed the yellow copies intended for the patient were attached to the forms and had not been given to the patient.

2. The hospital's Infection Prevention Coordinator failed to develop an effective system for identifying unsafe food handling practices that involved cool down of potentially hazardous foods, and for identifying that the preventative maintenance system for the ice-machine's lacked a sanitizing component in accordance with manufacturer's guidelines. Failure to sanitize ice-machines' could potentially place patients at risk of an infection. Cross Reference A-0749.



20059

Based on observation, interview and record review, the hospital failed to ensure patient care was provided in a safe environment as evidenced by:

1. Review of the medical records for five of the five patients reviewed (Patients 7. 46, 51, 52, and 53) who had been in restraint and seclusion (R&S) during their hospitalization showed documentation the patients were sedated with medications after the restraints were applied. There was no intensification of monitoring for potential risks and adverse response to physical restraints. There was no documentation to show their restraints were reduced or discontinued at the earliest possible time. This could potentially result in unnecessary patient restraint.

2. The hospital's failure to develop an effective system for identifying unsafe food handling practices that involved cool down of potentially hazardous foods and for identifying the preventative maintenance system for the ice-machine's lacked a sanitizing component in accordance with manufacturer's guidelines. These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

3. A staff member did not followed the hospital's P&P for hand hygiene during patient care resulting in the potential for the spread of infection.

Findings:

1. The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period.

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the medical record for Patients 7, 46, 51, 52, and 53 did not show evidence that once the unsafe situation ended, the use of restraint and seclusion was reduced or discontinued. There was no documented evidence to show attempts at restraint reduction were employed while the patients were documented to be quiet or sleeping. There was no consistent monitoring of the patients' food or fluid intake while in restraints. There was no documented justification for the continuation of R&S once the patient was observed to be quiet or sleeping. Cross Reference A-0154 and A-0174


23015

3. On 6/20/12, at 1015 hours, RN BB attempted to give Patient 29 her morning medications. RN BB was observed at a computer terminal at the nursing station. The RN left the computer terminal and obtained the medications from the cassette before proceeding to enter the patient's room. RN BB failed to perform any hand hygeine prior to passing the medications to the patient. At the completion of the medication pass, RN BB washed her hands. RN BB acknowledged she failed to wash her hands prior to passing medications to Patient 29.

Based on observation, interview and record review, the hospital failed to provide safe care for five of five patients who had been in restraint and seclusion (R&S) during their hospitalization (Patients 7, 46, 51, 52, and 53). All five patients were placed in physical R&S on the Behavioral Health Medicine Unit (BHU). The patients were restrained in the prone (Face Down) position with restraints applied to each limb and torso limiting free movement. Each patient was sedated with medications after the restraints were applied. There was no documentation of increased monitoring for the potential risks and adverse responses to the physical restraints. There was no documentation the patients received consistent monitoring of their intake of fluids while in restraints. All five patients showed the application of physical restraints was initiated as a result of an immediate threat to staff or patient's safety; however, there was no evidence that once the unsafe situation ended, the use of restraint and seclusion was discontinued. There was no evidence attempts at restraint reduction were initiated when the patient was documented to be quiet or sleeping. There was no documented justification for the continuation of the R&S once the patient was observed to be quiet or sleeping. These failures have the potential for causing physical injury during this period of immobilization and violate the patient's rights.

Findings:

The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the hospital's P&P titled: Seclusion and Restraint-BHM-2011DEC-3,11, showed it was the hospital's philosophy to promote the use of preventative strategies and the use of safe and effective alternatives to restraints and seclusion; to deter the actual use of restraints whenever possible; and to utilize the least restrictive measures. Preservation of a patient's rights, dignity and well-being will be maintained at all times.

The P&P showed the hospital endorses least restrictive measures whenever possible. The P&P showed the psychiatric program will use physical restraints only in extreme cases to protect the patient from injury to self and others. Patients will be restrained in five-point restraint and alternate removing opposite hand/leg until patient does not require restraining. Appropriate attention shall be paid every 15 minutes to a patient in R&S, especially in regard to use of the toilet, regular meals and bathing. A face to face (in person clinical evaluation) assessment for physical and psychological status of the patient will be done within one hour of restraint application. The face to face encounter would be used to determine the need to continue restraints.

On 6/18/12 at 1300 hours, an inspection of the Behavioral Health Unit was conducted.

1. Patient 7 was observed during the inspection in five point (each limb and torso) restraints in the prone position.

Medical record review for Patient 7 began on 6/18/12 at 1400 hours. Patient 7 was placed in R&S on 6/10/12 at 2055 hours, for agitated behavior and threatening staff.

Physician's orders dated 6/10/12 at 2055 hours, showed Patient 7 was to be administered Haldol 10 mg IM (intramuscular injection), Benadryl 50 mg IM, and Ativan 2 mg IM. The Drug Information Handbook for Nursing 2007, pages 375, 603, 753, showed the combination of drugs i.e. Haldol, Ativan and Benadryl are administered for their rapid tranquilizing effect on severely-agitated patients.

Documentation on the Seclusion/Restraint flow sheet dated 6/10/12, showed Patient 7 was asleep from 2215 hours to 2400 hours. There was no documentation to show restraint reduction was attempted during this time frame.

Documentation on the Seclusion/Restraint flow sheet showed Patient 7 was again placed in R&S on 6/17/12, at 2100 hours, for yelling, hitting the front door and being paranoid. Physician's orders dated 6/18/12 at 0950 hours, showed Patient 7 was to be administered Haldol 10 mg IM, Benadryl 50 mg IM, and Ativan 2 mg IM.

Documentation on the seclusion/restraint flow sheet showed Patient 7 was sleeping while in restraints on 6/18/12 at 0400 hours, 1245 hours, and 1300 hours to 1500 hours, with no attempt at restraint reduction during these times. Absent was documentation of Patient 7's clinical response to R&S and justification for continuation. Additionally, there was no documentation of the amount of fluids offered or consumed by Patient 7 while he was in restraints. Patient 7 was in restraint and seclusion for a total of 19 1/2 hours.

2. On 6/18/12 at 1430 hours, a medical record review was conducted for Patient 46. Patient 46 was admitted on a legal hold for danger to self, others and gravely disabled. Patient 46 attempted to strike out at staff and was placed in R&S on 6/4/12 at 1545 hours. Patient 46 was provided emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM. There was no vital sign documentation after administration of the medications

Documentation on the R&S Flow sheet showed Patient 46 was sleeping from 1630 hours to 1700 hours, 1730 to 1800 hours, and 1845 hours to 2000 hours. There was no documented evidence Patient 46 had restraint reduction attempted from 1545 hours to 2100 hours. Absent was documentation of Patient 46's clinical response to R&S and justification for continuation.

3. On 6/18/12 at 1445 hours, a medical record review was conducted for Patient 51. Patient 51 was placed in R&S on 6/14/12 at 1800 hours, for throwing himself against a door.

Documentation showed Patient 51 was in R&S from 1800 hours to 2000 hours, and was asleep from 1830 hours to 1900 hours. There was no documented evidence restraint reduction was attempted during that time. Absent was documentation of Patient 51's clinical response to R&S and justification for continuation.

4. On 6/18/12 at 1500 hours, a medical record review was conducted for Patient 52. Patient 52 was placed in R&S on 6/16/12 at 1535 hours. Documentation dated 6/16/12 at 1645 hours, and at 1730 to 1800 hours, showed Patient 52 was asleep while in R&S. Absent was documentation of Patient 52's clinical response to R&S and justification for continuation.

5. On 6/18/12 at 1515 hours, a medical record review was conducted for Patient 53. Patient 53 was admitted on 6/10/12 at 1630 hours, directly into R&S from the gurney after being transferred from another hospital. Documentation on the legal hold showed Patient 53 was labile, tearful, and unable to follow staff's instruction.

Documentation showed on 6/10/12 at 1645 hours, Patient 53 was administered emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM.

Documentation showed on the Seclusion/Restraint Flow Sheet dated 5/10/12, showed Patient 53 was sleeping from 1700 hours to 2000 hours. Restraints were removed at 2000 hours. There was no evidence of restraint reduction attempts from 1700 hours to 2000 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

Documentation showed on 6/11/12 at 2345 hours, Patient 53 was placed in R&S when she became assaultive towards staff and unable to follow staff's instructions.

Documentation showed tranquilizing medication was administered at 2400 hours, and Patient 53 was

Based on observation, interview and record review, the hospital failed to provide safe care for five of five patients who had been in restraint and seclusion (R&S) during their hospitalization (Patients 7, 46, 51, 52, and 53). All five patients were placed in physical R&S on the Behavioral Health Unit (BHU) and each patient was restrained in the prone position (positioned on the abdomen face down). All five patients were physically restrained as a result of an immediate threat to staff or the patient's safety; however, there was no evidence that once the unsafe situation ended, the use of restraint and seclusion was discontinued. There was no documented evidence to show attempts at restraint reduction or discontinuation when the patients were documented as quiet or sleeping. These failures have the potential for causing physical injury during this period of immobilization and violate the patient's rights for unnecessary restraints.


Findings:

The Department of Health and Human Services, Office of the Inspector General, highlights in a report titled: Reporting of Deaths Related to Restraint and Seclusion, September 2006, showed between August 2, 1999 and December 31, 2004, 104 behavior management related deaths associated with restraint and seclusion that occurred during this time period

The U.S. Food and Drug Administration issued a safety alert titled: Potential Hazard with Restraint Devices. The document estimates there may be at least 100 deaths or injuries annually associated with the use of restraints, many deaths occurring when the patient is trying to get out of the restraint or while attempting purposeful behavior. Use of restraints must be for a strictly defined period of time. Restraint related deaths have occurred as a result of inadequate monitoring. Restraint use should be a temporary solution to a situation.

Review of the hospital's P&P titled: Seclusion and Restraint-BHM-2011DEC-3,11, showed it was the hospital's philosophy to promote the use of preventative strategies and the use of safe and effective alternatives to restraints and seclusion; to deter the actual use of restraints whenever possible; and to utilize the least restrictive measures. Preservation of a patient's rights, dignity and well-being will be maintained at all times.

The P&P showed the hospital endorses least restrictive measures whenever possible. The P&P showed the psychiatric program will use physical restraints only in extreme cases to protect the patient from injury to self and others. Patients will be restrained in five-point restraint and alternate removing opposite hand/leg until patient does not require restraining. Appropriate attention shall be paid every 15 minutes to a patient in R&S, especially in regard to use of the toilet, regular meals and bathing. A face to face (in person clinical evaluation) assessment for physical and psychological status of the patient will be done within one hour of restraint application. The face to face encounter would be used to determine the need to continue restraints.

On 6/18/12 at 1300 hours, an inspection of the Behavioral Health Unit was conducted.

1. Patient 7 was observed during the inspection in five point (each limb and torso) restraints in the prone position.

Medical record review for Patient 7 began on 6/18/12 at 1400 hours. Patient 7 was placed in R&S on 6/10/12 at 2055 hours, for agitated behavior and threatening staff. Physician's orders dated 6/10/12 at 2055 hours, showed Patient 7 was to be administered Haldol 10 mg IM (intramuscular injection), Benadryl 50 mg IM, and Ativan 2 mg IM. The Drug Information Handbook for Nursing 2007, pages 375, 603, 753, showed the combination of drugs i.e. Haldol, Ativan and Benadryl are administered for their rapid tranquilizing effect on severely-agitated patients.

Documentation on the Seclusion/Restraint flow sheet dated 6/10/12 showed Patient 7 was asleep from 2215 hours to 2400 hours. There was no documentation to show restraint reduction was attempted during this time frame.

Documentation on the Seclusion/Restraint flow sheet showed Patient 7 was again placed in R&S on 6/17/12, at 2100 hours, for yelling, hitting the front door and being paranoid. Physician's orders dated 6/18/12 at 0950 hours, showed Patient 7 was to be administered Haldol 10 mg IM, Benadryl 50 mg IM, and Ativan 2 mg IM.

Documentation on the seclusion/restraint flow sheet showed Patient 7 was sleeping while in restraints on 6/18/12 at 0400 hours, 1245 hours, and 1300 hours to 1500 hours, with no attempt at restraint reduction during these times. Absent was documentation of Patient 7's clinical response to R&S and justification for continuation. Patient 7 was in restraint and seclusion for a total of 19 1/2 hours.

2. On 6/18/12 at 1430 hours, a medical record review was conducted for Patient 46. Patient 46 was admitted on a legal hold for danger to self, others and gravely disabled. Patient 46 attempted to strike out at staff and was placed in R&S on 6/4/12 at 1545 hours.

Patient 46 was provided emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM. Documentation showed on the R&S Flow sheet showed Patient 46 was sleeping from 1630 hours to 1700 hours, 1730 to 1800 hours, and 1845 hours to 2000 hours. There was no documented evidence Patient 46 had restraint reduction attempted from 1545 hours to 2100 hours. Absent was documentation of Patient 46's clinical response to R&S and justification for continuation.

3. On 6/18/12 at 1445 hours, a medical record review was conducted for Patient 51. Patient 51 was placed in R&S on 6/14/12 at 1800 hours, for throwing himself against a door. Documentation showed Patient 51 was in R&S from 1800 hours to 2000 hours, and was asleep from 1830 hours to 1900 hours. There was no documented evidence restraint reduction was applied during that time. Absent was documentation of Patient 51's clinical response to R&S and justification for continuation.

4. On 6/18/12 at 1500 hours, a medical record review was conducted for Patient 52. Patient 52 was placed in R&S on 6/16/12 at 1535 hours. Documentation dated 6/16/12 at 1645 hours, and at 1730 to 1800 hours, showed Patient 52 was asleep while in R&S. Absent was documentation of Patient 52's clinical response to R&S and justification for continuation.

5. On 6/18/12 at 1515 hours, a medical record review was conducted for Patient 53. Patient 53 was admitted on 6/10/12 at 1630 hours, directly into R&S from the gurney after being transferred from another hospital. Documentation on the legal hold showed Patient 53 was labile, tearful, and unable to follow staff's instruction.

Documentation showed on 6/10/12 at 1645 hours, Patient 53 was administered emergency dose medication intervention which consisted of Haldol 5 mg IM, Ativan 2 mg IM and Benadryl 50 mg. IM.

Documentation showed on the Seclusion/Restraint Flow Sheet dated 5/10/12, showed Patient 53 was sleeping from 1700 hours to 2000 hours. Restraints were removed at 2000 hours. There was no evidence of restraint reduction attempts from 1700 hours to 2000 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

Documentation showed on 6/11/12 at 2345 hours, Patient 53 was placed in R&S when she became assaultive towards staff and unable to follow staff's instructions. Documentation showed tranquilizing medication was administered at 2400 hours, and Patient 53 was documented to being asleep from 2400 hours to 0330 hours. Restraints were removed at 0330 hours. There was no evidence of restraint reduction attempts on 6/11/12, from 2400 hours to 0330 hours. Absent was documentation of Patient 53's clinical response to R&S and justification for continuation.

On 6/18/12 at 1000 hours, an interview was conducted with RN Z. RN Z was asked how Patient 7 was assessed for restraint reduction. The RN stated Patient 7 was uncooperative and threatening. RN Z was asked about offering of fluids, intake and output, and other assessment requirements for patients in R&S. RN Z stated a Patient Care Technician (PCT) was assigned to observe and m

Based on record review and staff interview, the hospital's Collaborative Practice Council failed to provide an ongoing monitoring and evaluation of the newly implemented IV Insulin protocol in the ICU. This failure placed patients receiving an IV insulin drip at risk of harm or death due to unclear directions of the IV insulin protocol.

Findings:

On 6/20/12, review of the hospital's Collaborative Practice Council's P&P showed the council involved Pharmacy, Nursing and Medical Staff. Pharmacy provided the leadership and was responsible for all medications throughout the hospital.

Per review of the Nursing Performance Improvement Plan, the primary goal was the ongoing improvement of the delivery, quality, efficiency and outcome of patient care and services. The goal would be accomplished through systematic examination of information provided through ongoing monitoring, evaluation and improvement activities. All of these performance activities would be done in accordance with standards of professional health care practices, regulatory and licensing agencies at same time supporting the overall mission and strategic plans of the hospital.

The Nursing Review process of the performance improvement plan was described as setting improvement aims that would be measurable within the patient population. Measures would be established to determine if a specific change actually led to an improvement. The organization would therefore identify changes that would most likely result in improvement. The testing of the changes was then diagrammed into the acronym of PDSA - plan, do, study, act. The change should be planned, then tried, the results observed, and then action taken on what was learned; however, the process which the hospital used for action-oriented learning was not evident when the IV insulin protocol was changed in ICU.

Review of three patient records (Patients 21, 22, and 28) in the ICU revealed there were two different IV insulin protocols in use. Random interviews among the ICU staff on how to follow the directions provided by the protocols revealed conflicting results.

Per interview with RNP 2 and the CICU Clinical Specialist on 6/20/12 at 1118 hours, the old insulin protocol form, dated 3/18/10, was changed approximately on 11/11. The new protocol was approved by different committees on 12/11 before it was implemented on 1/12. The training of the nurses occurred approximately during 11/11, but RNP 2 and the Clinical Specialist stated they did not document the training. When asked if the effectiveness of the new insulin protocol had been reviewed, RNP 2 stated "pitfalls were noted following the new IV insulin protocol, warranting one to one teaching among the nursing staff on one or two occasions." When asked if the insulin protocol changes were monitored by Pharmacy or Nursing, RNP 2 and the Clinical Specialist stated they were unaware of any monitoring that existed.

Further interview of the Pharmacy Clinical Manager on 6/20/12 at 1400 hours, revealed old insulin protocol forms, dated 3/2010, remained in physicians' offices and were being faxed to the Pharmacy department with patient's orders. The old protocol was not identified by other pharmacists as an outdated insulin protocol.

On 6/20/12 at 1627 hours, hospital administration was notified of the surveyor team's concerns regarding the health and safety of ICU patients receiving IV insulin. The team discussed the implementation of a protocol change with no documented inservice training of nursing, the lack of ongoing monitoring on the effectiveness of the protocol, and the lack of action taken despite identification of the insulin protocol flaws.

By 6/21/12 at 1100 hours, the team met with the Collaborative Council to discuss their corrective action plan on the IV insulin drip for ICU realizing the immediacy of the concern.

Based on medical record reviews and interviews, the hospital failed to ensure the QAPI program in the hospital included a program to identify and reduce medical errors the use of two high-risk medications, droperidol and IV insulin which can cause serious harm to patients. The hospital placed patients in an unsafe environment by not identifying the improper administration of these two drugs.

Findings:

1. The hospital failed to ensure the use of the medication droperidol was monitored to ensure use of the medication was appropriate per the hospital's P&P and the FDA guidelines. (Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates that droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.)

Improper use of droperidol was identified for six of the seven patients (Patients 37, 38, 39, 40, 41 and 42) reviewed with orders for the medication. There was no ongoing program of monitoring by the hospital of the use of droperidol.

Droperidol was identified as being administered improperly during a State survey conducted on 3/24/10. The Plan of Correction (POC) from the hospital showed the hospital would remove droperidol from the hospital's formulary and the drug would not be available for use.

Despite the hospital's POC to make droperidol unavailable for use, a hospital P&P/protocol dated March 2012, identified that droperidol would be permitted to be used within certain parameters; however, review of the medical records for Patients 37, 38, 39, 40, 41 and 42 on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3 showed physicians continued to administer droperidol improperly outside the protocol parameters.

At the conclusion of the record review, RNP 1, RPH 2 and RPH 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42. RPH 3 stated droperidol was not supposed to be available in the L&D OR. When asked, RPH 3 confirmed Pharmaceutical Services had not monitored the use of droperidol when the drug was again made available for use. There was no documented evidence to show the use of droperidol had been identified and included in the QAPI program to reduce medical errors.

During a meeting with hospital administration on 6/21/12 starting at 1800 hours, MD E stated anesthesiologists in the OR had wanted droperidol available for use. The Medical Staff had not doubted the anesthesiologists would use the drug within the parameters of the protocol developed in March 2012. At that time the Medical Staff persuaded the hospital to make droperidol available within the parameters of the protocol; however, the drug was not to be available or used in the L&D OR. As was discovered, not only was the drug in the L&D OR, but contrary to hospital policy, anesthesiologists administered the drug without identifying the patient's QT interval. Cross Reference A-0500 #1.

2. The hospital failed to ensure errors in the use of intravenous (IV) insulin for patients in the critical care units were identified and further monitoring was conducted to reduce medication errors. (Insulin is a high-alert medication which lowers blood sugar (BS). Improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.

Insulin medication errors were identified for three of the three patients reviewed with orders for IV insulin using the Intensive Insulin Drip Order form on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours (Patients 21, 22, and 54). RPH 3 stated the Pharmacists did not monitor the administration of intravenous insulin.

At a meeting with RNP 2 and RN T on 6/20/12 starting at 1120 hours, they stated they had found instances of high BS in cardiac surgery patient on IV insulin and had reviewed the insulin administration for those patients. In each case it was noted the RN had not administered the IV insulin per the guidelines of the IIDO. RNP 2 and RN T stated they had counseled these nurses on a one on one basis. However, there was no documentation to show such training had occurred. Moreover, RNP 2 and RN T stated they did not know if the insulin errors were more widespread. They were unable to state their findings had been shared with the Pharmacy staff. There was no evidence provided to show anyone in the hospital was aware of the intravenous insulin administration errors. Cross Reference A-0500 #2.

The Director was asked the procedure for the authentication of physician's telephone or verbal orders. The Director explained when a physician was in the hospital he/she entered a patient's orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign queue (an electronic system) to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.


26881


Based on interview and record review, the hospital failed to ensure the quality assurance program to measure, analyze and track the quality of medical record documentation processes in the open record as evidenced by:

1. Errors were found in the open medical records for two of three open recovery room records reviewed (Patients 10 and 59) which contained inaccurate post anesthesia assessments. Cross Reference to A 1005.

2. One of three open recovery room records contained a history and physical which had not been authenticated and there was no update to the history and physical on the day of surgery. (Patient 10). Cross Reference to A 0952.

3. Two of two open records reviewed of patients receiving Propofol (a powerful intravenous sedative) had incomplete medication orders (Patients 20 and 54). Cross Refence to A 0353.

4. Verbal and/or telephone physician's orders for patient care were not authenticated by a physician's signature as correct within 48 hours for three patients (Patients 25, 48,49). Cross Reference to A 0457.

These failures created the risk of substandard medical records and substandard healthcare for all patients using the hospital.

Findings:

The hospital policy, Plan for Improving Organization Performance (revised 9/2011), read in part, "Department Directors and Managers are responsible for quality care/service within their scope and include, but are not limited to: ongoing quality control activities and monitoring of trends within the area of service, as appropriate. Trends are further measured and assessed resulting in identification of opportunities for improvement within the department and in conjunction with other departments."

During an interview with the Director of Health Information Services on 6/19/12 at 1045 hours, she stated the medical records staff examined the closed records after the patient was discharged, but not open records. The Director stated she had oversight over the Medi-Tech portion of the electronic record, but not other portions of the medical record. The Director stated portions of the medical record were completed in other departments, and those departments were to provide oversight of the accuracy and completeness of those portions of the medical record, including labor and delivery, the operating room record, the cardiac catheterization laboratory, and cardiology.

The Director stated she had received no feedback from those departments regarding difficulties with completing their portions of the medical records. The Director stated members of the Quality department reviewed the closed medical record, but did not examine the open medical record.

The Director was asked the procedure for the authentication of physician's telephone or verbal orders. The Director explained when a physician was in the hospital he/she entered a patient's orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign queue (an electronic system) to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.


26881


Based on interview and record review, the hospital failed to ensure the quality assurance program to measure, analyze and track the quality of medical record documentation processes in the open record as evidenced by:

1. Errors were found in the open medical records for two of three open recovery room records reviewed (Patients 10 and 59) which contained inaccurate post anesthesia assessments. Cross Reference to A 1005.

2. One of three open recovery room records contained a history and physical which had not been authenticated and there was no update to the history and physical on the day of surgery. (Patient 10). Cross Reference to A 0952.

3. Two of two open records reviewed of patients receiving Propofol (a powerful intravenous sedative) had incomplete medication orders (Patients 20 and 54). Cross Refence to A 0353.

4. Verbal and/or telephone physician's orders for patient care were not authenticated by a physician's signature as correct within 48 hours for three patients (Patients 25, 48,49). Cross Reference to A 0457.

These failures created the risk of substandard medical records and substandard healthcare for all patients using the hospital.

Findings:

The hospital policy, Plan for Improving Organization Performance (revised 9/2011), read in part, "Department Directors and Managers are responsible for quality care/service within their scope and include, but are not limited to: ongoing quality control activities and monitoring of trends within the area of service, as appropriate. Trends are further measured and assessed resulting in identification of opportunities for improvement within the department and in conjunction with other departments."

During an interview with the Director of Health Information Services on 6/19/12 at 1045 hours, she stated the medical records staff examined the closed records after the patient was discharged, but not open records. The Director stated she had oversight over the Medi-Tech portion of the electronic record, but not other portions of the medical record. The Director stated portions of the medical record were completed in other departments, and those departments were to provide oversight of the accuracy and completeness of those portions of the medical record, including labor and delivery, the operating room record, the cardiac catheterization laboratory, and cardiology.

The Director stated she had received no feedback from those departments regarding difficulties with completing their portions of the medical records. The Director stated members of the Quality department reviewed the closed medical record, but did not examine the open medical record.

Based on administrative and dietary staff and dietary department document review, the hospital failed to have an ongoing QAPI program that addressed the complexity and scope of Nutrition Care Services which resulted in failure to identify issues in safe food handling practices and food storage and sanitation, all of which could result in food borne illness.

Findings:

During the survey of the hospital, from 6/18 - 6/21/12, deficient practices were observed related to:

1. Safe and sanitary food services operation. Cross Reference A-0620 and A-0749 #1 and #2.

2. Lack of organization and oversight of the dietary department. Cross Reference A-0619.

3. Ensuring patient nutritional needs were met. Cross Reference A-0395, A- 0467, A-0621, and A-0631.

The Nutrition Care Department covered food service and patient nutrition care on both the Mission Viejo and Laguna Beach Campuses with a total licensed patient beds of 552, with meals and patient care in the behavioral unit, chemical dependency and medical areas.

In an interview on 6/21/12 at 1100 hours, the the Director of Quality Outcome stated the review of the Nutrition Care Services Department's quality program as reported to the Quality Committee was the same quality program that had been developed and reported quarterly for the past six years. The Director of Quality Outcome acknowledged the quality program for the Nutrition Care Department for both the Mission Viejo and Laguna Beach Campuses, was not working well. The Director stated the hospital's quality improvement program had focused on patient care and not on the dietary or food service aspects of the Nutrition Care Department. The Director confirmed the Nutrition Care Services activities at this time did not show opportunities for improvement, rather were primarily monitoring activities.

An interview with the FSD on 6/21/11 at 0905 hours, and concurrent review of performance indicators for 2011, revealed the dietary department was submitting data on multiple processes (including kitchen refrigerators, patient refrigerators, food temperatures, dishroom temperatures, and sanitation check lists) within the department. The FSD acknowledged all of the indicators of the department were meeting departmental set thresholds at mostly 100 percent. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of safe food handling systems within the department including staff practices of handwashing and maintaining clean environment.
In addition, other nutrition related areas such as patient weight monitoring and nutrition care on the chemical dependency and behavioral health units did not have any quality improvement performance improvement programs.

Based on interviews and document reviews, the hospital failed to identify two high risk and potentially problem prone drugs, droperidol and IV insulin, as priorities for inclusion in the hospital's QAPI program. The improper administration of these high risk drugs had the potential to result in serious adverse events for patients.

Findings:

1. The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads: "Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic-used to treat N&V.) A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, droperidol should NOT be given."

The medical records for Patients 37, 38, 39, 40, 41 and 42 were reviewed on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3. Patient 37 and 38 records showed QT intervals GREATER than the maximum identified in the hospital's droperidol protocol and in the FDA BBW.

Thus, the physicians in the ED did not comply with hospital protocol or with the FDA BBW and placed patients in a potentially adverse situation.

Patients 39, 40, 41 and 42 each received droperidol in the L&D OR during a Cesarean Section. (a surgical procedure during which one or more incisions (cuts) is made into the mother's abdomen and uterus to deliver one or more babies.

Contrary to hospital protocol and contrary to the FDA BBW, there is no evidence the QT intervals for Patients 39, 40, 41 and 42 in the L&D OR were measured. With no QT interval measurement, there could be no determination if the administration of droperidol placed these patients in potentially serious adverse circumstance.

RNP 1, RPH 2 and 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42 and acknowledged there was no evidence anyone in the hospital was aware of the errors. RPH 3 acknowledged that Pharmaceutical Services did not monitor the use of droperidol.

2. The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive intravenous insulin using the Intensive Insulin Drip Orders (IIDO) form. Insulin is a high-alert medication which lowers blood sugar (BS). Improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death."

For Patient 21 - There were eight instances where insulin was administered in error to Patient 21, seven instances where insulin was administered in error to Patient 22, and five instances where insulin was administered in error to Patient 54. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

RPH 3 stated that Pharmacists did not monitor the administration of intravenous insulin. Data provided by RPH 3 showed that between January and June 2012, there were 56 patients that received intravenous insulin.

At a meeting with RNP 2 and RN T on 6/20/12 starting at 1120 hours, they stated they had found instances of high BS in cardiac surgery patients on IV insulin. The RNs stated they had reviewed the insulin administration for those patients. In each case it was noted the RN had not administered the IV insulin per the guidelines of the IIDO. RNP 2 and RN T stated they had counseled these nurses on a one on one basis. However, there was no documentation to show such training had occurred. Moreover, RNP 2 and RN T stated they did not know the insulin errors were more widespread. They were unable to state their findings had been shared with the Pharmacy staff. There was no evidence provided to show anyone in the hospital was aware of the intravenous insulin administration errors. Cross Reference to A 0500 #2.

Based on interviews and document reviews, the hospital's Governing Body failed to ensure adequate resources were allocated and sufficient numbers of Pharmacist and/or other personnel were available to properly review medication orders, monitor the use of medications, control drug distribution and to identify, analyze and correct medication errors to improve patient safety. This resulted in high-risk drug errors not identified, medication distribution not controlled, medication errors vastly underreported, wrong and unlabeled medications found in patient cassettes on the units, and large numbers of medication doses administered in the ED not reviewed. The lack of properly assessing drug use, identifying weaknesses in the drug use system and controlling the distribution of medications potentially placed patients at risk for an adverse event.

Findings:

1. Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates that droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death).

The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads:"Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic.) A baseline ECG (Electrocardiogram) within prior 48 hours is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QT interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, Droperidol should NOT be given."

On 6/20/12 starting at 1325 hours, seven patient records were reviewed with RNP 1, RPH 2 and RPH 3. Two of the seven patients reviewed (Patients 37 and 38) were found to have received doses of droperidol although their QT intervals were GREATER than 450 msec.

Four of the seven patients reviewed (Patients 39, 40, 41 and 42) received droperidol in the L&D OR. There was no evidence the QT intervals for these patients were measured. The findings were confirmed by RNP 1, RPH 2 and RPH 3. RPH 3 stated Pharmacists were not able to monitor the use of droperidol as they did not have enough time to do so. RPH 3 further stated droperidol was not supposed to be stocked in the L&D OR. Thus, there was no pharmacy monitoring or controlling the distribution of a high-risk drug.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. Patients 21, 22 and 54 were found to have received a total of 20 wrong doses of intravenous insulin. (Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death." The findings were confirmed by RNP 1 and RPH 2. RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.


3. The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."

Data provided by RPH 2 identified there were 336 medication errors reported in 2010, and 399 errors reported in 2011, for both the Mission Viejo and Laguna Beach Campuses. Data provided by RNP 1 identified there was a total of 92,000 patient days in 2010 and 94,000 in 2011.

Thus, according to the research performed by the IOM, the hospital should be reporting, on average, about 93,000 errors per year (the average patient days for 2010 and 2011) or more than 200 times the number of errors actually reported (93,000/400).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from three hospitals between October 1 and October 31, 2004, were reviewed using the Institute for Healthcare Improvement's Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:
a) 38% of identified adverse events were medication errors.
b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.

The data from both hospital campuses also showed there were about 23,000 discharges in 2010 and 2011. According to the HA study, the hospital should be reporting about 122,000 (5.3 x 23,000) errors per year. This is about 300 times the number actually reported (122,000/400).

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011" identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

During an interview with RPH 1, RPH 2 and RPH 3 on 6/21/12 starting at 1425 hours, they stated they knew the hospital was underreporting medication errors but had to first focus on priorities such as the more serious errors and the entering physician orders.

4. Data provided by RPH 1 identified:

a. There are approximately 14,000 patients seen at the Mission Viejo Campus ED.

b. Approximately 30,000 doses of medication were removed from the automated dispensing cabinets (ADC's) in the Mission Viejo ED and administered to patients each quarter (3 months).

c. 100 Mission Viejo ED patient records were reviewed each quarter for the appropriate use of medications.

Thus, less than 1% of the 14,000 patient records (100/14,000) and less than 1% (214/30,000) of the 30,000 doses were reviewed to ensure medication use in the ED was appropriate and safe. During an interview with RPH 1 on 6/21/12 starting at 1425 hours, it was stated there was not enough time to audit more patient records.

5. A review of patient cassettes located on 3 E and 3 W of the Mission Viejo Campus revealed three of the cassettes contained medications either unlabeled or not ordered for that patient. An additional two cassettes contained medications; however, there were no patients assigned to those cassettes. This was confirmed by RPH 2, RN N and RN M.

6. Work volume versus Pharmacist hours for April 2012, was provided by RPH 1. Ten full time Pharmacist's work volumes per time period were analyzed. The analysis showed Pharmacists entered orders, reviewed medication orders, provided consultations and answered questions in between 0.86 and 1.9 minutes per order.

The American Society for Health-Systems Pharmacists (ASHP), the internationally recognized professional society which establishes standards of practice for pharmacists practicing in hospitals in its Standard III: Optimizing Medication Thera

Per interview with RNP 2 and the CICU Clinical Specialist on 6/20/12 at 1118 hours, the previous IIDO form, dated 3/18/10, was updated approximately on 11/11. The new IIDO protocol was approved by different committees on 12/11, before it was implemented on 1/12. The training of the nurses occured approximately in 11/11, but RNP 2 and the CICU Clinical Specialist stated they did not document the training. When asked if the effectiveness of the new insulin protocol had been reviewed, RNP 2 stated "pitfalls were noted following the new IV insulin protocol, warranting one to one teaching among the nursing staff on one or two occassions." However, no documentation of the one to one training was provided.



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Based on interviews and medical record reviews, the hospital failed to ensure the RNs were competent in using the hospital Insulin Intensive Drip Orders (IIDO) for three of three patients reviewed (Patients 21, 22 and 54). (Insulin is a high-alert medication which lowers blood sugar (BS). The danger in not following the IIDO is that in an attempt to control high BS, improper doses of insulin can cause hypoglycemia (severely low BS).The recognized dangerous side effect of insulin is hypoglycemia. Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.")

Findings:

The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive IV insulin using the IIDO form.


a. For Patient 21 - There were eight instances where IV insulin was administered in error. For example, at 0006 hours on 5/30/12, Patient 21's BS was 431. The documented insulin rate was 6 units per hour. According to the IIDO, since the BS did not decline by 60, the dosing algorithm (which identified the rate) should have moved over to the next higher level. This did not occur. The documented rate of 6 units per hour should have been 9 units per hour per the algorithm. About one hour later at 0053 hours, Patient 21's BS was 386. Again, the BS did not decrease by 60 so the dosing algorithm should have been moved again to the next higher level. This did not occur. The documented rate of 12 units per hour should have been 15 units per hour per the algorithm.

b. For Patient 22 - There were seven instances where IV insulin was administered in error. For example, at 2000 hours on 6/16/12, Patient 22's BS was 278. Since the BS did not decline by 60 (the BS at 1900 hours was 317), the dosing algorithm should have been moved to the next higher level. Instead, the RN kept the dose at the same algorithm and documented a rate of 9 units per hour. According to the IIOD algorithm, the insulin rate should have been 15.5 units per hour.

c. For Patient 54 - There were five instances where IV insulin was administered in error. For example, at 0200 on 6/18/12, Patient 54's BS was 330, an increase of 44 over the measurement at 0100. Again, the IIDO called for a move to the next higher algorithm which should have been F. However, since algorithm F had no values, the RN should have called the MD to determine what rate was to be administered. There was no documented evidence to show the RN called the MD. The RN continued to use the wrong algorithm for the next four hourly doses. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

2 a. Patient 20 was observed on 6/19/12 at 1000 hours. The patient was in the CICU and there was a bottle of milky white fluid labeled propofol suspended from the bedside IV pole.

The EMR orders by MD I, dated 6/16/12, for propofol for Patient 20 were reviewed and read, propofol drip 10 mg/ml, usual infusion rate: 10-50 mCg/kg/min, Max infusion rate: 100 mCg/kg/min. There was no starting dose, no titration instructions and no target sedation level specified for the medication. There were no clarifying orders seen.

The orders in the paper medical record for Patient 20 were also reviewed and did not contain any handwritten orders regarding propofol.

The Nurse Manager for the CICU was interviewed on 6/19/12 at 1005 hours. The Nurse Manager reviewed the propofol orders for Patient 20 and stated the sedation level desired should have been specified by the physician in the order.

RN K was interviewed on 6/19/12 at 1010 hours and confirmed there was no handwritten order or clarification of the propofol order for Patient 20.

RN L, who was caring for Patient 20, was interviewed on 6/19/12 at 1015 hours. RN L stated she usually expected titration parameters and would contact the physician if the titration parameters were not in the medication orders. RN L stated she was not aware of the physician being contacted for clarification of the incomplete propofol order.

b. The medical record of Patient 54 was reviewed on 6/20/12. The record included a 6/16/12 handwritten order by MD I for "Diprivan drip for sedation". There was no initial dose specified, titration rate, or description of the level of sedation desired.

During an interview with RN T on 6/20/12 at 1000 hours, she reviewed the medical record and stated that she did not see the starting dose or nursing titration parameters on the propofol orders. The RN stated she did not see any clarifying contact with the physician regarding the propofol sedation goal.

During an interview with RN U on 6/20/12 at 1015 hours, she stated she was the nurse caring for Patient 54. RN U stated propofol orders were initiated by MD I after the patient was intubated (given a breathing tube). The RN stated she recalled calling the physician for clarification of the dosing, but confirmed she had not written down the clarifying orders. RN U stated the level of propofol had been adjusted up and down since the initiation on 6/16/12, by herself and other nurses, but without any specific titration orders being documented.

In an interview with the Pharmacy Clinical Manager on 6/19/12 at 1435 hours, he stated that the hospital previously used the paper order form for propofol which provided titration guidance from which the physician could select. The Pharmacy Clinical Manager stated the titration guidance from in the paper order set had not been made a part of the EMR order set.

A blank hospital order set, Pain, Sedation, Agitation Orders (dated 11/10) was reviewed and included a pre-printed page of sedation target score descriptions and dosing warnings, along with spaces for the physician to indicate the starting dose, titration rate, and sedation score target.

The medical record of Patient 54 was further reviewed and showed documentation four nurses caring for Patient 54 had titrated propofol for an intravenous intake amount between 10.4 and 17.1 ml between 6/16/12 and 6/19/12, without any physician orders specifying titration parameters or rates.

3. During an observation on 6/20/12 at 1255 hours in the recovery area at the Laguna Beach Campus, the medical record of Patient 61 was reviewed. The record contained notations of Dilaudid (a powerful pain reliever), being administered eight times in the recovery room, and Oxycodone (a powerful pain reliever) one tab being administered twice in the recovery room. However, there was no physician's order on the record for those medications.

During a concurrent interview with the Nurse Manager of Surgical Services, she confirmed there was no order on the medical record for the pain relievers administered to Patient 61. The Nurse Manager stated the nurse had not yet recorded the verbal order he received for the medications. When asked about the actual dose of the Oxycodone tablets given, the Nurse Manager conferred with the nurse and stated it must have been 5 mg, as that what was the dose available in the ADC.



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Based on interviews and record reviews the hospital failed to ensure RN's:

1. Administered intravenous (IV) insulin according to physician's orders for three of three patients reviewed (Patients 21, 22 and 54). (Insulin is a high-alert medication which lowers blood sugar (BS). The danger in not following the IIDO is that in an attempt to control high BS, improper doses of insulin can cause hypoglycemia (severely low BS).The recognized dangerous side effect of insulin is hypoglycemia. Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death.")

2. Administered propofol (also known as Diprivan, a powerful intravenous sedative) to two patients (Patients 20 and 54), with initial dose and titration goal orders from the physician, resulting in the risk of medication dosing errors and a poor health outcome.

3. Did not administer medications for one patient (Patient 59), without a medication order for the medications on the record in the recovery room , creating the risk of a medication administration error and a poor health outcome for that patient.

Findings:

1. The medical records for Patients 21, 22 and 54 were reviewed on 6/19/12 with RNP 1, RPH 2 and RPH 3 starting at 1400 hours. According to physician's orders, each patient was to receive intravenous (IV) insulin using the intense insulin drip orders (IIDO) form.

a. For Patient 21 - There were eight instances where IV insulin was administered in error. For example, at 0006 hours on 5/30/12, Patient 21's BS was 431. The documented insulin rate was 6 units per hour. According to the IIDO, since the BS did not decline by 60, the dosing algorithm (which identified the rate) should have moved over to the next higher level. This did not occur. The documented rate of 6 units per hour should have been 9 units per hour per the algorithm. About one hour later at 0053 hours, Patient 21's BS was 386. Again, the BS did not decrease by 60 so the dosing algorithm should have been moved again to the next higher level. This did not occur. The documented rate of 12 units per hour should have been 15 units per hour per the algorithm.

b. For Patient 22 - There were seven instances where IV insulin was administered in error. For example, at 2000 hours on 6/16/12, Patient 22's BS was 278. Since the BS did not decline by 60 (the BS at 1900 hours was 317), the dosing algorithm should have been moved to the next higher level. Instead, the RN kept the dose at the same algorithm and documented a rate of 9 units per hour. According to the IIOD algorithm, the insulin rate should have been 15.5 units per hour.

c. For Patient 54 - There were five instances where IV insulin was administered in error. For example, at 0200 on 6/18/12, Patient 54's BS was 330, an increase of 44 over the measurement at 0100. Again, the IIDO called for a move to the next higher algorithm which should have been F. However, since algorithm F had no values, the RN should have called the MD to determine what rate was to be administered. There was no documented evidence to show the RN called the MD. The RN continued to use the wrong algorithm for the next four hourly doses. RNP 1 and RPH 2 confirmed the findings for Patients 21, 22 and 54.

Administering the wrong doses of intravenous insulin placed patients in a potentially serious adverse situation.

Based on medical record review and interview, the hospital failed to ensure verbal and/or telephone physician orders for patient care were authenticated by physician signature as correct within 48 hours for three of 116 sampled patients (Patients 25, 48, and 49). When verbal or telephone orders were not reviewed and signed by a physician as correct in a timely manner there was the potential for transcription error and risk to patient safety.

Findings:

Review of the hospital's P&P Physician Orders, Critical Results and Consultations, last reviewed 1/06, showed the prescriber must countersign verbal and telephone orders within 48 hours.

The Director of Health Information Services was interviewed on 6/19/12 at 1030 hours. The Director explained when a physician was in the hospital he/she entered a patient's orders directly into the patient's electronic record. However, if the nurse received a verbal or telephone order from the physician, the order was entered in the patient's electronic record by the nurse or clerical staff. The presence of a telephone or verbal order needing a signature went to the physician's E Sign que to alert a signature was needed. When asked if there was any follow up by the medical record staff to ensure these orders were signed within 48 hours, the Director stated no, her department did not monitor incomplete orders until after the patient's discharge.

1. The closed medical record for Patient 48 was reviewed on 6/20/12 at 1330 hours with the Clinical Informatics Consultant. An order change for Zofran (anti-nausea medication) was entered into the electronic record by a pharmacist on 5/29/12 at 1156 hours. The order was not electronically signed by the physician until 6/2/12 at 2352 hours (four days later).

2. The closed medical record for Patient 49 was reviewed on 6/20/12 at 1335 hours with the Clinical Informatics Consultant. A telephone order for IV potassium was entered into the electronic record on 5/29/12 at 1954 hours. The order was not signed electronically by the physician until 6/6/12 at 0000 hours (eight days later).


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3. On 6/19/12 at 1057 hours, Patient 25's medical record was reviewed. Review of the physician's orders showed a telephone order dated 6/10/12, for Boost TID orally (nutrition supplement three times a day) by a nurse.

On 6/19/12 at 1152 hours, RN P reviewed Patient 25's paper medical record and electronic medical record. The RN stated the telephone order for the Boost Enlive supplement was the order entered as it was the hospital's approved substitute for Boost. RN P stated the order had not been signed and authenticated by the practitioner responsible for the care of the patient.

Further review of Patient 25's electronic medical record showed RD 2 had entered a telephone order for a Jevity 1 Cal Enteral Feed on 6/16/12.

On 6/19/12 at 1154 hours, RN P reviewed Patient 25's electronic medical record. The RN verified the physician had not authenticated the telephone order for the enteral feeding. According to RN P, the medical staff by-laws indicated that telephone orders required the physician's authentication within 48 hours.

4. On 6/18/12 at 1000 hours, a inspection/tour of the Acute Rehabilitation Unit (ARU) was conducted. Antibiotic ointments in a open plastic tray were found stored on an unlabeled shelf next an open container labeled "Used Batteries."

On 6/18/12 at 1020 hours, an interview with the ARU Charge Nurse (RN W) was conducted. RN W stated the medications should not be stored in this area.







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3. Review of the hospital's P&P titled "Medication Administration" (Code CPC-201MAR-1.M.3.1) showed "Verbal/telephone orders are to be written down when received and repeated back to the physician for confirmation."
On 6/18/12 at 1115 hours, a tour of the Mission Viejo Campus 3 West Oncology/Medical Unit took place with the Medication Safety Officer. A random selection of patient charts showed three of three patients records reviewed (Patients 17, 18 and 19) contained written telephone orders that did not indicate the telephone order was read back to the physician. The Medication Safety Officer stated that all telephone orders "must have read back."


27873


Based on interviews and observations the hospital's pharmacy failed to ensure:

1. Medications on the 3rd floor nursing units, including high-risk medications, were contained in six patient cassettes that were properly labeled, medications were stored in the right patient cassette (drawer)

2. Medications were removed when there was no longer physician's order for their use.

3. The P&P for telephone and verbal orders to be read back to the prescriber was implemented.

4. Medications were stored separately from other items on the Acute Rehabilitation Unit. This could potentially result in a medication error.


Findings:

1. Nursing unit 3 E on the Mission Viejo Campus was visited on 6/18/12 starting at 0850 hours, with RPH 2. The medication cart was opened revealing patient cassette drawers.
* Note: The room numbers have been altered to protect patient privacy.

a. The drawer for Room A Bed 2 was reviewed with RN N. The drawer contained 2 vials of Lovenox. Lovenox is a special form of heparin which is administered either intramuscularly or subcutaneously to thin the blood. It is a high-risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA) strongest warning. The Lovenox vials were not labeled with a patient's name or directions for use. RN N, who was caring for the patient in Room A, stated the patient had no order for Lovenox. Thus a high-risk medication with no patient label was sitting in a drawer for a patient who had no order for the drug creating an unsafe situation.

b. The drawer for room Room B Bed 1 was reviewed with RN U. The drawer contained 1 vial of Humulog insulin and 1 vial of Humulin R insulin. Neither vial was labeled with a patient's name or directions for use. RN U, caring for the patient in 367-1 said there was an order for Humulog for that patient but not for Humulin R. Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death." Thus, 2 different dosages of insulin, a high-alert medication, were sitting in a drawer for a patient with no patient label; one was ordered for the patient the other was not, creating the potential for a serious adverse event.

2. Nursing unit 3 W on the Mission Viejo Campus was visited on 6/18/21 starting at 0945 hours with RPH 2. The medication cart was opened revealing patient drawers.

c. The drawer for room Room C Bed 2 was reviewed with RN Q. The drawer contained the following medications, all with no patient name or directions for use: Lactulose (an osmotic laxative), Docusate (a stool softener), Furosemide (a diuretic which is used to increase urination), Celebrex (an anti-inflammatory drug used to relieve pain. It is a high-risk medication that contains a Black Box Warning (BBW) and senna (a stimulant laxative). According to RN Q, there was no patient assigned to room Room C Bed 2. So, unlabeled and unauthorized medications were sitting in a drawer assigned to a bed with no patient in the bed creating another opportunity for a potential adverse event.

d. The drawer for room Room D Bed 1 was reviewed with RN V. The drawer contained promethazine. Promethazine is both an anti-emetic (to relieve nausea and vomiting) and an antihistamine (to relieve allergic symptoms). Promethazine is also a high-risk drug with a Black Box Warning (BBW). RN V, who was caring for the patient in Room D Bed 1, stated the patient was no longer on promethazine, it had been discontinued the day before. Yet the high-risk medication was still available for use which created another potential adverse event.

e. The drawer for room Room E Bed 1 was reviewed with RN M. The drawer contained Megace. Megace is a drug used to treat breast and endometrial cancer. Lexicomp, a nationally recognized drug information source identifies Megace as a hazardous agent which is to be used with "appropriate precautions for handling and disposal". RN M stated the patient in Room E Bed 1 had no physician's order for Megace. RN M stated it was for a previous patient who had been discharged. So, we have yet another opportunity for a patient to receive unauthorized medication which is considered hazardous.

f. The drawer for room Room F Bed 1 was reviewed with RN M. The drawer contained Humulin R insulin which was not labeled with a patient's name or directions for use. According to RN M, who was caring for the patient in Room F Bed 1, there was no physician's order for Humulin R insulin. As described in the visit to 3 E, under (b) above, insulin is a high-risk drug that could result in serious patient harm.

RPH 2 stated that pharmacy was not aware the above referenced medications were stored in the patient drawers.

Based on interviews and record reviews the hospital failed to ensure there were a sufficient number of Pharmacists to review medication orders, monitor drug use, control drug distribution and to identify, analyze and correct medication errors to improve patient safety. This resulted in high-risk drug errors not identified, medication distribution not controlled, medication errors were vastly underreported, wrong and unlabeled medications were in patient cassettes (drawers), and large numbers of medication doses administered in the ED were not reviewed. The lack of a proper assessment of drug use, identification of weaknesses in the drug use system, and controlling the distribution of medications placed patients at risk for an adverse event

Findings:

1. Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicate the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicates droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart as measured on an electrocardiogram (EKG). A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.)

The hospital's protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations "reads: "indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate. (Droperidol is a second or third line antiemetic.) A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, Droperidol should NOT be given."

On 6/20/12 starting at 1325 hours, seven patient records were reviewed with RNP 1, RPH 2 and RPH 3. Two of the seven patients reviewed (Patients 37 and 38) were found to have received doses of droperidol although their QT intervals were GREATER than 450 msec.

Four of the seven patients reviewed (Patients 39, 40, 41 and 42) received droperidol in the L&D OR. There was no evidence the QT intervals for these patients were measured. Thus, droperidol was administered to Patients 39, 40, 41 and 42 improperly and contrary to the hospital protocol and the FDA BBW. The findings were confirmed by RNP 1, RPH 2 and RPH 3. RPH 3 stated Pharmacists were not able to monitor the use of droperidol as they did not have enough time to do so. RPH 3 further stated droperidol was not supposed to be stocked in the L&D OR. Thus, there was no pharmacy monitoring or controlling the distribution of a high-risk drug. Cross Reference to A 0353.

2. On 6/19/12, starting at 1400 hours, Patient's 21, 22 and 54's medical records were reviewed with RNP 1, RPH 2 and RPH 3. The patients were found to have received a total of 20 wrong doses of intravenous insulin. Insulin is a high-alert medication which lowers blood sugar (BS). The danger is that the improper administration of insulin can cause hypoglycemia (severely low BS). Lexicomp, a nationally recognized drug information source indicates: "Profound and prolonged episodes of hypoglycemia may result in convulsions, unconsciousness, temporary or permanent brain damage or even death."

The findings were confirmed by RNP 1 and RPH 2. RPH 2 and RPH 3 both stated Pharmacists were not able to monitor the use of intravenous insulin as they did not have sufficient time to do so.

3. The Institute of Medicine (IOM is a nationally recognized organization which focuses on medication safety), in a book entitled "Preventing Medication Errors: Quality Chasm Series (2007)" concluded that, "on average, a hospital patient is subject to at least one medication error per day."

Data provided by RPH 2 identified there were 336 medication errors reported in 2010, and 399 errors reported in 2011, for both the Mission Viejo and Laguna Beach Campuses. Data provided by RNP 1 identified there were a total of 92,000 patient days in 2010 and 94,000 in 2011.

Thus, according to the research performed by the IOM, the hospital should be reporting, on average, about 93,000 errors per year (the average patient days for 2010 and 2011) or more than 200 times the number of errors actually reported (93,000/400).

A study entitled "Global Trigger Tool Shows That Adverse Events in Hospitals May be Ten Times Greater Than Previously Measured" was published in Health Affairs (HA) dated April 12, 2011, pages 581 to 589. The study identified that closed medical records for 795 patients from three hospitals between October 1 and October 31, 2004, were reviewed using the Institute for Healthcare Improvement's Global Trigger Tool. The study found that Safety Indicators and Hospital Voluntary Reporting "fail(ed) to detect more than 90 percent of the adverse events that occur among hospitalized patients." The study also showed:

a) 38% of identified adverse events were medication errors.

b) That each patient was subjected to 5.3 medication errors during his/her hospital stay.

The hospital's data also showed there was a yearly average of about 23,000 discharges in 2010 and 2011. According to the HA study, the hospital should be reporting about 122,000 (5.3 x 23,000) errors per year rather than the 400 per year actually reported. So, according to the HA study, the hospital should be reporting more than 300 times the number of errors actually reported.

The Agency for Healthcare Research and Quality (AHRQ) in its annual "Hospital Survey on Patient Safety Culture 2011" identified that 54% of the hospitals, on average, reported no events at their hospitals during the past 12 months. Although the initial numbers appear that more than half of hospitals have no incidents, it's more likely they simply go unreported according to AHRQ. "This is an area for improvement for most hospitals because underreporting of events means potential patient safety problems may not be recognized or identified and therefore may not be addressed," according to AHRQ.

During an interview with RPH 1, RPH 2 and RPH 3 on 6/21/12 starting at 1425 hours, they stated they knew the hospital was underreporting medication errors but they had to focus on priorities first such as entering physician orders into the pharmacy system.

4. Data provided by RPH 1 identified:

a.There were approximately 14,000 patients seen in the Mission Viejo ED;

b. Approximately 30,000 doses are removed from the automated dispensing cabinets (ADC's) in the Mission Viejo ED and administered to patients each quarter (3 months).

During an interview with RPH 1 on 6/21/12 starting at 1425 hours, she stated she reviewed 100 Mission Viejo ED patient records (which yielded 214 doses (30,000 doses/14,000 records)) each quarter for the appropriate use of medications. 100 records and 214 doses represented 7-tenths of 1% (0.7%) of the 14,000 patient records and 30,000 doses administered. Thus, more than 99% of the medication doses removed and administered to patients in the Mission Viejo ED were never reviewed by a Pharmacist. When advised the number of records and doses reviewed was a very small percentage of the total, RPH 1 stated there was not enough time to audit more patient records.

5. A review of patient drawers located on 3 E and 3 W of the Mission Viejo Campus revealed:

a.Three drawers contained medications that were not labeled.

b. Three drawers contained medications that were not ordered for that patient.

c. Two drawers contained medications that were discontinued.

d.One drawer contained five unlabeled medications for which there was no patient, since there was no patient assigned to that room.

This was confirmed by RPH 2, RN N and RN M. RPH 2 further stated the pharmacy was not aware of the impro

5. Malignant Hyperthermia (MH) is an inherited muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis. " (http://www.mhaus.org/patients-and-families/#.T6rWblI2cTY ).

During a tour of the pre-operative and post-operative areas of the Laguna Beach Campus on 6/19/12 at 1115 hours, an observation of the Malignant Hyperthermia Drug Box took place with the Manager of Pharmacy Operations, Laguna Beach. This drug box contained only one liter of sterile water for injection. Sterile water is used to reconstitute Dantrolene©, a medication used to treat MH. Thirty-six vials of Dantrolene© were available: each vial of Dantrolene© requires 60 milliliters of sterile water for reconstitution into a usable, injectable solution. Therefore, over 2 liters of sterile water would be needed to reconstitute this entire supply of Dantrolene© in an emergent MH crisis. There was no pharmacist on site after hours as the Laguna Beach Campus pharmacy was not a 24 hour pharmacy and was serviced by the Mission Viejo Campus after hours.

In addition, a tour of the OR at the Laguna Beach Campus took place on 6/19/12 at 1530 hours with Nurse Manager Surgical Services, Laguna Beach. Observation of a medication refrigerator revealed no Sodium Chloride 0.9% Solution (Normal Saline or NS) was available in a chilled state for use during an MH emergency. "A minimum of 3,000 milliliters of refrigerated cold saline solution for IV cooling" is recommended by the Malignant Hyperthermia Association of the United States (MHAUS). ().

The Nurse Manager stated this refrigerator was recently defrosted and there was a failure to place the 0.9% Sodium Chloride solution back into the refrigerator.

In addition, the Association of periOperative Registered Nurses (AORN) also provides recommendations about the treatment, necessary supplies and medications used in an MH emergency which generally parallel or refer to MHAUS. Supplies as referenced by these organizations were not found located in a central location (such as a dedicated MH Cart as referenced in the above MHAUS documents) - only an emergency box containing the medications was available.

A review of the hospital's Clinical Guideline titled " Malignant Hyperthermia (MH), Management of " (latest review/revision date provided: 11/2009), failed to indicate supplies and cold 0.9% sodium chloride solution (as recommended by MHAUS/AORN) be available for immediate use during an MH emergent situation.




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Based on interview and medical record reviews the hospital failed to:

1. For Droperidal: Maintain its Plan Of Correction (POC) for the improper administration of droperidol, cited during a State survey in March 2010. Ensure Pharmaceutical Services monitored the safe use of droperidol for six of the seven patients reviewed (Patients 37, 38, 39, 40, 41 and 42) per hospital P&P and FDA warnings. Ensure Pharmaceutical Services safely distributed droperidol and made certain droperidol was not available in the L&D OR.These failures placed patients at immediate risk for irregular heart rates and/or rhythms and sudden death.

2. Monitor the safe use of the Intensive Insulin Drip Orders (IIDO) protocol.

3. Ensure Medications on the 3rd floor nursing units, including high-risk medications, were contained in patient cassettes that were properly labeled, medications were stored in the right patient cassette (drawer) and the medications were removed when there was no longer physician's order for their use.

4. Identify, analyze and correct medication errors to improve patient safety.

5. To provide certain fluids and supplies that constitute a fully stocked Malignant Hyperthermia Medication (MH)/Supply Cart.

The lack of properly assessing drug use, identifying weaknesses in the drug use system and controlling the distribution of medications placed patients at risk for an adverse event.

Findings:

1. Droperidol was identified as being administered improperly during a State survey conducted on 3/24/10. The POC from the hospital showed the hospital would remove droperidol from the hospital's formulary and the drug would not be available for use.

Droperidol is a medication used to treat nausea and vomiting and is a high risk medication that contains a Black Box Warning (BBW). A black box warning means that medical studies indicated the drug carries a significant risk of serious or even life-threatening adverse effects. It is the U.S. Food and Drug Administration's (FDA's) strongest warning. The FDA BBW indicated droperidol should not be given for QT intervals greater than 440 milliseconds (msec) for males and 450 msec for females. The QT interval is a measure of electrical activity in the heart. A prolonged QT interval is a risk factor for irregular heartbeats and sudden death.

For Patients 37 and 38, droperidol was administered in the ED, although contraindicated due to measured QT intervals. For Patients 39, 40, 41 and 42, droperidol was administered in the L&D OR with no documented evidence of a measurement of the patients QT interval, contrary to hospital policy.

The hospital's P&P protocol for the use of droperidol, dated March 2012, was reviewed on 6/20/12 at 1335 hours. The protocol, under "special considerations" reads: "Indicated to treat or reduce the incidence of N&V (nausea and vomiting) in patients for whom other treatments are ineffective or inappropriate droperidol is a second or third line antiemetic). A baseline ECG (Electrocardiogram) (within prior 48 hours) is required prior to administration of the first dose to determine if a prolonged QT interval is present. If the baseline QTc interval is > (greater than) 440 msec (milliseconds) for males or >450 msec for females, droperidol should NOT be given."

Despite the hospital's POC to make droperidol unavailable for use, the protocol described above, dated March 2012, identified that droperidol would be permitted to be used within certain parameters. However, review of medical records showed physicians continued to administer droperidol improperly outside the protocol parameters.

The medical records for Patients 37, 38, 39, 40, 41, and 42 were reviewed on 6/20/12 starting at 1325 hours, with RNP 1, RPH 2 and RPH 3.

a. Review of Patients 37 and 38's medical records showed QT intervals GREATER than the maximum identified in the hospital's droperidol protocol and in the BBW when administered by physicians in the ED.

Patient 37 is a 43 year old male. His record revealed droperidol was administered on 5/25/12 in the ED at 1330 hours. Documentation showed a QT interval of 467.

Patient 38 is a 62 year old female. Her record revealed droperidol was administered on 5/25/12 at 1546 hours, in the ED. Documentation showed a QT interval of 462.

b. Patients 39, 40, 41, and 42 each received droperidol in the L&D OR during Cesarean Section ( a surgical procedure during which one or more incisions (cuts) is made into the mother's abdomen and uterus to deliver one or more babies).

Patient 39 received droperidol on 5/26/12 at 2016 hours. There was no documentation in the record a QT was measured.

Patient 40 received droperidol on 5/26/12 at 0925 hours. There was no documentation in the record a QT was measured. There was no documentation in the record a QT was measured.

Patient 42 received droperidol on 6/1/12 at 1361 hours. There was no documentation in the record a QT was measured.

Contrary to hospital protocol and contrary to the FDA BBW there was no documented evidence the QT intervals for Patients 39, 40, 41, and 42 in the L&D OR were measured. With no QT interval measurement, there could be no determination if the administration of droperidol placed these patients in a potentially serious adverse position.

At the conclusion of the record review, RNP, RPH 2 and RPH 3 all confirmed the findings for Patients 37, 38, 39, 40, 41, and 42. RPH 3 stated droperidol was not supposed to be available in the L&D OR confirming Pharmaceutical Serv

Based on observation and staff interview, expired medication vials and biologicals were found available for patient use in the OR and the ED of the Mission Viejo Campus. Patient use of outdated medications and biologicals offered no assurance of its maximum efficacy.

Findings:

A. On 6/18/12 at 0930 hours, during the initial tour of the ED accompanied by OA 1, more than a dozen vials of expired sterile water, dated 3/12, were found inside the unit's wound dressing cart available for patient use. Inside the unit's pediatric crash cart, a box of expired glucometer strips to test blood sugar level was also found.




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B. During a tour of OR 1 on 6/18/12 at 1125 hours, a clear plastic box secured with a plastic lock and containing medications was seen. A label on the side of the box indicated the next medication to expire was lidocaine, expiration date 10/1/12. However, through the clear plastic cover of the box was seen a cardboard box of Epinephrine 1:10,000, 1 ml, with the expiration date of 6/1/12.

During a concurrent interview with RN J, she confirmed the expiration date on the epinephrine box.

Based on food storage and food production and service observations, dietary staff interview, and dietary document review, the hospital failed to ensure the Food and Dietetic Service Director developed and monitored written procedures according to standards of practice for operational processes at the hospital's Mission Viejo and Laguna Beach Campuses. Failure to develop and monitor standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

The hospital failed to ensure food intended as part of the hospital's disaster plan was maintained at appropriate temperatures at all times at the Laguna Beach Campus and at the Mission Viejo Campus that the emergency food was not expired. Failure to maintain disaster foods at the correct temperatures and to ensure that food items were not expired may result in lack of availability of an adequate food supply in the event of a disaster, compromising the medical status of patients.

Findings

1. During several interviews with the Food and Dietetic Service Director (FSD) from 6/18 to 6/21/12, there were observations made that reflected lack of oversight of food service operations. During the interviews conducted with the FSD, she indicated that while she bore the ultimate responsibility of foodservice operations, she managed the day to day foodservice operations through the use of an Assistant Director of Nutrition Services (who had primary oversight responsibilities at the Laguna Campus) and a Clinical Nutrition Manager.
As a result of this management organizational structure, the FSD was not fully aware of the issues that affected safe food handling practices. For example, although there was a cool down procedure at the facility, there was no consistent monitoring of the process to ensure food was prepared and maintained in a safe manner. Food storage practices identified during the survey process revealed deficient practices such as storing raw fish directly above ready to serve food products. Cross Reference A-0749 #1.

During random review of selected departmental policies and procedures related to identified deficient practices in dietetic services, it was noted policies did not consistently provide sufficient procedural guidance that reflected current standards of practice or the department had not developed procedural guidance for all functions.

a. There was no procedure that provided comprehensive guidance to staff on the proper washing of produce (specifically items such as cantaloupes that can be considered potentially hazardous foods).

b. There was no documented monitoring of safe cool down of potentially hazardous foods.

c. The position description of the Clinical Nutrition Manager did not include the State Regulatory Requirement of oversight of dietary operations.

d. The position description of the Assistant Director of Nutrition Services showed the following: "Supervises staff assigned to non-patient food services, Managing Chef, Assistant Chef, and Food production staff. However, the Nutrition Care Assistants and the Registered Dietitian at the Laguna Campus also reported to the Assistant Director of Nutrition Services. Cross Reference A-0619.
In an interview with the FSD on 6/21/11 at 0905 hours, performance indicators for 2011 were reviewed. Documentation showed the dietary department was submitting data on multiple processes within the department. Cross Reference A-0276.

The FSD acknowledged that all of the indicators of the department were meeting departmental set thresholds. It was noted that while the department was monitoring some food service performance indicators, there was no evaluation of safe food handling systems within the department including staff practices of hand washing and maintaining clean environment.

2. On 6/19/12 at starting at 1020 hours, at the Laguna Beach Campus food service the following were observed with concurrent staff interviews:

a. The Assistant Director of Operations stated the facility used a product for washing and reducing pathogens in fruit and vegetables.

Cook 3 stated during the observation that all fruit and vegetables were soaked for 10 minutes in the antimicrobial fruit and vegetable wash before they were pealed or prepared for service. Cook 3 stated all fruits including cantaloupe were just soaked. He stated there was no brushing to remove dirt or debris in the netting of the exterior of the cantaloupe.

Review of the manufacturer's literature on 6/19/12 at 1130 hours, showed the antimicrobial wash directions for a soak-wash procedure stated to "agitate and brush produce as needed."

Review of the FDA Food Code 2009 showed raw fruits and vegetables should be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready to eat form.

The facility practice did not adequately clean the cantaloupe or other membranous or ground grown vegetable to ensure imbedded dirt and debris was removed to prevent growth of microorganisms from the surface of the vegetables and fruit prior to cutting and preparing for service.

3. Starting on 6/18/12 at 0900 hours, at the Mission Viejo Campus food service the following were observed with concurrent staff interviews:

a. The cooling down of potentially hazardous foods (foods that require time/temperature control for safety to limit pathogenic microorganism growth or toxin formation) had not been done in accordance with the hospital's policy and procedure. Cross Reference to A-0749 #1.

b. The 3-compartment sink (wash and sanitize food service equipment) temperature taken by the Executive Chef of the wash compartment was 90.8 degrees F. The Executive Chef stated, "It should be 110 degrees F."

The hospital's policy and procedure entitled Warewashing (last revised 3/09) indicated, "Purpose: To maintain safe infection control standards, all utensils used for eating, drinking and in the preparation and serving of food and drink shall be cleaned and disinfected or discarded after each use..., Three-Compartment Sink Dish Washing Procedure; ...The "wash water shall be 110 degrees F."

Wash solution temperature that is less than 110 degrees F may inhibit removal of organic matter, such as animal fats, and the performance of the detergent may be adversely affected. (FDA Food Code 2009)

4. During the lunch tray line (patient meal tray assembly), there was a reach-in refrigerator with five thawed, 4 fluid ounce cartons of "health shake." The individually packaged health shakes contained manufacturer's guidelines that indicated, "Use within 14 days of thawing."

The Director of Food Service and the Retail Manager both stated the health shakes were not dated as to when they were thawed to ensure they were used within the manufacturer's recommended shelf-life

5. The walk-in freezer contained one six pound frozen, sealed and unopened beef tenderloin, undated. The Director of Food Service and the Retail Manager both stated they could not determine how long the frozen meat had been in the freezer since it was taken out of its packaging box that had contained the label with the date.

The Director of Food Service and the Retail Manager acknowledged that without a date on the frozen meat, dietary staff would be unable to ensure that it was used within the hospital's policy and procedure for storage of frozen foods to ensure food quality.

6. The dry food storage room contained seven nutritional supplements, designed for patients with kidney disease, that contained an expiration date by the manufacturer of "6/1/12." The Director of Food Service and the Retail Manager stated they did not know what that date meant.

On 6/21/12 at 1350 hours, the Clinical Nutrition Manager stated the date of 6/1/12, that was on the nutritional supplements was a discard date. The Clinical Nutrition Manager acknowledged the expired nutritional supplements should not have been available to dietary staff to provide for patient use.

6. On 6/19/12 at 1325 hours, observation of the disaster food supply at the Laguna Beach

4. On 6/19/12 starting at 1020 hours, at the at the Laguna Beach Campus food service site,
the condenser grills in the produce and dairy walk-in refrigerator were observed to be covered with black debris.

The Assistant Director of Operations reached up and brushed loose debris from the grill and dispersed it into the produce on the shelves. The Assistant Director confirmed the condenser grills were dirty and should be cleaned. He stated the food service staff were to notify the engineering staff to clean as needed. The Assistant Director further stated environmental and food service rounds were conducted each week and the dirty condensers had not been identified.


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On 6/18/12 at 1100 hours, a tour and inspection of the Acute Rehabilitation Unit (ARU) was conducted. The Program Director and the Charge Nurse were in accompaniment. A large, gas cylinder confined to a metal rack on wheels was observed in the activity/therapy room.

The Program Director was asked to demonstrate the volume of gas in the cylinder. The Director made several attempts to turn the gas on but failed to do so. The Director concluded the gas cylinder must have a faulty regulator. When asked if the gas cylinder was ever used, the Director stated it was used when patients required a respiratory care treatment.

Inspection of the oxygen cylinder showed no maintenance sticker. The Program Director did not know the maintenance schedule for the oxygen regulator.

On 6/18/12 at 1115 hours, an interview was conducted with RT 1 who was assigned to the ARU. RT 1 stated the tank was utilized for patients during treatments while in the therapy room. RT 1 stated he did not know the maintenance schedule for oxygen cylinder regulators.


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3. On 6/18/12, an initial tour of the Mission Viejo Campus ED trauma area was conducted accompanied by OA 1. The following was observed:


a. A rusty metal container containing 12 E-tank oxygen cylinders was found stored against the wall. The wheels of the container, including the handle, were noted to be rusty which would prevent a thorough cleaning of its surfaces.


b The portable x-ray film holder that was rolled from one trauma bed to another was noted to have a rusty body, surface, and arms. The original light khaki paint on the equipment had become rusty brown with chipped edges.


c. A fiberoptic scope used for difficult airway intubation (process of inserting a breathing tube to a patient's trachea) was noted to be hanging on the trauma area wall beside a "difficult airway cart." The scope did not have an indicator to show when it was last maintained and cleaned. There was no maintenance log presented to show when the scope was last used.


On 6/18/12 at 1100 hours, the ED Nurse Manager acknowledged it was not a good idea to keep rusty equipment in an area where staff needed a sterile field for invasive procedures.

When interviewed on 6/18/12 at 1105 hours, the Respiratory Therapist Manager was unable to state when the fiberoptic scope was last used or maintained.

4. On 6/19/12 at 1015 hours, during the initial tour of the ICU of the Laguna Beach Campus accompanied by the Nurse Manager, the unit refrigerator used for patients was found in need of defrosting to maximize its efficiency.

The ICU Nurse Manager acknowledged the finding as soon as the amount of ice accumulated inside the refrigerator was observed.


22781

Based on observation, the hospital failed to ensure equipment and supplies were maintained in an acceptable level of safety and quality to assure dependable equipment function for patient care.

Findings:

1. The hospital policy, Periodic Maintenance Program (revision date 2/2012), read in part, "Periodic Maintenance shall be scheduled as follows: Devices classified as having average or minimal maintenance requirements shall be scheduled for annual inspections. Devices classified as having extensive maintenance requirements shall be scheduled for semi-annual inspections."

On 6/18/12 at 1100 hours, the Mission Viejo Campus OR was toured. In OR Rooms 1 and 2 the following was found:

a. Radios for staff use were observed in both rooms. There were no biomedical stickers (stickers applied to show the medical equipment was safe, functional and properly configured) on the radios.

b. In Room 1, the Stryker cart (video cart used to accommodate medical imaging video equipment for multiple specialty procedures in the operating room), the printer, and the Pneumo Sure (machine used during surgical procedure) did not have a biomedical sticker.

c. The Tram Rac (containing monitors used during surgical procedures) in Room 2 showed the biomedical check had been due 1/12.

d. The monitor on an anesthesia cart showed the biomedical check had been due 5/12.



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5. The 3 E unit at the Mission Viejo Campus was toured with RN B on 6/18/12 at 1055 hours. A blanket warmer in a room off of the hallway was observed at a temperature of 132 degrees F. Review of the temperature log for the warmer showed instructions for the temperature to not exceed 120 degrees F. Further review of the log showed the warmer's temperature had not been checked and documented since 5/12/12. RN B stated the temperature should be checked daily.


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2. During a tour of the Laguna Beach Campus OR 5 on 6/18/12 at 1550 hours, a pharmaceutical catheterization kit marked expired 10/10, was observed on a shelf.

During a concurrent interview with the Nurse Manager Surgical Services, she confirmed the catheter was beyond its expiration date.

Based on observation, interview and record review, the hospital's Infection Prevention Coordinator failed to develop an effective system for:

1. Identifying unsafe food handling practices that involved cool down of potentially hazardous foods and for identifying that the preventative maintenance system for the ice-machine's on the Mission Viejo Campus lacked a sanitizing component in accordance with manufacturer's guidelines. Failure to sanitize ice-machines' could potentially place patients at risk of an infection.

2. On the Laguna Campus identifying proper hand hygiene was done in the Dietary Department and identifying unsafe food handling practices that involved cool down of potentially hazardous foods which could potentially result in a food borne illness.

3. Ensuring staff were aware of correct glucometer cleaning practices which could potentially result in cross contamination.

4. Ensuring the correct use of a quality assurance marker was used to assure sterility of surgical instruments which created the increased risk of infection for all patients using the facility.

5. Ensuring sterile packages in the Laguna Beach Campus ED were marked with the date, sterilization indicator and initial of the technician who stocked the packages and on the Mission Campus ED ensuring storage of sterilized plastic packs of equipment and supplies by the trauma beds were labeled with stickers indicating the stock date, the expiration date and the technician's initial; the "difficult airway cart" did not contain a fast track laryngeal mask airway (LMA) with its sterile packaging ripped open; a wound cart did not contain unwrapped disposable scissors and forceps ready for patient use which increased the risk of using contaminated equipment and supplies.

6. Ensuring an instrument for eye examination that magnifies the ocular surface was not stored in a patient's bathroom which could result in contamination of the instrument.

7. Ensuring on the Mission Viejo Campus the surgical recovery area was clean and on the Mission Viejo Campus and Laguna Beach Campus the surgical operating rooms were maintained to ensure cleanliness.

8. Ensuring staff washed hands prior to and following patient care.

9. Ensuring a glucose drink, a commercially prepared drink containing a measured amount of glucose used specifically for patients to ingest as a test for diabetes, was not stored along with human tissue, blood, and urine specimens in the laboratory of the Mission Viejo Campus.

Findings:

1. Mission Viejo Campus:

a. According to the hospital's P&P entitled Temperature Requirements, last revised 3/09, "Whenever food has been prepared so that it becomes potentially hazardous, or is potentially hazardous, or is potentially hazardous food that has been heated, it shall be rapidly cooled if not held at or above 135 degrees F. After heating or hot holding, potentially hazardous food shall be cooled rapidly according to the following: *From 135 degrees F to 70 degrees F within 2 hours. (Note: The time for cooling begins when the temperature drops below 135 degrees F.) * From 70 degrees F to 41 degrees F or below within 4 hours. (Note: This allows a total cumulative cooling time of 6 hours.)

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to food borne illness. The initial 2-hour cool is a critical element of this cooling process. (FDA Food Code Annexes, 2009).

On 6/18/12 at 1033 hours, in the walk-in freezer was a large container of frozen cooked meatloaf with a label that indicated, "6/6/12, Use by 9/6/12." According to the Retail Manager the meatloaf was cooked on site on 6/6/12.

On 6/18/12 at 1088 hours, the hospital's Critical Control Point - Cooling log was reviewed. There was no logged entry documented to show the meatloaf cooked on 6/6/12, was cooled down to ensure food safety.

At that time, FSW 5 stated he had cooked the meatloaf on 6/6/12, and did not log the cool down of the meatloaf.

The Director of Food Service stated she had not directed dietary staff to log all the potentially hazardous foods that were cooled down "because we have this process down so tightly."

The Critical Control Point - Cooling log, dated from 7/8/12 - 6/16/12, was reviewed. According to the log, on 6/8/12, chicken noodle soup started the cool down process at a temperature of 210 degrees F and reached 81 degrees F two hours after the initial cool down period began.

FSW 5 stated he had completed the logged entry for the chicken noodle soup on 6/8/12. FSW 5 stated when the soup was 81 degrees F, two hours after the initial cool down began, he placed the food item on ice and placed it in the walk-in refrigerator to continue to cool down. The Director of Food Service, the Executive Chef, and the Clinical Nutrition Manger, Registered Dietitian who was present for the interview, reviewed the cool down log for that food item. All staff verified that continuing to cool down the item was their cool down practice. None of the staff present recognized a problem with that system.

According to the directions located at the top of the cooling log, "Foods not used for immediate service must be cooled from 140 degrees F to 70 degrees F within 2 hours.."

During the same interview, FSW 5 stated he did not always have time to check the 2 hour temperature at 2 hours because he would be too busy with another task at that time.

On 6/18/12 at 1132, in a reach-in refrigerator was a full pan of cooked pasta and a full pan of cooked rice that were prepared on site the day before. FSW 6 stated he had cooled down the items but he never logged the cool down of pasta or rice on the cooling down log.

The Director of Food Service acknowledged the dietary staff was not cooling down potentially hazardous food in accordance with the directions located on the cooling log. The Director of Food Service stated, "I guess we were really focusing on the 6 hour temperature, thinking that was the important one."

The Director of Food Services stated the hospital's Infection Prevention Coordinator did rounding of the kitchen with her at least on a quarterly basis.

Review of the last three documented rounds of the Infection Prevention Coordinator indicated "Cooling: potentially hazardous foods (TCS) to observe food cooled from 140 degrees F to 70 degrees F within 2 hours and 70 degrees F to 41 degrees F within 4 hours and test food and check records..." were all checked "yes" as having been in compliance with hospital policy.

The Infection Prevention Coordinator failed to ensure that there was an effective system in place to ensure that a method of food service which involved a high risk, high volume and problem prone method of cooking which involved cool down would have a system to monitor and proactively prevent a potential for food borne illness with medically compromised patients. The cooling log completed by dietary staff log had reflected that the cooling down of potentially hazardous foods had not been done in accordance with the directions on the log. In addition, the Director of Food Services trained the dietary staff that they did not have to log the cool down of the meat entrees that were cooked to be served on other days thus inhibiting an effective monitoring system to identify unsafe food handling practices.

b. On 6/18/12 at 1215 hours, a white paper towel was swiped along the inside of the ice-machine along the rim of the ice-machine chute. The Retail Manager acknowledged that the towel then had a brown discoloration. The top part of the ice-machine had brown furry substances that clung to the outside vent. The Director of Food Services stated due to the air flow and vents in the kitchen that they had a hard time keeping that area clean.

On 6/18/12 at 1513 hours, Facilities Staff 6 stated he was one of the persons responsible for cleaning the inside of the ice-making apparatus of the ice machines in the kitchen the nourishment rooms