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Based on record review and interview with key personnel on February 11, 2014, it was determined that the facility failed to be in compliance with the State of Maine Rules for the Licensing of Hospitals, Chapter 112, Section 3.2., which states that a critical access hospital must protect patient rights and comply with the Federal Condition of Participation:

Findings include:

1. Maine Revised Statues Title 22, subtitle 2, part 4 indicated "beginning October 1, 2010, a facility or health care provider subject to the licensing or certification process shall obtain, prior to hiring an individual who will work in direct contact with a consumer, criminal history record information on that individual."

a. Based on review of personnel files and interviews with the Manager of Human Resources, four (4) of fourteen (14) personnel files (File 2, 5, 10, 13) lacked evidence that a criminal history was done prior to hire.

b. This finding was confirmed by the Manager of Human Resources on February 12, 2014 at 10:30 AM who stated that "we do them, remove them after a year and then we only do annual Office of the Inspector General (OIG) checks."

2. 42 CFR (Code of Federal Regulations) 482.13(a)(1), Patient's Rights, states, "The hospital must inform each patient, or when appropriate, the patient's representative of the patient rights, in advance or furnishing or discontinuing patient care whenever possible."

a. Review of the emergency records of ten (10) patients indicated a lack of documentation that the patient's were informed of their rights prior to the hospital furnishing care.

b. The above finding was confirmed by the Director of Quality Management on February 12, 2014 at approximately 10:30 AM.

c. A clinical record review conducted on February 11 and 12, 2014 revealed that two (2) of twenty-seven (27) closed records {Patient T, and Patient W}, and one (1) of three (3) open records {Patient G}, failed to contain documentation that the patients had been provided information regarding their rights as patients.

d. This finding was immediately confirmed by the Director of Inpatient Services who said, " I don't see it ..."


3. 42 CFR 482.13(a)(2)(ii) [The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. 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.] The grievance process must specify time frames for review of the grievance and the provision of a response.

a. The facility policy "Complaints and Concerns/Grievance policy," under section B, practitioner complaints, lacked evidence of a time frame for review and response to the patient grievance/complaint against a physician at the hospital.

b. This finding was confirmed by the Quality Manager on February 12, 2014 at approximately 8:15 AM.

c. The facility "Complaints and Concerns/Grievance policy" indicated that the complaint should be closed within a reasonable timeframe (if at all possible within 30 days).

d. Review of the facility grievance log indicated that Complainant B voiced his/her complaint on December 5, 2013, and a response was sent to the complainant with the results of the investigation on January 8, 2014 (34 days later). There was no documentation to indicate that the complainant was notified on day seven to express that the investigation would take longer than seven (7) days.

e. Review of the facility grievance log indicated that Complainant C voiced his/her complaint on November 18, 2013, and a response was sent to the complainant with the results of the investigation on January 6, 2014 (49 days later). There was no documentation to indicate that the complainant was notified on day seven to express that the investigation would take longer than seven (7) days.

Based on tours of the facility and the outpatient areas, review of policies and procedures, review of information provided, and interviews with key staff on February 11-12, 2014, it was determined that the CAH failed to maintain the facility to ensure the safety of patients and staff.

Findings include:

1. On February 11, 2014, at 10:30 AM, during a tour of the Surgical Services outpatient area it was observed that one light fixture in the hallway had dead flies that were visible.

2. On February 11, 2014, at 10:45 AM, during a tour of the Orthopedic Rehabilitation outpatient area, the following was observed:

a. In the patient bathroom, it was noted that the screen in the sink was rusty and the vent was dusty.

b. In the hallway and in the stairwell to the basement, each ceiling had one (1) missing tile.

c. The floor in the hallway had two (2) cracked tiles. Many tiles had separations between them, and therefore the floor cannot be sanitized properly.

d. Torn vinyl was noted on one (1) treatment table and on the "Total Gym" in the exercise equipment room which can not be sanitized.

e. In one (1) treatment room, parallel bars had unpainted wooden bases which can not be sanitized.

f. In the reception area, there was a set of stairs that had a damaged riser under the first step that was not able to be sanitized.

g. In the exam room at the end of the hallway, there were cleansers, a leg brace, dishes, a dish rack and light bulbs stored under the sink.

h. In the exercise equipment room, two (2) stools were noted to have rusty casters.

i. In the exercise equipment room, there was one (1) linen cart that had casters coated with dust and the linen cart in the exam room at the end of the hall had a rusted base

3. The above findings were confirmed by the Director of Facilities on February 11, 2014 at approximately 11:30 AM.

4. On February 11, 2014, at 2:30 PM, during a tour of the Emergency Department, the following was observed:

a. In the housekeeping closet, five (5) pails of disinfectant and seven (7) other containers of cleansers and disinfectants were stored on the floor.

b. The drain for the ice machine found in the kitchenette had no air gap to prevent backflow.

c. There were four (4) broken floor tiles outside the consultation room that created a surface which could not be sanitized.

d The Critical Care Room One (1) had an IV pole with corroded casters which was not able to be sanitized.

e. The soiled utility room had a linen cart with a rusted base that was not able to be sanitized.

f. One (1) of two (2) bathrooms in the waiting area contained a seam in the floor that was not sealed and, therefore created a surface that could not be sanitized.

g. One (1) of two (2) bathrooms in the waiting area contained a hole in the wall and, therefore created a porous surface that could not be sanitized.

h. One (1) of two (2) water fountains contained lime build up around the bowl drain, creating a surface which cannot be sanitized.

5. The above findings were confirmed by the Director of Facilities on February 11, 2014 at approximately 3:15 PM.

6. On February 12, 2014, at approximately 8:15 AM, during a tour of the Obstetrics Department, the following was observed:

a. An exam room had dust on top of the cabinet.

b. The Labor & Delivery Room #2 had a non-functioning ceiling light, had a bathroom with wall damage, and the "Murphy Bed" did not have a protective cleanable cover.

c. The medication and immunization refrigerator in the clean supply room had a non-functioning back-up alarm system which was required by the CDC (Center for Disease Control).

d. A clean utility room had a non-functioning ceiling light.

e. A soiled utility room contained a linen hamper with rusty casters.

f. The medical gas storage room had dirty walls and floors and dusty oxygen canisters. Additionally, the wall near the door to the outside had an irregular surface and the bottom
of the door frame was rusted.

g. The housekeeping closet had ten (10) pails of cleansers and disinfectants stored on the floor.

h. Room 101 had dust on the top of the mirror frame, the top of the picture frame, and on the top of the wood molding.

i. Room 102 had dust on the top of the wood molding and had a pull cord in the bathroom tied to the grab bar.

7. These findings were confirmed by the Risk Manager on February 12, 2014 at approximately 9:10 AM.

8. On February 12, 2014, at approximately 9:15 AM, during a tour of the Medical/Surgical Department, the following was observed:

a. The Hazardous Chemical Storage Room had nine (9) cardboard boxes stored on the floor.

b. A soiled utility room contained a linen hamper with rusty casters.

c. The Sterilization Room accessed from the the Medical/Surgical area had four (4) drain
pipes leading into a drain that did not have the required air gaps.

d. The hallway had eleven (11) cracked floor tiles that could not be sanitized.

e. The kitchenette in a clean utility room had a cabinet with dust on the top surface.

f. The public bathroom had dust on the top of the fire annunciator and on the top of the light
fixture that was over the sink. Additionally, the emergency pull cord was wrapped around the grab bar.

h. The Anteroom had a light fixture containing many dead insects.

i. Room 114 had dust on all horizontal surfaces above eye level.

j. Room 118 had a recliner chair with torn vinyl which could not be sanitized and an IV (intravenous) pole with rusty casters. Additionally, a picture on the wall had dust on the top of the frame and the pull cord in the bathroom was wrapped around the grab bar.

k. Room 119 had a picture on the wall that had dust on the top of the frame.

l. Room 122 had a light in the shower that contained eight (8) dead flies.

9. These findings were confirmed by the Risk Manager on February 12, 2014 at approximately 10:45 AM.

10. In a Tour of the kitchen at approximately 12:15 PM on February 12, 2014, the housekeeping closet in the kitchen had two (2) containers of cleaning solution on the floor. This finding was confirmed by the Food Services Manager at that time.

11. In a tour of the Operating Room areas at 2:00 PM on February 12, 2014, the following was observed:

a. Operating Room 2 had a damaged wall which was not able to be sanitized.

b. The ACU (Ambulatory Care Unit) had a computer stand with a broken lower shelf that had soiled tape on it, therefore having a surface that could not be sanitized and had a soiled laundry bin that had a rusty base that could not be sanitized.

12. These findings were confirmed with the Surgical Director on February 12, 2014 at approximately 2:40 PM.

13. During a tour of the Central Sterilization area at approximately 2:45 PM, on February 12, 2014, the following was observed:

a. The Central Sterilization Room had a dusty exhaust vent and one back table next to the pre-wash had rusty casters.

b. The sterile supply storeroom had floor tiles with spaces between the tiles and a damaged wall, both of which created surfaces which could not be cleaned and sanitized.

14. These findings were confirmed with the Surgical Director on February 12, 2014 at approximately 3:20 PM.

15. During a tour of the Oncology "Rose Room" area, the following was found:

a. The vital sign machine had a maintenance due date of 3/2013.

b. There was a patient floor scale with no maintenance sticker.

c. There was a "Respironic" CPAP machine that had no maintenance sticker.

16. During a tour of the Rehabilitation room, the following was found:

a. The Hydroculator heater had a maintenance due date of 1/2014.

b. The "Big Table" had a torn vinyl covering that could not be properly sanitized.

c. In the wall cabinet, there was a Neuromuscular stimulator machine that had a maintenance due date of 1/2012.

17. During a tour of the Oncology "Rose Room" area the following was found:

a. The vital sign machine had a maintenance due date of 3/2013.

b. There was a patient floor scale with no maintenance sticker.

c. There was a "Respironic" CPAP machine that had no Maintenance sticker.

Based on review of policies and procedures, tours of the facility and the outpatient area on February 11-12, 2014, it was determined that the facility failed to have a preventative maintenance program that would ensure that all mechanical, electrical and patient care equipment were maintained in safe operating condition.

Findings include:

1. Calais Regional Hospital Policy titled: 'Electrical Safety/Personal Electrical Equipment' stated, "Procedure: All Personal electrical equipment is checked throughout the maintenance department prior to being used."

2. Calais Regional Hospital Policy titled: 'Electrical Safety/Non Clinical Equipment' stated, "Procedure: At least once a year, a qualified maintenance person is assigned the task of checking the general condition and electrical safety of each cord-connected piece of electrical equipment......"

3. During a tour in Surgical Services outpatient area at on February 11, 2014 at 10:30 AM, it was observed that a vacuum cleaner located in the file room did not have a maintenance sticker.

4. During a tour in the Orthopedic Rehabilitation outpatient area on February 11, 2014 at 10:45 AM, the following was observed:

a. In an office near the stairwell, a fan did not have a maintenance sticker.

b. In the equipment exercise room, a piece of electronic equipment and two (2) treadmills had expired maintenance stickers (electrical safety inspections due on January 2014).

c. In one treatment room, a portable ultrasound machine had an expired maintenance sticker (January 2014).

5. The above findings were confirmed by the Director of Facilities on February 11, 2014 at approximately 11:30 AM.

6. During an interview with the Director of Plant Maintenance/Safety on February 11, 2014 at 2:00 PM, he stated, he "did not know that the electrical safety on non-clinical equipment had to be checked once per year."

7. During a tour of the Emergency Department on February 11, 2014 at 2:30 PM, the following was observed:

a. A refrigerator in the staff room had an expired maintenance inspection sticker (October 8, 2012).

b. A microwave oven in the doctor's call area had no maintenance sticker.

c. The standing scale in the triage room had no maintenance sticker.

d. The refrigerator in the kitchenette had an expired maintenance sticker (September, 2012).

8. The above findings were confirmed by the Director of Facilities on February 11, 2014 at approximately 3:15 PM.

9. During a tour of the Obstetrics Department on February 12, 2014 at 8:15 AM, the following was observed:

a. In the kitchenette area, a refrigerator had an expired maintenance sticker (October, 2012) and a toaster (last inspected in September 2012).

b. The supply room in the nursery had a fan without a maintenance sticker.

10. These findings were confirmed by the Risk Manager February 12, 2014 at approximately 9:10 AM.

11. During a tour of the Medical/Surgical Department on February 12, 2014 at 8:15 AM, it was observed that the kitchenette in a clean utility room had a toaster and a Keurig coffee maker with no maintenance stickers. The refrigerator, microwave oven, and coffee maker all had expired maintenance stickers.

12. These Findings were confirmed by the Risk Manager February 12, 2014 at approximately 10:45 AM.

13. During a tour of the kitchen on February 12, 2014 at approximately 12:15 PM, it was observed that the kitchen area had kitchen equipment, including the Robot Coupe, slicer, large mixer, microwave oven, conveyor toaster, Aladdin plate base warmer, blender, and coffee maker which had either unreadable or no maintenance stickers. Additionally the four (4)-slot toaster, table top mixer in the kitchen, as well as the microwave oven and toaster in the cafeteria had expired maintenance stickers.

14. These findings were confirmed by the Food Services Manager on February 12, 2014 at approximately 1:45 PM.

15. During a tour of the Operating Room Suite on February 12, 2014 at 2:00 PM, the following was observed:

a. Operating Room 2 and ACU (Acute Care Unit) each had a razor that had no maintenance sticker.

b. The procedure area had a Sony radio that had an expired maintenance sticker of January 14, 1999.

c. The ACU area had a standing scale with no maintenance sticker.

16. These findings were confirmed with the Surgical Director on February 12, 2014 at approximately 3:20 PM.

Based on tours of the facility, document review, and interview with key staff on February 12, 2014, it was determined that the facility failed to ensure that drugs and biologicals were stored appropriately.

Findings include:

1. During a tour of the Oncology Rose Room on February 12, 2014, five (5) blue top blood collection tubes were found to be expired (December, 2013).

2. These findings were confirmed with the Risk Manager on February 12, 2014 at approximately 2:00 PM.

3. During a tour of the Operating Room 2 on February 12, 2014 at approximately 2 PM, the following was observed:

a. In the malignant hyperthermia refrigerator, four (4) one thousand cubic centimeter (1000 cc) bags of normal saline solution were expired (July, 2013) and one (1) 3000 cc bag of normal saline was expired (December 2013).

b. In an anesthesia cart, one (1) 20 milliliter vial of Labetolol Hydrochloride was opened but not labeled with the date opened.

c. These findings were confirmed with the Surgical Director on February 12, 2014 at approximately 2:30 PM.

Based on review of temperature and humidity logs, review of policies and procedures, and tours of the Surgical Suite on February 11-12, 2014, it was determined that the facility failed to maintain the temperature and humidity in the surgical suite according to acceptable professional standards.

Findings include:

1. The Calais Regional Hospital Maintenance Policy #3003, stated, "HUMIDITY CONTROL: Low and high limits are set at 35 degrees to 65 degrees for the Inpatient Care Units and the Surgical suites." This policy did not address temperature control.

2. The 2012 AORN (Association of Perioperative Registered Nurses) Perioperative Standards and Recommended Practices were reviewed on February 12, 2014. These standards stated, "Recommendation V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. V.c. Temperature should be maintained between 68 degrees to 73 degrees F (20 degrees to 23 degrees C) within the operating room suite and general work areas in sterile processing. V.c.3. A temperature of 70 degrees to 75 degrees F (21 degrees to 24 degrees C) should be maintained in recovery areas and cardiac catheterization rooms."

3. Temperature and Humidity graphs for two (2) Operating Rooms were reviewed from January 27, 2014 to February 12, 2014. Neither the temperature or the humidity was consistently maintained according to the 2012 AORN standards adopted by the facility.

4. The Director of Facilities/Safety was interviewed on February 12, 2104, at approximately 4:00 PM. He stated the software package could not provide the surveyor with graphs of the temperature for the recovery area or the humidity for the recovery area, the instrument processing area or the sterilizing area.

5. Although no evidence of increased hospital acquired infections existed in the operating suite, the potential impact of the temperature not being maintained according to the standards established is that the patients and staff are exposed to cold or hot temperatures that could lead to either infections or over heating. Additionally, heating, ventilation, and air conditioning systems dilute and remove contaminates from the air and control airflow patterns.

6. The above findings were confirmed by the Director of Facilities/Safety on February 12, 2104 at approximately 4:00 PM.

Based on document review and interview with key personnel on February 11, 2014, it was determined that the facility failed to follow their policies.

Findings include:
1. The Radiation Safety Policy states "...Protective "lead" gloves and aprons ...are checked two times a year for breakage or cracks ..."

2. The "Documentation of Gloves & Aprons Inspections for CRH" was reviewed. Documentation revealed that the protective equipment was checked on December 31, 2012, and again on November 30, 2013.

3. During an interview with the Radiology Director on February 11, 2014 at 11:30 AM, she confirmed that the protective equipment is only checked annually, despite the policy requirement of safety checks being conducted twice a year.

Based on document review and interview with key personnel, on February 11, 2014 at approximately 1130 AM, it was determined that the facility failed to provide nursing care in accordance with the patient's needs.

Findings include:

1. The Department of Nursing "Staffing Plan" for inpatient units indicates that the licensed staff core staffing for "Census" "<10" is "3D 3N" (3 RN's on day shift and 3 RN's on night shift).

2. A review of the "Daily Staffing Sheet" for December 25, 2013 indicates that the patient census for the Med/Surg was 9 (nine). The "Daily Staffing Sheet" further indicated that there were only 2 (two) RN's assigned to patient care for the period 7:00 PM to 7:00 AM.

3. This finding was confirmed by the Director of Inpatient Nursing on February 11, 2014 at 11:35 AM, who said, "We had scheduled for 3 nurses but we had a call out and couldn't get anyone to come in."

Based on Document review and interview with key personnel, on February 11, 2014 at approximately 1330, it was determined that the facility failed to have verbal orders policies and procedures in accordance with accepted standards of practice.

Findings include:

1. During a review of General Nursing Policies and Procedures it was noted that the "Physicians' Orders, Transcription of" policy regarding "Verbal/Telephone Orders," failed to require "Date" and "Time" of the order.

2. This finding was immediately confirmed by the Director of the Inpatient Unit who stated, "That is easy to correct ... I can revise that policy to include that."

3. On February 11, 2014 at approximately 2:00 PM, the Director of the Inpatient Unit provided a draft copy of the revised "Physicians' Orders, transcription of" Policy that included "correct date" and "time written" as requirements for transcribing "Verbal/Telephone Orders." The Director reported "This policy will be sent to the Board for approval."

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to follow their policies.

Findings include:

1. The Calais Regional Hospital Swing Bed Program Resident Rights policy states "Upon admission to the Calais Regional Hospital Skilled Nursing Swing Bed Program your rights, as a resident must be explained to you ..."

2. A review of four (4) swing bed patient medical records revealed that the hospital staff failed to inform four of four (4 of 4) patients of their patient rights upon admission (Records JJ, KK, LL, MM).

3. This finding was confirmed with the Director of Case Management at on February 12, 2014 at 11:30 AM.

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to notify the patient of the reason for discharge.

Findings include:

1. A review of Medical Record MM revealed that the hospital staff failed to inform the patient of the reason for discharge from the Swing Bed Program.

2. This finding was confirmed with the Director of Case Management on February 12, 2014 at 2:00 PM.

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to provide the patient with a notice of discharge.

Findings include:

1. A review of Medical Record KK revealed that the hospital staff failed to provide the patient a notice of discharge from the Swing Bed Program.

2. This finding was confirmed with the Director of Case Management on February 12, 2014 at 11:15 AM. She stated, "I did not give him a letter of discharge ..."

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to provide the patient with a notice of discharge, which included all the required elements.

Findings include:

1. A review of Medical Record MM revealed that though the hospital staff provided the patient a notice of discharge from the Swing Bed Program titled "Notice of Medicare Provider Non- Coverage," the notice failed to include all the required elements.

2. The "Notice of Medicare Provider Non- Coverage" failed to include: reason for discharge, location where the patient was being transferred, the required information for the Long Term Care Ombudsman, the required information for the Office of Aging and Disability, and the required information for Substance Abuse and Mental Health Services.

3. This finding was confirmed with the Director of Case Management at on February 12, 2014 at 2:00 PM.

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to include all the elements required in the Comprehensive Assessment.

Findings include:

1. A review of Medical Record LL revealed that though the hospital staff conducted a comprehensive assessment, it failed to include all the required elements. The record failed to include assessment of the patient's vision, psychosocial well-being, continence, disease diagnosis and health conditions, and discharge potential.

2. A review of Medical Record MM revealed that though the hospital staff conducted a comprehensive assessment, it failed to include all the required elements. The record failed to include assessment of the patient's mood and behavior patterns, psychosocial well-being, continence, disease diagnosis and health conditions and skin condition.

3. This finding was confirmed with the Director of Case Management on February 12, 2014 at 2:00 PM.

Based on document review and interview with key personnel on February 12, 2014, it was determined that the facility failed to establish a Comprehensive Care Plan in one (1) of four (4) records reviewed.

Findings include:

1. A review of Medical Record LL revealed that the hospital staff failed to establish a Comprehensive Care Plan. The patient was admitted to the Swing Bed Program on November 27, 2013, for palliative care. The patient died on December 16, 2013.

2. See Tag C-0388 finding # 1 for additional information regarding the Comprehensive Assessment of this patient.

3. This finding was confirmed with the Director of Case Management on February 12, 2014 at 2:00 PM. She stated "I can't find a care plan for this patient ..."