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

TRINITY HOSPITALS 407 3RD ST SE MINOT, ND 58701 April 17, 2013
VIOLATION: MEDICAL STAFF - APPOINTMENTS Tag No: A0046
Based on record review, policy and procedure review, review of bylaws, meeting minutes, credentialing records, and staff interview, the governing body failed to ensure 1 of 1 physician (Physician #1) who administered conscious sedation to a patient while changing dressings had privileges for conscious sedation. Failure of the governing body to ensure physicians have privileges for procedures, including conscious sedation, limits the governing body's ability to ensure physicians are qualified and competent to perform the procedures.

Findings include:

Review of governing board bylaws titled "Bylaws of Trinity Health" occurred on 04/16/13. These bylaws, effective June 1, 2012, stated,
". . . Article 7 - Medical Staff
7.1 Medical Staff. The Board of Directors has responsibility for safety and quality . . . for hospital performance. This includes . . . qualifications . . . of the Medical Staff. In this context, the governing body shall assure the following: . . .
7.1.3 Receipt and approval of recommendations from the Medical Executive Committee (MEC) for appointment and reappointment of privileges for practitioners . . ."

Review of Trinity Hospitals Medical Staff Bylaws occurred on 04/16/13. These bylaws, effective June 2011, stated,
". . . Article VI. Medical Staff Appointment & Clinical Privileges
. . . 6.1 Exercise of Privileges
A practitioner providing clinical services at the Hospital may exercise only those privileges specifically granted to him by the Board . . ."

Review of the medical staff executive committee meeting minutes occurred on April 16-17, 2013. The 01/08/13 minutes included an attached letter sent to providers and a copy of the updated sedation policy. The letter, dated 02/28/13, stated, "Enclosed is the updated sedation policy for Trinity Health. This has been reviewed through the departments and approved by the Medical Executive Committee. . . . This policy summarizes qualifications . . ."

Review of the policy "Procedural Sedation/Anesthesia Policy" occurred on 04/17/13. This policy, approved 12/12, stated,
". . . I. Policy: a. Definitions: . . . v. Moderate sedation (Conscious Sedation . . .) . . .
II. Staff qualifications for Administration and Monitoring of Sedation: a. Physician: . . . ii. May provide Moderate Sedation with additional privileging. . . ."

- Review of Patient #29's closed medical record occurred on April 10-11, 2013. A physician's progress note, dated 03/30/13 at 7:55 a.m., stated, ". . . [Patient #29] had dressing changes at bedside yesterday under conscious sedation. . . ."

- Review of Physician #1's credentialing file occurred on 04/17/13. The file lacked evidence the governing body had granted Physician #1 privileges for moderate sedation on or before 03/29/13.

During interview, on 04/11/13 at 11:00 a.m., an administrative nursing staff member (#1) reported she met with Physician #1 immediately after completion of Patient #29's procedure on 03/29/13 and informed Physician #1 the Hospital had not granted him privileges for conscious sedation.
VIOLATION: QAPI Tag No: A0263
Based on observation, review of policy and procedure, review of safety event reports, review of the Hospital's "Clinical Excellence and Patient Safety Plan" (CEPS), record review, and staff interview, the Hospital failed to complete a comprehensive review of data obtained through the safety event reporting process and failed to ensure monitoring of infection control practices (Refer to A266); failed to set priorities for performance improvement, focusing on high risk areas, considering the severity of problems, and implement measures and corrective actions to prevent further occurrences and failed to ensure monitoring of infection control (Refer to A283); failed to measure, analyze, and track all adverse patient events and medical errors and implement preventative actions and mechanisms (Refer to A286); and failed to implement and maintain an ongoing program for quality improvement regarding investigation of events reported by Hospital staff (Refer to A309).

These failures have the potential to affect the health and safety of all patients receiving services from the Hospital and limited the Hospital's ability to ensure quality and continuity of care for all patients served.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observation, review of policy and procedure, review of safety event reports, record review, and staff interview, the Hospital failed to complete a comprehensive review of data obtained through the safety event reporting process, including significant medical errors, which affected 3 of 3 patient closed records (Patients #29, #32, and #34), and failed to ensure proper infection control practices occurred for 2 of 2 sampled patients (Patient #9 and #10) observed having blood obtained for glucose monitoring. Failure to monitor all safety events, including privatizing high risk safety events, staff performance, root cause, and implement measures and evaluate the effectiveness of those measures has the potential to affect the health and safety/care provided to all patients receiving services from the Hospital.

Findings include:

Review of the Hospital's "Facility-Wide/Safety" reporting policy, occurred on 04/11/13. The policy, dated January 2011, and revised on March 2013, stated:
". . . PURPOSES:
1. To create a culture of safety that promotes open communication about healthcare safety events/variances. . . .
3. To identify factors contributing to safety events/variances/near misses to prevent their recurrence and to improve patient care and treatment.
4. To provide data for quality improvement activities.
5. To identify procedural changes that could eliminate or reduce injuries to patients, employees, providers, or visitors. . . .
POLICY:
. . . The Board delegates this responsibility to the appropriate QI [Quality Improvement] Committees to review safety events/variances for overall trends and patterns . . .
Definitions:
A safety event is a variance not consistent with the desired care of our patients . . . It is an actual event or a near miss situation that could result in an injury to a patient . . . events may be related to professional practice . . . procedures, and systems . . .
The department leader: a. Reviews the safety event report to verify the information is complete and correct . . . reviews all actions, identifies contributing causes/conditions responsible for event, communicates with other departments as necessary, and electronically signs off at the bottom. . . .
Follow-up:
. . . If it is an event that could change the clinical course of the patient, the provider should be notified as soon as possible. . . .
Routing:
Safety events are entered into the electronic data base, compiled quarterly, and analyzed looking for trends. . . .
The QI Medical Staff reviews clinical safety events. . . .
The Board of Directors reviews safety events."

- Review of QI committee meeting minutes occurred on 04/17/13. The committee met on 10/23/12, 12/06/12, 01/22/13, 02/25/13 and 03/26/13.

Review of safety event reports occurred on April 8 - 11, 2013. An event report identified Patient #34 received anesthesia two times in January 2013 for the same surgical procedure. Refer to A 353. The QI minutes did not reflect the review of this medical error in the February or March 2013 meetings.

Review of the safety event report regarding Patient #34 identified the event occurred on 01/26/13, report written on 01/27/13, and the completion of three follow up reports by:
* an administrative surgical staff member (#5), dated 01/30/13, which identified concerns regarding the anesthesia department and the administration of the medication.
* Physician (#8), dated 01/31/13, identified the main issue was not following policy, as well as Physician (#20) failed to respond. The report lacked evidence of recommendations and/or corrective action as a result of the event.
* an administrative anesthesia staff member (#7), dated 03/18/13, which stated, ". . . Give us your recommendations on what needs to be done as a result of this event: Clear go ahead prior to anesthesia induction. Surgeon on call that schedules surgery needs to be reachable. . . ."

Review of Anesthesia Department Staff Meeting notes occurred on 04/17/13. The minutes, dated 02/27/13, identified seven of eight medical doctors of anesthesia (MDA's) in attendance. The minutes stated, ". . . [Physician (#20)] - his start time is a chronic problem, [Physician (#8)] has asked that you be patient with his start time. All felt this is a huge dissatisfaction to patients and to staff. MDA's want it fixed and would like . . . to press the issue. It is felt by all this is very poor patient care. . . . Discussed with [Physician (#8)] after our group meeting. It will take 2 orthopedic surgeons to replace [Physician (#20)]. The agreement right now is that he should start at [3:00 p.m.] during weekdays and [1:00 p.m.] during weekends. . . . This agreement will not change . . ."

- Review of the safety event report regarding Patient #32 identified the event occurred on 03/30/13, and an initial report written on 04/02/13. The report identified Physician (#2) accepted a patient from a referring critical access hospital (CAH) and eight minutes after the CAH had the the patient enroute via an air ambulance, Physician (#2) phoned the emergency department at the CAH to indicate he had changed his mind and would no longer accept the patient as "It's going to be too much work for me."

A "Follow-up Preview," dated 04/09/13, identified the "Report reviewed" and referred to the Department of Surgery Chair (Physician #3) for review or action. Due to the absence Physician #3, no action occurred from March 31-April 14, 2013. A staff member (#2) reported no other physician or administrative staff member reviewed the event regarding Patient #32. The Hospital did not assure any medical staff or other administrative staff took action on the report until 15 days or more after the event occurred.

Failure to provide treatment placed Patient #32 at risk of unnecessary pain and risk of further complications.

- Review of the Hospital safety event report and record review regarding Patient #29 occurred on April 10-11, 2013. The event occurred on 03/29/13, and a staff member wrote up the event report on 03/30/13. The summary, dated 04/02/13, stated ". . . Event noted. MD's [Medical Doctor] should be following proper procedure for doing dressing changes. Versed and Fentanyl [sedative-hypnotic and opioid analgesic used for moderate sedation] to give a patient for a procedure such as dressing change is procedural sedation. [Physician #1] does not currently have procedural sedation privileges. . . . Immediate Action Taken: Event noted." The Event Summary lacked additional information regarding preventive measures implemented including education, further monitoring, measures with both the physician/provider and all applicable staff members.

Following discussion regarding a lack of corrective action for this issue, with a supervisory nursing staff member (#2) on 04/10/13 at 10:00 a.m., this staff member (#2) provided a "Follow-up Preview" for this Event Summary. The "Follow-up Preview," dated 04/10/13 at 12:30 p.m., stated ". . . Summary Finding: [Physician #1] want [sic] to change dressings on the unit with procedural sedation with ICU [Intensive Care Unit] staff to monitor the patient. This was arranged and then the physician told the staff that they should change the dressings and he was going to leave the unit.
Immediate Action Taken: Administration notified, after discussion and meetings, it was decided to take the patient to surgery to do the procedure. . . . Recommendation . . . hospital policy needs to be followed and staff education as to the appropriate steps needed to be done." The event lacked evidence of corrective action for the physician involved and monitoring for similar events.

- On 04/08/13 at 4:40 p.m. to 4:50 p.m. a nurse (#17) obtained a glucometer and checked the blood glucose level of Patient #9, diagnosed with acquired immunodeficiency syndrome (AIDS), and then immediately checked Patient #10's blood glucose with the same glucometer. The nurse failed to disinfect the glucometer between patients and before placing it back into storage for use on the next patient. The staff member failed to perform proper infection control practices regarding the disinfection of the glucometer: Refer to A 749.

During interview, on the morning of 04/17/13, two administrative staff members (#1 and #3) identified:
* the infection control department does not monitor the staff practices regarding the cleaning of glucometers. The staff members did not provide evidence of data collection, root cause analysis, measures implemented to prevent reoccurrences, and the evaluation of the measures implemented.
* Safety measures for problem areas identified in safety reports do not necessarily carry over from one department to another, even on nursing units.
* Stated the Clinical Excellence and Patient Safety (CEPS) department does review all safety event reports and makes sure investigations occur, and if not will send out reminders to ensure this occurs. The staff member (#3) stated the CEPS department determines the department's responsible for corrective action. The staff member did not state who provided oversight for the plan and corrective action.
* Stated the Hospital reviews safety events however understood the importance of prioritizing high-risk events
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on policy and procedure review, and review of Safety Event reports, the Hospital failed to set priorities for performance improvement, focusing on high risk areas, considering the severity of problems, and implement measures and corrective actions to prevent further occurrences as evidence by review of significant medical errors which affected 3 of 3 sampled patient's closed records (Patients #29, #32, and #34), and failed to ensure proper infection control monitoring and practices occurred for 2 of 2 sampled patients (Patient #9 and #10) observed having blood glucose monitoring. Failure to recognize, prioritize, and monitor high risk areas affected these patients and has the potential to affect health outcomes, patient safety, and quality of care for all patients served.

Findings include:

Review of the "Clinical Excellence & Patient Safety Plan" occurred on April 16-17, 2013. The plan, dated May 2011, included a "Prioritization Matrix" which stated, "Where there is a need to determine appropriate resource allocation within the organization to meet the established goals of the organization, the Prioritization Matrix assists in selecting which of the projects, competing for the Care System resources, takes precedence. This tool is also used both intra and inter-departmentally."

Review of the Hospital's policy on "Facility-Wide/Safety" reporting policy, occurred on 04/11/13. The policy, dated January 2011, and revised on March 2013, stated:
" . . . The Board delegates this responsibility to the appropriate QI [quality improvement] Committees to review safety events/variances for overall trends and patterns . . .
Definitions:
A safety event is a variance not consistent with the desired care of our patients . . . It is an actual event or a near miss situation that could result in an injury to a patient . . . events may be related to professional practice . . . procedures, and systems . . .
The department leader: a. Reviews the safety event report to verify the information is complete and correct . . . reviews all actions, identifies contributing causes/conditions responsible for event, communicates with other departments as necessary, and electronically signs off at the bottom. . . .
Follow-up:
. . . If it is an event that could change the clinical course of the patient, the provider should be notified as soon as possible. . . .
Routing:
Safety events are entered into the electronic data base, compiled quarterly, and analyzed looking for trends. . . .
The QI Medical Staff reviews clinical safety events. . . .
The Board of Directors reviews safety events."

- The Hospital's "Facility-Wide/Safety" policy failed to address the Hospital's expectation for high-risk events, and who and how notification should occur, other than the provider.

- Review of three safety event reports occurred on April 8-11, 2013. The reports identified three patients affected (Patient #29, #32, and #34) and addressed care provided by physicians/providers. Refer to A 266. Review of the reports showed:
* Patient #34: Event occurred on 01/26/13, report written on 01/27/13, and departments involved responded on 01/30/13, 01/31/13, and 3/18/13. The last reviewer stated, ". . . Give us your recommendations on what needs to be done as a result of this event: Clear go ahead prior to anesthesia induction. Surgeon on call that schedules surgery needs to be reachable. . ."

- Patient #29: Event occurred on 03/29/13, report written on 03/29/13, and a summary completed on 04/02/13. The event report identified no immediate action taken. The event lacked evidence of corrective action for the physician involved and monitoring all physicians for performing procedures credentialed for.

- Patient #32: Event occurred on 03/30/13, report written on 04/02/13. A "Follow-up Preview," dated 04/09/13 (10 days later), identified the "Report reviewed" and referred to the Department of Surgery Chair for review or action. The Hospital did not assure any medical staff or other administrative staff member took action on the report for 15 days after the event occurred.

Each event lacked evidence of determining causative factors, an action plan, implementation of measures to prevent reoccurrences and the evaluation of those measures.

- On 04/08/13 from 4:40 p.m. to 4:50 p.m., observation showed a nursing staff member (#17) failed to clean a glucometer (blood glucose monitoring device) between patient use. After performing an accucheck on Patient #9, diagnosed with acquired immunodeficiency syndrome (AIDS), the nurse immediately checked Patient #10's blood glucose with the same glucometer without sanitizing it first. The nurse also failed to sanitize the glucometer before placing it back into storage for use on the next patient. Failing to monitor infection control practices has the potential to affect all patients and cause preventable illnesses.

The Hospital failed to set priorities for its performance improvement activities including high-risk events.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on record review, policy, procedure form, and staff interview, the Hospital failed to ensure informed consent and written consent occurred prior to invasive procedures for 1 of 4 invasive procedure (vascular catheter/dialysis shunt) performed on Patient #31, and 3 of 3 invasive procedures (placement of a vena cava filter, debridement of decubitus ulcer, and jejunostomy tube placement) performed on Patient #5. Failure to obtain informed and written consent does not ensure the patient's wishes and/or designated person to exercise the patient's right to participate in the development and implementation of the patient's plan of care.

Findings include:

Review of a Hospital form titled "Request for Performance of Operations, other Special Procedures and for Administration of Anesthesia" occurred on 04/11/13. The form allowed a provision for the patient or representative to sign a consent for all operations and other special procedures. The consent form also provided for a "Physician Affirmation" signature, date and time, acknowledgement the patient received information of a "procedure or treatment and sedation plan as well as the reasonably anticipated benefits, risks, alternatives or side effects, including potential problems that might occur . . . I believe the patient or representative understands."

Review of the Hospital policy on "Consent/Informed" occurred on 04/11/13. The policy, dated December 2010, stated, ". . . The treating physician/provider is responsible to provide the patient with adequate information in terms that a layperson can understand to enable them to participate in care decisions and enable them to make an intelligent and rational decision. This information can be provided verbally . . . Patient understanding is verified by the patient signature on the consent form. . . . The Informed Consent form shall be used for any operative or invasive procedure or treatment . . ."

- Review of Patient #31's medical record occurred on April 09-11, 2013. The record identified the patient had four invasive procedures while hospitalized . The record lacked a written consent for a vascular catheter/dialysis shunt on the patient's last day of stay in the Hospital.

- Review of Patient #5's record occurred on April 09-11, 2013. The record identified the patient had three invasive procedures (placement of a vena cava filter, debridement of decubitus ulcer, and jejunostomy tube placement) without evidence of informed consent.

During interview on 04/11/13 at 11:50 a.m., an administrative staff member (#2) verified Patient #31's record lacked a written consent for the vascular catheter and Patient #5's record lacked evidence of informed consent for the three procedures. The staff member stated if the physician failed to sign a consent form, then the Hospital expected the physician to include the informed consent in a progress note.
VIOLATION: PATIENT RIGHTS: ADVANCED DIRECTIVES Tag No: A0132
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and facility policy and procedure review, the hospital failed to comply with 1 of 1 inpatient's advance directive (Patient #15). Failure to follow the advance directives set forth by a patient is an infringement of their rights.

Findings include:

Review of the facility policy titled "Advanced Medical Directives" occurred on 04/11/13. This policy, revised July 2008, stated, ". . . PROCEDURES: Patient Information/Documentation of Advance Directives:
1. Trinity Hospital will accept all AMDs (Advance Medical Directives) and will insure incorporation of these directives in the patient's medical record. There will be no documentation of AMDs available in the Emergency Trauma Center (ETC) unless an AMD is provided to the ETC staff by the patient, the patient's family, or the patient's physician at the time of admission. AMD tracking only begins once a patient has been admitted . Any Physician and/or any Trinity Hospital employee who receives an original or a copy of a patient's AMD or revocation of AMD from any person, shall immediately see that the same is forwarded to the Nursing Supervisor on duty at that time . . . c. In the event an individual has been a patient at Trinity Hospital, the AMD will be forwarded to HIM [Health Information Management] for inclusion in the medical record . . .
DURABLE POWERS OF ATTORNEY FOR HEALTH CARE ADMINISTRATION:
1. A patient may, while competent, execute a Durable Power of Attorney for Health Care (DPAHC) enabling them to retain control over their own medical care during periods of incapacity through the prior designation of an agent to make health care decisions on their behalf.
2. A DPACH becomes operative when the patient lacks capacity to make health care decisions, as certified in writing by the patient's attending physician and noted in the patient's medical records . . .
After consultation with the attending physician and other health care providers, unless otherwise restricted by the terms of the DPAHC, the agent shall be entitled to:
a. Request, review and receive any information, oral or written, regarding the patient's physical or mental health, including medical and hospital records;
b. Execute any releases or other documents which may be required in order to obtain such information;
c. Consent to the disclosure of such medical information;
d. Make health care decisions in accordance with the agent's knowledge of the principal's wishes and religious or moral beliefs as stated orally or as contained in the DPAHC or in any properly executed Living Will; or
e. If the principal's wishes are unknown, make health care decisions in accordance with the agent's assessment of the principal's best interests.
4. When a clinical situation arises which may result in the necessity of the patient to make a health care decision and it appears that the patient is incapable of making such decision, Nursing will verify the existence of a DPAHC by reviewing the patient's current medical chart. If the existence of a DPAHC is verified, Nursing will ensure that a copy of the document is placed immediately behind the current admission record and the attending physician will be notified, documenting this in the medical record
5. A patient's primary physician, having knowledge of the patient's DPAHC, is bound to follow the directives of the patient's designated agent to the extent they are consistent with the North Dakota Durable Power of Attorney for Health Care statute and any specific directives listed in the DPAHC. Subject to the provisions of this policy, Chapter 23-06.5 of the North Dakota Century Code and any express limitation set forth by the principal in the DPAHC, the agent has the authority to make any and all health care decisions on the principal's behalf that the principal could make if competent. In the event that an immediate health care decision must be made, and after reasonable attempts, the agent is unable to be reached, the attending physician may proceed to attempt to contact any alternate agents who may have been named in the DPAHC, in the descending order of their appointment. The first available agent in the order of priority who is contacted may then make health care decisions on behalf of the patient in accordance with this policy. The medical record shall be documented with the attempts made to contact the primary agent or other agents with greater priority. . . ."

Review of Patient #15's medical record occurred on April 09-11, 2013 and identified the hospital initially admitted the patient on 03/21/13 (to the rehabilitation unit) with diagnoses of [DIAGNOSES REDACTED]#15 resided on the medical floor at the time of survey. (Exact transfer dates to each floor in the hospital unknown).

Patient #15's Durable Power of Attorney for Health Care, signed 01/12/12, identified the patient designated and appointed [Family Member A] as her attorney in fact (agent) to make health care decisions for her if she became unable to make her own health care decisions. The document stated, "For the purposes of this document, 'health care decision' means consent, refusal of consent, or withdrawal of consent to any care, treatment, service, or procedure to maintain, diagnoses, or treat an individual's physical or mental condition . . . If the person designated as my agent . . . is not available or becomes ineligible to act as my agent to make a health care decision for me or loses the mental capacity to make health care decisions for me . . . then I designate and appoint the following persons to serve as my agent to make health care decisions for me as authorized in this document, such persons to serve in the order listed below:
a. First Alternate Agent: [Family Member B] . . .
b. Second Alternate Agent: [Family Member C]. . . ."

Review of physician's hospital progress notes identified the hospital spoke with Patient #15's alternate agent (Family Member B) rather than her primary agent (Family Member A) as identified in the following notes:
*04/02/13, ". . . I had a long discussion with the patient's daughter [Family Member B]. I discussed the option of giving her Dilantin in addition to Keppra to see if this improves her nonconvulsive status. She has agreed with this approach. . . ."
*04/03/13, ". . . History of Present Illness: The patient is an [AGE]-year-old female who was in [Assisted Living Facility] and then went to rehabilitation. She was having difficulties with ADLs [activities of daily living] with increasing weakness and confusion . . . She had altered mental status . . . Neurology was consulted . . . Initial EEG [electroencephalography] did not show status, but subsequent EEGs did show status with generalized myoclonic jerking. It was recommended to the patient's family that the patient be intubated and be put in a drug induced coma to try to break the seizures and also it would help facilitate getting an MRI [Magnetic Resonance Imaging] to look at her brain . . . Impression: This is a patient with respiratory failure with nonconvulsive [DIAGNOSES REDACTED]. The patient is now on a Versed drip. She is breathing over and above the vent [ventilator]. . . ."
*04/03/13, ". . . There is no sign of improvement. The patient continues to be lethargic, confused, and at times agitated . . . There was no sign of improvement . . . suffers from nonconvulsive status with unknown underlying cause . . . Plan: I had a long discussion with the patient's daughter, [Family Member B]. At this moment the plan is to proceed with more aggressive management, including intubation and sedative therapy . . . We will get an MRI done today. If there is evidence for hypoxic brain injury on MRI, then the likelihood of recovery from this will be very low; therefore, we will not keep her intubated in burst suppression pattern for more than 24 hours. If her MRI is unremarkable, after 24 hours I will taper down her medication to see if she wakes up. If she does not wake up, we will keep her intubated on midazolam for another 24 hours . . . The patient will be intubated and transferred to the ICU. . . ."
*04/08/13, ". . . History of Present Illness: . . . She has been on Dilantin and Keppra, both of which were still unable to break the seizures, even utilized at the same time. We sent her down to the ICU, sedated her, and intubated her, and on the initial dose of midazolam it still did not break the seizure activity. She ended up on a very high dose of midazolam. With a total of 48 hours of suppression still were unable to break her nonconvulsive status. After a long discussion with neurology and the family, ultimately the decision was to go to code level 4, comfort cares only. Yesterday I talked again with one of the daughters at length, and she was concerned that the patient might be trying to communicate a little bit more and was wondering if things might be changing. We repeated an EEG again yesterday which showed no difference from previous ones, still in nonconvulsive status. The patient does remain code level 4 with comfort cares at this time. . . ."

The facility failed to notify Patient #15's appointed agent [Family Member A] and obtained consents and signatures from the patient's first alternate agent [Family Member B] for the following documents/procedures:
*Consent Form for a MRI, signed 03/31/13
*Consent Form for Patient Rights, signed 04/01/13
*Consent Form for a lumbar puncture with sedation, signed 04/01/13
*Consent Form for a MRI of the brain with and without contrast and with sedation, signed 04/01/13
*Consent Form for a MRI, signed 04/02/13
*Notice of Medicare Rights, signed 04/02/13
*Consent Form for a peripherally inserted central catheter (PICC), signed 04/03/13

Review of Patient #15's medical record lacked evidence the hospital notified the patient's primary Power of Attorney regarding admission, transfers within the hospital, and on her declining condition; and failed to attempt to contact the primary Power of Attorney to obtain consent for procedures and direction on how to proceed with her plan of care once the patient was unable to make her own health care decisions.
VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY Tag No: A0143
Based on observation, record review, and staff interview, the Hospital failed to ensure staff provided personal privacy and dignity for 9 of 30 sampled active patients (Patient #11, #12, #13, #15, #16, #17, #20, #23, and #36) observed during medical/nursing treatments and entering patient's room without knocking, and failed to ensure staff provided dignity and comfort for 2 of 11 sampled closed patients (Patient #28 and #29) reviewed. The failure of staff to ensure the patient's personal privacy and dignity limited the Hospital's obligation to fulfill the patient's right to respect, dignity, and comfort.

Findings include:

- Patient #29's record review occurred on April 09-10, 2013. A "Safety Event Summary and Follow-up History," dated 04/02/13, identified a physician called a nurse (not on the specific nursing unit) at 1:45 p.m. to obtain supplies, including a (heart) monitor and medications in order to complete a dressing change for Patient #29's burns. The event report stated that upon arrival to the floor, the nurse discovered the physician was in the operating room. The nurse paged the physician at 2:05 p.m. and the physician said he would be back in one hour to do the dressing change. The report stated, ". . . Pt. [patient] was informed of this and was upset with the fact he had to wait an hour and his right arm was exposed to air. Mother also present, voicing concerns of sterility in the meantime. . . ."

During interview, on 04/11/13 at 11:00 a.m., an administrative nursing staff member (#1) and a supervisory nursing staff member (#3) agreed the Hospital staff should not have removed Patient #29's dressings or should have applied other dressings until the physician arrived for the dressing change.

- A "Safety Event Summary and Follow-up History," regarding Patient #28, identified on 03/05/13 at 7:30 a.m., ". . . Was told in report from night shift nurse that patient was left up in chair all night. When this nurse went in to check on patient, urine had leaked out of her brief due to brief being saturated with urine. . . ."

During interview, on 04/11/13 at 11:00 a.m., an administrative nursing staff member (#1) and a supervisory nursing staff member (#3) confirmed the Hospital staff failed to provide Patient #28 a change in position and the medical record failed to identify the staff offered to toilet or change Patient #28's brief from 8:00 p.m. to 8:00 a.m. (12 hours).

Patient #29 waiting for over an hour after the physician planned a dressing change, and nursing staffs' failure to provide toileting assistance for Patient #28 does not enhance each patients' right to dignity, respect and comfort.





- On the morning of 04/09/13, a nurse (#26) entered Patient #23's room to administer medication. While standing at Patient #23's bedside, the nurse told an unidentified staff member outside the door that Patient #20 was scheduled for a procedure that morning.





- During an observation on 04/08/13 at 4:02 p.m., a nurse (#17) entered Patient #12's room without knocking on the door prior to entering.

- During observation of medication pass on the morning of 04/09/13, a nurse (#15) entered Patient #36's room on three separate occasions to deliver medication. Observation showed Patient #36 shared the room with another patent. During one of the medication passes, a physician (#16) also entered the room without knocking.

- Observation in the hallway of the nursing unit on the morning of 04/09/13 showed a cart containing medical supplies placed outside an unidentified patient's room, which appeared as if staff were about to complete a procedure on the patient. Observation of the patient's room showed the door open with the patient lying in bed covered partially with a hospital gown and bed sheet; and showed the bed elevated and angled toward the middle of the room and door. Due to the position of the patient in the room and with the open door, persons passing through the hallway could view the patient.





- During observation on the afternoon of 04/09/13, a cardiopulmonary services staff member (#25) entered Patient #16's room to perform a diagnostic test without knocking on the door.

- During observation on the morning of 04/09/13, a nurse (#24) entered Patient #16's room to deliver medication without knocking on the door.

- During observation of medication administration on 04/09/13 at 10:45 a.m., a nurse (#24) entered Patient #17's private room without knocking on the door.

- On the afternoon of 04/09/13, a cardiopulmonary services staff member (#25) entered Patient #11's room to perform a diagnostic test without knocking on the door. The staff member (#25) left the door open while he completed the test which resulted in exposure of Patient #11's upper chest and abdomen by those walking by her room.

- During observation on 04/09/13 at 3:15 p.m., a nurse (#18) admitted Patient #13 in his hospital room with the door completely open to the corridor. While the nurse (#18) asked the patient questions regarding his personal identifying information and medical history, hospital staff and visitors stood in the corridor near Patient #13's open door, and the patient's door across the hall remained open with numerous visitors in the room.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of the Hospital's "Clinical Excellence and Patient Safety Plan" (CEPS), review of Safety Event reports (accidents and incidents) and staff interview, the Hospital failed to measure, analyze, and track all adverse patient events and medical errors and implement preventative actions and mechanisms that include feedback and learning throughout the hospital as evidenced by the review of 3 of 3 closed patient records (Patient #29, #32 and #34) who experienced medical errors. Failure to take corrective action may affect the outcome of all patients.

Findings include:

Review of the "Clinical Excellence & Patient Safety Plan" occurred on April 16-17, 2013. The plan, dated May 2011, stated:
". . . PURPOSE . . . The CEPS Plan keeps us mindful of the ongoing need to improve patient care, prevent medical errors and eliminate hazardous conditions through the ongoing assessment, measurement and analysis of systems and processes. . . . Ongoing measurement and analysis facilitate early identification of variation and risk to assure appropriate preventive actions and to eliminate undesired variation in systems and processes. . . . Analysis of near events and actual events to identify underlying concerns with systems and processes through root cause analysis and other tools. . . . ."

- Review of three safety event reports occurred on April 8-11, 2013. The reports identified three patients (Patient #29, #32, and #34) affected by medical errors. Refer to A 266. Each event report lacked evidence of determining the root cause of the incident/event and putting corrective measures in place. Review of the events identified specific staff/providers involved in the event. Each event failed to ensure corrective action occurred not only with the affected staff/providers, but including a system change or other mechanism to ensure compliance, feedback and learning throughout the hospital.

All three safety event reports identified physicians who failed to respond for patient treatment and/or conducted a sedation without credentialing privileges. Review of the physician/provider call schedules showed between January 24-31, 2013 Physician #20 took call for four consecutive days in a row, and in the month of April 2013, this pattern continued. Staffing schedules showed Physician #2 scheduled, uninterrupted, on call for two weeks in a row in April 2013. Record review did not identify these scheduling patterns as possible contributing factors when looking for causative factors.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and staff interview, the Hospital's governing body (or organized group who assumes full legal authority) failed to implement and maintain an ongoing program for quality improvement regarding investigation of events reported by Hospital staff for 3 of 3 closed patient records (Patient #28, #30, and #33). Failure to implement and maintain ongoing quality improvement limited the Hospital's ability to ensure quality of patient care, ensure ability of staff to respond appropriately to requests for care, and ensure the continuity of patient care.

Findings include:

- The Hospital's "Safety Event Summary and Follow-up History," regarding Patient #28, identified the following, dated 03/05/13 at 7:30 a.m., "BRIEF FACTUAL DESCRIPTION: Was told in report from night shift nurse that patient was left up in chair all night. When this nurse went in to check on patient, urine had leaked out of her brief due to brief being saturated with urine. . . . This nurse then called in a CNA [certified nursing assistant] to assist in cleaning up patient and putting her back to bed."

Review of Patient #28's medical record on April 10-11, 2013 identified the Hospital staff failed to reposition and change the patient's brief for a 12 hour period on March 04-05, 2013. (Refer to A-0395)

The Hospital's "Working Copy" for this Safety Event, provided on 04/09/13, identified a "General Investigation Due Date" of "03/20/13" and lacked results of any investigation of this Safety Event. Following discussion regarding this investigation, on 04/10/13 at 10:00 a.m., a supervisory nursing staff member (#2) reported the Hospital staff failed to complete this investigation. This staff member (#2) provided "Follow-up Preview" for this Safety Event, dated 04/10/13 at 4:50 p.m., which stated ". . . Immediate Action Taken: Plan will be to monitor then [sic] nurse involved and re educate her on hourly rounding and turning protocol and monitor her documentation. Will have her rewiew [sic] the policies with regards to the braden [sic] scale and watch the hourly rounding video. . . . Due Date: 04/24/2013 . . ."

- The Hospital's "Safety Event Summary and Follow-up History," regarding Patient #30, identified the following, dated 01/11/13 at 2:25 p.m., "BRIEF FACTUAL DESCRIPTION: Ward clerk received [sic] a call from the patient's room stating that she was in need of some help, an iv [intravenous fluid] pump could be heard beeping in the background. A staff nurse went to the room to check on the patient and reset the iv pump. When [the] nurse entered the room the patient was found between the bed and the armed [sic] chair next to it. Patient stated that she was 'done on the bedpan and was trying to get back into bed on her own.' . . . the patient also stated that 'I rang earlier and no one came down to get me.' . . ." The Safety Event Summary and Follow-up History lacked evidence of an investigation or corrective action regarding this event.

Review of Patient #30's medical record on April 10-11, 2013 identified the Hospital admitted the patient on 01/10/13 and discharged the patient on 01/16/13. Admission diagnoses included pneumonia, urinary tract infection, and a history of dementia. The medical record identified Patient #30 received a physical therapy evaluation on 01/11/13 at 2:15 p.m. and a staff member assisted the patient with perineal care and ambulation with her walker at 2:28 p.m.

Patient #30's medical record also included a Nursing Progress Note, dated 01/11/13 at 4:45 p.m., which repeated the events that are identified on the Safety Event Summary and Follow-up History at 2:25 p.m.

Following discussion regarding this event, on 04/10/13 at 10:00 a.m., a supervisory nursing staff member (#3) reported the Hospital staff failed to complete this investigation.

- Review of Patient #33's complaint to the Hospital occurred on April 10-11, 2013. Patient #33 and her mother submitted the complaint to the hospital on [DATE].

The complaint statement included ". . . Receptionist at front desk . . . didn't seem to understand that pt. [patient] had a severe burn that could not allow her sit down and wait. Asked receptionist for ice pack and only received one - not enough. . . . We left and got ice at the gas station and went to [another provider's convenience clinic] where she (daughter) was diagnosed with 2nd and 3rd degree burns and treated. . . ."

The Hospital's investigation of the complaint included the following statements:
*02/06/13, 8:45 a.m. - "Frontline admissions staff need education in patient interactions. . . . was an admissions issue, not ETC [emergency treatment center]."
*02/15/13, 10:30 a.m. - "I can't see that this patient was triaged by a nurse. There is a note saying not found in lobby x [times] 3. A burn should get at least a quick assessment by an RN [registered nurse]. I am not sure why that did not happen."

During interview, on 04/11/13 at 10:30 a.m., a supervisory ETC staff member (#27) confirmed the statements from the Hospital's investigation. This staff member reported staff planned to schedule department wide staff training however the facility failed to provide additional information regarding this training.

Failure to analyze all safety events for improvement of care including addressing system problems limited the Hospital's ability to ensure corrective action occurred.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on review of the Hospital's Medical Staff Bylaws and Rules and Regulations, review of the surgery and anesthesia department meeting minutes, call schedules, credentialing files, review of patient safety event documentation, review of a professional reference, record review, and staff interview, the Hospital failed to ensure the medical staff was accountable to the governing body for the appropriateness of patient care (Refer to A347) and failed to ensure the Medical Staff followed its bylaws (Refer to A353).

These failures resulted in delayed patient care, placed the patients at risk of complications, unnecessary pain, and adverse clinical outcomes; and limited the Hospital's ability to provide the necessary services to meet the needs of the patients.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, review of Hospital Medical Staff Bylaws, professional reference, and staff interview, the Hospital failed to ensure the medical staff was accountable to the governing body for the appropriateness of patient care, for 1 of 4 closed emergency department (ED) patient records (Patient #25). Failure to recognize Patient #25's low hemoglobin during the patient's ED visit resulted in delayed patient care and placed the patient at risk of complications related to bleeding and low hemoglobin.

Findings include:

Review of the Hospital's Medical Staff Bylaws occurred on 04/16/13. The Bylaws, adopted on 06/14/11, stated "Article I., Section 6. RESPONSIBILITIES OF EACH MEMBER, A. Each member agrees to provide appropriate . . . care of his patients. . . ."

The Mayo Clinic Internet site, mayoclinic.com, identified "normal" female hemoglobin levels as "12.0-15.5 grams/dl [per deciliter]."

Review of the Hospital's complaint investigation files identified Patient #25 contacted the Hospital by telephone on 11/14/12 regarding a visit to the ED on 04/12/12. Review of Patient #25's ED record identified the patient (MDS) dated [DATE] at 6:26 p.m. complaining of shortness of breath, chest pain, left arm pain, and jaw pain. The ED record identified laboratory blood values including "HGB [hemoglobin] 8.1 g/dl [grams per deciliter] LOW." The ED record also identified Patient #25 received the antianxiety medication, Ativan and Inapsine, a sedative and anti-nausea medication. The ED record stated Patient #25 ". . . was pain free and asymptomatic" at the time of discharge and to follow up with her physician as needed.

Patient #25's complaint to the Hospital indicated she continued to not feel well and she was seen at a physician's clinic office on 04/16/12. Laboratory blood values at the physician's office showed a Hgb level of "7.1" g/dl. The clinic physician recommended admission to the Hospital. Patient #25 returned to the Hospital's ED on 04/16/12 for admission. Patient #25's History and Physical, dated 04/16/12 at 5:08 p.m., included ". . . hemoglobin 7.1 [g/dl] . . ."

The patient's complaint on 11/14/12 initiated the Hospital's investigation of Patient #25's visit to the ED on 04/12/12. The physician reviewer's Issue Investigation Summary, dated 12/05/12 at 11:15 p.m. (nearly eight months after the ED visit), stated ". . . the hemaglobin [sic] is low at 8.1 [g/dl] and was normal two months prior. This should have trigered [sic] further investigation for bleeding sourse [sic]. There is no mention of [sic] discussion for need of follow up for this and no specific follow up timeframe is given. Anemia is not listed as a diagnosis. In reviewing the chart the low hemaglobin [sic] does not seem to be addressed at all. This should have been addressed at minimum with either further exam or discussion for close follow up. Scoring as follows: Outcome 1, Effect on Patient 2, Documentation 1, Overall Physician Care 3, Problem Identification - problem with physician diagnosis.

Immediate Action Taken: Reivewed [sic]. Letter to [Physician #4] for feedback. . . ."

Following interview regarding this investigation, on 04/11/13 at 11:30 a.m., a supervisory nursing staff member (#3) provided "Physician Scoring Guidelines, Revised 03/2012" for the scoring used in this Summary. These Guidelines identified the following definitions for the above scores:
"Outcome 1 - No adverse outcome . . .
Effect on Patient 2 - Increased monitoring or observation (e.g. [example given] vital signs]) . . .
Documentation 1 - No issue with documentation . . .
Overall Physician Care 3 - Physician care inappropriate . . .
Problem Identification - problem with physician diagnosis - 2 . . ."

The Hospital failed to identify inappropriate care of Patient #25 on her admission to the hospital on [DATE]. Patient #25's complaint to the Hospital initiated the investigation. The Hospital failed to ensure Physician #4's accountability for appropriateness of care provided until after Patient #25's complaint, nearly eight months after the patient's ED visit.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

1. Based on review of the Hospital's safety event summary, review of the Hospital's Medical Staff Rules and Regulations, and staff interview, the Hospital failed to ensure the Medical Staff followed its bylaws for 1 of 1 patient initially accepted for transfer to the Hospital and then denied treatment (Patient #32). Failure to provide treatment after accepting transfer placed the patient at risk of unnecessary pain and complications related to his injury.

Findings include:

Review of the Hospital's Medical Staff Rules and Regulations occurred on 04/16/13. The Rules and Regulations, adopted 11/10/09, stated "PART TWO. ATTENDANCE OF PATIENTS . . . 2.3 APPROPRIATE MEDICAL SCREENING EXAM (MSE/EMTALA [Emergency Medical Treatment And Labor Act]) . . . any patient being sent to Trinity via ambulance by an outside facility or physician for diagnosis or therapeutic treatment is required to have a MSE [medical screening examination]. . . .

A medical screening exam (MSE) is the process required to reach with reasonable clinical confidence, the point at which it can be determined whether or not an EMC [emergency medical condition] exists . . .

An emergency medical condition (EMC) is one that manifests itself by acute symptoms of sufficient severity (e.g. [example given] severe pain, psychiatric disturbances and/or symptoms of substance abuse) that the absence of immediate medical attention could reasonably be expected to result in 1) placing the health of the individual . . . in serious jeopardy, or 2) serious impairment to bodily functions, or 3) serious dysfunction of any bodily organ or part . . . "

- Review of the Hospital's "Safety Event Summary and Follow-up History" occurred on April 08-09, 2013. The Event Summary, dated 03/30/13 at 11:50 p.m., identified ". . . BRIEF FACTUAL DESCRIPTION: I received a phone call from [a referring critical access hospital (CAH)] with the following concern: on the evening of Friday, March 30, 2013, they received a patient by the name of [Patient #32] who had been involved in a work-related incident whereby he severed 4 fingers. The ED [emergency department] physician phoned our facility and spoke with [Physician #2] who accepted the patient. Based on his acceptance of the patient, [referring CAH] staff dispatched [air ambulance service] for transport of the patient to our facility. Patient was discharged to [air ambulance service] at 10:42 [p.m.]. At 10:50 p.m., [Physician #2] phoned the ED physician at [referring CAH] and indicated he had changed his mind and no longer would accept the patient stating 'It's going to be too much work for me.' The physician immediately phoned [air ambulance service] to stop transport and bring the patient back to [referring CAH]. They phoned another facility and arranged for transport."

The "Follow-up Preview," dated 04/09/13 at 2:25 p.m., stated ". . . Immediate Action Taken: Report reviewed. To Dept [Department] of Surgery Chair for review/action. . . ." During interview, on 04/10/13 at 10:00 a.m., a supervisory nursing staff member (#3) reported the Department of Surgery Chairman (Physician #3) had been out of town the week of March 31-April 06, 2013. Physician #3 also left town beginning April 10, 2013 and the Hospital anticipated he would be out of town through April 14, 2013. Staff member (#3) reported no other physician or administrative staff member reviewed the event regarding Patient #32. Staff member (#3) anticipated Physician #3 would review this event after his return on 04/14/13, 15 days after the event occurred. Staff member (#3) also reported Physician #2 was out of town the week of April 07-12, 2013.

Failure to review, follow up, and provide appropriate action according to the Medical Staff Bylaws placed all patients at risk of compromised care.





2. Based on record review, review of medical staff bylaws and rules and regulations, review of surgery and anesthesia department meeting minutes, call schedules, credentialing files, patient safety event documentation, and staff interview, the Hospital failed to follow their bylaws ensuring enforcement of its rules and regulations within the hospital by failing to ensure the designated practitioner provided on-call coverage for 1 of 1 patient (Patient #34) requiring services from the designated practitioner's specialty. Failure to ensure the designated practitioner fulfilled his responsibility to provide on-call coverage placed Patient #34 at risk of adverse clinical outcomes and limited the Hospital's ability to provide the necessary services to meet the needs of the patients.

Findings include:

Review of the "Medical Staff Rules and Regulations" occurred on 04/10/13. The rules and regulations, approved October 2011, stated, ". . . Part two. Attendance of patients . . . 2.2 Practitioner's Responsibility For Coverage. Each practitioner is responsible for the care of his/her patients in any unit . . . of the hospital. . . . Failure to comply with these rules will result in disciplinary and corrective action . . . 2.2-1 Participation In The On-Call Roster. Each member of the active and associate staff . . . agrees that when he/she is designated practitioner on call for the Emergency and Trauma Center or any other unit of hospital, he will accept responsibility during the time specified by the published schedule for providing care to the patient . . . for which he/she is providing on-call coverage. Refusal to . . . provide care within the members' specialty may subject the member to discipline and corrective action . . ."

- Review of Patient #34's closed medical record occurred on 04/09/13 and identified the Hospital admitted the [AGE] year old patient on 01/25/13 following a transfer from another facility due to a right hip fracture. The patient's initial treating medical provider's examination, dated 01/25/13 at 10:55 p.m., stated, ". . . Impression and Plan. Diagnosis. Closed hip fracture . . . Calls-Consults - 01/26/13 [12:08 a.m.], [Physician (#20), an orthopedic surgeon], recommends Admit to hospitalist will see in the morning. . . ." An examination from the consulting Physician (#20), dictated on Saturday, 01/26/13 at 4:12 p.m., stated, ". . . Past Medical History: Significant for: 1. Stroke after surgery. 2. Hypertension [high blood pressure]. 3. Colon cancer. . . . 7. Anemia chronically. . . . Plan: Treat her with a medium length trochanteric fixation nail. She understands the plan and she wanted me to proceed with surgery today."

Review of Patient #34's consent form, dated 01/26/13 at 8:25 p.m., identified the surgery as a right hip open reduction internal fixation. The patient's perioperative record, dated 01/26/13, listed 9:26 p.m. as the "time in" operating room (OR), with 11:06 p.m. as the "time out" of OR and indicated, ". . . Case terminated after anesthesia started . . ." An anesthesia record, dated 01/26/13, revealed an anesthesia start time of 9:26 p.m. and a stop time of 11:12 p.m., and showed a note which stated, ". . . [9:50 p.m.] order to abort procedure [and] wake pt [patient]. . . ."

- Review of a Patient Safety Event form involving Patient #34, dated 01/27/13 at 2:20 a.m., stated, ". . . Pt was brought to OR at [9:00 p.m.]. Surgeon [Physician #20, the designated on-call orthopedic surgeon] was paged at [8:50 p.m.] 30 [minutes] to OR. No call back received. Surgeon was paged at [9:37 p.m.] room 6 ready. No call back received. [10:09 p.m.] room 6 ready. No call back received. OR staff states that they called his cell phone and also tried texting him multiple times. [Physician (#9), an Anesthesiologist or MDA] paged surgeon at [10:09 p.m.], [10:19 p.m.], [10:23 p.m.]. No call back received. [Name of hotel] called. . . . [Physician (#8), an administrative physician] paged surgeon at [11:23 p.m.], [11:28 p.m.], and [11:32 p.m.] . . . [10:20 p.m.] [Physician (#9)] paged house supervisor inquiring if I knew his whereabouts. Stated that I had not seen or spoken to [Physician (#20)]. [11:15 p.m.] [surgical staff member (#21)] called house supervisor and informed me of what had been going on in surgery. . . . He stated that they were unable to locate [Physician (#20)] and that patient had already been taken out of OR and was extubated . . . [11:20 p.m.] [Physician (#9)] call [sic] house supervisor stating that he had just talked to family and they were very upset. He stated that he had personally talked to [Physician (#8)] and they were finding a different surgeon to come see the patient. . . . [11:42 p.m.] [Physician (#9)] notifies house supervisor that he had spoken to [Physician (#8)] and that [Physician (#22), another orthopedic surgeon] was on his way to come in to see the patient. Family was notified of this and was satisfied that another surgeon was coming to see her as they no longer wished to have [Physician (#20)] as her surgeon. . . ."

The above event form included three follow up reports from different administrative staff members. The first follow up report, completed by an administrative surgical staff member (#5), dated 01/30/13, stated, ". . . Event Investigation Summary: Summary Finding: [Physician (#20)] was delayed for . . . surgical procedure by [name of another physician]. He noted to give him a 30 minute heads up when sending for his patient after [name of other physician] case was finished and he left. OR circulator had scrub tech page [Physician (#20)] with a 30 minute heads up when she was sending for the patient. This page was done through the operator. Patient came to the OR. Anesthesia put the patient to sleep after the patient came to the OR. [Physician (#20)] had not called back. Several attempts were made to contact [Physician (#20)], including calling the motel where he lives, all were not responded to. Decision was made to wake patient up and go to recovery. [Physician (#9)] made this decision and went to visit the family. . . . Risk Mitigation Poll [and] Recommendation: Give us your recommendation on what needs to be done as a result of this event: I have visited with [surgical staff member (#11)] about the things we could have done to change some of the events that took place. The most important was that there was no go ahead for anesthesia from [Physician #20], that we can never assume go ahead without the exact call for go ahead. . . ."

A second follow up report, completed by an administrative physician (#8), dated 01/31/13, stated, ". . . Event Investigation Summary: Summary Finding: Two main issues: 1) [Physician (#20)'s] failure to respond. 2) However main issue is policy not followed. patient should not have been taken back to OR without surgeon's OK, and should not have had anaesthesia [sic] without confirming that the surgeon was in hospital and available. Immediate Action Taken: Patient taken care of by [Physician (#22)], who after I phoned him agreed to come and see the patient. . . . [Physician (#20)] was asleep at home. His pager and phone, eventhough [sic] were with him, did not wake him up. Will follow up as to why policy was not followed with anesthesia and OR Director. . . ." The report lacked evidence of needed recommendations as a result of the event.

A third follow up report, completed by an administrative anesthesia staff member (#7), dated 03/18/13, stated, ". . . Event Investigation Summary: Summary Finding: Findings are accurate. Anesthesia should never proceed without go ahead from surgeon that they are in house and ready to go. Immediate Action Taken: Because the surgeon never responded for 2.5 hours after the first call . . . the patient had to be emerged . . . and the family informed and allowed to make a decision on 2nd surgeon. . . . Risk Mitigation Poll [and] Recommendation: Give us your recommendations on what needs to be done as a result of this event: Clear go ahead prior to anesthesia induction. Surgeon on call that schedules surgery needs to be reachable. . . ." The report lacked timely completion as staff completed the report nearly two months after the event occurred.

- During an interview on 04/09/13 at 4:00 p.m. with the administrative staff (#4, #5, and #7) regarding the event on 01/26/13 involving Patient #34, an administrative surgical staff member (#4) stated the OR call team arrived to complete cases (surgery) on 01/26/13 and confirmed Patient #34's surgery as one of the scheduled cases of the day. The staff member (#4) stated an unexpected "higher priority case", requiring a different surgeon, delayed Patient #34's surgery. The administrative surgical staff member (#4) stated the circulating nurse (#11) communicated with the patient's physician (#20) about the delay and stated he told her to page him 30 minutes before OR staff were ready for Patient #34. An administrative anesthesia staff member (#7) stated once ready, the circulating nurse (#11) and an anesthesia staff member (#10) paged the physician (#20) with a 30 minute "heads up" and took Patient #34 to the OR. The staff member (#7) stated OR staff proceeded with Patient #34's preparation for surgery and delivery of anesthesia as planned given they notified the physician (#20) and assumed the physician's (#20) presence in the hospital, thinking he would arrive in the OR as they had not heard anything different otherwise.

During the interview, the three administrative staff members (#4, #5, and #7) stated they discussed Patient #34's event with each staff member involved one on one and stressed the importance of never delivering anesthesia in an effort to proceed with surgery without verbal confirmation from the surgeon.

- During an interview on 04/10/13 at 4:15 p.m., a physician (#9) involved in Patient #34's event, stated the nurse (#11) gave the physician (#20) a "heads up" by page 30 minutes prior to Patient #34's surgery and took the patient to the OR suite where staff positioned the patient on the OR table and the certified registered nurse anesthetist (CRNA) (#10) prepared for induction (the delivery of anesthesia). He stated the Hospital utilized pagers which delivered a sound and message alert upon receipt of a page. The physician (#9) stated the CRNA (#10) paged him to the room for induction, after which he noticed the physician (#20) absent from the OR. He stated he asked the OR staff where the physician (#20) was and this was when staff began communicating concerns with one another that the physician (#20) had not responded to staff's multiple pages, texts, and phone calls. The physician (#9) stated an administrative physician (#8) spoke with the physician (#20) personally once he finally arrived at the Hospital and stated the anesthesia department discussed the event with all levels of anesthesia staff at a meeting a couple weeks later.

During an interview on 04/11/13 at 10:50 a.m., a surgical staff member (#11) involved with Patient #34's event, stated she had been working with the same physician (#20) throughout the day on 01/26/13 and completed three patient cases prior to Patient #34's case. The staff member (#11) stated Patient #34's case became delayed due to a "higher priority case" which she communicated with the physician (#20) about. She stated she told the physician (#20) the case delaying Patient #34 would not be long (a couple hours at the most) and stated the physician (#20) told her to page him 30 minutes before the OR was ready for Patient #34. The staff member (#11) stated she assumed the physician (#20) stayed in the Hospital as he knew the delay would not be long, he had to perform Patient #34's surgery, and he told her to page him with a 30 minute "heads up." She stated a member of the surgical department administrative staff (#5) spoke with her personally about Patient #34's event and stated the facility has not made a change in the process as a whole, but she is more conscious of the process, stating she would personally make sure verbal confirmation occurred with the surgeon prior to proceeding with surgery.

During an interview on 04/11/13 at 11:15 a.m., an anesthesia staff member (#10) involved in Patient #34's event, stated the patient's case, posted (placed on the schedule) for a while, became bumped due to an emergent case. The staff member (#10) stated the physician (#20) seemed frustrated about this and stated in general to several OR staff members within the room that he was going to lay down and instructed staff to give him a 30 minute heads up when ready for Patient #34. The anesthesia staff member (#10) stated staff notified the physician (#20) with the 30 minute heads up and proceeded as usual, bringing Patient #34 to the OR, positioning and putting the patient to sleep. After 20 minutes of being in the room (10 minutes of being ready), the staff member (#10) stated staff tried paging and texting the physician (#20) again. During this time, he stated the other OR staff members in the room specifically verbalized outloud that they notified the physician (#20) 20 minutes ago and stated he should be here. The staff member (#10) identified nights and weekends as the time when the potential for adverse events is the greatest due to the limited number of staff.

- During an interview on 04/10/13 at 2:00 p.m., two administrative staff members (#3 and #28) involved in the review of patient events, stated an administrative Physician (#8) followed up with the Physician (#20) involved in Patient #34's event one on one at the time of the event and felt as if the physicians handled the concern, therefore did not present the issue further to the Medical Staff. The staff members (#3 and #28) failed to mention or provide information on specific measures the Hospital put into place to monitor and ensure similar events do not occur.

During a telephone interview on 04/10/13 at 4:25 p.m., an administrative physician (#8) involved in the follow up of Patient #34's event, stated once OR staff could not reach the physician (#20) the night of the event, staff notified him and he presented to the Hospital immediately to help with the situation. He stated anesthesia staff should never start a patient case without verbal confirmation from the surgeon that it is okay to proceed, identified delivering anesthesia in the absence of the physician as the main concern of Patient #34's event, and stated he recommended anesthesia develop and implement a policy reflecting this. The physician (#8) stated he spoke with the physician (#20) one on one about the event and stated the physician (#20) went to the hotel where he resided and fell asleep, stating he did not hear his pager or the phone due to being "very tired." The administrative physician (#8) expressed the physician (#20) had been exhausted and stated the physician (#20) typically took call four out of seven days a week and went home (leaves town) on days off, mentioning the physician (#20) had just gotten back from days off when the event occurred on 01/26/13. He stated the Hospital's trauma cases have dramatically increased in the past two years leaving the Hospital "very busy." The physician (#8) identified the physician (#20) as responsible and confirmed this event as an isolated event with no follow up needed due to this fact. The physician (#8) stated he did not document the discussion with the physician (#20) and failed to mention or provide information on specific measures the Hospital put in place to monitor and ensure similar events do not occur.

Review of the Hospital's call schedule (a list of each provider on-call according to department or specialty) for the month of January 2013 occurred on 04/09/13 and confirmed the physician (#20) on-call for orthopedic services on 01/26/13. Further review of the call schedule showed the physician (#20) on-call for orthopedic services the day before the event (01/25/13) and for two days after the event (January 27 and 28, 2013).

Review of the physician's (#20) credential file occurred on 04/17/13 and identified the following:
*A completed form for reappointment recommendation, signed 05/08/12, stated, ". . . prior concerns [regarding] interpersonal communication discussed, none recently. . . ."
*A variance report, dated 11/17/11, stated, ". . . lack of communication between hospitalist and orthopedic surgeon. . . . practice pattern of rounding and preferring to do surgeries so late in day may have also contributed to . . . delaying the start of therapies to prepare patient for surgery. . . ."

- An interview occurred on 04/10/13 at 3:10 p.m. with four administrative staff members (#1, #3, #4, and #7). One of the staff members (#3) stated the Department of Surgery held monthly meetings for the Medical Director, Managers, Director of Surgical Services, Chief Nursing Officer, Surgeons, and all who could attend, and stated the surgeons held meetings, but did not know when these meetings occurred. An administrative staff member (#1) stated the Hospital canceled the February, 2013 Department of Surgery Meeting and stated staff did not discuss Patient #34's event at the March, 2013 Department of Surgery meeting.

Review of the Department of Surgery meeting minutes from 2013 occurred on 04/11/13 and identified a canceled meeting on 02/22/13 and showed a meeting held on 03/22/13 which included the chief of surgery, chief of medical staff, chief of anesthesiology, several different surgeons, and several different department managers and administrative staff. The meeting minutes lacked evidence those in attendance discussed and addressed Patient #34's event on 01/26/13.

Review of Anesthesia Meeting Minutes, dated 02/27/13, occurred on 04/17/13 and identified seven of eight MDA's in attendance. The minutes stated, ". . . [Physician (#20)] - his start time is a chronic problem, [Physician (#8)] has asked that you be patient with his start time. All felt this is a huge dissatisfaction to patients and to staff. MDA's want it fixed and would like . . . to press the issue. It is felt by all this is very poor patient care. . . . Discussed with [Physician (#8)] after our group meeting. It will take 2 orthopedic surgeons to replace [Physician (#20)]. . . ."

- Upon thorough review of Patient #34's event, the Hospital identified and addressed the delivery of anesthesia in the absence of the surgeon as a concern, but failed to identify the availability and responsibility of the designated on-call practitioner, Physician (#20), as a concern related to the event. The physician (#20) failed to respond and deliver care to Patient #34 knowing the patient required his services on the evening of 01/26/13 and failed to respond as the designated on-call practitioner. The Hospital failed to consider all factors which could have potentially contributed to the failure of the physician (#20) to respond including his exhaustion, call schedule, patient load, increase in trauma cases, behavior, prior incidents, and concerns of fell ow staff members, and failed to develop and implement specific measures and provide monitoring of those measures to ensure a similar event did not occur.

Patient #34's event lacked review from key personnel in a timely manner and discussion and follow up of the event among the appropriate departments/committees. Failure of the Hospital to consider all aspects of the event, identify potential causative factors, implement strategies to correct identified concerns, evaluate the effectiveness of the strategies implemented, and ensure the improvements remained in place, put future patients at risk for adverse events.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, record review, review of policy and procedure, safety event summaries, and facility logs, and patient, family, and staff interview, the Hospital failed to ensure a registered nurse supervised and evaluated the nursing care provided and failed to assess all of the patient's care needs (Refer to A395); and failed to ensure a registered nurse assigned the nursing care of a patient to other nursing personnel in accordance with the patient's needs (Refer to A397).

These failures resulted in unnecessary pain and an increased risk of infection, pressure sores, and falls to the patients; a delay in treatment which could potentially be life-threatening; and limited the Hospital's ability to meet the nutritional needs of the patients.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
1. Based on record review, review of Hospital policy and procedure, safety event summaries, and staff interview, the Hospital failed to ensure a registered nurse supervised and evaluated the nursing care for 1 of 1 sampled closed record of a burn patient (Patient #29) and 1 of 1 sampled closed record of an incontinent patient dependent on staff for transfers (Patient #28). Failure to ensure Patient #29's burn dressings remained intact until the physician was ready to change the dressings resulted in damaged tissue exposed to air for approximately 50 minutes, unnecessary pain, and increased risk of infection experienced by Patient #29. Failure to offer Patient #28 a change in position and failure to change her soiled brief placed her at risk of urinary tract infection, pressure sores, and falls if she attempted to self transfer.

Findings include:

Review of the Hospital policy and procedure, "Care of Minor Burns," occurred on 04/11/13. This document, revised June 2009, stated "DEPARTMENT: Nursing - Emergency /Trauma Center . . . PURPOSE: 1. Alleviate pain, 2. Prevent infection . . . PROCEDURE: . . . 3. Apply sterile towels soaked in cold sterile saline for 1-20 minutes. (This will stop the burning process and help alleviate pain.) . . ."

- The Hospital's "Safety Event Summary and Follow-up History," regarding Patient #29, identified the following, dated 03/29/13 at 1:50 p.m.: "BRIEF FACTUAL DESCRIPTION: [Patient #29] was transferred from ICU [Intensive Care Unit] [Room number] to [Room number]. Pt. [Patient] needed dressing changes. [Physician #1] stated he would do them on the floor needing pain meds. [medications] I was called by [Physician #1] at 1:45 p.m. needing a monitor, [medication names] for dressing changes. Upon arrival up to [Room number], [Physician #1] was in OR [operating room], I paged [Physician #1] at 2:05 p.m. and he stated he would be back in 1 hour to do dressing change. Pt. was informed of this and was upset with the fact he had to wait an hour and his right arm was exposed to air. Mother also present, voicing concerns of sterility in the meantime. [Physician #1] at the bedside at 2:20 p.m. to do dressing changes, Dressing changes were completed with no sterility. . . . Prior to patient being transferred, the nurse taking care of the patient [nurse's name] had talked with [Physician #1] in regards to doing the dressing change in ICU or on the floor. [Physician #1] stated he would do it later on the floor."

Review of Patient #29's closed medical record occurred on April 10-11, 2013. The Hospital admitted the patient on 03/27/13. The physician's admission history and physical stated ". . . IMPRESSION: . . . 5. Superficial second degree burns of right arm, approximately 7% to 8%. 6. Superficial second degree burns of right leg, approximately 2% to 3% . . . 9. First degree burn of left ankle, about 1%. . . ."

A physician's progress note, dated 03/30/13 at 7:55 a.m., stated ". . . [Patient #29] had dressing changes at bedside yesterday under conscious sedation. . . ." The progress note describes the patient's burn injuries to the right arm and leg and stated ". . . We redressed all these wounds . . ."

A nursing progress note, dated 03/29/13 at 6:19 p.m., stated "2:45 p.m. - [Physician #1] at the bedside, right arm, right thigh, and left lower leg dressings completed at this time. . . ." The author of this progress note also initiated the "Safety Event Summary and Follow-up History" at 1:50 p.m. on 03/29/13.

During interview, on 04/11/13 at 11:00 a.m., an administrative nursing staff member (#1) and a supervisory nursing staff member (#3) agreed the Hospital staff should not have removed Patient #29's dressings or should have applied other dressings until Physician #1 arrived for the dressing changes.

- The Hospital's "Safety Event Summary and Follow-up History," regarding Patient #28, identified the following, dated 03/05/13 at 7:30 a.m., "BRIEF FACTUAL DESCRIPTION: Was told in report from night shift nurse that patient was left up in chair all night. When this nurse went in to check on patient, urine had leaked out of her brief due to brief being saturated with urine. . . . This nurse then called in a CNA [certified nursing assistant] to assist in cleaning up patient and putting her back to bed."

Review of Patient #28's closed medical record occurred on April 10-11, 2013. The Hospital admitted the patient on 02/24/13 and discharged the patient on 03/07/13. Admission diagnoses included pneumonia and dementia. The patient's nursing assessment, dated 03/04/13 at 8:51 p.m., identified "confusion, disorientation, weakness" and "incontinence" of urine.

Patient #28's Nursing Interactive Flowsheets identified the following:
*03/04/13
6:00 p.m. - ". . . put in chair . . . Fluids offered, Fluids Taken . . ."
8:00 p.m. - ". . . Sitting in chair . . . No needs identified . . . Asleep . . ."
8:25 p.m. - ". . . Sitting in chair . . . Small volume nebulizer . . ." (Respiratory Therapy treatment)
8:48 p.m. - ". . . Pain Intensity - 4 . . . Generalized . . ." (Position not identified.)
9:19 p.m. - ". . . Blood Glucose . . . 306 mg/dl [milligrams per deciliter]" (Position not identified.)
10:00 p.m. - ". . . No needs identified . . . Asleep . . . Up to chair . . ."
12:00 p.m. - ". . . Sitting in chair . . . No needs identified . . . Asleep . . ."
*03/05/13
2:00 a.m. - ". . . No needs identified . . . Asleep . . . Up to chair . . ."
4:00 a.m. - ". . . No needs identified . . . Asleep . . . Up to chair . . ."
6:00 a.m. - ". . . No needs identified . . . Asleep . . . Up to chair . . ."
8:00 a.m. - ". . . Sitting in chair . . . Asleep . . . Pain addressed, Questions answered, Requests addressed . . ."
10:00 a.m. - ". . . Asleep . . . No needs identified . . . In bed . . ."

During interview, on 04/11/13 at 11:00 a.m., an administrative nursing staff member (#1) and a supervisory nursing staff member (#3) confirmed the Hospital staff failed to provide Patient #28 a change in position and the medical record failed to identify the staff offered to toilet or change Patient #28's brief from 8:00 p.m. to 8:00 a.m. (12 hours).






2. Based on record review, and staff interview, the Hospital failed to ensure a Registered Nurse (RN) supervised and evaluated the nursing care for 1 of 1 sampled patient closed record (Patient #31) identified with chest pain. Failure to respond timely to Patient #31's chest pain resulted in delay in treatment and could potentially be life-threatening.

Findings include:

- Review of Patient #31's record occurred from April 8-11, 2013. The record identified, on 01/05/13, nursing staff transferred Patient #31 from the intensive care unit (ICU) to a medical nursing unit. The ICU, while monitoring Patient #31 on telemetry noted Patient #31 in afib with a ventricular rate of 160-170 beats per minute (bpm) at 4:54 p.m. and the (ICU) nurse notified the physician at 5:00 p.m. and an order for Digoxin (to slow the heart rate) given. The patient's Medication Administration Record identified the first dose of Digoxin given at 5:44 p.m. Nursing notes (on the nursing unit) identified that at 7:45 p.m. the patient's heart rate in the 150's (bpm) and complaining of chest pain. The nurse's notes identified the nurse notified the physician at 6:02 p.m. and an order received for transfer the the ICU given.

During interview on the afternoon of 04/10/13, an administrative nurse (#2) stated she would expect staff nurses to respond immediately if a patient experienced chest pain either by administering medications as ordered or by calling the physician for orders. The nurse stated the facility has no policy/procedure/protocol for chest pain.






3. Based on observation; review of facility policy and procedure; and patient, family, and staff interview, the Hospital failed to assess all of the patient's care needs for 4 of 4 patients (Patient #13, #37, #38, #39) who experienced and expressed concerns with the Hospital's meal service regarding the availability and delivery of meals, the meal ordering system, and staff assistance with meals. Failure to assess all patient care needs limited the Hospital's ability to ensure and meet the nutritional needs of the patients.

Findings include:

Review of the facility policy titled "Diet Orders" occurred on 04/11/13. This policy, revised January 2008, stated, "PURPOSE: To indicate where the responsibility of ordering diet lies. POLICY: Diet orders are determined by the physician or primary care providers and are entered in the patient's online medical record under orders. PROCEDURE: Diet Order reports are printed in the Nutrition Services Department 3 times per day at 5 am, 10 am, and PM. The diet clerks and/or diet technicians review the reports and use them when patients order room service. The diet orders can be viewed under orders listed on the patient's chart. The order lists patient's name, age, sex, room number, allergies, diet order, date, food preferences, texture modifications, and whether patient is a candidate for Room Service, and time of the order . . . Nursing Service or the dietetic staff will communicate all subsequent changes in diet orders . . . Nursing staff communicates room changes or discharges via computer. . . ."

- Observation of patient care on 04/08/13 at 4:30 p.m. showed a nurse (#13) entered Patient #37's room and performed an assessment on the patient. Observation showed a meal tray recently delivered to Patient #37 and the patient stated he was very hungry as he had not eaten since breakfast because he did not know how to order food by himself. The nurse (#13) told Patient #37 staff could help him order, but didn't offer any further assistance, left the room, and went on to the next patient.

- Observation of patient care on 04/08/13 at 4:55 p.m. showed a nurse (#14) entered Patient #38's room, performed an assessment, and repositioned the patient. A woman in the room, identified by Patient #38 as her daughter, stated the patient ordered turkey for supper last evening and the turkey arrived with gravy over the top, which the patient did not want or order. The daughter stated the patient tried to eat the turkey anyway, but could not as the gravy was very salty and the patient could not have salt due to her diet. The nurse (#14) stated Patient #38's record showed a cardiac diet, which is usually no or low salt, and stated the dietary staff are aware of the patient's diet and should not send anything salty.

- During an interview on 04/09/13 at 11:20 a.m., Patient #39 stated the Hospital admitted him the prior evening around 10:00 p.m. and assumed staff brought a menu into his room this morning as the menu had not been there before. The patient and his wife stated they did not know what to do with the menu as staff did not explain the menu or meal service.

During an interview on 04/09/13 at 11:50 a.m., a nurse (#15) stated the Hospital utilized a meal ordering system and patients independently order their meals from the dietary department off a menu provided to the patient upon admission. The nurse (#15) stated staff placed an order in the electronic medical record (EMR) to the dietary department for patients unable to order their own meals. The dietary staff then send all of that patient's meals to the nursing unit for staff to deliver.





- Observation on 04/09/13 at 3:15 p.m. showed a nurse (#18) reviewed admission questions and paperwork with Patient #13. The admitting nurse (#18) did not educate the patient or his wife on the facility's procedure for ordering and receiving meals and failed to give them a menu.

On 04/09/13 at 5:25 p.m., Patient #13's wife approached the ward clerk at the nurse's station, stated her husband was hungry, asked if he could eat, and questioned who ordered and assisted patients with their meals. The ward clerk (#19) gave Patient #13's wife a menu and told her to call the phone number on the menu to order his meal.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, review of the Emergency Trauma Center (ETC) log, review of Hospital policies and procedures, review of the Hospital's Complaint Log, and staff interview, the Hospital failed to ensure a registered nurse assigned the nursing care of a patient with burns (Patient #33) to other nursing personnel in accordance with the patient's needs. Failure to triage the patient's injuries resulted in the patient experiencing pain, delayed treatment, and sought treatment at another facility for reported second and third degree burns.

Findings include:

Review of the Hospital policy and procedure, "Triage," occurred on 04/11/13. This document, revised June 2009, stated "PURPOSE: The function of the triage nurse is to direct incoming patients, sort and briefly assess Emergency Trauma Center [ETC] patients, assign them placement in the ETC and initiate advanced triage as needed. . . . POLICY: The duties of the triage nurse are as follows: . . .
2. Perform brief patient assessment . . .
3. Sort ETC patients according to their need for urgent care. . . . Assign appropriate triage acuity . . .
4. Initiate advanced triage as needed (eg [example given] - giving patient ice . . .
6. Orientation of the patient to the waiting room and expected time of wait until ETC evaluation and care. . . ."

Review of the Hospital policy and procedure, "Care of Minor Burns," occurred on 04/11/13. This document, revised June 2009, stated "DEPARTMENT: Nursing-Emergency/Trauma Center . . . PURPOSE: 1. Alleviate pain, 2. Prevent infection . . .
PROCEDURE: 1. Place patient in room on cart. Elevate extremities and cover patient with a clean sheet.
2. Pain management should not be neglected. Anticipate pain control orders.
3. Apply sterile towels soaked in cold sterile saline for 10-20 minutes. (This will stop the burning process and help alleviate pain) . . .
4. Obtain baseline data, A. Obtain vitals [signs] . . . B. History . . .
5. Notify physician and carry out orders. . . ."

Review of the Hospital's Complaint Log occurred on April 08-09, 2013. The log identified the nature of Patient #33's complaint as "Access/Admission" and "sub nature" as "Left Without Being Seen" [LWBS].

Review of Patient #33's complaint to the Hospital occurred on April 10-11, 2013. Patient #33 and her mother submitted the complaint to the hospital on [DATE].

The Hospital's ETC Log identified the Hospital admitted Patient #33 to the ETC on 01/03/13 at 6:40 p.m. for treatment of "Lt. [Left] leg burnt with boiling water" and discharged the patient at 8:08 p.m. (one hour, 28 minutes later) due to "Elopement." The Hospital lacked a record of treatment for Patient #33's admission to the ETC on 01/03/13.

The complaint statement included ". . . Receptionist at front desk . . . didn't seem to understand that pt. [patient] had a severe burn that could not allow her sit down and wait. Asked receptionist for ice pack and only received one - not enough. . . . We left and got ice at the gas station and went to [another provider's convenience clinic] where she (daughter) was diagnosed with 2nd and 3rd degree burns and treated. . . ."

The Hospital's investigation of the complaint included the following statements:
*02/06/13, 8:45 a.m. - "Frontline admissions staff need education in patient interactions. . . . was an admissions issue, not ETC."
*02/15/13, 10:30 a.m. - "I can't see that this patient was triaged by a nurse. There is a note saying not found in lobby x [times] 3. A burn should get at least a quick assessment by an RN [registered nurse]. I am not sure why that did not happen."

Review of the ETC Log identified the Hospital admitted 64 patients to the ETC for the period 11:45 a.m. to 11:03 p.m. on 01/03/13. The Log also showed the ETC treated 36 patients during the one hour, 28 minutes Patient #33 was in the ETC.

During interview, on 04/11/13 at 10:30 a.m., a supervisory ETC staff member (#27) confirmed the statements from the Hospital's investigation. This staff member reported staff planned to schedule department wide training. The facility failed to provide additional information regarding the department-wide staff training.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, review of policy and procedure, review of professional literature, record review, and staff interview, the Hospital failed to implement measures to identify and investigate infection control practices and failed to follow professional standards of care relating to infection control practices (Refer to A749).

This failure may allow transmission of organisms and pathogens from patient to staff, to other patients, or to visitors; and from one environment to another.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, review of policy and procedure, review of professional literature, record review, and staff interview, the Hospital failed to implement measures to identify and investigate infection control practices and failed to follow professional standards of care relating to infection control practices during observations of patient care on 2 of 4 days of survey (April 08-09, 2013) Failure to follow established infection control practices may allow transmission of organisms and pathogens from patient to staff, to other patients, or to visitors; and from one environment to another.

Findings include:

A Centers for Disease Control and Prevention (CDC) publication titled "Infection Prevention during Blood Glucose Monitoring and Insulin Administration," dated 05/02/12, page 1, stated, ". . . The . . . CDC . . . has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring . . . CDC is alerting all persons who assist others with blood glucose monitoring . . . of the following infection control requirements: . . . Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared. . . ."

A Centers for Disease Control and Prevention publication titled "Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration," dated 03/08/11, stated, ". . . General: . . . Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. . . . Blood Glucose Meters: 1. . . . Infectious agents, such as HBV [hepatitis B Virus] can be transmitted through indirect contact transmission, even in the absence of visible blood. . . . Healthcare personnel hands can become contaminated with blood at various points while performing assisted blood glucose monitoring including pricking the patient's finger or handling the test strip. Blood can then be transferred to the meter . . . 2. . . . FDA [Food and Drug Administration] has recently released guidance for manufacturers regarding appropriate products and procedure for cleaning and disinfection of blood glucose meters. . . . 'The disinfection solvent you choose should be effective against HIV, Hepatitis C, and Hepatitis B virus. . . . Please note that 70% ethanol solutions are not effective against viral bloodborne pathogens and the use of 10% bleach solutions may lead to physical degradation of your device. . . ."

A Healthcare Infection Control Practices Advisory Committee (HICPAC) publication titled "Guideline for Prevention of Catheter-Associated Urinary Tract Infections 2009", not dated, page 13, stated, ". . . III. Proper Techniques for Urinary Catheter Maintenance . . . B. Maintain unobstructed urine flow. . . . 2. . . . Do not rest the bag on the floor. . . ."

Review of the policy "Isolation Precautions" occurred on 04/11/13. This policy, approved October 2012, stated, ". . . II. Contact Precautions. In addition to Standard Precautions, use Contact Precautions for patients identified or suspected to be infected or colonized with epidemiologically important microorganisms. . . . B. Gloves and hand hygiene. Wear gloves upon entering room. Remove gloves before leaving the patient's environment and perform hand hygiene immediately with an antimicrobial agent or the hospital approved alcohol based handrub. . . . Conditions requiring Contact Isolation . . . 2. Drug resistant organisms. MRSA [methicillin resistant staphylococcus aureus] . . ."

The following observations showed staff failed to perform proper infection control practices regarding contact precautions, disinfection of a glucometer, and maintenance of a urinary catheter bag:
*On 04/08/13 between 4:40 p.m. to 4:50 p.m. a nurse (#17) obtained a glucometer from a plastic caddy in the report room next to the nurse's station. The nurse (#17) checked the blood glucose level of Patient #9 (diagnosed with acquired immunodeficiency syndrome (AIDS)) and then immediately checked Patient #10 with the same blood glucose monitor. The staff member (#17) brought the glucometer back into the report room and placed it in the plastic caddy. The nurse failed to disinfect the glucometer between patients and before placing it in the caddy in the report room.
*On 04/08/13 at 4:00 p.m. and 5:15 p.m., observation revealed Patient #1 in her room after returning from surgery and showed her urinary catheter bag on the floor under the bed. Nursing staff had been in Patient #1's room monitoring her vital signs, pain, and surgical site during and between the above times and failed to attach the urinary catheter bag in the appropriate place.
*On 04/09/13 at 8:20 a.m., observation showed a nursing staff member (#12) donned a gown and gloves and entered Patient #35's room to assist the patient with a shower. A sign on the outside of the patient's door read "Contact Precautions" and the nursing staff member (#12) stated staff placed Patient #35 in contact precautions or isolation due to MRSA. After assisting the patient with the shower, the staff member (#12) removed her gown and gloves, immediately placed a new pair of gloves on, and took the soiled linen and garbage out of Patient #35's room and carried the items to the soiled utility room down the hall. Upon returning to Patient #35's room a few moments later, the nursing staff member (#12) donned a gown and gloves and proceeded to fix the patient's bed. When asked about performing hand hygiene, the nursing staff member (#12) stated she washed her hands in the clean utility room down the hall and indicated that as the place she would wash her hands after assisting Patient #35. The staff member (#12) stated nursing staff typically wash their hands in the clean utility room after assisting Patient #35 due to the fact the patient used the sink in her room. Observation showed the nursing staff member (#12) failed to perform proper hand hygiene after removing gloves and prior to leaving an isolation room.

During an interview on 04/08/13 at 5:12 p.m., an administrative nursing staff member (#3) confirmed staff should disinfect the glucometer between each patient.

During an interview on 04/11/13 at 9:00 a.m., an infection control nurse (#6) stated staff must follow contact precautions and remove their gown and gloves and perform hand hygiene prior to leaving an isolation room. An administrative nurse (#3) stated staff must complete hand hygiene immediately after patient care at the patient's room, not in another room down the hall. Both of the staff members (#3 and #6) stated the Hospital required urinary catheter bags stored off the floor, attached to the side of the patient's bed frame.

During interview, on the morning of 04/17/13, two administrative staff members (#1 and #3) identified:
* the infection control department does not monitor the staff practices regarding the cleaning of glucometers. The staff members did not provide evidence of data collection, root cause analysis, measures implemented to prevent reoccurrences, and the evaluation of the measures implemented.
VIOLATION: PRE-ANESTHESIA EVALUATION Tag No: A1002
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, review of anesthesia department meeting minutes, patient safety form, and staff interview, the Hospital failed to deliver anesthesia services consistent with safety practices for 1 of 1 patient (Patient #34) who underwent general anesthesia without the presence of the surgeon in the Hospital. Failure to ensure the surgeon's presence in the Hospital prior to placing a patient under general anesthesia risked Patient #34's safety, placed the patient at risk of adverse clinical events and caused the patient to undergo general anesthesia twice. This failure has the potential to place all patients requiring anesthesia services at risk of patient safety.

Findings include:

Review of Patient #34's closed medical record occurred on April 08-09, 2013 and identified the Hospital admitted the [AGE] year old patient on 01/25/13 following a transfer from another facility due to a right hip fracture. Patient #34's medical provider's emergency room (ER) documentation, dated 01/25/13 at 10:55 p.m., stated, ". . . Impression and Plan. Diagnosis. Closed hip fracture . . . Calls-Consults - 01/26/13 [12:08 a.m.], [Physician (#20), an orthopedic surgeon], recommends Admit to hospitalist will see in the morning. . . ." The patient's consult documentation from Physician (#20), dictated 01/26/13 at 4:12 p.m., stated, ". . . Past Medical History: Significant for: 1. Stroke after surgery. 2. Hypertension [high blood pressure]. 3. Colon cancer. . . . 7. Anemia chronically. . . . Plan: Treat her with a medium length trochanteric fixation nail. She understands the plan and she wanted me to proceed with surgery today."

Review of Patient #34's consent form, dated 01/26/13 at 8:25 p.m., identified the surgery as a right hip open reduction internal fixation. The patient's perioperative record, dated 01/26/13, listed 9:26 p.m. as the time in operating room (OR) with 11:06 p.m. as the time out of OR and indicated, ". . . Case terminated after anesthesia started . . ." An anesthesia record, dated 01/26/13, revealed an anesthesia start time of 9:26 p.m. and a stop time of 11:12 p.m. and showed a note which stated, ". . . [9:50 p.m.] order to abort procedure [and] wake pt [patient]. . . ."

Review of a Patient Safety Event form involving Patient #34, dated 01/27/13 at 2:20 a.m., stated, ". . . Pt was brought to OR at [9:00 p.m.]. Surgeon was paged at [8:50 p.m.] 30 [minutes] to OR. No call back received. Surgeon was paged at [9:37 p.m.] room 6 ready. No call back received. [10:09 p.m.] room 6 ready. No call back received. OR staff states that they called his cell phone and also tried texting him multiple times. [Physician (#9), an MDA] paged surgeon at [10:09 p.m.], [10:19 p.m.], [10:23 p.m.]. No call back received. [Name of hotel] called. . . . [Physician (#8), an administrative physician] paged surgeon at [11:23 p.m.], [11:28 p.m.], and [11:32 p.m.] . . . [10:20 p.m.] [Physician (#9)] paged house supervisor inquiring if I knew his whereabouts. Stated that I had not seen or spoken to [Physician (#20)]. [11:15 p.m.] [surgical staff member (#21)] called house supervisor and informed me of what had been going on in surgery. . . . He stated that they were unable to locate [Physician (#20)] and that patient had already been taken out of OR and was extubated . . ."

The above event form included three follow up reports from staff members. The first follow up report completed by an administrative surgical staff member (#5), dated 01/30/13, stated, ". . . Event Investigation Summary. Summary Finding: [Physician (#20)] was delayed for . . . surgical procedure by [name of another physician]. He noted to give him a 30 minute heads up when sending for his patient . . . and he left. OR circulator had scrub tech page [Physician (#20)] with a 30 minute heads up when she was sending for the patient. This page was done through the operator. Patient came to the OR. Anesthesia put the patient to sleep after the patient came to the OR. [Physician (#20)] had not called back. Several attempts were made to contact [Physician (#20)] . . . all were not responded to. Decision was made to wake patient up and go to recovery. . . . Risk Mitigation Poll [and] Recommendation: Give us your recommendation on what needs to be done as a result of this event: I have visited with [surgical staff member (#11)] about the things we could have done to change some of the events that took place. The most important was that there was no go ahead for anesthesia from [Physician #20], that we can never assume go ahead without the exact call for go ahead. . . ."

A second follow up report completed by Physician (#8), dated 01/31/13, stated, ". . . Event Investigation Summary. Summary Finding: Two main issues: . . . main issue is policy not followed. patient should not have been taken back to OR without surgeon's OK, and should not have had anaesthesia [sic] without confirming that the surgeon was in hospital and available. Immediate Action Taken: Patient taken care of by [Physician (#22)], who after I phoned him agreed to come and see the patient. . . . Will follow up as to why policy was not followed with anesthesia and OR Director. . . ."

A third follow up report completed by an administrative anesthesia staff member (#7), dated 03/18/13, stated, ". . . Event Investigation Summary. Summary Finding: Findings are accurate. Anesthesia should never proceed without go ahead from surgeon that they are in house and ready to go. Immediate Action Taken: Because the surgeon never responded for 2.5 hours after the first call . . . the patient had to be emerged . . . Risk Mitigation Poll [and] Recommendation: Give us your recommendations on what needs to be done as a result of this event: Clear go ahead prior to anesthesia induction. . . ." The report lacked timely completion as staff completed the report nearly two months after the event occurred.

During an interview on 04/09/13 at 4:00 p.m. with the administrative staff (#4, #5, and #7) regarding the event on 01/26/13 involving Patient #34, an administrative surgical staff member (#4) stated the OR call team arrived to complete cases (surgery) on 01/26/13 and confirmed Patient #34's surgery as one of the scheduled cases. The staff member (#4) stated an unexpected "higher priority case", requiring a different surgeon, delayed Patient #34's surgery. The administrative surgical staff member (#4) stated the circulating nurse (#11) communicated with the patient's physician (#20) about the delay and stated he told her to page him 30 minutes before OR staff were ready for Patient #34. An administrative anesthesia staff member (#7) stated once ready, the circulating nurse (#11) and an anesthesia staff member (#10) paged the physician (#20) with a 30 minute "heads up" and took Patient #34 to the OR. The staff member (#7) stated OR staff proceeded with Patient #34's preparation for surgery and delivery of anesthesia as planned given they notified the physician (#20) and assumed the physician's (#20) presence in the hospital, thinking he would arrive in the OR. During the interview, the administrative staff (#4, #5, and #7) stated they discussed Patient #34's event with each staff member involved one on one and stressed the importance of never delivering anesthesia in an effort to proceed with surgery without verbal confirmation from the surgeon.

During an interview on 04/10/13 at 4:15 p.m., a physician (#9) involved in Patient #34's event, stated the nurse (#11) gave the physician (#20) a "heads up" by page 30 minutes prior to Patient #34's surgery and took the patient to the OR suite where staff positioned the patient on the OR table and the certified registered nurse anesthetist (CRNA) (#10) prepared for induction (the delivery of anesthesia). He stated the Hospital utilized pagers which delivered a sound and message alert upon receipt of a page. The physician (#9) stated the CRNA (#10) paged him to the room for induction, after which he noticed the physician (#20) absent from the OR. He stated he asked the OR staff where the physician (#20) was and this was when staff began communicating concerns with one another that the physician (#20) had not responded to staff's multiple pages, texts, and phone calls. The physician (#9) stated the anesthesia department discussed the event with all levels of anesthesia staff at a meeting a couple weeks later.

During an interview on 04/11/13 at 11:15 a.m., an anesthesia staff member (#10) involved in Patient #34's event, stated the patient's posting (placement on the surgical schedule) occurred for a while and became bumped due to an emergent case. The staff member (#10) stated the physician (#20) seemed frustrated about this and stated in general to several OR staff members within the room that he was going to lay down and instructed staff to give him a 30 minute heads up when ready for Patient #34. The anesthesia staff member (#10) stated staff notified the physician (#20) with the 30 minute heads up and proceeded as usual, bringing Patient #34 to the OR, positioning and putting the patient to sleep. The staff member (#10) identified nights and weekends as the time when the potential for adverse events is the greatest due to the limited number of staff.

During a telephone interview on 04/10/13 at 4:25 p.m., an administrative physician (#8) involved in the follow up of Patient #34's event, stated anesthesia staff should never start a patient case without verbal confirmation from the surgeon that it is okay to proceed and identified delivering anesthesia in the absence of the physician as the main concern of Patient #34's event. The physician (#8) stated he recommended anesthesia develop and implement a policy reflecting this.

During an interview on 04/10/13 at 2:00 p.m., two administrative staff members (#3 and #28) involved in the review of patient events, stated an administrative anesthesia staff member (#7) discussed the event at the department level. The staff members (#3 and #28) failed to provid information on specific measures the Hospital put into place to monitor and ensure similar events do not occur.

An interview occurred on 04/10/13 at 3:10 p.m. with four administrative staff members (#1, #3, #4, and #7). One of the staff members (#7) stated the anesthesia department held meetings twice a month for the CRNA and MDA staff members and stated anesthesia staff discussed Patient #34's event at the department meeting on 02/07/13. Another staff member (#1) stated the Hospital did not develop a policy regarding a process for anesthesia staff to follow as a result of the patient's event. The administrative staff (#1, #3, #4, and #7) classified Patient #34's event as an isolated event and assured a similar event would never occur, but did not provide information on specific measures the Hospital put into place to monitor and ensure similar events did not occur.

Review of the anesthesia department's Group Staff Meeting minutes occurred on 04/10/13. The meeting occurred on 02/07/13, included MDA and CRNA staff, and stated, ". . . Surgeon needs to be in house prior to induction. It is our responsibility to be sure they are here before we induce or place spinal. . . ."

Review of Patient #34's event showed the Hospital identified anesthesia's failure to confirm the presence and availability of the surgeon in the hospital prior to delivering anesthesia. The event lacked review from key personnel and discussion among the appropriate department/committee in a timely manner as anesthesia staff's review of the event occurred on 03/18/13 (nearly two months after the event) and discussion with anesthesia staff occurred on 02/07/13 (nearly two weeks after the event).

Failure of the Hospital to implement strategies to correct identified concerns, evaluate the effectiveness of the strategies implemented, and ensure the improvements remained implemented placed future patients at risk for adverse events.