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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 hospital's ongoing functions. Cross Reference A57.

2. The Governing Body did not ensure patient rights were protected as anesthesia consents were not done properly; patient wishes regarding advanced directives were not formulated; patient confidentiality was not protected; care was not provided in a safe environment because there was inadequate disinfection of optical stylets; infection control practices were not implemented; inspection of the electrical devices was not conducted; and patient emergency call lights did not work. Cross Reference A115.

3. The Governing Body did not ensure the hospital had an ongoing quality appraisal and PI program that addressed the complexity and scope of food and dietetic services and the radiology department PI analyzed and validated the data to ensure the radiation safety for employees and physicians exposed to ionizing radiology had radiation safety badges on during the fluoroscopy procedures. Cross Reference A273.

4. The Governing Body did not ensure the QAPI program tracked and reviewed the use of physician-owned intubation equipment in the hospital and assessed the availability, required training, and reprocessing for that equipment. Cross Reference A283.

5. The Governing Body did not ensure the quality of services was provided by the medical staff as there was no organized system being used for performance appraisal of the medical staff. The medical staff were being approved for reappointment who did not have supporting references or did not meet the qualifications for the categories of reappointment requirement. The medical staff's bylaws were not enforced to ensure the quality of care because there was unauthorized use of physician owned instruments without correct disinfection between uses. Specific criteria had not been developed for the appointment of allied health professionals. An obstetric provider did not perform and document a physical examination on one patient who had surgery and an obstetric provider did not provide an update to the history and physical for one patient with a normal vaginal delivery. Cross Reference A338.

6. The Governing Body did not ensure the comprehensive nursing assessments and care plans for nutrition care were completed. Cross References A395 and A396.

7. The Governing Body did not take responsibility for the safe and effective operation of the dietary services. Cross Reference A618.

8. The Governing Body did not ensure the infection control practices were developed and implemented. Cross Reference A747.

9. The Governing Body did not ensure the surgical services were provided in a safe and sanitary manner. Cross Reference A940.

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 interview and record review, the Governing Body failed to ensure the Chief Executive Officer:

1. Ensured the protection and promotion of the patients' rights to care in a safe environment were maintained. Cross Reference A115.

2. Ensured the quality of services was provided by the medical staff as there was no organized system being used for performance appraisal of the medical staff. The medical staff were being approved for reappointment who did not have supporting references or did not meet the qualifications for the categories of reappointment requirement. Cross Reference A338.

3. Ensured the physician's order for administration of an anesthetic medication was carried out. Cross Reference A405.

4. Ensured the medications and biologicals were dated and available for use. Cross Reference A505.

5. Ensured the nutritional needs of all patients were met and safe food handling, production, food and water supply, and storage were implemented. Cross Reference A618.

6. Ensured the infection control practices were developed and implemented. Cross Reference A747.

7. Ensured the surgical services were provided in a safe and sanitary manner. Cross Reference A940.

Findings:

In an interview with the hospital administration represented by the Chief Medical Staff on 1/11/13 at 1330 hours. The Chief Medical Staff acknowledged the findings and concerns regarding patient care safety, medical staff reappointment and performance appraisal, unauthorized use of physician-owned instruments without correct disinfection between uses, expired medications and biologicals, medication administration, nursing assessments, infection control practices, surgical services, and dietary services.

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

1. The hospital failed to ensure the informed consent for anesthesia included documentation of what method of anesthesia the patient consented to and there was no explanation by an anesthesiologist of the anesthesia planned prior to the patient signing the form. Cross Reference A131.

2. The hospital failed to ensure the patient's wishes regarding an advanced directive were formulated. Cross Reference A132.

3. The hospital failed to ensure the infection control practices were followed in accordance with the national standards and the hospital's P&P; failed to inspect and monitor the electrical devices brought in to the CDRC by the patients to ensure fire safe functionality; failed to ensure the emergency call light signal systems found in the patient's bathroom and shower room were functional; failed to have a non-physically compromised refrigerator containing vaccines; and failed to maintain clean ceiling vents in the CDRC's storage room. Cross References A144 and A749.

4. The hospital failed to provide safeguards to prevent the content of patient health information being disclosed to unauthorized persons without the patients' written or verbal authorization to release such information. Cross Reference A146.

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 record review, the hospital failed to ensure the informed consent for anesthesia included documentation of what method of anesthesia the patient consented to for one patient (Patient 11). In addition, there was no explanation by an anesthesiologist of the anesthesia planned prior to the patient signing the form for one patient (Patient 19). This created the risk of the patients who signed anesthesia consents being deprived of their rights to participate in the plan of care.

Findings:

The hospital's P&P titled Standards of Anesthesia Care, undated, read in part, "Documentation of the preanesthetic evaluation shall be made on the patient's hospital record prior to the induction of anesthesia and shall include the following: Patient interview, appropriate physical examination, review of relevant diagnostic studies, and formulation and discussion of an anesthesia plan with the patient ...", and "The anesthesiologist will obtain the patient's informed consent prior to the proposed anesthetic procedure."

1. Medical record review of Patient 11, a pregnant woman, was conducted on 1/7/13. The medical record contained an Informed Consent for Anesthesia signed by the patient. The pre-printed form read in part, "I have or will have explained to me and I agree to permit the administration of one or more of the following alternative forms of anesthesia which may be suitable for the procedure I am about to have: General Anesthesia - including intravenous agents and inhaled gases, which will cause unconsciousness. Regional Anesthesia - including needle injections near major nerves, which will temporarily cause me to lose pain sensation s in certain areas of my body. Local Anesthesia - including local anesthetic agents with or without intravenously administered sedatives." The form was signed by the patient at 0635 hours, and by the anesthesiologist at 0700 hours.

The document did not show what method of anesthesia was actually proposed to the patient or which method of anesthesia the patient was consenting to. The documentation did not show if the anesthesiologist had obtained the informed consent prior to the patient being asked to sign the form.

2. Review of the medical record of Patient 19 showed the patient was seen in the GI pre-procedure holding area on 1/9/13 at 0850 hours. The medical record contained an anesthesia consent form that had been signed by the patient, but not by the anesthesiologist.

During a concurrent interview with the GI Perioperative Services RN, she stated the anesthesiologist had not seen Patient 19 to discuss the anesthesia.

Based on interview and record review, the hospital failed to ensure the patient's wishes regarding an advanced directive were formulated for three of 25 patients' medical records reviewed for advanced directives (Patients 7, 14, and 71). This created the risk of patients' advanced directive desires not being implemented for these patients.

Findings:

The hospital's P&P titled Advance Health Care Directive dated 3/8/10, showed to protect each adult patient's right to control the decisions relating to his/her own health care includes the decision to have life-sustaining treatment withheld or withdrawn. During the admission, the RN will assess and document the following in the "Advance Directive" section of the "Patient History" record as to whether the patient has an AHCD.

1. On 1/7/13 at 0929 hours, Patient 7 was interviewed in the Preoperative area. Patient 7 stated she could not recall the staff had asked her about an AHCD.

Review of the medical record for Patient 7 showed the patient was discharged from the hospital and there was no documented evidence of an AHCD found in the medical record.


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2. The medical record of Patient 71, an 85 year old, showed the patient was admitted for surgery on 1/8/13 at 1055 hours. The medical record did not contain information about an advanced directive.

In a concurrent interview with RN 4, she reviewed the medical record and stated she could not find information regarding an advanced directive in the medical record.

In a concurrent interview with IT Staff 1, he reviewed the medical record and stated the advanced directive information was not in the medical record.

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

1. Ensure the infection control practices were followed in accordance with the national standards and the hospital's P&P.

2. Inspect and monitor the electrical devices brought in to the CDRC by the patients to ensure fire safe functionality.

3. Ensure the emergency call light signal systems found in the patient's bathroom and shower room were functional.

4. Have a non-physically compromised refrigerator containing vaccines.

5. Maintain clean ceiling vents in the CDRC's storage room.

Findings:

1. Beginning on 1/7/13, the hospital-wide infection control breaches were observed when the hospital failed to ensure the disinfection of optical stylets used on six patients; failed to implement a system for disinfection for optical stylets brought to the hospital by the anesthesiologists; failed to ensure the air inlets for three ORs were free from rust; failed to ensure the OR table was free from adhesive tape residuals; failed to ensure the anesthesia carts in the ORs were free from dust; failed to develop and implement a P&P for personal belongings brought into the restricted areas; failed to ensure the wet contact time was sufficient for disinfection of the OR; failed to ensure the needles and syringes were kept sterile and wrapped until they were used; failed to ensure the anesthesiologists cleaned the IV ports prior to injection in the ORs; failed to ensure the anesthesiologists did not use one needle to draw medications from four different vials in the OR; failed follow the CDC's guidelines to discard multidose vials 28 days after opening in the ORs, ED, and CCU; failed to ensure the clocks were visible at the obstetric OR's scrub sinks to time the surgical scrubs; failed to ensure the hand hygiene practices followed the CDC guidelines; failed to ensure the PPE was removed properly; failed to ensure the PPE was worn appropriately for one of one family member observed wearing PPE; failed to ensure the equipment remained in sterile packaging until needed for use; failed to prevent commingling of personal hygiene items in the CDRC; and failed to ensure dietary and/or nursing management staff provided effective oversight of the infection control aspects of dietetic services. Cross Reference A 749.

2. Review of the hospital's P&P titled Patient and Visitor Owned Electrical Equipment showed the patients are requested to complete and sign the Release of Hospital for Use of Electrical or Electronic Medical Devices brought in by patients. Additionally, personal electric items brought in by patients, family, and/or visitors must be visually inspected by nursing staff. Nursing will observe cords, plugs and basic housing for obvious physical defects and report any questions or concerns immediately to engineering.

On 1/7/13, a tour of the CDRC was conducted with the Director of the CDRC and the RN 11 in accompaniment. Observed in Patient 31's room was a hair dryer and a curling iron. Both items were plugged into a duplex electrical outlet. A concurrent interview was conducted with the Director. The Director was asked about the electrical devices brought in by patients. He stated the devices are not checked by biomedical services; however, an inspection of the device for defects by nursing staff was expected. He stated the nurse would inventory the device on the Patient Valuables Inventory Sheet and list the device that was inspected. RN 11 concurred the electronic devices would be checked and inventoried by the nursing staff.

Observed in Patient 32's room was a hair dryer and an electric razor. The hair dryer was plugged in to an adaptor that was plugged into a duplex outlet. The Director and RN 11 stated these items would have been inspected and listed on the inventory sheet as well.

Review of Patient 31's and Patient 32's medical records showed a Patient Valuables Inventory sheet; however, there was no listing of the patients' electronic devices found in both patients' rooms.

3. The hospital's P&P titled Call Light System-Patient Communication showed the call light signal system will be maintained in operating order in all nursing units. The Call light system will provide both visible and audible signal communication.

During the tour and inspection of the CDRC on 1/7/13, a patient's bathroom and shower room emergency call light signal system failed.

4. The kitchen in the CDRC was inspected on 1/7/13, and found to have a small refrigerator. Inspection of the refrigerator showed influenza and pneumococcal vaccines were the only items stored in the refrigerator. The package containing influenza vaccines had a strip of adhesive tape on the exterior of the packaging with a handwriting "STAFF" on it. In addition, inspection of the door to the refrigerator showed cracks and other penetrations to the refrigerator door frame. There were excessive ice build-ups in the freezer compartment.

5. The CDRC's storage room's air vent was inspected on 1/7/13, and found to be cluttered with dust and debris.

Based on observation, interview, and record review, the hospital failed to provide safeguards to prevent the content of patient health information being disclosed to unauthorized persons without the patients' written or verbal authorization to release such information. Patients in the therapeutic recovery program were asked to print their full names with their signatures on the sign-in sheets to attend the chemical dependency program that allowed other patients and members of the community who also attended the program to identify the patients. In addition, one employee had faxed a surgery schedule containing 145 patients including names, dates of birth and the surgeries to be performed to an unauthorized person. This created the risk of confidentiality of patient health information being disclosed.

Findings:

1. The hospital's P&P titled Patient Rights showed personal privacy of patients was respected and case discussion, consultation, examination, and treatment are confidential.

On 1/10/13, a tour of the outpatient CDRC group room was conducted. A concurrent interview was conducted with the DCD 1 of the CDRC who was accompanying during the tour. The DCD was asked how the patients from the chemical dependency program, who are in the outpatient-continuation phase of their treatment, had signed in the group session. The DCD provided three sign-in sheets as examples of how patients were signing in for the program. Review of the sign-in sheets dated 11/19, 12/3, and 12/4/12, showed the patient was to print their full names followed by their signatures. The DCD stated there was no redacting of the patients' names and stated members of the community were also invited to attend the recovery outpatient program. DCD 1 agreed the names of the patients from the hospital's program and the members from the community were recorded on the sign-in sheets. The DCD was asked about the patients who were attending the outpatient program activities and if this was continuation of treatment. The DCD stated "yes."

An interview was conducted with an Assistant Director of Health Information Management. She was asked about sign-in sheets and the confidentiality of the patient's names who were attending the recovery program. She stated patient's names should be considered confidential and available only to designated hospital professional staff and not to other patients or the public.

2. The hospital's P&P titled Facsimile (FAX) Transmission Security showed the purpose of the P&P was to provide reasonable guidelines for protecting the privacy, confidentiality, and integrity of PHI transmitted by fax to physicians or to their healthcare providers, healthcare facilities, payors or administrative organizations. The sender was to verify the recipient's fax number before transmitting and alert the recipient, if possible, to expect the fax and follow up if it is not received. For new and unverified fax numbers, a test fax should be sent prior to faxing patient medical information.

Review of the hospital's List of Individuals showed a list of 145 patients was scheduled for the surgeries. The List of Individuals contained 145 patients' names, dates of birth, and surgeries to be performed on these patients.

Further review of the List of Individuals showed on 11/29/12, one employee had faxed the List of Individuals which included the surgery schedules of 145 patients to the real estate office instead of the hospital's surgeon.

An interview was conducted with the hospital's Director of Risk Management. She was asked about the breach of PHI. She acknowledged the employee had faxed a surgery schedule for 145 patients to the wrong recipient. She stated this failure was a result of the employee not dialing properly or initiating a test fax prior to faxing the actual document to determine appropriate recipient location. The Director of Risk Management stated the faxed PHI was sent to a real estate office by mistake and the involved patients were notified of the PHI breach.

Based on interview and document review, the hospital failed to have an ongoing quality appraisal and PI program that addressed the complexity and scope of food and dietetic services which resulted in failure to identify issues in safe food handling practices, food storage, and sanitation all of which could result in food borne illness. In addition, the radiology department PI failed to analyze and validate the data to ensure the radiation safety for employees and physicians exposed to ionizing radiology had radiation safety badges on during the fluoroscopy procedures. This created the risk of poor health outcomes for the patients to meet their nutritional needs and for the staff to be safe during the radiation procedures.

Findings:

1. In an interview on 1/10/13 beginning at 1100 hours, the performance improvement plan for the hospitals' food and nutrition services was reviewed. It was noted the hospital was conducting activities related to food services such as receiving, storage, food preparation, and temperature control the performance improvement program did not fully identify unsafe food handling practices related to time/temperature control of potentially hazardous foods or the storage timeframes for raw meats (cross reference A749). Similarly while the hospital was conducting performance improvement activities related to clinical nutrition care the studies focused on whether or not nutrition assessment timeframes were met and whether or not the department's medical nutrition therapy guidelines were followed, the departments' performance improvement plan did not identify diets were implemented without physicians' orders or the menus did not meet nutritional needs based on standards of practice (cross references A629, A630, and A631).



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2. During an interview with the Radiology Director on 1/8/13 at 0925 hours, he stated he was not able to find evidence of applications for radiation safety badges or readings on the radiation badge logs for two pain management physicians who used fluoroscopy during procedures, MD 16 and MD 17. He stated the radiology staff was not aware some physicians providing radiation services were not wearing badges.

The radiology department performance graphs dated 8/21/12, of radiation safety for employees and physicians exposed to ionizing radiology were reviewed and contained graphic presentations of radiation exposure based on the safety badge readings for staff and physicians, and the action plan was "continue monitoring." The graphs did not reflect data for personnel who did not have radiation safety badges.

During a second interview with the Radiology Director on 1/8/13 at 1005 hours, when asked if any staff was studying how often the staff was wearing their radiation safety badges, he stated they were not studying that issue.

During an interview with the Dir of Patient Safety on 1/10/13 at 1145 hours, when asked about validation of data regarding radiation exposure in the hospital, she stated the PI department did not validate data because the PI personnel are not subject matter experts.

Based on interview and record review, the QAPI program did not track and review the use of physician-owned intubation equipment in the hospital and did not assess the availability, required training, and reprocessing for that equipment. This created the increased risk of poor health outcomes for the patients in the hospital who required intubation for mechanical ventilation.

Findings:

The medical record of Patient 72 who had a surgery on 12/31/12, was reviewed on 1/9/13, and showed intubation was performed by MD 8 using a Shikani optical stylet.

During an interview with MD 8 on 1/9/13 at 1430 hours, he stated he used the Shikani device for intubations and believed there were fewer adverse effects of intubation using the device. He stated he brought in his own Shikani device for use at Newport Beach campus because there were few available for use, and he used the device up to three times per day. He stated at other locations where he performed services, he used the devices owned by those facilities. He stated he had not been approached by the hospital regarding using his own equipment for intubation and had not been asked not to use his own equipment prior to 1/8/13. He stated after use, he cleaned the optical stylet using alcohol, betadine, and again alcohol.

The record of Patient 74 was reviewed on 1/10/13. The patient had a fractured vertebra in her neck and had a surgery on 12/28/13. The anesthesia record indicated intubation occurred using a Shikani with neck stabilization by MD 11.

During an interview with MD 11 on 1/9/13 at 1405 hours, he stated there were two different optical stylet devices used for difficult intubations. He stated the Leviton was used by physicians with smaller hands and the Shikani was used by physicians with larger hands. He stated few used the Shikani and he had used it fewer than 10 times and believed the hospital did not supply enough of the optical stylets to allow a chance to practice its use. He stated for Patient 74, the Shikani allowed him to intubate the patient without moving the fractured neck. He stated it was an advantage to use the Shikani optical stylet if the anesthesiologist was skilled at using it and it saved lives. He stated two weeks prior, MD 8 had assisted him with a difficult airway using the Shikani. He further stated after use, he would give the optical stylet to Anesthesia Tech 1 to clean.

A sample of 30 sampled patients' anesthesia records with dates of surgery on 12/28, 12/29, and 12/31/12, were reviewed in which 6 patients were intubated using the optical stylets. In addition to Patients 72 and 74, Patients 75 and 78 were intubated for 12/28/12 surgeries using the Levitan optical stylet and Patients 76 and 77 were intubated for 12/28 and 12/29/12 surgeries using the Shikani optical stylets.

During interviews with the GI Techs, Anesthesia Tech 1, and the Executive Dir of Peri-operative Services, they were not able to supply evidence that the optical stylets used by the anesthesiologists were being cleaned and maintained per the hospital's P&P (Cross Reference A749).

In an interview with MD 5, the Medical Director of the Operating Room/Surgical Services on 1/9/13 at 1550 hours, he stated when the physicians first asked for the hospital to purchase the Shikani optical stylets, they were told no because there were too many different instruments that were being offered to the hospital for purchase. He stated subsequently he believed the anesthesia group was offered a good deal on the purchase of the instruments through their provider group. He stated he thought 7 to 10 were using their own optical stylets. He further stated he assumed they followed the manufacturer's directions for cleaning the devices.

In an interview with the CQO on 1/10/13 at 1040 hours, he stated the hospital's staff should have reported the use of personal equipment by the anesthesiologists.

Based on interview and record review, the hospital failed to have an organized medical staff operating under the approved bylaws as evidenced by:

1. The hospital failed to have a system for routine monitoring of the quality of care being provided by the medical staff. Cross Reference A340.

2. The hospital failed to examine all credentials of medical staff members prior to reappointment and appoint members only to the categories for which they were qualified. Cross Reference A341.

3. The hospital failed to ensure the medical staff followed the hospital's P&P on the use and disinfection of equipment in the hospital. Cross Reference A353.

4. The hospital failed to ensure criteria were developed for the selection of allied health practitioners who were part of the medical staff. Cross Reference A357.

5. The hospital failed to implement bylaws that included requirements for a physical exam to be performed prior to surgery and ensure the prenatal record was updated prior to delivery. Cross Reference A358.

6. The medical staff failed to ensure the reappointment requirement of one RNFA met the reappointment requirement. Cross Reference A363.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the safety and efficacy of the services provided by the medical staff.

Based on interview and record review, the hospital failed to have a system for routine monitoring of the quality of care being provided by the medical staff. This created the risk of substandard healthcare being provided by the medical staff.

Findings:

1. During a review of the credential files of 11 physicians (MDs 8, 17, 18, 19, 20, 21, 22, 23, 25, and 26) on 1/9/13 and 1/10/13, the files did not contain information needed to establish the quality of services rendered by the physicians at the time of reappraisal and reappointment.

The Medical Staff Bylaws dated 10/10, regarding reappointment to the medical staff, read in part, "The reappointment form shall include all information necessary to update and evaluate the qualifications of the applicant, including but not limited to information concerning licensure, continuing medical education, professional performance, clinical judgment, physical and mental health status, including tuberculosis status, peer recommendations, professional ethics, compliance with the Bylaws and Medical Staff Rules and Regulations ..." and "It shall be the responsibility of the chairs of the clinical departments and divisions, working through their departments and divisions and with the assistance, as appropriate, of standing committees, to design and implement an effective program to monitor and assess the quality of professional practice in each department and division and to promote high quality of practice in each department and division ..."

During an interview with Medical Staff Officer 4 on 1/9/13 at 1510 hours, she stated the medical staff had developed a system for tracking medical staff's performance, but the system was changing and no system was currently in use. She stated there were no specific indicators for the anesthesiologists' performance that were being assessed.

During an interview with Medical Staff 3 on 1/10/13 at 1300 hours, she stated data regarding grievances about the physicians was not being pulled into the reappraisal and reappointment process. She stated physician performance parameters had been selected, but data was not currently being gathered about physician performance.

During an interview with Medical Staff 4 on 1/10/13 at 1320 hours, she stated there was no current method for forwarding grievance issues to the chief at the time of reappointment.

In an interview with the Chief of the Medical Staff on 1/10/13 at 1545 hours, he concurred there was not a system in place for collecting and analyzing physician performance data. He stated a system was developed but was found to be inadequate for the purpose, was no longer in use, and a new system was planned. He stated the departments were in the process of selecting criteria for use in reviewing the performance of the medical staff.

2. During a review on 1/11/13 at 1310 hours, of the credential files of NP 1, reappointed 7/2012, RNFA 3, reappointed on 10/2011, and PA 1, reappointed on 6/2012, the files did not contain data regarding the quality of the services provided by those allied health providers.

During a concurrent interview with Medical Staff 1, she stated there was no evaluation by a supervising staff member in the files and no system for collecting quality data on allied health providers.

Based on interview and record review, the hospital failed to examine all credentials of medical staff members prior to reappointment and appoint members only to the categories for which they were qualified. This created the risk of substandard healthcare being provided by the medical staff.

Findings:

1. The Medical Staff Bylaws dated 10/10, regarding reappointment to the Medical Staff read in part, "The reappointment form shall include all information necessary to update and evaluate the qualifications of the applicant, including but not limited to information concerning licensure, continuing medical education, professional performance, clinical judgment, physical and mental health status, including tuberculosis status, peer recommendations, professional ethics, compliance with the Bylaws and Medical Staff Rules and Regulations ..."

During the review of the credential file of MD 8 on 1/9/13, the file did not contain professional references from other physicians or other medical facilities from the time of reappointment in 5/11. The reappointment application dated 3/18/11, had a section for "Hospital Affiliations" in which the physician was to include the names of surgery centers and hospitals at which he provided services, but the section was left blank.

During an interview with Medical Staff Officer 4 on 1/9/13 at 1510 hours, she reviewed the file and was unable to find references from the time of reappointment. She stated if the medical staff member's activity level was low, references were requested at reappointment, but if the level of activity was high, letters of reference were not being requested. She concurred the area on the reappointment application to record other facilities where services were performed was left blank.

During an interview with Medical Staff 3 on 1/10/13 at 1300 hours, she stated usually they would contact other hospitals regarding whether the medical staff member was in good standing there if they provided services elsewhere. She stated at reappointment, a minimum of two professional references were obtained, with one of the references being the signature of the department chair on the reappointment documents.

During an interview with Medical Staff 1 on 1/10/13 at 1320 hours, she stated the staff must have assumed the blank section on the application meant the physician did not supply services at other facilities, but that should have been verified.

2. The credential file of MD 24 was reviewed on 1/10/13, and contained an "Activity Profile" indicating the physician attended 1 of 7 medical staff meetings held in his reappointment periods, one on 1/12/11, but no meetings in 2010 or 2012. The form indicated the required attendance for active staff was 50% of the meetings or 3 meetings. The form indicated his requirement for meeting attendance to maintain active staff status was not met and he was recommended for affiliate, not active, staff status. According to the Reappointment Recommendations form in the credential file, on 10/16/12, the department chair signed indicating that MD 24 met all requirements for reappointment to active status and MD 24 was reappointed to active status in 11/12.

Based on interview and record review, the hospital failed to ensure the medical staff followed the hospital's P&P on the use and disinfection of equipment in the hospital. This created the risk of substandard health outcomes for the patients treated with unauthorized equipment.

Findings:

The Medical Staff Bylaws dated 10/10, read in part, "...the ongoing responsibilities of each Member include, but are not limited to ...providing patients with the quality of care that meets the professional standards of the Medical Staff."

The hospital's P&P titled Loaner Equipment/Instruments dated 3/1/10, read in part, "Items/instrumentation/tray(s) must be processed according to FDA-cleared manufacturers' written instructions, in accordance with Hoag Hospital 's policies."

The manufacturer's Instructions for Cleaning, Disinfecting and Sterilization of the 30000-V Stylet Shaft contained specific instructions for cleaning, disinfecting, and sterilizing the optical stylet and listed specific Cidex (a disinfectant chemical) preparations and Steris system (sterilizing equipment) as the recommended methods for use in processing the optical stylet.

The anesthesia records of 30 sampled patients with dates of surgery on 12/28, 12/29, and 12/30/12, were reviewed on 1/9/13, and showed that 6 patients (Patients 72, 74, 75, 76, 77 and 78) had an optical intubation stylet used to facilitate placement of a breathing tube prior to surgery.

The medical record of Patient 72 from a surgery on 12/29/12, showed intubation was performed by MD 8 using a Shikani optical stylet.

During an interview with MD 8 on 1/9/13 at 1430 hours, he stated he used the Shikani stylet up to three times a day for intubating the patients. He stated he used his own Shikani stylet at the hospital, and he believed half of the anesthesiology group, approximately 20-25 physicians, used their own equipment in the hospital. He stated he cleaned the optical stylet by wiping it with alcohol, betadine, and again with alcohol. He stated that if he was required to sterilize the optical stylet, he would need to have two of the optical stylets.

During an interview with the OR Medical Director on 1/9/13 at 1550, he stated Shikani intubating stylets were owned and brought to the hospital by anesthesiologists on staff. He stated previously he had been aware of a few, 7 to 10, anesthesiologists using their own intubation devices, but was now aware that more than 20 were doing so. He stated most anesthesiologists used the instruments only for difficult intubations, but a few used the optical stylets for every case. He stated he had assumed they followed manufacturer's guidelines for cleaning, but had now discovered the instruments were not being put through sterile processing. He stated the manufacturer's recommendations for reprocessing the optical stylets were not being followed by the anesthesiologists and he was not aware of documentation being kept to provide a tracking mechanism in the event of a communicable infection.

During the review of email communications of the contracted anesthesiology provider group, the treasurer on 6/10/11, authorized reimbursement by the group for the group members wishing to purchase an optical stylet for intubation.

In an interview with the Director of Perioperative Services on 1/9/12 at 1550 hours, she stated according to the hospital's P&P, instruments to be used in the hospital were to be brought to sterile processing the prior day for cleaning and inspection.

In an interview with the Director of Infection Prevention on 1/10/13 at 1050 hours, she stated the infection control department was surprised by the physicians bringing in their own equipment and lack of disinfection of the equipment. She stated, "I had no idea this was happening." She stated the use of the equipment should have been proposed to the Peri-operative Value Analysis Committee for discussion.

Based on interview and record review, the hospital failed to ensure criteria were developed for the selection of allied health practitioners who were part of the medical staff. This created the risk of substandard healthcare by those practitioners.

Findings:

The allied health professionals roster was presented by the hospital on 1/7/12, and comprised approximately 125 practitioners including psychologist, scrub techs, perfusionists, physician assistants, nurse practitioners, and RNFAs.

During the review of the Medical Staff Bylaws dated 10/10, the bylaws contained a section on allied health professionals that read, "The Medical Staff shall make recommendations to the Board of Directors concerning AHP status as reflected in the Medical Staff Rules and Regulations along with the qualifications, responsibilities, specification of services, and application process."

During an interview with Medical Staff 1 on 1/11/13 at 1310 hours, the criteria for credentialing of the RNFA, PA, and NP were requested. She stated there was no specific criteria for credentialing the allied health providers.

Based on interview and record review, the hospital failed to implement bylaws that included requirements for a physical exam to be performed prior to surgery for Patient 11 and failed to ensure the prenatal record was updated prior to delivery for Patient 10. This created the increased risk of poor health outcomes for those patients.

Findings:

The Medical Staff Rules and Regulations dated 11/12, included the requirement for inpatient H&P that "Inpatient records require a comprehensive history and physical which includes: chief complaint, present and past illness, present medications/allergies, relevant past social and family histories, systemic review, examination, conclusions/impressions, and plan of care for the patient." The rules also allowed "If a history and physical exam has been performed and recorded up to thirty (30) days prior to admission (such as in the practitioner's office history and physical), a durable, legible copy of this report may be used.", and also "Vaginal deliveries: prenatal records must be provided at 36 weeks and will serve as the history and physical. The prenatal record must be updated at the time of delivery. Updates are to reflect the patient's current condition: "No changes' or Additions and changes to the history and/or subsequent changes in the physical findings since the exam was performed. The updates must be signed, dated and timed."

1. During a review of the medical record of Patient 10 on 1/7/13 at 0940 hours, the record did not contain data from an antepartum visit performed within 30 days prior to admission and did not show the H&P examination was updated at the time of delivery because there were no hospital notes by the obstetrician prior to delivery. The last antepartum visit documented was 11/29/12. Patient 10 was admitted to Labor and Delivery on 1/5/13, and had a vaginal delivery on 1/6/13.

During a concurrent interview with the Director of Womens Health, she stated the physicians were to send to the hospital a prenatal record and provide an update of the H&P examination after the patient's arrival at the hospital.

During an interview with the Manager of Labor and Delivery on 1/7/13 at 1020 hours, she stated the updated H&P examination was to be recorded on the progress notes.

During a second interview with the Director of Womens Health on 1/7/13 at 1350 hours, she stated they did not have a requirement for an updated H&P examination for a vaginal delivery.

During an interview with RN 15 on 1/7/13 at 1020 hours, she reviewed a cabinet of medical records forwarded from the doctor's office and stated there was no H&P examination for the patient since 5/31/12. She stated there was a progress note on 1/6/13, postpartum, and it did not include evidence of an updated physical examination such as a heart and lung exam.

2. The Medical Staff Rules and Regulations dated 11/12, read in part, "Planned C-Section: History and physical is performed and documented on the chart prior to the C-Section", "Tubal Ligations: History and physical is performed and recorded on chart prior to procedure (prenatal records do not suffice)", and "Inpatient records require a comprehensive history and physical which includes: chief complaint, present and past illness, present medications/allergies, relevant past social and family histories, systemic review, examination, conclusions/impressions, and plan of care for the patient."

Review of the medical record of Patient 11 on 1/7/13 at 1055 hours, it was noted the patient had a scheduled cesarean section (removal of the fetus from the uterus via an incision in the abdominal wall) and tubal ligation (sterilization procedure) on 1/7/13 at 0730 hours, and there was no comprehensive H&P examination in the medical record because the physical examination was not documented.

In a concurrent interview with the Director of Womens Health, she concurred there was no H&P examination by the surgeon for Patient 11 in the medical record.

In an interview with the Labor and Delivery Operating Room Manager on 1/7/12 at 1055 hours, she reviewed the medical record of Patient 11 and stated she had a scheduled cesarean section in the morning of 1/7/13 at 0730 hours, and the operative note was written. She stated there was no physical examination by the surgeon in the medical record yet, although there were vital signs and the patient's height. She stated there was a prenatal H&P examination from the surgeon's office dated 6/12, but none since admission. She stated she believed the physician was performing the physical examination, but was not documenting it.

In an interview with the Labor and Delivery Manager on 1/7/12 at 1100 hours, she stated Patient 11's surgeon was no longer in the hospital and had returned to her office.

In an interview with MD 2 on 1/7/13 at 1030 hours, he stated cesarean section patients needed to have full H&P examinations.

Based on interview and record review, the medical staff failed to ensure the reappointment requirement of one RNFA was documented to meet the criteria. This created the increased risk of poor health outcomes for the patients.


Findings:

On 1/9/13 at 0920 hours, an RN was observed working in the hospital's outpatient surgical center. The RN was not wearing an identification badge to identify her name and job title. During a concurrent interview, the Administrator of the outpatient surgical center stated the RN was RNFA 1.

On 1/10/13, RNFA 1's credential file was reviewed and showed the RNFA's most recent reappointment was granted on 3/13/12. Review of the Reappointment Worksheet 2012, showed the followings items were left blank:

* Verification section for certifications (if applicable) for DEA and OIG NPDB.
* Verification Results, Hospital Affiliations returned/verified
* Liability Cases yes/ no

The verification showed the last query was 3/24/08.

On 1/10/13 at 1000 hours, Medical Staff 1 and 2 were interviewed. Medical Staff 1 stated the hospital rule for reappointment of allied workers was every two years. Medical Staff 1 was a new employee and the process was completed before her hiring. Medical Staff 1 was not aware the reappointment requirement was incomplete. When asked for the hospital's bylaws, Medical Staff 1 provided a hospital P&P titled Processing RNFA Application dated 12/10/98, showed the credentialing process included an annual reappointment including verification of continued employment or verification of continued sponsorship, competency, verification of 200 hours as an RNFA per year, and 30 hours continuing education requirements. Medical Staff 1 stated there was no further updated P&P for reappointment of allied staff.

Based on record review, interview, and record review, the hospital failed to ensure the comprehensive nursing assessments for two of four medical records reviewed for nutrition care (Patients 51 and 53) were completed. Patient 51, who was pregnant, had a documented 10 pound weight increase in 5 days with no documented nursing assessment. Patient 53, who was underweight with documented weight loss, had no accurate nutritional screening completed at the time of admission. This created delayed nutritional care, further compromising medical status for those patients.

Findings:

Review of the hospital's P&P titled Assessment dated 2/3/04, showed the RN was accountable for assuring a patient assessment was completed and utilizing the data from the assessment in an effort to update the plan of care and to document patient progress related to the outcome goals. The purpose of the assessment was to "identify patient/family needs, identify problems ..." The policy also delineated the responsibility of the RN to ensure "continuing care needs are assessed and communicated to other disciplines as necessary."

1. Patient 51 was admitted to the hospital for prenatal care and possible preeclampsia (a condition in pregnancy characterized by high blood pressure and sometimes fluid retention). The patient's admission height was 5 feet 11 inches and weight was 155 pounds.

A history and physical dated 1/3/13, noted Patient 51 was 31 weeks pregnant and the total weight gain for the pregnancy was 12 pounds. An admission diet order dated 1/3/13, was a regular diet and a nutrition consult was ordered.

A nutrition assessment dated 1/5/13, completed by the DTR noted the patient's total weight gain was below the recommended goal for current gestation. Patient 51 was referred to the RD for further assessment.

A follow up weight dated 1/8/13 taken at 0800 hours, was 165 pounds, a gain of 10 pounds in 5 days.

Review of nursing flow sheets and physician progress notes beginning on 1/8/10, failed to reveal an assessment or any notation of the 10 pound weight gain.

In an interview on 1/9/10 beginning at 1430 hours, with RN 9 she was asked to describe an assessment for a patient with weight gain. RN 9 stated she would be concerned about a 10 pound weight gain as Patient 51 had not had any IV fluids during the previous 5 days in the hospital. RN 9 also stated nursing staff should have discussed the weight gain with the physician.

2. Patient 53 was admitted to the hospital with pneumonia and respiratory failure. The patient's admission weight was 110 pounds, height was 5 feet 7 inches, and BMI was 17.2. BMI provides a reliable indicator of body fatness for most people and is used to screen for weight categories. Patients with a BMI of less than 18 have a greater risk of death due to respiratory failure than those with a BMI ranging from 20-22. Patient 53's ideal body weight based on height was documented as 135 pounds.

A physician's history and physical dated 1/7/13, noted the patient experienced a recent weight loss.

A nursing admission assessment dated 1/7/13, failed to note the weight loss or the patient's lowered BMI.

An admission physician's order dated 1/7/13, showed the patient was NPO. A follow-up diet order dated 1/8/14, was for a ground diet.

A comprehensive nutrition assessment dated 1/9/13, (2 days after admission) showed the patient experienced a weight loss of 25% during the previous 10 months. Patient 53's estimated nutritional needs were documented as 1500-1700 calories and 50-65 grams of protein. It was also noted the patient was deemed to be at high nutritional risk.

Review of the dietary intake for four meals from 1/8/13-1/10/13, showed an average of 20%. Additional review revealed on 1/8/13, the patient's intake was documented at 20% and it was estimated the total caloric intake was limited to 300 calories and 16 grams of protein for 2 meals.

In an interview on 1/10/13 beginning at 0930 hours, with RD I she stated the average length of stay for patients was 3.8 days. RD I also acknowledged the nutrition risk screening which was completed did not accurately reflect the nutritional status of Patient 53, resulting in delayed nutritional assessment and interventions. RD I also stated patients who were identified at nutritional risk at the time of admission would receive a nutrition assessment no later than 24 hours after admission.

Based on record review and interview, the hospital failed to ensure comprehensive care plans were developed for one of four patients reviewed for nutritional care (Patient 53). Patient 53 was identified at high nutritional risk, underweight and demonstrated poor dietary intake. This created lack of consistent implementation of interventions, further compromising medical status for this patient.

Findings:

Medical record review for Patient 53 showed a history and physical dated 1/7/1. The history and physical showed Patient 53 experienced a recent weight loss.

A comprehensive nutrition assessment dated 1/9/13, (2 days after admission) noted Patient 53's weight loss was 25% during the previous 10 months. Patient 53's estimated nutritional needs were documented as 1500-1700 calories and 50-65 grams of protein. It was also noted the patient was deemed to be at high nutritional risk.

Review of dietary intake for 4 meals from 1/8/13-1/10/13, showed an average of 20%. Additional review revealed on 1/8/12, the patient's intake was documented at 20% and it was estimated the total caloric intake was 300 calories and 16 grams of protein for the 2 meals. Review of the patients' dietary cardex, printed on 1/10/13, which was part of the hospitals' menu system and not part of the hospitals' medical record noted the implementation of interventions for her decreased appetite. Review of Patient 53's interdisciplinary care plan failed to show documentation a nutrition care plan was developed to address the patient's recent weight loss and poor intake.

In an interview on 1/9/13 beginning at 1430 hours, with RD H, she stated the RD would include nutritional interventions as part of the comprehensive nutrition assessment. She acknowledged the interventions would not be transferred to the hospitals' interdisciplinary care plan. She also acknowledged it was not likely that other health care professionals would routinely seek out assessments in the electronic medical record and would rather likely rely on the interdisciplinary care plan. She also stated the RD had the capability of entering information onto the care plan.

Based on observation, interview, and record review, one of five ED RNs failed to demonstrate correct use of the pediatric Broselow tape. This could potentially result in a delay in responding to a pediatric emergency.

Findings:

The Broselow-Luten Color Coding system is a complete system used by healthcare providers in critical situations with pediatric patients. The Broselow tape is the first step in determining the proper dosage of medication and/or equipment to use on the child. The tape is laminated and color coded. The red arrow is put at the child's head and at the measurement of the child's feet there are references to color bars on the tape informing rescuers of equipment sizes needed to perform emergency resuscitation on the child. A reference bar also includes weight zones on the tape which show pre-calculated medication dosages. Designated resuscitation equipment is contained in corresponding, color coded equipment drawers/pouches.

The hospital's P&P titled Code White-Pediatric Patients dated 10/8/12, showed a pediatric crash cart would be present at pediatric codes. Observation of the ED pediatric crash cart on 1/7/13, showed the ED used the Broselow-Luten Color Coding system for the pediatric crash cart.

On 1/7/13 at 0915 hours in the Newport Beach campus ED, RN 18 was asked to simulate the use of the Broselow tape. The RN put the first color block section at the child's head instead of the arrow. In an emergency, this could potentially result in the child's weight being incorrectly calculated resulting in incorrect equipment and medication doses.

Based on interview and record review, the hospital failed to ensure the physician's order for administration of an anesthetic medication was carried out for one patient (Patient 70). This resulted in the patient not receiving a local anesthetic agent for pain relief.

Findings:

On 1/9/12, review of the closed medical record for Patient 70 showed an IV infusion of calcium chloride infiltrated on 10/2/12. An order was written by MD 16 to administer procaine 10% (local anesthetic) intradermal (between the layers of the skin) on 10/2/12 at 2243 hours. The medication was not given.

During an interview on 1/9/12, the Director of Patient Safety and Compliance stated the RN overlooked this order because there was another order for an antidote to the calcium chloride infiltration, hyaluronidase which was written by MD 15. However, hyaluronidase would not address the issue of pain at the IV infiltration site.

Based on record review and interview, the hospital failed to ensure the medical records for two patients (Patients 60 and 61) were consistent with pharmacy medication records regarding the administration of medications during the surgical procedures to ensure complete medical records. This created the risk of poor health outcomes for those patients.

Findings:

On 1/9/13 at 0800 hours, review of a pharmacy report regarding the doses given of droperidol, a medication used during surgery to prevent nausea and vomiting, showed from 9/15/12 to 1/3/13, 28 patients had received the medication during surgical procedures.

On 1/9/13 at 1420 hours, review of the electronic medical records for patients receiving droperidol was initiated with RN 4. Review of the electronic medical records for Patients 60 and 61 showed both patients had undergone a surgical procedure. Review of the medication area on the surgical procedure reports and the medication administration records for these two patients showed they had not received droperidol.

On 1/9/13 at 1430 hours, the Director of Pharmacy provided billing forms that were sent to the pharmacy for the medications given during the surgical procedures for Patients 60 and 61. The forms showed a "one" had been written on the form after the medication droperidol to indicate the patient had received the medication during their surgical procedures.

The information supplied by the pharmacy was not consistent with the information contained in the patients' electronic medical records.

Based on interview and record review, the hospital failed to ensure the medical records were legible for five patients (Patients 11, 12, 68, 71, and 73). This created the risk of substandard health outcomes for those patients.

Findings:

1. During a review of the medical record of Patient 11 on 1/7/13 at 0940 hours, the anesthesia record was illegible.

In a concurrent interview with the Dir Womens Health, she concurred the anesthesia record could not be read.

2. The Medical Staff Rules and Regulations dated 11/12, read in part, "Medical record entries are to be dated, timed, signed and authenticated and their authors identified."

a. During a review of the medical record of Patient 71 on 1/8/13, the consent form contained an undated physician's signature.

In a concurrent interview with RN 4, she did not see a date by the physician's signature on the consent.

b. During a review of the medical record of Patient 73 on 1/10/13, the record contained a consent form, a H&P examination, and an update to the H&P, all signed by the physician, but there was no time of completion filled in on any of the documents.

c. During a review of the medical record of Patient 12, in the neonatal intensive care unit on 1/7/12 at 1330, there was a record containing a handwritten verbal order regarding the IV fluids and total parenteral nutrition dated 1/5/13. There was no time written on the order and it had not been signed by the ordering physician.

In a concurrent interview with RN 2, she stated the time should have been written on the order and the order should be signed by the physician within 48 hours.

3. During review on 1/11/13 of the medical record for Patient 68, it was observed the patient's pre-surgical H&P examination completed on 1/4/13, was illegible.

Based on observation and interview, the pharmacy failed to prepare for emergency treatment cart and ensure the supply and provision of emergency medications stored in the kits were consistent with standards of practice and appropriate for a specified emergency condition. This created the risk of substandard health outcomes for the patients.

Findings:

On 1/7/13 at 1020 hours, during a tour of the PACU in the Pavilion. The malignant hyperthermia cart inspection revealed the laboratory gray tubes (for blood work) 3 x 5 ml was missing, one set of primary IV (15 drops/cc) was missing, and two sets of primary IV (60 drops/cc) were missing.

Review of the pharmacy audit sheet showed the last inspection was conducted on 12/5/12. The audit showed the malignant hyperthermia cart was inspected and there were no problems identified.

During a concurrent interview with the Director of Perioperative Services, the Director revealed the pharmacy was responsible for checking the malignant hyperthermia cart monthly. An interview with Pharmacist 1 revealed the pharmacist was checking for the medications in the malignant hyperthermia carts and the OR staff should check for the treatment supplies.

Review of the hospital's P&P titled Malignant Hyperthermia Management dated 3/1/10, failed to specify the staff responsible for inspecting and refilling of the malignant hyperthermia cart.

Based on observation and interview, the hospital failed to ensure the IV infusion bags were dated after being removed from their protective outer wraps; failed to to ensure outdated medications were available for use; and failed to ensure expired sutures were not available for use. This could potentially result in ineffective medications and biologicals being used for the patients.

Findings:

1. On 1/7/13, a tour of the ED at Newport Beach campus was conducted. At 1040 hours, inspection of the medication room showed the following minibags undated and without its protective covers: six 100 ml 0.9% sodium chloride minibags, eleven 50 ml 0.9% sodium chloride minibags, three 50 ml 5% dextrose and water minibags, and eight 100 ml 5% dextrose and water minibags. The ED RN Charge Nurse was unaware the IV bags needed to be dated after removal from its outer wraps.

According to the manufacture's guidelines of the IV solution bags, the IV bags are covered with a protective outer wrap as a moisture barrier. Outer wraps control the amount of water vapor that escapes from a solution. Hence, once the outer wrap is removed the rate of evaporation increases because the bags are exposed to room air and subsequently the manufacturer's expiration date is no longer effective. The manufacturer of the IV solutions used by the hospital also recommends discarding of 50 ml IV bags 15 days after removal of the outer wrap and 100 ml bags 30 days after removal of the outer wrap.

On 1/8/13 at 1345 hours, the Director of Pharmacy stated out of wrapper minibags were to be discarded after 15 days. He stated there was no P&P addressing this.

2. Review of the hospital's P&P titled Control of Nonconforming Products or Services, effective date of 12/14/12, showed outdated medications would be returned to the pharmacy.

On 1/7/13 at 1050 hours, the resuscitation room in the ED was toured. A vial of lidocaine 1% with epinephrine 1:100,000 units (used as a local anesthetic) with an expiration date of 12/1/12, was found on the chest tube insertion kit. The finding was verified by the ED RN Charge nurse who was present during the tour.

3. On 1/7/13 at 1030 hours, in the Clean Utility Room B in the ED of Newport Beach campus, seven packages of expired sutures were found. Three packages of Vicryl 3.0 expired in 7/12; two packages of Ethicon 0 expired in 1/12; one package of Ethicon 3.0 expired in 1/11; and one package of Monocryl 6-0 expired in 7/12. The ED RN Charge Nurse who was present at the time verified the finding.

Based on interview and record review, the hospital failed to ensure all staff performing procedures using ionizing radiation were monitored for radiation exposure. This created the risk of unmonitored radiation exposure.

Findings:

The hospital's P&P titled Radiation Safety Monitoring, Personnel, undated, read in part, "Personnel monitoring devices such as film badges, Luxel badges or TLD rings will be issued to individuals working with radiation generating equipment and/or radioactive materials" and "Individuals assigned monitoring devices must wear them whenever on duty."

During an interview with the Radiology Director on 1/8/13 at 0925 hours, he stated he was not able to find evidence of applications for radiation safety badges or readings on the radiation badge logs for two pain management physicians, MD 16 and MD 17, who used fluoroscopy during the procedures. The Radiology Director concurred it would be safer for the physicians to wear radiation safety badges. He stated the radiology staff was not aware some physicians providing radiation services were not wearing badges.

During another interview with the Radiology Director on 1/8/13 at 1005 hours, when asked if any staff was monitoring to ensure the staff was wearing their radiation safety badges, he stated it was the responsibility of the physician with fluoroscopy certification to ensure the safety of the staff present.

Based on interview and document review, the hospital failed to develop a P&P addressing qualified personnel providing conscious sedative agents to the patients for radiology services. This created substandard quality healthcare outcomes for the patients.

Findings:

On 1/11/13 at 1050 hours, the Operations Director of Imaging Services stated in the imaging procedure room, the staff could vary depending on the procedures. If the patient required sedation analgesia, one RN would be assigned to monitor the patient and two radiology department staff and an attending physician would be in the room. The staff in charge of the radiology department would assess the situation and determine the staffing each day for each procedure room. The Operations Director then provided the hospital's Practice Guidelines that showed the RN staffing levels should always be sufficient to provide one nurse for each procedure room to prepare, provide, and monitor patient care as well as perform other departmental activities such as quality assurance. The Operations Director further stated the radiology department did not have a specific guideline or P&P to address proper staffing ratio.

According to California Board Of Registered Nursing, revised on 7/97, for Conscious Sedation, it showed the RN administering the agents to render conscious sedation would conduct a nursing assessment to determine administration of the drug is in the patient's best interest. The RN would also ensure all safety measures are in force including back-up personnel skilled and trained in airway management, resuscitation, and emergency intubation if complications occur. RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the RN.

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

1. The hospital failed to ensure entree substitutes were of equal nutritive value. Cross Reference A628.

2. The hospital failed to ensure the diets were ordered by by the physicians. Cross Reference A629.

3. The hospital failed to ensure regular and therapeutic menus had met the nutritional components to meet the current national standards including the RDA and DRI of the Food and Nutrition Board of the National Research Council. Cross Reference A630.

4. The hospital failed to have a therapeutic diet manual that accurately reflected physician-ordered diets and current standards of practice. Cross Reference A631.

5. The hospital failed to ensure food and water supplies were adequate per the hospital's disaster preparedness plan. Cross References A701 and A703.

6. The hospital failed to ensure dietary and/or nursing management staff had provided effective oversight into the infection control aspects of dietetic services to prevent unsafe food handling practices and unsafe food items. Cross Reference A749, #17.

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

Based on observation, interview, and document review, the hospital failed to ensure the entree substitutes were of equal nutritive value. Failure to offer substitutes of equal value may result in compromising nutritional and medical status.
Findings:

During food production observations on 1/7/13 beginning at 1130 hours, Dietary Staff G was observed preparing grilled cheese sandwiches. In a concurrent interview, Dietary Staff G stated the sandwiches would be used as entrees for the noon meal. It was also noted there were 2 slices of cheese on each sandwich. Additional observation revealed the hospital was purchasing cheese with 160 slices per five pounds of cheese, each weighing ½ ounce, which resulted in a sandwich with one ounce of cheese.

In a follow up interview with RD I, she stated the intent was for the protein portion of the entree to be three ounces of edible protein. RD I also acknowledged the sandwich, as prepared, would not be of equitable nutritional value.

Review of the hospital's document titled Grilled American Cheese dated 5/6/11, revealed the standardized recipe was not equitable to three ounces of protein as the recipe guided staff to place 1.5 ounces of cheese on the sandwich.

Based on observation, interview, and document review, the hospital failed to ensure the diets of two of the four patients (Patients 50 and 52) reviewed for nutrition care were ordered by the physicians. Failure to secure physician's orders for diets served may result in compromising patients' medical status.
Findings:

1. During trayline observation at Newport Beach campus on 1/7/13 beginning at 1100 hours, it was noted Patient 50 had a physician's order for mechanical soft diet. It was also noted on the tray ticket, there were hand written instructions designating a consistent "CHO" diet. Concurrent review of the hospital's document titled "Patient Visit Report" dated 1/7/13, showed the physician's diet order was a mechanical soft diet. The physician had not ordered a CHO diet.

In a concurrent interview with RD I, she stated the "CHO" diet was a way to designate patients with diabetes who required insulin. RD I further stated, for these patients, the standard protocol provided 60 grams of carbohydrate at breakfast and lunch and 75 grams of carbohydrate at dinner. RD I stated this order set initiated the "carbohydrate protocol" which was described as the method by which nursing staff provided insulin. RD I stated the protocol guided nursing staff on insulin dosages based on the amount of carbohydrates the patients were ordered at any given meals.

In an interview with RN 5, she stated Patient 50 was not on an insulin regimen and therefore, the CHO protocol was not applicable.

Review of Patient 50's electronic medical record on 1/7/13 at 1445 hours, with information technology staff also revealed there was no physician-ordered diet for the mechanical soft.

Patient 50 was admitted on 1/3/13, with a physician's order for 1800 CHO protocol diet.

On 1/5/13, the 1800 calorie CHO diet was discontinued and an NPO was ordered by the nursing staff on behalf of the physician as a conditional order.

In a concurrent interview with RD I, she described the NPO order as conditional for a "dysphagia" (difficulty swallowing) screen. RD I also stated conditional orders were not necessarily implemented at the time they were entered; they may be activated at a later time depending on whether the "condition," as outlined in the order, was present. In the case of Patient 50, it was dysphagia screening.

On 1/7/13 at 1255 hours, an electronic entry for a mechanical soft, 1800 calorie diet with a carbohydrate protocol was entered by nursing staff. There was no documentation to show the physician had ordered this diet nor was this diet authenticated by a physician as received as a telephone order.

On 1/7/13 at 1530 hours, the surveyor requested the P&P for conditional orders. On 1/8/13 beginning at 0930 hours, the hospital presented an undated typed document that provided an example of a conditional order. RD H stated the hospital did not have a P&P for conditional orders and particularly in relationship to diet orders. Review of hospital's P&P titled "Orders and Test Results, Verbal and Telephone" dated 5/3/04, showed "Telephone ...should be signed by prescribing physician within forty-eight (48) hours."

2. Patient 52 was admitted with a diagnosis of acute respiratory failure. An admission diet order dated 1/7/13, was for an 1800 calorie, total lifestyle change diet that included the hospital's carbohydrate protocol.

A Comprehensive Nutrition Assessment dated 1/7/13, showed the patient reported weight loss that was related to poor intake. It was also noted Patient 52's caloric needs were 1328-1660 calories. The assessment showed during the course of hospitalization the patient's dietary intake was reported as 0%. The RD also implemented the addition of Glucerna (a nutrition supplement) on a daily basis. Review of physician's orders failed to document an order for the supplement.

Review of Patient 52's dietary intake for 1/8/13, revealed for breakfast and lunch, the patient consumed 1200 of the physician ordered 1800 calorie diet. The recorded calories included the supplement.

In an interview on 1/10/13 beginning at 1030 hours, with RD H, she stated the hospital's physician committee approved the implementation of supplements without physicians' orders. The RD also stated the protocol for implementation of the supplements was not part of the physician approved diet manual. It was part of the department's guidelines titled "Medical Nutrition Therapy 2012/2013 Evidence Based Medical Nutritional Therapy." Concurrent review of the section related to nutrition supplements showed the various types of supplements available and listed the diagnoses for which the supplements might be implemented.

While the hospital developed the concept of the initiation of nutritional supplements as nutritional intervention, the system was not included in the hospital's diet manual. Nutrition parameters or medical nutrition therapy protocols for implementation were not developed; a system for timely evaluation of the progress and/or effectiveness of the intervention was not developed; and a system to ensure the nutrition intervention did not exceed the specified nutritional parameters of the physician ordered diet was not developed.

RD H acknowledged as Patient 52's appetite improved, it would be likely that the physician-ordered 1800 calorie restriction diet would be exceeded. RD H also stated the RD would not re-evaluate dietary intake until regularly scheduled follow up visits that could occur anywhere from two to four days after an assessment for patients at moderate or high nutritional risk.

The practitioner responsible for the care of the patient and ordering of the diets is the patient's physician.

Medical Nutrition Therapy protocols are a plan or set of steps, which are based on systematically analyzed evidence and clearly define the level, content, and frequency of nutrition care that is appropriate for a disease or condition in settings in which they are implemented. The protocols are predefined written procedural methods patient and diagnosis specific and approved through the hospital medical staff per the Academy of Nutrition and Dietetics.

Based on interview and document review, the hospital failed to ensure regular and therapeutic menus had met the nutritional components to meet the current national standards including the RDA and DRI of the Food and Nutrition Board of the National Research Council. This had the potential for patients in the hospital not to receive adequate nutrition or meet the estimated recommended dietary allowances for all nutrients.

Findings:

On 1/9/13 at 0800 hours, the hospital's nutrient analysis for the regular and therapeutic diet menus was reviewed. It was noted the analysis was comprehensive but the menu did not meet the patients' nutritional needs based on age and gender. For example, the analysis provided showed there were nutrients such as biotin, folate, niacin, magnesium, and pantothenic acid that were below the current national standard. For these minerals, the menu provided 11-58% of the DRI.


Additionally, the analysis demonstrated the fiber for the seven day non-select regular diet contained 15 to 28 grams of fiber. The DRI for fiber ranges from 25-38 grams/day. The hospital's menus were inadequate in fiber depending on the age and gender. Similar levels of fiber were found in the carbohydrate controlled and cholesterol/sodium restricted diets.


On 1/9/13 beginning at 1430 hours, RD I was interviewed regarding the nutrition analysis of the regular and therapeutic menus. RD I stated the hospital recently developed the nutritional analysis; however, it had not yet fully analyzed the individual nutrient deficit and it was a "work in progress."


The provisions of the DRI, which included the RDA's Adequate Intake and Acceptable Macronutrient Distribution Range developed by the Food and Nutrition Board under the aegis of the Institute of Medicine, are used to evaluate nutritional adequacy of patient menus. The menus used were not evaluated to ensure they met the required nutrients nor were deficiencies in nutrients noted in the diet manual when it was not possible to meet the DRI/RDA such as in the instance of a clear liquid diet.

Based on observation, interview, and document review, the hospital failed to have a therapeutic diet manual that accurately reflected physician-ordered diets and current standards of practice. Lack of a current and comprehensive diet manual that reflected hospital-developed diets may result in inaccurate guidance to dietary and hospital staff when following physician-ordered diets to meet the nutritional needs of the patients and further compromising medical status.

Findings:

1. During trayline observations on 4/23/12 beginning at 1115 hours, it was noted greater than 10 random patients had TLC, 1800 calorie CHO physician-ordered diets. In a concurrent interview with RD I, she stated a TLC diet was essentially a cardiac diet. The CHO portion of the order was intended to be a consistent carbohydrate diet that offered 60 grams of carbohydrate at breakfast and lunch respectively and 75 grams of carbohydrate at dinner. A consistent carbohydrate diet indicated as part of the treatment for a diabetic diagnosis, generally would not limit the number of calories consumed and rather limit the amount of carbohydrate per meal. In addition, the number of carbohydrates would be consistent between breakfast, lunch, and dinner each day per the American Diabetes Association.

Additionally during the trayline observation were two random physician-ordered DASH diets.

In an interview and concurrent diet manual review with RD I on 1/7/13 beginning at 1430 hours, the diet variations were reviewed. It was noted the manual did not contain a carbohydrate diet that was specific to the hospital's menu but a conceptual guidance of the principles of diabetic meal planning.

Review of the TLC diet guidelines showed the diet would contain between 25-35% of calories from fat with less than 200 mg of cholesterol per day and less than 2400 mg of sodium. RD I stated when this diet was ordered the dietary staff offered the patients the cholesterol/sodium modified diet.

Review of the nutritional analysis showed for three of the three days reviewed the cholesterol content of the menu exceeded the physician-approved maximum of 200 mg/day. Similarly, the sodium content for two of three days exceeded the physician-approved maximum of 2400 mg, ranging from 2900 to 4200 mg/day. The hospital did not have a nutritional analysis for the DASH diet.

The diet manual would ensure the diets offered met the current standards of practice and included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet, and sample meal plans consistent with the hospital's menu and standard of practice references.

The diet manual had some of the elements, not all elements were present for each routinely ordered diet which would allow the hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare the patients' diets.

Based on observation, interview, and document review, the hospital failed to ensure the food supply was adequate based on the hospital's developed plan. Failure to ensure adequate food supply for patients and staff may result in further compromising nutritional and medical status.

Findings:

On 1/8/13 beginning at 1340 hours, the hospital's disaster preparedness plan for dietetic services was reviewed. The hospital had committed to be self-sufficient for a total of 2500 patients and staff for a period of 96 hours (4 days). The hospital's disaster menu consisted of hermetically sealed items such as juice, bottled water, and precooked and canned entrees such as ravioli and chili. Review of the hospital's inventory revealed there was an inadequate supply of the entrees. For example, the hospital designated a 6-ounce serving of ravioli. The inventory consisted of 16 cases which would equate to approximately 1500 servings. Similarly, the inventory consisted of approximately 1700 servings of chili, rather than the 2500 planned servings. In a concurrent interview with Dietary Staff J, he stated he prepared the inventory and acknowledged he did not fully compare the inventory to the RD's disaster-approved menu.

Based on observation, interview, and document review, the hospital failed to ensure water supply was adequate to meet hydration and patient care needs for the hospital's licensed bed counts as well as staff required to care for patient needs at the Newport Beach and Irvine campuses. This failure put patients and staff at risk of dehydration in the event of a disaster that required the hospital to shelter in place with no outside resources available.

Findings:

Newport Beach campus:

1. On 1/8/13 beginning at 1340 hours, the hospital's disaster preparedness plan for dietetic services was reviewed. The hospital's water supply consisted of five gallon bottles as well as 16.9 ounce water bottles. In an interview with RD H, she stated in development of the menu she designated each person would receive 64 ounces of fluid, primarily in the form of water bottles. It was noted the hospital's water inventory consisted of approximately 6600 gallons of water. The hospital had committed to be self-sufficient for a total of 2500 patients and staff for a period of 96 hours. In a concurrent interview with RD H, she was asked to describe how the hospital determined the inventory of water that was required. RD H stated the hospital had a disaster preparedness committee and supply was determined at the committee level. RD H also stated she was responsible for ensuring the hydration needs of patients and staff. RD H stated she felt 64 ounces was adequate although she did not have a standard of practice or reference for that amount, rather based it on typical hydration needs for a healthy population rather than medically compromised patients and staff who might be required to have increased physical activity during a disaster.

In an interview on 1/8/14 beginning at 1440 hours, with Administrative Staff K and L, they described the premise for disaster preparedness plan. The staff confirmed the hospital's self-sufficiency plan was for 96 hours. When Administrative Staff L was asked to describe the emergency water supply, Administrative Staff L described the hospital's inventory of stored water. Administrative Staff L concurrently reviewed the hospital's undated document titled "Disaster & Emergency Operations Plan." Review of the plan revealed on page 8 of 16, the plan consisted of actions such as monitoring inventories, memorandums of understanding with vendors, and a statement that the hospital had supplies on hand for a 96 hours; however, there was no evaluation of the amount of water that would be required to meet hydration needs of patients and staff as well as other required water needs for staff and patients related to patient care activities.

In a follow up interview with on 1/9/13 at 1050 hours, with Administrative Staff L, he was asked to further describe the amount of water required for disaster preparedness. Concurrent review of an undated hospital document titled "Water Failure" revealed the document was a conceptual design of the location of water supplies, water loss procedures, and water distribution. The document also showed the "fluid requirements are ½ to 1 gallon per day;" however, there was no basis for this determination. Additionally the calculation was for 500 patients and 2500 staff. Other hospital documents designated that all supply was for 2500 people including staff. It was also noted if the hospital provided 64 ounces of fluid to 2500 patients and staff for 96 hours, it would require a minimum of 5,000 gallons of water, leaving only 1600 gallons for 2500 people for the remainder of the disaster. Administrative Staff L acknowledged he did not know which nationally accepted reference the water supply was based. Administrative Staff L stated he would check on it.

As of 1/10/13 at 1130 hours, no additional information with respect to the evaluation of the hospital's water needs for medically compromised patients and staff members was provided.

Irvine campus:

2. On 1/7/13 beginning at 1100 hours, the disaster food and water plan was reviewed. There were 200 gallons of water stored in the kitchen storeroom. Review of the Nutrition and Food Service Disaster Meal Plan dated 11/6/12, indicated the plan for Irvine campus would be for 305 patients and staff for 4 days. When the fourth day disaster menu was reviewed, it indicated 16 ounces of water was to be given for breakfast and 8 ounces for lunch and dinner. Upon further review there was another menu from the electronic computer system that indicated 16 ounces of water to be given at all meals.

Review of the disaster menu order/inventory indicated there would also be 58 cases of 16.9 ounce bottles (24 bottles per case) stored in the kitchen area.

On 1/8/13 at approximately 0900 hours, observation and interview were conducted with RD M and the Dietary Staff N. Only 47 cases of water were observed in the kitchen area.

At 0920 hours, an interview was conducted with RD M. RD M stated they were planning to provide 1/2 gallon (64 ounces) per person of drinking water per day. RD M stated she was not sure about the water for hygiene purposes but one of the hospital's staff would know. RD M stated she was not aware the menu did not provide the 1/2 gallon per person per day. RD M stated they would need to revise this to make it correct.

On 1/8/13 at 1305 hours, an interview was conducted with the Director of Corporate Facilities. The Director stated the hospital's plan was for one gallon per person per day for 96 hours (4 days). They did not plan to use the water in the boiler in case of a disaster at the Irvine Campus, which was why it was not in the P&P. The Director stated she was not aware until now there was not enough water on hand. The Director further stated she knew they had more water at the Newport campus.

On 1/8/13 at 1450 hours, an interview was conducted with RD H regarding water at the Irvine Campus during a disaster or emergency. RD H stated they based the number of patients on the average census, not the licensed beds. RD H stated they would use the hot water heater/boiler for additional water for hygiene.

Review of the hospital's document titled Hoag Hospital Irvine Campus undated, indicated the Irvine campus would have a two phases of disaster supply and readiness for the Food and Nutrition Department. It indicated the total people counts would be 350 and the water requirements were "1/2 to 1 gallon per day in optimal conditions; however, there was no basis for this determination. It also indicated if rationing is necessary, fluid drinking water can be limited to 16-24 ounces and other sources of liquid such as juices should be considered.

Review of the hospital's P&P titled Emergency Procedures Manual dated 6/1/10, indicated emergency foods will be sufficient for three days. This number was different from what was stated during the interviews.

Review of the hospital's P&P titled Water Failure undated, indicated for emergency water supply and preparedness at the Irvine Campus, there was water in the Food and Nutrition Services and larger quantities were available by utilizing the domestic hot water tanks in the central plant. There was no detail on how to obtain or transport this water during an emergency. There was no detail to say how much water was available there.

It is unclear how much water should be stored in the hospital since there was conflicting numbers on documents and what exactly would be done during a disaster or emergency.

Based on observation and interview, the hospital's CVICU failed to maintain their medication cabinet in a safe operating condition.

Findings:

On 1/7/13 at 1100 hours, during the initial tour of the CVICU's medication room accompanied by the Critical Care Director, loose hinges on two cabinets were found which made the doors of the cupboards unable to lock. Inspection of the cupboards revealed overstocked IV bags in the overhead cupboards which could present injury to staff when these overhead cupboards were opened, especially with loose hinges.

The Critical Care Director acknowledged the needs to fix the medication cabinet hinges and relocate heavy supplies at a lower level.

Based on observation, interview, and record 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 ensure the system for disinfection for optical stylets brought to the hospital by anesthesiologists was implemented; the hand hygiene practices were implemented; the medication safety standard practices were implemented for four of four observations; the anesthesia carts in the restricted surgical services areas were cleaned and dust free for four ORs (Newport Beach OR, Pavilion OR, and outpatient surgical center); the P&P for personal belongings brought into the restricted areas was developed and implemented; commingling of personal hygiene items were prevented in the Chemical Dependency Recovery unit; the hand hygiene practices followed the CDC guidelines; the PPE was removed and worn appropriately; and the equipment remained in sterile packaging until needed for use. Cross Reference A749.

2. The hospital failed to ensure the air inlets for three ORs (OR 1, OR 2 and OR 3) at Newport campus were free from rust; the OR table was cleaned thoroughly for the OR at Irvine campus; the wet contact time was sufficient for disinfection of the OR; the correct procedure of cleaning the ORs was followed; the medications in syringes were not carried in the anesthesiologists' pockets in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center; the anesthesiologists cleaned the IV ports prior to injection in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center; the anesthesiologists did not use one needle to draw medications from four different vials in the OR of the outpatient surgical center at Irvine campus; the outdated multidose vials were not used in the ORs at Pavilion and Irvine campuses; and the clocks were visible at the obstetric OR's scrub sinks to time the surgical scrubs. Cross Reference A951.

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 failed to:

1. Ensure the disinfection of optical stylets used on six of 30 surgical patients reviewed (Patients 72, 74, 75, 76, 77, and 78) and failed to implement a system for disinfection for optical stylets brought to the hospital by the anesthesiologists.

2. Ensure the air inlets for three ORs (OR 1, OR 2 and OR 3) at Newport campus were free from rust.

3. Ensure the OR table in OR 1 at Irvine campus was free from adhesive tape residuals.

4. Ensure the anesthesia carts in OR 2 and OR 3 at Newport Beach campus, OR 17 at the outpatient surgical center, and OR 1 at Irvine campus were free from dust.

5. Develop and implement a P&P for personal belongings brought into the restricted areas.

6. Ensure the wet contact time was sufficient for disinfection of the OR.

7. Ensure the needles and syringes were kept sterile and wrapped until they were used.

8. Ensure the anesthesiologists cleaned the IV ports prior to injection in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center.

9. Ensure the anesthesiologists did not use one needle to draw medications from four different vials in the OR of the outpatient surgical center at Irvine campus.

10. Follow the CDC's guidelines to discard multidose vials 28 days after opening in the ORs, ED, and CCU.

11. Ensure the clocks were visible at the obstetric OR's scrub sinks to time the surgical scrubs.

12. Ensure the hand hygiene practices followed the CDC guidelines for two of 25 observations for hand hygiene.

13. Ensure the PPE was removed properly for one of one observation.

14. Ensure the PPE was worn appropriately for one of one family member observed wearing PPE.

15. Ensure the equipment remained in sterile packaging until needed for use.

16. Prevent commingling of personal hygiene items in the CDRC.

17. Ensure dietary and/or nursing management staff provided effective oversight of the infection control aspects of dietetic services.

These failures created the increased risk of transmission of infections and further compromised acutely ill patients' clinical conditions.

Findings:

1. The hospital's P&P titled Loaner Equipment/Instruments dated 3/1/10, read in part,"Items/instrumentation/tray(s) must be processed according to FDA-cleared manufacturers' written instructions, in accordance with Hoag Hospital's policies."

The manufacturer's Instructions for Cleaning, Disinfecting, and Sterilization of the 30000-V Stylet Shaft contained specific instructions for cleaning, disinfecting, and sterilizing of the optical stylets, and listed specific Cidex (a disinfectant chemical) preparations and Steris system (sterilizing equipment) as the recommended methods for use in processing the optical stylets.

The anesthesia records of 30 sampled patients with dates of surgery on 12/28, 12/29, and 12/30/12, were reviewed on 1/9/13, and showed 6 patients (Patients 72, 74, 75, 76, 77, and 78) had an optical intubation stylet used to facilitate placement of a breathing tube prior to surgery.

The medical record of Patient 72 from a surgery on 12/29/12, showed intubation was performed by MD 8 using a Shikani optical stylet.

During an interview with MD 8 on 1/9/13 at 1430 hours, he stated he used the Shikani stylet up to three times a day for intubating the patients. He stated he used his own Shikani stylet at the hospital, and he believed half of the anesthesiology group, approximately 20-25 physicians, used their own equipment in the hospital. He stated he cleaned the optical stylet by wiping it with alcohol, betadine, and again with alcohol. He stated that if he was required to sterilize the optical stylet, he would need to have two of the optical stylets.

The medical record of Patient 74 from a surgery on 12/28/12, was reviewed on 1/9/13. and showed intubation was performed by MD 11 using a Shikani optical stylet.

During an interview with MD 11 on 1/9/13 at 1405 hours, he stated after use, he would give the optical stylet to Anesthesia Tech 1 to clean.

In interviews with Anesthesia Tech 1 on 1/9/13 at 1045 hours and at 1540 hours, he stated the Shikani optical stylet was processed in the GI equipment processing area, the Olympus washer. He stated that he believed the optical stylets were just sent through with other loads, and the processing was not documented. He stated there was no method for tracking to whom the processed optical stylets belonged. He stated the hospital owned 3 of the optic stylets, but they were rarely used. He stated the physician-owned optical stylets were processed by hospital staff upon request.

During an interview with GI Tech 1 on 1/9/13 at 1000 hours, he stated the GI processing area was used for processing GI scopes and also bronchoscopes, but not scopes used by anesthesia.

During an interview with GI Tech 2 on 1/9/13 at 1005 hours, he stated no scopes used in intubation were processed in the GI equipment processing area.

The log for the Olympus disinfecting machine on 12/28, 12/29, and 12/30/12, was reviewed and did not include documentation of the optical stylets being processed on those dates. One load was run on 12/28/12, but the patients intubated with optical stylets were not listed on the load. Although the medical record of Patient 77 showed an optical stylet was used on 12/29/12, there were no loads run on that date, nor on 12/30/12.

In an interview with Executive Director of Peri-Operative Services on 1/9/13 at 1050 hours, she stated there was no tracking of the use or disinfection of optical stylets used in intubation.

In an interview with the Director of Infection Prevention on 1/10/13 at 1050 hours, she stated the infection control department was surprised by the physicians bringing in their own equipment and lack of disinfection of the equipment. She stated, "I had no idea this was happening." She stated the use of the equipment should have been proposed to the Peri-operative Value Analysis Committee for discussion.


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2. On 1/7/13 at 1340 hours, during the tour of OR 1, OR 2, and OR 3 at Newport Beach campus with the Director of Perioperative Services, it was observed the air inlet screen panels in the three ORs had large areas of rust which were directly located above the spaces of the sterile fields during an operation. The Director stated the engineering department was responsible for fixing the rusted areas.

On 1/10/13 at 1210 hours, during an interview, the Director of Engineering stated the department was aware of the rusted panels in the ORs. In the past, the department had painted the rusty areas twice and the rust came back. The department was going to replace the air inlet screen panels.

3. According to the AORN's Perioperative Standards and Recommended Practices, 2012 edition, for Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, the Recommended Practice IX, read in part, "Work practices must be designed to minimize risk of exposure to pathogens. The environment should be kept in a clean and sanitary condition by cleaning and decontaminating all equipment and environmental surfaces between procedures."

On 1/7/13 at 1340 hours, during the tour of OR 1 at Irvine campus, it was observed the OR table had multiple areas of adhesive tape residuals on the table frame. The Director of Surgical Services stated the Director was not aware of this.

4. According to the AORN's Perioperative Standards and Recommended Practices, 2012 edition, for Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, the Recommended Practice I, read in part, "Patients should be provided a safe, visibly clean environment. Exogenous flora are mainly aerobes. Health care-associated infections have been linked to external sources, which can include environmental surfaces. Microorganisms can contaminate ORs in surgical practice settings. Cleaning reduces the amount of dust and organic debris in surgical environments. All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical procedure of the day. The cleaning should be performed on a scheduled basis."

The following was observed in the surgical restricted areas:

* On 1/7/13 at 1020 hours, in Pavilion OR 17, the anesthesia cart equipped with medications and anesthesia supplies had dust in each drawer. Two drawers had dark red and brown spots. On the right side of the cart were an external container of sterile packages of esophageal stethoscopes and intubation stylets and a used needle covered with dry alcohol pad. In addition, in OR 2 and OR 3 at Newport Beach campus, the anesthesia carts had dust in each drawer.

During a concurrent interview with the Director of Perioperative Services, he stated the anesthesia technicians were responsible for cleaning and supplying the carts.

* On 1/8/13 at 1020 hours, in OR 1 at Irvine campus, the anesthesia cart had dust in the drawers. A concurrent interview with Anesthesia Tech 2 revealed the anesthesia technicians should have cleaned it.

5. On 1/8/13 at 0820 hours, during an interview, the Director of Perioperative Services stated there was a concern for possible risk for infection that the surgical staff including anesthesiologists had been informed they were not allowed to bring personal items into the surgical restricted areas. The Director was responsible for monitoring the environment.

On 1/9/13 at 0825 hours, the hospital's outpatient surgical center was toured with the Director of Surgical Center. The following was observed:

* MD 10 wheeled a brief case into OR 3. During a concurrent interview, MD 10 stated he was told it was okay to bring a personal bag to the OR as long as the bag was closed for compliance with the infection control requirement.

* MD 14 walked into OR 2 with a personal bag.

* MD 7 carried a business bag into OR 4.

* In OR 2, a cloth shopping bag was noted on the base of the stand that held the cautery machine. In the bag was a plastic sandwich bag containing four bottles of eye drops. The Director removed the bag to a nearby nursing station. However, the Director could not identify whom the bag belonged to. RNFA 1 showed up and stated that was her bag. When the Director questioned RNFA 1 about the eye medication bottles in the bag, RN 10 (OR 2's circulator RN) came out of OR 2 and explained the medications were used by her for the patients in the OR. RN 10 further stated the sandwich bag and medications accidentally fell into RNFA 1's personal bag. The Director inspected the eye medication bottles and stated they were eye dilating agents and would only be used in health care facilities.

During an interview, the Director stated no individuals should bring in their personal items to the restricted surgical areas unless authorized. However, the Medical Staff did not follow it.

On 1/11/13 at 1210 hours, during an interview, the Director of Infection Prevention stated the hospital did not have a P&P for bringing in personal items to the restricted surgical services areas.

6. On 1/9/13 at 0940 hours, in the outpatient surgical center, cleaning of OR 2 between cases was observed. Scrub Tech 1 put on a pair of gloves, took a Sani-wipe, and cleaned the back table upper level to lower level surfaces, the station used for irrigation solution infusion, the stool, and the floor to wipe some stained spots on the floor. Scrub Tech 1 removed the gloves, put the supply bags for the next case on the top of the back table. Hand hygiene was not performed after the gloves were removed. It was 25 seconds for the wet time observed. However, review of the manufacturer's recommendations showed the wet time was 4 minutes.

7. According to APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health Care dated 4/10, showed for aseptic technique, the staff never store needles and syringes unwrapped because sterility cannot be ensured. The staff remove the sterile needles/cannulas and/or syringes from the packages immediately before use and never store or transport syringes in clothing or pockets.

The following was observed:

* On 1/7/13 at 1020 hours, in the Pavilion OR, MD 6 was observed walking from the preop area into the OR with two medication-filled syringes in his pocket. The medications were later administered to the patient.

* On 1/8/13 at 0927 hours, during the observation of a procedure at Irvine campus, MD 7 was observed with two medication-filled syringes in his pocket.

* On 1/9/13 at 0825 hours, during the observation at the outpatient surgical center, MD 9 was observed carrying four medication-filled syringes in his pocket.

On 1/8/13 at 1420 hours, during an interview, MD 5, the Medical Director of the OR stated he was not aware of the APIC guidelines. MD 5 stated most of the times, the anesthesiologists would prepare the medication syringes in the OR and carry those syringes in their pockets. The Anesthesiologists assessed the preop patients and administered the medications to the patients to reduce the patients' anxiety.

On 1/11/13 at 1210 hours, the Infection Control Practitioner was interviewed. The Infection Control Practitioner stated she was not aware the anesthesiologists carried medication-filled syringes in their pockets. The Infection Control Practitioner had provided the in-services of safety injections for all the hospital's staff .

8. According to an APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health dated 4/10, the use of safe injection practices is critical to prevent microbial contamination of products administered to patients. The IV ports and vial stoppers should be disinfected by wiping and using friction with a sterile 70% isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swabs to allow the ports to dry before accessing. This position paper also indicated to use a new syringe and a new needle for each entry into a vial or IV bag and cleanse the access diaphragms of vials using friction with a sterile 70% isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swabs to allow the diaphragms to dry before inserting any devices into the vials.

The following was observed:

* On 1/7/13 at 1010 hours, in the Pavilion OR, MD 6 was observed connecting a secondary IV piggyback to the port of a patient's primary IV line. MD 6 did not disinfected the IV port.

* On 1/8/13 at 0925 hours, at Irvine campus, MD 7 was observed administering an IV medication via the patient's primary IV line. There was no disinfecting of the IV port.

* On 1/9/13 at 0903 hours, in the outpatient surgical center, MD 9 was observed administering the medications via the patient's primary IV line. There was no disinfecting of the IV port.
9. According to an APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health Care dated 4/10, the use of safe injection practices is critical to prevent microbial contamination of products administered to patients. This position paper also indicated to use a new syringe and a new needle for each entry into a vial or IV bag.

On 1/9/13 at 0903 hours, MD 9 was observed using the same needle to draw medications from four different medication vials (two vials of 10 ml of normal saline and two vials of antibiotics). After mixing the medications, MD 9 administered to the patient via the IV port. No disinfection of the IV port was observed.

10. According to CDC's guidelines for Safe Practices for Medical Injections showed a multidose vial should be dated when opened and discarded within 28 days unless the manufacturer specifies a different timeframe for the opened vial.

The following was observed:

* On 1/7/13 at 1020 hours, in Pavilion OR 17, an opened vial of Anectine (muscle relaxant) in the anesthesia cart was not dated to indicate when it was opened.

* On 1/8/13 at 1020 hours, in OR 1, two opened medication vials (Glycopyrrolate and Neostigmine) were not dated to indicate when it was opened.

A concurrent interview with Anesthesia Tech 2 revealed the anesthesiologists were responsible to date these vials to indicate when they were opened.

11. During a tour of the obstetric department's surgical suite on 1/8/13 at 1145 hours, there were no clocks visible at the scrub sinks for staff to time their surgical scrubs.

During an interview with the Operating Room Manager on 1/8/13 at 1205 hours, she concurred there were no clocks visible in the scrub sink areas. She further stated her scrub technicicians used timed surgical scrubs and that there should be a clock visible.


12. According to the CDC's guidelines for Hand Hygiene in Health Care Settings dated 10/02, handwashing and hand antisepsis are to decontaminate hands after removing gloves. In addition, the CDC's recommendation for hand hygiene updated 7/30/12, is to perform hand hygiene after contact with the patient's skin.

On 1/8/13 at 0852 hours, MD 13 was observed performing the EGD and colonoscopic procedures for a patient. MD 13 wore gloves while performing the EGD procedure. After finishing the EGD procedure, MD 13 removed the gloves, put on new pair of gloves, and continued the colonoscopic procedure. No hand hygiene was observed.




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b. On 1/8/12 at 1100 hours, RT 1 was observed with Patient 69 administering a respiratory treatment. The RT assessed the patients lungs and applied a mask with a nebulizing respiratory treatment over the patient's nose and mouth. The RT then went to a computer and entered data without removing her gloves or performing hand hygiene. After the patient's treatment the computer was wheeled outside the room and left in the hall. The patient had a diagnosis of pneumonia (infection of the lungs).




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13. Review of the hospital's P&P titled Infection Prevention Policy for Isolation Precautions: Standard and Transmission based (Contact, droplet and airborne) Precautions dated 5/16/12, showed for contact precautions, a gown and gloves should be put on prior to entering the patient's room. The gown and gloves should be removed and complete hand hygiene was done when leaving the patient's room.

On 1/8/12 at 1330 hours, during the observation of the patient treatment rooms on the 7th floor, an RN was observed in a contact isolation room wearing a gown and gloves. The RN came to the door of the isolation room still wearing the gown and gloves. The RN leaned out the door of the room and pulled the computer on wheels over to the door of the room. The RN lifted the top of the computer and then went back into the room. A few minutes later, the RN was observed leaving the contact isolation room after having removed the gown and gloves. Without disinfecting the contaminated computer on wheels, the RN began pushing the computer cart down the hall.

14. On 1/9/12 at 0920 hours, a family member for Patient 6 was observed at the bedside. Patient 6 was in a contact isolation room. The family member was bending over the siderails of the bed and straightening the patient's bedding. The family member was wearing a gown and gloves. However, the gown had not been secured at the back of the neck and the front of the gown was falling down to the family member's waist area exposing the front of their clothing.


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15. During a tour of the CCU's supply room, an opened package containing an endotracheal tube, size 7.0 mm (a tube inserted to a patient's trachea to provide airway) was found lying on one of the central carts ready for patient use.


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16. On 1/7/13, a tour of the CDRC was conducted. Multiple occupied patient rooms were inspected and personal hygiene items (i.e. tooth brushes) were observed on a counter top or other common areas near the sinks. There was no labeling or identification as to which patients the brushes belonged to.


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17. a. Cooked foods are considered to be potentially hazardous and require monitoring of time/temperature control during storage. PHF are susceptible to growth of bacteria associated with foodborne illness. It would also be the standard of practice to ensure that on-premises labeling is accurately presented. Additionally a refrigerated, ready-to-eat, potentially hazardous shall retain the date marking of the earliest-prepared or first-prepared ingredient (Food Code, 2009).

During the initial tour on 1/7/13 beginning at 0930 hours, it was noted in walk-in refrigerator A, there were more than 5 one-gallon bags of liquid identified by the Dietary Staff A as vegetable soup and additional bags of white liquid as clam chowder. It was noted the bags were labeled with a date of 1/713, as well as a use by date of 1/13/13. It was also noted the bags were labeled with the date but none of the bags were labeled with the content.

In a concurrent interview with Dietary Staff A, he stated that the first date on the soup label was the preparation date and the second was an expiration date. In a follow interview on 1/9/12 beginning at 1330 hours, with Dietary Staff B, he was asked to describe how he ensured that previously cooked foods were safe to use at a later time. He stated that once the item was cooked cooling temperatures would be monitored and recorded on the facility cooldown log. Concurrent review of hospital document titled "Cooling Temperature Log" beginning on 1/23/12, revealed none of the observed items were entered into the log. Dietary Staff A additionally offered the bags of soup observed on 1/7/13, were actually cooked on some other date, were frozen and the 1/7/13 date that was observed was actually the date that the items was pulled from the freezer.

A follow up observation on 1/9/13 at 1400 hours, in Refrigerator A revealed there were bags of unlabeled soup identified by Dietary Staff A as tortilla soup and unlabeled Bolognese sauce. It was noted that the Bolognese sauce was dated 1/4/13, and was frozen, yet the tortilla soup dated 1/7/13 was fully thawed. Additionally it was noted the vegetable soup was fully thawed and the clam chowder was still frozen. Dietary Staff A acknowledged the departments' dating procedure was likely not accurate and did not effectively reflect either preparation/thawing dates or safe food handling practices.

Review of hospital's P&P titled Food Procurement, Receiving and Storage 3101 dated 1/2/13, revealed foods held in refrigerated or other storage areas are appropriately labeled and dated.
b. Raw animal foods that are cooked using a non-continuous cooking process shall immediately after initial heating be cooled according to the time and temperature parameters specified for cooked PHF. Cooked PHF shall be cooled within 2 hours from 135ºF to 70°F and within a total of 6 hours from 135ºF to 41°F or less (Food Code, 2009).

During the initial tour on 1/7/13 beginning at 0930 hours, it was noted in walk-in Refrigerator A were four sheet pans of chicken that were partially cooked as they had grill marks on the outside and were raw on the inside. In a concurrent interview with Dietary Staff A, he stated the chicken was grilled at approximately 0500 hours, and would be used throughout the day. In an interview on 1/9/13 beginning at 1330 hours, with Dietary Staff A, he stated once the items were cooked they would be monitored for cooldown. Concurrent review of hospital document titled "Cooling Temperature" log beginning 11/23/12, revealed while the chicken was a daily item on the menu and would routinely be served as the non-select entrée for the noon meal on Mondays there were no cooldown monitoring entries. The only entry for chicken during that timeframe was for fully cooked chicken rather than partially cooked chicken. Dietary Staff A acknowledged these items were not monitored per safe food handling guidelines or the standard of practice within the hospital.

c. During the initial tour on 1/7/13 beginning at 0930 hours, it was noted in Refrigerator A, there were two bins each of raw, fully thawed salmon and chicken. It was noted the chicken was dated 1/4/13, with an expiration date of 1/10/13. Similarly the fish had a date of 1/6/13, with an expiration of 1/13/13. In a concurrent interview with Dietary Staff A, he stated these items were received fresh rather than frozen and all food items had an expiration date of seven days. Dietary Staff A was asked to describe the origin of the standard. He stated he was unsure; however, to his knowledge that had always been the departmental standard. The USDA's guidelines for thawed poultry and fish are 1-2 days under refrigeration and 3-4 days for whole cuts of meats and poultry. In a follow up interview on 1/8/13 at 1100 hours, with RD C she stated at one time the hospital hired a consultant to evaluate dietetic services and it was based upon that advice that the hospital procedures were changed to reflect a 7-day holding time for all food items. A holding time of seven days is exclusively reserved for ready to eat potentially hazardous foods per Food Code, 2009.

d. During the initial tour on 1/7/13 beginning at 0930 hours, it was noted the hospital was using pre-packaged cartons of soda syrup for beverage machines. In an interview on 1/7/13 at 1030 hours, with Dietary Staff C she was asked to describe how the plastic dispensing lines were changed on the sealed boxes. Dietary Staff C described a process whereby the plastic spigot was removed from the empty carton and was immediately placed in a new carton. The surveyor asked if there was any regular maintenance of the lines to which she replied that there was not. In a concurrent interview with Dietary Staff D he confirmed that this was the standard procedure within the hospital.

On 1/9/13 at 0900 hours, review of the manufacturers' guidelines obtained by the hospital revealed the manufacturer recommended a weekly cleaning of the syrup connectors with a chlorine based sanitizer.

e. During general food production observations on 1/7/13 at 1100 hours, Dietary Staff E was observed washing romaine lettuce. In a concurrent interview with Dietary Staff E, she was asked to describe the process. She stated she tore off the outer leaves of the heads of lettuce, soaked them in a sink containing a vegetable wash and then placed them upside down in a plastic bin with holes to drain. She further stated the leaves would be cut the following day.

In a concurrent interview with Dietary Staff A he stated the lettuce was previously washed by the vendor when the outside leaves were cut off. Further inspection of the packaging noted there was no indication that the item was previously washed. He also stated the item would be more thoroughly washed after it was cut. It would be the standard of practice to ensure that vegetables would be thoroughly washed in water to remove soil and other contaminants before being cut per Food Code, 2009.

f. On 1/7/13 beginning at 1115 hours, Dietary Staff F was asked to describe the cleaning process for large in-place cooking equipment such as the griddle. Dietary Staff F described a process whereby he would rinse out foodstuffs; wash the equipment with soap and water and would rinse it out by filling it up with water. The surveyor also asked him to describe the use of the sanitizing solution that was in a red bucket beneath the equipment. He stated it was the solution used on counter tops. He further stated he did not use that solution in the large equipment. It would be the standard of practice to ensure that all cooking equipment was effectively sanitized per Food Code, 2009. During food production observations it was noted that the grilled cheese sandwich substitute was not equal in nutritive value to the main entrée.

Review of hospital's P&P titled "Cleaning and sanitizing Equipment and Structures 3103" dated 1/2/13, showed staff was to wipe down clean equipment with sanitizer.

g. On 1/9/13 beginning at 1400 hours, breast milk storage practices were observed in the NICU. It was noted in the freezer, there were two small bottles of expressed breast milk that were liquefied. In a concurrent interview with RN 7, she stated the infants' mother expressed the breast milk at home and brought it to the hospital. She also stated since there was an adequate supply of stored milk in the refrigerator she decided to place the bottles in the freezer. She further stated it was the hospital procedure to accept only frozen breast milk from home. RN 7 acknowledged since the breast milk was liquid rather than frozen it would not be possible to ensure that the milk was stored and/or transported in a manner to ensure its' safety.

Review of the hospital's P&P titled Collection and Storage of Expressed Breast Milk for the Healthy Newborn dated 9/27/12, showed it was limited to the collection of expressed breast milk within the hospital. The P&P did not provide staff guidance on safe handling of the breast milk when brought from home. In an interview on 1/9/15 beginning at 1400 hours, with RN 6 she confirmed this was the only policy on collection and storage of breast milk.

h. On 1/9/13 beginning at 1425 hours, infant formula preparation practices were reviewed in the NICU. In a concurrent interview with RN 8, the surveyor asked her to describe infant formula preparation techniques within the NICU. She stated since they did not have a hood to prepare the infant formula they used only hermitically sealed manufacturers' formula; however, nursing staff did add fortifiers to infant formula or expressed breast milk when ordered by the physician. RN 8 stated there were 4 sinks available, designated as formula preparation areas. It was noted some of the sinks were within the patient care areas of the NICU and others were within common areas of the unit. It was also noted in addition to the handwashing sink there were paper supplies, plastic bins and tags stored directly adjacent to the sink. The surveyor asked RN 8 how nursing staff ensured the area was a clean environment. She stated several times each day nursing staff were instructed to wipe down the area with a pre-moistened sanitizer cloth. She demonstrated that the product used was Sani-cloth Superwipes manufacturered by PDI. Review of manufacturers' guidelines for the product revealed "PDI's Sani-Cloths are not designed for use on food contact surfaces, Super Sani-Cloth are considered disinfectants for non-food contact surfaces."

Review of the hospital reference published by the American Dietetic Association titled "Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Healthcare Settings-Second Edition" recommended while small amounts of infant formula may be prepared without the benefit of a formula preparation room all the considerations of food preparation areas should be followed to ensure minimizing the risk of cross contamination. These considerations would include elements such as evaluation of potential contaminants as well as environmental factors specific to the location of the preparation area.

i. On 1/7/13 at 1035 hours, an observation was made with the RD M and Dietary Staff O at the Irvine campus cafeteria reach-in refrigerator of raw sushi rolls that included: salmon rolls and spicy tuna rolls. A concurrent interview was conducted with the RD M and Dietary Staff O. The Dietary Staff O stated they have a sushi come that brings the sushi and stocks the reach-in refrigerator. The Dietary Staff O stated the vendor just brings different sushi rolls.

According to Food Code 2009, published by the Food and Drug Administration showed the following:

* Raw animal foods such as eggs, fish, meat, poultry, and foods containing these raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a time;

* A raw animal food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare; or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, may be served or offered for sale upon consumer request or selection in a ready-to-eat form if: the food establishment serves a population that is not a highly susceptible population.

j. On 1/7/13 at 1045 hours, the ice machine in the kitchen was observed to have a thick white substance surrounding the chute. A concurrent interview was conducted at this time with the RD M. The RD M stated a contract company cleaned and serviced the ice machine twice a year and the kitchen

Based on interview and record review, the hospital failed to ensure only a designated requestor would approach the family for organ donation for two of five RNs interviewed (RNs 16 and 17). This could potentially result in failure to obtain organ/tissue donation.

Findings:

Review of the Hospital's P&P "Organ/Tissue Donation" effective date of 12/7/11, showed the OPO is notified of all deaths in the hospital. This notification and consultation allows for the families of every suitable deceased patient to be provided with the option of organ and/or tissue donation by a trained requester provided by the appropriate agency.

On 1/7/13 at 1445 hours, during tour rounds of the Newport Beach Site ED, RN 16 was asked about the organ donation process in the event of a patient death in the ED. The RN stated she would notify the OPO and the ED physician would ask the family about organ donation. Also on 1/7/13 at 1500 hours, RN 17 was asked about the organ donation process in the event of a patient death. The RN stated it was a mutual process and she would supply emotional support and ask the family about organ donation.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services were provided in a safe and sanitary manner as evidenced by:
The hospital failed to ensure air inlet screen panels were not rusty; the OR table was cleaned thoroughly for the OR at Irvine campus; the anesthesia carts were not dusty and free of blood stains in the main ORs at Newport Beach campus, Irvine campus, and outpatient surgical center; the P&P to address prohibiting bringing personal belongings into the ORs was developed and implemented; the wet contact time was sufficient for disinfection of the OR; the correct procedure of cleaning the ORs was followed; the medications in syringes were not carried in the anesthesiologists' pockets in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center; the anesthesiologists cleaned the IV ports prior to injection in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center; the anesthesiologists did not use one needle to draw medications from four different vials in the OR of the outpatient surgical center at Irvine campus; the outdated multidose vials were not used in the ORs at Pavilion and Irvine campuses; and the clocks were visible at the obstetric OR's scrub sinks to time the surgical scrubs. Cross Reference A 951.

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 failed to:

1. Ensure the air inlets for three ORs (OR 1, OR 2 and OR 3) at Newport Beach campus were free from rust.

2. Ensure the OR table in OR 1 at Irvine campus was free from adhesive tape residuals.

3. Ensure the anesthesia carts in OR 2 and OR 3 at Newport Beach campus, OR 17 at the outpatient surgical center, and OR 1 at Irvine campus were free from dust.

4. Develop and implement a P&P for personal belongings brought into the restricted areas.

5. Ensure the wet contact time was sufficient for disinfection of the OR.

6. Ensure the needles and syringes were kept sterile and wrapped until they were used.

7. Ensure the anesthesiologists cleaned the IV ports prior to injection in the ORs of Newport Beach campus, Irvine campus procedure room, and outpatient surgical center.

8. Ensure the anesthesiologists did not use one needle to draw medications from four different vials in the OR of the outpatient surgical center at Irvine campus.

9. Ensure the hand hygiene practices followed the CDC's guidelines.

10. Follow the CDC's guidelines to discard multidose vials 28 days after opening in the ORs, ED, and CCU.

11. Ensure the clocks were visible at the obstetric OR's scrub sinks to time the surgical scrubs.

These failures created the risk of substandard surgical outcomes for the patients.

Findings:

1. On 1/7/13 at 1340 hours, during the tour of OR 1, OR 2, and OR 3 at Newport Beach campus with the Director of Perioperative Services, it was observed the air inlet screen panels in the three ORs had large areas of rust which were directly located above the spaces of the sterile fields during an operation. The Director stated the engineering department was responsible for fixing the rusted areas.

On 1/10/13 at 1210 hours, during an interview, the Director of Engineering stated the department was aware of the rusted panels in the ORs. In the past, the department had painted the rusty areas twice and the rust came back. The department was going to replace the air inlet screen panels.

2. According to the AORN's Perioperative Standards and Recommended Practices, 2012 edition, for Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, the Recommended Practice IX, read in part, "Work practices must be designed to minimize risk of exposure to pathogens. The environment should be kept in a clean and sanitary condition by cleaning and decontaminating all equipment and environmental surfaces between procedures."

On 1/7/13 at 1340 hours, during the tour of OR 1 at Irvine campus, it was observed the OR table had multiple areas of adhesive tape residuals on the table frame. The Director of Surgical Services stated the Director was not aware of this.

3. According to the AORN's Perioperative Standards and Recommended Practices, 2012 edition, for Recommended Practices for Environmental Cleaning in the Surgical Practice Setting, the Recommended Practice I, read in part, "Patients should be provided a safe, visibly clean environment. Exogenous flora are mainly aerobes. Health care-associated infections have been linked to external sources, which can include environmental surfaces. Microorganisms can contaminate ORs in surgical practice settings. Cleaning reduces the amount of dust and organic debris in surgical environments. All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical procedure of the day. The cleaning should be performed on a scheduled basis."

The following was observed in the surgical restricted areas:

* On 1/7/13 at 1020 hours, in Pavilion OR 17, the anesthesia cart equipped with medications and anesthesia supplies had dust in each drawer. Two drawers had dark red and brown spots. On the right side of the cart were an external container of sterile packages of esophageal stethoscopes and intubation stylets and a used needle covered with dry alcohol pad. In addition, in OR 2 and OR 3 at Newport Beach campus, the anesthesia carts had dust in each drawer.

During a concurrent interview with the Director of Perioperative Services, he stated the anesthesia technicians were responsible for cleaning and supplying the carts.

* On 1/8/13 at 1020 hours, in OR 1 at Irvine campus, the anesthesia cart had dust in the drawers. A concurrent interview with Anesthesia Tech 2 revealed the anesthesia technicians should have cleaned it.

4. On 1/8/13 at 0820 hours, during an interview, the Director of Perioperative Services stated there was a concern for possible risk for infection that the surgical staff including anesthesiologists had been informed they were not allowed to bring personal items into the surgical restricted areas. The Director was responsible for monitoring the environment.

On 1/9/13 at 0825 hours, the hospital's outpatient surgical center was toured with the Director of Surgical Center. The following was observed:

* MD 10 wheeled a brief case into OR 3. During a concurrent interview, MD 10 stated he was told it was okay to bring a personal bag to the OR as long as the bag was closed for compliance with the infection control requirement.

* MD 14 walked into OR 2 with a personal bag.

* MD 7 carried a business bag into OR 4.

* In OR 2, a cloth shopping bag was noted on the base of the stand that held the cautery machine. In the bag was a plastic sandwich bag containing four bottles of eye drops. The Director removed the bag to a nearby nursing station. However, the Director could not identify whom the bag belonged to. RNFA 1 showed up and stated that was her bag. When the Director questioned RNFA 1 about the eye medication bottles in the bag, RN 10 (OR 2's circulator RN) came out of OR 2 and explained the medications were used by her for the patients in the OR. RN 10 further stated the sandwich bag and medications accidentally fell into RNFA 1's personal bag. The Director inspected the eye medication bottles and stated they were eye dilating agents and would only be used in health care facilities.

During an interview, the Director stated no individuals should bring in their personal items to the restricted surgical areas unless authorized. However, the Medical Staff did not follow it.

On 1/11/13 at 1210 hours, during an interview, the Director of Infection Prevention stated the hospital did not have a P&P for bringing in personal items to the restricted surgical services areas.

5. On 1/9/13 at 0940 hours, in the outpatient surgical center, cleaning of OR 2 between cases was observed. Scrub Tech 1 put on a pair of gloves, took a Sani-wipe, and cleaned the back table upper level to lower level surfaces, the station used for irrigation solution infusion, the stool, and the floor to wipe some stained spots on the floor. Scrub Tech 1 removed the gloves, put the supply bags for the next case on the top of the back table. Hand hygiene was not performed after the gloves were removed. It was 25 seconds for the wet time observed. However, review of the manufacturer's recommendations showed the wet time was 4 minutes.

6. According to APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health Care dated 4/10, showed for aseptic technique, the staff never store needles and syringes unwrapped because sterility cannot be ensured. The staff remove the sterile needles/cannulas and/or syringes from the packages immediately before use and never store or transport syringes in clothing or pockets.

The following was observed:

* On 1/7/13 at 1020 hours, in the Pavilion OR, MD 6 was observed walking from the preop area into the OR with two medication-filled syringes in his pocket. The medications were later administered to the patient.

* On 1/8/13 at 0927 hours, during the observation of a procedure at Irvine campus, MD 7 was observed with two medication-filled syringes in his pocket.

* On 1/9/13 at 0825 hours, during the observation at the outpatient surgical center, MD 9 was observed carrying four medication-filled syringes in his pocket.

On 1/8/13 at 1420 hours, during an interview, MD 5, the Medical Director of the OR stated he was not aware of the APIC guidelines. MD 5 stated most of the times, the anesthesiologists would prepare the medication syringes in the OR and carry those syringes in their pockets. The Anesthesiologists assessed the preop patients and administered the medications to the patients to reduce the patients' anxiety.

On 1/11/13 at 1210 hours, the Infection Control Practitioner was interviewed. The Infection Control Practitioner stated she was not aware the anesthesiologists carried medication-filled syringes in their pockets. The Infection Control Practitioner had provided the in-services of safety injections for all the hospital's staff .

7. According to an APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health dated 4/10, the use of safe injection practices is critical to prevent microbial contamination of products administered to patients. The IV ports and vial stoppers should be disinfected by wiping and using friction with a sterile 70% isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swabs to allow the ports to dry before accessing. This position paper also indicated to use a new syringe and a new needle for each entry into a vial or IV bag and cleanse the access diaphragms of vials using friction with a sterile 70% isopropyl alcohol, ethyl/ethanol alcohol, iodophor, or other approved antiseptic swabs to allow the diaphragms to dry before inserting any devices into the vials.

The following was observed:

* On 1/7/13 at 1010 hours, in the Pavilion OR, MD 6 was observed connecting a secondary IV piggyback to the port of a patient's primary IV line. MD 6 did not disinfected the IV port.

* On 1/8/13 at 0925 hours, at Irvine campus, MD 7 was observed administering an IV medication via the patient's primary IV line. There was no disinfecting of the IV port.

* On 1/9/13 at 0903 hours, in the outpatient surgical center, MD 9 was observed administering the medications via the patient's primary IV line. There was no disinfecting of the IV port.
8. According to an APIC's position paper for Safe Injection, Infusion, and Medication Vial Practices in Health Care dated 4/10, the use of safe injection practices is critical to prevent microbial contamination of products administered to patients. This position paper also indicated to use a new syringe and a new needle for each entry into a vial or IV bag.

On 1/9/13 at 0903 hours, MD 9 was observed using the same needle to draw medications from four different medication vials (two vials of 10 ml of normal saline and two vials of antibiotics). After mixing the medications, MD 9 administered to the patient via the IV port. No disinfection of the IV port was observed.

9. According to the CDC's guidelines for Hand Hygiene in Health Care Settings dated 10/02, handwashing and hand antisepsis are to decontaminate hands after removing gloves.

On 1/8/13 at 0852 hours, MD 13 was observed performing the EGD and colonoscopic procedures for a patient. MD 13 wore gloves while performing the EGD procedure. After finishing the EGD procedure, MD 13 removed the gloves, put on new pair of gloves, and continued the colonoscopic procedure. No hand hygiene was observed.

10. According to CDC's guidelines for Safe Practices for Medical Injections showed a multidose vial should be dated when opened and discarded within 28 days unless the manufacturer specifies a different timeframe for the opened vial.

The following was observed:

* On 1/7/13 at 1020 hours, in Pavilion OR 17, an opened vial of Anectine in the anesthesia cart was not dated to indicate when it was opened.

* On 1/8/13 at 1020 hours, in OR 1, two opened medication vials (Glycopyrrolate and Neostigmine) were not dated to indicate when it was opened.

A concurrent interview with Anesthesia Tech 2 revealed the anesthesiologists were responsible to date these vials to indicate when they were opened.

11. During a tour of the obstetric department's surgical suite on 1/8/13 at 1145 hours, there were no clocks visible at the scrub sinks for staff to time their surgical scrubs.

During an interview with the Operating Room Manager on 1/8/13 at 1205 hours, she concurred there were no clocks visible in the scrub sink areas. She further stated her scrub technicicians used timed surgical scrubs and that there should be a clock visible.

Based on interview and record review, the hospital failed to ensure one surgical patient (Patient 11) had a H&P examination on record prior to having the surgery on 1/7/13. This created the risk of a substandard surgical outcome for the patient.

Findings:

The Medical Staff Rules and Regulations dated November, 2012, read in part, "Planned C-Section: History and physical is performed and documented on the chart prior to the C-Section", "Tubal Ligations: History and physical is performed and recorded on chart prior to procedure (prenatal records do not suffice)", and "Inpatient records require a comprehensive history and physical which includes: chief complaint, present and past illness, present medications/allergies, relevant past social and family histories, systemic review, examination, conclusions/impressions, and plan of care for the patient."

Review of the medical record of Patient 11 on 1/7/13 at 1055 hours, it was noted the patient had a scheduled cesarean section (removal of the fetus from the uterus via an incision in the abdominal wall) and tubal ligation (sterilization procedure) on 1/7/13 at 0730 hours, and there was no comprehensive H&P examination in the medical record because the physical examination was not documented.

In a concurrent interview with the Director of Womens Health, she concurred there was no H&P examination by the surgeon for Patient 11 in the medical record.

In an interview with the Labor and Delivery Operating Room Manager on 1/7/12 at 1055 hours, she reviewed the medical record of Patient 11 and stated she had a scheduled cesarean section in the morning of 1/7/13 at 0730 hours, and the operative note was written. She stated there was no physical examination by the surgeon in the medical record yet, although there were vital signs and the patient's height. She stated there was a prenatal H&P examination from the surgeon's office dated June, 2012, but none since admission. She stated she believed the physician was performing the physical examination, but was not documenting it.

In an interview with the Labor and Delivery Manager on 1/7/12 at 1100 hours, she stated Patient 11's surgeon was no longer in the hospital and had returned to her office.

In an interview with MD 2 on 1/7/13 at 1030 hours, he stated cesarean section patients needed to have full H&P examinations.