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Based on interview and record review, the hospital's GB failed to ensure the effective operation of the grievance process for one of two grievances reviewed (for Patient 47). Patient 47's grievances were not thoroughly investigated and there was no documented evidence a written communication was provided to the patient reflecting the results of the investigation and actions taken as per the hospital's P&P. These created the risk of not addressing the grievances for this patient.

Findings:

The hospital's P&P titled Complaints and Grievances, Patient dated 12/15/14, showed a letter or electronic email is considered a grievance. This includes written complaints from an inpatient, an outpatient, a released discharged patient, or a patient's representative regarding patient's care. A patient grievance is a written letter or email made during an admission or a verbal complaint made to the hospital by the patient or the patient's representative regarding the patient's care.

All formal and informal grievances will be investigated to determine if opportunities exist to improve processes and systems related to the issues reported.

Once a concern or complaint has been identified as a grievance, every attempt will be made to resolve the grievance within seven calendar days or as soon as possible. The patient and/or patient's representative will receive written communication from the organization within seven calendar days of the receipt of the grievance (seven calendar days is timed from the initiation of the grievance). The communication shall outline the results of the investigation and actions taken.

On 1/13/15, review of the hospital's event log showed the sections to document the patient/person affected, event type, narrative description, and management review.

The hospital's event log showed an entry for "Grievance" type event for Patient 47. The document showed Patient 47 had notified the hospital on 1/2/15, of concerns regarding care received on 12/31/14. The concerns included the nurse had ignored the patient, was argumentative, and did not manage the patient's pain effectively. The sections for the dates of sending out the 7-day and final letters to the person who filed grievances were left blank. There was no documentation of any medical record review or staff interviews in response to the patient's allegations.

The Management Review section of the event log for Patient 47's grievances indicated the Department Manager spoke with the patient briefly prior to discharge. The patient had recommended to list the nurse as a DNR staff. The file status indicated the file was signed off by the primary Manager.

Further review of the document showed no documented evidence of the investigation and written notification provided to the patient regarding the results of the investigation and actions taken to resolve the patient's grievances as per the hospital's P&P.

During an interview with the Director of QA on 1/14/15 at 1345 hours, she stated there was no documentation in the incident database regarding review of the medical record or staff interviews conducted related to Patient 47's concerns. She stated she thought Patient 47's allegations were a complaint, not a grievance because they were written on a comment card. She stated if the patient had emailed the concerns, they would be considered as a grievance. The Director of QA further stated the Department Manager had spoken to the patient and told her the patient was satisfied. She stated the grievances were to have an investigation and the 7-days and final letters were to be sent to the patient/patient's representative.

During an interview with the Department Manager on 1/15/15 at 1300 hours, she stated she did speak with the patient about the concerns. She stated she did not review the patient's medical record regarding pain medication administration because she thought Patient 47's concerns were more about the nurse's attitude issues.

Based on interview and record review, the hospital failed to ensure a safe environment for one patient of 29 sampled patients (Patient 49). Used patient care items such as IV tubings of the IV fluid and antibiotic bags were not properly removed from the room prior to Patient 49 moving into that room. As a result, Patient 49 was attached to the IV tubings of the IV fluid and antibiotic bags that belonged to another patient who had previously occupied the room. There was no documented evidence the disclosure of the event including unanticipated outcomes was provided to Patient 49. This created the risk of violating the patient's right to be in a safe environment and not fully informing the patient regarding unanticipated outcomes from the incident.

Findings:

The hospital's P&P titled Guidelines for Open Communication of Unanticipated Outcomes effective 5/1/09, read in part, "Patients, and where appropriate, their families are informed about the outcomes of care, including unanticipated outcomes. The practitioner and/or representative of hospital administration will disclose what is to be communicated. Disclosure of the event will take place as close as possible to the awareness of the event."

Review of the hospital's incident log on 1/13/15 at 1035 hours, an incident report involving Patient 49 dated 1/4/15, was reviewed with RN 14. During a concurrent interview, RN 14 stated the IV fluid and Vancomycin (antibiotic) medication bags with the IV tubings of the patient who previously occupied the room were left in the room after the patient had been transferred to another hospital. Patient 49 was moved into that room and was attached to the IV tubings of the IV fluid and Vancomycin medication bags that belonged to the transferred patient.

During an interview with MD 1 on 1/13/15 at 1150 hours, he stated he was not sure if Patient 49 was told of a possible exposure to disease from the incident.

During an interview with the Interim Director of IP and IP Consultants 1 and 2 on 1/13/15 at 1420 hours, they reviewed the event details for the re-use of the IV tubings, and stated the use of the IV tubings by the two patients should be treated as potential blood exposure for the second patient (Patient 49).

The documentation of incident disclosure to Patient 49 was requested on 1/13/15, but was not provided as of the exit date on 1/15/15. The hospital failed to provide a disclosure of the event including unanticipated outcomes as per the hospital's P&P.

During an interview with the Interim Director of IP on 1/15/15 at 0845 hours, she stated she did not believe there had been a disclosure to Patient 49 regarding a potential blood exposure.

Based on interview and record review, the hospital's QAPI program failed to ensure the quality of data collected regarding hand hygiene, SSIs, and CAUTIs and analyze the collected data to improve performance and patient care. These created the increased risk of persistent poor healthcare practices in the hospital.

Findings:

1. The Infection Prevention Program Plan - Annual Review showed hand hygiene had been identified as a prioritized risk due to the lack of compliance, posing a risk of transmission of pathogens to the patients and staff.

The hospital's P&P titled Hand Hygiene effective 12/10/14, read in part, "All personnel are expected to implement appropriate hand hygiene practices on a consistent basis." and "Hand hygiene requirements apply to all care settings and services".

During an interview with RN 15 on 1/12/15 at 1050 hours, she explained hand hygiene audits were not being conducted in all patient care areas. She stated while she was trained to do the hand hygiene audits, she assigned the audits to other nurses to do.

During an interview with IP Consultant 1 on 1/13/15 at 1318 hours, she stated 750 hand hygiene audits had already been performed and there was a video from the CDC for the nurses performing hand hygiene to watch by the end of December 2014. She stated all of the observers were to be trained and the observations were to be validated.

In interviews with the Director of QA on 1/13/15 at 1010 and 1320 hours, she stated it had not been verified that everyone performing hand hygiene audits had watched the video from the CDC. She was not sure who was responsible for reporting the data to the IP Department. She stated the follow-up to the hand hygiene program had not been formalized yet. During a second interview with the Director of QA on 1/14/15 at 0945 hours, she stated she was not able to show documented evidence of the QAPI program involvement with the collected data for hand hygiene.

2. The hospital Infection Prevention Program Plan FY 2015 effective 1/5/15, read in part, "The scope of the infection prevention program addresses all services and sites of care in the organization. It includes surveillance, prevention and control of infections in patients, visitors, staff, healthcare providers, volunteers, contract personnel, and students within the organization.", "Surveillance of hospital acquired infections and community acquired infections is performed under the direction of the Infection Prevention Committee.", and "Surveillance data will be analyzed appropriately and used to monitor and improve infection prevention, control and healthcare outcomes."

Review of the email sent by IP RN 2 to RN 20 dated 1/14/15, showed the list of SSIs determined by the IP nurse on 1/14/15. The list contained data regarding seven infections that occurred between 10/19 and 12/15/14. Three of the SSIs were shaded with a note indicating these SSIs had not had the department investigation form, "Review of Surgical Site Infection", completed.

During an interview with IP RN 1 on 1/13/15 at 1350 hours, she stated when a possible SSI was identified, the department investigation forms were sent to the OR Director and Manager at the main campus and the OR Director at the Laguna Beach campus to complete. She stated there was no policy addressing how to complete the department investigation forms. She stated there were no logs to keep track when the department investigation forms were sent out or returned.

During an interview with the Director of QA on 1/13/15 at 1405 hours, she stated the department investigation forms were to be reviewed and revised. She stated some department investigation forms completed by the perioperative staff were not put into the database. During a second interview with the Director of QA on 1/14/15 at 0930 hours, she stated they needed to establish a turnaround time for the SSI department investigation forms.

During an interview with the Director of Peri-Op on 1/14/15 at 0915 hours, she stated she sent the department investigation forms to the clinical coordinator nurses who were overseeing the OR service lines. She expected the investigtation forms to be returned in 48 hours. She stated she scanned the completed investigation forms to the IP Department. She stated she assumed the Laguna Beach campus would return the investigation forms promptly as well. She stated the department investigation forms for the infection cases identified in October and November 2014, were completed by the nurse but not returned to her. In addition, she said the department investigation forms were sent to the nurse managers on 12/16/14, for the identified infections from 11/17/14 to 12/9/14. However, the investigation forms had not been returned. She stated there was no tracking system for these investigation forms. There was a possibility that the investigation forms had been sent back, but she did not know.

3. During an interview with RN 17 on 1/15/15 at 1015 hours, she stated she mentored the nurses who performed IP tasks on each unit. She stated the nurses were asked to investigation when a CAUTI was found. The request for the departmental investigation was sent directly to the department, not to her. She stated she was not sure if there was a policy addressing the investigation for CAUTIs.

When asked for the audit tool for the department investigation of CAUTIs, RN 17 provided an email from IP RN 2 dated 12/11/14, which provided the expectations for the departmental investigation of the CAUTIs, included the following questions:

* Did the indwelling urinary catheter meet criteria for placement?

* Was the infection related to the insertion of indwelling urinary catheter?

* Was there documentation showing the urinary catheter was needed every shift?

The email showed the expectation for the investigation to be completed and returned to the IP Department within one week.

During an interview with IP RN 2 on 1/15/15 at 1100, she stated the request for the department investigation of the CAUTIs would be sent by email, but there was no formal tracking system to ensure the department had investigated the CAUTIs and returned the investigation forms to her. She was asked for an example of such email communication for a CAUTI identified in late December 2014. She provided an email that described Patient 59's fungal CAUTI identified on 11/19/14, related to the indwelling urinary catheter inserted on 11/15/14, for review.

The email dated 12/15/14, regarding Patient 59's CAUTI was sent from IP RN 2 to a nurse on the IP Team on the Cardiac Telemetry Unit where the CAUTI was identified and to RN 17, but not to the department manager, requesting the department investigation of the CAUTI. The completed investigation was to be returned in a week. The document showed a week later on 12/22/14, the IP Team RN responded she would "not be back to work until after the holidays and therefore will not have access to do a drill down." She sent a copy of her response to RN 16, the Cardiac Telemetry Manager.

In the 12/22/14 email, RN 16 replied to IP RN 2 that the indwelling catheter was not placed 11/15/14, but on 11/11/14. She stated the patient came to the Cardiac Telemetry unit on 11/17/14. RN 16 indicated because the patient had been in the care of another unit when the catheter was placed, her unit "should not have to take credit" for the CAUTI discovered on 11/19/14. RN 16's email read, "I did not review for daily documentation of necessity by the physicians."

During an interview with the Director of QA on 1/14/15 at 1415, she stated the GB did not specify the frequency of data collection regarding SSIs, hand hygiene, or CAUTIs. She stated the frequency of reporting was defined, but not the frequency of data collection.

Based on interview and record review, the hospital failed to ensure the QAPI program identified opportunities for improvement and changes that would lead to improvement, creating the risk of substandard healthcare outcomes to the patients in the hospital.

Findings:

During an interview and concurrent document review with the PI Analyst on 1/15/15 at 1125 hours, she stated she worked with Risk Management staff to review all the QREs. The QREs related to the physician's practices or suggested by the clinician would be sent to the medical staff for peer review process. However, the hospital did not have a guideline to prioritize the cases for peer review or response and close the cases.

Review of the QRE 1028xx report for the event on 12/8/14, showed the event was categorized as a severity level 6, ''severe permanent harm", surgical event. The Director Clinical Perioperative Services requested a peer review process for this QRE. The documentation showed the peer review request was sent on 1/13/15, more than a month after the event on 12/8/14, and the reviewing status was pending. The PI Analyst stated she received a call from the Director a couple of days before and started to work on this QRE. The PI Analyst stated there were approximately 75 QREs on the list that needed peer review.

Based on interview and record review, the hospital failed to ensure all adverse events were investigated, analyzed, and formed the basis for learning and improvement of services, creating the increased risk of persistent poor practices and substandard healthcare outcomes in the hospital.

Findings:

1. The hospital Infection Prevention Program Plan FY 2015 effective 1/5/15, read in part, "Prevention and control efforts will include activities such as: ...Addressing outbreaks, epidemics, and unusual occurrences in a timely manner..."

The online CDC Injection Safety Information for Providers, FAQs regarding Safe Practices for Medical Injections accessed 1/16/15, include the following:

* Everything from the medication bag to the patient's catheter is a single interconnected unit.

* All of the components are directly or indirectly exposed to the patient's blood and cannot be used for another patient.

* Syringe that intersects through ports in the IV tubing or bags also becomes contaminated and cannot be used for another patient.

* Separation from the patient's IV by distance, gravity and/or positive infusion pressure does not ensure that small amounts of blood are not present in these items.

The hospital's P&P titled Body/Fluid Exposure - Post Exposure Management effective 12/30/13, read in part, "In the event of an exposure involving a guest, visitor, or patient, the supervisor at the exposure location will do the following:

* Notify Occupational Health, and the nursing supervisor if after hours.

* Escort the exposed person and the source person to the ED for evaluation and possible treatment with anti-retroviral agents and counseling.

* Evaluation in the ED may include the following baseline laboratory work for exposure source person: rapid HIV, hepatitis B antigen, and hepatitis C antibody; and HIV antibody, hepatitis B and C antibodies for exposed persons.

Review of the hospital's incident log on 1/14/15, showed an incident involved Patient 49 on 1/3/15. The incident report indicated the previous patient's IV fluid and Vancomycin medication bags with the IV tubings attached had been left in a room after the patient was transferred to another hospital. Patient 49 was moved into that room and attached to the IV tubings of the IV fluid and Vancomycin medication bags that belonged to the previous patient. The incident report indicated IP RN 1 and MD 1 had been notified about the occurrence, and MD 1 felt there was no risk of infection for Patient 49, and no follow-up was required.

During an interview with MD 1 on 1/13/15 at 1150, he recalled the incident of the used IV bags and tubings being connected to the patient. He stated he felt the second patient (Patient 49) was not at risk for a transmissible disease from the previous patient if the tubings were not in direct contact with the patient (not the same needle used) because the fluid was gravity fed.

However, during an interview with the Interim Director of IP, IP Consultants 1 and 2 on 1/13/15, at 1420 hours, they reviewed the event details for the reuse of the IV tubings and stated the use of the IV tubings by the two patients should be treated as a potential blood exposure for Patient 49 and investigated due to the risk of infection to the patient.

The hospital failed to investigate and analyze the incident involving Patient 49 to prevent reoccurrence and improve patient care.


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2. Review of Patient 42's medical record was initiated on 1/14/15. The medical record showed the patient was admitted to the hospital on 1/1/15, and discharged on 1/8/15. The patient was readmitted to the hospital on 1/9/15, within 24 hours after discharge.

a. Patient 42's medical record for the admission on 1/1/15, showed the following:

* The ED Adult VS & Pain Assessment dated 1/1/15 at 1143 hours, showed Patient 42's oxygen saturation (concentration of oxygen in the blood) level was 95% (normal oxygen saturation levels are between 92% to 100%) on room air.

* The Physical Assessment Telemetry dated 1/8/15 at 1446 hours, showed Patient 42's oxygen saturation level was 94% with oxygen at three liters per minute via nasal cannula (a device to deliver oxygen).

* The Physical Assessment Telemetry dated 1/8/15 at 1545 hours, showed the patient's oxygen saturation level was 85% on room air and the patient was at rest.

* The Event/Shift/Hand-Off dated 1/8/15 at 1545 hours, showed Patient 42's oxygen saturation level was 93% when the patient was at rest and received oxygen at 3.5 liters per minute via nasal cannula. The patient' oxygen saturation levels were "85% - 86%" on room air, below the patient's baseline upon arrival to the ED on 1/1/15. The physician was called. The Case Manager was informed for home oxygen needs. The patient was discharged at 1730 hours. There were no other interventions implemented to address the patient's low oxygen saturation levels prior to discharge.

Further review of the medical record showed no documented evidence the nursing staff had conducted a nursing assessment during the two hours period prior to discharge of Patient 42 as per the hospital's P&P. Cross reference to A392, example #1. The patient was readmitted to the hospital on the following day, 1/9/15, with sepsis (infection) secondary to influenza.

b. Review of Patient 42's medical record for the readmission on 1/9/15, showed the following:

* The ED Adult Triage Assessment dated 1/9/15 at 1522 hours, showed Patient 42 was pale upon arrival to the ED. The patient's oxygen saturation level was 88% with oxygen at four liters per minute via nasal cannula at home. The oxygen administration rate was increased to six liters per minute by the paramedic team. The patient's temperature was 100.7 degrees Fahrenheit.

* The Emergency Department Report dated 1/9/15, showed Patient 42's temperature had increased to 103.3 degrees Fahrenheit on 1/9/14 at 1600 hours. The patient had fever and sepsis secondary to influenza A with complications of hypotension (low blood pressure).

Patient 42 was observed in the ICU (a special unit of the hospital that provides intensive care medicine) on 1/12/15.

During an interview with the Director of QA on 1/14/15 at 1415 hours, she stated the readmissions were detected through data collection for certain diagnosis codes. She stated the care management department might track inappropriate discharges and readmissions and report them to the utilization management committee, but the QA department did not.

An interview and concurrent medical record and document review was conducted with the Director Care Management, Clinical Coordinator, and QA Analyst on 1/15/15 at 0845 hours. The Clinical Coordinator stated the reasons for readmission would be researched when the patient was readmitted to the hospital within 24 hours or the next business day. If the patient had new symptoms, it would not trigger to input the patient's information into the QRE system for the QA department to review. If an inappropriate discharge or quality of care was concerned, staff would input the patient's information to the QRE system for review and subsequently, the case would be referred to the appropriate departments involving care issues. The Director Care Management stated if anyone had concerns with the quality of care and/or inappropriate discharge, he/she would be able to enter the information into the QRE system for review. He/she would use his/her judgement to decide whether the case would be reported to the QRE system for review. However, there was no specific criteria established for staff to follow in determining as to whether the patient cases would be reported to the QRE system for review.

The Director of Care Management also stated Patient 42's discharge on 1/8/15, was an appropriate discharge. She felt there was no quality of care concerns. She was asked whether Patient 42's readmission was reported for the QRE review. On 1/15/15 at 1035 hours, the Director Care Management stated Patient 42's readmission was not reported to the QRE system for review.

The hospital failed to analyze Patient 42's readmission within 24 hours event to identify possible causes and improve patient care. There was no specific criteria established for referring the quality care concern cases for QRE review.

Based on interview and medical record review, the hospital failed to ensure the physician had completed the discharge summary as per the hospital's Medical Staff Bylaw for one of 29 sampled patients (Patient 37), creating the risk of a substandard healthcare outcome to this patient.

Findings:

The Medical Staff Bylaws approved 11/17/14, read on pages 12-13, "Each member of the medical staff shall: ...Prepare and complete in timely fashion the medical and other required records for all patients he admits or in any way provides care to in the hospital including compliance with such electronic health record policies and protocols as have been implemented". The Medical Staff Policies and Procedures regarding Medical Record Documentation revised 2/12, read, "A record is considered delinquent if not completed within fourteen (14) days of discharge."

Review of the medical record for Patient 37 was conducted on 1/12/15. The medical record showed the patient came to the ED on 12/23/14, and was discharged at 1050 hours. There was a discharge summary dictated by the physician, but the document was not signed by the physician.

During a concurrent interview with RN 19, he stated the physician did not sign the discharge summary in a timely fashion. The blank signature line showed "This is not considered FINAL until Signed by a Physician."

Based on interview and medical record review, the hospital failed to ensure nursing staff provided ongoing assessments of the needs of two of 29 sampled patients (Patients 37 and 42). The nursing staff did not assess Patient 42 at discharge as per the hospital's P&P and Patient 37's pain timely. These created the risk of substandard healthcare outcomes to these patients.

Findings:

1. The hospital's P&P titled Assessment/Re-assessment of Patients effective 12/4/14, showed a discharge assessment must be done within two hours of the time the patient is discharged from the hospital. The discharge assessment include the following:

* Full set of vital signs and a pulse oximetry reading. Result must be within normal limits for the patient.

* Reassessment of the patient's neurological, cardiac, and respiratory systems will be done and be within normal limits for the patient.

Review of Patient 42's medical record was initiated on 1/12/15. The patient was admitted to the hospital on 1/1/15 at 1227 hours, discharged on 1/8/15 at 1730 hours, and readmitted to the hospital on 1/9/15.

The ED Adult VS & Pain Assessment dated 1/1/15 at 1143 hours, showed Patient 42's oxygen saturation level was 95% on room air.

The Hospitalist Progress Note dated 1/8/14 at 1321 hours, showed Patient 42 had acute respiratory failure. The patient had early pulmonary edema likely secondary to fluid overload and the plans were to discontinue the IV fluids and administer Lasix (diuretic) one time.

The Physical Assessment Telemetry dated 1/8/15 at 1446 hours, showed Patient 42's oxygen saturation level was 94% with oxygen at three liters per minute via nasal cannula.

The Physical Assessment Telemetry dated 1/8/15 at 1545 hours, showed the patient's oxygen saturation level was 85% on room air and the patient was at rest.

The Event/Shift/Hand-Off dated 1/8/15 at 1545 hours, showed Patient 42's oxygen saturation level had decreased to 93% when the patient was at rest and received oxygen at 3.5 liters per minute via nasal cannula. The patient' oxygen saturation levels were "85% - 86%" on room air. The physician was called. The case manager was informed for home oxygen.

The Vital Signs record dated 1/8/15 at 1606 hours, showed Patient 42's oxygen saturation level was 94%. However, there was no documented evidence to show whether the patient received oxygen at that time.

The Discharge Checklist Adult dated 1/8/15 at 1720 hours, showed the section for Physical Assessment Completed Prior to Discharge Per Policy was filled in with "Yes."

Further review of the medical record showed the patient was discharged at 1730 hours. However, there was no documented evidence to show nursing staff had assessed the patient's neurological, cardiac, and respiratory systems within two hours prior to discharging the patient as per the hospital's P&P.

During an interview and concurrent medical record review with the QA Analyst on 1/15/15 at 1040 hours, the QA Analyst confirmed the finding.


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2. The hospital's P&P titled Pain Management effective 7/1/12, indicated a pain score of 7-10 (with 0 = no pain and 10 = worst pain) is considered as severe pain. Reassessment of pain level should occur within an hour of the medication administration and periodically to determine if the pain medication was effective. Reassessments may be guided by the onset and duration of action of the medications used.

Review of the medical record of Patient 37 was conducted on 1/12/15, and showed the patient came to the ED on 12/23/14. During a triage assessment at 0622 hours, the patient reported a pain level of 10. At 0721 hours, the nurse administered Dilaudid (opioid analgesic) and Toradol (opioid analgesic) via IV for a continued pain level of 10. The next pain assessment was documented at 0723 hours, two minutes after the IV pain medications were administered, and showed the patient's pain level was 10. The follow-up pain assessment was not completed until 1020 hours, nearly three hours later, and showed the patient's pain level was 7.

During a concurrent interview with RN 19, he stated no additional pain assessments were completed prior to the 1020 hours reassessment. He stated the 0723 hours assessment, two minutes after the medications were administered, was too soon to evaluate the effectiveness of the administered pain medications. The patient was not reassessed in a timely manner to determine the effectiveness of the pain medication.

Based on observation, interview, and medical record review, the hospital failed to ensure nursing staff developed a specific care plan to address the care needs for positive influenza and/or droplet precautions for one of 29 sampled patients (Patient 42). This created the risk of not providing appropriate, consistent, and quality care to this patient.

Findings:

During an observation on 1/12/15 at 1530 hours, Patient 42 was observed staying in a room with droplet precautions.

Review of Patient 42's medical record was initiated on 1/12/15. The patient was readmitted to the hospital on 1/9/15.

The History & Physical Report dictated on 1/10/15 at 0932 hours, showed Patient 42 was readmitted one day after discharge from the hospital. The patient's influenza screen showed a positive result for influenza virus type A.

However, review of the Patient's Plan of Care-General Medical failed to show a care plan was developed to address the patient's care needs related to influenza and droplet precautions.

An interview and concurrent medical record review was conducted with RN 11 and the Nurse Manager Med/Surg on 1/12/15 at 1530 hours. RN 11 stated Patient 42 was placed on droplet precautions for a positive influenza. When asked, RN 11 was unable to find documented evidence to show a care plan was developed to address the patient's care needs related to influenza and droplet precautions.

Based on observation, interview, and record review, the hospital failed to ensure an active IC program to prevent the spread of infections in accordance with the hospital's P&P and nationally recognized infection control practices and guidelines as evidenced by:

The hospital failed to implement and maintain the IC program related to PPE, equipment and surgical service areas cleaning, the use of indwelling urinary catheter, negative pressure monitoring for airborne isolation room, reuse of the single use patient care items, hand hygiene, a system to track, investigate, and analyze the identified SSIs and CAUTIs, and employee and medical staff immunizations. Cross reference to A749.
The cumulative effect of these systemic failures resulted in the hospital's inability to provide quality healthcare in a safe environment.

Based on observation, interview, and record review, the hospital failed to implement and maintain the IC program as evidenced by:

1. One of the physicians (MD 6) did not utilize a personal facial protective equipment during the procedure.

2. Two staff were observed wearing an isolation gown in the hallway.

3. The OR RNs were not inserviced on how to properly document the sterilization logs.

4. The equipment were not thoroughly cleaned. The sterilizer doors were dusty. The two IV pumps readily for use had multiple black spots.

5. The hospital staff failed failed to properly clean the surgical service areas of the two hospital campuses and outpatient GI center.

6. The hospital failed to ensure the necessity for the use of an indwelling urinary catheter for Patient 40 to prevent UTI.

7. Negative pressure monitoring was not performed daily when the room was occupied by Patient 38 who was on airborne precautions as per the hospital's P&P.

8. There was no documented evidence EVS 2 was screened or offered the tetanus (bacterial disease), diphtheria (bacteria infection) and pertussis (whooping cough) vaccinations as per the hospital's P&P.

9. The hospital failed to ensure the single use patient care items were not reused for another patient. The IC program failed to investigate the incident involving Patient 49 related to reuse of single use patient care items and possible blood exposure.

10. The hospital's staff failed to perform hand hygiene as per the hospital's P&P. The IC program failed ensure hand hygiene audits were performed by trained staff for the pre-procedure and post-procedure care areas at the outpatient GI center.

11. The IC program failed to develop a system to track, investigate, and analyze the identified SSIs and CAUTIs to minimize infections and improve patient care.

12. The hospital failed to ensure the influenza vaccination, or declination was applied to each member of the medical staff annually.

These failures created the increased risk of spreading infections and diseases throughout the hospital.

Findings:

1. The hospital's P&P titled Personal Protective Equipment - Endoscopy Lab dated 12/10/12, showed mask and goggles, or a facial shield should be used during patient care activities that are likely to generate splashes and sprays of blood , body fluids, secretions, or excretions.

On 1/12/15 at 1140 hours, MD 6 was observed performing a colonoscopy procedure for a patient in the outpatient GI lab at the main hospital. There was no documented evidence MD 6 utilized a personal facial protective equipment during the procedure.

2. On 1/12/15 at 1557 hours, the engineering staff was observed wearing an isolation gown walking in the hospital hallway. During a concurrent interview with the engineering staff, he stated he was working on the surgical service area. He was on his way to get a tool from the engineer department and return to the surgical service area.

Two minutes later, the respiratory therapist was observed wearing an isolation gown and shoe covers walking in the hallway of the telemetry unit. During a concurrent interview, he stated he responded to an emergency situation and the emergency was canceled.

3. On 1/12/15, the IUSS logs were reviewed with the Lead SPD Tech. The following was identified:

a. The log for sterilizer #19 showed on 1/1/15, the load # 010104 was crossed out and replaced with "4" and a staff's initial.

b. The log for sterilizer #17 showed on 1/1/15, a load # documented was illegible. The load number was crossed out and replaced with "4" and a staff's initial.

On 1/12/15 at 1440 hours, during an interview, the SPD Supervisor stated the above documentations (a and b) were documented by the OR RNs for two IUSS loads on 1/1/15. The documentation for the load numbers were not consistent with how the SPD staff would document on the log sheets. Therefore, the SPD staff had made the corrections on the log sheets by crossing out the original entries. During a concurrent interview with the OR Educator, she stated the hospital was aware of the sterilization log documentation problems that were cited during the last CMS survey. She had a plan to provide inservices to the OR RNs, but she had not done so.

4. On 1/13/15 at 1050 hours, two decontamination rooms between ORs were observed. The OR staff were observed going to the substerile area to get supplies and returning to the OR multiple times. Two sterilizers #17 and #19 were observed to have visible dust on the sterilizer doors. During a concurrent interview, the Lead SPD Tech stated the SPD staff were responsible for cleaning the sterilizers.

In the substerile room next to OR 2, two IV infusion pumps were observed with multiple black spots. These IV infusion pumps were ready for use. According to the Perioperative Director, those infusion pumps were disinfected by the Central Department and distributed to the OR for use. The Perioperative Director stated these black spots were adhesive tape residues from the previous uses.


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5. The hospital staff failed to properly clean the surgical service areas as follows:

a. The hospital's P&P titled Cleaning of Operative Procedure Areas effective date 12/8/14, showed Sanimaster 4 (disinfectant) or OxyCide (disinfectant) may be used for cleaning. Horizontal surfaces, equipment, examination table, and other items used during a procedure are cleaned between the patients.

The hospital's P&P titled Bio-Hazard Spill Clean Up effective 1/1/12, showed the medical waste is bio-hazardous waste containing blood and or body fluids, or any other infectious agent. The clean up for bio-hazardous waste includes the following:

* Restrict access to the spill area.

* Soak up any liquid with absorbent bead, or disposable towels. Place saturated materials in a red bio-hazard bag.

* Sanitize the affected area with Sanimaster 4 by diluting the disinfectant one ounce per gallon. Sanitizing may be accomplished through wet mopping of the area or by sanitizing with a cloth thoroughly moistened with the Sanimaster 4 solution. Contact time is 10 minutes.

Review of the manufacturer's instructions for use of OxyCide showed contact time for the use of OxyCide was three to five minutes.

During an observation of OR 6 at Laguna Beach campus on 1/12/15 at 1440 hours, accompanied by the Director Nursing Administrative, EVS 2 was observed cleaning OR 6. The following was identified:

* Two blood spill areas were observed on the OR floor. EVS 2 was observed wearing gloves and shoes covers, using a towel to clean the head lamps, putting the towel over the blood spill area, stepping on the towel, using his feet to rub the blood spill area with the towel, picking up the towel, and putting it into the hamper. He repeated the same steps when cleaning another blood spill area. He did not change his shoe covers and continue to clean the OR. EVS 2 failed to clean the blood spill areas as per the hospital's P&P.

* EVS 2 was observed holding a new dry towel and spraying the dry towel with OxyCide solution. Then he was observed using the same towel to clean the OR pad, OR table frame, monitor cable, anesthesia cart, monitor, C-arm machine, surgical carts, IV pole, computer keyboard, two Stryker machines (a surgical equipment), and telephone. The surfaces of these items were wet less than one minute.

* EVS 2 did not change the gloves or wash his hands when completing the tasks that had contaminated the gloves. For example, EVS 2 was observed pushing the overflowed trash items down into the trash bag. Then he brought the trash bag outside of the OR and returned to the OR. He did not change gloves or wash his hands.

* After EVS 2 removing the gloves, he did not wash or sanitize his hands. For example, EVS 2 was observed removing the gloves after mopping the floor. He did not wash his hands, then was observed holding a new pillow case, putting a pillow into the pillow case, and placing it on the OR table.

In a concurrent interview with EVS 2, he stated he used OxyCide solution for cleaning. The wet contact time was five minutes.

The Director Nursing Administrative confirmed the above findings. She stated the blood spills on the floor should be contained. She confirmed EVS 2 had stepped on the blood areas and moved around the room without changing his shoe covers while cleaning and mopping the floor. She confirmed the EVS did not change gloves and wash his hands when he needed to do so. She confirmed the surfaces of the patient care equipment were not wet for five minutes during cleaning as per the manufacturer's recommendations.

b. During an observation of OR 2 at the main hospital on 1/13/15 at 1057 hours, an oxygen saturation sensor was observed on the floor. There were visible blood stains on the floor. The EVS staff was observed mopping the floor and the dirty mopping pad went over the oxygen saturation sensor on the floor multiple times. The ST was observed picking up the oxygen saturation sensor and wiping it with a Sani-wipe (disinfection wipe). Then he was observed using the same Sani-wipe to disinfect the anesthesia VS monitor and other patient care equipment. This observation was confirmed with the PI Staff 1.

c. The contracted cleaning service document for the outpatient GI center read, "All Surgery floors must be cleaned on a daily basis."

During an observation of GI procedure room 2 at the outpatient GI center on 1/12/15 at 1050, the floor of GI procedure room 2 was observed to have a layer of dark material covering an 8 feet by 3 feet segment of flooring in front of the GI equipment. A moist Sani-wipe was used to remove the material, and it was easily removed with two quick wipes.

During a concurrent interview with IP Consultant 1, she concurred there was visible dark material the floor, and it could be easily removed with the moist wipes.

During an interview with the GI Center Manager on 1/12/15 at 1055 hours, she stated the floors were to be mopped each night. She stated the cleaning crew completed the audit forms to show the areas had been cleaned. She reviewed the OR Terminal Cleaning Log forms and stated the cleaning contractor had not completed the forms previous workday. She further stated the nurses also completed an audit form in the morning.

The audit form, Surgical Suites Terminal Cleaning Quality Inspection, for 1/12/15, completed by RN 15, showed all areas were inspected and the box for "met" was checked for each one. For item 13 of the audit form, "Floor (corners/edges) free from dust/soil", showed the box for "met" was checked.

During an interview with RN 15 on 1/12/15 at 1100 hours, she stated she completed the audit form in the morning of 1/12/15. She stated she indicated the floor was free from dust and soil because her impression of soil was bio-hazardous waste, such as blood, not dirt from foot traffic. She concurred the floor of GI procedure room 2 did not appear to have been mopped.

6. The hospital's P&P titled Urinary (Indwelling) Catheter Guideline effective date 5/1/14, showed the following:

* Criteria for the use of an indwelling urinary catheter included strict intake and output monitoring, urinary retention, post surgery, incontinence that impairs healing on coccyx or sacrum, and comfort care. Urinary retention is an inability to void due to urinary obstruction/retention or when intermittent catheterization is difficult; patient who is chemically paralyzed.

* The plan is to reassess continued need for indwelling catheter every shift, using the above criteria.

* If patient does not meet criteria for having catheter, discuss discontinuation with the physician.

* Assess if the patient's elimination needs can be managed by an alternative method.

* Discontinuation of an indwelling urinary catheter may be performed by a RN without a physician's order when a patient is no longer meets criteria for an indwelling catheter. A physician's order is required for discontinuation of an indwelling urinary catheter placed for purpose of any pathology or surgery related to the genitourinary system and/or pelvic fractures.

Review of Patient 40's medical record was initiated on 1/12/15. The patient was admitted to the hospital 12/7/14, discharged to the BHU on 1/7/14, and readmitted to the ICU on 1/8/15, and transferred to the medical/surgical floor on 1/9/15 at 1915 hours.

The physician's order dated 1/8/15 at 1417 hours, showed an order to insert an indwelling urinary catheter to gravity due to inability to void, urinary retention, and restriction of intake and output.

Review of the Urinary Catheter to Gravity form dated 1/8/15 at 1852 hours, showed the indwelling urinary catheter was inserted on 1/8/15. The criteria for the use of the indwelling urinary catheter was "inability to void." The amount of urine output was 65 ml.

The physician's order dated 1/9/15 at 1713 hours, showed an order to transfer the patient to the medical/surgical with telemetry.

The Transfer Patient form dated 1/9/15 at 1915 hours, showed Patient 40 was transferred from the ICU to medical/surgical floor.

The Urinary Catheter Assessment-Indwelling forms dated 1/9/15 at 0800 hours, 1/10/15 at 1207 hours and 2200 hours, 1/11/15 at 0930 hours and at 2115 hours, and 1/12/15 at 0830 hours, showed the indwelling urinary catheter was inserted on 1/8/15. The criteria for the use of indwelling urinary catheter was "inability to void", "strict intake and output," and "urinary retention." The document showed the patient was assessed for the indwelling catheter removal. However, there was no documented evidence the assessment was completed and the indwelling urinary catheter was removed.

The Hospitalist Progress Notes dated 1/9/15 at 1342 hours, 1/10/15 at 0354 hours, and 1/11/15 at 1528 hours, showed Patient 40 denied inability to void. There was no documented evidence to show the physician had reevaluated the necessity to use the indwelling urinary catheter for the patient since the indwelling urinary catheter was inserted on 1/8/15.

Further review of the medical record showed no documented evidence to show how Patient 40's ability to void was being assessed. There was no documented evidence to show the physician had ordered to continue the use of the indwelling urinary catheter or strict intake and output monitoring on the medical/surgical unit.

On 1/12/15, the patient was on the medical/surgical unit and observed to have the indwelling urinary catheter in place.

An interview and concurrent medical record review was conducted with the Nurse Manager Med/Surg and RN 11 on 1/12/15 at 1325 hours. The Nurse Manager stated a new set of physician's order should be obtained when the patient transferred from the ICU to the medical/surgical unit, including the use of an indwelling urinary catheter and strict intake and output monitoring. When asked, they were unable to find documented evidence to show the physician had ordered to continue the use of indwelling urinary catheter and strict intake and output monitoring.

The Nurse Manager Med/Surg and RN 11 were asked how to assess the patient for inability to void or urinary retention. The Nurse Manager stated an indwelling urinary catheter would be discontinued and the patient would be monitored for voiding. If the patient was unable to void, a straight catheterization would be performed on the patient. When asked, RN 11 stated Patient 40 had the indwelling urinary catheter since 1/8/15. When asked, the Nurse Manager Med/Surg and RN 11 were unable to find documented evidence to show the indwelling urinary catheter was discontinued to assess the patient's ability to void since 1/8/15. When asked, they were unable to find documented evidence to show the physician had reviewed the necessity of the use of an indwelling urinary catheter for the patient since the indwelling urinary catheter was inserted on 1/8/15.

The hospital failed to ensure the necessity use of indwelling urinary catheter for Patient 40 to prevent urinary tract infection.

7. The hospital's P&P titled Aerosol Transmissible Disease Exposure Control Plan dated 7/1/13, showed negative pressure monitoring is performed by the facility department of the hospital daily while the room is occupied by an AirID patient. AirID was defined as an aerosol transmissible disease transmitted through dissemination of airborne droplet nuclei, small particle aerosols, or dust particles containing the disease agent for which all is recommended by the CDC or CDPH.

During an observation on 1/13/15 at 0940 hours, Patient 38 was observed staying in Room A with airborne precautions.

Review of Patient 38's medical record was initiated on 1/13/15. The patient was admitted to the hospital on 12/29/14.

The Infectious Disease Progress Notes dated 1/9/15 at 1815 hours, 1/10/15 at 1434 hours, 1/11/15 at 1102 hours, and 1/12/15 at 1434 hours, showed a recommendation to continue airborne and contact isolation.

Review of the electronic summary of Patient 38's isolation precaution records from 12/30/14 at 0113 hours through 1/13/15 at 2000 hours, showed the following:

* On 1/9/14 at 1900 hours, Patient 38 was on standard precautions.

* On 1/10/15 at 0827 hours and 2000 hours, and 1/11/15 at 0903 hours and 2000 hours, Patient 38 was on airborne and contact precautions.

During an interview and concurrent document review with the Assistant Director Facilities on 1/13/14 at 1030 hours, the Assistant Director Facilities stated the negative pressure room would be monitored for negative pressure every shift or three times a day.

On 1/13/14 at 1040 hours, the Assistant Director Facilities provided documents showing Room A was monitored for negative pressure on 1/12 and 1/13/14. The Assistant Director Facilities confirmed there was no documented evidence to show Room A was monitored for negative pressure on 1/9, 1/10, and 1/11/15.

8. The hospital's P&P titled Vaccinations effective date 1/1/12, showed Occupational Health will offer vaccinations to all susceptible employees with potential for occupational exposure to diphtheria and pertussis. Employees, who decline to accept a recommended and offered vaccination, shall sign the declination form for each declined vaccine. Tetanus, diphtheria, and pertussis vaccinations will be administered once per adult lifetime per the CDC's recommendations. An interval of two years or more since the most recent tetanus toxoid containing vaccine is recommended.

Review of EVS 2's personnel file was conducted on 1/14/15 at 1400 hours, with the Occupational Health nurse. The EVS 2's date of hire was 7/1/09. When asked, the Occupational Health nurse was unable to find documented evidence to show EVS 2 was screened, offered, or declined the tetanus, diphtheria, and pertussis vaccinations.


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9. The hospital failed to ensure the used single use patient care items were not reused for another patient. The IC program failed to investigate the incident involving Patient 49 related to reuse of single use patient care items and possible blood exposure. Cross reference to A286, example #1.

10. The Infection Prevention Program Plan FY 2015 effective 1/5/15, read in part, the scope of the IP program addresses all services and sites of care in the organization. It includes surveillance, prevention, and control of infections in patients, visitors, staff, healthcare providers, volunteers, contract personnel, and students within the organization.

The hospital's Infection Prevention Program Plan - Annual Review showed hand hygiene had been identified as a prioritized risk due to the lack of compliance, posing a risk of transmission of pathogens to patients and staff.

The hospital's P&P titled Hand Hygiene effective 12/10/14, read in part, "All personnel are expected to implement appropriate hand hygiene practices on a consistent basis.", "Hand hygiene requirements apply to all care settings and services.", and "Indications for handwashing or hand antisepsis: 1. Entering and exiting a patient's room." In addition, the P&P showed staff should perform hand hygiene or hand antisepsis after removing gloves.

* During an observation in the GI lab of the hospital on 1/12/15 at 1100 hours, MD 6 was observed removing gloves after a colonoscopy procedure. There was no hand hygiene observed by MD 6. This finding was confirmed with the QA Analyst.

* The Progressive Care Stroke Unit was toured with RN 22, the Co-Leader of the QUEST program, and the Performance Improvement Analyst on 1/12/15 at 1115 hours. A hospital staff was observed exiting a patient room. The staff wore gloves on both hands, walked to the nurses' station, removed the gloves, put them in the trash, and then exited the station. This staff did not use the hand wash sink at the station or use hand gel to sanitize his hands. When asked for the identity of the staff, RN 22 stated he was a physician.

* During an observation in the pre-procedure area of the outpatient GI center on 1/12/15 at 1125 hours, one of the GI physicians was observed touching the patient's gown while speaking with the patient seated in the pre-procedure area. He subsequently left the room, went down the hallway, opened a door, and went into another area. He was not observed performing hand hygiene after patient contact.

* EVS 2 did not performed hand hygiene after contaminating and removing the gloves when cleaning OR 6 at Laguna campus on 1/12/15 at 1440 hours.

During a concurrent interview with IP Consultant 1, she stated the physician should use hand sanitizer or wash hands when leaving the room after patient contact.

During an interview with RN 15 on 1/12/15 at 1050 hours, she was asked about hand hygiene audits at the outpatient GI center. She stated the nurses performed hand hygiene audits for staff coming in and out of the two procedure rooms but not in the pre-procedure and post-procedure areas. She stated no one was to do the audits. She stated she was trained to do the audits but had assigned other nurses to do the audits.

During an interview with IP Consultant 2 on 1/13/15 at 1315, he stated they had not specified the details as to where the observations would take place.

During an interview with IP Consultant 1 on 1/13/15 at 1318, she stated there was a video from the CDC for the nurses performing hand hygiene to watch by the end of December 2014. She stated all of the observers were to be trained and the observations were to be validated.

In an interview with the Director of QA on 1/13/15 at 1320, she stated it had not been validated that everyone performing hand hygiene audits had watched the video.

The hospital's staff failed to perform hand hygiene as per the hospital's P&P. The IC program failed ensure hand hygiene audits at the outpatient GI center was performed by trained staff and were performed in the pre-procedure and post-procedure care areas.

11. The hospital Infection Prevention Program Plan FY 2015 effective 1/5/15, read in part, "The scope of the infection prevention program addresses all services and sites of care in the organization. It includes surveillance, prevention and control of infections in patients, visitors, staff, healthcare providers, volunteers, contract personnel, and students within the organization.", "Surveillance of hospital acquired infections and community acquired infections is performed under the direction of the Infection Prevention Committee.", and "Surveillance data will be analyzed appropriately and used to monitor and improve infection prevention, control and healthcare outcomes."

a. Review of the email sent by IP RN 2 to RN 20 dated 1/14/15, showed the list of SSIs determined by the IP nurse on 1/14/15. The list contained data regarding seven infections that occurred between 10/19 and 12/15/14. Three of the SSIs were shaded with a note indicating these SSIs had not had the department investigation forms, "Review of Surgical Site Infection", completed.

Review of the SSI department investigation forms showed spaces for documenting the peri-operative circumstances that could have contributed to an infection, including the use of antibiotics peri-operatively, whether the patient was normothermic (normal temperature) and whether loaned surgical instruments were used in the case.

During an interview with IP RN 1 on 1/13/15 at 1350 hours, she stated when a possible SSI was identified, the department investigation forms were sent to the OR Director and Manager at the main campus and the OR Director at the Laguna Beach campus to complete. She stated there was no policy addressing how to complete the department investigation forms.

During an interview with MD 1 on 1/14/15 at 0850 hours, he stated it was left to the OR staff and the surgeon to investigate the SSIs. The IP Department would investigate if there was a commonality found. He stated he believed the IP Department's job was to call the infection to the attention of the surgeon and OR Staff.

During an interview with the Director of Peri-Op on 1/14/15 at 0915 hours, she stated she sent the department investigation forms to the Clinical Coordinator nurses who were overseeing the OR service lines. She stated there was no policy addressing how to investigate a SSI and there was no documentation of training for the nurses to complete the investigation form. She stated she assumed the IP Department would look at the issues related to anesthesia, such as the administration of peri-operative antibiotics as she did not have access to the anesthesiologists' records. She stated she did not have a range of temperatures that constituted normothermia temperatures but thought the item on the investigative form was referred to the patient temperatures in the pre-operative through PACU areas. She stated generally the Clinical Coordinator would go through the sterilizer logs for loaner instruments, but the information about whether this step occurred was not documented.

b. During an interview with IP RN 1 on 1/13/15 at 1350 hours, she stated there were no logs to keep track when the department investigation forms were sent out or returned.

During an interview with the Director of QA on 1/13/15 at 1405 hours, she stated the department investigation forms were to be reviewed and revised. She stated some department investigation forms completed by the peri-operative staff were not put into the database. During a second interview with the Director of QA on 1/14/15 at 0930 hours, she stated they needed to establish a turnaround time for the SSI department investigation forms.

During an interview with the Director of Peri-Op on 1/14/15 at 0915 hours, she stated she expected the investigation forms to be returned in 48 hours. She stated she scanned the completed investigation forms to the IP Department. She stated she assumed the Laguna Beach campus would return the investigation forms promptly as well. She stated the department investigation forms for the infection cases identified in October and November 2014, were completed by the nurses but not returned to her. In addition, she said the department investigation forms were sent to the Nurse Managers on 12/16/14, for the identified infections from 11/17/14 to 12/9/14. However, the department investigation forms had not been returned. She stated there was no tracking system for these investigation forms. There was a possibility that the investigation forms had been sent back, but she did not know.

During an interview with MD 1 on 1/14/15 at 0900 hours, he stated the hospital had not used the collected data to determine the risks that could contribute to the SSIs. He stated the SSIs were last entered into the database on 9/25/14.

c. Patient 59's CAUTI was not investigated. There was no system in place to track the department investigation forms for CAUTIs. There was no policy addressing the CAUTIs investigation. Cross reference to A273, example #3.

The IC program failed to develop a system to track, investigate, and analyze the identified SSIs and CAUTIs to minimize infections and improve patient care.

12. The hospital's P&P titled Influenza: Seasonal Influenza Plan effective 8/26/14, read "Healthcare workers: a. Inactivated or attenuated vaccine is used for vaccination of healthcare workers." and "Influenza vaccine is offered free of charge to all employees, volunteers, physicians and students."

The CDC's guidelines for immunizations of health care workers showed the following:

* "Healthcare workers include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff."

* "...recommends that health care providers receive vaccinations for diseases for which routine vaccination or documentation of immunity is recommended because of risks in the workplace (i.e. hepatitis B, seasonal influenza, measles, mumps, rubella, pertussis, and varicella)."

* "Healthcare organizations should review health care provider vaccination and immunity status at the time of hire and at least annually thereafter."

The credential files of four physicians were reviewed with the Medical Staff Coordinator on 1/14/15 at 1340 hours.

For two physicians (MDs 7 and 8), there was no documented evidence to show the physicians either received a flu vaccine or signed a declination of influenza vaccination.

The Staff Coordinator stated the hospital did not have a policy as yet to require the medical staff to either receive a flu vaccination or to sign a declination. The Staff Coordinator stated they were working on a policy; however, the policy would not be effective until the next flu season.

The hospital did not ensure the influenza vaccination, or declination was applied to each member of the medical staff annually.

Based on observation, interview, and record review, the hospital failed to ensure a RN continuously monitored a patient and documented the patient's CO2 during the administration of conscious sedation, creating the risk of substandard healthcare outcomes to the patients in the hospital.

Findings:
According to the California Board of Registered Nursing for Conscious Sedation, the RN must be competent to perform the function, and the function must be performed in a manner consistent with the standard of practice. The RN would be held accountable for knowledge of the medication and for ensuring the proper safety measures are followed. 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 registered nurse. RN functions as described in this policy may not be assigned to unlicensed assistive personnel.

The hospital's P&P titled Moderate/Deep/Dissociative Sedation/Analgesia Administration for Non Anesthesia Providers reviewed 3/12, showed all patients receiving conscious (moderate) sedation will receive a comparable standard of care and be monitored by appropriately qualified personnel throughout the medical center. The equipment in the procedure room includes a CO2 monitoring equipment. The requirements for the number of qualified individuals for moderate sedation requires physician , RN and provisions for additional personnel must be made appropriate to the procedure. During the procedure, the RN should monitor continuously the patient after the administration of the agents, which include to monitor the CO2 to maintain CO2 at 35-45 Torr or within 10 Torr of baseline and complete the documentation as outlined on the Moderate/Deep Sedation Assessment and Monitoring Record.

On 1/12/15 at 1028 to 1100 hours, a VS monitor was observed to be located at the end of the patient's gurney. RN 10 was providing patient care in the outpatient GI lab Room 2. The RN was observed administering versed (sedative medication) and fentanyl (potent pain medication) to a patient via peripheral IV, monitoring, and recording the VS. The RN also assisted with positioning of the patient per the physician's request and filled out the lab requisites for pathology. The VS monitor and the CO2 alarm reading were flashing and showed "47" when the RN was standing at the back of the VS monitor. There were no interventions taken immediately.

At 1205 hours, RN 10 was interviewed. RN 10 stated CO2 was one of the vital signs he monitored during the patient's conscious sedation, and the normal CO2 reading was 25-45 Torr. RN 10 was not aware of the CO2 alarm went off because he was standing at the back of the VS monitor. Review of the documentation for Procedure Monitoring (every 15 minutes and PRN) after the procedure was terminated showed the patient's CO2 documented at the start time was 25 Torr. The documentation throughout the procedure showed "47" had not been documented in the record.

In an interview with the Manager of Heritage Endoscopy Center on 1/12/15 at 1210 hours, she stated the staffing for GI lab was one RN in the procedural room to conduct patient services for conscious sedation and circulating nurse.



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Based on interview and record review, the hospital failed to ensure the H&P examinations were complete within 30 days of the admission for two of 29 sampled patients (Patients 34 and 35), creating the risk of substandard health outcomes to these patients.

Findings:

1. The Medical Staff Bylaws dated 11/17/14, read on page 14, "Assure prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies, a medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration."

The Medical Staff Policies and Procedures, Medical Record Documentation dated 10/9/13, showed the H&P is to include a chief complaint, relevant past, family and social history, all pertinent findings resulting from an assessment of all the systems of the body, a thorough physical examination, an admitting diagnosis, and a statement for the course of action planned for the patient while in the hospital.

The medical record of Patient 35 was reviewed on 1/12/15, and showed the patient came to the GI center on 1/7/15, for a colonoscopy with multiple biopsies. The record contained a 2 ½ page typed comprehensive H&P examination dated 11/19/14, 54 days prior to the procedure date. The record also contained a Short Form History and Physical Examination dated 1/7/15, but that document omitted most the of patient's medical history, review of systems, surgical history, family and social history, and medications.

In an interview with the CMO on 1/13/15 at 1030, she concurred the 1/7/15 H&P examination was incomplete and the 11/19/14 H&P examination was completed more than 30 days prior to the date of the procedure.


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2. The hospital P&P titled Moderate/Deep/Dissociative Sedation/Analgesia Administration for Non Anesthesia Providers reviewed 3/12, showed all patients receiving conscious (moderate) sedation will receive a comparable standard of care and be monitored by appropriately qualified personnel throughout the medical center. The equipment in the procedure room include a CO2 monitoring equipment. The requirements for the number of qualified individuals for moderate sedation include the physician to complete the Pre-Moderate/Deep/Dissociative Sedation Patient Evaluation. The Physician should complete a H&P assessment to include heart, lung, and airway assessment with ASA scores relevant to the patient's diagnosis, condition, and proposed procedure prior to the procedure. An interval note within 24 hours prior to the procedure identifying any changes is to be completed by the physician performing the procedure.

On 1/12/15 at 1057 hours, during an interview with Patient 34, the patient stated he was deaf to the right ear and asked the surveyor spoke to his left ear. In addition, the patient stated he had two times of the colonoscopy examinations and polyps were removed in the past, and this was his third time follow-up colonoscopy examination. The patient also stated he had asthma and used inhaler daily.

During the time out observation of the procedure on 1/12/15 at 1140 hours, the patient was confirmed to be allergic to sulfa drugs and levaquin (antibiotic medication). The patient stated Levaquin could make his throat close up.

Patient 34's medical record review was initiated on 1/12/15 at 1204 hours. The H&P signed by MD 6 on 9/2/14, showed the patient was screened for colonoscopy. The past surgical procedure was not included. The examination for ears showed no change of hearing. The patient's allergies were not documented in the H&P. MD 6 updated and signed this H&P at 1/12/15 at 1020 hours, to indicate "I have reviewed the H&P and examinated the patient. There are no changes from the H&P (9/2/14)."

Review of the Pre-sedation Physician Assessment dated 1/12/15, showed the patient was evaluated utilizing ASA scores and it was appropriate to administer planned moderate sedation. The assessment for ASA classification boxes for both classes I and II was checked (ASA class I: no organic, physiologic, biochemical, or psychiatric disturbance, normal healthy patient and class II: mid-moderate systemic disturbance, may or may not be related to reason for surgery). The assessment for Mallampati classification (used to predict the ease of intubation, it assesses the height of the mouth, the distance from the tongue base to the roof of the mouth to determine the space to work on), showed the box for both classes I and II were checked. The assessment for skin color, oxygen, bowel sounds, and difficulty swallowing were left blank.

On 1/12/15 at 1210 hours, MD 6 was interviewed. MD 6 crossed out the ASA class I and stated the patient should be ASA class II. The above findings were confirmed with QA Analyst at 1210 hours.