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Based on observations and interviews, the hospital failed to ensure that patient care equipment was safe for patient use in 2 of 2 in patient units (Medical Surgical Unit [MSU], Labor Delivery Recovery Post-Partum Unit [LDRP]) and 2 of 4 outpatient units (Aroostook County Surgical Services and Positive Steps).

Findings include:

1. During a tour of the MSU on April 10, 2017, at approximately 1:45 PM, in Clean Storage Room #309, the surveyor observed the following medical care items with expired expiration dates:

a. Three Vacutainer Specimen Collectors, (sterile container to transport biological samples to the laboratory), with an expiration date of "2016-10" (October 31, 2016).

b. Four Vacutainer Specimen Collectors, with an expiration date of "2017-03" (March 31, 2017).

c. One Pediatric Catheter Kit, size "5 French" (child urinary catheter) with an expiration date of "2016-09" (September 30, 2016).

d. One package of Steri-Strips, (sterile adhesive strips used instead of stitches to close wounds), with an expiration date of "2015-01" (January 31, 2015).

e. Six packages of Steri-Strips, with an expiration date of "2016-02" (February 29, 2016).

The above findings were confirmed by the MSU Nurse Manager on April 10, 2017, at approximately 1:45 PM.

2. During a tour of the LDRP on April 10, 2017, at approximately 3:00 PM, in the nurse's station, the surveyor observed the crash cart (a cart containing equipment necessary to treat a cardiac arrest). This cart contained at total of three adult defibrillator pads that were all labeled with an expiration date of March 31, 2017. This finding was confirmed by the LDRP Nurse Manager on April 10, 2017, at approximately 3:00 PM.

3. During a tour of Aroostook County Surgical Services on April 11, 2017, at 10:34 AM, the surveyor observed an opened bottle of Iodoform packing strip (medication impregnated gauze used to pack wounds) with an expiration date of January 2017 in a cabinet in Room 1. This finding was immediately confirmed with the Licensed Practical Nurse and the Practice Manager, at the time of the observation.

4. On April 10, 2017 at 1:00 PM, in Public Restroom in the Positive Steps Corridor, the surveyor observed a nurse call light pull cord that was too short (two inches long); therefore, was not reachachable if someone were to fall on the floor. This finding was confirmed with the Maintenance Manager at the time of the observation.

Based on observations and interviews, the hospital failed to ensure the hospital was maintained in a way to promote cleanliness in 7 of 13 hospital departments observed (Acute Care Patient Units, Emergency Department, Rehabilitation Services, Laboratory, Surgical Services, Radiology Services, and Respiratory Services) and in one elevator (Elevator #1).

Findings include

On April 10, 2017, from 12:30 PM to 3:45 PM and on April 11, 2017, from 8:00 AM to 3:50 PM, during tours of the hospital with the Maintenance Manager the following was observed:

1. There were cork boards in all patient rooms.

2. There was worn finish and damaged wood on the wooden bumper rails in Room 346, on the window sills and the cabinet faces in the laboratory, and on the inner edge of the door to the Emergency Department supply room.

3. There were missing or damaged pieces of floor tile in the bathroom outside of the Occupational Therapy training kitchen, in Room 311, and outside the clean side of the linen area.

4. There was a significant accumulation of dust in the following locations: on the top edge of the white board and the shelf over the bed in Room 332, on the top edge of the white boards in Rooms 305, 308, 312, and 315, on the top edge of the closet door in Rooms 208 and 206, and on the privacy curtain track in the Emergency Department Room 8.

5. There were missing pieces of laminate on the lower walls in elevator #1.

6. There was worn finish on wooden furniture on four chairs in the Palliative Care Room, on a foot board in the Supply Room on level 3, on a table in Room 208, and on a bench in the Cardiopulmonary bathroom.

7. There was damage to the wall in Room 308, in Operating Room 2, and in the Respiratory Supply Room.

8. There was chipped or missing paint, which exposed unfinished wood, on the air conditioner pipe cover in Sleep Area 1 in the Sleep Lab, and on a cabinet and a cart in the Central Sterilization Room.

9. There was a splintered wall protection board in Sleep Area 2 of the Sleep Lab.

10. There was cracked laminate on the window sill and counters in Rooms 211 and 212.

11. There was loose and missing laminate and rough textured patches on a work table and on two hand washing sinks in the laboratory.

12. There was tape on the wall in Operating Room 3 and on the folding table in the Linen Room.

13. There was missing cove base in Room 202.

14. There was a rough and irregular finish on the shower wall in the shower of Room 208.

15. There was lifting and loose wall paper and missing paint below the faucet in the shower in Room 205.

16. There was torn vinyl in the following areas: on the treatment bed cover and on a foam positioning wedge in Room 343/345; on wheelchairs (numbered 5021, 5039, 5027, and 5020) and a reclining chair in the third floor Storage Room; on wheelchair number 5016 in the Ambulatory Care Unit; on a stool seat in the Wound Clinic; on a head pad cover in Operating Room 3; on a recliner in Room 208; on the arm board of a the draw chair in Draw Room 1 of the phlebotomy laboratory area; and on the seats of two stationary bikes in the Cardiopulmonary Gym.

17. There were cracked arm pads on six crutches in the Positive Steps Supply Room.

18. There was rust/corrosion in the following areas: on the base of the intravenous (IV) pole in Bay 4 of the Ambulatory Care Unit; casters on a table in Operating Room 1; casters on a suction unit stand in Operating Room 2; on the base of the Cabot Pump pole, caster and base on an IV pole, and casters on a table in Operating Room 4; casters on an IV pole in the Respiratory Supply Room; caster on two stools in the Emergency Department Room 7; and on a wire basket in the Ethylene Oxide Room of Central Sterilization.

19. There were soiled handgrips on two armogometers (equipment used to exercise a patient's arms) in the Cardiopulmonary Gym.

20. There were nurse call pull cords that were too long and touching the floor in the following areas: in the bathrooms of Rooms 211, 212, 303, 311, 312, 332, 338, 346, 352/354, and 359, in Bay 1 of the Ambulatory Care Unit, in the Public Restroom of the Laboratory, and in the Public Restroom of the Respiratory area.

21. There was a soiled base on two hamper bases in the Nursery and on one linen hamper in X-Ray Room 2.

22. There was a transfer board (a board used to assist the movement of a patient) stored on the floor in the Computerized Tomography Room.

23. There were stained ceiling tiles, which indicated past water leakage and created a habitat for mold growth, in the following areas: three tiles in the Laboratory and one tile in the Mammography Room.

Findings 1 through 20 created a surface which could not be easily cleaned and sanitized.

The above findings were confirmed with the Maintenance Manager at the times of the observations.

Based on observations, interviews, and document reviews conducted by Life Safety Code surveyors, it was determined that the Critical Access Hospital was not in full compliance with 42 CFR §483.70(a), the Life Safety Code.

Please see the Life Safety violations cited on the Centers for Medicare and Medicaid Services (CMS) form 2567 dated April 12, 2017, for the Maine State Fire Marshal's Office Life Safety Code survey.

Based on record reviews and interview, the hospital failed to ensure that services, related to restraints, were provided in accordance to the hospital's written policies for 1 of 6 records reviewed in which restraints were utilized (Record L).

Findings include:

The hospital's policy for restraints, in Part 3, indicated that documentation would be completed every 15 minutes and would include safety/security checks, ongoing assessment by the Registered Nurse for the need of the continuation of the restraint and any negative patient response and assessment of the need to change treatment. The policy also indicated documentation would be completed every two hours and would include the following: the release of the restraint and range of motion (while awake); circulation and sensation checks; the need for toileting while awake or as requested; the offering of fluids or food, if applicable (while awake); skin care; position change; level of consciousness/orientation; and patient tolerance.

The hospital's policy for restraints, in Part 4, indicated that when a restraint was used there must be documentation in the patient's record of "the patient's response to the intervention(s) used, including the rationale for continued use of the intervention."

Documentation in Record L indicated the patient was restrained for over two hours. There was no documentation in the record of 15 minute and two hour monitoring. In addition, there was no documentation to indicate the patient's response to the intervention of restraint usage or the rationale for the continued use of the restraint.

This finding was confirmed by the Manager of Acute Care on April 11, 2017 at approximately 2:30 PM.

Based on observations, document reviews, and interviews, the hospital failed to ensure that policies were followed to ensure that expired medications were unavailable for patient use in 2 of 4 outpatient areas (Speciality Clinics and Aroostook County Surgical Associates).

Findings include:

The hospital's policy titled "Expired Medications and Other Usable Medications" indicated that on a monthly basis the Pharmacy Department would monitor all medications for expiration dating and damage or contamination.

The hospital's policy titled "Ampule and Vial Policy" indicated that multidose injection vials were to be dated with the date of the first entry and discarded after 28 days. This means the date the vial was first punctured would be documented on the vial and the vial would be discarded 28 days later.

1. On April 11, 2017, a tour of the Specialty Clinics was conducted with the Nurse Manager and the Licensed Practical Nurse (LPN). The following was observed:

a. In Lane 2 (a patient examination room), there was a locked medication cabinet that contained one 50 milliliter (ml) vial of one (1) percent (%) injectable Lidocaine (an injectable anesthetic) that was approximately half empty. There was no documentation on the vial to indicate the date of the first entry or the date in which it should be discarded. This finding was confirmed with the Nurse Manager and the LPN at approximately 8:40 AM.

b. In Lane 4 (the eye, ear, nose, throat patient examination room), there was a locked medication cabinet that contained the following:

- A glass dispenser with a plastic nasal instilling nozzle that contained an unknown amount of topical four (4)% Lidocaine (an anesthetic). The dispenser was approximately 25% empty. The dispenser was not labeled with the date it was filled, the expiration or the discard date.

- A glass dispenser with a plastic nasal instilling nozzle, which contained an unknown amount of Oxymetazoline Hydrochloride (a nasal decongestant). The dispenser was not labeled with the date it was filled, the expiration date, or the discard date.

- A 30 ml plastic spray bottle that contained an unknown amount of Oxymetazoline Hydochloride. The bottle was not labeled with the date it was opened or the discard date.

- A 50 ml vial of topical four (4)% Lidocaine. The vial was approximately 50% empty. The vial was not labeled with the date it was opened or the discard date.

The above findings were confirmed with the Nurse Manager and the LPN at approximately 8:43 AM.

2. On April 11, 2017, a tour of the Aroostook County Surgical Associates was conducted with the Practice Manager and the two LPNs who work in the practice. The following was observed:

a. The locked medication cabinet, located in the hallway, contained:

- An opened 40 milligram (mg)/1 cubic centimeter vial of Kenolog (a corticosteroid). This vial was not labeled for multidose use and the expiration date was October 2016. As of April 11, 2017, over five months after the expiration date, this vial had not been discarded.

- A 50 mg vial of 1% injectable 10 mg/ml Lidocaine that contained a scant amount of medication. The vial was opened on February 23, 2017 and had a label that said "discard after 28 days." As of April 11, 2017, 47 days after the vial was opened, it had not been discarded.

- A bottle of Benzoin Tincture (a topical skin adhesive) was opened on February 23, 2016 and had a label that said "discard after 1 year." As of April 11, 2017, one year and 47 days after the bottle was opened, it had not been discarded.

The above findings were confirmed with the Practice Manager and the two LPNs at approximately 10:15 AM.

b. In Room 1 (a patient examination room), there was a bottle of Iodoform packing strip (medicated gauze that is used to pack wounds) that expired January 2017. As of April 11, 2017, over two months after the expiration date, this bottle had not been discarded.

These findings were confirmed with the Practice Manager and the two LPNs at approximately 10:34 AM.

Based on interviews and a review of documents, the hospital failed to follow accepted standards of practice for infection control in relation to sterilization of surgical instruments for instruments that the hospital had an insufficient inventory of.

The finding includes:

1. On 4/11/17, at approximately 2:00 PM, the surveyor was informed, during an interview with the Nurse Manager of Surgical Services, that some surgical instruments were sterilized using the Immediate Use Steam Sterilization (IUSS) method because the hospital only had one of the specialized instruments.

On 4/11/17, the surveyor reviewed the hospital's IUSS logs. In January 2017, the cystoscope (an instrument used for urological procedures) was sterilized by the IUSS method due to the lack of scopes. In February 2017, the microdrill (an instrument used for orthopedic procedures) was sterilized by the IUSS method due to the lack of additional drills.

On 4/12/17, the surveyor requested a copy of the practice guidelines the hospital was using. The Nurse Manager stated that they were using the Association of PeriOperative Registered Nurses, (AORN) 2017 edition guidelines. Upon review, the AORN 2017 edition, page 872, stated that the IUSS method should not be used as a substitute for sufficient instrumentation inventory.

On 4/12/17, at 1:30 PM, the Nurse Manager revealed that an instrument sterilized by IUSS was used in the surgical procedure for one of the four post-operative infections reported in 2016.


Based on observations and interviews, it was determined that the facility failed to ensure that proper protective clothing was worn in the Central Sterilization area for 1 of 1 observations (April 11, 2017), patient dishes were sanitized during the dishwasher rinse cycle for 2 of 2 racks of dishes observed, and that food was served in a sanitary manner for 1 of 1 observations (April 11, 2017).

1. On April 11, 2017, at 10:30 AM, the Materials Manager provided the surveyor and the Maintenance Manager protective clothing to put on prior to entering the clean side of the central sterilization area. This clothing consisted of a bonnet for a hair restraint and plastic coat to cover the upper body and arms. No other protective clothing was provided. When the surveyor and the Maintenance Manager entered the clean area of the central sterilization area, they were greeted by the Central Sterilization Technician who did not question protective clothing being worn by the surveyor and the Maintenance Manager.

On April 12, 2017 at 8:45 AM, the Surgical Services Nurse Manager stated that anyone entering the Central Sterilization clean side is required to wear the same protective clothing as they would when entering an operating room.

The hospital's Surgical Attire Policy indicated that all who enter semi-restricted and restricted areas of the surgical suite or procedure areas would wear appropriate surgical attire. The policy lists scrubs or disposable jump suits, hair covers, and shoe covers as appropriate attire.

2. On April 11, 2017, from 11:00 AM to 12:00 PM, during a tour of the kitchen, the dishwasher rinse temperature gauge was observed not to reach the sanitizing temperature (180 degrees Fahrenheit) during the rinse cycle when two racks of dishes were run through the dishwasher by a kitchen staff member. The Dietary Manager confirmed the lack of required rinse temperature at that time and ran four more empty racks through the dishwasher before the gauge indicated the required temperature. In a conversation between the Dietary Manager and the staff person, the staff person indicated that she did not know to check the rinse temperature to ensure the dishes were being properly sanitized.

3. On April 11, 2017, at 11:35 AM, during the patient tray assembly, the cook was observed to handle patient menus and patient foods intermittently without changing his gloves between handling menus and patient foods, potentially contaminating the patient foods. This finding was confirmed by the Dietary Manager at the time of the observation.

Based on document review and interview, the hospital failed to ensure that Registered Nurses (RNs), working in the Acute Care Unit, completed specialized qualifications for 1 of 4 RNs reviewed (RN #A).

The finding includes:

The hospital's policy for unit credentialing for RNs indicated RNs working on the acute care unit were required to have Advance Cardiac Life Support (ACLS) and Pediatric Advanced Life Support (PALS) certification.

A review of RN A's personnel record revealed that there was no evidence the RN completed ACLS and PALS certification.

This finding was confirmed with the Director of Human Resources on April 12, 2017, at 11:30 AM.

Based on review of documents and interviews,the hospital failed to ensure that the quality assurance program evaluated 1 of 7 services that affect patient health and safety (surgical services).

Findings include:

The Risk/Quality Manager produced a report on April 12, 2017, indicating the facility performed 1331 surgeries in calendar year 2016.

On April 10, 2017, the document titled Houlton Regional Hospital Quality Assessment Plan 2016 was reviewed. It stated "The Quality Assessment/Improvement/Risk Management Program involves all hospital departments and services, including those services furnished under contract and shall focus on indicators related to improving health outcomes and to prevention and reduction of medical errors."

On April 10, 2017 through April 12, 2017, the meeting minutes of the Medical Staff Executive Committee, the Operating Room Committee, and the Quality Committee were reviewed. There was no evidence of discussions of surgical quality improvement indicators related to the care by surgeons.

The Risk/Quality Manager produced a report on April 11, 2017, titled Quality Improvement Projects 2015-2016. There were no quality improvement initiatives involving the care by surgeons, including urology surgery, general surgery, orthopedic surgery, or gynecological surgery.

During an interview on April 12, 2017, at 9:30 AM, the Risk/Quality Manager and the Director of Medical Affairs confirmed that there were no performance improvement initiatives in place for surgical services.

Based on document reviews and interviews, the hospital failed to ensure that patients were informed of their patient rights prior to care in 4 of 5 Swing Bed records reviewed (Records A, B, D, and E).

Finding includes:

1. During a review of Record A, it was determined that the patient was admitted on April 1, 2017. Documentation indicated that the patient was not informed of his/her rights until April 3, 2017. This finding was confirmed with both the Swing Bed Nurse Manager and the Patient Care Coordinator at the time of the record review on April 10, 2017, and again at 2:30 PM.

2. During a review of Record B, it was determined that the patient was admitted on April 3, 2017. Documentation indicated that the patient was not informed of his/her rights until April 4, 2017. This finding was confirmed with both the Swing Bed Nurse Manager and the Patient Care coordinator at the time of the record review on April 10, 2017, and again at 2:30 PM.

3. During a review of Record D, it was determined that the patient was admitted on April 8, 2017. Documentation indicated that the patient was not informed of his/her rights until April 10, 2017. This finding was confirmed with both the Swing Bed Nurse Manager and the Patient Care Coordinator at the time of the record review, and again at 2:30 PM.

4. During a review of Record E, it was determined that the patient was admitted on March 20, 2017. Documentation indicated that the patient was not informed of his/her rights until March 21, 2017. This finding was confirmed with both the Swing Bed Nurse Manager and the Patient Care Coordinator at the time of the record review, and again at 2:30 PM.