HospitalInspections.org

Based on document review and interviews with key staff on July 22-24, 2014, it was determined that the facility failed to follow all State regulations.

Findings include:

1. 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(a)(2), which states "The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance..."

2. A review of the 2013 complaint log was conducted on July 23-24, 2014. There were three (3) complaints logged during the year.

3. A review of the 2014 complaint log was conducted on July 23-24, 2104. There had been three (3) complaints logged thus far in 2014. Additionally, during the recertification survey, two (2) complaints that had been received by the Division were investigated by the surveyors. The hospital was aware of the existence of these complaints, however, there was no documentation on the complaint log that these complaints existed.

4. One (1) complaint logged in on May 23, 2014, was reviewed to determine if the facility followed its "MRH Patient Complaint and Grievance" policy.

5. The "MRH Complaint and Grievance" policy stated, "4. Complete an incident report for all situations that require more than a simple remedy..."

6. There was no evidence that an incident report had been made for the May 23, 2014 complaint, which required more than a simple remedy.

7. These findings were confirmed with the Vice President of Quality & Clinical Support on July 23, 2014, at 3:30 p.m. She stated, "I don't think I documented this well...there is no incident report...this complaint was against a physician...I talked to the Practice Manager about it...I guess I don't utilize the incident reports enough....I agree that I didn't follow the policy...."

8. 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(a)(2), which state, "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 Board must approve and be responsible for the effective operation of the grievance process and must review and resolve grievances..."

9. The "MRH Patient Complaint and Grievance" policy stated, "The MRH Board of Directors has delegated the responsibility for...the grievance process ...to the Professional Affairs Committee [PAC]."

10. The PAC meeting minutes were reviewed for the time period between September 19, 2013 - April 24, 2014. Though the review of complaints is a standing agenda item, the committee had failed to discuss complaints since September 19, 2013.

11. These findings were confirmed with the Vice President of Quality & Clinical Support on July 23, 2014, at 4:00 p.m. She stated, "Standing agenda items are high profile items...the expectation is that new complaints would be brought forward...I guess it's time for me to bring the [complaint] log to them..."

12. 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(a)(2), which states "The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance...that in the resolution of the grievance, the hospital must provided the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion."

13. The "MRH Patient Complaint and Grievance" policy stated, "A written notice... of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process and the date of completion."

14. On July 23, 2014 a review of the letters sent to the three (3) complainants was conducted. All three (3) letters were missing required elements. Additionally,the letter dated May 26, 2014 , was written in the future tense (indicating what the writer planned to do regarding the investigation).

15. Theses findings were confirmed with the Vice President of Quality & Clinical Support on July 23, 2014, at 4:00 p.m. She stated, "Yes, I wrote the letters...I guess I could do a better job..."

16. 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(e)(11), which states "Physician and other LIP training requirements must be specified in hospital policy. At a minimum, the physician & other LIP's authorized to order restraint or seclusion....must have a working knowledge of the hospital policy regarding the use of restraint or seclusion."

17. A review of the "Policy for Patient Restraint" was conducted on July 24, 2014. It stated, "Physicians and other licensed independent practitioners must have a working knowledge of this policy regarding the use of restraints."

18. A review of documentation revealed that no physician & LIP education had been conducted since October 26, 2011.

19. Theses findings were confirmed with the Vice President of Quality & Clinical Support on July 24, 2014 at 1000. She stated," We don't have any documentation since October 26, 2011, that our physicians & midlevel's have been educated on the restraint policy. We have had staff come on service since 2011, and we have no evidence or documentation of training..."

20. 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(e)(4)(ii), which states "[The use of restraint or seclusion must be --] implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law."

21. The facility policy for patient restraint directed that "patient's must be re-assessed every 6 hours for need of 1:1 care."

22. The medical records of Patient's PP, QQ, RR, SS, TT, and UU all lacked evidence that the patient's were reassessed every six (6) hours per facility policy.

23. These findings were confirmed by the Info Technology Nurse Specialist on July 24, 2014, at 12:50 p.m.

24. 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(e)(8)(i), which states "Unless superseded by State law that is more restrictive--(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older."

25. The medical record of Patient SS indicated that he/she was placed in restraints at 12:50 a.m., and was not released until after 5:45 a.m., over four (4) hours later, at which time the order for restraint was discontinued.

26. The above finding was confirmed by the Info Technology Nurse Specialist on July 24, 201, at 12:50 p.m.

27. 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 (e)(5), which states "The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under (sub section) 481.12 (c) and authorized to order restraint or seclusion by hospital policy in accordance with State law."

28. The medical record of Patient UU indicated that a restraint had been in use from 10:30 p.m. until 7:50 a.m. Nursing documentation indicated that "order obtained", however, no physician's order was found in the medical record.

28. The above finding was confirmed by the Info Technology Nurse Specialist on July 24, 2014, at 12:50 p.m.

Based on observations and record reviews and interviews with key staff on July 22, 2014, it was determined that the facility failed to ensure that the State law requiring that prior to hiring an individual who will work in direct contact with a consumer, a criminal history record for that individual is obtained.

Findings include:

1. The Maine Revised Statutes Annotated, Title 22, Subtitle 2, Part 4, Chapter 401, subsection 1724 states; "Beginning October 1, 2010, a facility or health care provider subject to the licensing or certification processes of chapter 405 ... shall obtain, prior to hiring an individual who will work in direct contact with a consumer, criminal history record information on that individual, including, at a minimum, criminal history record information from the Department of Public Safety, State Bureau of Identification."

2. A randomly selected review of eleven (11) personnel files was reviewed to determine compliance with State regulations. Of these records three (3) of three (3) employees hired on or after October 1, 2010, failed to have evidence of a criminal background check containing at a minimum, criminal history record information from the Department of Public Safety, State Bureau of Identification.

3. The Director of Human Resources stated that she was not aware that the contracted agency conducting criminal background checks for the hospital did not obtain all the information identified in the State law. On July 22, 2014, at approximately 1 p.m., she concurred that the background checks currently conducted for the hospital did not meet the State required standards.

Based on document review, observations during tours, and interviews with key staff on July 22-24, 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 program 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 program to ensure that non pharmaceutical supplies were not outdated (See Tag C-0222);

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

5. The CAH failed to ensure proper ventilation in the Surgical Suite (See Tag C-0226).

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

32893

Based on tours of the facility, review of information provided and interviews with key staff on July 22-24, 2014, it was determined that the hospital failed to maintain the facility to ensure the safety of patients.

Findings include:

1. During a tour of the hospital conducted on July 22, 2014 at approximately 1:00 p.m., the following was found:

a. Med/Surg Floor; The electrical room on the Med/Surg floor had an open cardboard box containing several fluorescent tubes leaning against the wall. The sink room on the Med/Surg floor has stained ceiling tiles. Patient room 209 has loose wall covering. Patient room 211 has loose base molding.

b. ASU: ASU room 303 door is chipped and nonintact surface. ASU room 301 door is chipped and nonintact surface.

c. Emergency Room: Stained ceiling tile in Triage Room. Damaged wall in Cardiac Room. Boxes and equipment on floor under shelves in the lean utility room. Chipped door in Trauma room.

d. Lab: Multiple chipped and nonintact work surfaces. Many cardboard boxes stored under shelves, desks and all over the floor. Flooring is damaged and in poor repair. The Director of Physical Plant reported that the flooring is scheduled to be replaced.

e. Women's Locker room (across from Lab): Tub room is being used for storage. One (1) Infant warmer with a Synernet maintenance tag due 08-2013. Two (2) Infant warmers without maintenance tags. One electrical fan with maintenance tag dated 8-11-07. One (1) ear, and nose syringe with expiration date 08-2013. One (1) oxygen tubing with expiration date 09-2012.

f. Anesthesia Work Room: Missing one (1) ceiling tile. A cardboard box in stored on the floor beneath the shelving. There is an open floor penetration.

g. Kitchen: The ice machine drains in the kitchen and Cafe have an inadequate air gaps.

h. Central Sterile Supply: Pre-Clean room: Pipe insulation on central washer is damaged. Door casing is corroded near the floor. Central Sterile Room: There are three fiberboard pegboards that are porous and unable to be sanitized. All of the work surfaces have chips and are unable to be properly sanitized. There are two (2) fabric chairs that are unable to be sanitized. There is tape stuck to multiple surfaces that is unable to be sanitized. There is a desk with a front edge that is porous and unable to be properly sanitized. There is a stereo with external speakers, multiple CD cases and CD's on the desk that cannot be properly sanitized. The flooring is need of replacement. The Physical Plant Director reported that the flooring is scheduled for replacement.

i. Endo Room: Lab Specimen tubes, specimen cups, multiple cleaning supplies, a paper screen, and other patient supplies were located under the sink. This finding was confirmed by the Chief of nursing Operations on July 23, 2014 at approximately 10:00 a.m.

2. During a tour of the White Birches Medical Center on July 23, 2014, the following was found:

a. PT/Therapy Gym: Therapy table had a torn, nonintact surface. The trampoline was torn.

b. Treadmill Room: Two (2) exercise bikes had torn seat cushions.

c. Weight Room: Leg curl machine has a torn cushion with no maintenance tag. Body Solid machines have multiple torn cushions with no maintenance tag. Situp bench has torn cushion with no maintenance tag. Multimax weight machine has multiple torn cushions with no maintenace tag. Blue seating bench has torn cushion.

d. OT/Speech Room: A fabric chair which is not easily sanitized. Two (2) therapy pads with holes in surface. Trampoline with torn cover.

3. During a tour of the Operating rooms conducted on July 23, 2014 at approximately 2:15 p.m., in the Operating Room corridor two (2) oxygen bottles were freely standing on the floor with no support or method to prevent them from falling. The gas shut off valves were not properly labeled indicating what areas they controlled.

Based on observations and interviews with key staff on July 23, 2014, it was determined that the facility failed to ensure that the preventative maintenance program included non-pharmaceutical supplies being maintained to ensure the safety of the patients.

Findings include:

1. The pediatric crash cart located on the medical-surgical unit contained four (4) packages of electrocardiograph (EKG) electrodes in unopened containers with an expiration date of 2014-01, and one (1) opened container with an expiration date of 2013-08.

2. The clean storage room on the medical-surgical unit contained one (1) bottle of hydrogen peroxide and one (1) bottle of isopropyl alcohol that were opened but not dated when opened.

3. The crash cart located in the Intensive Care Unit contained two (2) packages of pediatric defibrillator pads with an expiration date of 3/28/14.

4. The crash cart located in the CT Scanner room contained an airway kit with the following items expired:
a. One (1) 2.5 mm endotracheal tube with expiration date of 07-2013
b. One (1) 4.0 mm endotracheal tube with expiration date of 07-2013
c. One (1) 5.0 mm endotracheal tube with expiration date of 07-2011
d. One (1) 5.5 mm endotracheal tube with expiration date of 04-2013
e. One (1) 6.5 mm endotracheal tube with expiration date of 07-2013
f. One (1) 7.0 mm endotracheal tube with expiration date of 09-2012
g. One (1) 7.5 mm endotracheal tube with expiration date of 07-2013
h. One (1) 8.5 mm endotracheal tube with expiration date of 09-2012
i. One (1) 9.0 mm endotracheal tube with expiration date of 07-2013
j. One (1) 10.0 mm endotracheal tube with expiration date of 05-2013
k. One (1) endotracheal tube introducer with expiration date of 03-2011
l. One (1) Aluminum endotracheal stylette with expiration date of 03-2012

5. The laryngoscope blade handle did not contain any batteries, and no batteries were present in the airway kit, making the apparatus inoperable.

6. In a box located adjacent to the cardiac defibrillator the following expired defibrillation pads were noted:
a. Two (2) with expiration date of 08-2009
b. Two (2) with expiration date of 04-2014
c. One (1) with expiration date of 12-2008
d. One (1) with expiration date of 03-2008
e. One (1) with expiration date of 05-2008

7. In a box located adjacent to the cardiac defibrillator the following expired EKG electrodes were noted:
a. One (1) package with expiration date of 09-2013
b. Two (2) packages with expiration date of 03-2007
c. Three (3) packages with expiration date of 11-2009

8. The policy titled "Multi-Dose Vial Policy" stated that a multi-dose vial will be: "1. Date and initial when the vial is opened." and "4. Discard all products no later than one month.

9. A policy related to expired non-pharmaceutical items was requested on July 23, 2014 and July 24, 2014. No Policy was provided prior to the survey exit.

10. All expired and unlabeled opened items were immediately removed from these locations and either disposed of or replaced with non-expired replacements. Items that were non-functional were returned to operating status prior to the surveyor leaving the area.

11. These findings were confirmed by the Radiology/Nuclear Medicine Technician and the Pharmacy technician on July 23, 2014, at approximately 3:45 p.m. The Pharmacy Technician stated, "I know that pharmacy is not responsible for checking these things, I thought the Department [radiology] was responsible to check those things."

12. During a tour of White Birch outpatient rehab clinic, in the pool room, the first aid kit contained an open bottle of Alcohol with a manufacturer's expiration date of February 2011. The kit was last checked in 2013 without this bottle being removed.

13. The above finding was confirmed by the Vice President of Physician Practice, on July 22, 2014, at approximately 2:15 p.m.

14. A tour of the White Birches Medical Center, conducted on July 23, 2014, the following was found in an unlocked wall cabinet in the unlocked and open medical records/storage room:
a. One (1) opened vial of Dexamethasone Sodium Phosphate 20mg/ml failed to be labeled with the date that it was opened and eleven (11) unopened vials of the same medication
b. One (1) opened bottle of Acetic Acid with an expiration date of 5/30/2014
c. One (1) opened bottle of Maximum Strength Antacid, 12 fl oz with an expiration date of 01/14
d. One "Phoresor Iomed" with a maintenance due date of September 2013

15. On July 23, 2014 at approximately 10:30 a.m., The Department Director of PT/OT Rehab stated "We have never been instructed to date them..." with regards to the open medications.

16. During a tour of the Operating rooms conducted on July 23, 2014 at approximately 2:15 pm the following was found:

a. The Anesthesia Work Room contained seven (7) 25 ga Sproat needles with expiration date of 2014-05

b. The stainless steel, four drawer "Block Cart" located adjacent to the scrub sink outside of Operating Rooms One (1) and Two (2) contained the following:
1. One (1) Touhy nerve block set with expiration date of 12-2012
2. One (1) Touhy nerve block set with expiration date of 03-2013
3. Eleven (11) Stimuplex A insulated needles 22 ga 2 inch with expiration date of 12-2013
4. One (1) Stimuplex insulated A needle 22 ga 6 inch with expiration date of 02-2011
5. One (1) Stimuplex insulated needles 22 ga 2 inch with expiration date of 11-2012
6. Two (2) Stimuquick nerve block needles with expiration date of 04-2013
7. Two (2) Stimuquick nerve block needles with expiration date of 06-2014
8. One (1) Intralipid 20% fat emulsion 250 ml with an expiration date of 02-2014
9. One (1) Combined spinal epidural needle with an expiration date of 04-2004
10. One (1) Combined spinal epidural needle with an expiration date of 04-2014

c. The Difficult Airway Cart contained the following:
1. One (1) lighted wand for intubation had the sterile packaging broken
2. Two (2) Air trac optical laryngiscopes with an expiration date of 10-2010
3. One (1) Air trac optical laryngiscope with an expiration date of 09-2010
4. One (1) Tracheal tube exchanger with an expiration date of 12-2002
5. Five (5) laryngeal tubes with expiration date of 8-2006
6. One (1) laryngeal tube with expiration date of 10-2006
7. Two (2) Sterile gloves with expiration date of 03-2013
8. One (1) Sterile gloves with expiration date of 09-2012
9. One (1) BD 20ml syringe with expiration date of 12-2013
10. Twelve (12) Branch scope valves with expiration date of 05-2013
11. Two (2) Branch scope valves with expiration date of 03-2007

d. The Pediatric Crash Cart in Operating Room 2 contained one (1) Infant Face Mask with an expiration date of 9-04-08 and one (1) infant face mask with an expiration date of 06-2004.

e. The Anesthesia Cart located in Operating Room 2 contained one (1) bottle of Ventolin 90 mcg with an expiration date of 12-2012.

f. The Anesthesia Cart The Anesthesia Cart located in Operating Room 1 contained one (1) bottle of Ventolin 90 mcg with an expiration date of 05-2014.

g. These finding were immediately confirmed by the CRNA on July 23, 2014 at approximately 2:30 p.m., who removed the expired items from use at the time of their discovery.

17. On July 23, 2014 at approximately 12:00 p.m., the Physical Plant Director explained that no printed or electronic maintenance schedule or list exists for the clinical and patient care equipment that is not electrical and/or is not maintained by the contractor (Synernet) providing clinical engineering services. He further confirmed that the only list of clinical equipment that is available is the list that is developed by the clinical engineering contractor, stating "No, we don't have an equipment listing other that the Synernet list."

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









32893

Based on observations, policy review and interviews with key staff on July 22, 2014, it was determined that the facility failed to assure that the policy for storage of sample medications was followed by the Urology clinic.

Findings include:

1. The facility policy "drug samples" stated that "a separate sample drug dispensing log shall be maintained for the sample drugs provided to the patients. The log shall contain the following information: Date give, patient name, name and strength of drug sample, lot number, quantity given, and physician giving the medication."

2. During tour and observations of the sample medication closet, it was noted that the following items were inaccurately accounted for:
a. The log book indicated that for Cialis, 20 milligram, there were three (3) boxes, and one was signed out, the closet only contained one box remaining, and there should have been two (2) boxes.
b. The log book indicated that for Levitar, 20 milligram, there were two (2) boxes, and one was signed out, the closet contained none, and there should have been one box.
c. The log book indicated that for Visicare, 5 milligram, there were eight (8) boxes, and four (4) were signed out, the closed only contained three (3), and there should have been four (4).
d. The log book indicated that for Visicare, 10 milligram, there were eight (8) boxes, and four (4) were signed out, the closed only contained three (3), and there should have been four (4).

3. The above findings were confirmed by the Vice President of Physician Services and the Clinical Coordinator of Urology Clinic on July 22, 2014, at 2:10 p.m. The Clinical Coordinator stated that the physicians might have dispensed them and not written it down, but she wasn't sure.

Based on review of policies and procedures, review of information provided and interviews with key staff July 23 and 24, 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 "Environment Humidity, Air Temperature in Surgical Areas" Policy states: All procedure and surgical areas must... have a minmum of 15 air exchanges per hour... "

3. During several interviews with the Physical Plant Director, on July 23 and 24, 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. On July 24, 2014 at 8:35 am the Physical Plant Director explained, "I don't have any way of monitoring the air exchanges in the OR's."

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.

30938

Based on review of policies and procedures, review of information provided and interviews with key staff July 22-24, 2014, it was determined that the governing body failed to assume full legal responsibility for determining, implementing, and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment.

Findings include:

1. During a tour of the facility on July 23, 2014, at approximately 2 p.m., while inspecting medication "code carts," it was observed that sealed medication cassettes were used in the code carts.

2. The most recent policy titled "Maintenance of Code Cart Medication" revised August 28, 2002, stated on page 3 of 3; "2. Insert tray into dust cover ... 7. Wrap in plastic wrap."

3. During the tour no plastic wrap or separate dust covers were noted on the drug cassettes.

4. During an interview with the Director of Pharmacy on July 24, 2014, at approximately 12 noon, he stated that the use of separate dust covers and plastic wrap have "not been used for years."

5. The pharmacy policy manual contained a document, signed by the Director of Pharmacy in March 2014, indicating that all pharmacy policies had been reviewed and deemed accurate.

6. On July 24, 2014, at approximately 1 p.m., the Director of Pharmacy stated, "I apparently did not review that policy closely enough."

7. See Tags C-0152, C-0224 and C-0276 for additional information about policies not being administered to ensure that quality care is being provided in a safe environment.

Based on observations, document review and interviews and staff, July 22-24, 2014, it was determined that the facility failed to properly store patient medications

Findings include:

1. The "Medications Storage and Preparation Areas" policy stated, " Drug storage and and preparation areas shall include but are not limited to medication refrigerators...." and "8. Drugs are stored under the proper conditions of sanitation..."

2. During a tour of the Emergency Department on July 21, 2014, at 10:05 a.m., two (2) bottles of propocaine hydrochloride ophthalmic solution (an eye drop medication) were found stored in a refrigerator labeled "food only". The refrigerator was utilized for storage of staff food.

3. This was immediately confirmed with the Chief Nursing Officer (CNO), who stated, "I don't know why they are in there, but I will find out..." At 2:20 p.m., he confirmed that the eye drops originated from the hospital pharmacy, and were improperly stored.

4. A review of the policy was conducted with the Vice President of Quality on July 24, 2014. She concurred that the policy was vague regarding storage of refrigerated medications, and confirmed that medications should not be stored in a staff refrigerator.

Based on record reviews completed on July 23-24, 2014, it was determined that the facility failed to assure that the patient records were accurately documented.

Findings include:

1. A review of Record M on July 23, 2014, contained a physician's order for blood pressure (BP) and respiratory rate (RR) every four (4) hours while on Patient Controlled Analgesia (PCA). The medical record's nursing notes and vital sign sheets lacked evidence that the BP and RR were done between 10:30 p.m. and 6:00 a.m.

2. This finding was confirmed by the Director of Inpatient Services on July 23, 2014, at approximately 2:00 p.m.

3. During the record review of Adverse Drug Reactions, Record YY was noted to contain the following irregularity.

a. On July 16, 2014, the physician documented; "While receiving the first dose of vancomycin, the patient developed hyperemia and pruritus of the neck and scalp and was given Benadryl and Pepcid... She will need premedication for every vancomycin dose."

b. The Discharge Summary dictated July 19, 2014, stated under the heading HOSPITAL COURSE; "...She had no rash or untoward reaction to vancomycin."








30938

Based on record review and interviews with key staff on July 24, 2014, it was determined that the facility failed to assure that all medical records contained an informed consent for treatment that was signed by the patient prior to receiving care/treatment.

Findings include:

1. Record R, was admitted on July 21, 2014, indicated that there was no informed consent for treatment by the hospital.

2. This finding was confirmed by the Director of Inpatient Services on July 23, 2014, at approximately 2:00 p.m., who stated "the patient was unable to sign and his/her daughter will be in to sign today."

Based on observation and interview with key personnel on July 23, 2014, at approximately 10:10 am, it was determined that the facility failed to maintain the confidentiality of patient record information and provide safeguards against unauthorized use.

Findings include:

1. During a tour of the White Birches Medical Center the medical records/storage room was found with the door wide open and unattended by staff.

2. Stored on shelves in the middle of the room were a large number of patient medical records that were clearly visible from the door.

3. There were no staff members within sight of the room an the records were situated in such as a way as to make the names and other information written on the outside of the records clearly readable from the open doorway.

4. Next to the shelves there were two (2) light blue transparent plastic bags labeled "laundry" within which there were medical records that could be clearly seen.

5. The closest person to the room was a patient that could be seen through the slightly opened door of the room across the hall from the records room. This patient was observed to be alone.

6. On July 23, 2014, at approximately 10:10 a.m., the Department Director of PT/OT Rehab Services confirmed that the room is left open "during the day because we go in and out of there constantly... and we keep other things in there..." The Director also explained that the records in the blue plastic laundry bags were "ready to be shredded."

7. An inspection of the surrounding area confirmed that there was no method of observing nor controlling access to the room when the door is open.

Based on review of documentation, observations during tours of the facility, review of committee meeting minutes, review of inpatient and outpatient medical records,and interviews with key staff July 22-24, 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 its total program evaluation if the established policies were followed and any changes needed (See Tag C-0335);

2. 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);

3. The CAH failed to assure that all patient care services and other services affecting patient health and safety are evaluated (See Tag C-0337);

4. The CAH failed to take appropriate remedial action to address deficiencies found through the quality assurance program (See Tag C-0342): and

5. The CAH failed to document the outcomes of all remedial actions (See Tag C-0343).



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

Based on review of the Program Evaluation for 2012-2013, it was determined that the facility failed to determine if all established polices were followed and if any changes in the policies were needed.

Findings include:

See Tags C-0222, C-0224 and C-0276 for additional information regarding policies being followed and/or out dated policies.

Please see Tag C-0337 for additional information regarding evaluation of the appropriateness of the diagnosis and treatment furnished to radiology patients at the CAH.

Based on review of information provided, review of policies and procedures and interviews with key staff July 22-24, 2014, it was determined that the facility failed to evaluate all patient care services and other services affecting patient health and safety.

Findings include:

1. The Millinocket Regional Hospital Quality Assurance/Quality Improvement (QA/QI) 2014, Hospital and Medical Staff Departments/Programs stated," ...1. All hospital and medical staff programs, services, departments and functions including contracted services related to patient care shall participate in ongoing QA/PI activities."

2. A review of five (5) contracts on July 24, 2104, revealed that two (2) of the five (5) did not contain any documentation that required the contractor to participate in the facility quality program.

3. During an interview on July 24, 2014, at 11:20 a.m., the VP (Vice President) of Quality stated that if the contracts did not contain that requirement that it was an oversight on her part.

4. A review of the MRH Performance Improvement log for the first quarter of 2013 for the cardiopulmonary department indicated that for the performance measures, with a goal of 100%, the results were 75%. No further studies were done on this performance measure.

5. A review of the MRH Performance Improvement log for the first quarter of 2014 for the cardiopulmonary department indicated that for the performance measures, with a goal of 100%, the results were 79%. This was not followed during the next quarter, but the action was to "repeat study in 1 year to check progress."

6. A review of the MRH Performance Improvement log for the second quarter of 2014 for the cardiopulmonary department indicated that for the performance measures, with a goal of 48 hours (or less), the results were 33.82 hours. No further studies were done on this performance measure and a new set of performance measures were made for the third quarter of 2014.

7. The above findings were confirmed by the Director of Radiology on July 22, 2014, at approximately 1:45 p.m. In an interview with the Vice President of Quality, she stated, "I usually scan the reports and file them until I have to pull them together for the Performance Improvement committee, I guess I didn't realize they were not doing a continuous study."

Based on review of information provided and interviews with key staff July 22-24, 2014, it was determined that the CAH failed to act upon deficiencies found through the quality assurance program.

Findings include:

During an interview with the Vice President of Quality and Clinical Support on July 24, 2014, she stated that she had not paid particular attention to the quality reports that had been submitted to her until it was time to compile the quarterly reports for the Board. Additionally, she stated that she usually just files them.

Based on review of information provided and interviews with key staff July 22-34, 2104, it was determined that the facility failed to document the outcomes of all remedial action related to the department quality reports.

Findings include:

During an interview with the Vice President of Quality and Clinical Support on July 23, 2014, at approximately 11 a.m., she stated that she knows quality and what is expected but she guesses that she needs to be more on top of things and hold people accountable.