HospitalInspections.org

Based on interview and record review, the facility did not ensure that grievances were promptly investigated for three of three complainants (Patients 53, 54 and 55), creating the risk of unresolved grievances for those three patients, the risk of unrecognized poor practices, and the risk of substandard healthcare for all patients using the facility.

Findings:

1. The grievance of Patient 55 was reviewed on January 17, 2012, with the DCQI. The complaint contained multiple allegations, including allegations about being asked to sign a consent while already sedated, vital signs not taken as frequently as required after the procedure, and that the physician's behavior was substandard.

During a review of the medical record of Patient 55 on January 19, 2012, at 10 a.m., there were orders for vital signs to be taken each 15 minutes x 2, then each 30 minutes x 2. The record contained one set of post-operative vital signs at 11:57 (a.m.), and incomplete sets (just one parameter recorded) of vital signs at 12:04 (p.m.) and 15:54 (3:54 p.m.). The consent form was reviewed, and there was no time documented on it to indicate whether the consent was obtained prior or after sedation was administered.

During a concurrent interview with CQI Staff 1, she stated that she was unable to find documentation of the orders for vital signs being carried out.

CQI Staff 1 stated that after she investigated the grievance, she communicated to the DCQI verbally, but did not document the investigation.

During an interview with the DCQI on January 19, 2012, at 10:15 a.m., she stated that normally an investigation was completed and a synopsis was done in writing, but in this case it was not done in writing. She stated she did not remember CQI Staff 1 discussing the grievance investigation with her.

2. The grievance of Patient 53 from November 8, 2011, was reviewed on January 19, 2012, at 10:15 a.m., and contained allegations of inappropriate physician behavior towards the patient and towards the nurse, and the physician prescribing discharge medications to which the patient was allergic.

During a review of the grievance files with the DCQI on January 19, 2012, at 10:15 a.m., she stated that there was no documentation of an investigation of the grievance.

3. The grievance of Patient 54 from August 27, 2011, was reviewed on January 19, 2012, at 10:30 a.m., and contained allegations regarding physician and nurse communication and behavior.

During a concurrent review of the grievance files with the DCQI, she stated that the grievance was to have been investigated by a nurse manager who is on leave. She stated that she did not know if the grievance had been investigated. She concurred that the grievance was several months old.

The facility policy, "Management of Patient Complaints/Grievances, reviewed 9/10", indicated, "All attempts will be made to resolve patient grievances as soon as possible..." The policy further indicated, "Grievances shall be reviewed, investigated and resolved within a reasonable time frame."

Based on interview and record review, the facility failed to ensure that an effective system was in place to respond to all grievances. There was no functioning system to respond to grievances regarding the medical staff, creating the risk of unresolved grievances for all patients with complaints about the medical staff, and the risk of unrecognized poor practices and substandard healthcare for all patients using the facility.

Findings:

The grievance of Patients 53, 54, and 55, reviewed with the DCQI on January 17, 2012, contained allegations regarding physicians.

During an interview with the DCQI on January 19, 2012, at 9:30 a.m., she stated that the medical staff grievance investigation and response were not given oversight by the grievance committee, and that investigation and response to grievances about physicians were not being done in the medical staff area. She stated that the medical staff office does not have a formal grievance investigation and follow-up policy in place, and that investigation and response were not being done in the medical staff area.

During an interview with the PRD on January 20, 2012, at 8:35 a.m., she stated that there were not enough personnel available to handle the grievances, and that she was not receiving prompt cooperation when asking for help from facility staff in resolving grievances.

A review of the grievance files and medical staff document, including credential files and the medical staff grievance log, on January 17, 19, and 20, 2012, failed to show evidence that the grievances of Patients 53, 54, and 55 (see A118) were investigated and resolved.

The facility policy, "Management of Patient Complaints/Grievances, reviewed 9/10," indicated, "Patients have the right to register complaints without fear of retribution, to have their complaints investigated and resolved, and be provided with timely follow-up..." The policy further indicated, "The Governing Board has delegated responsibility of reviewing and resolving the grievances to a Grievance Committee composed of a multidisciplinary group to include Risk Management, Patient Safety Officer, Patient Relations, and ex-officio members as needed."

Based on interview and record review, for three of three grievances reviewed (Patients 53, 54, and 55), the facility failed to provide a written response to the complainant with information about the investigation and results of the process, creating the risk of unresolved grievances for those three complainants, and the risk of unrecognized poor practices and substandard healthcare for all patients using the facility.

Findings:

1. The grievance of Patient 53 was reviewed on January 19, 2012, at 10:15 a.m., and contained allegations of inappropriate physician behavior towards the patient and towards the nurse, and the physician prescribing discharge medications to which the patient was allergic.

During a review of the grievance files with the DCQI on January 19, 2012, at 10:15 a.m., she stated that there was no documentation of a response to the complainant regarding the grievance.

2. The grievance of Patient 54 from August 27, 2011, was reviewed on January 19, 2012, at 10:30 a.m., and contained allegations regarding physician and nurse communication and behavior.

During a concurrent review of the grievance files with the DCQI, she stated that the grievance was to have been investigated by a nurse manager who is on leave. She stated that she did not know if a response had been provided to the complainant. She stated that the facility's policy was to respond to the complainant within seven days.

3. During an interview with the DCQI on January 19, 2012, at 10 a.m., she stated that it was felt that the allegations regarding Patient 55 could not be substantiated, and the grievance was "closed out." She stated that usually a written response to the patient was provided, but there was a breakdown in the hospital process.

The facility policy, "Management of Patient Complaints/Grievances, reviewed 9/10," indicated, "All attempts will be made to resolve patient grievances as soon as possible..." The policy further indicated, "Grievances shall be reviewed, investigated and resolved within a reasonable time frame...The patient response shall be generated within a timeframe of 7 days from the receipt of the grievance."

Based on interview and record review, the facility:

1. Failed to ensure documentation regarding the benefits of a transfer from the ER to another facility for further medical care outweighed the risks of a transfer, for two of 66 sampled patients (Patients 48 and 49). this failure could lead to patient's inappropriate and/or uninformed transfer for two of 66 sampled patients (Patients 48 and 49), and

2. Failed to ensure the patient's representative (Patient 4) was provided information regarding the care planning and treatment of the patient in order to make an informed decision. This failure had the potential to result in the patient receiving care and/or treatment without weighing its risks and benefits.

Findings:

1a. A review of Patient 48's record was conducted. Patient 48 was transported by ambulance to the ER on July 20, 2011, with an altered level of consciousness at 12:22 a.m. At 7:20 a.m., the nursing re-assessment indicated the patient was alert and oriented to her name, place and date, and denied distress. Patient 48 was transferred to another facility at 8:28 p.m.

Further record review failed to show documentation that the medical benefits of the transfer versus the risks of the transfer were discussed with Patient 48.

b. A review of Patient 49's record was conducted. The patient presented to the ER on July 18, 2011, at 3:49 p.m., after being involved in an assault in which he sustained multiple fractures of the jaw. The patient was sedated due to combative behavior and intubated (mechanical support to assist with breathing).

Patient 49 was transferred to another facility on July 18, 2011, at 5:15 a.m. Further record review failed to show documentation that the medical benefits of the transfer outweighed the risks of transfer, as the patient continued to have an altered level of consciousness and was unable to consent to the transfer.

A review of the facility's policy, "Acceptance Of Patients: Acceptance Of Patients Transferred To Other Facilities: Acceptance Of Patients Transferred From Other Facilities, (Revised 3/09)," was conducted.

The policy indicated, "The hospital shall also send the patient's written certification that (i) all reasonable steps were taken to secure an informed consent, and (ii) that the medical benefits of the transfer outweigh the risks of transfer...The hospital shall also send a completed "Transfer Summary Form..."

An interview was conducted with the ER Director on January 18, 2012, at 2:15 p.m., who stated neither the Transfer Summary Form, or documentation that the benefits of the transfer from the ER to another facility outweigh the risks of a transfer was noted in the records of Patient 48 or Patient 49.



25338

2. On January 17, 2012, Patient 4's record was reviewed. Patient 4 was admitted to the NICU on January 12, 2012. The patient had a lumbar puncture (a procedure that is performed in order to collect a sample of the cerebrospinal fluid) and a blood transfusion on January 16, 2012.

Review of the form titled, "Consent to Surgery/Special Procedures/Anesthesia," dated and signed by Patient 4's parent was reviewed. The consent indicated, "Lumbar Puncture." The form had a section, "Physician Certification" that would certify that the physician had discussed the procedure with the patient or legal representative, including the risks and benefits of the procedure, and any other information about the procedure or surgery. The section did not have the date, time, and signature of the physician.

The form titled, "Blood Transfusion Information and Consent (with physician verification)," dated and signed by Patient 4's parent was reviewed. The consent had a section, "Physician Verification of Informed Consent" that would certify that the physician had provided information concerning the advantages, disadvantages, risks and benefits of the procedure. The section did not have the date, time, and signature of the physician.

On January 17, 2012, at 3:30 p.m., Patient 4's record was reviewed with the DNP, CNO, and CNS. The facility was not able to find documented evidence in Patient 4's record that the physician had discussed the lumbar puncture and blood transfusion procedures with the patient's responsible party (parent/s). The CNO stated there should have been documentation from the physician for both procedures.

The facility policy titled, "Informed Consent" revised May 2009, was reviewed. The policy indicated, "Informed Consent...Documenting Informed Consent...The physician is responsible for obtaining the informed consent and for documenting this discussion on the record..."

Based on observation, interview and record review, the facility failed to ensure a facility policy and an Interdisciplinary Plan of Care were implemented for one of 66 patients (Patient 43), who was placed into a canopy hospital bed system (a fully enclosed bed with netting, designed to keep a person within the boundaries of the bed). This failure had the potential to result in improper use of the bed and the potential of entrapment which can lead to serious injury or death for the patient.

Findings:

A tour and observation of the acute rehabilitation unit was conducted on January 19, 2012, at 11 a.m. Patient 43 was in his hospital room and observed lying within the confines of a Posey 8070, a canopy hospital bed system.

An interview was conducted with CN 1 on January 19, 2012, at 11:15 a.m., who stated the canopy bed was being used for Patient 43 as the patient attempts to get out of the bed and had a fall on the acute rehabilitation unit.

A review of Patient 43's record indicated the patient was admitted to the facility on December 17, 2011, with a diagnosis of a traumatic brain injury, and transferred to the acute rehabilitation unit on January 3, 2012.

A review of the "Physician Order Non-Violent/Non-Behavioral Restraint," document dated January 18, 2012, at 9 a.m., noted the indications for use of the canopy bed for Patient 43 as a restraint was because the patient was, "Unable to comprehend or follow directions to refrain from activities that can injure self. Observed trying to climb out of bed when instructed not to do so. Cognitively impaired. Will not ask for assistance. Disconnects and /or removes therapeutic devices."

A review of the Professional User Manual for the Posey Bed 8070 was conducted. The manual indicated, "Improper use of the Posey Bed may lead to serious injury or death. Patient monitoring should be established by hospital protocol and the patient's care plan. As with any less restrictive restraint system, it is important to be familiar with the indications for use, the contraindications for use and in particular, risks associated with entrapment, suffocation, choking, and falls."

An interview was conducted with the DCQI on January 19, 2012, at noon, who stated the facility does not have a policy for the use of the canopy bed system.

A review of Patient 43's "Care Plan," dated January 17, 2012, noted a problem as "Restraints" with one of the interventions indicated as, "Posey seclusion bed." Further record review failed to show specific interventions related to the patient's safety or care while the patient was in the confines of the bed to reduce the risk of entrapment and possible suffocation.

An interview was conducted with CN 1 on January 20, 2012, at 8:50 a.m., who stated there were no specific interventions reflected in the care plan for the use of the canopy bed system.

A review of the facility policy, "Interdisciplinary Plan Of Care Documentation, Reviewed Date: 05/11" was conducted.

The policy indicated, "To ensure that a plan of care is developed for each patient upon hospitalization that reflects that patient's needs based on the nursing assessment with contribution from other disciplines...The plan will take into account information about the patient's bio-psycho-social problems, interventions and evaluation of progress toward mutually established goals."

Based on interview and document review, the facility failed to analyze the quality indicator data related to the use of CPOE (Computerized Physician Order Entry) collected to monitor the effectiveness of the implementation of the CPOE.

Findings:

During an interview on January 17, 2012, at 3 p.m., the MSO stated that CPOE, hospital wide implementation of electronic mode of physician order entry, went live in August 23, 2011, hospital wide. The MSO stated that there were near misses and actual medication errors that occurred from the use of CPOE, but the information could be analyzed yet since the facility was still waiting for meaningful use data. The MSO stated she was the one compiling the data in charge of the medication errors occurring in the hospital, but was unable to provide documented evidence that data related to CPOE was captured, collected, analyzed, and trended.

During an interview on January 19, 2012, at 1 p.m., Dell Staff stated that they collected data related to CPOE, compiled the data, and presented it in the form of dashboard, such that quality department should be able to analyze the data. The facility was not able to provide documented evidence of the requested data.

During concurrent interview, the DOP acknowledged that work was continuing to increase the efficiency and ease of the use of the CPOE, and that the rollout of the CPOE could have been planned better and spending many hours tuning and fitting the CPOE to meet the needs of the hospital. The DOP further added that the facility did not know what to expect when it was rolled out and due to the complexity and the time-consuming process of entering orders in the CPOE system, the physicians refused to use it.

The DOP also stated that the compliance of CPOE was tracked by the number of orders entered via CPOE vs. manual paper order. The facility was able to provide the data for January 2012, and was not able to provide data for previous months.

During an interview on January 20, 2012, at 12:30 p.m., the DCQI stated that the hospital did not have the aggregated data in dashboard format that showed trends like other Performance Improvement projects yet.

The Facility was not able to provide documented evidence that any quality indicator data were tracked and trended to show the effectiveness of the implementation of the CPOE.



26881

During an interview with the DCQI on January 20, 2012, at 10 a.m., she stated the quality program does not have oversight of the information technology implementation at this time.

Based on interviews and record reviews, the quality assurance program failed to provide quality oversight for the facility's grievance process, creating the risk of a failed grievance process, the risk of unrecognized poor practices, and the risk of substandard healthcare for all patients using the facility.

Findings:

During a review of medical records and grievance files, the facility did not ensure that grievances were promptly investigated, and did not ensure written responses to the grievances for three of three grievances randomly selected for review (Patients 53, 54, and 55) (see A118 and A123).

During an interview with the PRD on January 20, 2012, at 8:35 a.m., she stated that there were not enough personnel available to handle the grievances, and that she was not receiving prompt cooperation when asking for help from facility staff in resolving grievances.

During an interview with the DCQI on January 19, 2012, at 9:30 a.m., she stated that the medical staff grievance investigation and response were not given oversight by the grievance committee, and that investigation and response to grievances about physicians was not being done in the medical staff area. She stated that the medical staff office does not have a formal grievance investigation and follow-up policy in place and that investigation and response were not being done in the medical staff area.

The facility policy, "Management of Patient Complaints/Grievances, reviewed 9/10," indicated, "Patients have the right to register complaints without fear of retribution, to have their complaints investigated and resolved, and be provided with timely follow-up." The policy further indicated, "The Governing Board has delegated responsibility of reviewing and resolving the grievances to a Grievance Committee composed of a multidisciplinary group to include Risk Management, Patient Safety Officer, Patient Relations, and ex-officio members as needed."

During a review of the facility policy, "Management of Patient Complaints/Grievances, reviewed date 9/10," the algorithm depicting the flow of grievances indicated that the grievance committee was to report outcomes to the Quality Council.

During a review of the Quality Dashboard 2010-2011, the quality indicators listed did not include parameters to assess the adequacy of the grievance process.

Based on interview and record review, the facility failed to ensure that data regarding medical staff performance was included in one physician's (DR 1) medical staff records and utilized for appraising the staff members, creating the risk of unrecognized substandard medical staff performance by the physician.

Findings:

During a review of the medical staff credential files and medical staff complaint log with MSC on January 19, 2012, at 2:30 p.m., she stated that complaints regarding physicians should be placed in the medical staff complaint log and reviewed by the Department Chair, who was responsible for reviewing the evidence of DR 1's performance prior to reappointment.

During a review of DR 1's credential file and the medical staff complaint log on January 19, 2012, two complaints about DR 1 were seen in the medical staff complaint log. Two additional complaints seen in the facility complaint log for the time period August 2011 to December 2011, regarding DR 1 were not seen in the medical staff complaint log, and there was no documentation in the medical staff files to support that all four complaints regarding DR 1 for the April 2011 to November 2011 time period had been seen by the Department Chair.

A November 19, 2011 form, containing a review of DR 1 for reappointment, contained a question about whether DR 1 had been subject to repeated complaints. The Department Chair indicated that DR 1 had not been the subject of repeated complaints and signed the form recommending reappointment. DR 1 was reappointed to the medical staff by the Governing Body on December 15, 2011.

During an interview of the MSC on January 19, 2012, at 2:40 p.m., she stated there was no way to know whether the Department Chair was aware of the grievances at the time he completed the form recommending reappointment.

During an interview with the DCQI on January 19, 2012, at 9:30 a.m., she stated that the medical staff grievance investigation and response were not given oversight by the grievance committee, and that investigation and response to grievances about physicians was not being done in the medical staff area.

The facility policy, "Medical Staff Code of Conduct, revised 12/09," indicated in part, "Disruptive Behavior is behavior manifested through personal interaction with practitioners, Hospital personnel, patients, family members or others, which tends to interfere with or inhibits, the ability of others to provide high quality patient care; is inconsistent with a safe working environment; falls below the professional or ethical standards of our Medical Staff; contributes to a hostile work environment; or subjects others to physical, verbal or emotional abuse..." The policy further indicated, "...Reports of disruptive behavior shall be entered into the Medical Staff database for tracking and trending purposes as part of the ongoing quality improvement process."

Based on interview and record review, the facility failed to ensure two physicians (DR 2 and DR 5), followed the medical staff bylaws when they performed planned surgeries without verifying and marking the operative site on Patient 14 and Patient 57, respectively, resulting in surgery being performed on areas that was different than that described in the pre-operative documentation for the patients, and the increased risk of a wrong site surgery for the patients.

Findings:

1. During a review of Patient 14's medical record, the pre-operative H&P dated October 13, 2011, indicated that surgery was planned in the right axillary area.

During interviews with RN 3 on November 7, 2011 and January 19, 2012, she stated that she was the pre-operative nurse for Patient 14 on October 14, 2011. She stated that DR 2 came in to talk to Patient 14, but she did not see him mark the site of surgery.

During interviews with RN 4 on November 7, 2011 and January 19, 2012, she stated that she was the circulating nurse for Patient 14 on her October 14, 2011, date of surgery. She stated that she observed that Patient 14 had a scar on the left side of her body and positioned the patient with the left side up. She stated that surgical site had not been marked.

The facility policy, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, reviewed 3/11," indicated, "The physician performing the procedure in conjunction with the patient shall clearly mark the procedure site/side with the word, "yes" to enhance the reliability of the process."

The facility's "Medical Staff Rules and Regulations, revised 9/2011" stipulated that the surgeon shall mark the surgery site prior to surgery, with the patient awake and aware.

2. During a review of the medical record of Patient 57, on January 17, 2012, Patient 57 was admitted to the facility for surgery on January 16, 2012. Pre-operative documentation included the Surgery Booking Sheet and Physicians Pre-Op Order Sheet, signed by the surgeon on January 4, 2012, which indicated the procedure to be performed and consented was a "laparoscopic single port LEFT salpingo-oophorectomy (procedure performed using a camera and instruments through small incisions in the abdominal wall to remove the left ovary and left fallopian tube)." The consent form signed by the patient on January 12, 2012, was for an "examination under anesthesia, laparoscopic LEFT salpingo oopherectomy, possible exploratory laparotomy."

The post-operative documentation for Patient 57 was also reviewed. The procedure recorded on the Operative Assessment Progress Note was a laparoscopic lysis of adhesions, left salpingo-oophorectomy and right ovarian cystectomy.

During an interview with RN 9 on January 18, 2012, at 11:40 a.m., she stated that for laparoscopic surgery, no site marking was done.

The facility policy, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, reviewed 3/11," indicated, "The surgical site will be marked for laparoscopic cases that involve operating on organs that have laterality (i.e., kidneys, ovaries)."

The facility's "Medical Staff Rules and Regulations, revised 9/2011," stipulated that the surgeon shall mark the surgery site prior to surgery, with the patient awake and aware.

Based on interview and record review, one surgeon (DR 2), performed surgery on Patient 14 for which he had not been granted privileges, creating the risk of substandard surgical outcome for Patient 14.

Findings:

The medical record of Patient 14 was reviewed and indicated that DR 2 performed a scar revision surgery on Patient 14 on October 14, 2011.

During a review of the credential file of DR 2 on January 20, 2012, no privilege for scar revision was granted to the surgeon.

During an interview with RN 10 on January 20, 2012, at 11:10 a.m., she stated that DR 2 does not have privileges to perform scar revision surgery.

During an interview with Scheduler 1 on January 20, 2012, at 11:05 a.m., she stated that if asked to schedule a scar revision surgery for DR 2, she would check to see if he had privileges to perform such a surgery. She then checked the computer and stated that he did not have core privileges, which might include scar revision, listed. She stated that if he did not have specific privileges she would call the Medical Staff Office to ask if he could be scheduled for the surgery, but that she did not document this verification process.

During an interview with the MSC on January 20, 2012, at 11 a.m., she stated that there was no documentation that the scheduler had called the Medical Staff Office.

The facility's "Medical Staff Bylaws, revised 4/2011," indicated, "Except as otherwise provided in these bylaws, a member providing clinical services at this hospital shall be entitled to exercise only those clinical privileges specifically granted."

Based on observation, interview, and record review, the facility failed to ensure their policies regarding assessment and identification of patients with food and/or drug allergies was implemented for two of 66 sampled patients (Patients 42 and 46), which had the potential for patients to suffer an allergic reaction.

Findings:

A review of the facility's policy, "Color-Coded Patient Identification Wristband use," dated February 2008, indicated, "Red wristbands shall be used to identify patients with allergies. The list of allergies should be written in the medical record in accordance with hospital policy. Allergies should include allergies to medication(s), food, environmental allergens or other substances that may cause an allergic reaction in the patient."

1. An observation of the pediatric unit was conducted on January 17, 2012, at 10 a.m. Patient 42 was observed in the hospital bed with her family member. The patient's family member stated Patient 42 was allergic to milk and if she drank milk she got very ill, vomits, and had to be taken to the emergency room to receive Reglan (medication used to stop vomiting) intravenously.

The patient's family member then stated she told the admitting nurse about the patient's allergy to milk and that Patient 42 received milk on her breakfast tray, and she removed it before the patient drank it.

Upon observation it was noted that Patient 42 did not have a red wristband on.

A review of Patient 42's record was conducted. Patient 42 was admitted to the facility on January 16, 2012, with a diagnosis of low blood sugar (hypoglycemia) and generalized weakness. Record review failed to show that Patient 42 was allergic to milk.

A review of the facility policy, "Pediatric Admission Assessment (revised/reviewed date 7/10)," noted, "Upon admission to pediatrics, the RN will complete an admission history and physical assessment within 60 minutes."

An interview was conducted with RN 6 on January 17, 2012, at 10:30 a.m. RN 6 stated Patient 42 should have a red wristband on to indicate that the patient has an allergy. RN 6 stated the patient did receive milk on her breakfast tray and that the patient's allergy to milk should have been documented in the initial patient assessment.

An observation of Patient 42 was conducted on January 18, 2012, at 11 a.m. The patient did not have a red wristband on.

2. An interview was conducted with Patient 46 on January 18, 2012, at 11 a.m. Patient 46 stated she was admitted to the facility via the emergency room on January 15, 2012, with nausea, vomiting, and diarrhea, and had her gallbladder removed on January 16, 2012. Patient 46 stated she was allergic to Cipro.

Patient 46 further stated before her surgery she had a red wristband on, but it had been removed and was not replaced after the surgery. Upon observation, it was noted that the patient was not wearing a red wristband.

An interview was conducted with RN 7 on January 18, 2012, at 11:30 a.m., who stated a red wristband should be placed on all patients with allergies.

Based on observation, interview, and document review, the facility failed to administer one of 14 medication opportunities, according to scheduled administered time without documentation indicating the reason for the late administration for one of four patients observed for medication administration (Patient 36).

Findings:

Medication pass observation was conducted on January 18, 2012, at 9 a.m. with RN 20.

During the review of Patient 36's medical record, it was noted that there was a physician order for Lasix (medication to remove excess body fluid and to help lower the blood pressure) 40 mg to be administered intravenously once a day written on January 17, 2012.

The eMAR (electronic Medication Administration Record) was reviewed and it was noted that the medication was scheduled to be administered to the patient at 9 a.m., once a day. However, the electronic documentation indicated the dose of Lasix was administered at 12:12 p.m., on January 18, 2012 (3 hours and 12 minutes after the scheduled time). There was no other documentation made to explain why the medication was given more than 3 hours after the scheduled administration time.

During an interview on January 18, 2012, at 2:30 p.m., RN 20 stated that she did not give the medication at scheduled time due to the patient having a low blood pressure, but confirmed that no documentation was made in the patient's record and did not indicate physician was notified of the late administration of the medication.

Review of the facility's policy and procedure titled, "Medication Administration" indicated,

"Scheduled medications will be considered 'late' if not administered within 60 minutes from the Physician's order and subsequent eMAR task, unless otherwise documented or noted in the patient's electronic medical record accordingly..."

Based on interview and record review, the facility failed to ensure the medical record was accurately written and completed for two of 66 sampled patients (Patients 7 and 4).

For Patient 7, the medical record contained a discrepancy on the site of where the procedure was performed.

For Patient 4, the facility failed to ensure the physician responsible for obtaining the informed consent for the lumbar puncture (a procedure that is performed in order to collect a sample of cerebrospinal fluid) and blood transfusion, documented the discussion in the medical record.

These failures resulted in an incomplete and/or inaccurate medical record and had the potential to result in patients to receive procedures without receiving necessary information to make an informed decision.

Findings:

1. The record for Patient 7 was reviewed with the MRD on January 20, 2012, at 9:15 a.m. The Physician Orders, dated January 10, 2012, indicated ORIF (Open Reduction Internal Fixation - a surgical procedure to repair a fracture), of the "left" distal radius. The Consent to Surgery, and Anesthesia Record, dated January 16, 2012, also indicated a procedure of ORIF of the "left" distal radius.

The Surgical Post-Operative Assessment Note, signed by the Physician on January 16, 2012 at 6 p.m., indicated a pre and post-op diagnosis of "left" radial fracture displaced.

The Operative Report, dictated on January 16, 2012, at 6:10 p.m. and transcribed the same day at 7:26 p.m., indicated a pre and post diagnosis of "left" distal radius displaced fracture. However, the operation/procedure performed indicated, ORIF of "right" distal radius fracture, instead of "left".

In a concurrent interview with the MRD, she stated the person that transcribed the dictation should have noted the discrepancy in the Operative Report that indicated the procedure was performed on the "right" instead of the "left", and placed a "pending" note on the report to alert the physician of the discrepancy. The MRD stated an "pending alert" was not placed on this record.




25338

2. On January 17, 2012, Patient 4's record was reviewed. Patient 4 was admitted to the NICU on January 12, 2012. The patient had a lumbar puncture (a procedure that is performed in order to collect a sample of cerebrospinal fluid) and a blood transfusion on January 16, 2012.

The form titled, "Consent to Surgery/Special Procedures/Anesthesia," dated and signed by Patient 4's parent was reviewed. The consent indicated, "Lumbar Puncture." The form had a section, "Physician Certification" which would certify the physician had discussed the procedure with the patient or legal representative, including the risks and benefits of the procedure, and any other information about the procedure or surgery. The section did not have the date, time, and signature of the physician.

The form titled, "Blood Transfusion Information and Consent (with physician verification)," dated and signed by Patient 4's parent was reviewed. The consent had a section, "Physician Verification of Informed Consent" which would certify that the physician had provided information concerning the advantages, disadvantages, risks and benefits of the procedure. The section did not have the date, time, and signature of the physician.

On January 17, 2012, at 3:30 p.m., Patient 4's record was reviewed with the DNP, CNO, and CNS. The facility was not able to find documented evidence in Patient 4's record that the physician had discussed the lumbar puncture and blood transfusion procedures with the patient's responsible party. The CNO stated there should have been documentation from the physician for both procedures.

The facility policy titled, "Informed Consent" revised May 2009, was reviewed. The policy indicated, "Informed Consent...Documenting Informed Consent...The physician is responsible for obtaining the informed consent and for documenting this discussion on the record..."

Based on interview and record review, the facility failed to:

1. Ensure all physician orders were dated and timed for one of 66 sampled patients (Patient 40), which could result in inaccuracies with the medical record and potentially impact the provision of medical care, and

2. Ensure physician treatment and medication orders were completely written upon transfer to another care unit that ensure continued care for one of 66 sampled patients (Patient 32), resulting in the risk of substandard medical care for the patient.

Findings:

1. A review of Patient 40's record was conducted on January 17, 2012, at 11:30 a.m. Patient 40 was admitted to the facility on January 14, 2012, in active labor.

The physician's signature section of the "OB Admit Labor and Delivery Orders," noted as a telephone order taken by the RN on January 14, 2012, at 7 p.m., was not authenticated by the physician with the date or time.

The physician's "Post Partum Orders-Vaginal Delivery," and the "OB VTE Prophylaxis Screening Orders For Obstetrics (OB)," did not indicate the date or time the orders were given.

A review of the facility's "Medical Staff Rules & Regulations Adopted May 1993, Revised April 2011," indicated, "All practitioners' orders shall be written clearly, legibly, and completely...The responsible practitioner shall sign, time and date all verbal orders within 48 hours."

An interview was conducted with RN 5 on January 17, 2012, at 11:45 a.m., who stated all physician's orders need to include the date and time of the orders.



26881

2. During a review of the medical record of Patient 32 on January 18, 2012, at 11 a.m., the record contained a physician order to "transfer to ICU with same orders" without specifying the exact orders.

In an interview with RN 13 on January 18, 2012, at 2:55 p.m., she stated that physicians were not allowed to write blanket orders, and that the orders should have been rewritten when the patient was transferred to a different level of care.

According to the facility's "Medical Staff Rules and Regulations," it indicated, "...Order Writing...All practitioners' orders shall be written clearly, legibly, and completely...Orders which are illegible or improperly written will not be carried out until re-written or understood by the nurse. The sole use of 'renew', 'continue order', and similar terms are not acceptable."

Based on interview and record review, for two of 66 sampled patients (Patients 14 and 57), the facility did not ensure that the policy for informed consent was fully implemented, resulting in the risk of a failure to recognize those patients' right of self-determination.

Findings:

1. The medical record of Patient 14 was reviewed and included a pre-operative H&P completed by PA 1 which documented that the risks and benefits of a surgery were discussed and that surgery in the right axillary region was planned. The preoperative H&P was completed on October 13, 2011, but was not authenticated by the physician until seven days after the October 14, 2011 surgery.

During an interview with RN 4 on January 19, 2012, at 1:20 p.m., she stated that DR 2 or his PA completed the pre-operative H&P on his patients. She stated that the informed consent for the surgery obtained by the surgeon was documented on that H&P. She stated that the PA was able to obtain informed consent in the physician's office.

During an interview with the Director of Surgical Services on January 19, 2012, at 1:30 p.m., she stated that the surgeon was required to authenticate, by signing, an H&P done by the PA prior to surgery.

The facility policy, "Informed Consent, revised 5/09," indicated, "The patient's physician is responsible for providing the information the patient needs to order to make an informed decision and for obtaining the patient's informed consent or refusal for the recommended procedure."

2. The medical record of Patient 57 was reviewed on January 17, 2012. Patient 57 was admitted to the facility for surgery on January 16, 2012. Pre-operative documentation included the Surgery Booking Sheet and Physicians Pre-Op Order Sheet, signed by the surgeon on January 4, 2012, indicated the procedure to be performed and consented was a "laparoscopic single port LEFT salpingo-oophorectomy (procedure performed using a camera and instruments through small incisions in the abdominal wall to remove the left ovary and left fallopian tube)." The consent form signed by the patient on January 12, 2012, was for an "examination under anesthesia, laparoscopic LEFT salpingo oophorectomy, possible exploratory laparotomy." The PN-Surgical Operative Assessment Progress Note indicated that the pre-operative diagnosis was "left lower quadrant pain, persistent left adnexal mass, simple cyst right ovary."

The post-operative documentation for Patient 57 was also reviewed. The procedure recorded on the Operative Assessment Progress Note was a laparoscopic lysis of adhesions, left salpingo-oophorectomy and right ovarian cystectomy.

The operative record was reviewed and did not show evidence of an emergency condition requiring that the right ovarian cyst which had been noted prior to surgery, but was not on the consent form, be removed.

During an interview with RN 8 on January 17, 2012, at 11:30 a.m., she stated there was no consent for removing the cyst from the right ovary.

The facility policy, "Informed Consent, revised 5/09," was reviewed. The policy indicated, "The hospital's role in the informed consent process is to verify that the physician obtained the patient's informed consent before the physician is permitted to perform the procedure or that an exception (such the emergency exception) applies that allows treatment to proceed."

Based on observation, interview, and document review, the facility failed to keep accurate record of controlled substances that accounted for controlled substances located inside the Disaster Cart in the pharmacy.

Findings:

During the tour of the Pharmacy with the DOP and the MSO on January 20, 2012, at 1:30 p.m., it was revealed that the pharmacy kept two Disaster Kits containing medications requiring a key to unlock. Included in the kits were the following controlled substances according to the Disaster Cart Charge Form:

Valium (medication for anxiety and seizure) injectable vials 10 mg/2 ml;
Morphine sulfate (narcotic pain medication) injectable vials 10 mg/ml; and,
Meperidine (narcotic pain medication) injectable vials 100 mg/ml.

During a concurrent interview, the DOP did not indicate the controlled substances were inspected and counted. Also, the DOP stated that they should have been accounted for in the Controlled Substance Inventory Log binders and acknowledged that he was not able to account for them.

During a concurrent interview, Pharmacy Staff 15 also indicated there was no documentation in the Controlled Substance Log Binder that the medications were signed out for 100 vials of morphine sulfate 10 mg/ml and 100 vials meperidine 100 mg/ml.

Inspection of the Controlled Substance Inventory Log binders did not indicate the correct inventory, as they did not account for the amount of the controlled substance contained in the Disaster Kits.

Review of the facility's policy and procedure titled, "Narcotic Control Policy and Procedures" indicated,

"Perpetual narcotic inventory logs will be appropriately maintained to record all additions to or dispensing from inventory."

Based on observation, interview, and document review, the facility failed to control drugs and biological for provision of pharmaceutical services to meet the needs of the patients by failing to:

1. Have enough cold saline injectable bags readily available as part of the treatment for Malignant Hyperthermia (a life threatening condition from the exposure to certain anesthetic agents);

2. Keep a content list outside the Malignant Hyperthermia (MH) cart;

3. Replace daily Controlled Substance Administration Record for pharmacy review in accordance with the facility's policy and procedure;

4. Ensure that one refrigerator in the surgery department was maintained at the correct temperature, creating the risk of pharmaceutical items being damaged, and the risk of substandard healthcare for surgery patients whose care involved those pharmaceuticals; and

5. Ensure a complete order for intravenous sedative medication was obtained before administering the medication, creating the risk of incorrect medication administration and a poor health outcome for two of 66 sampled patients (Patients 56 and 66).

Findings:

1. The OB/L&D Operating Room was toured on January 18, 2012, at 1:15 p.m., with the OBM (OB Manager) and it was observed there was a Malignant Hyperthermia Cart (a cart containing necessary medications to immediately treat a life threatening condition from the exposure to certain anesthetic agents) with a content list that indicated there would be twelve 1000-ml large volume bags, containing Normal Saline 0.9 percent, in the medication refrigerator in the Operating Room.

The medication refrigerator was observed to contain only two bags of 1000 ml Normal Saline.

During a concurrent interview, the OBM stated there were no other large medication refrigerator located in OB/L&D Unit and acknowledged that there were only two large volume normal saline for injection available in the medication refrigerator.

According to MHAUS (Malignant Hyperthermia Association of the United States - a leading organization with a mission to promote optimum care and scientific understanding of MH and related disorders) recommended medications and supplies for the hospitals to have readily available, which included, "a minimum of 3000 ml (3 bags of 1000 ml) of refrigerated cold saline solution for IV (intravenous) cooling."

Review of the facility's policy and procedure titled, "Malignant Hyperthermia" indicated that the treatment included the following:

"Actively cool the hyperthermic patient. Use IV (intravenous) cold saline 15 ml/kg (1000 ml for an average 70 kg patient) every 15 min(ute) x 3 doses, to keep core temp(erature) < 39 degree Celcius, but greater than 36 degree Celcius."

2. The OB/L&D Operating Room was toured on January 18, 2012, at 1:15 p.m., with the OBM (OB Manager) and it was observed there was a Malignant Hyperthermia Cart and that a content list was not present outside the cart.

During a concurrent interview, the OBM acknowledged that there was not a content list for MH Cart.

According to the California Code of Regulations, Title 22, Section 70263(f)(2),

"The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

3. During the tour of the facility Cardiac Catheterization Laboratory on January 18, 2012, at 2:30 p.m., the controlled substances were inspected and it was noted that the facility's "24 Hour Controlled Substance Administration Record" documented entries for January 17, 2012 and January 18, 2012.

During an interview, the DOP stated that the Controlled Substance Administration Sheet was reconciled weekly on Fridays and not daily.

During an interview, CC Manager stated that the sheet was not exchanged until all the provided spaces on the sheet were filled out.

According to the facility's policy and procedure titled, "Narcotic Control Policy and Procedures" indicated,

"The 24 Hour CSA (Controlled Substance Administration) Record will be replaced daily or upon delivery of the next standard or scheduled supply of controlled substances."



26881

4. During a tour of OR 9 on January 19, 2012, at 10:45 a.m., the Refrigerator and Freezer Temperature Record Log was reviewed. The log indicated, "Acceptable temperatures Refrigerator 45 degrees F (Fahrenheit) - 32 degrees F." The temperatures on the daily record ranged from -5 ?C (23 degrees F) to 46 degrees F, all outside of the acceptable temperature range. There was a space on the form to record action taken, but no indication that any action had been taken.

The temperature gauge was examined, and was noted to measure both -3 Centigrade (26 ?F) and 46 ?F at the same time.

During a concurrent interview with the Director of Surgical Services, she stated that the temperatures recorded on the log were not correct, and that they appeared to need a new temperature gauge.

The contents of the refrigerator were examined and included heparin vials and GEM blood gas calibrator ampules with packaging indicating they were to be maintained at 2-10 degrees Centigrade (36-50 degrees F).

5. During a review of the medical record of Patient 66 (ICU patient), on January 18, 2012, at 10:45 a.m., the record contained an order for Propofol (a sedative administered by vein) written on January 16, 2012, at 3:26 p.m., that did not include directions for the amount of the medication to be administered. The record did not contain documented evidence that the order was clarified with the physician.

During a review of the medical record of Patient 56 (ICU patient), on January 18, 2012, the medical record contained an order dated January 14, 2012, at 3:30 p.m., for "Propofol drip titrate to comfort," without any starting dose or specific titration parameters. The record did not contain documented evidence that the order was clarified with the physician.

During an interview with RN 11 on January 18, 2012, at 10:45 a.m., she stated that the Propofol for Patient 66 was running at 40, and was not being titrated.

During an interview with DR 3 on January 18, 2012, at 10:50 a.m., he reviewed the medication order for Patient 66 and stated that he did not know the level of sedation to which the medication was being titrated.

In an interview with Pharm Staff 16 on January 18, 2012, at 10:55 a.m., he stated that the ordering physician should be specifying the level of sedation to which the Propofol should be titrated.

In an interview with the DOP on January 20, 2012, at 10:30 a.m., he stated that when an incomplete medication order was provided, the staff should obtain a clarification of the order from the physician.

Based on observation, interview, and document review, the facility failed to ensure only licensed personnel have access to secured medication area in accordance with the facility's policy and procedure.

Findings:

On January 19, 2012, at 3:30 p.m., the hospital's outpatient ICON (Institute of Clinical Orthopedics and Neurosciences) in La Quinta, CA, was toured and it was noted that Staff 15 possessed keys to the cabinets and drawers containing medications.

During a concurrent interview, Outpatient Staff 15 stated that a set of keys were kept by the physician in charge of the clinic, the staff nurse, and herself. Staff 15 stated that she was not a licensed staff.

During an interview on January 20, 2012, at 1:50 p.m., the DOP stated that only licensed staff should have the possession of the keys to the medications and that Outpatient Staff 15 should not have been in possession of the keys.

Review of the facility's policy and procedure titled, "Medication Administration" indicated,

"All medications are to be stored in suitable secure locations...All Keys to secured medication areas will be in the possession of a licensed professional staff at all times..."

Based on observation and interview, the facility failed to remove expired medications in L&D refrigerator and outpatient imaging center located in La Quinta, CA (offsite location).

Findings:

1. On January 18, 2012, at 2:10 p.m., the L&D medication refrigerator was inspected and it was noted that there was an open vial of tuberculin PPD (diagnostic aid to determine tuberculosis infection) 1ml vial dated "1/16/12" (written in ink) on the vial.

During a concurrent interview, the OBM stated multi-dose vials have 30 day expiration date after opening and that the staff should write expired date on the open vial. The OBM could not tell whether the written date on the vial was the day the vial was open or the expiration date.

During a concurrent interview, the DWS stated that according to the date written on the vial, the drug could no longer be used.

Review of the pharmacy reference, Lexicomp, indicated that open vials of Tuberculin PPD vials should be discarded in 30 days.

2. On January 19, 2012, at 3 p.m., the hospital's outpatient Imaging Center located in La Quinta, CA, was toured and it was noted in the medication refrigerator located in the hall, there were seventeen bottles of barium sulfate 0.1 percent with the expiration date of September 2011.

During a concurrent interview, Outpatient Staff 2 stated that they were not being used and that expiration date was not checked by the pharmacy. Outpatient Staff 2 also stated when medications were needed, they were picked up by the clinic staff at the main hospital pharmacy located in Palm Springs.

During a concurrent interview, the director of imaging center acknowledged they were expired.

On January 20, 2012, at 1:50 p.m., during an interview, the DOP stated that the pharmacy did not visit the Outpatient Clinics to inspect the medications used in the Clinic.

Based on observation, record reviews, and staff interviews, the hospital failed to ensure that the Director of Food and Nutrition Services was effective in the daily management of the dietary services when two previously cooked corned beef roasts (a potentially hazardous food) were not safely cooled as specified by department policies and procedures. This failure to ensure the corned beef roasts were safely cooled, created the potential to result in an outbreak of food borne illness in a hospital with a licensed bed capacity of 353 (cross refer A749).

Findings:

During the initial tour of the kitchen on January 17, 2012, at 11:25 a.m., two corned beef roasts between 7 and 10 pounds each were observed in the walk-in refrigerator. The two roasts had been previously cooked and were intact; they were covered tightly with plastic wrap. The label on the plastic wrap indicated that the roasts had been cooked on January 16, 2012 (the day before). A temperature check of the middle of the thickest portion of each roast registered 51.6 degrees Fahrenheit (F) and 51.1 ?F.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (PHF) has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic microorganisms. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provides for cooling from 135 ?F to 41 ?F or 45 ?F in 6 hours, with cooling from 135 ?F to 70 ?F in 2 hours.

During a concurrent interview with executive chef (EC), he stated that both the corned beef roasts had been cooked on January 16, 2012 (the previous day), and had been placed in the freezer for rapid cooling. He stated that he had removed the roasts from the freezer to the refrigerator late in the day on January 16, 2012. He further stated that the cool down temperatures of the two roasts had been monitored by Cook 1 and recorded on the Cooling Log.

A review of the hospital's Cooling Log, dated December 22, 2011 through January 17, 2012, showed an entry for corned beef dated January 16, 2012. The beginning temperature was recorded as 175 ?F. The next temperature was recorded at 12 p.m., it was labeled, "Cold Temperature 70 ?F within 2 hours" and was 38 ?F. There were no other recorded temperatures for the corned beef. The Cooling Logs further indicated that the standard for cooling cooked potentially hazardous foods was for the food to reach 70 ?F within 2 hours and from 70 ?F to 40 ?F within an additional 4 hours.

During an interview with Cook 1 on January 17, 2012, at 11:30 a.m., he stated he had placed the two corned beef roasts in the freezer after cooking them the previous day. He did not cut the roasts into smaller pieces. He further stated that he recorded the temperature two hours later at 12 p.m., to be 38 ?F. He further stated that the two roasts had not been removed from the refrigerator the day of the observation. He was unable to explain how the temperature of the two corned beef roasts could now be greater than 51 ?F if they had reached 38 ?F twenty-four hours earlier and had remained in the refrigerator ever since.

Concurrent interviews with the EC and the Director of Food and Nutrition Services (DFNS) also revealed that they were unable to explain why the two corned beef roasts were greater than 51 ?F twenty-four hours after they were recorded to be 38 ?F. The DFNS stated that the corned beef roasts probably never reached the proper temperature. He further stated that it was the EC's responsibility to monitor Cook 1's work and ensure the cooked PHF was safely cooled. The EC stated that he did not check the temperature of the two roasts when he removed them from the freezer the day before.

Based on observation, record review, and interview, the facility failed to implement infection control and prevention policy and procedures by:

1. Failing to ensure the respiratory therapist appropriately donned a cover gown and secured her long hair while caring for a patient, whose sputum tested positive for MRSA, which had the potential to result in the spread of MRSA infection to other patients and staff;

2. Failing to ensure the opened bottle of OPA Cidex test strips, located at the DI offsite outpatient in La Quinta, CA, was discarded according to manufacturer's instructions. This had the potential to result in inappropriate sanitation of devices for patient use; and

3. Failing to ensure drinks were not stored in the laboratory refrigerator dedicated for reagents storage at the Cancer Center offsite outpatient in La Quinta, CA. This had the potential to result in contamination of the reagents and any other laboratory testing products and specimen.

Findings:

1. The facility's policy and procedure entitled, "Contact / Enteric Contact Precautions" revised date April 2009, stipulated that Contact Precautions were for patients that are known or suspected to be infected with pathogens that require additional control measures to prevent transmission by direct contact with the patient (hand or skin to skin contact when performing patient care activities) or indirect contact with environmental surfaces or patient care items in the patient's environment.

The policy and procedure further indicated that staff should wear gloves and a cover gown while in a Contact Isolation room during the course of providing care to avoid the transfer of microorganisms to other patients or environments.

The facility's policy and procedure entitled, "Appearance and Hygiene" revised date December 2007, indicated, "The procedure's Infection Control Considerations- Personnel in patient care areas shall confine long hair in such a manner that the hair cannot fall forward while performing patient care."

During a tour of the TICU on January 18, 2012, at 8:40 a.m., an observation was made of the RT in a Contact Isolation room. The RT was observed with the yellow cover gown hanging off of her shoulders and at mid chest. The RT was observed with long hair hanging loose in front of her face as she leaned forward to suction Patient 20's tracheostomy tube. The RT was observed several times to push her hair away from her face with her soiled gloved hands.

A review of Patient 20's record indicated the patient's sputum tested positive with MRSA on January 1, 2012.

On January 18, 2012, at 9:25 a.m., an interview was conducted with the RT. She stated, "I am assigned mostly to the ICU area....I tied the gown when I started. My hair was outside the gown. I do get isolation training and in-serviced one time a year."

On January 18, 2012, at 11:45 a.m., in an interview with IP 1, he stated he conducts Infection Control training for staff on hire and annually. He stated staff were trained to wear isolation cover gowns before entering an isolation room and to tie it at the neck and back.



25338

2. On January 19, 2012, at 3:20 p.m., a visit was made to the facility's offsite outpatient Diagnostic Imaging, located at La Quinta, CA. In the Ultrasound Room, a bottle of "Cidex OPA Test Strips (strips used to indicate if the concentration of a sanitizing solution is within effective concentration)" was available for use. The test strip bottled was labeled, "Opened June 30, 2011...Discard September 30, 2011."

In a concurrent interview with the DI Director, he stated the test strips should have been discarded.

On January 20, 2012, the facility policy titled, "Cidex OPA Solution Test Strips," dated July 5, 2011, was reviewed. The policy indicated, "...Always note the date the bottle was opened and the 'do not use after' date in the space provided on the bottle..."

The Cidex OPA Test Strips insert indicated, "Precautions: Do not use any remaining strips 90 days after opening the bottle...Improper storage or use of test strips may result in false readings..."

3. On January 19, 2012, at 3:50 p.m., a visit was made to the facility's offsite outpatient Cancer Center, located at La Quinta, CA. The center had a laboratory room, which had a reagent refrigerator. The refrigerator was labeled from outside with, "No Food or Drink." In the refrigerator, two cans of soda were stored together with the reagents. In a concurrent interview with the Cancer Center SM, she stated, "(The refrigerator) should not have food or drink."

On January 20, 2012, the facility policy titled, "Infection Control Policy - CCC Laboratory," approved January 15, 2012, was reviewed and indicated, "Laboratory...No food or drinks may be stored in laboratory refrigerators except those designated for food only..."

Based on observation, interview, and record review, the facility failed to identify, investigate, and control potential sources of infectious disease by failing to:

1. Ensure documented justification for the continued use of invasive lines and tubes of two patients (Patients 32 and 56), which could result in potential source of infection;

2. Ensure documented evidence of Pneumococcal vaccination, or declination or discussion supporting intentional delay in providing the vaccine, creating the risk that vaccination may be unintentionally be missed during her stay for one patient (Patient 32);

3. Ensure post-operative infection surveillance, via follow-up phone call, was done for all cardiac catheterization laboratory patients, creating the increased risk of undiscovered infectious processes associated with that area;

4. Ensure the medical staff was being screened for infectious diseases per facility policy, creating the increased risk of infection for all patients coming into contact with medical staff; and

5. Adhere to a food cool down process that allowed food to be maintained at temperatures to minimize the risk of bacterial growth, creating the risk of infection for all patients consuming foods cooled in the facility kitchen.

Findings:

1. During a review of the medical record of ICU Patients 56 and 32 on January 18, 2012, the records contained pre-printed stickers regarding the continued need for intravenous lines and Foley catheters (tubes to the bladder) dated January 15, 16, and 17, 2012. The stickers had spaces for the physician to indicate the continued need for the tubes and intravenous lines, and spaces to specifically note whether they continued to be needed, but the spaces were left blank. The reasons for continuing the lines and tubes were not indicated, nor were the need for continued lines and tubes verified.

During an interview with RN 12 on January 18, 2012, at 10:55 a.m., she stated that the doctors were not filling out the stickers regarding the need for continued use of the tubes and lines.

During an interview with DR 3 on January 18, 2012, at 11:20 a.m., he stated that the physicians should be filling out the stickers or discontinuing the tubes and lines. He stated that some physicians might be documenting the continued need for tubes and lines in the progress notes, but after reviewing the physician notes for Patient 56, he stated that there was no documented continued need for the Foley catheter.

2. During a review of the medical record of ICU Patient 32 on January 18, 2012, the record contained a pre-printed form, Physician Order-Vaccine Assessment, dated January 15, 2012. The nurse completed the form and checked the boxes indicating that the patient met the criteria for pneumococcal and influenza vaccinations. However, there was no indication that the vaccines had been given, and no physician's signature on the form, and no documentation of a declination or reason for postponing the Pneumococcal vaccine.

In an interview with RN 13 on January 18, 2012, at 2:55 p.m., she reviewed the medical record of Patient 32 and stated that the patient met the criteria for a Pneumonia vaccine, and that no vaccine was given, and no reason for not giving it had been recorded in the patient's record. She stated that the policy was for the nurse to obtain either an order for the vaccine or a declination.

3. During an interview with the CC Manager on January 19, 2012, at 11:45 a.m., he stated that procedures in the cardiac catheterization laboratory included the placement of pacemakers. When asked about monitoring for post-operative infections, he stated that a telephone call was made to the patients 24 to 48 hours after discharge to inquire about their well-being.

On January 20, 2012, at 11:30 a.m., the Cardiac Catheterization Laboratory follow up phone call log from December 2011 was reviewed, and for multiple patients there was no evidence that any calls were attempted (the log column was blank where follow-up attempts were to be recorded), while for some other patients there was a note that one call was attempted, but the patient was not reached.

During a concurrent interview with the CC Manager, he stated that they usually made two follow-up phone call attempts. He stated, for the patients where the follow-up column was blank, he "guessed" those patients were missed.

During an interview with the CNO on January 20, 2012, at 9:50 a.m., she stated that the follow-up phone call was very important, as some patient were not even opening their bag of discharge medications until called. She stated that she did not believe the follow-up call was memorialized in policy, but that the facility-wide practice was to attempt to call the patient three times.

4. During a review of physician credential files on January 19, 2012, the files did not contain evidence that tuberculosis screening had been done.

In an interview with the MSC on January 19, 2012, at 3 p.m., she stated that employee health handled tuberculosis screening, and that physicians were not required to undergo tuberculosis screening.

During an interview with IP 1 on January 20, 2012, at 3 p.m., he stated that he had attempted to include the medical staff in the required screening for tuberculosis, but that the medical staff resisted.

The facility policy, "Preventive Immunization and Screening of Healthcare Personnel to Reduce the Risk of Transmission of Infectious Diseases, revised 10/10," indicated:

"The purpose of this policy is to provide a safe environment for all healthcare personnel (HCP) and patients by following Centers for Disease Control and Prevention (CDC) and Occupational Safety & Health Administration (OHA) standards for immunization and screening to reduce the risk of transmission of the following infectious diseases: Hepatitis B, Influenza, Measles, Mumps, Rubella, Tetanus, Diphtheria, Acellular Pertussis, Varicella (Chicken Pox), Tuberculosis..."

"...Healthcare Provider (HCP) means all paid and unpaid persons working in healthcare settings who have the potential for exposure to patients and/or infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air. " and

"It is expected that all HCP actively engage all appropriate measures to prevent the spread of communicable diseases either by vaccination, by antibody testing, by skin testing, by utilizing personal protective equipment (PPE), or by utilizing a combination of these controls where appropriate."

The policy references the national guidelines that support testing of healthcare personnel.

According to CDC's MMWR: Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC) dated December 26, 1997 indicated:

"Because of their contact with patients or infective material from patients, many health-care workers (HCWs) (e.g., physicians, nurses, emergency medical personnel, dental professions and students, medical and nursing students, laboratory technicians, hospital volunteers, and administrative staff) are at risk for exposure to and possible transmission of vaccine-preventable diseases. Maintenance of immunity is therefore an essential part of prevention and infection control programs for HCWs."

The facility's "Medical Staff Bylaws, revised 4/2011," indicated, "Basic Responsibilities of Medical Staff Membership...abiding by the medical staff bylaws, medical staff rules and regulations and policies..."



28135

5. During the initial tour of the kitchen on January 17, 2012, at 11:25 a.m., two corned beef roasts between 7 and 10 pounds each were observed in the walk-in refrigerator. The two roasts had been previously cooked and were intact; they were covered tightly with plastic wrap. The label on the plastic wrap indicated that the roasts had been cooked on January 16, 2012 (the day before). A temperature check of the middle of the thickest portion of each roast registered 51.6 degrees Fahrenheit (?F) and 51.1 ?F.

According to the 2009 US Food and Drug Administration's Food Code (3-501.14 Cooling) safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (PHF) has been consistently identified as one of the leading contributing factors to foodborne illness. During slow cooling, PHF are subject to the growth of a variety of pathogenic microorganisms. If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. The Food Code provision for cooling provides for cooling from 135 ?F to 41 ?F or 45 ?F in 6 hours, with cooling from 135 ?F to 70 ?F in 2 hours.

During a concurrent interview with executive chef (EC), he stated that both the corned beef roasts had been cooked on January 16, 2012 (the previous day), and had been placed in the freezer for rapid cooling. He stated that he had removed the roasts from the freezer to the refrigerator late in the day on January 16, 2012. He further stated that the cool down temperatures of the two roasts had been monitored by Cook 1 and recorded on the Cooling Log.

A review of the hospital's Cooling Log, dated December 22, 2011 through January 17, 2012, showed an entry for corned beef dated January 16, 2012. The beginning temperature was recorded as 175 ?F. The next temperature was recorded at 12 p.m., it was labeled "Cold Temperature 70 ?F within 2 hours" and was 38 ?F. There were no other recorded temperatures for the corned beef. The Cooling Logs further indicated that the standard for cooling cooked potentially hazardous foods was for the food to reach 70 ?F within 2 hours and from 70 ?F to 40 ?F within an additional 4 hours.

During an interview with Cook 1 on January 17, 2012, at 11:30 a.m., he stated he had placed the two corned beef roasts in the freezer after cooking them the previous day. He did not cut the roasts into smaller pieces. He further stated that he recorded the temperature two hours later at 12 p.m., to be 38 ?F. He further stated that the two roasts had not been removed from the refrigerator the day of the observation. He was unable to explain how the temperature of the two corned beef roasts could now be greater than 51 ?F if they had reached 38 ?F twenty-four hours earlier and had remained in the refrigerator ever since.

Concurrent interviews with the EC and the Director of Food and Nutrition Services (DFNS) also revealed that they were unable to explain why the two corned beef roasts were greater than 51 ?F twenty-four hours after they were recorded to be 38 ?F. The DFNS stated that the corned beef roasts probably never reached the proper temperature. He further stated that it was the EC's responsibility to monitor Cook 1's work and ensure the cooked PHF was safely cooled. The EC stated that he did not check the temperature of the two roasts when he removed them from the freezer the day before.

During an interview with the IP 1 on January 19, 2012, at 2:40 p.m., he stated that his department did surveillance rounds in the dietary department a minimum of two times a year. He stated that during these rounds, the Cooling Logs were reviewed to be sure cooked PHF has been safely cooled. He stated that they did not actually put a thermometer in the food to determine if the logs had been filled out accurately. He stated that taking temperatures would be required to ensure that the forms accurately reflect the temperature of the cooling PHF and safe cooling occurred.

Based on interview and record review, the facility failed to provide surgical services that were organized and consistent with acceptable standards of practice and in accordance with the facility policy by failing to:

1. Ensure a physician (DR 2), had privileges to perform a specific surgical procedure, resulting in DR 2 performing a scar revision for which he was not privileged (refer to A353, A363, and A945);

2. For Patient 14, ensure the surgery performed was consistent with the pre-op H&P. In addition, the physician failed to mark the surgical site/side prior to surgery, resulting in an inconsistent surgery performed to Patient 14 compared to what was planned pre-operatively, and risk for the wrong site/side surgery (refer to A951);

3. Ensure the Cardiac Catheterization (CC) Room's temperature and relative humidity (RH) was monitored by CC staff knowledgeable of the acceptable ranges within the facility policy and in accordance with the AORN standards and NFPA requirements. This had the potential to result in out of range temperature and/or relative humidity to go undetected (refer to A951);

4. For Patient 57, ensure the surgery performed was consistent with the consent; the deviation from the consent was discussed with the operating room staff and documented; and the physician marked the surgical site/side prior to surgery, resulting in an inconsistent surgery performed on Patient 57 compared to what was documented as planned pre-operatively (refer to A951); and

5. For Patient 14, ensure there was a properly executed informed consent prior to surgery. The consent did not indicate a site/side for the procedure. Also, the facility failed to ensure that the physician discussed the risks and benefits of the surgery with the patient and obtained informed consent, creating the risk that Patient 14 was not given the information needed to supply consent for the operation performed, resulting in an inconsistent surgery performed to the patient compared to what was planned pre-operatively (refer to A955).

The cumulative effects of these systemic problems resulted in the failure of the facility's surgical department to provide organized, safe, and consistent care and treatment to the patients.

Based on interview and record review, the facility failed to ensure a physician (DR 2), had privileges to perform a specific surgical procedure. As a result, DR 2 performed a scar revision for which he was not privileged.

Findings:

The record for Patient 14 was reviewed and indicated the following:

a. DR 2 ordered a "scar revision," dated October 5, 2011.

b. The "Desert Pain Care Booking Sheet," was faxed to Surgery Scheduling on October 5, 2011. The booking sheet indicated a procedure date of October 14, 2011, with the type of procedure to be performed as "scar revision."

c. The consent form, dated October 13, 2011, listed the operation or procedure as, "scar revision."

d. The Surgical Post-Operative Assessment Note, signed by DR 2 on October 14, 2011, indicated the procedure performed was, "scar revision."

On January 20, 2012, at 11:05 a.m., the surgery scheduler was interviewed. The scheduler stated surgical booking sheets were faxed to her to schedule a specific surgery. She stated there was a binder that listed all facility doctors and what specific privileges they had. The scheduler stated if there was any question, or if the physician wanted to schedule a surgery for which he did not have documented privileges, then she would contact Medical Staffing to determine if it was okay to schedule. The scheduler looked up Dr 2's privileges and was unable to determine if he had privileges to do a "scar revision."

In a concurrent interview with the Director of Surgical Services, she stated DR 2 did not have specific privileges to perform a "scar revision."

The Pain Medicine Delineation of Privileges for DR 2 was reviewed. Scar revision was not listed as an included privilege.

The facility's "Medical Staff Bylaws, revised 4/2011," indicated, "Except as otherwise provided in these bylaws, a member providing clinical services at this hospital shall be entitled to exercise only those clinical privileges specifically granted."

Based on interview and record review, the facility failed to ensure Surgical Services' policies and procedures were implemented and enforced in accordance with acceptable standards of medical practice and surgical patient care by:

1. For Patient 14, failing to ensure the surgery performed was consistent with the pre-op H&P. In addition, the physician failed to mark the surgical site/side prior to surgery. This failure resulted in an inconsistent surgery performed to Patient 14 compared to what was planned pre-operatively, and risk for the wrong site/side surgery;

2. Failing to ensure the Cardiac Catheterization (CC) Room's temperature and relative humidity (RH) was monitored by CC staff knowledgeable of the acceptable ranges within the facility policy and in accordance with the AORN standards and NFPA requirements. This had the potential to result in out of range temperature and/or relative humidity to go undetected; and

3. For Patient 57, failing to ensure the surgery performed was consistent with the consent; the deviation from the consent was discussed with the operating room staff and documented; and the physician marked the surgical site/side prior to surgery. These failures resulted in an inconsistent surgery performed on Patient 57 compared to what was documented as planned pre-operatively.

Findings:

1. The record for Patient 14 was reviewed and indicated the following:

a. The pre-op H&P, dated October 13, 2011, indicated, the patient, "Is experiencing discomfort secondary to the current placement of the IPG (implantable pulse generator- a device used for pain management) device... The IPG pocket is located inferior to the right axilla and has mild tenderness to palpation. There is quite a bit of scar tissue and a well healed surgical scar in the midline of the thoracic spine (mid back area)... The plan is to proceed with revision of the IPG pocket as well as the surgical scar. There was no documented evidence of an old IPG site or scarring on the left side, and no documented evidence of a plan for revision of the IPG pocket/scar on the left side.

b. The physician's order, surgery booking sheet, informed consent, and the surgical post-op assessment note, all indicated a surgical procedure of "scar revision," (no side/site identified).

c. The OR Intraop Record, dated October 14, 2011, documented the patient position as right lateral (leaving the left side exposed), skin prep site as left chest, and procedure as "revision scar."

d. The Pre-Anesthesia Evaluation and the Anesthesia Record dated October 14, 2011, both indicated a procedure of "neuroma (Any tumor derived from cells of the nervous system) removal." Which was inconsistent with all of the other documents that indicated "Scar removal."

e. The Operative Report, dated October 14, 2011, indicated the operation performed was, "revision of the implantable neurostimulator pocket incision" (no site identified). The description of the procedure did not indicate the location of the surgery, other than the patient was placed in a right lateral position (left side exposed), and the axillary area (no side) was prepped and draped.

On November 7, 2011 and January 19, 2012, RN 2 was interviewed. RN 2 stated she was the pre-op interview nurse for Patient 14. RN 2 stated Patient 14 came in the day before her scheduled surgery. RN 2 witnessed the patient sign the consent and ensured the informed consent matched the physician orders. She asked Patient 14 about the procedure to be performed and the patient pointed to her right side and stated, "I'm getting my Frankenstein scar fixed." RN 2 was not aware at that time that Patient 14 had multiple scars.

On November 7, 2011 and January 19, 2012, RN 3 was interviewed. RN 3 stated she was the pre-op nurse for Patient 14 on the day of her surgery. RN 3 stated as part of her usual duties, she reviewed the informed consent. She noticed it did not contain a site or side, but it did match the physician orders, the booking sheet, and the schedule. She did not further question this because the patient pointed to and showed her the scar on the right side. RN 3 stated she started the IV access site on the left because it was opposite side of surgery. RN 3 stated she did not see a scar on the left side. RN 3 stated the physician always comes in to talk with the patient prior to surgery and would mark the site/side at that time. She stated the physician came in to talk to Patient 14, but did not see him mark the site of surgery.

On November 7, 2011 and January 19, 2012, RN 4 was interviewed. RN 4 stated she was the circulating nurse for Patient 14 on the day of her surgery. RN 4 stated she saw Patient 14 in the pre-op area prior to surgery. She stated at that time Physician 1 was at the foot of Patient 14's bed, and he should have marked the site then (prior to taking patient back to the OR). She also stated, the IPG pump was located on the right side of the patient but Physician 1 had stated he would not be doing anything with the IPG. RN 4 stated the scar on the left side was visible, and she never saw a scar on the right. RN 4 stated she positioned Patient 14 in the OR and placed the patient in a right lateral position, with the left side up. RN 4 stated prior to the start of surgery, a time out was performed and the consent indicated scar revision, she did not further question why the site was not marked because she was not aware of other scars on the right side or mid back. RN 4 stated the surgery was performed on the patient's left side.

The policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery," with a reviewed date of March 2011, was reviewed. The policy indicated the following:

a. The facility shall identify the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures.

b. The physician performing the procedure in conjunction with the patient shall clearly mark the procedure side/site with the word "Yes" to enhance the reliability of the process.

c. For purposes of this policy, the surgeon/physician performing the procedure is ultimately responsible for the verification process and shall verify the surgical site.

d. Prior to performing the procedure, the surgical/ procedural team will take a moment ("time out"). "Time-out" must be performed immediately before starting the procedure. "The team shall verbally verify the following: ..., Confirmation that the correct side and site are marked, An accurate procedure consent form, Agreement on procedure to be done, and Correct patient position..."

e. For scheduled operative/invasive procedures, the proposed side/site must be clearly identified on the scheduling form.

f. All relevant documentation including the consent form, H&P, and diagnostic data shall be verified by the pre-procedural nurse/procedural team. If there are any discrepancies or uncertainties, the pre-procedural nurse/procedural team shall call the surgeon/physician for clarification prior to the start of the procedure.

On January 20, 2012, at 1:45 p.m., the Chief of Medical Staff was interviewed. He stated the concerns regarding Patient 14 was brought to Medical Staff. He stated their findings also concluded that the surgical site was not marked and that the surgery performed did not match the pre-op H&P and the consent. The Chief of Medical Staff stated DR 2 was brought in for peer review and counseled.



25338

2. On January 18, 2012, at 3:20 p.m., a tour of the two Cardiac Catheterization rooms was conducted with the CC Manager. The CC Room 1 did not have any device readily accessible to indicate the relative humidity, but had a digital thermostat panel that indicated the room's temperature.

In a concurrent interview with the Manager, he stated Plant Operations (Plant Ops) monitored the temperature and RH in both of the CC rooms. He stated he received a fax early every morning that contained the temperature and RH readings. He would document the readings in the log to ensure that both temperature and RH were within acceptable range. When the manager was asked, he was unable to state the acceptable ranges (temp and RH). He stated, "It's on the log." The temperature and RH log was reviewed and indicated the acceptable ranges were 30 to 68% (RH) and 62 to 70 ?F (temperature). The manager stated what was on the log were the acceptable ranges.

On January 19, 2012, at 9:40 a.m., the facility policy titled, "OR Temperature, Humidity Monitoring," approved May 22, 2010, was reviewed with the DPO, CNO, IP 1, and IP 2. The DPO stated the facility's policy was applicable to the CC rooms. The temperature range was 68 to 75 ?F and the RH range was 35 to 60%. The DPO stated the facility used a "double-check" system where the plant ops staff monitored the ranges and faxed a copy of the ranges to the departments, which ensured the department staff would know if the temperature and RH readings were within the acceptable ranges.

The "Cardiac Cath (CC) Lab (Room) Humidity and Temperature Log" was reviewed with the DPO. The DPO stated the ranges on the log were the old ranges and not current. The DPO stated the log needed to indicate the temperature and RH ranges within the facility policy.

The policy indicated, "Purpose: To provide a monitoring and feedback system for maintaining appropriate humidity and temperature for the Operating Rooms (OR) and Cardiac Catheterization Rooms as proper functioning of these components minimizes the risk of fire hazard and infection to the patient...Relative humidity should be maintained between 35% to 60% within the perioperative suite, including operating rooms (OR & Labor and Delivery) and cardiac catheterization rooms...Temperature should be maintained in a range between 68 ?F to 75 ?F..."

In a concurrent interview, IP 2 stated the 2011 AORN recommendations were to keep the OR's temperature between 68 to 73 ?F and the Cardiac Catheterization Rooms between 68 to 75 ?F. She stated there was no change in the RH ranges, 30 to 60%.

According to the NFPA, the relative humidity should be equal or greater than 35% in anesthetizing locations.



26881

3. The medical record of Patient 57 was reviewed on January 17, 2012. Patient 57 was admitted to the facility for surgery on January 16, 2012. Pre-operative documentation included the Surgery Booking Sheet and Physicians Pre-Op Order Sheet, signed by the surgeon on January 4, 2012, indicated the procedure to be performed and consented was a "laparoscopic single port LEFT salpingo-oophorectomy (procedure performed using a camera and instruments through small incisions in the abdominal wall to remove the left ovary and left fallopian tube)." The consent form signed by the patient on January 12, 2012, was for an "examination under anesthesia, laparoscopic LEFT salpingo oophorectomy, possible exploratory laparotomy." The PN-Surgical Operative Assessment Progress Note indicated that the pre-operative diagnosis was "left lower quadrant pain, persistent left adnexal mass, simple cyst right ovary."

The post-operative documentation for Patient 57 was also reviewed. The procedure recorded on the Operative Assessment Progress Note was a laparoscopic lysis of adhesions, left salpingo-oophorectomy and right ovarian cystectomy.

a. During an interview with RN 8 on January 17, 2012, at 11:30 a.m., she stated there was no consent for removing the cyst from the right ovary. She stated that with ovaries, "it seems like we are not doing sides--they usually write possible bilateral."

The facility policy, "Informed Consent, revised 5/09," was reviewed. The policy indicated, "The hospital's role in the informed consent process is to verify that the physician obtained the patient's informed consent before the physician is permitted perform the procedure or that an exception (such the emergency exception) applies that allows treatment to proceed."

b. During an interview with RN 9 on January 17, 2012, at 11:45 a.m., she stated that if the surgeon deviated from what was discussed in time-out, it should be discussed with the OR staff. She reviewed the medical record and stated that there was no discussion of a change in the intended surgery noted in the post-op note.

c. During an interview with RN 9 on January 18, 2012, at 11:40 a.m., she stated that for laparoscopic surgery, no site marking was done.

The facility policy, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, reviewed 3/11," indicated, "The surgical site will be marked for laparoscopic cases that involve operating on organs that have laterality (i.e., kidneys, ovaries)."

Based on interview and record review, the facility failed for one of 66 sampled patients (Patient 14), to ensure there was a properly executed informed consent prior to surgery. The consent did not indicate a site/side for the procedure. Also, the facility failed to ensure that the physician discussed the risks and benefits of the surgery with the patient and obtained informed consent, creating the risk that Patient 14 was not given the information needed to supply consent for the operation performed.

Findings:

The "Consent to Surgery / Special Procedures / Anesthesia," dated and signed by Patient 14 on October 13, 2011, was reviewed. The consent indicated a "scar revision," as the operation or procedure to be performed. The consent did not indicate a site/side for this procedure.

On January 19, 2012, RN 2 was interviewed. RN 2 stated she was the pre-op interview nurse for Patient 14. RN 2 stated Patient 14 came in the day before her scheduled surgery. RN 2 witnessed the patient sign the consent and ensured the informed consent matched the physician orders. She asked Patient 14 about the procedure to be performed and the patient pointed to her right side and stated, "I'm getting my Frankenstein scar fixed." RN 2 was not aware at that time that Patient 14 had multiple scars. RN 2 stated the consent should have indicated the site and side of the scar revision.

On November 7, 2011 and January 19, 2012, RN 3 was interviewed. RN 3 stated she was the pre-op nurse for Patient 14 on the day of her surgery. RN 3 stated as part of her usual duties, she reviewed the informed consent, physician orders, booking sheet, and schedule, to ensure they all matched. RN 3 stated all forms indicated, "scar revision," with no site/side indicated. She noticed they did not contain a site or side, but did not further question this because the patient pointed to and showed her the scar on the right side. RN 3 stated she did not see a scar on the left side, and at that time was not aware that Patient 14 had multiple scars. RN 3 stated the consent should have indicated the site and side of the procedure.

The policy titled, "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery," with a reviewed date of March 2011, was reviewed. The policy indicated the following:

a. The facility shall identify the correct patient, procedure and anatomical side/site prior to all operative and invasive procedures.

b. Prior to performing the procedure, the surgical/ procedural team will take a moment ("time out"). "Time-out" must be performed immediately before starting the procedure. "The team shall verbally verify the following: ..., An accurate procedure consent form..."

c. For the verification process the policy indicated, "For scheduled operative/invasive procedures, the proposed side/site must be clearly identified on the scheduling form... The words 'right' and 'left' must be clearly spelled out."

d. "All relevant documentation including the consent form...shall be verified by the pre-procedural nurse/procedural team. If there are any discrepancies or uncertainties, the pre-procedural nurse/procedural team shall call the surgeon/physician for clarification prior to the start of the procedure.

e. Any discrepancies identified during the verification process and/or the "Time Out" process must be resolved prior to the start of the procedure.



26881

The preoperative H&P for Patient 14 was reviewed and indicated that the risks and benefits of the surgery were discussed with the patient by the PA, who performed the H&P. No additional documentation was found in the medical record indicating that a second discussion regarding the risks and benefits of the proposed surgery with Patient 14 by the surgeon occurred.

The facility policy, "Informed Consent, revised 5/09," indicated, "The patient's physician is responsible for providing the information the patient needs in order to make an informed decision and for obtaining the patient's informed consent or refusal for the recommended procedure."

During an interview with the MSC on January 20, 2012, at 11 a.m., she stated that PAs cannot, in lieu of the physician, provide surgical risks and benefits information to the patient.

Based on observation, interview, and record review, the facility failed to ensure that a post-anesthesia assessment was completed while the patient was alert for Patient 58, resulting in the risk of an inadequate post-anesthesia assessment and poor health outcome for that patient.

Findings:

During an observation of Patient 58 from her arrival in the PACU on January 17, 2012, at 10:50 a.m. until 10:55 a.m., the patient appeared somnolent. The staff was speaking to her in loud voices, but the patient was not able to cooperate with their requests. Supplemental oxygen was placed on the patient.

During a review of the medical records of Patient 58 on January 17, 2012, Anesthesia Record indicated that she received general anesthesia. The Extubation/Post Op note made by the CRNA (nurse anesthetist) on the Anesthesia Record indicated the patient was Alert, responsive and cooperative at 10:50 a.m., upon extubation. The Post-Anesthesia Exam documented by the CRNA at 10:55 a.m., indicated that the patient was awake and responsive, but the boxes for alert and oriented were not checked. The box for respiratory, within pre-op baselines, was checked despite the fact that the patient was on supplemental oxygen.

During an interview with RN 8 on January 17, 2012, at 11:45 a.m., she stated that Patient 58 was not alert or able to participate in her own care upon arrival in the PACU after surgery.

During a review of the facility's "Advance Practice Allied Health Practitioners Rules and Regulations, approved 3/18/10," the supervising physician is to, "Assure that the AHP provides services in accordance with accepted medical standards..."

According to the Practice Guidelines for Post-Anesthesia Care, formulated by the American Society of Anesthesiology and published in March 2002, routine post-anesthesia monitoring should include monitoring of respiratory function, cardiovascular function, mental status, temperature, pain, nausea and vomiting, and postoperative hydration.