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.

CALAIS REGIONAL HOSPITAL 24 HOSPITAL LANE CALAIS, ME 04619 March 6, 2013
VIOLATION: ORGANIZATIONAL STRUCTURE Tag No: C0960
Based on review of one Emergency Department medical record, review of policies and procedures, review of committee meeting minutes, review of staff education programs, review of the Calais Regional Hospital Hospital -Wide Performance Plan, and interviews with key staff on march 5-61, 2013, it was determined that the Governing Body failed to assume legal responsibility for the conduct of the CAH as an institution.

The evidence is as follows:


1. The Governing Body failed to ensure that the medical staff was accountable for the quality of care provided to patients (see Tag c- 0241

2. The Governing Body failed to be fully responsible for the implementing and monitoring of policies governing the CAH's total operation (see Tag C - 0241);

3. The CAH failed to ensure that all patient care and services affecting patient health and safety are evaluated (see Tags C -0336 and C-0337;

4. These findings represented an Immediate Jeopardy to a patient seeking emergency treatment at Calais regional Hospital; and

5. An interium safety plan was accepted and implemented on March 6, 2013.

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.
VIOLATION: GOVERNING BODY OR RESPONSIBLE INDIVIDUAL Tag No: C0962
See Tags C-0152, C-0336 and C-337 for information regarding the administration of policies.
VIOLATION: COMPLIANCE WITH FED, ST, AND LOCAL LAWS Tag No: C0810
Based on review of one Emergency Department medical record, review of policies and procedures, review of committee meeting minutes, review of staff education programs, review of the Calais Regional Hospital Hospital -Wide Performance Plan, and interviews with key staff on March 5-6, 2013, it was determined that the CAH and its staff failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, 3.2, Patient Rights in Critical Access Hospitals and the Federal Condition of Participation: Patient Rights, 482.13 (c)(2).

The evidence is as follows:

1. The CAH failed to provide a safe environment for all patients in the Emergency Department (see Tag C-0152);

2. These findings represented an immediate Jeopardy to a patient seeking emergency treatment at Calais Regional Hospital; and

3. An interium plan was accepted and implemented on March 6, 2013.



The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.
VIOLATION: COMPLIANCE STATE AND LOCAL LAWS AND REGS Tag No: C0814
Based on review of one medical record, policies and other information provided and interviews with key staff on March 5 and 6, 2013, the critical access hospital failed to provide a safe environment for patients as required by "Rules for the Licensing of Hospitals," Section 3.2 "Patient Rights in Critical Access Hospitals" which stated that a critical access hospital must protect patients rights and comply with the Condition of Participation contained in 42 C.F.R. Subsection 482.13(c)(2). 42 C.F.R. Subsection 482.13(c)(2) stated that the patient has the right to receive care in a safe setting.

Findings include:

1. Upon review of Patient A's Emergency Department (ED) record, it was noted that this patient was admitted to Calais Regional Hospital by ambulance on February 5, 2013 at 04:25 with chief complaint of "I overdosed", stating that he/she took a total of anywhere between 50 to 100 mg of oxycodone which actually belonged to a deceased friend, as well as #20 tablets of Ultram 50 mg. and 10 tablets of Sinemet and also 2 shots of liquor. Upon clinical record review on March 6, 2013, it was noted that this patient was determined to be a moderate risk for suicide. In an interview on March 6, 2013 at 10:00, the admitting physician (Dr. A) stated that he made this determination based on his assessment at time of admission because patient stated regret for his/her actions, called the ambulance himself/herself, and was not actively suicidal at that time.

2. The Department of Nursing Policy entitled "Suicide /Homicide Safety Precautions,Potential for Violence: Self Directed or Directed at Others" stated: "Patients admitted with a diagnosis of suicide/homicidal ideation will be admitted to a safe room close to the nurses station, if available. A monitored camera room will be utilized when possible. In the ED, room 4 should should be utilized whenever possible." According to the Director of Emergency Services in an interview on March 6, 2012 at 10:00, Patient A was admitted to Room 1, as Room 4 was occupied. During tour of ED on March 6, 2013 at 10:00, it was noted that Room 1 was set up as a typical emergency room with oxygen, suction, vital signs equipment, light fixture and cupboards with doors and draws for supplies and linen. There were a stretcher and two chairs in the room. Cupboards and light fixture were unable to be removed. There were linens and supplies in the cupboards. Room 1 could be seen at an angle from the nurses station. With the door of the room open, the surveyor was able to observe the bottom of bed and a chair in the room. All corners of the room could not be seen. Nursing staff demonstrated how the equipment could be removed when a suicidal patient was admitted and how they observed the room from the nurses station. In an interview on March 6, 2013, the nurse on duty at the time of the incident stated that the linen had not been removed from the cupboards, and the patient was able to access the hospital gown. Patient A also stated he/she was going to hang himself/herself.

3. The Department of Nursing Policy entitled "Suicide /Homicide Safety Precautions,Potential for Violence: Self Directed or Directed at Others" stated: "Purpose: Because the potential for violence is characterized by aggressive behavior with the potential for harming self or others the purpose of this policy is to provide the safest environment for patients until transfer to an appropriate facility. Patient with suicidal /homicidal ideation will be protected form self-injury or harm while in Calais Regional Hospital." Procedure included " #10-Staff will inspect the specified room for potential hazards using the Suicide Precautions Room Safety Checklist (See Attachment) before patient is put into the room" and #16-No unnecessary linen or towels will be left in the room. The attachment did not include a box to indicate that linen had been removed from the cupboard. During an interview on March 6, 2013 at 10:00, the nurse and the ward clerk stated that the room was set up as required. Upon review of the clinical record on March 6, 2013, there was no evidence of the checklist in the clinical record.

4. The Emergency Department policy titled "Behavioral High Risk Patients/Precautions for Safety" stated: "If the patient does not need emergency medical treatment but has the potential to endanger himself or others a secure room will be provided (all potentially dangerous equipment be removed.)" Patient A was placed in Room 1. The ward clerk and the nurse on duty at time of incident were interviewed on March 6, 2013 during tour at 10:00. They stated that the room was set up with all potentially dangerous equipment removed. In an interview on March 6, 2013, the nurse on duty at the time of the incident stated that the linen had not been removed from the cupboards, and the patient was able to access the hospital gown. Patient A also stated he/she was going to hang himself/herself.

5. Upon review of Patient A's clinical record on March 6, 2013, it was noted that this patient was found standing on a chair with gown tied to the light fixture and stated that he/she was going to hang himself/herself. Upon interview on March 6, 2013 at 10:20, the nurse on duty at the time of the incident stated that the linens were not removed form the cupboards and the patient was able to access the extra hospital gown which he/she tied around the light fixture. During tour of ED on March 6, 2013 at 11:00 linen and supplies were observed in the cupboard.

6. The Department of Nursing Policy entitled "Suicide /Homicide Safety Precautions,Potential for Violence: Self Directed or Directed at Others" included under "Procedure #1-All patients that present to the ED requesting to be seen will have a Nursing Mental Health History and the "Risk of Harm Assessment" will be completed. Furthermore, at any time during the patient's stay that any member of the patient care team is concerned about mental health status or there has been a change in the patient's condition, the "Risk of Harm Assessment" will be completed and orders will be written or changed." " Risk of Harm Assessment " includes risk categories as Low, Moderate or High. Moderate Risk is defined as A) Place patient in safe room. B) Remove patient's clothes and belongings, search for weapons, and place in a safe area per valuables policy. Provide hospital attire. C) Place staff on standby (Housed in department to prevent elopement but does not need one on one observation. Level of staff observation to be determined by provider, charge nurse, RN caring for patient, and/or security.) D) Patient must stay in ED until discharge or transfer E) Provide bathroom privileges allowed F) Patient visitation must be cleared by provider and/or nursing .

7. The nursing documentation in Patient A's medical record on February 5, 2013 at 22:45 included: "patient attempted to barricade [himself/herself] in [his/her] room by pushing chair against the door and sitting down -----------------------------------------------------------Patient states that [he/she] would never ask for help again and that [he/she] just wanted to go home. States that [he/she] wishes [he/she] could join [his/her] friend who just died ." On February 6, 2013 nursing documentation included that at 07:58 "[Dr. B] informed that patient seems more agitated." At 09:00 " refused medication. [Dr. B] aware. " At 12:00 " Patient refused meal tray." At 13:00 "Patient pacing in room." At 14:00 "Patient refused vital signs." At 14:20, the nurse documented suicidal ideation, yes, description: patient was found with gown tied together around light fixture standing in a chair by Dr. A. Patient removed from room. Room changed to room 4. Security aware and at bedside.

8. In spite of nursing documentation of patient escalation in the clinical record, in interview on March 6, 2013 at 14:05, Dr. B. stated that he had reassessed the patient but had not documented that. He stated that physicians routinely document once daily at the end of their shift. When asked if he felt there was a need to change the risk score he stated no, there was no need to change the score. He determined that the behavior was based on the fact that the patient felt cooped up. There was no documentation in the clinical record of ongoing risk assessment by Dr. B.

9. For further information see Tags C-336 and C-337.

10. The potential outcome of failing to provide a safe environment for ED patients expressing suicidal ideation is that they may be able to attempt or complete suicide.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on review of one Emergency Department medical record review, review of policies and procedures, review of committee meeting minutes, review of staff education programs, review of the 2012 Calais Regional Hospital Hospital -Wide Performance Plan, and interviews with key staff on April 9-11, 2013, it was determined that the CAH failed to ensure that actual practices in the hospital reflected their current policies and procedures.

The evidence is as follows:

1. The CAH failed to provide a safe environment for all patients in the Emergency Department (see Tag C-0152);

2. The CAH failed to have an effective quality assurance program to evaluate the quality of care, treatment furnished in the CAH and the outcomes (See Tag C-0336);

3. The CAH failed to ensure that all patient care and services and other services affecting patient health and safety are evaluated (see Tag 337);

4. These findings represented an Immediate Jeopardy to a patient seeking emergency treatment at Calais Regional Hospital; and

5. An interim safety plan was accepted and implemented on March 6, 2013.

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
Based on review of one Emergency Department medical record review, review of policies and procedures, review of committee meeting minutes, review of staff education programs, review of the Calais Regional Hospital Hospital -Wide Performance Plan, and interviews with key staff on March 5-6, 2013, it was determined that the CAH failed to have an effective quality assurance program to evaluate the quality and appropriateness of care and of the outcomes.

Findings include:

1. The medical record of Patient A was reviewed on March, 6, 2013. The record stated that Calais Regional Hospital failed to keep Patient A safe while he/she was a patient in the Emergency Department, in February 2013, as evidenced by Patient A attempting to hang himself/herself by tying a johnny to a light fixture in the ceiling of the room (see Tag C-152).

2. The Calais Regional Hospital Hospital-Wide Quality Assurance/Performance Improvement Plan 2012 was reviewed on March 6, 2013. It stated, " I. Purpose: The Hospital Wide Quality Assurance/Performance Improvement (QAPI) Plan of Calais Regional Hospital is designed to serve as a guide to assist hospital departments and medical staff to identify opportunities for improvement. Over the years the focus of quality improvement efforts has shifted from a retrospective to a prospective process. The quality improvement process is designed to assist all providers at all levels of care. Therefore the ongoing monitoring and evaluation of clinical patient care should be implemented through a process known as continuous quality improvement (CQI)."

3. The Risk Manager was interviewed on March 6, 2013 at 11:25. He stated that he did not do a "mini" Root Cause Analysis related to the incident involving Patient A. He further stated that he did not think at the time that he reviewed the case, that the incident was a "near miss." He stated that he decided that it was a "near miss" yesterday after discussion with the surveyor and will schedule a Root Cause Analysis [RCA] next week.

4. On March 6, 2013, a review was made of the CRH ED meeting minutes of February 19 and 20, 2013. There was no discussion documented in those minutes about the incident related to Patient A on February 6, 2013, or any changes that would need to be made to provide a safer environment for suicidal patients.

5. Please see Tag C-0337 for additional information.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
Based on review of one clinical record, policies and other information provided and interviews with key staff on March 5 and 6, 2013, it was determined that the CAH failed to evaluate an incident which affected patient health and safety.

Findings include:

1. The policy titled "Variance Reporting" stated: "A patient variance form should be completed for any unexpected event that occurred or could have but did not just because of a "good catch" on the part of a patient/family/visitor or staff member.

2. Upon review of variance report dated February 5, 2013, on March 6, 2013 it was noted "@ 14:20 patient was found standing on bed with gown tied around light fixture. Patient said [he/she] was going to hang [himself/herself.] [Dr. A] helped patient down. Patient placed on 1:1 observation. Security aware... No injury noted." The section for Severity included five check boxes: "Class I-no injury, Class II- Injury , no treatment required, Class III-Injury, treatment required, Class IV-Near Miss/Could have resulted in serious injury-good catch, Class V-Sentinel Event." Class I-no injury was checked for severity of incident. Outcome section and Suggestions For Prevention of Similar Future Occurrences sections were left blank. In the Department Director Section under action required, it was noted to be "yes" and statement "this should be reviewed in a minor "RCA" (root cause analysis) to see what could have been done differently". In the Risk Manager Section documentation stated: "Reviewed and will follow up with ED Director". According to interview with Risk Manager on March 6, 2013 at 11:25, he stated that he reviewed the variance report and spoke with staff in the ED. He stated he did not document his actions. He further stated that he did not do the "mini" root cause analysis related to this incidence because at the time he reviewed the incident he did not think that it was a "near miss". He determined it to be a "near miss" on March 5, 2013 after discussion with the surveyor and had scheduled a Root Cause Analysis for the next week.

3. The hospital policy titled "Sentinel Event Policy and Procedure" stated: "According to the Maine Department of Health and Human Services, a Near Miss Event is an event or situation that did not produce a patient injury but only because of chance, which may include, but is not limited to, robustness of the patient or a fortuitous timely intervention."

4. Upon interview on March 6, 2013 at 10:20, the nurse who completed the variance report and documented the incident in the clinical record stated that that she had talked to the Head Crisis worker regarding the incident but didn't document that conversation. She further stated that she had spoken to the Risk Manager after the fact and he told her it was not a Sentinel Event and there was no harm. At the time, she wrote the variance report she did not consider it a "near miss."

5. A review of the Emergency Department meeting minutes of February 19 and 20, 2013 was completed. There was no evidence that the incident related to the patient identified in the variance report on February 6, 2013 had been discussed or any changes needed to provide a safer environment for suicidal patients.

6. In an interview with the Director of Emergency Services on March 6, 2013 at 12:14, she stated that there was discussion in the ED meetings, but it was not documented. She stated that she did have handwritten notes. These notes were reviewed and included the following: " The remaining gowns need to be pulled; Room #1 and #2 were the safest; totes were needed to put stuff in, and that maybe a camera could be used " . She further stated that none of those suggestions had come to fruition because the Director of Nursing had been out sick and the finances at the hospital were being looked at closely.