HospitalInspections.org

Based on review of one Emergency Department medical record, four Inpatient Care Unit patient records, 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, review of the Plan of Correction dated March 29, 2013, and interviews with key staff on April 9-11, 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)(1), (c)(2), (e), (e)(3), (e)(8),(e)(4)(ii), (e)(16)(v), and (f)(2).

The evidence is as follows:

1. During a complaint investigation, an Immediate Jeopardy situation was discovered based on the inability of the CAH to keep Emergency Department patients safe from suicide attempts. Additionally, the CAH failed to identify or recognize the seriousness of the issue. For additonal information please see CMS Form 2567 dated March 6, 2013.

2. In spite of a Plan of Correction submitted March 29, 2013, the CAH continued to fail to provide a safe environment for all patients in the Emergency Department (See Tag C-0152);

3. The CAH failed to protect the privacy of all patients on the Inpatient Care Unit and the Emergency Department (See Tag C-0152);

4. The CAH failed to use and implement restraints as determined by hospital policy (See Tag C-0152);

5. The CAH failed to require appropriate staff to have a working knowledge of the hospital's policy regarding the use of restraints (See Tag C- 0152); and

6. The CAH failed to maintain the confidentiality of record information (See Tag C- 308).


The cumulative effect of these deficient practices resulted in this Condition of Participation remaining out of compliance.

Based on review of one Emergency Department medical record, policies and other information provided and interviews with key staff on April 10 and 11, 2013, it was determined that the CAH 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 PP's Emergency Department (ED) Record, it was noted that this patient was admitted on March 27, 2013, from a group home. Triage note by nursing at 6 p.m. noted that the patient had been brought to the ED by law enforcement and had been aggressive and assaultive towards staff at the group home where [he/she] was a resident and had been "banging [his/her] head against the wall". Physician initial evaluation noted "Apparently the child does have a history of mildly self-injurious behavior including cutting [him/her] self with tacks or small pieces of glass or pins. [He/She] seems to have escalating behavior over the time that [he/she] has been at the children's home". It was noted that patient had been in the group home for about three weeks. It was noted that at the group home on the day of admission to the ED that: "Today, the child became quite rambunctious wanting to leave and had to be partly restrained."

2. Upon review of the initial crisis evaluation conducted by Aroostook Mental Health Center (AMHC) Crisis Services on March 25, 2013, it was noted that: "Client had been transferred to CRH [Calais Regional Hospital]-ED after having eloped (for the third time) from [group home] and subsequently found by the police entering the river (after client saw that the police had located [him/her])." The lethality assessment included the following comment: " Client denied any current SI [suicidal ideation] but in previous evaluation (3/5/2013) it was reported that the client threatened to jump off [his/her] two story deck-father intervened. Client has history of suicidal gestures but no actual attempts. Client has a history of engaging in cutting behavior -serious recent cutting episode while at [group home] during which client continued to cut and refused to give [his/her] cutting device to staff-threatening to swallow it when staff attempted to intervene. Client has impulsively eloped 3 times from [group home] requiring police intervention." Initially the client was approved to go back to group home with a behavioral contract, but in a contact note dated March 27, 2013, it was noted that group home staff were unable to keep client safe and he/she presented with "increased anxiety, aggressive behavior". Staff of group home called police to escort client to ED. "Assessment Summary and Crisis Plan" by AMHC crisis counselor dated March 27, 2014, stated "Client would benefit from higher level of care" and "1. Client will remain at CRH-ER, on this date." There were notes by crisis for each day patient remained in ED until a bed was found for admission to psychiatric care. Transfer documentation in clinical record noted that this patient was discharged to psychiatric care on April 4, 2013.

3. 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. Patient with suicidal/homicidal ideation will be protected from self injury or harm while in Calais Regional Hospital.

4. Upon review of the clinical record on April 10, 2013, it was noted that the clinical record included the order sheet titled "Suicidal/Homicidal Precautions Order Set". This order dated March 27, 2013, noted this patient was " Moderate Risk of Harm". It further noted that patient was on 1:1 observation for reason of "Patient is under care of DHS [Department Human Services] in group home, not capable of autonomy."

5. 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."

6. Upon review of the Patient PP's clinical record on April 10, 2013, it was noted that the patient's activity order on March 27 at 10:45 p.m. was " per precautions order set (see #4 above for details of this order) and on March 28, 2013 at 9:10 a.m. order noted "continue these orders, " on March 29, 2013, at 2:50 p.m. order noted " in room with attendant, precaution order sheet, " and at 6:51 p.m. order noted "in room with attendant," March 29, 2013, at 2:33 p.m. an order noted "may use floor computer." There was no time frame included in this order. On March 30, 2013, there was no activity order. On March 31, 2013, at 8:23 a.m. activity order noted "attend with patient," on April 1, 2013, at 10:50 a.m. and 6:55 p.m. activity order noted "1:1 constant, on April 2, 2013, at 9 a.m. and 9 p.m. activity order noted constant 1:1" , on April 3, 2013 at 10:49 activity order noted "in room may shower with attendance, may use floor computer if behaves, 1400-1500 this afternoon," on April 4, 2013, at 9 a.m. activity order noted " 1:1 constant may shower, " on April 5, 2013, at 10:15 a.m. it was noted "renew above orders for 12 hours." Patient was transferred to psychiatric facility by ambulance at 1650.

7. Upon review of clinical record on April 10, 2013, the following was noted in nursing documentation:

a. On March 30, 2013, at 5:30 p.m. noted: "patient over to IPCU [in patient care unit] on computer with 1:1 [staff named]" at 5:55 p.m. "patient back from floor", at 6:27 "patient over to floor to read a book with [staff named]," at 10 p.m. "Patient down to IPCU on computer," and at 11 p.m. "returned to ER." Also noted on March 30, 2013, at 2:45 p.m. was "patient ok'd by [MD named] to go have a shower on inpt [in-patient]. Pt. ambulated over with [CNA named]."

b. On March 31, 2013, noted at 11:50 a.m. "Pt [patient] is starting to swear and use the "F" word. Pt appears extremely hyper at this time." At 2:48 p.m. "Pt gone to inpatient care accompanied by [female staff named], 1:1 for shower." Noted "back from the shower" at 3:17 p.m. At 9:15 p.m., it was noted that "Pt has been increasingly restless tonight. Acting out by standing on the stretcher and needing to be told several times by staff to sit down. Pt spoken to by writer and warned that his/her defiance would not be tolerated and he/she need to remain lying or sitting on stretcher at all times."

c. On April 1, 2013, noted at 10:30 a.m. "Pt making disruptive noises using toy as a balloon, blowing in and out. Pt given IPAD prior but writer removed it from room when pt wouldn't ' t give writer the toy. Pt then threw the toy in the hallway." At 11 a.m. it was noted "Pt out of ER, over to IPCU with [staff named], ok'd with [MD named]." At 11:51 a.m. it was noted " Pt returned from IPCU with CNA [Certified Nursing Assistant]. Pt twirling in hallway. Attempting to enter soiled utility room. Pt asked to return to room. "At 7:25 it was noted " Pt is in Pt ' s library on IPCU with 1:1 sitter for safety." At 7:34 it was noted that patient returned from IPCU. At 7:40 it was noted "Pt gone back to computer lab with [staff named] 1:1 staff at this time." At 7:45 it was noted " Noted pt. and sitter at front desk. Observed pt. walk through door and outside door open. Writer immediately went to front door and asked pt to step back from the door and return to the ER. Pt stated it wasn ' t right for us to keep [him/her] inside when it was so nice outside. Writer paged security to front door stat. Writer again asked pt to return to ER and asked MD's permission for [him/her] to be outside. Pt bolted around writer and ran across parking lot. Security arrived and pursued pt at this time. Writer returned to ER and had staff call Washington County Dispatch for CPD [Calais Police Department] backup now." It was noted by nursing staff that group home and patient ' s father had been notified of elopement. At 8:13 p.m. it was noted "Pt returned to ED accompanied by Calais Police Officer. Pt back in ED Rm. 4 and tables with drinks and magazines removed from room. [Security officer named] from security at bedside for 1:1 safety observation at this time. Rest of evening it was noted that patient had nosebleed, complained of stomach ache and was agitated. MD made aware, was seen by physician and lab work ordered."

d. On April 2, 2013, noted, "patient refusing medications by mouth until advised he would have medication by injection. Pt was also advised to cooperate with behavior so privileges could be restored. He/she remained on 1:1 with security staff."

e. On April 3, 2013, it was noted that privilege and shower on IPCU were restored accompanied by security staff and still on 1:1 with security staff.

d. Nursing documentation for remainder of stay noted patient remained agitated about being there and was on 1:1 observation by security staff.

8. The nursing documentation and activity orders did not contain documented evidence that orders for visits to the IPCU were specific for daily visits except on April 3, 2013, or for safe escorts. Please refer to #6 above for safe escort information.

9. A tour was conducted of the IPCU (Inpatient Nursing Care Unit) on April 11, 2013, at 10 a.m. accompanied by the ward clerk/CNA [Certified Nursing Assistant] on duty at that time. The shower used by the patient from the ED was located near the nurses' station. It was a large room in which staff could be in the room if a patient was assessed as suicidal, and still give patient privacy. She stated she was not sure if someone was with the identified patient inside bathroom. Then staff and surveyor walked down long corridor from nurses station to a lounge at the end. This lounge is where the computer is located. We then walked the two corridors that lead from IPCU to ED. The staff demonstrated how one corridor is accessed with a keyless entry leading to a back door into the ED and the other which was a direct route to front entrance to the hospital located near the entrance to the ED. This staff person was familiar with this patient who visited unit regularly and stated " [He/She] was a good kid. Very smart on the computer. [He/She] was always with [his/her] 1:1." According to interview with Risk Manager on April 11, 2013, at 9:30 a.m., the safe route was considered to be the corridor with no access to the front entrance of the hospital.

10. For further information see Tags C-336 and C-337 for additional information related to the assessment of the incident..

11. The potential outcome of failing to provide a safe environment for ED patients who are at risk of elopement is that they may indeed elope and encounter harm while outside the confines of the CRH.

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Based on review of policies and procedures, review of Emergency Department and Inpatient Care Unit medical records, April 9-11, 2013, it was determined that the CAH failed to provide personal privacy 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)(1) stated that the patient has the right to personal privacy.

Findings include:

1. During a facility tour on April 9, 2013, at 1055, a child was observed seated beside the ward clerk behind the front nurses ' station on the Inpatient Care Unit. The child appeared to be approximately eight (8) or nine (9) years of age.

2. It was observed that behind the nurses' station, adjacent to the computer screen, there was a live simultaneous video display of four (4) patients at risk for falling. This screen was clearly visible to the child.

3. During an interview with the Director of Inpatient Care Unit she stated " She [the child] shouldn't ' t have been there ... and the doctor knew that ... yes, she is the physician ' s child ... " Additionally she confirmed that the child is nine (9) years old.

4. At 1145 on April 9, 2013, during an interview with the Chief Nursing Officer, she confirmed that the parent of the child was a Hospitalist. She also stated " this physician is on probation for this very issue. She has been noncompliant with the plan [of correction]. We have extended her probation ... I thought we had this resolved ... it clearly isn ' t ... "

5. At 1400 on April 10, 2013, during an interview with the Chief Nursing Officer, she stated that she had counseled this particular physician "multiple times" regarding the child care issue. She stated, " My dates didn't say what was talked about but I can develop a list. My administrative assistant can help me develop the list." However, later on April 10, 2013, the Chief Nursing Officer produced a document titled, ' Meetings with [Physician named] by the CNO', with the dates that [Physician named]had been counseled and including what the counseling had entailed. The date 2-5-13 only documented that [Physician named] had met with the CNO [Chief Nursing Officer].

6. At approximately 1435 on April 10, 2013, the CNO produced another document titled, ' Meetings with [Physician named] by the CNO'. This document had information filled in now about the 2-5-13 meeting with the CNO. And later at approximately 1500, another document describing the counseling meetings was presented to the surveyor. This document dated 4-9-13 and titled, '[Physician named] Extended Probation and follow-up documentation'. This document was signed by the CNO.

7. The first two (2) documents presented to the surveyor on April 10, 2013, had two (2) dates where it was documented that child care was discussed. The last document that was presented to the surveyor only contained documentation one time regarding the child care issue and the plan to eliminate that issue.

8. A review of Physician B's personnel file revealed documentation dated February 13, 2013, titled " 3 Month review for [Physician named]". It stated, " The areas that have been an issue are:.....Bringing daughter to work - disrupting own ability to work and the unit staff as well, despite counseling not to do so......Plan:..........." Utilize CRH Staff input and resources to support with some of [Physician named] personal needs, such a child care..."

9. At 1430, on April 10, 2013, during an interview with the ward clerk revealed that the child " always settles into that nook. "

10. During a review of inpatient medical records on April 10, 2013, and Emergency Department (ED) records reviewed on April 11, 2013, it was revealed that four (4) out of four (4) inpatients and one (1) of one (1) ED patient, being video monitored failed to be informed that they were being video monitored (Records G, H, I, K and NN).

11. A review of the policy titled, ' Camera Monitoring' was conducted on April 11, 2013. It stated, " Patients being visually monitored will be made aware that they are being visually monitored for patient safety or patient ' s family " .

12. The above findings related to the inpatients were confirmed with the Director of Inpatient Care Unit on April 10, 2013 at 1500. She stated, " I don ' t have any documentation that the patients are aware of the camera " .

13. A review of the policy titled, ' Camera Monitoring' was conducted on April 11, 2013. It stated, " Admitted patients with a physician ' s order or a nursing order ... "

14. A review of medical records G, H, I, and K was conducted. It was revealed that four (4) out of four (4) contained signed consents which stated, " I also authorize CRH to utilize video monitoring for close observation when so ordered by my physician. "

15. Records H and I failed to contain a physician ' s order for video monitoring.

16. These findings were confirmed by the Chief Nursing Officer on April 11, 2013.

17. Emergency Department medical records were reviewed on April 11, 2013. One (1) Medical Record NN, contained documentation that a video camera was utilized. This record contained no documentation that the patient had been made aware that the camera was being utilized.

18. A staff nurse and the Director of the Emergency Department were interviewed on April 11, 2013, at approximately 1000. They both stated that the patients were told about the cameras but that it was not documented in the patient's medical record.

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Based on review of medical records, hospital policy and interviews with key staff on March 10 and 11, 2013, it was determined that the CAH failed to protect patient ' s rights 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 patient rights and comply with the Condition of Participation contained in: 42 C.F.R.:

1. Subsection 482.13(e) which states; "All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time."


2. Subsection 482.13(e)(3) - "The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm."


3. Subsection 482.13(e)(8) - "Unless superseded by State law that is more restrictive --
(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:
A. 4 hours for adults 18 years of age or older;
B. 2 hours for children and adolescents 9 to 17 years of age; or
C. 1 hour for children under 9 years of age."


4. Subsection 482.13(e)(16)(v) - "The patient's response to the intervention(s) used, including the rationale for continued use of the intervention."

Findings include:

A review of Policy NGN R-3, Title: " POLICY/PROCEDURE/ CARE STANDARD FOR THE USE OF RESTRAINTS " was conducted.
a. Section " II. (2) A restraint can only be used if needed to improve the patient's well-being and less restrictive interventions have been determined to be ineffective."
b. Section " II. (4) The condition of the restraint patient must be continually assessed, monitored, and reevaluated."
c. Section " IV. DOCUMENTATION REQUIREMENTS (ORDERS) " states; " A. Written orders are issued by a LIP and must include: 1. Clinical justification for use; 2. Time limit (not to exceed 24 hours; Time limited orders should indicate a start time and end time; i.e. restrain now (0900 until 1500). 3. Type of restraint. "
d. Section " V. DOCUMENTATION REQUIREMENTS (medical record) " states " A. MEDICAL RECORD DOCUMENTATION MUST INCLUDE: 1. Behavior necessitating restraint. 2. Least restrictive alternative intervention(s) attempted. 3. Times for application, initiation, early release attempts, monitoring, reapplication, removal. 4. Reassessment/behavior observation every 15 minutes (hard restraints), hourly, soft and other restraints, appropriate flowsheet. "

Medical Record WW

1. " PHYSICIAN'S ORDERS SHEET FOR USE OF RESTRAINTS " dated June 14, 2012, time: 1900 ordering soft wrist restraints was reviewed. Restraints were ordered from 1900-0700.

2. Patient progress notes dated June 14, 2012 indicated restraints were applied at 1900, nursing assessment conducted at 1915 with next progress assessment note at 2250. Additionally, there was no hourly assessment documented between 0025 and 0230, between 0330 and 0600 on June 15, 2012.

3. Documentation failed to include:
a. Least restrictive alternatives attempted before either mechanical or chemical restraints were utilized.
b. Reassessment/behavior observation hourly was not recorded in the medical record.
c. No documentation regarding early release attempts or removal.

4. These findings were confirmed by the Director of Emergency Services on April 11, 2013 at approximately 1340.

Medical Record XX

1. "PHYSICIAN ORDER SHEET FOR USE OF RESTRAINTS" dated March 10, 2013 at 1555 was written ordering wrist/ankle (leather or hard plastic) restraints. The time of the initial order was from: 1555 to 1755. A continuation reorder was noted for 1755 to 2055. The next renewal was documented from " 2210 to D/C Restraints, one at a time per protocol, if patient is corporative. " Restraints completely removed at 0245 (order written 2210 would have expired at 0210).

2. The record findings include:
a. Failure to renewal the restraint order at 2055, (the documentation does not indicate that the patient was removed from restraints at that time).
b. The restraint order written at 2210 fails to contain specific timeframe for the continuation of the restraints, should the patient not meet criteria for cooperation.
c. Failure to renew the restraint order at 0210.
d. These findings were confirmed by the Director of Emergency Services on April 11, 2013 at approximately 1346.

Medical Record YY

1. " Holding Orders " sheet ordered January 3, 2013, at 2103 contained an order stating, " Restrain Hands " .

2. This order is noted as " Done [ ] 0220 " .
a. Application occurred more than 5 hours after order written.

3. Patient progress notes indicated on January 4, 2013, at 0229 in the nurses notes: " soft wrist restraints applied bilat per dr orders. "

4. Patient progress notes dated January 4, 2013, indicates restraints were applied at 0229. There is no hourly assessment documented between 0631 and 0813 on January 4, 2013.

5. Order fails to contain:
a. Clinical justification for use
b. Time limit.
c. Type of restraint to be used, as dictated by Policy NGN R-3.

6. These findings were confirmed by the Director of Emergency Services on April 11, 2013, at approximately 1400.

Medical Record ZZ

1. Physician's order sheet for use of restraints dated June 13, 2012, time: 2000 ordered soft wrist and leg restraints. Restraints were ordered from " 2000 to 0400 Reassess" .

2. Patient Progress Notes dated June 13, 2012, at 2020 indicates restraints were applied. There was no documentation of alternatives attempted prior to application of restraints.

3. Patient Progress Notes dated June 14, 2012, at 0615 documented: " [physican named] in pt room to remove restraints. "

4. Facility failed to provide order for continuation of restraints from 0400 to 0615 on June 14, 2012.

5. Physician progress note dictated "14 June 2012 07:05 AM " by [physician named] stated; " ER COURSE AND MEDICAL DECISION MAKING: ...At 6:10 hours, lungs were clear, sleeping. At 6:15 hours, was awake. Wrist restraints were removed with the deal that he would not remove the leg restraints until his breakfast tray arrived ... "

6. The record fails to provide documentation as to the behaviors that necessitated the continued need for leg restraints after 0615.

7. These findings were confirmed by the Director of Emergency Services on April 11, 2013 at approximately 1415.

Medical Record E

1. A review of Medical Record E was conducted. The Physician Order Sheet for use of Restraints dated April 6 2013 at 1115 stated: " full side rails, soft wrist restraints " . The order includes reasons for use and a handwritten " Altered Mental Status " . Additionally, the Timed order for restraints was " 1115 to 1115 " . The order also stated, " Order is effective for no more than 24 hours. Physician must evaluate within one hour of this order ... "

2. Medical Record E failed to contain any nursing documentation of the restraint use except at 1230 on April 6, 2013, that said " Soft wrist restraints removed ... "

3. Physician progress note dictated " Sat 6 April 03:32 AM " by [physician named] stated in; " ER COURSE AND MEDICAL DECISION MAKING: ... " Patient initially needed to be restrained because of confusion, but became progressively more coherent over the next several hours and was able to answer questions, and patient did recall that [he/she] had been dizzy in the middle of the night, had attempted to get up and then thought [he/she] had fainted, but does not recall anything further. "

4. On April 10, 2013 at approximately 1200, the Director of Inpatient Care Unit confirmed the above findings and noted that this occurred in the Emergency Department.

5. Medical Record E failed to contain further documentation indicating:
a. Behavior necessitating restraint.
b. Least restrictive alternative intervention(s) attempted.
c. Times for application, initiation, early release attempts, monitoring, and reapplication
d. Reassessment/behavior observation

6. These findings were re-confirmed by the Director of Emergency Services on April 11, 2013, at approximately 1422.


7. The potential outcome of the restraint policy not being followed is that the immediate physical safety of patients could not be ensured.

































09447

Based on observations and interviews with key personnel April 9-11, 2013, it was determined that the facility failed to provide preventive maintenance programs to ensure that all essential mechanical, electrical, and patient care equipment is maintained in a safe operating condition.

Findings include:

1. On April 10, 2013, at 1425, the freezer unit in the medication refrigerator on the nursery unit was observed to have an excessive build up of ice. This finding was confirmed in an interview with the Maintenance/Environmental Services Supervisor on April 10, 2013, at 1425.

2. On April 11, 2013, at 0830, the cold pack freezer located in the Rehabilitation Services building was observed to have an excessive build up of ice on all four (4) shelves. This finding was confirmed in an interview with the Maintenance/Environmental Services Supervisor on April 11, 2013, at 0830.

3. On April 11, 2013, at 0830, the temperature in Rehabilitation Services, of the hot wax in the heating unit was recorded at 138 degrees Fahrenheit. The facility operating policy stated to maintain the temperature between 125 and 127 degrees Fahrenheit. This finding was confirmed in an interview with the Maintenance/Environmental Services Supervisor on April 11, 2013, at 0835.

4. On April 10, 2013, between 1300 and 1430, a surveyor observed that the casters on the ring stand, laundry cart, and the back table, were rusty in Operating Room #1. These findings were confirmed in an interview with the Nurse Manager on April 10, 2013, at 1430.

5. On April 10, 2103, between 1300 and 1430, a surveyor observed that the casters on the back table, ring stand, trash stand, were rusty in Operating Room #2. These findings were confirmed in an interview with the Nurse Manager on April 10, 2013, at 1430.

6. On April 10, 2013, between 1300 and 1400, a surveyor observed that the casters on the laundry cart and the chair were rusty in the Endoscopy Room. This finding was confirmed in an interview with the Nurse Manager on April 10, 2103, at 1430.

7. On April 10, 2103, between 1300 and 1430, a surveyor observed that the casters on the IV stand in Operating Room #1 were rusty. This finding was confirmed in an interview with the Nurse Manager on April 10, 2103, at 1430.

8. On April 10, 2013, between 1300 and 1430, a surveyor observed that the base on the IV stand in Operating Room #2 was not sealed. This finding was confirmed in an interview with the Nurse Manager on April 10, 2013, at 1430.

Based on observations and interviews between April 9 and April 11, 2013, it was determined that the facility failed to provide housekeeping services to ensure the premises were clean and orderly.

Findings include:

1. On April 9, 2013, between 1000 and 1500, a surveyor observed that the exhaust vents were dusty in the Cardiac Rehab Room, two (2) in the Patient Accounts Room, the janitor closet, Materials Management Office, Purchasing Office, clean side of laundry room, soiled side of laundry room, back of both dryers in the clean side of the laundry room, Administration wing bathroom, the male locker room and the female locker room. These findings were confirmed in an interview with the Maintenance/Environmental Services Supervisor on April 9, 2013, at 1500.

2. On April 11, 2103, between 0745 and 0859, a surveyor observed that the exhaust vents were dusty in bathrooms #1 and #2, in the Rehabilitation Services Building, and in the waiting room and bathroom #1 and #2 in the Surgical Services building. Thiese finding was confirmed in an interview with the Maintenance/Environmental Services Supervisor on April 11, 2103, at 0859.

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, review of Calais Regional Hospital Plan of Correction dated March 29, 2013, and interviews with key staff on April 9-11, 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. During a complaint investigation, an Immediate Jeopardy situation was discovered based on the inability of the CAH to keep Emergency Department patients safe from suicide attempts. Additionally, the CAH failed to identify or recognize the seriousness of the issue. For additonal information please see CMS Form 2567 dated March 6, 2013.

2. In spite of a Plan of Correction submitted March 29, 2013, the CAH continued to fail to ensure that all patient care services and other services affecting patient health and safety are evaluated (See Tags C-0336 and C-0337);

3. In spite of a Plan of Correction submitted March 29, 2013, the CAH continued to fail to provide a safe environment for all patients (See Tag C - 0152);

4. 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);

5. The CAH failed to provide personal privacy for all patients (See Tag C - 0152); and

6. The CAH failed to have a preventative maintenance program to ensure that the premises were clean and that all essential patient care equipment was in safe working order (See Tags C-022 and C-0225).

7. Please see Tags C-0152, C-0241 C-0271 and C-0276 for additional information regarding the Governing Body's responsibility to ensure the following of all policies and procedures.


The cumulative effect of these deficient practices resulted in this Condition of Participation remaining out of compliance.

See Tags C -0152, C -241, C-0271, C -0276, and C-0280 for information regarding the administration of policies.

Based on review of Policy NGN R-3, Titled, " POLICY/PROCEDURE/ CARE STANDARD FOR THE USE OF RESTRAINTS " and interviews with key staff on March 10, 2013, it was determined that the CAH failed to assure that health care services were furnished in accordance with appropriate written policies.

Findings include:

1. Policy NGN R-3 stated, "Unit General Nursing (Note: There is a separate policy per regulation covering skilled nursing residents for the Swing Bed Residents)."

2. The restraint policy for Swing Beds was requested.

3. An additional copy of Policy NGN R-3 was provided as the policy in place for Swing Bed residents.

4. The Chief Nursing Officer stated on March 10, 2013, at approximately 0930, "We don't actually have a different policy for swing beds; there is a separate copy of this policy [NGN R-3] in the Swing Bed policy book."

5. The facility failed to produce the "...separate restraint policy per regulation ..." that was described in Policy NGN R-3.

6. On March 10, 2013, at approximately 0935 it was confirmed with the Chief Nursing Officer that no other policies existed regarding patient restraints.

Based on review of medical records, review of policies and procedures and telephone interviews with key staff on April 17, 2103, at approximately 1350, it was determined that the CAH failed to ensure that drugs and biological's were administered in accordance with accepted professional standards.

Findings include:

1. A review of the Emergency Department Medical Record WW, on April 11, 2013, revealed that the order sheet contained a medication order written at 0240 for "Ativan 2 mg PO and Haldol 5 mg PO. RBTO [Physician named/Nurse named]."

2. The patient progress note dated June 15, 2012, at 0250 under heading "ER ASSESSMENT " stated, "Intravenous push medications: pt given 2 mg ativan iv followed by saline flush; iv patent " " Intramuscular medication: pt given 5 mg Haldol in left deltoid;...injection site."

3. The physician progress note dictated "Fri 15 June 2012, 08:13 AM" by [Physician named] stated, " ER COURSE AND MEDICAL DECISION MAKING:...[He/she] was monitored through the night, and received several administrations of Ativan 2 mg IV, and Haldol 5 mg P.O. for agitation."

4. These findings were confirmed with the Chief Nursing Officer by telephone on April 17, 2013, at 1448.

5. The potential impact of physician's orders not being followed is that patients could receive the wrong drug, wrong dose, at the wrong time, resulting in a serious medication reaction.

Based on observations and interviews on April 10, 2013, it was determined that the CAH failed to follow their policies related to maintaining equipment in a sanitary manner/condition, that would ensure that the nutritional needs of patients were met in accordance with recognized dietary practices.

Findings include:

1. On April 10, 2013, at 0750, a surveyor observed that the air gap on the drain line of the vegetable sink was not correct. The drain line consisted of a copper pipe that was one and one half (1 1/2) inches in diameter and was positioned one quarter (1/4) inch above the wastewater drain (sewer). The correct installation is a minimum of one inch (1) or twice the diameter of the pipe, which in this situation should have been three (3) inches above the wastewater drain. This finding was confirmed in an interview with the Food Service Supervisor on April 10, 2013, at 0810.

2. On April 10, 2013, at 0830 the following beverage products were observed to be outdated:
a) One (1) container of Sprite expired on April 3, 2013;
b) One (1) container of Sprite expired on December 30, 2012;
c) One (1) container of Ginger Ale expired on February 27, 2013:
d) One (1) container of Root Beer expired on May 25, 2012;
e) One (1) container of Root Beer expired on January 14, 2013;
f) One (1) container of Fanta Orange soda expired on November 23, 2012; and
g) One (1) container of Fanta Orange soda expired on February 19, 2013.

3. The above findings were confirmed in an interview with the Food Service Supervisor on April 10, 2013, at 0830.

4. On April 10, 2013, at 0840, a surveyor observed that one (1) fourteen (14) quart aluminum pot and one (1) twenty (20) quart aluminum pot, located on the pot and pan rack, were pitted on the food contact surface creating an unclean surface

5. This finding was confirmed in an interview with the Food Service Supervisor on April 10, 2013, at 0840.

6. On April 10, 2013, at 0905 a surveyor observed that three (3) two (2) pound loaf pans located on a shelf over the spice rack, were encrusted with a baked on substance creating an un cleanable surface. This finding was confirmed in an interview with the Food Service Supervisor on April 10, 2103, at 0905.

7. On April 10, 2013, at 0915 a surveyor observed that the Teflon coating was chipped on the seven inch saute pan. Teflon is a non-ingestible metal. This finding was confirmed in an interview with the Food Service Supervisor on April 11, 2013, at 1400.

The above deficiencies were corrected at the time of survey, the saute pan, stock pots and bread pan were removed from service. The air gap was corrected to three (3) inches and the soda was disposed of.

Based on observations, review of documentation, and interviews with key personnel, on April 10, 2013, it was determined that the facility failed to ensure that policies were reviewed at least annually by the group of professional personnel required under paragraph (a)(2) of this section.

Findings include:

1. A review of the Inpatient Care Unit policies was conducted on April 10, 2103. There was no documentation that these policies had been updated since November 22, 2011.

2. This was confirmed during an interview with the Director of Inpatient Care Unit on April 10, 2103, at approximately 1000.



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Based on observations during a facility tour on April 9, 2013, at 1055, it was determined that the CAH failed to have sufficient safeguards to ensure that all information regarding patients was limited to those individuals authorized as having a need to know.

Findings include:
1. A child was observed seated beside the ward clerk behind the front nurses' station. The child appeared to be approximately eight (8) or nine (9) years of age.

2. The surveyors immediately observed protected health information openly visible on the computer, to the view of the child.

3. The ward clerk had a list of patient names and data displayed on a computer screen within view of the child. When the surveyors asked the ward clerk how she was maintaining patient confidentiality with a child sitting next to her, the ward clerk shut the computer screen down and stated " the child can't read English, she's from Spain ... "

4. At 1430, during an interview with the ward clerk when asked "In your opinion, how do you know for sure she [the child] couldn't see the information on the computer screen?" the ward clerk replied, "She could! You ' re sitting where she was sitting and you can see what she sees ..." When the surveyor asked "You do agree that the child had access [to protected health information]?" the ward clerk replied " Absolutely. Yes. " Additionally she revealed that the child "always settles into that nook."

5. The Administrative Policy "Confidentiality Statement" was reviewed. It stated, "... This information from any source and in any form, including ... electronic display is strictly confidential. Access to confidential information is permitted on a need-to-know basis ..."

6. At approximately 1130 during an interview with the Director of Inpatient Care Unit she stated "every employee signs this upon hire."

7. A review of the Employee Handbook was conducted. On page twelve (12) it stated, "Customers rely on employees to demonstrate discretion and to follow the fundamental principle that only the customer's physician or other authorized personnel release customer information." On page forty-four (44), the handbook stated, " ...patients ... deserve to be treated with dignity, respect, and courtesy ... CRH will treat all patients with dignity, respect, and courtesy." On page forty-five (45) it stated, "Patient information will not be shared in an unauthorized manner."

8. A review of the "Hospital-Wide Orientation Checklist" was conducted. Under the section HIPPA/Privacy Review it stated, " ... " Customers rely on employees to demonstrate discretion and to follow the fundamental principle that only the customer's physician or other authorized personnel release customer information."

9. The above findings were confirmed with the Director of Inpatient Care Unit on April 9, 2013.

10. The potential outcome is that unauthorized persons could gain access to or alter protected patient information.

Based on review of Emergency Department medical records, review of Inpatient Care Unit records, review of restraint records, 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, review of the Calais Regional Hospital Plan of Correction dated March 29, 2013, 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. During a complaint investigation, an Immediate Jeopardy situation was discovered based on the inability of the CAH to keep Emergency Department patients safe from suicide attempts. Additionally, the CAH failed to identify or recognize the seriousness of the issue. For additonal information please see CMS Form 2567 dated March 6, 2013.

2. In spite of a Plan of Correction submitted March 29, 2013, the CAH continued to fail to provide a safe environment for all patients in the Emergency Department (see Tag C-0152);

3. In spite of a Plan of Correction submitted March 29, 2013, the CAH continued to fail to ensure that all patient care services and other services affecting patient health and safety are evaluated (See Tags C-0336 and C-0337);

4. The CAH failed to provide personal privacy for all patients (See Tag C-0152); and

5. The CAH failed to develop policies and procedures that reflected all State and federal regulations (See Tag C-0152).


The cumulative effect of these deficient practices resulted in this Condition of Participation remaining out of compliance.

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, review of the Plan of Correction received March 29, 2013, and interviews with key staff on April 9-11, 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 PP was reviewed on April 10 and 11, 2013. The record stated that Calais Regional Hospital failed to keep Patient PP safe while he/she was a patient in the Emergency Department, on April 1 2013, as evidenced by Patient PP eloping and being outside the CAH for a period of seventeen (17) minutes (see Tag C-0152).

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 April 11,2013, at 0945 a.m. He was questioned as to why the section of the variance report title "Risk Manager Section" was blank. He stated that he did see the variance report and talked with the nurse and that the patient was under observation and ED physician had allowed the patient to go to nursing unit for shower and to use the computer located near the SCU (special care unit). When he re-looked at the variance report he noted that the Director of Performance Improvement and the Director of Nursing had reviewed it. He stated, "This should have ended up on my desk." As he looked at the variance report handed to him by surveyor, he stated "as I look at this I'm having palpitations." He then stated that at the time of the incident the CNA had not been informed of the safe passage for this transport. He then drew a diagram of two hallways leading from the ED to IPCU (inpatient care unit), demonstrating one corridor not having egress to the front door and one having egress to front door. He then stated that the patient had been escorted through the corridor with egress to the front door and this is when he/she eloped. He then stated "I will schedule a Root Cause Analysis for next week."

4. On March 6, 2013, a review was to be made of the CRH Emergency Department meeting minutes from March 6, 2013 until April 11, 2103. There were no documented meeting minutes. Therefore the incident related to Patient PP on April 1, 2013, was not discussed within the department, or any changes that would need to be made to provide a safer environment patients.

5. Even though the Plan of Correction received March 29, 2013, stated re-education and clarification with the Risk Manager regarding Sentinel Events and Near Misses would occur by March 6, 2013, the Risk Manager failed to recognized another "Near Miss" on April 1, 2013. There was documentation that the re-education had occurred.

6. The Plan of Correction received March 29, 2013, stated that a Root Cause Analysis was held on March 15, 2013, regarding why the event in February 2013 occurred. Yet as of April 10, 2013, the elopement event of April 1, 2013, had not been recognized as a "Near Miss" and a Root Cause analysis had not been initiated.

7. Please see Tag C-0337 for additional information regarding the quality assurance program.

8. During a telephone conference call on April 11, 2013, at approximately 1300, the Medical Director of Blue Water Group, a physician who worked in the ED and was Chair of the Quality Committee, stated that he was not aware of the elopement that took place on April 1, 2013, and "yes" they should talk about it.

9. The potential impact of "Near Misses" continually being unrecognized is that patients could continue to be in an unsafe environment while hospitalized in the CAH.

Based on review of clinical records, review of policies, review of other information provided and interviews with key staff on April 9-11, 2013, it was determined that the CAH failed to evaluate incidents affecting 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. The Patient Variance Form dated April 1, 2013, at 19:46, was reviewed on April 10 and 11, 2013. It stated, 'Patient PP was on constant 1:1 safety observation per holding orders. Pt. had been given permission by MD to walk the hospital & go down to computer lab. Pt. went for walk [with] Candace, CNA (Certified Nursing Assistant) from IPCU (Inpatient Care Unit). Pt. had ran out front door @ entrance witnessed by [Staff named]. Calais PD (Police Department) made aware & [Physician named]. Pt. retrieved & brought back to ED (Emergency Department) 17 min. later. No injury noted."

3. The Patient Variance Form for Patient PP stated, "SEVERITY: Class I - No injury.........SUGGESTIONS FOR PREVENTION OF SIMILAR FUTURE OCCURRENCES: Do not allow safety and 1:1 pt's to go throughout hospital, regardless if 1:1 is [with] pt!"

4. The Patient Variance Form for Patient stated on the reverse side of the form, "FORWARD TO QUALITY MANAGEMENT WITHIN 3 DAYS." This section was blank. Other sections were completed by the Department Director. It was checked that Action was required.

5. 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."

6. An interview was conducted with the Risk Manager on April 11, 2013, at 9:45 a.m. He was questioned as to why the section of the variance report title "Risk Manager Section" was blank. He stated that he did see the variance report and talked with the nurse; that the patient was under observation and ED physician had allowed the patient to go to nursing unit for shower and to use the computer located near the SCU (special care unit). When he looked at the variance report he noted that the Director of Performance Improvement and the Director of Nursing had reviewed it. He stated "This should have ended up on my desk." As he looked at the variance report handed to him by surveyor, he stated "as I look at this I'm having palpitations." He then stated that at the time of the incident the CNA had not been informed of the safe passage for this transport. He then drew a diagram of two hallways leading from ED to IPCU (inpatient care unit), demonstrating one corridor not having egress to front door and one having egress to front door. He then stated that the patient had been escorted through the corridor with egress to the front door and this is when he/she eloped. He then stated "I will schedule a root cause analysis for next week."

7. There were no Emergency Department meeting minutes from April 1 - 11, 2013 to review. Therefore there was no documented opportunity to discuss Patient PP and the need for any changes that would provide a safer environment for Emergency Department patients.

8. During a telephone conference call on April 11, 2013, at approximately 1300, with the Medical Director of Blue Water Group, a physician who worked in the ED and was Chair of the Quality Committee, stated that he was not aware of the elopement that took place on April 1, 2013, and "yes" they should talk about it.

9. Please see Tag C-0152 for additional information regarding the furnishing of patient care service in accordance with applicable State and local laws.

10. The potential outcome of not identifying and reviewing incidents that affect patient health and safety is that the CAH would not make changes as necessary to ensure patients health and safety.