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Based on review of policies and procedures, medical records, Hospital's Complaint Log for 2010 and observations on October 12-15, 2010, it was determined that the hospital failed to furnish all patient care services in accordance with applicable State and local laws.

Findings include:

1. Title 22 Maine Revised Statutes Health and Welfare Chapter 1071 Child and Family Services and Child Protection Act Subchapter II Reporting of Abuse or Neglect ?4011-A.1.A (10) (10) States, " The following adult persons shall immediately report or cause a report to be made to the department when the person knows or has reasonable cause to suspect that a child has been or is likely to be abused or neglected ...a registered or licensed practical nurse ... " The CAH failed to identify a potential child abuse case and the need to report the suspicions (for further information see Tag C200).


2. The State of Maine Board of Nursing Rules and Regulations Chapter 8, C, (3) states: " adjustments and corrective actions as indicated. For aspects of anesthesia practice that require execution of the medical regimen, the certified registered nurse anesthetist shall be responsible and accountable to a physician or dentist. Without limitation, coordination and appropriate communication shall be deemed to have occurred if the prescribing physician or dentist shall have signed the patient's anesthesia record." The CAH failed to be knowledgeable regarding the regulations requiring the CRNA ' s to be accountable to a physician while administering anesthesia (for further information see Tag C324).

3. Section 3.2 of the ' Rules for the Licensing of Hospitals ' in the State of Maine stated, " A critical access hospital must protect patient rights and comply with the conditions for patient rights contained in 42 CFR Section 482.13, " and Section 482.13(a)(2) of the Condition of Participation: Patient ' s Rights stated, " The hospital ' s Governing Body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. "

4. A review of the first, second and third quarter's of the CAH's Complaint Log indicated that the hospital had received complaints from January to September 2010.

5. There was no documentation of trending of these complaints as of October 15, 2010.

6. This was confirmed with the Director of Quality Management during an interview on October 15, 2010. She also stated that only a few complaints had gone to the Quality Committee of the Board for review.

Based on review of medical records, review of policies and procedures, review of ambulance run sheets, review of patient care protocols, review of committee meeting minutes, Performance Improvement reports, review of staff education programs, review of professional standards of practice, review of Plan of Service Calais Regional Hospital Emergency Department 2010, review of Calais Regional Hospitals Hospital-Wide Performance Improvement Plan, review of Calais Regional Hospital Staffing plans, review of Calais Regional Hospital Medical Staff Rules and Regulations and Medical Staff Bylaws, and interviews with key personnel at the transferring hospital and the receiving hospital on September 17 and 21, 2010, and October 12-15, 2010, it was determined that the CAH failed to provide emergency care necessary to meet the needs of its patients.

The evidence is as follows:

1. CRH was cited for failure to reassess, failure to recognize a patient's deteriorating condition, failure to provide further stabilizing interventions prior to transfer, and failure to recognize the need for appropriate means of transfer for Patient B. For more information see Form CMS-2567, Complaint Validation Survey dated September 17, 2010.

2. On September 17, 2010, an interim safety plan was received. The plan stated, " The process changes that will be made are: 1. All patients will have a reexamination by the physician with a note of findings, changes, and any new treatment especially prior to transport. 2. Labs/x-ray abnormal values will be addressed and/or rechecked as necessary ... "

3. A revised Plan of Correction (POC), based on the Form CMS-2567, Complaint Validation Survey dated September 17, 2010, was received on October 7, 2010. This plan stated, " It is expected that the ED Physician ' s will utilize accepted standards of care established by the American College of Emergency Physician ' s for appropriate assessment and reassessment of a patients condition. The patient will not be considered stabilized until the treating physician has determined within reasonable clinical competence that the emergency medical condition that the patient presented to the ED with has been resolved, or that no material deterioration of the patient ' s condition is likely (in the event of a transfer), although the underlying medical condition may persist ...A reassessment will be undertaken; at least every two hours for patients who have an extended length of stay in the ED; and immediately prior to any transfer or final disposition of the patient (i.e., within thirty minutes if practicable). Additionally, the plan included the implementation of the Medical Stabilization Audit Form. "

4. On October 13, 2010, the survey team reviewed documentation related to the interim safety plan, developed September 17, 2010 and the POC dated October 7, 2010. In spite of the Interim Safety Plan dated September 17,2010 and the POC dated October 7, 2010, a random review of Emergency Department medical records demonstrated the CAH failed to ensure that all patients had a reexamination by the physician with a note of findings, changes, and any new treatment especially prior to transport and that labs/x-ray abnormal values were addressed and/or rechecked as necessary. The results of that random review follow.

5. Review of Patient IIIII's medical record on October 13, 2010, revealed that the patient arrived at 0258 on September 20, 2010 with a chief complaint of pain upper left quadrant, with the pain going into the patient's back. The patient went to X-ray at 0315, and returned from X-ray at 0326. 0400 Demerol 125 mg (milligrams), and Phenergan 25 mg, IM (intermuscular) given. 0450 Dilaudid 1 mg, diluted in 10 cc (cubic centimeters) normal saline flush given. The physician evaluated the patient at 3.40.52 a.m., the physician Emergency Department notes, stated, " upper abdominal pain and into his/her back starting at 7:30 p.m. ....pain is all across upper abdominal and into his/her back ...appeared to be in some discomfort ...he/she is tender everywhere, including over the lower rib cage and his/her thoracic spine area ...on recheck, after Demerol, still tender along the upper ribs, flinches with exam ...assessment; abdominal pain-upper-likely is muscular given the history and lack of associated symptoms-I have no idea why the pain medication has so little effect on him/her. Plan: given injection IM , IV (intravenous), to stop the pain and spasm and hopefully this will resolve it." The patient progress notes stated that at 0517 the patient was discharged to home in stable condition. Additionally, the results of the Abdominal X-rays, were interpreted on September 21, 2010. The results as documented were "an irregular radiodensity in the left hemi-pelvis as described above. Suggests clinical correlation for pelvic mass and recommend CT (Computerized Tomography) examination of the abdomen and pelvis as clinically indicated."

6. During an interview with the Medical Director of the Emergency Department on October 14, 2010, when asked if he was aware that Patient IIIII had been discharged with no follow-up regarding abnormal X-ray finding, he stated, " I am sure a CT scan was done, I ' ll check on it. "

7. During an interview with the attending Emergency Department physician, regarding Patient IIIII, on October 14, 2010 at 1020 a.m., when asked if she had seen the results of the CT scan, she stated, " No, I never saw his (radiologist) read (interpretation of results). "

8. During another interview with the Emergency Department Medical Director on October 14, 2010, at 11:30 a.m., he stated, " I did find in the system that [Patient IIIII] did have a CT scan on September 21, 2010, but I agree there is no documentation in [his/her] medical record. "

9. In spite of fact that Patient IIIII received several doses of pain medication prior to discharge, there was no documentation that demonstrated a reassessment of the patient 's pain level prior to discharge. Additionally, there was no documented evidence that Patient IIIII had been notified of the abnormal findings in the abdominal X-ray and any necessary follow-up.

10. Review of Patient DDDDD's medical record on October 13, 2010, revealed that the patient arrived on October 1, 2010, at 2008 and went immediately to X-ray. The Patient Progress Notes at 2008 stated, " Chief complaint: patient was in altercation this evening with a female. Patient found at 1944 in struggle with another individual. EMS (Emergency Medical Services) called at that time, and patient unresponsive to any stimuli. Patient smells of ETOH (Ethanol) at this time. Bruising and scratches noted on patient ' s body. Patient on back board and neck in collar at this time. The patient ' s neurological status was documented as unresponsive. 2020 patient back from X-ray at this time. 2135, catheter placed at this time. 2218 patient stable and lying on stretcher with neck collar still in place, and awaiting results of X-ray to come back. 2231 catheter removed at this time per doctor ' s order, 2327 patient discharged in stable condition. "

11. Patient DDDDD ' s medical record documented a physician ' s evaluation on arrival. The documentation of the evaluation stated, " CAT scan of head was negative, X-rays of pelvis negative, Urine blood 250 and Urine toxicology positive for cannabinoids and alcohol 329. Diagnosis alcohol intoxication. Significant history of alcoholism, recent altercation with bruises as diagramed, no apparent significant medical problems. "

12. On October 14, 2010, an interview was conducted with Patient DDDDD ' s attending Emergency Department physician. When the physician was asked if he followed up on the abnormal finding of blood in the urine, he stated, " No, I thought it was due to the catheterization. " The physician was then asked if he felt the abnormal laboratory finding should have been followed up on he stated, " Yes, I guess I didn't ' really know if it was due to the catheterization. " The physician was then asked if he had considered reassessing the patient based on the abnormal laboratory findings and the overall bruising on the patient 's body, he stated, " Well, I guess I didn't ' reassess to evaluate for any possible kidney involvement. "

13. In spite of Patient DDDDD ' s abnormal laboratory findings and multiple bruising, there was no documented evidence of a physician reassessment regarding these abnormalities in the medical record.

14. Review of Patient PPP's medical record on October 13, 2010, revealed that this three (3) year old child presented to the Emergency Department on September 22, 2010, with a chief complaint of " crossing legs for a couple of years ...patient will be walking and all of a sudden, lay on the ground and cross his/her legs. " The physician ' s note, indicated that the mother reported that the vaginal area may be " a little red " . The physician documented that there is no purulence, no lesions, the hymen seems to be intact ....and [introital] irritation ... " The medical record failed to contain any documentation to indicate any suspicion of potential child abuse, or that the Child Protective Service had been notified.

15. Title 22 Maine Revised Statutes Health and Welfare, Chapter 1071 Child and Family Services and Child Protection Act, Subchapter II Reporting of Abuse or Neglect ?4011-A.1.A (10) stated, " The following adult persons shall immediately report or cause a report to be made to the department when the person knows or has reasonable cause to suspect that a child has been or is likely to be abused or neglected ...a registered or licensed practical nurse ... "

16. In an interview with the Chief Nursing Officer (CNO), regarding Patient PPP, on October 14, 2010, she stated that she didn't know if Child Protective had been made aware of this potential abuse.

17. In spite of the fact that Patient PPP presented to the Emergency Department and was assessed on September 22, 2010, there was no documentation in the medical record that indicated the attending staff recognized the potential child abuse. The CNO provided documentation that the Director of Child Welfare had been notified of the findings on October 15, 2010.

18. Based on the identified non-compliance by the CAH, a Revised Interim Safety Plan was received by the survey team on October 13, 2010. The plan stated, " The process changes that will be made are: All patients will have a reexamination by the physician with a note of findings, changes, and any new treatment especially prior to transport. The Medical Stabilization Form will be used for auditing 100% of charts going forward from 10/13/10 until 100% compliance is achieved for 4 weeks. These audits will be accomplished within 24 hours of patient disposition ...2. Labs/x-ray abnormal values will be addressed and/or rechecked as necessary ... " Additionally, the Medical Stabilization Audit Form was amended on October 13, 2010 as part of the Revised Interim Safety Plan.

19. During an interview with Chief Executive Officer and the Chief of Staff on October 15, 2010, they stated that several issues and trends had been identified during the chart review. Therefore, the CAH failed to provide care in accordance with acceptable standards of practice, failed to identify the need for reassessment based on the patients emergency medical condition, failed to identify the need for patient reassessment based on abnormal laboratory findings and imaging studies, failed to provide physician reassessment of the patient at least every two (2) hours, failed to recognize the patients deteriorating condition, failed to provide stabilizing interventions prior to transferring, failed to recognize the requirement for transfer via an ACLS/paramedic (Advanced Cardiac Life Support) transport, failed to recognize the need for mandatory reporting for suspected child abuse, and failed to ensure documentation in the patients record that summarized the hospital course and subsequent outcomes.

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

Based on a tour of the facility and interviews with the Director of Maintenance and Safety on October 12-14 2010, it was determined that the hospital failed to assure that all patient care equipment and areas were maintained in safe operating condition.

Findings include:

1. During a facility tour, it was noted that there was no signage to indicate the locations of eye wash stations in the Recovery Room and Laboratory.

2. During a facility tour, the surveyor observed a sign designating a room as a "Changing Room". When the door was opened, the room contained hazardous chemicals used in the sterilizing equipment that was located near the Recovery Room Nurse's Station.

3. During tours of the hospital, wall-mounted sharps containers were installed at heights of sixty-four (64) or forty-eight (48) inches throughout the facility. NIOSH (National Institute for Occupational Safety and Health) standards require the height to be between fifty-two (52) and fifty-six (56) inches. In addition, the floor model sharp containers located throughout the facility, were light weight and could easily be knocked over.

4. A review of the information provided revealed there was no documentation that weekly cleaning and preventative maintenance checks were being documented as being conducted on eye wash stations.

Based on a tours of the interior and exterior of the hospital, observations, and interviews with the Director of Maintenance and Safety on October 12-14, 2010, it was determined that the hospital failed to have proper ventilation of the exhaust fumes of the boiler.

The finding include:

1. During a tour of the facility on October 13, 2010, a surveyor observed that periodically, fumes from the boiler entered the air exchanger and were dispersed into Classroom A, which was located adjacent to the kitchen and dinning room.

2. This was confirmed during an interview with the Director of Maintenance and Safety on October 13, 2010.

Based on review of the 2010 Governing Body meeting minutes, the 2010 Quality Assurance Committee meeting minutes, the 2010 Performance Improvement Committee meeting minutes, the 2010 Hospital Wide Performance Improvement Plan, The Departmental Services Plan and Dashboards 2010, review of facility wide policies and procedures, Emergency Department medical records, contracts, other information provided, and interviews with the Chief Executive Officer, the Chief Nursing Officer, Director of Quality Management, Director of Maintance and Safety, Emergency Department Contracted physicians, the Emergency Department Manager, the Infection Preventionist, Chief of Medical Staff, on October 12-15, 2010, it was determined that the CAH's Governing Body failed to assume full legal responsibility for the CAH's total operation and failed to ensure the policies and procedures in place provided quality health care and safety for patients, staff and visitors in the hospitals as evidenced by:

1. The CAH's [Critical Access Hospital ' s] Governing Body failed to assume full legal responsibility for and ensure the quality of patient care, and as a result, Emergency Department patients did not consistently receive appropriate assessment, treatment, stabilization and transfer (See Tag C200);

2. The CAH's Governing Body failed to hold the staff accountable for providing quality health care to the patients according to accepted standards of practice (See Tag C152 and Tag C200);

3. The CAH's Governing Body failed to ensure that an annual program evaluation was conducted in 2009 (See Tag C331);

4. The CAH failed to ensure that all patient care services and other services affecting patient health and safety are evaluated (See Tag C337);

5. The CAH failed to provide a safe environment for all patients and staff (See Tag C222);

6. The CAH failed to have infection control policies that reflected the AORN [Association peri-operative Registered Nurses] standard of practice (See Tag C278);

7. The CAH failed to include implementation of nationally recognized systems of infection control guidelines in their Infection Control Program (See Tag C278);

8. The CAH ' s Governing Body failed to ensure that CRNA ' s [Certified Registered Nurse Anesthetist ' s] were under the supervision of the operating practitioner (See Tag C324);

9. The CAH ' s Governing Body failed to ensure that all policies were evaluated, reviewed and/or revised on an annual basis (See Tag C334);

10. The CAH failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes (See Tag C336);

11. The CAH ' s Governing Body failed to ensure that appropriate remedial action to address deficiencies found through the quality assurance program was taken (See Tag C342);

12. The CAH ' s Governing Body failed to assume full responsibility for determining, implementing, and monitoring policies, to ensure that those policies were administered so as to provide quality health care in a safe environment (See Tag C241); and

13. The CAH ' s Governing Body failed to assure that contracted services were furnished to enable the hospital to comply with all acceptable conditions of participation (See Tag 285 and Tag C293).

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

Based on review of policies and procedures, review of the Governing Board Meeting minutes for the year 2010, review of medical records, interviews with key staff, it was determined that the Governing Body failed to ensure that policies were implemented, monitored and administered so as to provide quality health care in a safe environment.

Findings include:

1. Review of Infection Control Policies and Procedures, and interview with the Infection Preventionist on October 13-14, 2010, revealed that the Hospital Infection Control program did not utilize standardized nosocomial Healthcare Associated Infections (HAIs) surveillance definitions, therefore failed to ensure a system of appropriately identifying and reporting HAIs.

2. Review of the Infection Control Policies and Procedures, and interviews with the Infection Preventionist on October 13-14, 2010 revealed that the Infection Control Program failed to provide documentation that the CAH had developed and implemented policies and procedures that ensure:
a. the use of standardized definitions of nosocomial infections;
b. methods for monitoring and evaluating practices of asepsis; and
c. that disinfectants, antiseptics, and germicides are used in accordance with the manufacturers' instructions to avoid harming patients, particularly central nervous system effects on children.

3. In spite of the fact that the Director of Surgical Services indicated that the Department implements [Association peri-operative Registered Nurses] AORN nationally recognized recommendations, a review of the Hospital Surgical Services Policy and Procedure on Surgical Housekeeping and Environmental Care on October 12, 2010, revealed that the hospital failed to have policies that reflect the AORN Standard of Practice: " Recommended Practices for Environmental Cleaning in Surgical Practice Settings " in the following areas:
a. preparation of the (Operating Room) OR should include the performance of a visual inspection for cleanliness before case carts, supplies, equipment, and instrument sets are brought into the room;
b. all horizontal surfaces in the OR should be damp dusted before the first scheduled surgical procedure of the day;
c. unused rooms should be cleaned once during each 24 hour period during the regularly scheduled work week;
d. floors should be wet-vacuumed after scheduled cases are completed for the day or night;
e. personnel should receive initial education, training and competency validation on proper environmental cleaning methods, agent selection and safety precautions; and
f. a quality management program should be in place to evaluate products, processes, and outcomes of the environmental cleaning program.

4. It was determined during a tour of the Surgical Services department and interviews with the Director of Surgical Services on October 12, 2010, that rubber gloves utilized in the (Central Sterile Supply) CSS decontamination room are being reused. A review of the Hospital Surgical Services Policies revealed there was no policy or procedure developed to ensure this practice had been researched and established as a safe practice and there existed no defined safe procedures for the reuse of this personal protective equipment.

5. The potential outcome for failure to research and establish safe practices and procedures in the re-use of personal protective equipment (rubber gloves utilized in the decontamination room) may be cross contamination of the environment, and/or exposure of health care personnel to blood or body fluids.

Additional Information:

6. The CAH failed to provide the emergency care necessary to meet the needs of patients and defined in their policies and procedures (For further information See COP: Emergency Services Tag C200).

7. The CAH failed to provide quality care necessary to meet the needs of its patients by utilizing acceptable standards of practice as required by hospital policies and procedures (For further information see COP: Periodic Evaluation and Quality Assurance Review Tag C330).

8. The CAH failed to determine through the annual program evaluation whether established polices were followed and if any changes were needed in the policies (For further information see COP: Periodic Evaluation and Quality Assurance Review Tags C330, C331, C332, C333, C334, C335 and C336).

Based on review of policies and procedures, review of medical records, and interviews with key staff October 13, 2010, it was determined that the CAH failed to furnish emergency care according to their written policies.

Findings include:

The CAH failed to provide emergency services according to established policies (For further information see COP: Emergency Services Tag C200)

Based on observations, interviews with hospital department managers, review of Infection Control Committee minutes for 2009 and 2010, and Infection Control and Surgical Services Department policy and procedures on October 12-14, 2010, it was determined that the hospital failed to ensure a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel.

The findings include:

1. Although the hospital had designated in writing an individual as an Infection Control Officer, also referred to as Infection Preventionist (IP), an interview on October 13, 2010, with the IP and subsequent review of the IP ' s personnel files revealed that the current IP entered this position in 2008 with no previous IP or epidemiology experience or education. While in the position the IP had not attended a formal nationally recognized infection prevention and control or epidemiology training or education program.

2. The Infection Control Program must include implementation of nationally recognized systems of infection control guidelines. Since 1988, the Centers for Disease Control and Prevention: (CDC) has published recommendations for the use of nosocomial surveillance criteria in acute care settings. The CDC defines a nosocomial or Healthcare Associated Infection: (HAI) as a localized or systemic condition resulting from an adverse reaction to the presence of an infectious agent(s) or its toxin(s). There must be no evidence that the infection was present or incubating at the time of admission to the acute care setting. Once an infection is deemed to be health care associated in the acute care setting, the specific type of infection should be determined based on the CDC standardized definitions for surveillance. The definitions have been grouped into 13 CDC/National Health Surveillance Network (NHSN) HAI major type categories to facilitate data analysis.

3. Review of Infection Control Policies and Procedures, and interview with the Infection Preventionist on October 13-14, 2010, revealed that the hospital Infection Control Program did not utilize standardized nosocomial (Healthcare Associated Infections) surveillance definitions, therefore failed to ensure a system of appropriately identifying and reporting HAIs.

4. Review of the Infection Control Policies and Procedures, and interviews with the Infection Preventionist on October 13-14, 2010 revealed that the Infection Control Program failed to provide documentation that the CAH had developed and implemented policies and procedures that ensure:
a. the use of standardized definitions of nosocomial infections;
b. methods for monitoring and evaluating practices of asepsis; and
c. that disinfectants, antiseptics, and germicides are used in accordance with the manufacturers' instructions to avoid harming patients, particularly central nervous system effects on children.

5. In spite of the fact that the Director of Surgical Services indicated that the Department implements the Association of peri-Operative Registered Nurses (AORN) nationally recognized standards and recommendations, a review of the Hospital Surgical Services Policy and Procedure on Surgical Housekeeping and Environmental Care on October 12, 2010, revealed that the hospital failed to have policies that reflect the AORN Standard of Practice: " Recommended Practices for Environmental Cleaning in Surgical Practice Settings " in the following areas:
a. preparation of the operating room should include the performance of a visual inspection for cleanliness before case carts, supplies, equipment, and instrument sets are brought into the room;
b. all horizontal surfaces in the operating room should be damp dusted before the first scheduled surgical procedure of the day;
c. unused rooms should be cleaned once during each 24 hour period during the regularly scheduled work week;
d. floors should be wet-vacuumed after scheduled cases are completed for the day or night;
e. personnel should receive initial education, training and competency validation on proper environmental cleaning methods, agent selection and safety precautions; and
f. a quality management program should be in place to evaluate products, processes, and outcomes of the environmental cleaning program.

6. It was determined during a tour of the Surgical Services department and interview with the Director of Surgical Services on October 12, 2010, that rubber gloves utilized in the Central Sterile Supply decontamination room are being reused. A review of the hospital Surgical Services and Infection Control policies revealed there was no policy or procedure developed to ensure this practice had been researched and established as a safe practice and there existed no defined safe procedures for the reuse of this personal protective equipment.

7. The potential outcome for failure to research and establish safe practices and procedures in the re-use of personal protective equipment (rubber gloves utilized in the decontamination room) may be cross contamination of the environment, and/or exposure of health care personnel to blood or body fluids.

Based on review of policies and procedures, review of medical records and interviews with key staff October 13-15, 2010, it was determined that the CAH failed to consistently provide emergency services to outpatients according to accepted standards of practice and recommendations promoted by nationally recognized professional organizations.

Findings include:

The CAH failed to assess, stabilize, transfer and discharge patients according to acceptable standards of practice (For further information see COP: Emergency Services, Tag C200)

Based on review of policies and procedures, review of contracts, review of the 2010 Hospital Wide Performance Plan, the Departmental Services Plan and Dashboards for 2010, review of the 2010 Performance Improvement meeting minutes, and interviews with key staff October 13 - 15, it was determined that the CAH failed to assume responsibility for services provided through contracts by not identifying problems, implementing appropriate corrective actions, and monitoring the sustainability of the service.

Findings include:

1. The CAH Hospital Wide Performance Improvement Plan, stated, " I. Purpose: The Hospital Wide Performance Improvement (HWPI) Plan of Calais Regional Hospital is designed to serve as a guide to assist hospital departments and medical staff to identify opportunities for improvement ....Therefore the ongoing monitoring and evaluation of clinical patient care should be implemented through a process know as continuous quality improvement (CQI) ....II. Responsibility: The CRH Board of Directors has the ultimate responsibility for improving on organizational performance. The Board recognizes and accepts its legal responsibilities for the quality of care provided by the hospital to the community it serves. The Board of Directors has the final authority and responsibility for the implementation of a flexible, comprehensive, and integrated Performance Improvement Program ....The Board of Directors delegates all performance improvement activity oversight related to clinical care to the Medical staff and its Performance Improvement Committee to be implemented in cooperation with the administration and hospital departments.

2. During an interview on October 15, 2010, with the Director of Quality Management, it was confirmed that contracts were not being trended through the quality process.

3. The National Emergency Services [NES], Maine, Inc. contract stated, " 3. The medical services to be performed by the physicians will be specified by the Hospital but shall be performed by the physicians as independent contractors under and subject to the general supervision of the Hospital, its medical staff, and in compliance with the rules and regulations of the Hospital ....4. NES shall maintain an ongoing program of Quality Assurance/Performance Improvement (QA/PI), to augment/complement the Hospital program. "

4. During an interview with the Chief Executive Officer and the Chief of Staff, on October 15, 2010, they stated, "NES was not maintaining an ongoing program of Quality Assurance/Performance Improvement (QA/PI), to augment/complement the Hospital program".

5. An interview was conducted with one of CRH's NES contracted physicians on October 15, 2010. When asked if she participated in the hospital wide Quality Assurance program, she stated, " I do not participate in the QA program... "

Based on review of the Hospital Wide Performance Improvement Plan, the Performance Improvement meeting minutes, review of contracts and key staff on October 13 -15, 2010, it was determined that the CAH failed to ensure that a contractor furnished services that enabled the CAH to comply with all applicable conditions of participation. For additional information see Tag C285.

Based on review of surgical medical records, discharged patient medical records and interviews with key staff October 12-15, 2010, it was determined that the hospital failed to ensure a system where the medical records were legible, complete, accurately documented, and readily accessible.

Findings include:

1. Review of the Emergency Department discharge records, on October 15, 2010, revealed that in fifteen (15) of forty-five (45) records, the discharge instructions were illegible. (Records: AAA, BBB, CCC, DDD, EEE, GGG, HHH, III, JJJ, TTT, YYY, ZZZ, BBBB, GGGG, and HHHH)

2. Review of surgical records, on October 14, 2010, revealed that in nine (9) of ten (10) records, the Surgical Informed Consent form failed to include complete documentation of date and/or time. (Records: TTTT, VVVV, WWWW, XXXX, YYYY, ZZZZ, AAAAA, BBBBB, and CCCCC)

3. Review of surgical records, on October 14, 2010, revealed that in eight (8) of ten (10) records, the completed Operative Report was not included or accessible in the medical record. (Records: TTTT, VVVV, XXXX, YYYY, ZZZZ, AAAAA, BBBBB, and CCCCC)

4. An interview was conducted with the Medical Director of the Emergency Department on October 14, 2010. When asked to review the hand written discharge instructions for legibility, he agreed that the ones he reviewed were not legible.

5. An interview was conducted with the Surgical Services Nurse Manager on October 14, 2010. It was confirmed during this interview that the surgical records did not always contain the Surgical Informed Consent Form or the completed Operative Report.

Based on a review of anesthesia policies, review of anesthesia records and interviews with the Chief of Anesthesia, on October 12, 2010, it was determined that the Certified Registered Nurse Anesthetist ' s (CRNA's) at the hospital were not under the supervision of the operating practitioner.

Findings include:

1. During an interview on October 12, 2010, the Chief of Anesthesia described the anesthesia forms as containing an anesthesia plan and the anesthesia record. The Chief of Anesthesia stated that when anesthesia was administered by CRNA ' s, the anesthesia plan was completed by the CRNA prior to surgery, but there was no physician signature on the anesthesia record.

2. The Chief of Anesthesia described the anesthesia plan as a general description of the technique to be used, such as, "general anesthesia, or regional block", but did not necessarily contain the medications or doses to be used during the surgery. It also did not list adjunct medications to be used, nor did it list medications, doses or route of administration that may have been administered in the operating room that were not originally part of the plan.

3. The State of Maine Board of Nursing Rules and Regulations Chapter 8, C, (3) states, " adjustments and corrective actions as indicated. For aspects of anesthesia practice that require execution of the medical regimen, the Certified Registered Nurse Anesthetist (CRNA) shall be responsible and accountable to a physician or dentist. Without limitation, coordination and appropriate communication shall be deemed to have occurred if the prescribing physician or dentist shall have signed the patient's anesthesia record."

4. The Chief of Anesthesia confirmed that the anesthesia record was completed by the CRNA in the operating room during the procedure. The medications administered during the operative procedure, their dose, route of administration, and any adjuncts used, were recorded on the anesthesia record.

5. A review of ten (10) anesthesia records was completed during the survey. In the five (5) records in which the anesthesia was administered by the CRNA ' s, none (0) contained documentation of physician authentication on the anesthesia record.

Based on review of the 2010 Governing Body meeting minutes, the 2010 Quality Assurance Committee meeting minutes , the 2010 Performance Improvement Committee meeting minutes and the 2010 Hospital Wide Performance Improvement Plan, and The Departmental Services Plan and Dashboards 2010, policy and procedures, patient medical records, and interviews with the Chief Executive Officer, the Chief Nursing Officer , and the Director of Quality Management on October 12-15, 2010, it was determined that the CAH failed to ensure that the Quality Assurance program was effective to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment objectives as evidenced by:

1. The CAH failed to evaluate the quality of services provided through contracted services (See Tag C285);

2. The CAH failed to take appropriate and timely action to identify issues related to quality of patient care (See Tag C336);

3. The CAH failed to provide quality care necessary to meet the needs of its patients by utilizing accepted standards of practice required by the hospital (See Tag C200);

4. The CAH failed to determine through a yearly program evaluation whether established policies were followed and if any changes were needed in the policies (See Tag C335);

5. The CAH did not ensure that the documentation in their Performance Improvement Committee meeting minutes clearly described the extent to which discussion occurred and/or subsequent action was taken (See Tag C335 and C341);

6. The CAH failed to carry out or arrange for an annual evaluation of their total program (See Tag C331);

7. The CAH failed to ensure compliance with Title 22 Maine Revised Statutes Health and Welfare Chapter 1071 Child and Family Services and Child Protection Act Subchapter II Reporting of Abuse or Neglect ?4011 and The State of Maine Board of Nursing Rules and Regulations Chapter 8, C, (3) (See Tag C200 and C324);

8. The CAH failed to provide the emergency care necessary to meet the needs of patients (See Tag C200);

9. The CAH failed to take appropriate and timely actions to identify issues related to the quality of patient care (See Tag C342);

10. The CAH failed to have an effective Quality Assurance Program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. (See Tag C336);

11. The CAH failed to evaluate all patient care services and other services affecting patient health and safety (See Tag C337);

12. The CAH failed to ensure a system of appropriately identifying and reporting appropriate health care associated infections (nosocomial) (See Tag C241, Tag C278 and Tag C338);

13. The CAH failed to take appropriate remedial action to address deficiencies found through the Quality Assurance Program (See Tag C342);

14. The CAH failed to document the outcomes of all remedial actions related to Quality Assurance and Performance Improvement (See Tag C343); and

15. The CAH staff failed to consider the findings of an annual program evaluation and to take corrective actions as necessary (See Tag C341).

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

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to conduct an annual review of its total program.

Findings include:

1. The Hospital Wide Performance Improvement Plan, dated June 17, 2010, stated, "VII. Annual Plan/Program Evaluation. The Hospital Wide Performance Improvement Plan and Program will be reviewed annually. The review will be done to establish new goals, identify elements to be changed, etc when warranted. The review will include an assessment of plan/program impact on the quality of care, the delivery of services, and cost-effectiveness....Comparing the written plan with the PI (Performance Improvement) activities that were performed, assessing compliance with the Plan..."

2. The Governing Body meeting minutes for the year 2010 were reviewed. There was no documentation that an annual program review had been conducted for 2009.

3. The Quality Assurance Committee meeting minutes for the year 2010 were reviewed. There was no documentation that an annual program review was conducted in 2009.

4. It was confirmed during interviews on October 12-15, 2010, with the Chief Nursing Officer, the Director of Quality Management, and the Chief Executive Officer, that the hospital failed to conduct an annual review of its total program for 2009.

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to include in their annual program evaluation, a review of all CAH services, the number of patients served and the volume of services provided.

Findings include:

1. The Governing Body meeting minutes for the year 2010 were reviewed. There was no documentation that an annual program evaluation had been conducted for 2009.

2. The Quality Assurance Committee meeting minutes for the year 2010 were reviewed. There was no documentation that an annual program evaluation had been conducted for 2009.

3. During interviews with the Director of Quality Management and the Chief Executive Officer on October 12-15, 2010, it was confirmed that no annual program evaluation was completed for the year 2009.

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to conduct an annual review of its total program which included a review of a representative sample of both active and closed clinical records. For more information see Tag C332.

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to conduct an annual review of its total program which inclued a review of the CAH's health care policies.

Findings include:

The CRH Hosital Wide Performance Improvement Plan was reviewed on October 12-15, 2010. It stated, "III. Organization and scope:...Review of patient care related policies will occure at least annually by the appropriate manager/department head. New patient policies and policies with significant revisions will be forwarded to the Patient Care Committee for approval and acceptance. Their findings shall be reported to the PIC (Performance Improvement Committtee), QAC (Quality Assurance Committee) & Board of Directors." For more information see Tags C331 & 332.

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to conduct an annual review of its total program for which the purpose of the evaluation was to determine whether the utilization of services was appropriate, if the established policies were followed, and if any changes were needed to the policies.

Findings include:

1. The Governing Body meeting minutes for the year 2010 were reviewed. There was no documented evidence that the health care policies of the CAH were evaluated, reviewed and or revised as part of the annual program evaluation.

2. The Quality Assurance Committee meeting minutes for the year 2010 were reviewed. There was no documentation that the established policies were reviewed and updated as needed. Additionally, there was no documentation of changes that were needed to health care policies.

3. During interviews with the Director of Quality Management and the Chief Executive Officer on October 12-15, 2010, it was confirmed that no annual program evaluation was completed for the year 2009.

Based on document review and interviews with key staff on October 12-15, 2010, it was determined that the hospital failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Findings include:

Therefore, the CAH failed to provide care in accordance with acceptable standards of practice, failed to identify the need for reassessment based on the patients emergency medical condition, failed to identify the need for patient reassessment based on abnormal laboratory findings and imaging studies, failed to provide physician reassessment of the patient at least every two (2) hours, failed to recognize the patients deteriorating condition, failed to provide stabilizing interventions prior to transferring, failed to recognize the requirement for transfer via an ACLS/paramedic (Advanced Cardiac Life Support) transport, failed to recognize the need for mandatory reporting for suspected child abuse, and failed to ensure documentation in the patients record that summarized the hospital course and subsequent outcomes. For further information see Tag C200.



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Based on a review of the Hospital Wide Performance Improvement Plan, a review of the minutes of the Performance Improvement Committee from October 2009 through August 2010, interviews with the Director of Quality Management and the Chief of Staff it was determined that the CAH did not have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes.

Findings Include:

1. The Calais Regional Hospital ' s Hospital Wide Performance Improvement Plan stated, " ...Therefore the ongoing monitoring and evaluation of clinical patient care should be implemented through a process known as continuous quality improvement (CQI). " and, " Emphasizing on continuous improvement of areas that significantly affect patient care and outcomes, Utilizing an analytical and when appropriate, statistical approach to measure, assess, and improve the quality of services. "

2. The Hospital Wide Performance Improvement Plan, contained indicators to be measured, but did not contain targets to be achieved.

3. The Director of Quality Management stated during an interview on October 14, 2010, that the goals for the quality indicators were listed on the individual department dashboards, and were to achieve one hundred percent, 100% compliance. confirmed that the Medical Staff ' s CQI indicators were already at, or close to, 100%, and there was no ongoing work to increase performance on any of these clinical indicators.

4. A review of the minutes of the Performance Improvement Committee from October 2009 through August 2010, did not contain evidence that the medical staff considered additional quality, safety, or outcome indicators that could be improved.

Based on review of information provided, medical records, committee meeting minutes, and interviews with key staff on October 12-15, 2010, it was determined that the CAH failed to effectively evaluate all patient care services and other services affecting patient health and safety.

Findings include:

It was confirmed during interviews on October 12-15, 2010, with the Chief Nursing Officer, the Director of Quality Management, and the Chief Executive Officer, that the hospital failed to conduct an annual review of its total program for 2009. For more information see Tag C336.

Based on review of information provided, review of the infection control program, review of committee meeting minutes, and interviews with key staff on October 12-14, 2010, it was determined that the CAH failed to use appropriate methodologies and accepted standards of practice when evaluating nosocomial infections.

Findings include;

These findings were confirmed during an interview on October 13, 2010, with the Infection Control Officer. For more information see Tag C278.

Based on review of documentation provided, review of committee meeting minutes, Interview with key staff on October 12-15, 2010, it was determined that the CRH staff failed to consider the findings of the evaluations, including any findings or recommendation or the QIO (Quality Improvement Organization) and failed to take corrective action if necessary.

Findings include;

It was confirmed during interviews on October 12-15, 2010, with the Chief Nursing Officer, the Director of Quality Management, and the Chief Executive Officer, that the hospital failed to conduct an annual review of its total program for 2009. For more information see Tag C336.

Based on review of the CRH Hospital Wide Performance Improvement Plan, review of Performance Improvement Committee meeting minutes, department specific dashboards, and interviews with key staff on October 12-15, 2010, it was determined that the CAH failed to consistently take appropriate remedial action to address deficiencies found through their Quality Assurance Program.

Findings include:

1. The Calais Regional Hospital ' s Hospital Wide Performance Improvement Plan stated, " ...Therefore the ongoing monitoring and evaluation of clinical patient care should be implemented through a process known as continuous quality improvement (CQI). " and, " Emphasizing on continuous improvement of areas that significantly affect patient care and outcomes, Utilizing an analytical and when appropriate, statistical approach to measure, assess, and improve the quality of services. "

2. The Hospital Wide Performance Improvement Plan, contained indicators to be measured, but did not contain targets to be achieved.

3. The Director of Quality Management stated during an interview on October 14, 2010, that the goals for the quality indicators were listed on the individual department dashboards, and were to achieve one hundred percent, 100% compliance. confirmed that the Medical Staff ' s CQI indicators were already at, or close to, 100%, and there was no ongoing work to increase performance on any of these clinical indicators.

4. A review of the minutes of the Performance Improvement Committee from October 2009 through August 2010, did not contain evidence that the medical staff considered additional quality, safety, or outcome indicators that could be improved.

5. CRH department dashboards for performance indicators for 2010 was reviewed on October 12-15, 2010. The documentation failed to include indicators which were specific and measurable, and or measures taken to improve deficient processes and or systems.

6. The lack of specific measurable data on department specific dashboards for all CAH departments was confirmed by the Director of Quality Management on October 14, 2010.

Based on review of the CRH Hospital Wide Performance Improvement Plan, review of Performance Improvement Committee meeting minutes, department specific dashboards, and interviews with key staff on October 12-15, 2010, it was determined that the CAH failed to document the outcome of all remedial actions. For more information see Tag C342.