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.

PENOBSCOT BAY MEDICAL CENTER 6 GLEN COVE DRIVE ROCKPORT, ME 04856 April 11, 2014
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of documentation, review of policies and procedures and interviews with key staff between April 3 and April 11, 2014, it was determined that the hospital failed to have a functioning, effective Governing Body that was responsible for the hospital ' s compliance with the standards of the hospital, as well as the Conditions of Participation, as evidenced by:

1. The governing body failed to ensure that the emergency needs of patients were met and that policies and procedures governing medical care provided in the emergency department were established by and were a continuing responsibility of the medical staff (See Tag A-1100, Condition of Participation: Emergency Services).

2. The governing body failed to ensure that an adequate number of medical and nursing personnel qualified in emergency care were available to meet the needs anticipated by the emergency department (See Tag A-1100, Condition of Participation: Emergency Services).

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based on observation, review of: ten (10) Penobscot Bay Medical Center (PBMC), Emergency Department (ED) medical records and one (1) Primary Care medical record, policies and procedures, patient care protocols, hospital committee meeting agendas, hospital clinical committee meeting minutes, performance improvement plans, staff training and education programs, Emergency Department staffing schedules, and interviews with key staff on April 3-11, 2014, Penobscot Bay Medical Center failed to provide a timely assessment and treatment to a patient seeking emergency medical care in the Emergency Department. These findings represented an immediate jeopardy to the patients seeking emergency medical care at Penobscot Bay Medical Center.

The evidence is as follows:

1. Documentation provided by Penobscot Bay Ambulatory Family Medicine, indicated that Patient A contacted his/her primary care physician's office on January 27, 2014, at 0815, reporting he/she was not feeling well and wanted a call from the doctor. Patient A was put on the schedule with his/her physician at 4 PM. Patient A stated he/she wanted to be seen sooner. Documentation stated, "Pt sounded like [he/she] was struggling breathing on the phone. Please call and advise." Note dated January 27, 2014, at 1203 stated, "spoke W/[pt's physician] who recommends that the patient go to the ED. I contacted the patient and informed [him/her] that [he/she] could go to the ED. Report given to [an individual] in the ED."

2. A review of Patient A's Emergency Department record fails to document that the ED had been notified of the patient's pending arrival.

3. The Penobscot Bay Medical Center ED logs for the period January 20, 2014, through January 31, 2014, were reviewed on April 3, 2014. The log revealed that on January 27, 2014, ten (10) patients arrived in the ED in the hour prior to Patient A entering the ED at 1308. Four (4) patients arrived between 1302 and 1312 on January 27, 2014; all eventually classified triage level 3.

4. Of the ten (10) patients entering the ED, prior to Patient A on January 27, 2014, two (2) had chief complaints of chest pain, two (2) complained of urological problems, three (3) suffered traumatic injuries, the remaining three (3) complained of weakness, cough, and nausea.

5. Of the three (3) other patients arriving approximately the same time as Patient A, their chief complaints included; "weakness", "chest pain-high risk", and "flank pain".

6. The medical record of Patient A indicated that he/she arrived in the ambulatory ED on January 27, 2014, at 1308 and presented with a stated complaint of "Pain in back & chest." The triage assessment indicated that Patient A was triaged at 1338 (30 minutes after arriving in the ED) and given a triage priority of "3" on a 1-5 scale (1 being highest acuity). The ED log indicated Patient A's complaint as "Chest/Rib Pain: Non-cardiac". Patient A was returned to the ED waiting room where he/she was found in cardiac arrest approximately forty-five (45) minutes later. Patient A was declared dead on January 27, 2014, at 1433.

7. The PBMC Policy titled, 'Triage' was reviewed. It stated "when the ED provider is busy rendering patient care, urgent and non-urgent patient types will be triaged to assess their acuity and resource utilization according to the Emergency Severity Index, Version 4. Pre-established patient care protocols may be implemented. Emergent patients will be taken to the clinical area immediately. The registration process will not delay the medical screening exam." Additionally; the policy states: "7. When multiple patients present simultaneously the initial triage evaluation (spot check) will be comprised of the following: - presenting complaint, -"across the room assessment"; visual assessment of ABCs, pain status, and triage category, this will be followed by the completion of the comprehensive process by the triage or primary RN. ... 11. Those patients having non-urgent patient care needs will be placed in the ED waiting room ..."

8. Patient A's medical record failed to show evidence of an "initial triage evaluation (spot check)", as required by the triage policy.

9. The Charge/Triage nurse stated during an interview on April 4, 2014, at 1000 that she failed to document the initial triage evaluation (spot check) in Patient A's medical record.

10. During an interview with Nurse Manager Emergency Department, on April 3, 2014, at 1218, she indicated that the triage nurse performed a "spot check" which was never documented in the record. She stated that based on the review of the situation an "across the room" evaluation was completed. She stated that Patient A was found unresponsive by the Clinical House Supervisor who was making rounds through the ED. She reported that the House Supervisor noted Patient A was leaning against his/her son's arm and "appeared sick". When checked, Patient A was found to be in cardiac arrest. The ED Nurse Manager reported that at that time all of the 12 emergency department bays were filled and five patients were on gurneys in the hallway. Department staffing at the time of the incident included: 2 physicians, 4 Registered Nurses, 2 ED Technicians, and a receptionist. She reported that this is considered full staffing for the department.

11. Observation: Tour of Emergency Department (ED) was conducted on April 3, 2014, at approximately 13:00, accompanied by the ED Nurse Manger. The waiting area of the ED was observed, and included the ability of the triage nurse to have direct observation of individuals remaining in the waiting area. No patients were present in the waiting area during the tour. During the tour, it was determined that the ED was not at capacity, however the Nurse Manger indicated that almost all the beds were occupied. The patient tracking monitors were observed during the tour. Two (2) monitors are installed in the each of the following locations; Triage Room, Main Hallway and Nurses Station. These monitors allow staff to determine which beds are occupied and the current status of the patient. Additionally a dedicated second monitor provides status of patients waiting in the waiting area and included the time the patient has been waiting. The Nurse Manager indicated that the ED receptionist enters the patient into the ED log and this time is used to track the patient's waiting time. The Nurse Manager also stated that the utilization of the ED has increased and current utilization is getting close to capacity. The stated that the hospital is looking at the possibility of increasing the number of available ED beds.
12. The American College of Emergency Physicians Advanced Emergency Care, Emergency Medicine Manual, 7th Edition, Judith Tintinalli, Ed., Chapter 17, Chest Pain: Cardiac or Not, pages 111, 112 and 116 state, "Patients with acute nontraumatic chest pain are among the most challenging patients cared or by emergency physicians. They may appear seriously ill or completely well and yet remain at significant risk for sudden death or an acute myocardial infarction (AMI) ... ...Women, diabetics, the elderly, and patients with psychiatric disorders may have more atypical systems of ischemia ...it should be assumed that every patient with any risk complaining of chest pain may be having an AMI and should be evaluated for this diagnosis."

13. The American Nurses Association, Sheehy's Manual of Emergency Care, 7th Edition, Belinda Hammond, Ed, Chapter 7, Triage, pages 61, 65, state, " Triage is the process of rapidly sorting patient, who present to the Emergency Department (ED) to determine who needs to be seen immediately and who is safe to wait ...The word triage comes from the French word trier, which means to sort or choose...The purpose of triage is to put the right person in the right place at the right time for the right reason... Comprehensive triage is the most advanced system and is the process currently recommended by the Emergency Nurses Association's (ENA) Standards of Emergency Nursing Practice, which defines the practice as follows: The [emergency nurse] triages each patient and determines the priority of care based on physical, developmental, and psychosocial needs as well as factors influencing access to health care and patient flow through the emergency care system ...The triage nurse documents the initial findings in the medical record and reassesses the patients according to individual needs and departmental policy."

14. The Foundations of Emergency Care, Chapter 1, Introduction to emergency care, (Emma Tippins and Cliff Evans 2006), and states: "A decision that underestimates a person's level of clinical urgency may delay time critical interventions; furthermore, prolonged triage processes may contribute to adverse patient outcomes (Geraci and Geraci 1994; Travers 1999), and impede the assessment of others."

15. The impact of not providing a timely triage assessment and expedited assignment to a treatment bed, may contribute to increased negative patient outcomes up to and including death.

16. The PBMC policy titled, 'Emergency Department Surge Policy' was reviewed. It stated "Purpose: To establish a procedure to be implemented when conditions in the Emergency Department (ED) are such that a bottleneck for inpatient placement adversely impacts the ability of the department staff to care for new patient arrivals ... This procedure will be used to mobilize personnel and identify alternative temporary locations to facilitate the movement of admissions from the ED in an orderly manner and/or avoid a situation, which may lead to Emergency Department Diversion."

17. During an interview with the hospital's Chief Medical Officer (CMO) on April 4, 2014, he reported that the emergency department physicians held a meeting on February 27, 2014, to look at the "surge policy" for the emergency department. He indicated that the previous policy required the charge nurse, and ER physician, to declare a "surge". The new policy was implemented to better define what constituted a surge, and to assist personnel in understanding when to initiate the surge policy. A decision was made to conduct a mock surge drill sometime in April 2014. He indicated that the Hospitalist also met in February to address concerns regarding the surge policy.

18. A review of the February 27, 2013 Emergency Department meeting minutes reported that no evidence was found of the spot check assessment being documented or any evidence of the surge policy being activated on January 27, 2014.

19. The CMO stated during an interview on April 3, 2014, that the PBMC Emergency Department's Surge Policy was not implemented on January 27, 2014. The Triage Nurse concurred during an interview on April 4, 2014 at 1000 that the Emergency Department Surge Policy was not activated.

20. The impact of not implementing the Hospital's Emergency Department Surge Policy, prevented additional resources from being made available to the ED. These resources could have possibly eased the overcrowding in the ED by freeing ED beds or made additional ED beds available to patients remaining in the waiting area.

21. The PBMC policy titled, 'Chest Pain, Treatment of Suspected' was reviewed. It stated "to determine if the patient is experiencing cardiac related chest pain, such as angina pectoris, and to expedite sublingual nitroglycerin (NTG) administration by RN. Early recognition and restoration of cardiac blood flow to decrease the risk of myocardial damage." Procedure step number "1." states; "All patients presenting with a chief complaint of chest pain will be immediately assessed utilizing the nursing process."

22. The review of Patient A's medical record revealed that Patient A presented with a chief complaint of chest pain, however the medical record failed to indicate that Patient A received an immediate assessment utilizing the nursing process, per PBMC Policy, until after Patient A had been in the ED for thirty (30) minutes.

23. The impact of failing to follow the 'Chest Pain, Treatment of Suspected' Policy requiring "all patients presenting with a chief complaint of chest pain will be immediately assessed utilizing the nursing process.", could cause other patients presenting to the ED with chest pain, to receive delayed assessments and treatments for their medical condition.

24. During an interview with the Charge/Triage nurse, on April 4, 2014, at 1000, she stated that Patient A's primary care physician's office referred Patient A to the emergency department. She stated that Patient A arrived along with several other patients all within a few minutes. Reported that she immediately looked at Patient A, assessed Patient A's pain scale and conducted a brief face to face evaluation with Patient A. Reported that patient A stated "oh, I'm fine, I'm fine". That Patient A sat down in a waiting room chair and was complaining only of sinus drainage and that his/her neck hurt. Stated that Patient A was offered a stretcher in the hallway, but declined. The Triage Nurse indicated that she failed to document this initial assessment and intervention into Patient A's record.

25. The Triage Nurse reported that she checked the waiting room every thirty (30) minutes and noted that Patient A remained sitting with his/her son in the waiting room. She also reported that she called her supervisor requesting help with the situation in the emergency department which was becoming very busy. She reported that at 1338 she conducted the comprehensive triage and reviewed Patient A's past medical history with Patient A, and that Patient A was leading the history taking process and when she finished her assessment, Patient A said "that's all, it's probably a sinus infection" . She reported that Patient A was more focused on the nasal drainage and neck pain Patient A associated with that. The Triage Nurse stated that she did not feel that Patient A's complaint was cardiac based. She reported Patient A did not look sick and actually looked younger than his/her stated age.

26. Interview with the CMO, on April 3, 2014, at 1330. CMO indicated that the internal investigation of this incident resulted in identification of a problem related to the "patient flow process" through the emergency department. He indicated that following the Root Cause Analysis (RCA), the patient flow process through the emergency department was mapped out to identify bottlenecks preventing patient flow through the department. He further stated that the hospital utilized the "LEAN process" to address problems found in the RCA.

27. Despite the fact that an RCA was completed, the focus of that review appears to be on addressing patient flow through the ED, not the failure of interdepartmental communication, failure to documentation in the patient record, and failure by the Emergency Department staff to follow hospital policies including; implementing the ED Surge Policy, the Triage Policy and the 'Chest Pain, Treatment of Suspected' Policy.

28. The hospital was notified of the Immediate Jeopardy situation on April 3, 2014. At approximately 7:00 PM on April 3, 2014, an acceptable interim safety plan was received by the survey team. This plan was updated and accepted by the survey team on April 8, 2014. This plan included: policy revisions, training in triage, and ongoing monitoring of timeliness of patient triage, patient assessment, and triage accuracy.

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