HospitalInspections.org

Based on document review and interviews with key personnel on January 29, 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 "A critical access hospital must protect patient rights and comply with the conditions for patient rights contained in 42 CFR subset 482.13..." The Federal Condition of Participation: Patient's Rights 482.13(a)(2)(ii), requires [At a minimum] the grievance process must specify timeframe's for review of the grievance and the provision of a response" and at 482.13 (a)(2)(iii) which states " in its resolution of the grievance, the hospital must provide the patient with written notice...."

Findings include:

1. The facility policy "Patient Complaint, Grievance and Compliment Policy"stated that "resolution to complaints not involving immediate danger or easily resolved by the care giver will be accomplished within 30 days whenever possible." The policy also went on to state that "if a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purpose of these requirements." It continued: "On average, a time frame of 7 days for the provision of the response is appropriate. If a grievance cannot be resolved or if the investigation is not or will not be completed within 7 days, the hospital will inform the patient or the patient's representative in writing that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within 14 more additional days."

2. The Chief Executive Officer (CEO) confirmed that this policy was confusing and contradictory on January 29, 2014 at approximately 3:00 PM.

3. The surveyor requested six (6) grievances from the facility, which the facility had identified as grievances. Three (3) of six (6) grievances (File #1, #5 & #6) failed to contain evidence of a letter to the complainant (patient or patient's representative). Additionally, one (1) of three (3) grievances (File #3) did have a letter sent; however, the letter was sent eleven days after submission of the grievance. There was no documentation of a letter having been sent on day seven (7) per policy.

4. The surveyor confirmed this finding in an interview with the Quality Registered Nurse on January 29, 2014 at approximately 10:10 AM.

5. The surveyor requested six (6) complaints from the facility, which the facility identified as complaints. Of the six (6) complaints provided one (1), submitted on July 17, 2013, remained open and incomplete.

6. The above finding was confirmed by the CEO on January 29, 2014 at approximately 3:45 PM, who stated "it looks like a grievance to me" and later stated that "as far as we can determine the patient is still sitting by the phone waiting for when the complaint was finished".

7. In spite of the requirement to provide written notice, the facility policy "Patient Complaint, Grievance and Compliment Policy" stated: "patients will be informed of the complaint procedure by the staff member and by the quality improvement director when appropriate".

----------


30938

Based on observation and interview with key personnel on January 29, 2014, at approximately 0910, 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: Patient's Rights 482.13(c)(1) which states: The patient has the right to personal privacy.

Findings include:

For information regarding the failure to ensure the confidentiality of medical records see Tag C-0308.

Based on document review, observations during tours, and interviews with key staff January 28-30, 2014, it was determined that the CAH failed to maintain the facility and outpatient areas, as evidenced by:

1. The CAH failed to maintain the facility to ensure access to and safety of patients (See Tag C - 0221);

2. The CAH failed to develop a preventive maintenance programs to ensure that all essential mechanical, electrical, and patient care equipment are maintained in safe operating condition (See Tag C- 0222);

3. The CAH failed to develop preventive maintenance programs to ensure that the premises were clean and orderly(See Tag C - 0222);

4. The CAH failed to ensure that drugs and biologicals were appropriately stored (See Tag C - 0224);

5. The CAH failed to ensure proper ventilation, humidity and temperature control in the Surgical Suite (See Tag C - 0226); and

6. The CAH failed to have housekeeping and preventive programs to ensure that there was proper ventilation, lighting, and temperature control in all patient care areas (See Tag C - 0226).

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

Based on tours of the facility, review of information provided and interviews with key staff January 28-30, 2014, it was determined that the hospital failed to maintain the facility to ensure the safety of patients.

Findings include:

1. The Down East Community Hospital Policy # 8300-0104 titled, 'Maintenance Performance Standards' (described to the surveyor as the preventative maintenance program) stated: "PROCEDURE: All maintenance personnel will be responsible for performing the following functions: Plant Operations: All equipment included in scheduled maintenance program; All equipment logs and documentation system current; Scheduled Maintenance: Scheduled maintenance programs to be developed and implemented includes: Identification system for equipment; Incoming equipment procedure established; safety and performance testing procedure established for each item; Testing intervals defined for each piece of equipment. Biomedical Equipment: Ensure contractor complies with codes, standards and hospital policies and procedures; Inspection systems in place and documentation current."

2. During a tour of the Reid Emery Building Family Practice Upstairs, conducted on January 28, 2014 at 7:10 am, the following was found:

a. The seams in the vinyl floors were lifted and non-intact in all areas.

b. The Waiting Room walls and ceilings were damaged and in need of repair and painting.

c. The walls of the restroom near reception were damaged and in need of repair and painting.

d. The Examination Table in Exam Room 1 had a torn vinyl surface which was not easily sanitized.

e. In Exam Room 2, the patient privacy curtains were stained ,and the walls were damaged and in need of repair and painting.

f. The walls in Exam Rooms 2, 3, 4, 5, and 8 were damaged and in need of repair and painting.

g. The examination table in Exam Room 4 had a torn vinyl surface which was not easily sanitized.

h. In Exam Room 8, the examination table had a torn vinyl surface which was not easily sanitized, and there were cardboard boxes stored on the floor.

3. During a tour Reid Emery Building Family Practice Lower Level, conducted on January 28, 2014 at 8:10 am, the following was found:

a. The Waiting Room contained a soiled ceiling vent near rest room.

b. The Clean Utility Room contained dirty staff dishes in the sink.

c. Exam Room 1 contained an examination table with torn vinyl.

d. In the Boiler Room, one plastic bag and one cardboard box were stored on the floor. This was immediately corrected by maintenance.

4. During a tour Reid Emery Building Urology Area, conducted on January 28, 2014 at 9:00 am, the following was found:

In Exam Room 1, the walls were damaged and in need of repair and painting.

5. The CAH contracts with Maine Veteran's Home to provide nutritional services for patients. During a tour of the Maine Veteran's Home Kitchen, conducted on January 29, 2014, at approximately 11:00 am, the following was found:

The Chemical/Housekeeping Closet in the kitchen contained two (2) boxes of dish machine chemicals and one (1) spray bottle which were stored on the floor. Additionally, all brooms and mop handles were stored on the floor.

6. During a tour of the Pediatrics Practice, conducted on January 29, 2014 at 1:00 PM, the following was found:

The walls in the waiting area and Exam Room 2 were damaged and in need of repair and painting.

7. During a tour of the Orthopedics Practice, conducted on January 29, 2014 at 1:40 PM, the following was found:

a. In Exam Room 2, the walls in room and rest room were damaged and in need of repair and painting.

b. In Exam Room 3, the walls damaged and in need of repair and painting.

c. The Utility Room contained one (1) box of gowns found on the floor. These were moved to a pallet by maintenance.

8. During a tour of the Women's Health Center, conducted on January 29, 2014 at approximately 2:00 PM, the following was found:

a. The walls in the Hallway were damaged and in need of repair and painting.

b. In Exam Room 1, the walls damaged and in need of repair and painting.

c. In Exam Room 3, the vinyl on the exam table was torn and not easily sanitized.

d. In the Pediatric Treatment Room, the ceiling tile was stained and the walls had holes and wall patches in need of repair and painting.

e. Rehab Treatment Room 6 contained vinyl on exam table which was torn and not easily sanitized.

f. The walls in the Mammogram Waiting Area had holes and wall patches in need of repair and painting.

9. During a tour of the Milbridge Medical Center, conducted on January 30, 2014 at approximately 7:30 am, the following was found:

a. Room 1 contained a wall which was damaged and in need of repair and painting, and a stained ceiling tile.

b. The walls in Room 3 were damaged and in need of repair.

c. The walls in the Dirty Utility Room were damaged and in need of repair and painting.

d. In Bathroom 1, the fan was taped to the ceiling, and the light had no cover.

e. A wheelchair was being stored in the handicapped-accessible bathroom which did not allow a 5 foot radius access for a wheelchair to turn.

10. During a tour of the Rehab Department, conducted on January 30, 2014 at approximately 2:30 PM, the following was found:

a. In Rehab Treatment Room 6, the vinyl on exam table was torn and not easily sanitized.

b. A wall in Exam Room 1 had patches in need of repair and painting.

c. In Exam Room 2, the walls were damaged and in need of repair and painting, and a stool had torn vinyl and was not easily sanitized.

11. During a tour of the Down East Community Hospital Building, conducted on January 30, 2014 at approximately 2:30 PM, the following was found:

a. Main Entrance Waiting Area:

i. The Rest Room near waiting area had a sign on door indicating the door does not lock.

ii. The wall in waiting room had wallpaper peeling away from a column in need of repair.

b. In Cardiopulmonary, the echocardiogram area had missing paint on the walls.

c. Laboratory:

i. The Phlebotomy Area had a sink out of service that was being used as a storage area.

ii. The Chemistry Area had a stained ceiling tile.

d. Radiology:

i. The walls were damaged and in need of repair and painting.

ii. The vinyl floors had seams that were non-intact and lifting.

e. Emergency Department (ED):

i. The vinyl floors contained tears and lifting seams throughout ED area.

ii. The ED patient rooms had damaged walls in need of repair and painting,

iii. The ED patient room with beds #3 and #4 had significant dust on the door trim, the cabinets, and on the arm on lift over bed #3.

iv. The housekeeping closet had damaged walls needing repair and painting.

v. The walls in Room #6 had damage and were in need of repair and painting.

vi. The water fountain was corroded and had lime deposits.

f. Medical /Surgical:

i. The following patient care areas had damaged walls in need of repair and painting:

a. Room 215,
b. Room 217 (Isolation Room),
c. Room 233,
d. Palliative Care room,
e. Soiled Utility Room, and
f. Linen Room.

ii. Room 217 (Isolation Room) had dust on the door frame.

iii. Room 211 had a dark brown stain on the wall near the door.

iv. Room 209 had a sign posted on a window which stated: "Please do not open window as it does not stay up on its own."

v. The Supply Room had multiple stained ceiling tiles.

vi. Room 241 had an IV pole with dirty, greasy casters.

vii. Room 239 had an IV pole which was missing paint and not easily sanitized.

viii. The top surface of the Kitchenette refrigerator had dust.

g. OB Area:

i. The following patient care areas had damaged walls in need of repair and painting:
a. Room 256,
b. Room 257, and
c. Soiled Utility Room.

ii. Room 257 had an IV pole with missing paint and an not easily sanitized surface.

iii. The ceiling light in the Kitchenette was not working.

iv. The Nursery had dust on the door frame.

h. Boiler Room:

i. Pipe insulation on drain pipe behind number three (3) boiler was observed to be a frayed and open. The Director of Plant Operations said: "I think that's the last piece of asbestos in here ... we need to tape that up."

ii. There were loose electrical conductors on the floor near the number two feed pump that had wire nuts on the ends. The Director of Plant Operations stated: "they have been working on that pump..." He then indicated that the switch was "locked out" and indicated two switches that were switched to the "off" position and had "lock out" tags on them. An inspection of the tags showed that they had "#2 feed pump" on both tags. One tag had "1999" written on it.

iii. Main Power Panel number 4 had two (2) tool chests, material, and debris on and directly in front of the electrical panel.

iv. The "clean out" door to the chimney was ajar and unable to be closed.

i. Surgical Services Department

i. The door on Ambulatory Surgical Unit Room 5 contained chips and dents, and edges of the plywood on wall were unsealed and not easily sanitized.
ii. OR 1 contained:
a. A stainless steel table and trash cart with rusty casters which were not easily sanitized.
b. Dents and scratches on the walls.
c. An "Oscopy tower" which had adhesive residue and tape on the top.
d. A physician's "Cart" with trash on top and a lead shield that was visibly soiled on the top. A plastic open top container located on the side was labeled " do not use for trash" and contained trash and manila/paper folders. The physician remarked that the lead shield "doesn't work but we keep it until we get a replacement." The physician removed the paper folders from the plastic container and explained, "we don't need them here ... I will remove the cart from the room ... it can be store on another area..." The physician then removed the cart from the operating room.

iii. OR 2 contained a stainless steel table and trash cart with rusty casters that were not easily sanitized, and dents and scratches on the walls.

iv. Clean Work Room 3:

a. A portable air compressor with a built in air pressure tank typically used for construction work, was on the counter next to the sink and plugged into a wall outlet. The Surgical Services Director explained: "This is the compressor we were given to use to blow out the scopes until they get the new airline in."

b. The compressor name plate stated: "Porter Cable C 2002, Type 3," and a sticker located on the compressor tank stated: "Maintenance / By: Brene/ Date: 9/30/09."

c. The Assistant Surgical Services Director explained: "It has been safely two (2) to three (3) years [that this compressor has been in use] ... due to the need for 24 PSI."

d. Page 3 (three) of the Porter-Cable Pancake Compressor Instruction Manual stated: "DANGER: RISK OF EXPLOSION OR FIRE." This warning also stated: "Always remain in attendance with the product when it is operating." ... "Always turn off and unplug unit when not in use."

e. When asked for all information regarding how the compressor was operated and maintained on January 30, 2014, at approximately 1400, the Surgical Services Director reported that the compressor was turned "on at the beginning of the day to build up pressure, then turned off. It is not usually turned back on throughout the day" and "used approximately 7-12 [7:00 AM to noon]/day ... 3 days/week."

f. There was no indication on the air compressor or the manual that indicated that it was designed for or may be used for patient care or medical uses. In fact, Page 3 of the Porter-Cable Pancake Compressor Instruction Manual stated: "WARNING: This product contains chemicals, including lead, known to the State of California to cause cancer, and birth defects or other reproductive harm. Wash hands after handling." Page 4 (four) stated: "DANGER: RISK TO BREATHING (ASPHYXIATION) ... The compressed air ... may contain carbon monoxide, toxic vapors, or solid particles from the air tank. Breathing these contaminates can cause serious injury or death."

g. On January 30, 2014, at approximately 1420, the Director of Plant Operations was asked for information and documentation regarding the maintenance scheduled and performed for the portable air compressor. The Director stated: "I don't think that one's on anything." No further documentation or information regarding maintenance or inspection of the air compressor was provided.

v. Central Sterile Supply contained one (1) Jamshidi Bone Marrow Biopsy/Aspiration Tray with an expiration date of 10/31/13, and one (1) Jamshidi Bone Marrow Biopsy/Aspiration Tray with and expiration date of 12/31/13.

12. The potential impact of the facility failing to have systems for properly maintaining equipment is that patients and/or staff could be injured.

Based on observations, review of policies and procedures, and interviews with key staff on January 28 - 30, 2014, it was determined that the facility failed to follow their preventative maintenance policy to ensure safety for patients and staff.

Findings include:

1. The Down East Community Hospital Policy # 8300-0104 titled 'Maintenance Performance Standards' (given to the surveyor as the preventative maintenance program) stated: " Scheduled Maintenance program to be developed and implemented includes: Incoming equipment procedure established...Safety and performance testing procedure established for each item...Biomedical Equipment contracted Biomedical Services: Ensure contractor complied with codes, standards and hospital policies and procedures...Facility Maintenance: Inspection systems in place and documentation current."

2. During interviews with the Director of Plant Operations on several occasions, January 28-30, 2014, he stated that all equipment was to be inspected for safety on an annual basis. He stated that fans, toasters, microwaves, etc. were all to be included. He further stated that he did not realized that the Biomedical contractor had not completed all the things that needed to be done.

3. During a tour of the Reid Emery Building Upper Family Practice at 7:15 a.m. on January 29, 2014, the surveyor noted:

a. A refrigerator with nothing stored in it with ice buildup in freezer area.

b. Medical Equipment (cholesterol testing equipment and Urisys 1100) without any inspection tags.

c. Exam Room 8, which was used for storage, contained a portable heater without a sticker signifying inspection and an oxygen tank with no record of when it was inspected.

4. During a tour of the Lower Family Practice at 8:10 a.m.:- 9:00 a.m. on January 29, 2014, the surveyor noted:

a. The Clean Utility Room had no stickers signifying inspections on a thermometer and baby scale, and the PT/INR machine was without sticker signifying inspection.

b. The Soiled Utility Room had no stickers signifying inspections on a centrifuge and Urisys 1100 machine.

c. The low temperature refrigerator alarm was off.

d. In Exam Room 1, an electronic thermometer, ear/eye examination equipment, and an exam table had inspections stickers on them indicating inspections had been due for inspection on 8/2013.

e. In Exam Room 2, an electronic thermometer, ear/eye examination equipment, and an exam table had inspections stickers on them indicating inspections had been due on 8/2013.

f. In Exam Room 4, an electronic thermometer, ear/eye examination equipment, lamp, and an exam table had inspections stickers on them indicating inspections had been due on 8/2013.

g. In Exam Room 5, an electronic thermometer, ear/eye examination equipment, and an exam table had inspections stickers on them indicating inspections had been due on 8/2013.

h. In Exam Room 6, an electronic thermometer and ear/eye examination equipment had inspection stickers on them indicating inspections had been due on 8/2013. The Exam Table inspection sticker indicated table was to have been inspected on 8/12.

5. During a tour of the Urology Clinic at 9:00 am the same day, the surveyor noted:

a. The scale had an inspection sticker indicating it had been due for inspection on 7/13.
.
b. In Exam Room 1, the Exam Table and the ultrasound gel warmer had inspection stickers indicating they had been due for inspections on 8/13.

c. No inspection sticker was located on the ultrasound machine.

d. In the Staff Break Area, two oxygen tanks were being stored, but there was no documentation of the tanks being checked to see if they were full.

6. During a tour of the Kitchen at 11:00 a.m. - 12:10 p.m. on January 29, 2014, the surveyor noted that the Dish Machine record failed to contain all the temperature checks of the wash and rinse cycles. The temperature was not documented for two (2) out of three (3) checks on January 10 and one (1) of three (3) checks on both January 14 and 24, 2014.

7. During a tour of the Pediatrics at 1:10 p.m. on January 30, 2014, the surveyor noted:

a. In the Procedure Room, the lamp inspection was past due. The sticker indicated inspection had been due 6/2010, and the eye wash station had an unreadable last date of inspection on the sticker.

b. In Exam Room 2, no inspection sticker was located on the exam table.

8. During a tour of Orthopedics at 1:40 p.m. same day, the surveyor noted:

a. The Utility Room contained an oxygen tank with no record of oxygen level being checked.

b. In the Lab Room, the refrigerator alarm was turned off, and there was no record of temperatures being checked. Additionally, the Urisys 1100 and an Accucheck meter had no sticker indicating they had been inspected.

9. During a tour of the Women's Center at 2 p.m. on January 30, 2014, the surveyor noted:

a. The eye wash station in the staff area had a tag which stated last inspection was 2008.

b. The Urisys 1100 in the lab did not have a sticker indicating inspection.

c. In Exam Room 2, the portable ultrasound machine had no sticker indicating an inspection had been completed.

10. During a tour of Rehabilitation also on January 30, 2014, the surveyor noted a fan with inspection due date of 6/09 in Exam Room 2.

11. During a tour of Milbridge Medical Center the same day, the surveyor noted that the baby scales not inspected, there was no record that the eye wash station had been inspected, and the Accucheck meter had not been inspected.

12. During tours of the Maine CAH Areas on January 30, 2014, the surveyor noted:

a. The Café contained two (2) compressors with cooling fans which were dusty, and a freezer with sticker indicating last inspection of 03/07.

b. In the Medical/Surgical patient area, the following was noted:

i. In Room 217, an Isolation Room, there was no electrical safety inspection sticker on lamp, and the light over the bed had no sticker indicating an electrical safety inspection had been done.

ii. In Room 209 there was a sign on the window which stated: " Please do not open window as it does not stay up on its own."

iii. In the overflow/maternity room the shower room pull cord for the call light was across the room from the shower out of reach of anyone if they fell in the shower. Additionally, the air conditioner had no sticker indicating an electrical safety inspection had been done.

iv. The air conditioners in the palliative care rooms had no stickers indicating electrical safety inspections had been done.

v. The housekeeping closet contained an eye wash station with no record of inspection, and a sanitation bottle was found stored on the floor.

vi. The electric fan in Room 239 had no sticker indicating an electrical safety inspection had been completed.

vii. The refrigerator in the Medication Room had annual inspection sticker dated 2009.

b. In the OB area, the following was noted:

i. In Room 257 (Labor/Delivery), there was a cracked light cover, and a leaking sink held together with wire nuts under the sink. Additionally, the room contained an IV pump with a sticker stating the electrical safety inspection had been due 6/2013.

ii. In the Soiled Utility Room, the hot pack heater had no sticker indicating an electrical safety inspection had been completed.

iii. The Clean Utility Room was unlocked and contained an unlocked cabinet that held syringes with needles.

iv. The blanket warmer in the Nursery had a sticker stating the electrical safety inspection had been due 6/2013.

c. In the Boiler Room, the following was found:

i. Pipe insulation on drain pipe behind number three (3) boiler was observed to be a frayed and open. The Director of Plant Operations said: "I think that's the last piece of asbestos in here ... we need to tape that up."

ii. There were loose electrical conductors on the floor near the number two feed pump that had wire nuts on the ends. The Director of Plant Operations stated: "they have been working on that pump..." He then indicated that the switch was "locked out" and indicated two switches that were switched to the "off" position and had "lock out" tags on them. An inspection of the tags showed that they had "#2 feed pump" on both tags. One tag had "1999" written on it.

iii. Main Power Panel number 4 had two (2) tool chests, material, and debris on and directly in front of the electrical panel. Additionally, there were multiple, partially filled 5 gallon bottles of floor wax and floor stripper located in the Old Boiler Room beneath the stairs.

iv. The "clean out" door to the chimney was ajar and unable to be closed.

d. In the Surgical Services Department, the following was found:

i. OR 1 contained:
a. A stainless steel table and trash cart with rusty casters which were not easily sanitized.
b. An "Oscopy tower" which had adhesive residue and tape on the top.
c. A physician's "Cart" with trash on top and a lead shield that was visibly soiled on the top. A plastic open top container located on the side was labeled " do not use for trash" and contained trash and manila/paper folders. The physician remarked that the lead shield "doesn't work but we keep it until we get a replacement." The physician removed the paper folders from the plastic container and explained, "we don't need them here ... I will remove the cart from the room ... it can be store on another area..." The physician then removed the cart from the operating room.

ii. OR 2 contained a stainless steel table and trash cart with rusty casters that were not easily sanitized.

iii. Clean Work Room 3:

a. A portable air compressor with a built in air pressure tank typically used for construction work, was on the counter next to the sink and plugged into a wall outlet. The Surgical Services Director explained: "This is the compressor we were given to use to blow out the scopes until they get the new airline in."

b. The compressor name plate stated: "Porter Cable C 2002, Type 3," and a sticker located on the compressor tank stated: "Maintenance / By: Brene/ Date: 9/30/09."

c. The Assistant Surgical Services Director explained: "It has been safely two (2) to three (3) years [that this compressor has been in use] ... due to the need for 24 PSI."

d. Page 3 (three) of the Porter-Cable Pancake Compressor Instruction Manual stated: "DANGER: RISK OF EXPLOSION OR FIRE." This warning also stated: "Always remain in attendance with the product when it is operating." ... "Always turn off and unplug unit when not in use."

e. When asked for all information regarding how the compressor was operated and maintained on January 30, 2014, at approximately 1400, the Surgical Services Director reported that the compressor was turned "on at the beginning of the day to build up pressure, then turned off. It is not usually turned back on throughout the day" and "used approximately 7-12 [7:00 AM to noon]/day ... 3 days/week."

f. There was no indication on the air compressor or the manual that indicated that it was designed for or may be used for patient care or medical uses. In fact, Page 3 of the Porter-Cable Pancake Compressor Instruction Manual stated: "WARNING: This product contains chemicals, including lead, known to the State of California to cause cancer, and birth defects or other reproductive harm. Wash hands after handling." Page 4 (four) stated: "DANGER: RISK TO BREATHING (ASPHYXIATION) ... The compressed air ... may contain carbon monoxide, toxic vapors, or solid particles from the air tank. Breathing these contaminates can cause serious injury or death."

g. On January 30, 2014, at approximately 1420, the Director of Plant Operations was asked for information and documentation regarding the maintenance scheduled and performed for the portable air compressor. The Director stated: "I don't think that one's on anything." No further documentation or information regarding maintenance or inspection of the air compressor was provided.

e. In PACU, the refrigerator was last due for an annual inspection on 11/17/11.

f. In the Ambulatory Surgical Unit, the microwave inspection sticker was dated 5/12, the refrigerator inspection sticker was dated 11/17/11, the toaster inspection sticker was dated 5/12, and the coffee dispenser did not have an inspection sticker.

13. The potential impact of not having a preventive maintenance program that ensures that all essential mechanical, electrical, and patient care equipment is maintained in safe operating condition is that there is a risk of fire and electrocution, and a risk that equipment may fail to function as designed, thereby potentially impacting the life and safety of patients and staff.

Based on tours of the facility and interviews with key staff on January 29, 2014, it was determined that the facility failed to ensure that they had a effective housekeeping program.

Findings include:

1. During a tour of the Infusion Clinic, on January 29, 2014, it was observed that there was a privacy curtain that had stains on it.

2. The Daily Environmental Services 2nd Shift Checklist was reviewed on January 30, 2014. The Checklist stated, " CARDIAC REHAB/INFUSION CLINIC..change curtains (as needed)."

3. It was confirmed on January 29, 2014, by the Director of Plant Operations, that the curtain had stains.

-----------

Based on review of documentation and interviews with key staff, January 28-30, 2014, it was determined that the facility failed to maintain the temperature and humidity in the Surgical Department.

Findings include:

1. The 2012 Perioperative Standards and Recommended Practices were reviewed on January 30, 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."

2. A review of the temperature and humidity logs for the operating rooms from January 2013 to April 2013, revealed forty-two (42) days that the temperature was not maintained and twenty-four (24) days that the humidity was not maintained in Operating Room 1. Operating Room 2 did not maintain the temperature for fifty-two (52) days and did not maintain the humidity for twenty-seven (27) days.

3. A review of the logs revealed that neither the temperature or the humidity were being monitored in the recovery room or the sterile storage room.

4. During an interview with the Director of Surgical Services, on January 29, 2014, at 10:30 a.m., she stated that the Maintenance Department was not acting on the issues with the temperature and the humidity. She further stated that she had emails going back to March of 2011, where she had identified these problems and wanted them fixed. She added that the communication with the maintenance department was not good.

5. During another interview with the Director of Surgical Services on January 29, 2014, at approximately 10:40 a.m., she stated that the temperature and humidity problems still existed. She further stated that sometimes the tape on the sterile packages would crack because it was so dry. Also during this interview, she confirmed that the temperature and humidity were not always within the standards established.

6. 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.

7. The potential impact of the humidity not being maintained according to the established standards is that low humidity increases the risk of electrostatic charges, which pose a fire threat due to the oxygen enriched environment that may or may not have flammable agents present; and high humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures performed.

----------

Based on review of policies and procedures, review of information provided and interviews with key staff January 28-30, 2014, it was determined that the facility failed to ensure that the proper ventilation was maintained in the Surgical Suite.

Findings include:

1. The 2012 Perioperative Standards and Recommended Practices stated, "Recommendation V.a. The quality of air entering the operating rooms should be carefully controlled. V.a.2. A minimum of 20% of the incoming air (i.e., three air exchanges per hour) should be from the outdoors. V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows: Operating room: minimum of 15 exchanges per hour with a recommended range of 20 to 25 air exchanges. Postanesthesia care unit: six air exchanges per hour. Sterile storage area: four air exchanges per hour."

2. The Down East Community Hospital Policy #6600001 stated, "14. Air Exchanges: a. Operating Room air exchange rates - 25 per hour b. Endoscopy Room air exchange rate - 10 per hour."

3. During several interviews with the Director of Plant Operations, on January 30, 2014, he stated that the facility's system could not provide documentation about the number of air exchanges that were maintained in any of the Surgical Suite areas.

4. The potential impact of the number of air exchanges not being performed based on established standards is that microbial or chemical contaminates might not be removed from the areas and/or the sterile field could become contaminated, therefore increasing the risk of surgical site infections.

Based on review documentation, and interviews with key staff between January 28-30, 2014, 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 governing body failed to ensure the maintenance of the facility to ensure access to and safety of patients; to develop and implement preventive maintenance programs; to ensure that the premises were clean and orderly; and to have housekeeping and preventive programs to ensure that there was proper ventilation, lighting, and temperature control in all patient care areas (See Tag C-220, Condition of Participation: Physical Plant and Environment).

2. The governing body failed to ensure that policies were followed; that all policies were developed by the group; that all rules for storing drugs and biologicals were followed; that the procedures for reporting adverse drug reactions and errors were followed; that the system for identifying, reporting, investigating and controlling infections was followed; and that the nutritional needs of inpatients were met in accordance with recognized dietary practices (See Tag C-270, Condition of Participation: Provision of Services).

3. The governing body failed to utilize appropriate medical equipment for the cleaning of surgical equipment (See Tag C-320, Condition of Participation: Surgical Services).

4. The governing body failed to include a review of a representative sample of both open and closed clinical records; to include in its total program evaluation if the established policies were followed and any changes needed; and to ensure that there was an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the hospital (See Tag C-330, Condition of Participation: Periodic Evaluation and QA Review).


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 January 28 and 29, 2014, it was determined that the CEO failed to ensure that the Annual Program Evaluation included all the required elements and that the evaluation went before the Governing Board.

The findings are as follows:

1. A review of the document " Review Period: 2013 780 The Periodic Review and Evaluation of Services" was conducted. The annual program evaluation failed to include all the required elements (see Tags C-0330, C-0333, C-0334 & C-0335).

2. A review of one (1) year of Board of Trustees meeting minutes was conducted. There was no documentation that the annual program evaluation was presented to the governing board during that time period.

3. During an interview with the VP of Physician Services & Ancillary Services on January 28, 2014 at 3:00, she presented meeting minutes dated "June 27, 2012" that indicated that the governing board had last reviewed and approved an annual program evaluation on that date. She confirmed that the document " Review Period: 2013 780 The Periodic Review and Evaluation of Services" had not been presented to the governing body.

4. During an interview with the Chief Executive Officer on January 29, 2014 at 8:00, he confirmed that the document " Review Period: 2013 780 The Periodic Review and Evaluation of Services" had not been presented to the governing body. He reported that due to staff turnover in the quality assurance department, he felt that " the ball got dropped " . He also confirmed that the document failed to include all the required elements of an annual program evaluation.

Based on review of patient medical records, review of provided documentation, review of meeting minutes, and interviews with key staff on January 28-30, 2014, it was determined that that the CAH failed to provide quality health care services to patients in accordance with acceptable standards of practice.

Findings include:

1. The CAH failed to ensure that policies were followed (See Tag C- 0271);

2. The CAH failed to ensure that all policies were developed by the group (See Tag C-0272);

3. The CAH failed to ensure that all rules for storing drugs and biologicals were followed (See Tag C-0276);

4. The CAH failed to ensure that the procedures for reporting adverse drug reactions and errors were followed (See Tag C-0277);

5. The CAH failed to ensure that the system for identifying, reporting, investigating and controlling infections was followed (See Tag C-0278); and

6. The CAH failed to ensure that nutritional needs of inpatients were met in accordance with recognized dietary practices (See Tag C-0279).


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

Based on review of policies and procedures, observations, and interviews with key staff on January 29 and 30, 2014, it was determined that the facility failed to follow their policies related to food preparation .

Findings include:

1. A Maine Veterans' Homes Policy (given to the surveyor as a Down East Community Hospital policy) titled, 'Food Preparation' stated: "All cooked foods shall be maintained at an internal temperature of 140 degrees F or above during holding and serving."

2. On January 30, 2014, at approximately 11:40 a.m., this surveyor sampled the last tray to be delivered to the Medical Surgical Unit. The internal temperature of the mashed potatoes and the carrots was not maintained at 140 degrees F.

3. This finding was confirmed by the Dietician who actually took the temperatures of the food. She stated that the temperature should have been at 140 degrees for all the hot foods.

Based on review of the Maine Veterans' Homes Policy and Procedure Manual (given to the surveyor as the Down East Community Hospital Dietary Policies and Procedures), on January 29, 2014, it was determined that the facility failed to ensure that the policies and procedures related to Dietary were devleoped by the group of professional personnel.

The findings are as follows:

Please see Tag C-0280 for more information about the development of dietary policies and procedures.

Based on observations and interviews with key personnel on January 30, 2014, at 11:00 a.m., it was determined that the facility failed to keep outdated drugs from being available for patient use.

Findings include:

1. During an inspection of the anesthesia cart in Operating Room 1, the following was found: One (1) tube of Lidocaine 5%, 35.4 g.(grams) opened and partially used with no date of when the medication was opened.

2. During an inspection of the anesthesia Cart in Operating Room 2, the following was found:

a. One(1) tube of Lidocaine 5%, 35.4 g. opened and partially used with no date of when the medication was opened.

b. One(1) package of " Glucagon for injection", 1 mg with an expiration date of 10/2013.

3. These findings were immediately confirmed by the anesthesiologist who asked, " So we have to write the date on them when we open them?" and "How long is it good for after it is opened?"

4. The Down East Community Hospital policy titled 'SAMPLE DISPENSING BY DECH CLINICS' stated, "PROCEDURE:......Each drug (and strength) shall be recorded on a separate sheet to show a continuous balance at all times."

5. During a tour of the Family Practice area, upstairs in the Reid Emery building, on January 28, 2014, the surveyor observed the samples log. There were several pages for each drug. There was no perpetual inventory maintained to know exactly how many of each drug was on hand.

6. During a tour of the Women's Health Center on January 30, 2014, the samples log was reviewed. The Heparin Sodium Injection 10,000 units/milliliter page indicated there should be twenty one (21) and the count was twenty-two (22). The Sodium Bicarbonate 4.2% 5 milliliter vials said there were 6 vials missing and not accounted for. The Lidocaine Injection 2% 5 milliliters log stated that thirteen (13) were missing and unaccounted for.

7. The Medical Assistant was interviewed on January 30, 2014, at 9:55 a.m., and she stated that she thought the medications were probably given out to patients and just not recorded. She added that the physicians would go into the closet and give out medications and not write them down on the log.

8. During a tour of the Rehabilitation Department on January 30, 2014, at 10:15 a.m., it was observed that there was an open bottle of acetic acid 5% that had not been dated. Additionally, there was one bottle of Phonogel that expired on November 1, 2013.

Based on review of policies and procedures, review of medical records and interviews with key staff January 29-30, 2014, it was determined that the facility failed to follow its own policy regarding procedures for reporting medication errors in one (1) of four (4) medical records (RECORDS: JJ, KK, LL and MM).

Findings include:

1. The Down East Community Hospital policy titled 'ADVERSE DRUG EVENTS', stated, "PROCEDURE:.....the prescriber shall be contacted immediately in the event of a potential adverse drug reaction."

2. Four (4) medical records were reviewed January 30 and 31, 2014. Record LL did not contain any documentation that the medication error had been reported to the physician.

2. Record LL had a medication error documented at 2 a.m. on September 7, 2013. The patient was discharged at 1445 and the error was not discovered until 1900.

3. This finding was confirmed by the Infection Prevention Nurse on January 30, 2014 at 11:30 AM.

Based on observation, document review, and interviews with key personnel on January 28-30, 2014, it was determined that the facility failed to effectively monitor hospital disinfection practices, and environment of care surveillance.

Findings include:

1. During a survey of the Surgical Services Clean Work Room 3, conducted on January 29, at approximately 1600, the following was found:

a. A portable air compressor with a built in air pressure tank typically used for construction work, was on the counter next to the sink and plugged into a wall outlet. The Surgical Services Director explained: "This is the compressor we were given to use to blow out the scopes until they get the new airline in."

b. The compressor name plate stated: "Porter Cable C 2002, Type 3," and a sticker located on the compressor tank stated: "Maintenance / By: Brene/ Date: 9/30/09."

c. The Assistant Surgical Services Director explained: "It has been safely two (2) to three (3) years [that this compressor has been in use] ... due to the need for 24 PSI."

d. Page 3 (three) of the Porter-Cable Pancake Compressor Instruction Manual stated: "DANGER: RISK OF EXPLOSION OR FIRE." This warning also stated: "Always remain in attendance with the product when it is operating." ... "Always turn off and unplug unit when not in use."

e. When asked for all information regarding how the compressor was operated and maintained on January 30, 2014, at approximately 1400, the Surgical Services Director reported that the compressor was turned "on at the beginning of the day to build up pressure, then turned off. It is not usually turned back on throughout the day" and "used approximately 7-12 [7:00 AM to noon]/day ... 3 days/week."

f. There was no indication on the air compressor or the manual that indicated that it was designed for or may be used for patient care or medical uses. In fact, Page 3 of the Porter-Cable Pancake Compressor Instruction Manual stated: "WARNING: This product contains chemicals, including lead, known to the State of California to cause cancer, and birth defects or other reproductive harm. Wash hands after handling." Page 4 (four) stated: "DANGER: RISK TO BREATHING (ASPHYXIATION) ... The compressed air ... may contain carbon monoxide, toxic vapors, or solid particles from the air tank. Breathing these contaminates can cause serious injury or death."

g. On January 30, 2014, at approximately 1420, the Director of Plant Operations was asked for information and documentation regarding the maintenance scheduled and performed for the portable air compressor. The Director stated: "I don't think that one's on anything." No further documentation or information regarding maintenance or inspection of the air compressor was provided.

2. A tour of the Surgical Suite conducted on January 29, 2014 revealed a large container of unknown disinfectant that was unlabeled as to the name, date prepared/expired, and directions for use. An interview with the Surgical Services Director on January 29, 2014 at approximately 2:30 PM , revealed that she did not know the name of the disinfectant or manufacturer's contact time.

3. A tour of Radiology Services on January 30, 2014 , revealed another large container of unknown disinfectant that was unlabeled as to name, date prepared/expired, and directions for use. During an interview with the Infection Control Practitioner on January 30, 2014, at 11:30 a.m., she explained that "housekeeping personnel mix the product." She confirmed the disinfectant was unlabeled and Radiology Service's personnel would not know the disinfectant's name, directions for use, or expiration date of the product.

Based on review of the Maine Veterans' Homes Policy and Procedure Manual (given to the surveyor as the Down East Community Hospital Dietary Policies and Procedures), on January 29, 2014, it was determined that the facility failed to ensure that the policies and procedures related to Dietary were reviewed at least annually by the group of professional personnel.

Findings include:

1. The cover sheet in the front of the Maine Veterans' Home Dietary Manual, which showed documentation that review had occurred annually, had only the signature of the Chief Executive Officer of the home.

2. This finding was confirmed by the Dietary Manager of the Maine Veterans' Home on January 30, 2014 at approximately 3:30 PM.

Based on observation and interview with key personnel on January 29, 2014, at approximately 0910, it was determined that the facility failed to maintain the confidentiality of patient record information and provide safeguards against unauthorized use.

The findings follow:

1. During a tour of the lower level Family Practice office in Reid Emery Building, it was discovered that patient's medical records were stored and displayed in such a manner that patient's names were clearly visible and readable from the reception window used by all patients arriving and departing the practice.

2. This situation failed to prevent patient information from being disclosed to persons that are not authorized to have that information.

3. Hospital Policy #1001024 "Confidentiality" stated: "To limit both unauthorized and incidental disclosures ...and be vigilant about maintained the integrity of protected health information ..." and "Reasonable physical safeguards to maintain confidentiality of protected health information ..."

4. This finding was confirmed by the Physician Practice Manager on January 29, 2014, at approximately 0910. The Manager stated, "Yes, this is a problem that I have noted." She further reported, "I have just called for a shield to be brought over right now."

5. During a revisit to the building conducted on January 30, 2014, it was noted that a curtain arrangement had been installed to the shelving. This shielded the records closest to the receptionist window from direct view. However; the unshielded records, approximately 10 feet from the window and beyond , remained visible and readable. The Practice Manager stated: "I couldn't read them from here so I thought it was OK."

Based on observations, interviews with key personnel and document review on January 29 and 30, 2014, it was determined that the facility failed to perform surgical procedures in a safe manner. The findings follow:
During a survey of the Surgical Services Clean Work Room 3, conducted on January 29,2014 at approximately 1600, the following was found:

a. A portable air compressor with a built in air pressure tank typically used for construction work, was on the counter next to the sink and plugged into a wall outlet. The Surgical Services Director explained: "This is the compressor we were given to use to blow out the scopes until they get the new airline in."

b. The compressor name plate stated: "Porter Cable C 2002, Type 3," and a sticker located on the compressor tank stated: "Maintenance / By: Brene/ Date: 9/30/09."

c. The Assistant Surgical Services Director explained: "It has been safely two (2) to three (3) years [that this compressor has been in use] ... due to the need for 24 PSI."

d. Page 3 (three) of the Porter-Cable Pancake Compressor Instruction Manual stated: "DANGER: RISK OF EXPLOSION OR FIRE." This warning also stated: "Always remain in attendance with the product when it is operating." ... "Always turn off and unplug unit when not in use."

e. When asked for all information regarding how the compressor was operated and maintained on January 30, 2014, at approximately 1400, the Surgical Services Director reported that the compressor was turned "on at the beginning of the day to build up pressure, then turned off. It is not usually turned back on throughout the day" and "used approximately 7-12 [7:00 AM to noon]/day ... 3 days/week."

f. There was no indication on the air compressor or the manual that indicated that it was designed for or may be used for patient care or medical uses. In fact, Page 3 of the Porter-Cable Pancake Compressor Instruction Manual stated: "WARNING: This product contains chemicals, including lead, known to the State of California to cause cancer, and birth defects or other reproductive harm. Wash hands after handling." Page 4 (four) stated: "DANGER: RISK TO BREATHING (ASPHYXIATION) ... The compressed air ... may contain carbon monoxide, toxic vapors, or solid particles from the air tank. Breathing these contaminates can cause serious injury or death."

g. On January 30, 2014, at approximately 1420, the Director of Plant Operations was asked for information and documentation regarding the maintenance scheduled and performed for the portable air compressor. The Director stated: "I don't think that one's on anything." No further documentation or information regarding maintenance or inspection of the air compressor was provided.



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

Based on review of documentation, and interviews with key staff on January 28-30, 2014, it was determined that the CAH failed to ensure that the quality of the care and services provided at the facility were evaluated and data was collected to help identify any areas that needed improvement. The evidence is as follows:

1. The CAH failed to include in their periodic review of its total program, a review of a representative sample of both open and closed clinical records (See Tags C-0333, C-0334 & C-0335);

2. The CAH failed to include in its total program evaluation if the established policies were followed and any changes needed (See Tag C-0335); and

3. The CAH failed to ensure that there was an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the hospital (See Tag C-0336).


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

Based on review of the " Review Period: 2013 780 The Periodic Review and Evaluation of Services" document, and interviews with key staff on January 28 & 29, 2014, it was determined that the facility failed to include in their annual periodic evaluation, a review of a representative sample of both active and closed clinical records.

Findings include:

1. A review was conducted of the annual program evaluation on January 28- 29, 2014. There was no documented evidence that a representative sample of both open and closed records had been reviewed.

2. It was confirmed by the VP of Physician Services & Ancillary Services on January 28, 2014, that it was impossible to determine which records reviewed were opened or closed.

Based on review of the " Review Period: 2013 780 The Periodic Review and Evaluation of Services" document, and interviews with key staff on January 28 & 29, 2014, it was determined that the facility failed to include in their annual periodic evaluation, a review of policies & procedures.

Findings include:

1. A review was conducted of the annual program evaluation on January 28- 29, 2014. There was no documentation that a review of policies & procedures was conducted.

2. This was confirmed by the VP of Physician Services & Ancillary Services on January 28, 2014.

Based on review of the " Review Period: 2013 780 The Periodic Review and Evaluation of Services" document, and interviews with key staff on January 28 & 29, 2014, it was determined that the facility failed to determine whether the utilization of services was appropriate, the established policies were followed, and if any changes were needed.

Findings include:

1. The annual program review document, reviewed in its entirety on January 28, 2014, did not include any information regarding the utilization of services being appropriate, whether the established policies were followed, and if any changes were needed based on the review (See tags C-0153, C-0221, C-0222, C-0226, C-0270, C-0272, C-0276, C-0277, C-0280, C-0308).

2. This was confirmed by the VP of Physician Services & Ancillary Services on January 28, 2014.

Based on a review of documents, and interviews with the Chief of Emergency Medicine on January 28 - 30, 2014, it was determined that the Hospital did not have an effective quality assurance or performance improvement program to evaluate the quality or appropriateness of the care provided by the Emergency Physicians.

Findings include:

1 The Down East Community Hospital Quality Improvement Plan states, " III.Scope of the Quality Improvement/Patient Safety Program...Each hospital department and medical staff service will be required to identify at least one performance improvement indicator, which will be monitored by the Indicators Team. Indicator results are reported to the QIPS monthly ...other measures which may be appropriate to an individual service including high volume, high risk, problem prone, or low volume processes. "

2 The Emergency Physicians had two performance improvement indicators during 2013. They were treatment of Transient Ischemic Attacks, (TIA) and Trauma Care.

3 The results of these two performance improvement indicators for all of 2013 were one hundred percent, (100%). This was confirmed with the Chief of Emergency Medicine during a meeting on January 29, 2014. The Chief of Emergency Medicine also confirmed that there could be no improvement of these two indicators as they were already at 100% during the entire year.

4 During the same meeting with the Chief of Emergency Medicine, he stated that the Emergency Physicians were satisfied with their two indicators and did not see any need for new performance improvement indicators for 2013 or 2014.

5 The Chief of Emergency Medicine also confirmed that while Trauma and TIA were high-risk indicators, they were of low volume. He also confirmed there were no high volume indicators, nor were there any plans for new high risk or high volume indicators for 2014.

6 The minutes of the Emergency Physicians meeting from January 2013 through December 2013 were reviewed. There was no documentation of the retrospective case review discussions that would lead to future error prevention or learning as there was no documentation of the issues discussed nor discussions of changes in care that would improve health outcomes or patient safety.