HospitalInspections.org

Based on observations, record review, staff interview, and review of hospital documentation on all days of the survey (4/24/12 - 4/30/12), the Hospital failed to have an effective governing body legally responsible for the conduct of the Hospital. Findings include:

1. The Hospital failed to develop, implement, and maintain an effective ongoing hospital-wide, data-driven quality assessment and performance improvement (QAPI) program that reflected the complexity of the hospital's organization and services including contracted services.

(Please see A263)

2. The Hospital failed to provide a well-organized nursing service that ensured adequate delivery of nursing care to patients.

(Please see A385)

3. The Hospital failed to maintain an environment that promotes safety and well-being for the patients and staff which included the Main Hospital Laundry Area and on the Psychiatric Unit.

(Please see A700)

4. The Hospital failed to provide a sanitary environment throughout the Hospital and fully implement an active infection control program which prevents, identifies, reports, investigates, and controls infections and communicable diseases of patients and hospital personnel and fully integrates the program into its hospital-wide QAPI program.

(Please see A747)

Based on documentation review, observation and staff interview, the Hospital failed to develop an effective, ongoing, hospital-wide, data-driven Quality Assessment Performance Improvement (QAPI) program that reflected the complexity of the hospital's organization and services including contracted services. Finding included:

1. The Hospital failed to ensure that the QAPI program scope included review of all contracted services that included Ambulance, Staffing, Hospice, Laboratory, Radiology, Psychiatric, Laundry/Housekeeping, Swallow Studies, and Infusion Therapy Services, although required.

Please refer to A084 and A264.

2. The Hospital failed to measure, analyze, and track quality indicators for the contracted services of Ambulance, Staffing, Hospice, Laboratory, Radiology, Psychiatric, Laundry/Housekeeping, Swallow Studies, and Infusion Therapy Services, in the QAPI program.

Please refer to A267.

3. The Hospital failed to identify, develop, and implement performance improvement activities for the problem-prone areas of the Laundry.

Please refer to A285.

4. The Hospital's Leadership Group failed to ensure that an ongoing program for QAPI was defined, implemented, and maintained for all contracted services.

Please refer to A310.

5. The Medical Executive Committee failed to approve the delineation of privileges for one of two radiologists reviewed (Radiologist #1).

Please refer to A341.

Based on record reviews, observations and interviews, the Hospital failed to provide an organized nursing service that ensured adequate delivery of nursing care to patients. Findings include:

1. The Hospital nursing service did not have a Director of Nursing Service who was responsible for the operation of entire nursing services for all areas of the hospital. Review of the nursing organizational charts indicated that each site had a chief clinical officer (CCO) who reported directly to the chief executive officer (CEO) at each site not to a chief nursing officer.

See A386.

2. The nursing staff failed to assess 3 patients (#16, #24, and #33), in a total sample of 40 patients (31 active and 9 discharged patients), for signs and symtoms of hypoglycemia when scheduled routine finger stick blood sugars indicated the blood sugars were low and out of range, as well as failed to assess the risk for falls for 1 discharged patient with falls (#33). Both Patient #16 and #24 had untreated episodes of hypoglycemia, and Patient #33 fell and fractured a hip.

See A395.

3. The Hospital nursing service failed to ensure that adequate nursing care plans were developed, revised and/or implemented for 14 of 31 active records (#6, #7, #8, #12, #14, #15, #16, #17, #18, #20, #21, #24, #28, #26) and 2 of 9 closed records (#32, and #33) from a total sample of 40 records reviewed

See A396.

4. The Hospital nursing service failed to ensure that contracted nurse practitioners were credentialed with the oversight of the nursing administration in accordance with Massachusetts regulations Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.22 .

See A398

5. The Hospital nursing service failed to adhere to established policies for medication administration, resulting in a medication omission error.

See A405

6. The Hospital nursing service failed to utilize two staff to validate blood type prior to infusion, and failing to monitor patients for post transfusion reactions, in accordance with blood transfusion policy and procedures.

See A409.

Based on observation and interview, the Hospital failed to be in compliance with the Condition of Physical Environment specific to failure to maintain a sanitary environment and to ensure patient safety in the Main Hospital Laundry Area and on the Psychiatric Unit. Findings included:

1. During tour of the Laundry Area at the Main Hospital with the Director of Housekeeping/Facilities on 4/24/12 from 3:55 P.M. to 5:15 P.M., observations revealed the following risks to staff and patient health and safety, pertaining to potential cross-contamination of linens used for patient care and cross-contamination risks to staff health:

a. There was an open trough with grate and board covers. The trough contained water and debris from Washer #1 and Washer #2. The trough had stagnant water, debris build up, a strong sewer odor, and drain flies. A moderate accumulation of debris (laundry lint, dust), was observed on the grates. During interview with the Director regarding why there was debris on the grates, he said that the water and lint in the trough at times overflowed to above the grate level. He said this was because the flow of the trough was blocked. Interview with the Director indicated that the trough permitted the flow of gray water, from the two washers, into a septic system, located on site. When asked if he knew when the last time the trough and the septic system were cleaned and pumped, he said that it had not been cleaned for over one year. He also said that he lacked a cleaning schedule for the trough and the holding tank.

b. Interview with the Maintenance Director on 4/25/12 at 1:00 P.M., indicated that the staff person who cleaned the trough left 1 year ago, and the trough and Laundry Area had not been cleaned since he left. In addition, the trough was not on a cleaning and pumping schedule.

c. Interview with the Maintenance Director on 4/25/12 at 1:45 P.M. indicated that the trough was cleaned and the holding tank was being pumped today 4/25/12 (after the Surveyors brought it to his attention). Review of the Customer Service Report for the Septic System dated 4/25/12 (the second day of survey), read, "Pumped trough from washer to tank, and tank itself. Heavy amounts of lint in trough and tank. Possible pump failure. Recommend system be pumped every 3 months." The Maintenance Director indicated that it was not a pump failure, because the Plumber who came indicated the system lacked a pump.

d. Outside the Sorting Room for dirty laundry, was a plastic cart for personal protective equipment (gloves and gown). It contained 4 drawers, with one drawer that was broken. The outside of this cart was heavily dust and dirt laden. The inside drawers of the cart had a build up of dirt.

e. Dryer #1 and Dryer #2 had a full layer of lint on the lint screens with multiple balls of lint inside the collection bins. Interview with the Director of Housekeeping and review of the dryer vent cleaning sheets indicated the dryer vents were to be cleaned at the end of the last shift of the day. This had not been done.

f. Washer #1 and Washer #2 had a large build up of dirt, dust, detergent spillage, and debris on, around, and between them. The base of both washers had multiple layers of lint, dust, and cob webs. There was a large puddle of stagnant water behind the washers and a dirty glove on the floor next to Washer #1. Interview with the Director of Housekeeping indicated that the water was from a washer hose that had been leaking, and fixed a week ago. However, the hose was still leaking.

g. During interview with the Chief Executive Officer (CEO) on 4/25/12 at 9:00 A.M., the CEO stated that the conditions identified in the Laundry were not reported, but would be amended immediately.

2. During tour of the Psychiatric Unit with Nurse Manager (NM) #1, on 4/24/12 from 10:30 A.M. to 11:15 A.M., observations revealed the following:

a. The Janitor's Closet had debris and dirt on the floor with multiple cracked and chipped areas of the floor (making it impossible to adequately clean the floor). Three brooms were stored directly on the floor with dust build up within the broom. There was a string mop suspended over the handwashing sink and the mop strands were resting in the handwashing sink. There was a build-up of dirt in the handwashing sink. The sink basin was heavily stained. There was no soap for hand washing by the sink. There was a toilet brush in a pail and a used toilet plunger in a paper bag in this pail. There were 5 water stained ceiling tiles. There were clean mop heads stored in a dirty square plastic container, which was dust laden. There were 3 bottles of cleaning agents stored directly on the floor.

b. During an interview with the NM #1, he stated that the sink in the Janitor's Closet was a handwashing sink and there should have been soap available. He said that this Janitor's Closet was used by the patients for work study to clean the Dining Room tables and floors.

c. The Unit 2A Women's Patient Bathroom had a strong odor of urine. There were multiple areas of rust on the window frame in Shower Room #1. There was brownish grout between the tiles by the bathtub and in shower room #2. Shower Room #2 had a metal ceiling light frame with multiple areas of rust, and a soap dish holder with corrosion and a green sediment. The Shower control dials in Shower Room #1 and #2 had dial grip handles, which protruded and could be a safety hazard. There were 6 broken floor tiles: 2 in the handicap bathroom stall, 3 by the bathtub and 2 outside of Shower Room #2. There was a broken toilet paper holder in the handicap bathroom. There were 2 broken laundry hampers with broken lids and sharp edges. Additionally, both hampers had two foot long cords, which provided a risk for patient safety.

d. The Linen Chute Closet floor tiles were stained and had broken areas. There were water stains on the wall. The closet lacked a ceiling, and the pipes were visible.

e. Resident Room 220 had an electric clock radio with an approximate three foot long cord (a safety hazard), on a bureau. The two wardrobe closets in this room were not secured to the floor or the wall which could be an additional safety hazard to patients. When NM #1 was asked how many wardrobe closets were not secured, he said all 30 of them. By the side of bed 2, in this room, there was a locker built in to the wall. This locker had a metal handle with a circular hole intended for a lock, that was also be a patient safety hazard, because a patient could tie a rope/cord through the hole and injure him/herself.

f. Sharp Closet #2 (a locked closet to keep unit and patient items, that may not be safe for patients' use) had dirt and debris on the floor and was dust laden in the back of the closet. The following items were on the floor: a 2 by 2 gauze pad, a used Q-tip with a pink color on the tip of it, an empty box, and a glass piggy bank. The unit electrical items on the shelves in this closet were:
- One iron with an inspection sticker dated 3/14/08. The sticker identified 3/2009 as the next inspection date. The iron was not inspected on that date.
- One hair dryer with no inspection date
- Two curling irons with no inspection date

g. Sharps Closet #3 had dirt and debris on the floor.

h. The Storage Room contained the rubbish chute. The wall below the rubbish chute was stained with large amounts of spillage and had dirt and debris on the floor. The ceiling vent had a build up of dust.

i. The staff bathroom had a broken toilet paper holder and a rusty, dusty step stool under the handwashing sink. There were stained ceiling tiles, indicating water intrusion (leak). NM #1 said that he was unaware of where the leak was coming from, that it was probably an old leak. The NM said the ceiling tiles should have been changed.

j. The patient bathroom for the Seclusion Room had an unlocked, adjoining door to Room 202 (a shared bathroom). This bathroom (to be used by patients in seclusion) had a handicapped hand rail approximately 3 feet in length, that lacked an insert to prevent patients from tying items to it and injuring themselves. During the observation, NM #1 said it (the rail), was a patient safety hazard and must have been missed when all the other handicapped handrails were fitted with inserts.

Based on observation, record review and interview the Hospital failed to be in compliance with the Condition of Infection Control specific to: failure to provide sanitary environment; failure to adhere to Hospital infection control policies (i.e., contact precautions, handwashing, dressing change, and medication administration). Findings included:

1. Observations on Unit 2A on 4/24/12 at 11:00 A.M., Hemodialysis Unit on 4/24/12 at 2:05 P.M., the Laundry Area, at the Main Hospital on 4/24/12 from 3:55 P.M. to 5:15 P.M., the Sterilization Room on 4/25/12 at 1:10 P.M., and Unit 5B on 4/26/12 at 9:25 A.M., indicated unsanitary environmental and infection control issues.

Please refer to A749.

2. Based on observations and staff interviews, the Hospital failed to consistently enforce policies that governed the control and prevention of infection, specifically related to handwashing, contact precautions, tracking infections, conducting environmental rounds, and use of outdated sterile water for tracheostomy care for two (#8, #11) of 31 active patients.

Please refer to A749

3. Based on observations, review of facility infection control policies and staff interviews, the Hospital failed to ensure that staff consistently implemented infection prevention and control standards and maintained a sanitary environment.

Please refer to A700, A749.

4. Based on review of facility documentation and interview with the Infection Control Officer (ICO), the ICO failed to maintain a comprehensive log of incidents related to all infections and communicable diseases at the Main Hospital and the Off-site Campus, for both patients and staff.

Please refer to A750.

Based on observation, record review, and interview, the Governing Body failed to ensure that the services provided under contract for Ambulance, Clinical Staffing, Hospice, Laboratory, Radiology, Psychiatric, Laundry/Housekeeping, Swallowing Studies, and Infusion Therapy Services, were provided in a safe manner and were evaluated through the Hospital's Quality Assurance/Performance Improvement (QAPI) Program. Findings include:

1. The Hospital failed to have a QAPI program to evaluate that the contracted Laundry/Housekeeping Services were delivered in a safe and effective manner at the Main Hospital.

Observations in the Laundry Area from 4:05 P.M. to 5:00 P.M. on 4/24/12, revealed the following:

A. The Laundry Room contained a trench that led from the two commercial-sized washing machines to the far wall of the room. The trench was approximately two feet wide and 25 feet long. During interview with the Manager of Housekeeping and Laundry, during the observation, the Manager said that the trench was used to divert the gray water (dirty water from the washing machines) to a holding tank, before the water went to the city sewer system. Additionally, a pipe from the sink in the Sorting Room also drained into the trough.

The trough contained stagnant water, as the water flow was blocked by a build-up of lint and organic material (e.g., incontinent patients' feces, urine), from the laundry. A strong, foul odor that smelled like sewer gas was emitted from the trough. Sewer flies were observed flying above grates at the far end of the trough.

B. Observations revealed that the four-drawer cart, located outside the entrance to the Sorting Room, was dirty with built-up layers of grit and dust. The cart was used to hold clean gloves and cover gowns to be worn by staff who sorted the dirty laundry.

C. The Laundry and Sorting Room floors, windowsills, ceiling, three window fans, and two portable fans were dirty with built-up layers of dirt, dust, debris, and spider webs.

D. The three commercial-sized clothes dryers and the two commercial-sized clothes washers were dirty with built-up layers of dust, spillage, and spider webs. Two of the three clothes dryers (#1 and #2), contained lint on the lint screens. The floor of the compartment under all three dryers was dirty with lint balls, dust and debris.

During interview with the Manager of Housekeeping and Laundry, during the observation, the Manager said that staff were required to remove the lint from the lint screens and clean the underneath compartments at the end of each work day. The Manager also said that the last wash was done at 2:00 P.M. He acknowledged that the staff failed to follow Hospital policy, which required staff to clean the dryer screens and the underneath compartments at the end of the work day.

During interview with the Director of Plant Operations (DPO), during the observations, the DPO said the Hospital did not have a cleaning schedule for the trough, or a schedule for pumping of the holding tank. The DPO said that no work had been done on the trough for over one year, since the staff person previously responsible for the tasks, resigned from the Hospital.

Review of Quality Assessment Performance Improvement (QAPI) minutes for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for the Laundry and Housekeeping Services. During interviews with the Chief Executive Officer (CEO), Chief Financial Officer (CFO), Director of Quality, and the Main Hospital Chief Clinical Officer (CCO), at 2:30 P.M. on 4/30/12, they said that QAPI was not performed for the cleaning and maintenance of the Laundry equipment, trough, and the cleanliness of the laundry area.

Please refer to A263, A700 and A756.

2. The Hospital failed to have a QAPI program to evaluate that the contracted Laboratory Services were being delivered in a safe and effective manner for the Main Hospital and off-site Campus.

A. Review of listings of Contracted Services indicated that the laboratories of local hospitals provided laboratory and blood bank services for the Main Hospital and off-site Campus.

B. During interview with the Director of Quality at approximately 1:00 P.M. on 4/25/12, the Director of Quality said that the Hospital had a contract with local hospitals for all laboratory and blood bank services.

C. Review of QAPI minutes and data for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Laboratory Services.

D. During interviews with the CEO, CFO, Director of Quality, and the Main Hospital CCO, on 4/30/12 at 2:30 P.M., they said that QAPI indicators were not developed and monitored for Laboratory Services.

3. The Hospital failed to have a QAPI program to evaluate that the contracted Radiology Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services only indicated that a mobile radiology company provided radiology services for the Main Hospital and off-site Campus.

B. During interview with the Director of Quality at 1:00 P.M. on 4/25/12, the Director of Quality said that the mobile radiology company provided routine radiology services for inpatients. However, if a patient's injuries or condition was of a nature that required an immediate diagnosis, the patient would be transferred to a local hospital to have X-rays taken.

The listings of contracted services lacked indication that local hospitals also provided radiology services for the Main Hospital and off-site Campus.

C. Review of QAPI minutes and data, for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Radiology Services.

4. The Hospital failed to have a QAPI program to evaluate that the contracted Ambulance Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the off-site Campus had a contract with three companies for Ambulance Services. The listing of contracted services from the Main Hospital lacked indication of a contract with an ambulance company, although the Hospital routinely transported patients to the local hospital for urgent/emergent care.

B. Review of QAPI minutes and data, for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Ambulance Services.

5. The Hospital failed to have a QAPI program to evaluate that the contracted Clinical Staffing Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the off-site Campus had a contract with seven companies for Clinical Staffing Services. The listing of contracted services from the Main Hospital lacked indication of a contract with a Clinical Staffing company. However, during interview with the CFO on 4/26/12 at approximately 1:00 P.M., the CFO said that the Main Hospital had a contract with an agency to provide clinical staffing.

B. Review of QAPI minutes and data, for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Clinical Staffing Services.

6. The Hospital failed to have a QAPI program to evaluate that the contracted Hospice Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the off-site Campus had a contract with a company that provided Hospice Services. The listing of contracted services from the Main Hospital lacked indication of a contract with a Hospice Company. However, during interview with the Director of Quality on 4/26/12 at approximately 11:00 A.M., the Director of Quality said that the Main Hospital had a contract with an agency to provide hospice care.

B. Review of QAPI minutes and data for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Hospice Services.

7. The Hospital failed to have a QAPI program to evaluate that the contracted Psychiatric Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the listing did not identify that the Main Hospital had a contract with the Massachusetts Department of Mental Health (DMH) for Forensic Psychiatric Services. However, during interview with the Nurse Manager (NM) of Psychiatric Services on 4/24/12 at approximately 11:00 A.M., the NM said that the Main Hospital had a contract with the DMH for Psychiatric Services. The NM also said that the contract was for Forensic Psychiatric Services, and was the only one in the State.

B. Review of QAPI minutes and data for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Psychiatric Services.

C. During interview with the CCO at 2:00 P.M. on 4/30/12, the CCO said that it had been identified during the Accrediting Organization's on-site review, that the Psychiatric Service currently did not report to QAPI and needed to begin reporting to the QAPI Committee.

8. The Hospital failed to have a QAPI program to evaluate that the contracted Infusion Therapy Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the off-site Campus and the Main Hospital, each had contracts with companies for Infusion Therapy Services.

B. During interview with the Director of Quality at approximately 8:00 A.M. on 4/25/12, the Director of Quality said that the Hospital employed the services of an infusion company to insert peripherally inserted central catheters (PICC) lines and midline catheters (peripheral venous access devices between 3 to 10 inches in length) for patients. After the lines were inserted, the Director said that it was the responsibility of the Hospital Nurses to manage and care for the lines.

C. Review of QAPI minutes and data, for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Infusion Therapy Services. During interview with the CEO and CCO at 2:00 P.M. on 4/30/12, the CEO and COO said that the Hospital had not developed and implemented a QAPI plan for Infusion Therapy Services.

9. The Hospital failed to have a QAPI program to evaluate that the contracted Swallowing Study Services were being delivered in a safe and effective manner.

A. Review of listings of Contracted Services indicated that the Main Hospital had a contract with an imaging company to perform studies for patients with swallowing issues.

B. Review of QAPI minutes and data, for January to April 2012, indicated that the Hospital failed to develop, track and trend a QAPI plan for Swallow Studies Services. During interview with the Director of Rehabilitation Services at 2:00 P.M. on 4/30/12, the Director of Rehabilitation Services said that the Hospital had not developed and implemented a QAPI plan for Swallowing Study Services.

Based on staff interview, medical record review, and patient interview, the Hospital failed to investigate and resolve a verbal complaint, for 1 Patient (#18) from a sample of 31 active patients. Findings included:

For Patient #18, review of a progress note dated 4/7/12, indicated that the patient alleged that a male staff member had made an inappropriate sexual reference to the patient that made the patient uncomfortable. The note continued, "reporting staff (Mental Health Councilor #1) suggested the patient avoid any staff which make the patient feel uncomfortable."

Review of the Hospital Patient Complaint/Grievance Policy, indicated that "a grievance is any written or verbal complaint by a patient (or their representative), regarding any aspect of their care." The policy indicated the complaint/grievance would be investigated and a report would be provided to the patient in 7 days, whether it had been resolved or was still being investigated. All complaints were reviewed through Quality Assessment Performance Improvement (QAPI), for tracking and trending.

During interview with Registered Nurse (RN) #2, in the Unit 2A Nurses' Station on 4/25/12 at 10:15 A.M., RN #2 said that the allegation had been documented and the report was submitted to the Human Rights Officer, in accordance with the Department of Mental Health (DMH) requirements (the DMH is the licensing entity for Unit 2A). When the Surveyor requested to view the report, RN #2 notified the Human Right Officer (HRO) to bring the report to the Unit.

During interview with the HRO, in the Unit 2A Nurses' Station at 10:25 A.M. on 4/25/12, the HRO said that he did not have a report of the incident. The HRO said, although the event should have been reported, no report was filed on the patient's behalf. Therefore, the event was not investigated and reviewed in QAPI.

After the HRO said that he never received a report of the incident, RN #2 (who was present during the interview with the HRO), said that evidently he was mistaken and a report was not filed.

Based on medical record review, patient interview, and review of Hospital policy, the Hospital failed to ensure that 1 Patient (#18) from a total sample of 31 active patients, was not involuntarily confined alone in a room from which the patient was prevented (or perceived (s)he was prevented) from leaving.

1. Review of the Hospital policy titled "Physical, Mechanical, Medication Restraints and Seclusion," indicated that seclusion was defined as follows:

"Seclusion shall not include voluntary and collaborative separation from a group or activity, for the purpose of calming the patient.

Seclusion occurs when a patient is involuntarily confined in a room and is prevented from leaving, or believes that he or she will be prevented from leaving by means that include but are not limited to :
a. Manually, seclusion, locked doors, or "one way doors" that, cannot be open from the inside;
b. Physical intervention of staff;
c. Coercive measures, such as the threat of seclusion, sanctions, or loss of privileges that the patient would otherwise have, and used for the purpose of keeping the patient from leaving the room."

2. For Patient #18, medical record review indicated seclusion was implemented on two occasions, 4/9/12 at 1:35 P.M. and 4/12/12 at 9:40 P.M. Review of a physician's History and Physical completed on 4/3/12, indicated the patient had a history of sexual and physical abuse since the patient was a child.

3. During interview with Patient #18 in the Visitors' Room at 11:10 A.M. on 4/25/12, the patient said that the staff take him/her to the Quiet Room and it is not the treatment (s)he wants. The Surveyor asked the patient, When you are out-of-control, what works best to calm you down? The patient said, instead of grabbing me and putting me in the Quiet Room, I'd rather have them (staff) talk to me quietly and take me to the Comfort Room. When the staff grab me and take me to the Quiet Room, it increases my emotions (escalates behavior). I feel threatened. Sometimes the staff yell and argue with me. One time staff left red marks on my arms from holding me too tight. I have told the staff that I don't like to be grabbed. It reminds me of all the previous abuse events against me.

During interview with Patient #18, in the Patient's Room, at 1:40 P.M. on 4/25/12, the patient said that when (s)he gets upset, the staff tell the patient they are going to remove him/her. Two staff then grab one of the patient's arms and take the patient to the Quiet Room. The patient said (s)he can't leave the room because the staff stand in the doorway. "They (staff) tell me I can't leave until I calm myself down." The patient said (s)he is usually in the room anywhere from 1/2 to one hour and it is his/her perception that (s)he can't leave the room. On these two events, the patient was involuntarily taken to the Quiet Room.

Based on record review and interview, staff failed to follow Hospital policy and procedure for restraint assessment after the application of mitt and wrist restraints on one patient (#24), in total sample of 31. Findings include:

Patient #24, admitted 3/2012, had diagnoses of chronic lung disease with mechanical ventilation dependence, myelodysplastic syndrome, gastrostomy tube (GT) for feeding, and TPN (total parenteral nutrition via IV) for nutrition.

Review of the clinical record indicated the patient had been placed in hand mitts, beginning on 4/14/12, as a nonemergent restraint for pulling at, and disturbing medical equipment such as lines and tubes. Record review indicated the patient had poor judgement and was at risk of injuring self due to poor ability to understand consequences.

According to the Hospital restraint policy, an episode of physical restraint requires an authorized physician to conduct a face to face evaluation of the patient within one hour of initiating the restraint. During an interview on 4/25/12 at approximately 2:00 P.M., Nurse Manager (NM) #4, said nurse practitioners may do the face to face assessments.

Review of restraint documentation indicated the mitts were used sparingly. They were not used on 4/15, 4/16, 4/17, used briefly on 4/18, not used 4/19, and used again on 4/20. From 4/21 through 4/23/12, the hand mitts were not used. On 4/24/12 at 1:43 A.M., RN #13 obtained a telephone order to apply wrist restraints as a nonemergent restraint for pulling at, and disturbing medical equipment such as lines and tubes, and for frequent attempts to get out of bed and fall risk.

During an interview on 4/24/12 at approximately 10:00 A.M., RN #13 said the patient had become extremely agitated around 1:00 A.M. on 4/24/12, and was getting his/her hands underneath the tracheotomy, trying to pull it out. RN #13 said s/he called the on-call practitioner who was in the Hospital, who gave the order over the phone, for the wrist restraints.

Review of the physician orders of 4/25/12 at 2:00 P.M., indicated the order for the restraint had not been validated by the physician. During an interview on 4/25/12 at 8:00 A.M., NM #4, said that the physicians document their face to face restraint assessments in the physician's order for restraint, and this is to be done within one hour of the initial order for restraint. NM #4 said no face to face assessment was done for Patient #24 as required by Hospital policy.

Based on record review, policy review, and staff interview, the hospital failed to ensure that seclusion was implemented by a physician's order, for 1 Patient (#18) in a total sample of 31 active patients.

Findings included:

1. For Patient #18, medical record review indicated the hospital failed to ensure a physician's order was obtained when seclusion was implemented on two occasions, 4/9/12 at 1:35 P.M. and 4/12/12 at 9:40 P.M. Review of a physician's History and Physical completed on 4/3/12, indicated the patient had a history of sexual and physical abuse since the patient was a child.

2. Review of a Nursing Progress note dated and timed 4/9/12 at 1:45 P.M., indicated that the patient waited by the phone from 11:45 A.M. to 1:40 P.M. (The patient had a telephone plan as (s)he tended to monopolize the Unit's telephone). Upon staff intervention to have the patient leave the area near the telephone, the patient began to scream, was out of control, banged his/her fists on the wall, kicking his/her feet, flailing his/her arms. The patient was escorted to the Seclusion Room that the staff used as a Quiet Room. The patient was kicking, screaming and fighting as staff took him/her to the "Quiet Room." The medical record lacked a physician's order for seclusion.

3. Review of a Nursing Progress note dated and timed 4/12/12 at 9:40 P.M., indicated that the patient was disruptive on the Unit. The patient complained loudly about the other patients watching the news on TV, thereby, disrupting and agitating the other patients in the Day Hall. In the Day Hall, the patient was screaming and slamming his/her fists on the floor. At 6:15 P.M., the patient was held by staff and taken to the Quiet Room struggling and pushing against staff where the patient was released and sat on the bed. The patient remained in the Quiet Room for over two hours, until 8:30 P.M. The medical record lacked a physician's order for seclusion.

Based on review of credentialing files, the Medical Executive Committee failed to approve delineation of privileges for one of two radiologists reviewed (Radiologist #1). Findings include:

For Radiologist #1, review of the credentialing file indicated the radiologist was reappointed by the Governing Body for the period 12/29/11 through 12/20/13.

Review of the request for clinical privileges for radiology, signed and completed by Radiologist #1 on 12/20/11, indicated the radiologist applied for privileges to include: evaluations and examinations in radiology consistent with standards of good practice as well as evidence of satisfactory completion of training requirement for eligibility by the American Board of Radiology; radiologic interpretation of general plain film; ultrasound, and modified barium swallow.

The only approved privilege was for modified barium swallow on the request form, signed off by the President of the Medical Staff on 12/23/11. The Summary of Reappointment Verification form, the official confidential and privileged document generated by, or at direction of the "Credentials Committee," was signed by the credential committee chair as complete on 12/23/11, but not signed by the Medical Staff President for approval of Delineation of Privileges. However, the Governing Body's Chief Executive Officer (CEO), signed on 12/23/11, to indicate approval for reappointment, without the approval of the Medical Staff President, although required.

Based on review of Hospital organization and interviews, the Hospital did not have a Director of Nursing Service who was responsible for the operation of entire nursing service for all areas of the hospital. Findings include:

1. The Hospital was composed of two sites; the Main Hospital site and an Off site Campus, located approximately 35 miles east of the Main Hospital site. There were 124 beds at the Main Hospital and 47 beds at the Off site Campus.

Review of the nursing organizational charts indicated that each site had a chief clinical officer (CCO) who reported directly to the chief executive officer (CEO) at each site not to a Director of Nursing. The CEO at each site then reports to the executive director who oversees both sites.

During an interview on 4/25/12 at approximately 11:00 A.M., the CEO of the campus site said that there was no Director of Nursing of the Hospital just CCO at each site.

During an interview on 4/26/12 at 2:00 P.M., the CCO at the main site said that Hospital executive is planning on appointing a Director of Nursing to oversee both sites.

Based on record review and interview, the nursing staff failed to assess 2 of 3 patients (#16 and #25), in a total sample of 31 active patients, for signs and symtoms of hypoglycemia when scheduled routine finger stick blood sugars indicated the blood sugars were low and out of range, as well as failed to assess the risk for falls for 1 of 2 discharged patients with falls (#33.) Findings include:

1. Patient #25 was in a persistent vegetative state and was mechanically ventilated. The patient recently returned from the hospital with recurrent sepsis and pneumonia. The patient had a diagnosis of diabetes, end stage renal disease with hemodialysis, and was on a sliding insulin scale coverage. The physician orders indicated to call the physician for any blood sugar over 450 but did not indicate what to do if the blood sugar was out of range on the low side. Normal ranges were given as 70 -99.

On 4/6/12, at 6:00 A.M., the BS was recorded as 50. Review of the clinical record indicated there was no assessment of symptoms of hypoglycemia documented in the patient's condition such as vital signs, diaphoresis, or if the patient was restless. Nursing staff did call the nurse practitioner with the low blood sugar and an order was obtained to administer orange juice with three packets of sugar via the gastrostomy tube.

On 4/12/12 at 12:00 P.M., the patient's blood sugar was recorded at 56. Review of the clinical record indicated there was no assessment of symptoms of hypoglycemia documented in the patient's condition such as vital signs, diaphoresis or if the patient was restless. There was no evidence of any interventions for the low blood sugar in the clinical record.

Record review indicated there were no physician orders to intervene for low blood sugars. During an interview on 4/25/12 at approximately 11:00 A.M., the attending physician said the nursing staff should notify the medical staff if the blood sugar was less than 60 and should intervene with a glucose source due to the patient's fragile state.

During an interview on 4/25/12 at approximately 2:00 P.M., Nurse Manager #4 said that the Hospital had developed hypoglycemia protocols but had not put them in place as of yet, with plans to fully implement them by the first of June 2012. NM #4 said patients should have orders in place for low blood sugar parameters and interventions to manage those low sugars until the protocols are in place.

See A396.

2. Patient #16, has diagnoses of open surgical wound status post small bowel obstruction with intestinal fistula, diabetes, seizure disorder on Dilantin, recurrent deep vein thrombosis, and status post cerebral vascular accident with right hemiparesis and aphasia. The patient was assessed as alert and oriented and able to make needs known.

Review of physicians' orders indicated the patient received 72 unit of Lantus insulin each night and was on a sliding scale insulin coverage with finger stick blood sugars every six hours. The patient received nothing by mouth (NPO) and received all nutrition from total parenteral nutrition (TPN).

Review of blood sugars indicated that on 4/16/12, the patient's blood sugar was 63 at 6:00 A.M., below the acceptable low value of 70. Review of the clinical record indicated there was no assessment of the patient for signs and symptoms of hypoglycemia and there was no evidence of interventions to prevent the blood sugar for falling lower.

On 4/18/12, the 6:00 A.M. blood sugar was recorded as 50. Review of the clinical record indicated there was no assessment of the patient for signs and symptoms of hypoglycemia and there was no evidence of interventions to prevent the blood sugar for falling lower. The blood sugar was rechecked at 8:30 A.M. and remained low at 59 again with no clinical evidence of patient assessment or intervention.

On 4/19/12 at 11:30 A.M., the blood sugar was recorded as 63. Review of the clinical record indicated there was no assessment of the patient for signs and symptoms of hypoglycemia and there was no evidence of interventions to prevent the blood sugar for falling lower.

However, on 4/26/12, the 6:00 A.M. BS was 55 and staff called and obtained an order for Glucagon, intramuscularly. Record review indicated no assessment of the patient's signs and symptoms of hypoglycemia.

On 4/27/12, the 6:00 A.M., BS was 58, and nursing staff again called the physician and obtained an order to give Dextrose 50 mg intravenously (IV) but failed to document any assessment of the patient's condition such as signs and symptoms of hypoglycemia.

This record was reviewed with Nurse Manager #4, on 4/27/12 at approximately 11:00 A.M., who said that the nurses failed to assess the patient for hypoglycemia and failed to intervene when blood sugars were low on three occasions.

3. For Discharged Patient #33, at the Main Hospital, the Hospital failed to assess the falls risk for the patient with a history of falls.

Review of Patient #33's Medical Record and the 2/5/11 Hospital Investigation on 4/26/12 at 10:30 A.M. revealed that the patient had been admitted to the hospital 1/2011 with diagnoses that included sepsis, unstable diabetes mellitus, respiratory insufficiency (severe Chronic Obstructive Pulmonary Disease), status post lung transplant, chronic kidney disease, end stage renal disease (requiring hemodialysis), chronic kidney disease, Coronary Artery Disease, Congestive Heart Failure, chronic pancreatitis with multiple hospitalizations with the year previous to admission, and frequent falls.

The patient was described on admission as alert and oriented. There was no evidence in the patient's chart that a Fall Risk Assessment had been conducted.

Review of Nursing Notes indicated on 2/5/11 at 6:10 A.M., the patient's Blood Sugar was checked (Within Normal Limits). The patient used the call bell to summon assistance at 6:25 A.M. A Certified Nursing Care Assistant (CNCA) responded to the patient's request to pick up eyeglasses from the floor next to the patient's bed. At 6:30 A.M. another staff walked by and saw the patient lying on the floor. The patient stated he/she got out of bed to go to the bathroom and legs gave out. The patient fell. The patient complained of left thigh pain, had a small laceration and hematoma to the forehead. Bilateral hips were x-rayed and revealed an interrogate fracture of the left hip.

Chart review revealed and interviews with Unit Manager #3 and the Director of Quality Management on 4/26/12 at 11:45 A.M. acknowledged the hospital failed to assess the patient's fall risk related to the prevention of falls.

Based on observation, record review and interview, the Hospital failed to (a) develop nursing care plans for 12 of 31 active records (#6, #8, #12, #13, #14, #15, #16, #17, #18, #20, #24, and #26) and 2 of 9 discharged patients (#32 and #33); (b) failed to revise care plans for 2 of 31 active patients (#16 and #25) as the needs of the patients changed and (c) failed to consistently implement care plans for 8 of 31 active patients (#7, #8, #16, #17, #21, #24, #25, and #26). Findings include:

1. For 12 of 31 active patients, the Hospital failed to develop nursing care plans with appropriate nursing interventions in response to assessed nursing care needs. For example:

a. For Patient #8, the initial nursing assessment identified the patient as having fluid losses from a colostomy, being at risk for skin breakdown, and having existing wounds related to immobility from quadriplegia, having foot drop, pain, at risk for infection due to an indwelling catheter, and having a colonized wound infection with a drug resistant organism.

Review of the initial nursing care plan, dated 12/13/11, indicated the nursing staff had identified knowledge deficit, pain and potential for infection as problems but failed to develop any nursing interventions to address the problems.

b. For Patient #16, the initial nursing assessment identified the patient as having impaired as well as potential for skin breakdown due to open areas on the sacrum, obesity and immobility, infections, increased nutritional needs due to non-functioning bowel from surgery with an open abdominal surgical wound, increased nutritional needs for wound healing and inability to take oral nutrition, range of motion issues, pain and aphasia for which the patient used a communication book successfully.
Review of the nursing care plan indicated nursing had identified actual impaired skin integrity from immobility and surgery as problems but failed to develop any nursing interventions to address these problems. Alteration in nutrition was also identified but without any interventions identified to address the problem. There was no nursing care plan for pain.

c. For Patient #24, the nursing assessment identified the patient as having airway management issues secondary to chronic mechanical ventilation, presence of tracheostomy, recurrent pneumonia, need for continuous oxygen, and vegetative state; being high risk for skin breakdown due to immobility, diagnosis of diabetes and neurological dysfunction, having bilateral heel sores, at risk for infections due to use of an indwelling catheter and tracheostomy. Review of the clinical record indicated the patient had a femoral catheter in place for hemodialysis three times a week.
Review of the initial nursing care plan indicated nursing staff failed to develop a nursing care plan for the patient's end stage renal disease and dialysis nursing care needs. Although nursing staff identified problems of ineffective air way clearance, impaired gas exchange, actual impaired skin integrity related to immobility and diagnosis, and a high risk for further skin breakdown, nursing staff failed to develop nursing interventions to address these problems. Nursing also identified in the care plan potential for infection related to immobility, chronic diseases and artificial airway, nursing staff failed to develop any nursing interventions to address this problem in the care plan.

d. For Patient #26 at the Off-site Campus, the Hospital failed to develop a nursing care plan to address an active infection being treated with I.V. antibiotics.
Patient #26 was admitted on 3/15/12 with diagnoses including pneumonia, respiratory failure and status post tracheostomy tube placement.
Review of the physician's orders on 4/24/12 at 4:15 P.M., indicated that the patient was receiving an I.V. antibiotic initially started on 4/19/12 to treat an infection related to the lungs and/or breathing passages. Review of the interdisciplinary treatment plan for medical problems indicated the patient had a history of respiratory infections.
Review of the nursing care plan indicated the present infection and I.V. antibiotic treatment were not addressed in the nursing care plan.
During interview on 4/24/12 at 4:30 P.M., the Infection Control and Quality Assurance R.N. said that the patient was being treated for an active infection with I.V. antibiotics but this was not addressed in the nursing care plan.

e. For Patient #17, the Hospital failed to develop complete care plans which included interventions for all care areas identified by the interdisciplinary team.
Patient #17 was admitted in 4/2009 with diagnoses including respiratory failure, Amyotrophic Lateral Sclerosis (ALS, a progressive neuro degenerative disease) and was on gastrostomy tube feedings for nutrition support. Review of the nursing care plans revealed the care plans for the following areas: alteration in nutrition, potential for impaired skin integrity and potential for infection failed to identify any interventions to manage these problems.
During an interview on 4/26/12 at 11:00 A.M., Nurse Manager #3 said the care plans lacked interventions.

f. For Patient #6 the Hospital failed to develop a care plan for the care and treatment of a indwelling catheter.
Patient #6 was admitted on 4/19/12 with diagnosis including chronic bronchiectasis, empyema staus post pneumonia and respiratory failure.
On 4/24/12 at 2:30 P.M., record review indicated that the patient had an indwelling catheter in place.
Review of the nursing care plan indicated that the presence of an indwelling catheter was not addressed in the care plan.
During interview on 4/24/12 at 3:00 P.M., Nurse Manager #2 said that catheter care and treatment was not addressed in the nursing care plan. The Certified Nursing Assistant (CNA) used a daily worksheet to document their care.

g. For Discharged Patient #32 at the Main Hospital, the Hospital failed to develop an individualized care plan to prevent an accident with injury.
Review of Medical Record for Patient #32 and the 5/31/11 Hospital Investigation on 4/26/12 at 10:00 A.M. revealed that the patient had been admitted to the Hospital in 4/2011 with diagnoses that included malnutrition, severe weakness, difficulty in gait, volume overload, End Stage Renal Failure (requiring hemodialysis), recent increase in falls at home, diabetes mellitus, Heart disease, and arteriosclerosis. The patient was well known to the Hospital having been admitted there less than a year previous to this admission.
The patient was described on admission as confused with a Mental Status score of 5. The patient was assessed as a "high risk" for Falls with a score of 23, and a Fall History score of 10.
Review of Nursing Notes indicated on 5/31/11 at 10:44 P.M., the patient was standing in the bedroom and complaining of dizziness. The Nurse put the patient back to bed, and told the patient to stay in bed and call for assistance if the patient needed help. The nurse left the room and approximately 15 minutes later, heard the patient call, "Help, Nurse, Help.!" The Nurse found the patient on the floor. The patient stated, "I was trying to stand and my legs bent under and I twisted my right ankle." The Registered Nurse noted the right ankle to be swollen with skin abrasion to the right great toe. A stat X-ray revealed the patient suffered a fracture of the distal fibula.
Chart review indicated and Unit Manager #3 and the Director of Quality Management said during interviews on 4/26/12 at 11:45 A.M., that the hospital failed to assess the patient's fall risk and to develop an individualized care plan with interventions related to the prevention of falls.

h. For Discharged Patient #33, at the Main Hospital, the Hospital failed to develop an individualized care plan to prevent an accident with injury.
Review of Patient's #33's Medical Record and the 2/5/11 Hospital Investigation on 4/26/12 at 10:30 A.M. revealed that the patient had been admitted to the hospital 1/11 with diagnoses that included sepsis, unstable diabetes mellitus, respiratory insufficiency (severe Chronic Obstructive Pulmonary Disease), status post lung transplant, chronic kidney disease, end stage renal disease (requiring hemodialysis), chronic kidney disease, Coronary Artery Disease, Congestive Heart Failure, chronic pancreatitis with multiple hospitalizations with the year previous to admission, and frequent falls.
The patient was described on admission as alert and oriented. There was no evidence in the patient's chart that a Fall Risk Assessment had been conducted.
Review of Nursing Notes indicated on 2/5/11 at 6:10 A.M., the patient's Blood Sugar was checked (Within Normal Limits). The patient rang for assistance at 6:25 A.M. A Certified Nursing Care Assistant (CNA) responded to the patient's request to pick up eyeglasses from the floor next to the patient's bed. At 6:30 A.M. another staff walked by and saw the patient lying on the floor. The patient stated he/she got out of bed to go to the bathroom and legs gave out and fell. The patient complained of left thigh pain, had a small laceration and hematoma to the forehead. Bilateral hips were x-rayed and revealed an fracture of the left hip.
Chart review indicated, and Unit Manager #3 and the Director of Quality Management said during interviews on 4/26/12 at 11:45 A.M., that the hospital failed to assess the patient's fall risk and to develop an individualized care plan with interventions related to the prevention of falls.

i. For Patient #12, the Main Hospital failed to develop nursing care plans based on the patient's needs with appropriate interventions.
Patient #12 was admitted in 3/2012, and re-admitted on 4/12/12. Diagnoses included: small bowel obstruction requiring surgical intervention; weight loss with moderate malnutrition; anemia; diabetes mellitus with sliding scale Insulin (antidiabetic medication); Peptic Ulcer Disease with multiple duodenal ulcers treated with the antinuclear medication Protonix intravenously, and severe trigeminal neuralgia with associated pain.
Review of the clinical record revealed, and during interview on 4/25/12 at 10:37 A.M., Nurse Manager (NM) #3 said there were no care plans to address the patient's needs as follows:
- Malnutrition with low Albumin (poor healing).
- TPN (Total Parenteral Nutrition) via a PICC Line (Peripherally Inserted Central Catheter).
- Pain related to surgery and trigeminal neuralgia requiring the narcotic pain reliever Percocet.
- Diabetes Mellitus with Insulin.
- Potential for infection related to surgical incisions and a PICC Line.
- Potential for constipation related to bowel surgery and the use of narcotic medications.
- Potential for bleeding related to a history of bleeding ulcers.
- Severe blood loss anemia requiring a hospitalization at another facility for blood transfusions.

j. For Patient #14 the Main Hospital failed to develop nursing care plans based on the patient's needs with appropriate interventions.
Patient #14 was admitted to the hospital in 4/2012. Diagnoses included: multiorgan failure (including kidney, respiratory, and liver); hypokalemia (low potassium); multiple septic joints requiring surgeries treated with intravenous and pain medication therapy, and a urinary tract infection;
Review of the clinical record indicated the patient was admitted to the Hospital with an indwelling catheter. There was no evidence that nursing conducted an assessment or developed a care plan for the care of the catheter.
Further review of the clinical record revealed, and during interview on 4/30/12 at 8:00 A.M., NM #3 said the Hospital did not develop care plans with appropriate interventions as follows:
- Pain
- Administration of the blood thinning medication Heparin for the prevention of blood clots.
- Critically low Potassium levels and the patient's refusal for treatment with Potassium Chloride, as well as a history of cardiac arrest.
- Skin integrity
- Anemia
- Nutrition (very low Albumin levels).

k. For Patient #15, the Hospital failed to develop interventions to address the treatment of impaired gas exchange.
Patient # 15 was admitted on 3/30/12 with diagnosis including pancreatic cancer, gastric outlet obstruction and abdominal ascites.
On 4/25/12 at 1:45 P.M., record review revealed that the patient was receiving oxygen therapy at 2 liters/minute via nasal canula. The patient had a thoracentesis on 4/24/12. On 4/25/12 at 9:20 A.M., a rapid response was called due to respiratory distress.
Review of the nursing care plan identified a problem with impaired gas exchange related to Chronic Obstructive Pulmonary Disease, (COPD) but no interventions to address this issue.
During interview on 4/25/12 at 2:00 P.M., Nurse Manager #3 said the nursing care plan was incomplete.

l. For Patient #13, the Hospital failed to develop interventions to address this patient's pain.
Patient #13 was admitted on 4/11/12 with diagnosis including stage IV pressure ulcer, urinary tract infection and osteomyelitis.
The initial nursing assessment dated 4/11/12, identified the patient as having pain issues related to pressure ulcer on coccyx. Review of the nursing care plan lacked interventions to address pain.
m. For Patient #18, the hospital failed to develop a care plan with goals and interventions for the patient's asthma and use of the Quiet Room for de-escalation purposes.
Patient #18 was admitted on 4/3/12 with diagnoses including asthma, bipolar disorder, borderline personality disorder, mood disorder, and a history of physical and sexual abuse since a child.
Review of the patient's active medication list, indicated that the patient used an Albuterol Inhaler every 4 hours, as needed. During interview with Registered Nurse (RN) #1 at 9:00 A.M. on 4/25/12, the RN said that the patient needed to use the inhaler on a few occasions. The medical record lacked a nursing care plan to monitor the patient's asthma.
Review of Inpatient Progress Notes from 4/7/12 to 4/25/12, indicated that the staff utilized the unit's Quiet Room (the Seclusion Room was used as a quiet room), to de-escalate the patient on two occasions, 4/9/12 at 1:45 P.M. and 4/12/12 at 8:15 P.M.
During interview with Patient #18, in the Visitors' Room at 11:10 A.M. on 4/25/12, the patient was asked, What works best to calm you down? The patient said, instead of grabbing me and putting me in the Quiet Room, I'd rather have them (staff) talk to me quietly and take me to the Comfort Room. When the staff takes me to the Quiet Room it increases my emotions. Because of my past history of physical and sexual abuse, I feel threatened.
Review of the patient's Treatment Plan indicated that it lacked a de-escalation plan that included the use of the Quiet Room/Seclusion Room.

n. For Patient #20, medial record review indicated that the patient had large amounts of edema (score of 3 of 4) in both lower extremities, pain, wounds on toes, a tracheostomy (tube in the neck for breathing), and anxiety.
Continued medical record review indicated that the patient lacked a care plan with goals and interventions for the above issues. During an interview with Nurse manager (NM) #3, at 4:00 P.M. on 4/25/12, the NM said that the nursing interventions were based on physician orders and that the physician orders only stayed in the computerized medical record for 90 days, and must be reviewed by the physician. NM #3 said the orders have fallen by the wayside and therefore, so have the interventions. The NM said there were no nursing interventions for Patient #20.

2. The Hospital failed to revise care plans for 2 of 31 active patients(#16 and #25) as the needs of the patients changed. For example:
a. For Patient #16, the nursing care plan was not revised to address the patient's development of multiple Deep Vein thrombosis (DVT) and the use of anticoagulation medication.
Review of the clinical record indicated the Patient #16 was admitted with a right arm DVT, history of cerebral vascular accident (CVA) with right sided hemiparesis and aphasia. Review of the history indicated the patient suffered a gastrointestinal bleed (GIB) while on anticoagulation treatment which was stopped. In March 2012, record review indicated the patient developed a DVT of the left arm. A GI consult was obtained to consider the safety of anticoagulation treatment given there history of GIB. The GI physician indicated in the consult note of 3/12/12, that no anticoagulation was recommended due to the risk of recurrent bleeding. The attending physician started Lovenox 100 mg Subcutaneous twice a day approximately on April 20th , due to development of a right leg DVT.
As of 4/30/2012, the nursing care plan had not been revised to address the nursing care needs of the patient with DVT on anticoagulation.

b. For Patient #25, the nursing care plan was not revised to address the development of a DVT, addition of anticoagulation and subsequent adverse event of rectal bleeding requiring multiple transfusions. The patient was readmitted on 4/5/12, status post sepsis and pneumonia.
The acute hospital discharge summary indicated the patient was positive for HIT (Heparin Induced Thrombocytopenia), ordered all heparin stopped, and changed IV flushes and packing in the central line to Alteplase. On 4/15/12, the patient developed symptoms of recurrent DVT. A repeat HIT test was obtained which was negative and Heparin 5000 units subcutaneous (SQ) three times a day was restarted. On 4/16/12 the patient's hemoglobin and hematocrit was extremely low at 7.8 and 22, requiring blood transfusion. On 4/20/12, the patient began to actively bleed through the rectum and required transfusion with platelets. The Heparin was decreased to every twelve hours.
Review of the clinical record and nursing care plan indicated there was no revised care plan to address the patient's new problem of rectal bleeding and anticoagulation use.

3. The Hospital failed to consistently implement care plans for 8 of 31 active patients (#7, #8, #16, #17, #21, #24, #25 and #26). For example;
a. For Patient #8, the physician ordered weights to be done weekly and intake and outputs to be monitored every 24 hours. The patient received GT (gastrostomy tube) feeding at 65 cubic centimeters (ccs)/hour continuously, had a colostomy that drained liquid stool and a Foley catheter. Review of weekly weights from 3/1/12 through 4/26/12 indicated weights were not done on 3/15, 4/16 and 4/23/12. On 4/9/12 the patient's weight was recorded as 255 pounds and on 4/18/12, the weight was recorded as 280 pounds. No reweight was taken to address the 25 pound weight gain. The expected GT intake each 24 period was 1560 cc's. The patient was also ordered to receive a total of 400 cc's of water each 24 hours plus water flushes with each medication pass for a total GT intake of 2250.
Review of the 24 hour intakes from 4/12/12 through 4/25/12 indicated that GT intakes were not accurately recorded. For each day, intakes were only recorded at 520 ccs for 5 days, 1040 ccs for 2 days and 1960 ccs for one day.
During an interview on 4/26/12 at approximately 2:00 P.M., Nurse Manager #4 said the I and O's and weights were not monitored as ordered.

b. For Patient #25, a patient in a coma, record review indicated there was a physician order to check finger stick blood sugar (FSBS) every six hours and administer sliding scale insulin coverage as needed.
Review of the FSBS records indicated that on the following dates no BS were recorded: 4/7, 4/8, 4/9, 4/11, 4/13, 4/15, 4/16, 4/17, 4/18, 4/19, 4/20 and 4/21 at 6:00 P.M. On 4/23 and 4/25/12 at 6:00 A.M., BS were not recorded as ordered. The patient had two episodes of low blood sugars, one on 4/6 (50) requiring staff to administer orange juice and sugar via the GT and one on 4/12 (56) in which staff did not intervene.

c. For Patient #24, the nursing staff failed to provide Foley catheter care each day consistent with house policy and failed to monitor weights weekly per order. Patient #24 was admitted with a Foley catheter in place.
According to Hospital policy, catheter care is to be done daily with a soap and water wash of the external catheter and perineum. Review of the nursing daily hygiene notes indicated that from 3/31/12 through 4/22/12, 7 of 24 days catheter care was not provided. During an interview on 4/25/12 at 8:30 A.M. Nurse Manager #4 said nursing must trigger the care on the certified nurse assistant (CNA) work list so that it triggers a documentation trigger for the CNA and that did not appear to happen. Review of weekly weights for April 2012 indicated the 4/9/12 weight was not done.

d. For Patient #16, who receives nothing by mouth, all nutrition is derived from total parenteral nutrition (TPN), a concentrated IV substituting for complete meals. The patient has a GT draining to gravity and an open abdominal wound with a containment system also draining to gravity. The patient has physician orders to monitor weekly weights and I and O. Review of the weekly weights from admission on 12/28/11 indicated that weights were not done on 1/5/12. No weights were done on 2/6, 3/19 and 3/26. Review of output records indicated the GT and wound containment system drained 400- 650 ccs per day. However, no outputs were recorded for 4/16, 4/17, 4/21 and 4/23/12.
During an interview on 4/27/12 at 10:00 A.M., NM #3 said that the intakes were not done on those days as required.


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e. For Patient #26 at the Off-site Campus, the Hospital failed to obtain weekly weights consistently as ordered by the physician.
Patient #26 was admitted on 3/15/12 with diagnoses including pneumonia, respiratory failure and status post tracheostomy tube placement.
A 3/19/12 physician order read to weigh the patient weekly. Staff weighed the patient on 3/19/12 and did not weigh the patient again until 4/12/12, more than 3 weeks later. Staff failed to obtain weekly weights that were due on 3/26/12, 4/2/12 and 4/9/12.

f. For Patient #21 at the Off-site Campus, the Hospital failed to consistently monitor the patient's weight while the patient received TPN (total parenteral nutrition).
Patient #21 was admitted on 4/12/12 with diagnoses including metastatic cancer, pancreatitis and was on TPN (total parenteral nutrition) for nutrition support.
Record review on 4/24/12 at 3:00 P.M. indicated the Hospital weighed the patient twice since admission: on 4/12/12, the day of admission and three days later on 4/15/12. As of 4/24/12, the patient had not been weighed in 9 days.
Review of the Parenteral Nutrition Therapy Policy indicated that the Hospital would obtain "daily weights X 7, then at least weekly" while a patient was on TPN. The Hospital failed to follow their policy on obtaining daily weights for the first 7 days on TPN and then weekly weights thereafter.
On 4/25/12 the Quality Assurance R.N. provided the survey team with a "daily weight audit" form that the Hospital would implement to ensure weights were obtained as per the medical plan of care.

g. For Patient #17 at the Main Hospital, the Hospital failed to obtain weekly weights consistently as ordered.
Patient # 17 was admitted in 4/09 with diagnoses including respiratory failure, ALS (a progressive neuro degenerative disease) and was on gastrostomy tube feedings for nutrition support.
Record review on 4/25/12 at 2:00 P.M. revealed a 3/5/12 physician order to weigh the patient weekly and "if unable to obtain weight, report to nurse and document reason". Review of the patient's weights from 3/12/12 to 4/25/12 revealed staff failed to weigh the patient on 4/9/12 and failed to document a reason why.
During interview on 4/26/12 at 11:00 A.M., Nurse Manager #3 confirmed the missing 4/9/12 weekly weight and the lack of interventions on the above nursing care plans.

h. For Patient # 7 at the Main Hospital, the Hospital failed to obtain weekly weights consistently as ordered.
Patient # 7 was admitted in 2/12 with diagnoses including end stage renal disease on hemodialysis, hypertension and diabetes mellitus.
Record review revealed a physician order for weekly weights starting 2/20/12. Review of the patient's weights from 2/20/12 to 4/25/12 revealed staff failed to weigh the patient on 4/16/12.
During interview on 4/26/12 at 11:00 A.M., Nurse Manager #3 confirmed the missing 4/16/12 weekly weight.

Based on review of two of two credentialing files for contracted nurse practitioners ( NP #1 and #2), the Hospital failed to ensure that Hospital Nursing Administration provided adequate supervision and evaluation of the clinical activities which occur within the responsibilities of the nursing services. Findings include:

1. Standards of Practice as set forth in Massachusetts regulations Governing the Practice of Nursing in the Expanded Role, 244 CMR 4.22 specifies that a nurse may not practice in an expanded role within an institution until the approval of the governing body including the medical staff and nursing administrative staff, formally reviews and approves the guidelines under which she proposes to practice and is accepted. Such formal approval must be in writing and in accord with the bylaws.

2. Review of Nurse Practitioners' #1 and #2 credentialing files indicated reapproval, in writing, for clinical practice, from the Medical Director only. There was no evidence of any approval from the nursing administration for the clinical practices requested by the two Nurse Practitioner candidates. In addition, there was no evaluation of their clinical activities which occur within the responsibilities of the nursing services.

3. During an interview with the Chief Clinical Officer (CCO) on 4/27/12 at approximately 10:00 P.M., the CCO said the Hospital nursing administration does not provide any oversight clinically or during the credentialling process.

Based on observation, record review and staff interview, the facility failed to prepare and administer medications for one patient, (#35) in accordance with accepted standards of practice, out of a total sample 40. Findings include:

For Patient #35, the hospital failed to administer medications as ordered by the physician.

Patient #35 was admitted to the hospital on 4/20/12 with diagnosis including sepsis and status post craniotomy.

On 4/25/12, at 9:40 A.M., during the medication pass observation, RN #6 poured and administered Levothyroxine 100 (mcg) micrograms.

Patient #35 did not receive his/her daily dose of Levothyroxidine 200 micrograms.

Record review on 4/25/12, at 10:00 A.M., revealed that the physician had ordered Levothyroxine 200 mcg to be given daily starting on 4/21/12. On 4/23/12, the physician added Levothyroxine 100 mcg given on Monday, Wednesday, and Friday only.

RN #6 stated that he/she saw the additional dosage of Levothyroxine in the patient medication drawer in the morning. He/she failed to administer the medication because he/she felt that the medication was a duplicate dose sent from the pharmacy. The RN did not verify the order.

On 4/25/12, at 10:25 A.M., the Unit 3 nurse manager stated that the incorrect dose of Levothyroxine was administered.

Based on record review and interview, the Hospital staff failed to follow policy and procedures for the administration of blood products for one of two patients (#25), who received transfusions at the Off Site Campus. Findings include:

1. Patient #25, readmitted 4/2012, had diagnoses of recurrent pneumonia and sepsis, end stage renal failure on hemodialysis, and being in a vegetative state on a mechanical ventilator. The patient was fed via gastrostomy tube and had multiple open wounds.

Record review indicated that the patient was ordered to receive blood transfusion of three units of pack red cells (PRBC) secondary to a low hemoglobin of 7.8 and a low hematocrit of 23.6.

The Hospital policy and procedure for blood transfusion, revised on 2/2012, indicated that only a registered nurse may administer blood or blood products with a physician's order. Prior to starting the transfusion the RN and a second licensed provider will validate, against the transfusion form, at the bedside, the patient name, ID number, date of birth, donor number on the blood bag label, ABO group and Rh type on blood bag label, expiration date and then sign the transfusion record and form. Vital signs will be observed and documented pre transfusion prior to initiation of the blood product, 15 minutes after the initiation of transfusion at there conclusion of the transfusion and one hour post transfusion. The first 15 minutes of the transfusion, the product must be ran slowly and should be completed in less than four hours.

For Patient #25, a 300 cubic centimeter (cc) unit of leukocyte reduced red blood cells (LRBC's) was transfused on 4/16/12 starting at 12:05 P.M. and completed at 12:40 P.M. Vital signs were taken at pre- transfusion, at 15 minutes and at completion but not at one hour post completion per policy.

At 2:25 P.M. on 4/16/12, the patient received another 350cc unit of LRBC. Review of the blood transfusion form and lab slips indicated only one licensed signature for the validation checks instead of the two as required. The transfusion was started at 2:25 P.M. and completed at 4:50 P.M.

On 4/20/12, record review indicated the patient received 240 ccs of platelets due to a low platelet count of 69 and active bleeding. The transfusion started at 5:55 P.M. and was completed at 6:26 P.M. Review of the transfusion record indicated no vital signs were monitored at one hour post transfusion and documented as required by policy and procedure.

Based on record review, the Hospital failed to complete a medical history and physical exam for one patient (#11) in a total active sample of 31, within 24 hours of admission. Findings include:

For Patient #11, the facility failed to have a history and physical examination completed within 24 hours after admission. In addition, the history and physical had multiple areas left blank.

According to the Hospital's Policy for Record Content, dated 3/97 under #9b. it stated, "When a patient is admitted or prior to the performance of outpatient surgery, a History and Physical must be completed and on the chart within 24 hours."

Review of Patient #11's medical record indicated that this Patient was admitted on 3/19/12. This Patient's History and Physical Examination was not electronically signed by the Physician until 3/23/12, 4 days after admission.

Review of the admission History and Physical Examination indicated there were 3 blanks. It stated, "in October followed by (blank), rule out (blank) , (under the list of patient medication), (blank) 25 milligrams (mg), every (q) 8 hours (h) prn (as needed)."

Interview with the Health Information Manager on 4/25/12 at 12:00 P.M., indicated that this history and physical was completed 4 days after admission instead of within one day after admission. This Manager also stated there was no clarification (at the end of this History and Physical Examination) as to what information should be included in the blank spaces.

Based on observation and interview with staff, the facility failed to ensure that drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law, specific to locking medications during delivery to patient units.

Findings include:

1. Observations on 4/25/12 at 9:00 A.M. on Unit 2A and 1:05 P.M. to 2:00 P.M., on Units 3A, 5A and 5B , indicated that the Pharmacy staff at the Main Hospital, transported medications between the Pharmacy and the patient care units using carts with unlocked patient-specific bins. The patient-specific bins should be locked during transport to patient units.

2. During an interview with the Director of Pharmacy (DOP) on 4/25/12 at 2:25 P.M., the DOP said that medications were delivered to and stored on Unit 2A in unlocked patient-specific medication bins.

3. During an interview with Pharmacy Technician (PT) #1 on 4/25/12 at 10:05 A.M., PT #1 said that medications were delivered to Units 3A, 5A and 5B in unlocked, patient-specific, medication bins.

Based on observations, and staff interview at the Main Hospital, the Pharmacy failed to ensure that all drugs and biologicals were kept in a secure area and locked when appropriate.

Findings included:

A tour of Unit 5B was conducted on 4/25/12 at 1:45 P.M.

1. An unlocked medication refrigerator was noted in the alcove behind the nurses station where the public and/or unauthorized hospital personnel may have access. The medication refrigerator at the Hospital lacked commercial locking devices (Pyxis/Carefusion) or facility attached locking mechanisms, as required.

2. During an interview with the Director of Pharmacy (DoP) on 4/25/12 at 1:50 P.M., the DoP said that the refrigerator was not lockable. The Hospital did not provide a lock for the medication refrigerator, although required.

Based on observation during the tour of the Laundry Area and Unit 2A, the condition of the physical plant and the overall hospital environment was not maintained in such a manner that the safety and well-being of patients were assured. Findings included:

1. During tour of the Laundry Room at the Main Hospital with the Director of Housekeeping/Facilities on 4/24/12 from 3:55 P.M. to 5:15 P.M., observations revealed the following:

There were 2 upright fans in the Laundry Area. Fan #1, was plugged into a wall socket in the Sorting Room and lacked an electrical inspection sticker. Fan #2, was located near the handwashing sink and was not plugged in. This fan had black and silver electrical tape wrapped around the electrical cord. However, the electrical cord had visible frayed wires immediately next to the plug. There was no lock out sticker attached to the fan to indicate the fan was out of service.

During interview with the Chief Executive Officer (CEO) on 4/30/12 at 2:10 P.M., the CEO said that all electrical equipment required inspection stickers and electrical equipment that was not in use should contain a lock out sticker, to alert staff that the equipment was not safe for use.

2. During tour of the Psychiatric Unit with Nurse Manager (NM) #1, on 4/24/12 from 10:30 A.M. to 11:15 A.M., observations revealed the following:

The female patient bathroom had 2 shower and 1 bath control dials with protruding handles, that provided a safety hazard for patients.

There were 2 broken laundry hampers with broken lids and sharp edges. Both hampers also had attached, two foot long cords. The hampers provided a potential safety risk to patients.

Patient Room 220 had an electric clock radio with a three foot long cord (a safety hazard for patient injury) on a bureau.

The 2 wardrobe closets in Room 220 were not secured to the floor or wall, providing a potential safety risk to both patients and staff. (An agitated patient could potentially pull the wardrobe on top of him/herself or onto staff). When NM #1 was asked how many wardrobe closets were not secured, he said all 30 of them. The NM said that the Unit contained 30 of these wardrobes (two in each patient room).

Sharp Closet #2 (a locked closet to keep unit and patient items, that may not be safe for the patients) contained electrical items as follows:
- One iron with an electrical inspection date of 3/14/08 and an inspection due date of 3/2009. The iron was three years past due for inspection.
- One hair dryer with no electrical inspection date
- Two curling irons with no electrical inspection date.

The NM said that the above items required current electrical safety stickers.

The patient bathroom for the Seclusion Room had an unlocked, adjoining door to room 202 (a shared bathroom). This bathroom (to be used by patient's in seclusion) had an approximate 3 foot long handicapped grab bar. The handicapped grab bar was not fixed with an insert to prevent patients from attaching a cord-like item to the rail, to injure themselves. The grab bar was a potential safety risk.

During an interview and tour with NM #1 on 4/24/12 at 11:15 A.M., the NM acknowledged that the above identified issues were safety concerns that needed to be addressed.

Based on observations, review of facility infection control policies, and staff interviews, the Hospital failed to ensure that staff consistently implemented infection prevention and control standards to maintain a sanitary environment for 8 (#8, #9, #11, #14, #15, #19, #36, #37) of 31 active patients and one nonsampled patient (NS B).

Findings include:

1. The Main Hospital failed to minimize the risk of cross contamination during the use of a glucometer to test for fingerstick blood sugar (FSBS):

On 8/26/2010, the Centers for Disease Control (CDC) issued requirements for Infection Prevention during Blood Glucose Monitoring and Insulin Administration, supported by the Food and Drug Administration (FDA), that state fingerstick devices should never be used for more than one person. Whenever possible, point of care (POC) blood testing devices, such as blood glucose meter and PT/INR anticoagulation meter, should be used only on one patient, and not shared. If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.

On 4/24/12 at 4:30 P.M., Certified Nursing Assistant, (CNA) #3 was observed preparing to obtain FSBS for sampled patients #9, #19, and #36. CNA #3 gathered supplies at the nurses' station by removing 2 test strips from the original bottle, 2 alcohol pads, 2 gauze pads, a blood glucose meter, and 2 lancets.

CNA #3 brought these supplies into patient's #19 and #36 (who were roommates) room. She stacked an alcohol pad, a gauze pad, and 1 test strip in a pile on a shelf entering this room, and then placed the other alcohol pad, the other gauze pad and 1 test strip in a pile next to the first pile. The CNA placed the blood glucose meter on patient #36's bed.

CNA #3 washed hands, donned a pair of gloves, and picked up one of the piles of supplies and proceeded to obtain a FSBS from patient #36. Next, CNA #3 removed all the contaminated supplies and disposed of them into a sharps container. CNA #3 placed the blood glucose meter next to the second pile of supplies, removed gloves and washed hands.

After this procedure was done, without cleaning the blood glucose meter, the above procedure was repeated for patient #19. At this point, the remaining test strip was out of its original bottle for 10 minutes. (Per manufacturer's instructions, test strips are sensitive to heat, light and moisture and should be kept in their original bottle. Use each test strip immediately after removing it from the bottle).

After placing the contaminated meter back on the shelf in this room, the CNA disposed of all the contaminated supplies, removed gloves, and washed hands. Without cleaning the meter, the CNA picked up the meter with cleaned bare hands and brought the meter to the nurses' station. The CNA downloaded the meter's data into the computer and then placed the meter into the meter's storage container.

The contaminated meter remained in the container until CNA #2 removed the meter at 4:45 P.M. At that time, without cleaning the meter, CNA #2 gathered supplies and obtained a FSBS reading from Patient #37. CNA #2 then obtained another FSBS reading for Patient #15. Again, without cleaning the meter, brought the contaminated meter to the nurses' station and downloaded the data into the computer.

During interview, at that time, CNA #2 stated that the meter should be cleaned after each patient's use, and that she failed to follow the proper procedure.

CNA #3 and #2 failed to clean the glucometer after use and before returning the glucometer to the storage case, increasing the risk of cross contamination between patients.

During interview on 4/25/12 at 10:00 A.M., Nurse Manager #3 said that usually there are 3 glucometers on this unit, shared by all patients on this unit, and must be disinfected using bleach wipes after each patient use.

2. For Patient #9, the hospital failed to minimize the risk of cross contamination during the use of a glucometer to test for fingerstick blood sugar (FSBS).

On 8/26/2010, the CDC issued requirements for Infection Prevention during Blood Glucose Monitoring and Insulin Administration, supported by the Food and Drug Administration (FDA), that state fingerstick devices should be properly cleaned and disinfected after every use as described in the device labeling.

On 4/25/12 at 11:30 A.M., CNA #5 was observed preparing to obtain the FSBS for Patient #9. CNA #5 gathered supplies at the nurses' station by removing 1 test strip from the original bottle, 1 alcohol pad, 1 gauze pad, a blood glucose meter, and 1 lancet.

CNA #5 brought these supplies into Patient #9, and placed 1 alcohol pad, one 2 inch by 2 inch gauze, and 1 test strip on the overbed table. The glucose testing device was placed on the overbed table. CNA #5 washed hands, donned a pair of gloves and picked up one of the piles of supplies and proceeded to obtain a finger stick blood glucose from Patient #9. Next, CNA #5 removed all the contaminated supplies and disposed of them into a sharps container. CNA #5 then washed his /her hands and proceeded directly to the nursing station and placed the glucometer back into the charging station. The glucometer was not sanitized either prior to or after use by CNA # 5.

On 4/25/12, at 11:40 A.M., NM # 2 stated that CNA # 5 had not sanitized the blood glucose meter appropriately.

On 4/25/12 at 10: 40 A.M., the hand soap sanitizer located outside room 319-2 was not functioning. The battery pack was drained. In addition, the hand sanitizer located inside room 323-1 was empty.

On 4/25/12 at 10:40 A.M., NM #2 confirmed this, stating that these sanitizers were not functioning.

3. Observation on 4/25/12 at 10:30 A.M. revealed the following breaches in infection control during a dressing change:

After cleaning a pressure ulcer located on the sacral area on Patient #15, using the same dirty gloves, RN #7 proceeded to apply a debriding agent to the opened area. Wearing the same dirty gloves, RN #7 removed the glove on the right hand, reached into a pocket, and removed a marker pen.

Next RN #7 wrote the date on the secondary dressing using the marker, placed the marker back into her pocket, reapplied the dirty glove to the right hand, and applied the secondary dressing to the ulcer. Next RN #7 removed both gloves, and without any handwashing left the room. She proceeded to the nurses' station and started another task.

Per facility's policy, hand hygiene should be performed after removal of gloves.

In addition, a pair of scissors was on the floor after the dressing change. RN #7 picked up the scissors and placed them into her pocket without disinfecting them.

During interview after the observation with RN #7, she said that she should have washed her hands and changed her gloves.


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4. For Patient #14, the Main Hospital failed to follow facility policy during (a.) wound care per CDC Guidelines that are being utilized as Hospital policy and (b.) catheter care.

a. On 4/26/12 at 11:00 A.M., the surveyor asked NM (Nurse Manager) #3 which nurse would be changing Patient #14's wound dressings. RN (Registered Nurse) #10 approached the surveyor, and said that she would be changing the patient's dressing at approximately 1:00 P.M.

On 4/26/12 at 1:10 P.M., the surveyor observed RN #10 grab a handful of clean gloves and put them into her back pocket.

Upon entering the patient's room, RN #10 placed a Chux Pad (protective barrier) underneath the patient's right hip (20 staples were removed earlier in the day, and the patient needed the area painted with Betadine (antiseptic) after being cleansed with Normal Saline. Super Fluff gauze sponges were opened and placed directly on top of the bed linens, but still in their packages. The Nurse removed the dirty gloves and grabbed a pair of clean gloves from the back pocket. The nurse changed her gloves without first using gel or washing hands before moving to the next body part (right lower abdomen drain).

The right lower abdominal drain was cleaned with Normal Saline, then dried with gauze. There was a small amount of dried blood at the site. Gloves were removed and clean gloves taken from the back pocket and donned without using gel or handwashing between. The Nurse applied skin prep to the periphery of the drain site, and applied a new dressing.

RN #10 (with the same gloves), then adjusted the patient's indwelling catheter tubing (contaminated area), and without first using gel or handwashing, this Nurse moved directly to the wound on the patient's right knee, and using the contaminated gloves (used to adjust the catheter), opened clean dressing supplies (gauze sponges and added Normal Saline and opened a packet of the debriding agent Hydrogel). With the same dirty gloves, the Nurse removed the old dressing from the left knee. The old dressing was saturated with serosanguinous drainage.

The Nurse removed the dirty, contaminated gloves, and without first handwashing, grabbed another pair of clean gloves from her back pocket, and put them on. The Nurse cleansed the area with Normal Saline, applied Hydrogel and redressed the wound. The wound was beefy red and open with a large amount of drainage, but no signs of infection. New gloves were donned without using gel or handwashing before moving to the left foot second toe. The area was cleaned with Normal Saline and a protective dressing applied.

During interview on 4/26/12 at 1:35 P.M., RN #10 said that she wasn't aware that handwashing should be conducted between changing gloves. The Nurse also said she understood that it is an infection control issue to keep a supply of gloves in the pockets, and supplies put on top of the bed. The Nurse also said that she should have washed her hands and donned clean gloves after contaminating them while adjusting the patient's catheter, then moving on to the open draining wound on the right knee.

During interview on 4/30/12 at 7:15 A.M., NM #3 said that the Hospital's policy is based on CDC Guidelines, as well as APIC (Association for Professionals in Infection Control and Epidemiology, Inc.), and SHEA (Society for Healthcare Epidemiology of America).

During further interview, NM #3 said that RN #10 should have washed her hands and/or used gel after removing dirty gloves, and before donning clean gloves. UM #3 indicated that nursing staff would be inserviced regarding proper infection control practices per facility policy.

b. Review of the Main Hospital's current policy titled "Indwelling urinary catheter care and management" was revised 10/8/11. Page 2 of the policy included, "...Clean the outside of the catheter and the tissue around the meatus using soap and water...."
During interview on 4/30/12 at 8:45 A.M., CNA (Certified Nursing Assistant) #4 told the surveyor that for indwelling catheter care, she cleans the patient's meatus and catheter tubing with plain water (and not soap and water per policy). The surveyor asked the CNA if any soap is used, and the CNA said, "no."


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5. Observation on 4/24/12 between 9:30 A.M. and 10:00 A.M., during the orientation tour at the off-site campus, indicated that staff were not wearing protective gowns in contact precaution rooms correctly to prevent cross contamination of personal clothing. For example:

a. At 9:30 A.M., CNA #6, was observed in room 124, caring for a patient on contact precautions. CNA #6 had a protective gown on that was not tied in the back and was hanging off the shoulders exposing the CNA's personal clothing from the mid chest and arms to environmental surface contaminants.

b. At 9:40 A.M., RN #12 was observed in room 123 caring for another patient on contact precautions. RN #12 had a protective gown on that was not tied in the back, and was hanging off the shoulders exposing RN #12's personal clothing from the mid chest and arms to environmental surface contaminants.

c. At 10:00 A.M., RN #11 was observed in room 136, caring for a patient, who was also on contact precautions. RN #12 had a protective gown on that was not tied in the back, and was hanging off the shoulders exposing RN #12's personal clothing from the mid chest and arms to environmental surface contaminants.

During an interview on 4/25/12 at approximately 2:00 P.M., NM #4, said staff were not wearing protective gowns appropriately to prevent cross contamination in the contact precaution rooms based on the above observations.

6. Observation on 4/24/12 at 1:30 P.M., of the 1:00 P.M. medication pass at the off-site campus, RN #8 was observed to obtain a bottle of the liquid anti-infective medication Vancomycin from the unit refrigerator, and bring it into NS B's room. Observed on the outside of the patient's room was a sign indicating the patient was on contact precautions for Clostridium Difficile, a highly contagious bowel infection.

RN #8 was observed to administer 5 milliliters (250 mg) of liquid Vancomycin from the bottle through the patient's gastrostomy tube. RN #8 was about to leave the room and return the bottle to the common unit medication refrigerator when the surveyor intervened. When asked what the RN planned to do with the Vancomycin bottle, the RN replied she was going to return it to the medication refrigerator. When reminded the bottle was now in a contaminated area and could not be returned to a clean area, the nurse replied that she should have poured the dose in the medication room and labeled it, and not brought the bottle into the room since it could not be refrigerated there as required for medication integrity. Asked what had been done previously, RN #8 said that she and other staff just brought the bottle back to the medication room which potentially cross contaminated the refrigerator.

7. Patient #8 was diagnosed with respiratory failure requiring mechanical ventilation, quadriplegia, diabetes and a large sacral decubiti. The patient had a draining colostomy and a Foley catheter.

The Initial Nursing Assessment identified the presence of colonized Vancomycin Resistant Enterococcus (VRE), a multiple drug resistant organism, in the sacral wound, and the need for contact precautions.

Review of the infection control policies and procedures for transmission based precautions, dated 11/2009, states to use contact precautions for patients with known or suspected infections of evidence of syndromes that represent an increased risk of contact transmission. The procedure states to post a "Contact" precaution sign at the patient's door.

Observation of the patient's room on 4/26, 4/27 and 4/30/12 indicated there was no contact precaution sign on the patient's door.

8. During tour of the Laundry Area at the Main Hospital with the Director of Housekeeping on 4/24/12 from 3:55 P.M. to 5:15 P.M., observations revealed the following infection control issues:

a. Outside the Sorting Room for dirty laundry was a plastic cart for personal protective equipment (gloves and gown). It contained 4 drawers, with one drawer that was broken. The outside of this cart was heavily dust laden. The inside drawers of the cart had a build up of dirt.

b. Washer #1 and Washer #2 each had a large build-up of detergent spillage, dirt, dust, and debris on, around and between them. The base of both washers had multiple areas of lint and cobwebs. There was a large puddle of stagnant water behind the washers, and a dirty glove on the floor. Interview with the Director of Housekeeping indicated there was a washer hose that had been leaking, but it was fixed a week ago. The hose was still leaking.

c. There were 2 upright fans both with a large build of black dirt on the fan blades, wire cage, and base of the fan.

d. The handwashing sink for the Laundry staff had an empty soap dispenser.

e. During an interview with the Director of Housekeeping, he stated he would have the Laundry Room cleaned up.

9. During tour of the Psychiatric Unit with the Nurse Manager (NM) #1 on 4/24/12 from 10:30 A.M. to 11:15 A.M., observations revealed the following infection control issues:

a. The Janitor's Closet had a string mop suspended over the handwashing sink and the mop strands were resting in the handwashing sink. The handwashing sink was dirty and there was a build up of dirt in the sink. There was no soap for hand washing by the sink. There was a toilet brush in a pail, and a used toilet plunger in a paper bag in this pail. There were clean mop heads stored in a dirty square plastic container which was dust laden.

b. During an interview with the NM #1, he stated that this was a patients' handwashing sink in the Janitor's Closet, and there should be soap available to the patients.

c. The staff bathroom had turn knob handles not blade handles as required.

d. The handwashing sink in the hall outside the Seclusion Room had no soap in the soap dispenser, as well as no paper towels or receptacle for paper towels.

e. The Comfort Room hand sanitizer was not working. During interview with NM #1 during the observation, the NM said that sometimes the battery did not work. He did not have it fixed.

10. During tour of the Dialysis Unit on 4/24/12 at 2:20 P.M., indicated that the staff bathroom had knob turn handles, not blade handles as required.

11. During a tour of the Sterilization Room on 4/25/12 at 1:10 P.M. and review of the cleaning schedule log for disinfecting the bronchoscopes ( a tube passed down a patient's throat into the bronchus of the lungs to view the lungs for abnormalities), and fibro-optic endoscopes ( a tube to view the patient's throat), indicated the facility failed to change the disinfectant every 14 days. In addition, observation of how the bronchoscope and endoscope were cleaned, indicated the facility failed to follow the manufactures guidelines for rinsing the scopes as follows:

a. Review of the Bronchoscope/Endoscope Cleaning Log Sign Off Sheet indicated the MetriCide Solution was last changed on 2/13/12, and not again until 3/28/12 (44 days). Manufacturer's Directions for Use (DFU) required each batch of the disinfectant to be used for only 14 days. The disinfectant should have been changed on 2/27/12, 3/12/12, and then again on 3/26/12. Two changes were missed, and the third change was two days late.

b. Observation of the simulated cleaning and rinsing procedure for the bronchoscope on 4/30/12 at 8:20 A.M., indicated that the bronchoscope was only rinsed once to remove the MetriCide solution, not 3 times as recommended by the manufacturer. The Director of Respiratory Therapy
said he did not know he was supposed to rinse the scopes three separate times, changing the water between each rinse.

c. During an interview with the Director of Respiratory Therapy on 4/30/12 at 8:30 A.M., he stated that he rinsed the bronchoscope once with large amounts of water, but was not aware it had to be rinsed 3 times.

12. Observation on the Hemodialysis Unit on 4/24/12 at 2:05 P.M., revealed a housekeeping staff member enter the Dialysis Unit, remove a pair of clean gloves from a box of gloves on the clean dialysis cart, and then leave the unit. The Housekeeper did not wash his hands before taking the gloves. This breech in infection control contaminated the box of gloves.

Interview with LPN (Licensed Practical Nurse) #1, on 4/24/12 at 2:20 P.M., indicated that the gloves on the dialysis cart were used by the Dialysis Nurses and Technicians to provide care for patients receiving dialysis. LPN #1 said that this was not acceptable infection control practice and the Housekeeper should have performed hand hygiene before accessing the clean glove box.

13. Observations of tracheostomy (cleaning of the breathing tube in the patient's neck), care for Patient #11, in the patient's room, by Respiratory Therapist (RT) #1, revealed that there were breeches with handwashing prior to performing tracheostomy care. In addition, the RT #1 was using outdated sterile water for tracheotomy care.

a. Review of the manufacturer's guidelines for Sterile Water irrigant indicated it was for single use only. Any unused portion was to be discarded.

b. Observation on 4/26/12 at 8:20 A.M., revealed that RT #1 left unit 5B with the Surveyor, pressed the outside elevator button to call the elevator. When the elevator arrived, the RT pressed the inside elevator button to go to the Dialysis Unit on the 3rd floor. Upon entering the Dialysis Unit, The RT failed to perform hand hygiene before donning gloves over her now contaminated hands. RT #1 performed tracheotomy care for Patient #11, with dirty gloved hands. The Surveyor pointed out to this RT that she did not wash her hands. This RT said, "I washed my hands upstairs." The RT was unaware of proper hand hygiene practice.

c. During an interview with RT #1 on 4/26/12 at 8:45 A.M., the Surveyor asked this RT, "What do you use the 250 cc (cubic centimeter) bottles of sterile water for, and what is your policy for usage of the sterile water?" RT #1 stated, "We use them for tracheotomy care, we date them when we open them. I don't know, we go through them so fast, it's 24 hours, we throw them out after 24 hours." She was not aware of the manufacturer's guidelines on the sterile water bottles that read, no antibacterial or other substances has been added. Discard unused portion immediately after use.

d. During an interview with the Infection Control Officer (ICO) on 4/26/12 at 10:00 A.M., she said she was aware that the 250 cc (cubic centimeter) bottles of sterile water were single use only. However, staff were not aware of this requirement.

14. Observation on 4/26/12 at 8:40 A.M., of CNA #1's hand hygiene practices revealed;

a. The Surveyor accompanied the CNA to the Hemodialysis Unit. This CNA operated the elevator, touching the buttons, going from the 5th to the 3rd floor. She entered the Dialysis Unit and did not perform hand hygiene before doing performing direct care. When the Surveyor asked her if she had washed her hands before performing Patient #11's direct care, she said, "No, I did wash my hands upstairs." The Surveyor reviewed with her how she contaminated her hands en route to, and in the Dialysis Unit. She said "I should have washed my hands and I will now."

During interview with the The Infection Control Officer (ICO), on 4/26/12 at 10:15 A.M., the ICO said that hand hygiene before donning gloves was a CDC requirement and staff should perform hand hygiene before they put on a pair of clean or sterile gloves.

15. Observation on Unit 5B on 4/26/12 at 9:25 A.M. indicated the chairs in the Nurses' Station were in disrepair.

At the Nurses' Station, four chairs had large pieces of the rubber on both armrests missing. There was white adhesive tape covering the ends of two of the armrests, to cover a piece of metal that was protruding from the armrests.

During an interview with NM #3, on 4/26/12 at 9:25 A.M., the NM said that she realized the chairs could not be adequately cleaned and disinfected, posing a health risk to staff.

16. During an interview with the ICO on 4/26/12 at 10:15 A.M., she was asked, When did you last inspect the Laundry Area at the Main Hospital? she stated, "In January 2011." She said that she had not inspected the Laundry Area since.

She was asked if she was aware of the infection control (IC) issues on the Psychiatric Unit. The ICO indicated that she was not aware of the IC environmental issues on that Unit.

The ICO was asked if she was aware that there was a number of knob type handle faucets throughout the Hospital. She stated that she knew there was a lot of knob handle faucets, and that they needed to be replaced with the required blade-type handles (blade type handles facility hand washing). However, this had not been done.

The ICO was asked if she had any assistance with monitoring handwashing and staff's IC practices. She said no, she performs all the observations. She said she does only 40 hand hygiene observations per month. She acknowledged that this was not a valid number of observations.

The ICO was asked if she was aware that the Hospital was using expired sterile water. The ICO said that staff needed to label the sterile water container with the date it was opened and that it could be used for 24 hours. She was not aware the sterile water was a one-time-only use.

The ICO was asked, if she checked that the hand sanitizer dispensers to ensure they were working and had contained sanitizer. She stated that she checks them randomly, but not all of them. Maintenance checks the battery and housekeeping fills the dispensers.

During interview with the Chief Executive Officer (CEO) and the Chief Clinical Officer (CCO) on 4/30/12 at 1:40 P.M., the CEO and CCO said that it had been identified that additional support was needed for the Infection Control Nurse. The CCO said that the Accrediting Agency had identified that the Hospital should have one full time equivalent (FTE) for every 100 beds, and they needed to hire another 0.5 FTE for IC.

Based on review of facility documentation and interview with the Infection Control Officer (ICO), the ICO failed to maintain a comprehensive log of incidents related to all infections and communicable diseases, for both patients and staff. Findings included:

1. Review of Hospital Infection control Logs for 1/2012 to 4/2012, indicated that the only infections tracked were those of positive laboratory cultures.

2. During interview with the Infection Control Officer (ICO), in the ICO's office, on 4/26/12 at 10:15 A.M., the ICO said that she only captured infections identified by positive cultures (i.e. catheter associated urinary track infection, (CA-UTI), blood stream infections (BSI), and sputum infections). She said the Director of Respiratory Therapy reviewed X-ray reports to capture ventilator associated pneumoniae (VAP).

The ICO said that neither she, nor the Director of Respiratory Therapy captured other infections (i.e., non-cultured eye infections such as pink-eye, flu, UTIs without a catheter, bronchitis, pneumoniae not associated with ventilators, and employee infections), although required.

The ICO also said that she does not keep a log for tracking and trending communicable diseases like measles, mumps, Hepatitis B, or chicken pox.

Based on review of policy and procedure and interviews, the Hospital failed to make timely referrals to the Organ Procurement Organization (OPO), as per the mutual agreement of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation, and in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor, and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose. Findings include:

1. Review of the Hospital's Organ and Tissue Donation Policy and Procedures, revised on 11/2010, timely notification means the Hospital must contact the OPO by telephone as soon as an individual has died or is declared brain dead or ideally within one hour.

2. Review of the 2011 data for reporting of deaths to the OPO indicated that for 6/2011, the compliance rate was 50%, for 7/2011, the rate was 67%, for 8/2011, the rate was 80%, for 10/2011 the rate was 20%, and for 11/2011, the rate was 67%. The overall compliance rate for 2011 was 69% for reporting of deaths to the OPO. No data was available for the first quarter of 2012.

3. Review of the hospital logs for reporting of deaths maintained by the nursing supervisors indicated the following: from 2/1/11 through 4/26/11, 33 of approximately 63 deaths were not reported within one hour per the policy. Nineteen deaths were reported within 1-2 hours and 14 were reported to the OPO after 2 or more hours. All were refused by the OPO.

4. Review of the log sheets indicated that the supervisors were directed to report all deaths within "two hours" to the OPO which was not in accordance with the Hospital policy and procedure. On 4/27/12 at approximately 12:00 P.M., during an interview, the Chief Clinical Officer said that this was not consistent with policy and would be fixed.

Based on record review and interview, the Hospital failed to evaluate data sent by the OPO on death reporting to identify areas for improvement and failed to monitor timeliness of referrals to the OPO for potential performance improvement. Findings include:

1. Review of the OPO reporting logs sheets indicated that the nursing supervisors were directed to report all deaths within "two hours" to the OPO which was not in accordance with the Hospital policy and procedure which required the Hospital to report deaths within one hour. On 4/27/12 at approximately 12:00 P.M., during an interview, the Chief Clinical Officer said that this was not consistent with policy and would be fixed.

2. Review of the 2011 data for reporting of deaths to the OPO indicates that for 4/2011, the compliance rate was 50%, for 7/2011, the rate was 67%, for 8/2011, the rate was 80% for 10/2011 the rate was 20%, and for 11/2011, the rate 67%. The overall compliance rate for 2011 was 69% for reporting of deaths to the OPO. No data was available for the first quarter of 2012.

3. Review of the hospital logs for reporting of deaths maintained by the nursing supervisors indicated the following: from 2/1/11 through 4/26/11, 33 of approximately 63 deaths were not reported within one hour per the policy. Nineteen deaths were reported within 1-2 hours and14 were reported to the OPO after 2 or more hours. All were refused by the OPO.

4. On 4/27/12 at approximately 12:00 P.M., during an interview, the Chief Clinical Officer said there was no performance improvement plan in place to improve the reporting process and timeliness of reporting.

Based on staff interview, review of Quality Assessment Performance Improvement (QAPI) Committee meeting minutes and data, and review of Contracted Services Listings, the Hospital failed to ensure that the QAPI program scope included all contracted services.
Findings included:

1. Review of QAPI Committee meeting minute and data, indicated that the contracted services of Ambulance, Clinical Staffing, Hospice, Laboratory, Radiology, Psychiatric, Building (Laundry/Housekeeping), Swallow Studies, and Infusion Therapy were not included in the program scope for QAPI, although required.

2. During interviews with Administrative Staff that included the Directors of Quality of the Off-site Campus and Main Hospital, the Chief Executive Officer, and the Chief Clinical Officer of the Main Hospital at 2:30 P.M. on 4/30/12, the above Administrative Staff said the aforementioned contracted services were not included in the program scope or monitored through the QAPI Committee.

Based on observations, review of Quality Assessment Performance Improvement (QAPI) Committee minutes, and staff interviews, the Hospital failed to develop and implement performance improvement activities for the problem-prone areas of the Laundry. Findings included:

1. Observations in the Laundry Area of the Main Hospital from 4:05 P.M. to 5:00 P.M. on 4/24/12, revealed a 25 by 2 foot trough for (gray) washing machine water. The trough contained a build-up of stagnant water, a build-up of lint and dirt, sewer flies, and a foul odor that smelled like sewer gas. The build-up of lint and dirt was blocking the flow of the gray water, causing the dirty wash water to remain in the trough.

Additionally, the floor, windowsills, ceiling and window fans were dirty with a build-up of lint, dust, dirt, and spider webs.

During the interview with the Director of Plant Operations during the observation, the Director said that the Laundry Area, including the trough, had not been cleaned or maintained for at least one year. He said the employee, who was responsible for maintaining the area left one year ago, and the area had not been maintained since that staff person left.

During interview with the Chief Operating Officer (CEO) and the Chief Clinical Officer (CCO) on 4/30/12 at 2:10 P.M., the CEO and CCO said that the problem prone issues in the Laundry Area had not been identified and brought to the QAPI Committee.

Please refer to A700.

Based on staff interview, observations and review of committee meeting minutes, the Hospital's Leadership Group failed to ensure that an ongoing program for Quality Assessment Performance Improvement (QAPI) was defined, implemented, and maintained for all contracted services. Findings include:

1. Observations in the Laundry Area of the Main Hospital from 4:05 P.M. to 5:00 P.M. on 4/24/12, revealed a 25 by 2 foot trough for gray (washing machine) water. The trough contained stagnant water, a build-up of lint and dirt, sewer flies, and a foul odor that smelled like sewer gas. The build-up of lint and dirt was blocking the flow of the gray water, thereby causing the dirty wash water to build-up in the trough.

The whole Laundry Area was very dirty as evidenced by the floor, windowsills, ceiling, and window fans were dirty with a build-up of lint, dust, dirt, and spider webs.

The Director of Plant Operations said that the trough and the Laundry Area had not been cleaned or maintained for approximately one year.

Review of the QAPI committee meeting minutes and data for 1/2012 to 4/2012, indicated that the condition of the Laundry had not been identified and monitored through QAPI. The documentation lacked performance indicators for the contracted Laundry Services.

Please refer to A084 and A700.

2. Review of listings of contracted services for the Main Hospital and Off-site Campus indicated that the Hospital was utilizing the services of the following: five ambulance companies; six clinical staffing companies; one hospice organization; three laboratories; three radiology organizations; one psychiatric service; one swallowing studies company, and one infusion therapy company.

3. Further review of QAPI minutes indicated that the hospital had not defined, implemented, and maintained a program for the above contracted services.

4. During interview with Administrative Staff that included the Chief Executive Officer, Chief Clinical Officer, Directors of Quality for both sites, and the Director of Rehabilitation at 2:10 P.M. on 4/30/12, the Administrative Staff said that they had not included the contracted services identified above in their QAPI program.