HospitalInspections.org

Based on observations, staff interview and review of documentation, the Hospital failed to ensure the Governing Body was effective. Finding include:

During interview on 5/6/15 at 10:15 A.M. the Chief Executive Officer (CEO) stated that the governing body is responsible for the overall conduct of the hospital. Review of the Governing Body bylaws, revised 3/12/15, read, "Purpose. As directed by the Managers, the Governing Body of the Hospital hereby establishes that the purposes of the Hospital shall be to lease, develop, acquire, manage and/or operate a hospital and other facilities for the care and treatment of patients..."

The Hospital's governing body failed to effectively ensure:

1. Patient Rights were followed for the safety needs of 5 Patients (#2, #8, #10, #19 and #20) out of 32 active patients as follows:
For Patients #2, #8, and #10 issues included poor response time for a ventilatory alarm; lack of upper limb restraints to prevent removal of the patient's tracheostomy tube; issues with peripherally inserted central catheter and gastrostomy tube; and not leaving a call bell within reach for a Patient assessed to be a high fall risk.

Investigating grievances of Patients (#19 and #23) were not met, and the use of physical restraints for Patient (#19) was not met.

Please refer to A 115, A 122, A 123, A 144, A 164, A 168, A 170, and A 175.

2. Infection Control was monitored and maintained in an effective manner for the prevention, control, and investigation of infections and communicable diseases.

Please refer to A 747, A 748, A 749, and A 756.

3. The Organ,Tissue and Eye Procurement Program was effective as related to having a trained and designated requestor for organ, tissue and eye donations, to collaborate with the Organ Procurement Organization, and to contact potential patient donors for anatomical gifts.

Please refer to A 888, A 889, A 891, and A 892.

Based on record review, observation and staff interview the Hospital failed to protect and promote each patient's rights. Findings include:

1. The Hospital failed to ensure Patient Rights were met for the safety needs of 3 Patients (#2, #8, and #10) out of 32 active patients regarding response time for a ventilatory alarm, upper limb restraints to prevent removal of the patient's tracheostomy tube, peripherally inserted central catheter, and gastrostomy tube, and leaving a call bell within reach for a patient assessed to be a high fall risk.

Please refer to A 144.

2. The Hospital failed to follow its specific time frames for the review and response to complaints/grievances for 2 inpatients (#19 and #23).

Please refer to A 122.

3. The Hospital failed to provide the patient/family member with written notice of its complaint decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the complaint, and results of the complaint process and date of completion for one inpatient (#23).

Please refer to A 123.

4. The Hospital failed to provide a comprehensive restraint assessment, monitor a patient in restraints and obtain a physician's order for 1 day for the use of physical restraints for Patient #19.

Please refer to A 164, A 168, A 170, and A 175.

Based on observations, review of policies, and interviews, the Hospital failed to consistently ensure a sanitary environment and staff adherence to infection control policies and procedures to prevent transmission of infections and communicable diseases related to: medication administration; adherence to infection control policies and procedures; proper cleaning of equipment and the environment; proper infection control practice with a PermaCath dressing change and dialysis rinse back, proper compliance with employee vaccinations, ensure annual employee fit testing for respirators, proper adherence to PPE (personal protective equipment), affecting 11 of of 32 Active Patients from a total sample of 41 patients, 17 of 33 employees, and 3 of 6 Physicians. Findings include:

According to the Infection Prevention and Control Plan, dated 10/2013, it indicated the goal of the Vibra Hospitals of Western Massachusetts Infection Prevention and Control Program is to reduce the risk of acquisition and transmission of Healthcare Associated Infections (HAIs). To accomplish this goal effectively required an integrated and collaborative effort by all departments of the organization.

1. The Hospital failed to ensure the following: Nurses performing dialysis had impervious gowns, patients with MRSA (Methicillin Resistant Staphylococcus Aureus) infections were cohorted or received their dialysis at the end of the day, glucometers were disinfected appropriately to prevent cross contamination, appropriate hand hygiene, prevention measures for ventilator associated pneumonia related to elevation of the heads of the patient beds were followed. Observations on 5/4/15 and interview with the Infection Control Nurse (ICN) indicated the Hospital failed to ensure that infection control policies were implemented for 6 Patients (#10, #19, #20, #22, #29 and #31) from a total sample of 32 Active Patients.

Please refer to A 748.

2. The Hospital failed to ensure the following; Staff performed hand hygiene prior to administering medications and after direct patient care, failed to disinfect the Endoscopy Cart after an endoscopic swallowing examination, prevent the cross contamination of a bedside table via terminal cleaning for a new admission, use a sporicidal disinfectant (for Clostridium Difficile-C-diff) when terminally cleaning patient rooms diagnosed with C-diff, maintain annual fit testing for N95 respirators, and up to date employee immunization and vaccination status. Observations on 5/4/15 and interview on 5/7/15 with the Infection Control Nurse (ICN) and staff indicated the Hospital failed develop a system for controlling infections and communicable diseases for 7 of 32 Active Patients (#7, #10, #20, #21, #27, #30, and #32), for 17 of 33 Employees, and for 3 of 6 Physicians (#2 and #6, ).

Please refer to A 749.

3. The Hospital failed to ensure the Infection Control (IC) Quality Assessment Performance Improvement (QAPI) program for hand hygiene at the Hospital's Satellite was accurately implemented.

Please refer to A756.

Based on staff interviews and review of documentation, the Hospital Satellite failed to ensure that it had an effective Organ, Tissue and Eye Procurement Program. Findings include:

1. The Hospital failed to provide evidence that 2 of 2 applicable sampled discharged patients (#2 and #3) and/or their authorized persons were contacted with the option of being donors of anatomical gifts on admission or in a timely manner.

Please refer to A 888.

2. The Hospital Satellite failed to train and assign a designated requestor in the hospital to initiate requests for organ/tissue/and/or eye donations from patients or their authorized family members.

Please refer to A 889.

3. The Hospital Satellite failed to work with the Organ Procurement Organization (OPO) to educate staff about donation issues.

Please refer to 891.

4. The Hospital Satellite failed to work collaboratively with the Organ Procurement Organization (OPO) in regularly reviewing and evaluating death records to improve identification of potential donors.

Please refer to A 0892.

Based on observation, record review, family and staff interviews, the Main Campus Hospital and the Hospital's Satellite failed to follow their specific time frames for the review and response to complaints/grievances for 2 of 32 sampled active patients (Patients #19 and #23.) Findings include:

Review of the Hospital's Complaints and Grievances Policy (dated 11/18/14) indicated that complaints/grievances (verbal or written) were to be acknowledged and documented, forwarded to the Administrator or designee immediately, recorded with the name, date, patient/family name, issues or concern on the Hospital's complaint/grievance log, assigned the appropriate Department Head to be investigated and notification to the patient or family member of the investigation's progress within 3 days of the initial complaint or grievance, with a resolution to the patient or family (which was to be recorded on the complaint/grievance log.)

1. For Patient #23, the Hospital failed to forward a complaint about staff physical abuse to the appropriate Administrator or designee, failed to log the name, date, patient/family name, and issues verbally provided to the hospital from the patient's family member onto the complaint/grievance log, failed to assign an investigator, failed to investigate the issues and failed to notify the family member about the progress or resolution of the patient's grievance.

Patient #23 was admitted to the hospital in 1/2014 with diagnoses that included paranoid schizophrenia, Post Traumatic Stress Syndrome, hypertension, hypothyroidism, and hallucinations.

Clinical chart review of 5/5/15 indicated that a verbal account was received by the Hospital's Human Rights Officer (HRO) on 3/12/15, which alleged staff physical abuse with injury to Patient #23. The 3/13/15 written Complaint Form indicated the HRO was asked by Patient #23's family member/Legal Guardian about Patient #23 being assaulted by staff, resulting in bleeding and bruising. The HRO indicated in the 3/13/15 report that he had met with Patient #23 in the morning of 3/12/15 (time unknown) and the patient revealed to him "a substantial bruise on the inside of the right upper arm that was 3" (inches) by 4" in length and very purple in color." The HRO reported the bruise to the RNs (Registered Nurses) on the unit for that shift (shift time unreported), the RNs stated they would look into it, and that Patient #23 had pain medication available if needed. Patient #23 said that the bruise occurred when "a big guy and two Spanish guys dragged me out of the program area." Patient #23 was unable to recall who the staff were exactly or when the event occurred, only that it was "a couple of days ago." The report indicated that these events were reported to the Unit Program Director (UPD) verbally on 3/12/15. The HRO also indicated that he offered to photograph the "client's" bruise on 3/12/15 but Patient #23 refused.

Review of the patient's clinical record indicated no inpatient progress record notes on 3/12/15 that described the complaint's events or any RN's examination of Patient #23's bruised right arm and/or pain medication administration for the injury.

During interview of 5/5/15 at 10:10 A.M., Unit Nurse Manager #1 said that he had not received any information about the complaint allegations regarding Patient #23 until 3/23/15 (or almost 11 days after the hospital received the complaint). He said he believed the patient received the injury to the right upper arm when the patient lunged towards and hit the medication room's half-door shelf on/or about 3/10/15.

During interview of 5/5/15 at 1:24 P.M., the UPD said that the HRO was on vacation. She said the complaint allegations of physical abuse by staff were not investigated pursuant to the hospital's complaint/grievances policy. She said she was unaware of the complaint allegations until 3/23/15. "We dropped the ball," she said.

During interview of 5/5/15 at 2:00 P.M., the Director of Risk Management said she did not receive information about the complaint until 3/26/15. She said the hospital did not follow its policy and procedures to forward the documented complaint to the hospital Administrator or Director of Risk Management, did not record the date, patient/family name and issues or concerns on the complaint log, did not assign the appropriate Department Head to investigate the complaint, did not notify the family about the progress of the investigation in three days, determine a resolution and record the notification of a resolution on the complaint log.

Please refer to A 123.

2. For Patient #19, the Hospital Satellite failed to forward a family complaint about the patient's hospitalization to the appropriate Administrator or designee, failed to log the name, date, patient/family name, and issues verbally provided to the hospital from the patient's family member onto the complaint/grievance log, failed to assign an investigator, failed to investigate the issues and failed to notify the family member about the progress or resolution of the patient's grievance.

Patient #19 was admitted to the Hospital Satellite in 4/2015 with diagnoses that included dementia, coronary artery disease, pneumonia, peripheral vascular disease, chronic respiratory failure, and Abdominal Aortic Aneurysm (AAA).

Review of the patient's Care Notes, dated 5/3/15 at 1:54 A.M., indicated that, at the change of shift, it was reported that the patient's hernia was popping through abdomen, and that the "daytime nurse was not comfortable pushing hernia due to patient's history of AAA in 2014." At 12:20 P.M., nursing staff went to check on the patient's hernia. Upon lifting patient's gown, there was a large amount of blood on patient's left side of gown and across patient's abdomen. After assessing the patient, nursing staff noticed the patient bleeding through the skin of the abdomen without any noticeable abrasion, wounds or openings. After putting pressure on the area, an attending physician arrived to assess the patient and a pressure dressing was applied to the abdomen. The patient was transferred to the local hospital at 1:50 P.M. and returned back to the Hospital Satellite at 8:35 P.M., confused and with bilateral wrist restraints attached.

Physician Progress Notes of 5/3/15 indicated the patient was transferred to the local hospital for an abdominal CAT (Computerized Axial Tomography) Scan, which did not reveal any intra-abdominal pathology.

There was no indication in the facility's Progress Notes that the patient's family was ever notified about the cause or results of the abdominal bleeding.

The patient was observed on 5/4/15 at 9:30 A.M., during the initial hospital tour, and at 11:35 A.M. the patient was observed in bed with the head of the bed elevated, with a tracheostomy, ventilator, and indwelling Foley catheter. The patient was alert but unable to verbally communicate. The patient was in bilateral wrist restraints. The patient's family member and former Home Health Aide were present at each time. The family member was engaged in a discussion at 11:35 A.M. with Nurse #2.

During interviews with the patient's family member on 5/4/15 at 9:30 A.M. and at 11:45 A.M., the family member said that the Hospital Satellite did not provide a response to his/her complaints about the reasons for the patient's abdominal bleeding. The family member said that he/she received a telephone message from the Hospital Satellite nursing staff on 5/3/15 at 1:15 P.M., that the patient had been transferred to the local hospital due to abdominal bleeding. The family member immediately traveled to the local hospital on 5/3/15, and hospital staff told him/her that they could find no cause for the reported abdominal bleeding (such as injection sites or puncture). The family member said that he/she had asked the satellite's staff upon his/her arrival, on 5/4/15, for an explanation for the patient's bleeding and was given none by nursing staff or a physician. At 11:35 A.M. on 5/4/15, Surveyor observed the family member complaining to Nurse #2 about the circumstances surrounding Patient #19's 5/3/15 local hospital admission. No information was provided to the family member at this time by staff.

During interview on 5/4/15 at 4:35 P.M., the Chief Clinical Officer said that the documented reason for the Patient's 5/3/15 transfer to the hospital was due to the patient being "unresponsive." During interview on 5/4/15 at 5:35 P.M., both the Chief Clinical Officer and Director of Quality Management said they were unaware about the family's repeated complaints about the reasons why the patient was sent to the local hospital for abdominal bleeding and the lack of immediate response by the Hospital Satellite to the family member.

Based on record review and staff interviews, the Main Hospital Campus failed to provide the patient/family member with written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the complaint, and results of the complaint process and date of completion for 1 of 41 sampled patients (#23.) Findings include:

Review of the Hospital's Complaints and Grievances Policy (dated 11/18/14) indicated that complaints/grievances (verbal or written) were to be acknowledged and documented with notification to the resident or family member of the investigation's progress within 3 days of the initial complaint or grievance, with a resolution to the patient or family (which was to be recorded on the complaint/grievance log.)

For Patient #23, the Hospital failed to notify the patient/family member with written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the complaint, and results of the complaint process and date of completion.

Patient #23 was admitted to the hospital in 1/2014 with diagnoses that included paranoid schizophrenia, Post Traumatic Stress Syndrome, and hypertension, hypothyroidism.

Clinical chart review indicated that a verbal account was received by the Hospital's Human Rights Officer (HRO) on 3/12/15, which indicated alleged staff's physical abuse to Patient #23, resulting in a 3 x 4 inch bruise on the right upper arm. The report indicated that these events were reported to the Unit Program Director (UPD) verbally on 3/12/15. The HRO reported in the report that he had met with Patient #23 on 3/12/15 (time unknown) and had seen the bruise on the right upper arm which was dark purple in color.

The HRO reported the bruise to the RN's (Registered Nurses) on the unit for that shift and the RN's said they would look into it, and that Patient #23 had pain medication ordered if needed. Patient #23 said that the bruise occurred when "a big guy and two Spanish guys dropped me out of the program area." The Patient was unable to recall who the staff members were or exactly when the event occurred.

Review of the patient's clinical record indicated no inpatient progress record notes of 3/12/15 that described the complaint report's events or any RN's examination of Patient #23's bruised right arm and/or pain medication administration for the injury.

During interview of 5/5/15 at 1:24 P.M., UPD said that the HRO was on vacation. She said the complaint allegations of physical abuse by staff were not investigated pursuant to the hospital's complaint/grievances policy.

During interview of 5/5/15 at 2:00 P.M., the Director of Risk Management said that the hospital failed to notify the patient/family member with written notice of its decision.

Based on interview, observation and record review, the Main Campus Hospital failed to provide care in a safe manner for 3 Patients (#2, #8 and #10) in a total sample of 32 active patients regarding response time for a ventilatory alarm, applying restraints as ordered, and leaving a patient's (at high risk for falls) call bell in reach. Findings include:

1. During observations on Unit #3 on 5/4/15 at 9:50 A.M., the Surveyor heard an alarm while walking in the hallway. The Surveyor entered Patient #2's room, saw the patient in bed, observed Patient #2's ventilator alarm sounding for the second time. The ventilator read "High Pressure" in red (which can be an indicator that a patient's tracheostomy needs suctioning). This Patient had a tracheostomy and was connected to a ventilator. There was no staff response to the ventilator's alarms.

A. During an interview on 5/4/15 at 9:50 A.M. with Patient #2, Surveyor #2 asked, "Are you OK?" This Patient said, "I am OK but I need to be suctioned." (Patient #2 pointed to his/her tracheostomy). This Patient said that they (staff) usually take 15 minutes to answer his/her call bell and that is too long to wait when you need to be suctioned. Patient #2 said, "Watch and wait; they won't come in to take care of me for at least 10 to 15 minutes." The Patient was able to talk to Surveyor #2. He/she was not turning in bed or coughing (which triggers the alarms) The high pressure alarm went off intermittently 3 more times from 9:50 A.M. to 10:07 A.M. (17 minutes). This Patient said that this is what usually happens it is OK to get the nurse to suction me now. The Surveyor asked a Nurse, who was talking at the Nurses Station, to come to Patient #2's room because of his/her need for suctioning. The Nurse went to the Patient's room and he/she was suctioned.

B. The Surveyor observed on 5/6/15 at 10:20 A.M., Respiratory Therapist (RT) #3 performing tracheostomy care for Patient #2. The RT demonstrated how the ventilators high pressure alarm sets off a red light in the hallway above the doorway, and how it alarms at the nurses station and illuminates a light there as well. The RT demonstrated how Patient #2's alarms were working. He said that when you hear this high pressure alarm, nursing staff need to come into the Patient's room to see if they are OK, if they need suctioning, if they are coughing or turning in bed.

C. During an interview with the Acting Chief Nurse on 5/6/15 at 5:00 P.M., she was asked about Surveyor observations regarding Patient #2 and patient interview. She said that this matter would be addressed.



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2. For Patient #8, the Main Campus Hospital failed to follow the Physician's order for wrist restraints to prevent Patient #8 from removing his/her medical needed tubes and dressings.

Patient #8 was admitted to the Main Campus Hospital in 4/2015 with the following diagnoses: high fall risk, respiratory failure, chronic pain, anxiety, depression and incontinence.

Review of the clinical record indicated the patient had a Physician's order since admission for 2 soft wrist/limb restraints to be applied at all times to prevent this patient from pulling out medically-needed tubes (a tracheostomy tube, PICC line (peripherally inserted central catheter), gastrostomy tube (G-tube) and dressings (PICC line and G-tube dressings). The order indicated that the restraints were to be checked and removed every 2 hours to conduct a skin check, then reapply as ordered.

The care plan indicated to include the patient in activities of daily living.

The restraint care plan and daily assessments were not implemented as follows:
- On 5/4/15 from 3:00-4:15 P.M., the patient was observed by the surveyor sitting in the wheelchair in the hallway without the wrist restraints on.
- On 5/5/15 at 2:45-3:40 P.M., the patient was observed by the surveyor again sitting in the hallway in the wheelchair without the wrist restraints on for safety.

Review of the daily restraint assessments for 5/4/15 and 5/5/15 had no indication when or if the restraints should be removed.

During interview on 5/5/15 at 9:30 A.M., the Nursing Supervisor said the Physician's order should have been changed if the hospital was going to trial a restraint reduction for the patient. The Nursing Supervisor said there were no changes to the restraint order. Review of the daily assessments indicated the patient was checked every 2 hours to ensure the wrist restraints were on per order.

3. Patient #10 was admitted to the Main Campus Hospital in 4/2015. Diagnoses included: high fall risk, diabetes mellitus, seizure disorder, chronic pain, C-Diff colitis, and anemia. The facility failed to follow the Falls Care Plan despite the patient being at high risk for falls (per Admission Nursing Assessment). The Admission Nursing Assessment indicated the patient was very confused and disoriented, had fallen within the last 30 days and was considered to be at high risk for falls. The Falls Care Plan of 4/23/15 indicated to place the call light within reach of the patient.

On 5/6/15 at 9:30 A.M., the surveyor observed the patient sitting alone in the bedroom. The patient's back was to the bed and the wrist restraints were not attached to the chair for safety due to getting up unassisted and falling. The surveyor observed that the call bell was lying on the bed with no way for the patient to reach it, unless he/she got up from the wheelchair. The surveyor asked the patient what he/she would do if help was needed. The patient said that he/she would "push a button, but it's not here right now."

Based on observation, record review, family and staff interview, the Hospital Satellite failed to provide a comprehensive assessment for the use of restraints for 1 of 1 applicable sampled patients (#19.) Findings include:

The hospital's policy and procedures on Restraint Use, dated 10/2013, indicated that restraints are only used when less restrictive interventions had been determined ineffective in protecting the patient, staff or others from harm, that a comprehensive assessment of the patient would be conducted that included: a physical assessment of the patient to identify medical problems that were causing behavioral changes in the patient, the risks associated with the use of restraints which outweighed the risk of not using them, that alternative interventions (do not have to be tried), but should be considered as part of the assessment, and that the use of restraints be in accordance with a physician's order

Patient #19 was admitted to the Hospital Satellite in 4/2015 with diagnoses that included dementia, coronary artery disease, pneumonia, peripheral vascular disease, chronic respiratory failure, and Abdominal Aortic Aneurysm (AAA).

Review of the Referring Hospital's Discharge Records, dated 4/29/15, indicated that wrist restraints had been administered in the referring hospital. When the patient was admitted to the Hospital Satellite at 7:53 P.M., the patient was immediately placed in soft bilateral wrist restraints, per the restraint Order and Flow Record of 4/29/15.

Observation of the patient on 5/4/15 at 9:30 A.M., during the initial hospital tour and at 11:35 A.M. indicated the patient in bed with the head of the bed elevated, with a tracheostomy, connected to a ventilator, and had an indwelling Foley catheter. The patient was alert but unable to verbally communicate. The patient was in bilateral wrist restraints.

During interview on 5/4/15 at 11:45 A.M., the patient's family member said that the patient had bilateral wrist restraints on at the referring hospital, and continually since admission in the Hospital Satellite because of agitated attempts by the patient to pull on the tracheostomy tubing.

During record review with and interview on 5/4/15 at 2:30 P.M., the Director of Quality Management said that there was no evidence that a comprehensive restraint assessment had been provided the patient prior to the use of bilateral wrist restraints.

Please refer to A 168.

Based on observation, record review, family and staff interviews, the Hospital Satellite failed to provide a physician's order for the use of restraints for 1 of 1 applicable sampled patients (#19.) Findings include:

The hospital's policy and procedures on Restraint Use, dated 10/2013, indicated that restraints are only used when less restrictive interventions had been determined ineffective in protecting the patient, staff or others from harm, and that the use of restraints be in accordance with a physician's order

Patient #19 was admitted to the hospital satellite in 4/2015 with diagnoses that included dementia, coronary artery disease, pneumonia, peripheral vascular disease, chronic respiratory failure, and Abdominal Aortic Aneurysm (AAA).

Review of Patient #19's clinical record, dated 5/1/15 at 11:26 A.M., indicated that the patient was "restrained secondary to agitation."

Observation of the patient on 5/4/15 at 9:30 A.M., during the initial hospital tour and at 11:35 A.M. indicated the patient in bed with the head of the bed elevated, with a tracheostomy, connected to a ventilator, and had an indwelling Foley catheter. The patient was alert but unable to verbally communicate. The patient had soft wrist restraints applied to each wrist.

During interview on 5/4/15 at 11:45 A.M., the patient's family member said that the patient had bilateral wrist restraints applied at the referring hospital, and continually since admission, at the Hospital Satellite because of agitated attempts by the patient to pull on the tracheostomy tubing.

During record review with and interview on 5/4/15 at 2:30 P.M., the Director of Quality Management said that there was no evidence that a Physician's Order had been provided for the use of wrist restraints on 5/1/15, although required. The Director of Quality Management indicated that physicians' restraint orders were to be renewed daily. The restraint order for Patient #19 was not renewed for 5/1/15.

Please refer to A 170.

Based on observation, record review, family and staff interviews, the Hospital Satellite failed to consult the attending physician as soon as possible if the attending physician did not order restraints for 1 of 1 applicable sampled patients (#19.) Findings include:

The hospital's policy and procedures on Restraint Use, dated 10/2013, indicated that restraints are only used when less restrictive interventions had been determined ineffective in protecting the patient, staff or others from harm, and that the use of restraints be in accordance with a physician's order. Communication with the attending physician is required as soon as possible if the restraint was not ordered by the physician.

Patient #19 was admitted to the hospital satellite in 4/2015 with diagnoses that included dementia, coronary artery disease, pneumonia, peripheral vascular disease, chronic respiratory failure, and Abdominal Aortic Aneurysm (AAA).

Review of Patient #19's clinical record, dated 5/1/15 at 11:26 A.M., indicated that the patient was "restrained secondary to agitation."

Observation of the patient on 5/4/15 at 9:30 A.M., during the initial hospital tour and at 11:35 A.M. indicated the patient in bed with the head of the bed elevated, with a tracheostomy, connected to a ventilator, and had an indwelling Foley catheter. The patient was alert but unable to verbally communicate. The patient had soft wrist restraints applied to each wrist.

During interview on 5/4/15 at 11:45 A.M., the patient's family member said that the patient had bilateral wrist restraints applied at the referring hospital, and continually since admission, at the Hospital Satellite because of agitated attempts by the patient to pull on the tracheostomy tubing.

During record review and interview on 5/4/15 at 2:30 P.M., the Director of Quality Management said that there was no evidence that a Physician's Order had been provided for the use of wrist restraints on 5/1/15, and no evidence that staff had consulted the attending physician when there was no Physician's order for the wrist restraints.

Please refer to A 175.

Based on observation, record review, family and staff interviews, the Hospital Satellite failed to provide evidence of monitoring the condition of 1 of 1 applicable sampled patients (#19) in restraints. Findings include:

The hospital's policy and procedures on Restraint Use, dated 10/2013, indicated that restraints are only used when less restrictive interventions had been determined ineffective in protecting the patient, staff or others from harm, and that the use of restraints requires documentation when restraints are initiated and throughout the episode of restraint use.

Patient #19 was admitted to the hospital satellite in 4/2015 with diagnoses that included dementia, coronary artery disease, pneumonia, peripheral vascular disease, chronic respiratory failure, and Abdominal Aortic Aneurysm (AAA).

Review of Patient #19's clinical record, dated 5/1/15 at 11:26 A.M., indicated that the patient was "restrained secondary to agitation."

Observation of the patient on 5/4/15 at 9:30 A.M., during the initial hospital tour, and at 11:35 A.M. indicated the patient in bed with the head of the bed elevated, with a tracheostomy, connected to a ventilator, and had an indwelling Foley catheter. The patient was alert but unable to communicate verbally. The patient had soft wrist restraints applied to each wrist.

During interview on 5/4/15 at 11:45 A.M., the patient's family member said that the patient had bilateral wrist restraints applied at the referring hospital, and continually since admission at the Hospital Satellite, because of agitated attempts by the patient to pull on the tracheostomy tubing.

During record review with and interview on 5/4/15 at 2:30 P.M., the Director of Quality Management said that there was no evidence that the hospital satellite documented and monitored the use of restraints for Patient #19 on 5/1/15.

Based on review of the Main Campus Hospital's QAPI (Quality Assessment Performance Improvement) program documentation (indicators included falls, restraints and hand hygiene), and interview with Main Campus Hospital staff indicated that not all of the indicators were tracked and trended through the QAPI program. Findings include:

Review of the data for falls indicated that falls increased from 3 falls in 12/2014, to 6 falls in 1/2015, 14 falls in 2/2015 and 16 falls in 3/2015. The Hospital did not conduct a root cause analysis or tracking and trending or develop a plan to reduce the number of increased falls.

Further review indicated that the Hospital had no methodology with time frames and a plan to reduce falls, restraint use and improve staff use of hand hygiene.

During interview on 5/7/15 at 11:15 A.M., administrative staff (CEO {Chief Executive Officer}, Director of Quality Management/Risk Management and Corporate Nurses) said that collected data was not broken down into subsets that would allow comparison of performance among hospital units for each of the indicators, thus finding which areas of the hospital may be deficient for falls, restraints and hand hygiene.

Based on record review and staff interview, the Hospital Satellite failed to conduct incident investigations and analysis for 2 of 5 Discharged patients who had experienced falls (#4 and #5). Findings include:

Review of the hospital's Risk Management Plan, approved 4/30/15. indicated usual occupancies such as falls and serious physical injury, must immediately be reported to the Administrator on call and or to the Director of Quality Management (DQM), that an unusual occurrence report be completed within the shift by the employee witnessing or initially assessing the occurrence by using the on-line reporting system, that the DQM coordinates the investigative process, assigns an appropriate investigator, that the investigation begins within 24 hours of the reports or notification of unusual occurrences to determine if it meets the criteria for a Sentinel Event (i.e., serious physical injury) and that a comprehensive analysis of the occurrence be completed in 45 days.

1. For Discharge Patient #4, the hospital satellite failed to investigate and analyze a fall resulting in a fracture. Findings include:

Discharge Patient #4 was admitted to the hospital satellite in 1/2014 with diagnoses of pneumonia, peripheral vascular disease, spinal stenosis, hypertension, bipolar disorder and degenerative joint disease.

Review of the Clinical Record indicated Physical Therapy staff had reported (date unknown) that the patient told them about his/her unwitnessed fall in the bathroom while toileting self on 2/14/14 or 2/15/14. Review of the clinical record indicated that on 2/16/14, the patient complained of increased pain to the buttocks and right hip pain. On 2/17/14, the patient was transferred to the local hospital and found to have a right hip fracture with modest displacement. The patient was discharged from the Hospital Satellite on 2/28/14.

During interview with the Director of Quality Management on 5/4/15 at 5:00 P.M., she said that although the incident of a fall with fracture was reported, the Hospital Satellite did not document the incident report, investigate or analyze this unusual occurrence, per the hospital's policy and procedures.

2. For Discharge Patient #5, the Hospital Satellite failed to investigate and analyze an unwitnessed fall. Findings include:

Discharge Patient #5 was admitted to the hospital satellite in 6/2014 with diagnoses of respiratory failure.

Incident Report Form of 8/30/14 at 11:05 P.M. indicated the patient had an unwitnessed fall in the bedroom and was found on the floor after an alarm sounded. The patient's left arm was twisted behind the patient. The patient had attempted to ambulate to get a drink of water. The patient was described as having "multiple falls" prior to the 8/30/14 fall. The remaining sections of the Incident Report were blank for the following sections:

-The section to be completed by the Department Head,
-Contributing Factors to the Fall section,
-Prevention considerations section,
-Outcome delineation analysis such as those ranging from No Adverse Outcome to Severe Outcome section,
-Signatures and Dates,
-and the Section to be completed by Quality/Risk Management Department.

During interview with the Director of Quality Management on 5/4/15 at 5:00 P.M., she said that although the incident of a fall was reported, the hospital satellite did not complete the incident report, investigate or analyze this unusual occurrence, per the hospital's policy and procedures.

Based on observations, staff interviews, and policy review, the Main Campus Hospital's Dialysis Unit failed to ensure that appropriate care and services were provided by staff members observed (Nurse #3) and Certified Clinical Hemodialysis Technician (CCHT)(#1), to protect patients' accesses from injury for 2 of 3 sampled hemodialysis patients (#11 and #12) in a total of 32 active patients and 9 discharged patients, during the rinse-back phase (returning blood back to the patient) of dialysis treatments. Findings include:

Review of the Termination of Treatment policy for Arteriovenous Fistulas and Grafts (AVF/AVG), as well as for Central Venous Catheters (CVCs) of (1/16/09) included the following:
- "While closely monitoring the access site, return blood through the arterial line either by gravity, or by applying gentle pressure to the saline bag."
- "Do not apply excessive pressure on the saline bag; this may cause damage to the access."

1. For Patient #11, admitted to the Main Campus Hospital in 4/2015, with a diagnosis of end stage renal disease, staff failed to reinfuse the Patient's blood per the Hospital's Contracted Dialysis Service policy during the rinse-back phase of dialysis.

On 5/4/15 at 10:20 A.M., the Surveyor observed CCHT #1 during the rinse-back phase of dialysis for Patient #11. CCHT #1 twisted the Normal Saline bag 2-3 times, then excessively squeezed the bag in order to reinfuse the Patient's blood quickly, and not per policy using gentle pressure or gravity.

2. For Patient #12, admitted to the Main Campus Hospital in 2/2015, with a diagnosis of end stage renal disease, staff failed to reinfuse the Patient's blood per the Hospital's Contracted Dialysis Service policy during the rinse-back phase of dialysis.

On 5/4/15 at 10:37 A.M., the Surveyor observed Nurse #3 during the rinse-back phase of dialysis for Patient #12. Nurse #3 twisted the Normal Saline bag 2-3 times very tightly, then excessively squeezed the bag in order to reinfuse the Patient's blood quickly, and not per policy using gentle pressure or gravity.

During interview on 5/4/15 at 12:10 P.M., the Dialysis Nurse Manager said that it is not good practice to twist and squeeze the saline bags during the rinse back phase of dialysis, as this practice could damage patients' accesses.

Based on record review and staff interviews, the Main Hospital Campus failed to develop and keep current nursing care plans for 9 of 32 sampled in-patients (#7, #8, #11, #13, #14, #15, #16, #17 and #24). Findings include:

1. Patient #24 was admitted to the Hospital in 6/2014 with diagnoses that included Diabetes Mellitus.

Clinical Record review indicated the patient was administered Metformin (a medication to reduce blood sugar levels) 500 milligrams (mg) twice daily and was also to have Finger Stick Blood Sugars (FSBS) drawn twice a day. Frequently, the patient refused medication and/or his/her FSBSs drawn.

Clinical chart review indicated the hospital had not developed or implemented a plan of care to address the resident diabetes mellitus and patient refusals to treat the diabetes mellitus.

During interview on 5/7/15 at 12:15 P.M., Unit Manager #1 said that the hospital should have developed a care plan to address the patient's diabetes mellitus and refusals to treat this diagnosis.


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2. Patient #7, admitted to the Main Campus Hospital in 4/2015, had the following diagnoses: respiratory failure with tracheostomy and ventilator dependent; end stage renal disease (ESRD); pressure sores; Insulin Dependent Diabetes Mellitus; and the gastrointestinal infection Clostridium Difficile (C-Diff). The facility failed to develop care plans for:

A. Falls, despite the patient being assessed at high risk for falls per initial Nursing Assessment due to requiring total assistance from staff for all activities of daily living (personal hygiene, bathing, positioning, transfers) and requiring the head of the bed being raised 30 degrees at all times.
B. Dialysis, despite the patient being dialyzed in the facility 3 days per week through a central venous catheter requiring catheter dressing changes and monitoring. The patient also was having issues with the patency of the CVC and difficulty with completing treatments because of it.

C. Infection (C-Diff) despite the patient being treated with the anti-infective medication Vancomycin.

During interview on 5/5/15 at 9:30 A.M., the Acting Chief Executive said that the care plans should have been developed.

3. Patient #8 was admitted to the Main Campus Hospital in 4/2015 with the following diagnoses: respiratory failure; chronic pain; anxiety, depression and incontinence. Review of the clinical record, indicated the facility failed to develop care plans addressing the following issues:

A. Depression, despite being treated with the antidepressant medication Sertraline. Review of the clinical record had no indication that this medication was being monitored for side effects.

B. Chronic Pain, despite being medicated with the narcotic pain relieving medication Hydromorphone 2 milligrams every 4 hours as needed for pain.

C. Urinary Incontinence, despite being documented on the Intake and Output Flow Sheets that from admission the patient had many incontinent episodes and staff were depending on the patient to tell staff when he/she felt the need to urinate.

D. Upon admission to the facility the patient had a Physician's order for 2 soft wrist/limb restraints to be applied at all times to prevent this patient from pulling out medically-needed tubes (a tracheostomy tube, PICC line (peripherally inserted central catheter), gastrostomy tube (G-tube) and dressings (PICC line and G-tube dressings). The order indicated that the restraints were to be checked and removed every 2 hours to conduct a skin check, then reapply as ordered.

On 5/4/15 from 3:00-4:15 P.M., the patient was observed by the surveyor sitting in the wheelchair in the hallway without the wrist restraints on.

The Restraints Care Plan and daily assessments were not revised prior to the removal of the wrist restraints. Review of the daily restraint assessments for 5/4/15 and 5/5/15 had no indication when or if the restraints should be removed.

During interview on 5/5/15 at 9:30 A.M., the Nursing Supervisor said the Physician's order should have been revised if the facility was going to trial a restraint reduction for the patient. The Nursing Supervisor said there were no changes to the restraint order.

On 5/5/15 at 2:45-3:40 P.M., the patient was observed by the surveyor again sitting in the hallway in the wheelchair without the wrist restraints on for safety.

4. Patient #11 was admitted to the Main Campus Hospital in 4/2015. Diagnoses included end stage renal disease, diabetes with diabetic foot ulcers, chronic pain, hypothyroidism, hypotension and anemia. The Hospital failed to develop care plans for dialysis, anemia, hypothyroidism, and hypotension. The Hospital also failed to follow the Actual Skin Integrity care plan regarding the patient's diabetic ulcers. The following care plans were not developed:

A. Dialysis, despite the patient receiving hemodialysis 3 days a week via a central venous catheter.

B. Hypothyroidism, despite receiving the thyroid medication Levothyroxine daily since admission.

C. Hypotension, despite receiving the cardiac medication Midodrine as needed for low blood pressure on a regular basis.

D. Anemia, despite receiving the injectable red blood cell enhancing medication Aranesp weekly at dialysis and the Iron supplement Ferrous Sulfate 325 milligrams daily.

E. Review of the Skin Integrity care plan included, "Keep patient off problem area, elevate heels." On 5/4/15 at 11:00 A.M. and 5/6/15 at 10:30 A.M., the surveyor observed the patient during the dialysis treatments (4 hours). The patient's feet were flat on the bed, allowing for direct pressure on the unstageable ulcers on both feet. On 5/6/15 at 4:00 P.M., the surveyor observed the patient lying in bed. Both heels were wrapped in gauze, but the legs were crossed and the heels were flat on the bed and not elevated to relieve pressure.

During interview on 5/6/15 at 3:45 P.M., the Acting Director of Nursing said that the dialysis unit is not involved in the care planning process, and that care plans such as bone/mineral, anemia, hypotension, hypothyroidism, and care of the central venous catheter are not developed.



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5. For Patient #13, the Main Campus Hospital failed to develop a care plan for a medical area of care.

Patient #13 was admitted to the Main Campus Hospital on 3/2015 with diagnoses including acute kidney failure, depression, drug abuse, alcohol abuse and anxiety.

Review of the 5/2015 Physician's orders indicated orders for Cymbalta (antidepressant) 30 mg twice daily, Trazadone (medication for depression and insomnia) 50 mg daily and Lorazepam (medication for anxiety) 1 mg every 8 hours as needed.

Review of the current care plans indicated there were no care plans for the following medical conditions; substance abuse, depression and anxiety.

During an interview on 5/7/15 at 1:30 P.M., the Acting Chief Nurse Executive (CNE) said she was aware that there were care plans not developed for some of the patient's medical conditions including mental health and substance abuse.

6. For Patient #14, the Main Campus Hospital failed to develop a care plan for a medical area of care.

Patient #14 was admitted to the Main Campus Hospital on 1/2015 with diagnoses including acute and chronic respiratory failure, diabetes, depression and anxiety.

Review of the 5/2015 Physician's orders indicated orders for Citalopram (antidepressant) 40 mg daily and Lorazepam 0.5 mg every 4 hours as needed.

Review of the current care plans indicated there were no care plans for the following medical conditions; depression and anxiety.

During an interview on 5/7/15 at 1:30 P.M., the Acting CNE said she was aware that there was not a care plan developed relative to the patient's mood.

7. For Patient #15, the Main Campus Hospital failed to develop a care plan for a medical area of care.

Patient #15 was admitted to the Main Campus Hospital on 4/2015 with diagnoses including acute and chronic respiratory failure, diabetes, mild dementia and bipolar disorder.

Review of the 5/2015 Physician's orders indicated orders for Trazadone 50 mg daily, Mirtazapine (antidepressant) 15 mg daily, Lamotrigine (medication for bipolar) 25 mg twice daily, Fluoxetine HCL (antidepressant) 10 mg daily and Paliperidone Palmitrate (antipsychotic medication) 117 mg monthly.

Review of the current care plans indicated there were no care plans for the following medical conditions; cognitive deficits related to mild dementia and mood disorder.

During an interview on 5/7/15 at 1:30 P.M., the Acting CNE said she was aware that there were some care plans not developed relative to mood disorders and dementia.

8. For Patient #16, the Main Campus Hospital failed to develop a care plan for a medical area of care.

Patient #16 was admitted to the Main Campus Hospital on 4/2015 with diagnoses including hypoxia, pneumonia, alcohol and substance abuse and depression.

Review of the 5/2015 Physician's Orders indicated orders for Lorazepam 1 mg every 8 hours as needed and Escitalopram Oxalate (antidepressant) 10 mg daily.

Review of the current care plans indicated there were no care plans for the following medical conditions; alcohol/substance abuse and depression.

During an interview on 5/7/15 at 1:30 P.M., the Acting CNE said she was aware that there were some care plans not developed relative to drug and alcohol abuse and mood.

9. For Patient #17, the Main Campus Hospital failed to develop a care plan for a medical area of care.

Patient #17 was admitted to the Main Campus Hospital on 4/2015 with diagnoses including left hip abscess, human immunodeficiency virus (HIV) and alcohol and drug abuse.

Review of the 5/2015 Physician's Orders indicated orders for Efavirenz (medication used to treat HIV) 600 mg daily, and Nafcillin (antibiotic) 2 grams daily.

Review of the current care plans indicated there were no care plans for the following medical conditions; infections and substance abuse.

During an interview on 5/7/15 at 1:30 P.M., the Acting CNE said she was aware that there were some care plans not developed relative to substance abuse and that there should have been a care plan in place addressing the management of the patient's infections.

Based on observation and interview for 4 Patients (#7, #11, #16, #20) out of a total of 32 active Patients, the Hospital failed to ensure that staff administered medications via feeding tube per Hospital policy and Physician orders, administered medications as ordered (2 hour and 40 minute delay). In addition, they failed to rotate injection sites for Heparin and Insulin to prevent injection complications and failed to order medications for the correct route of administration. Findings include:

1. Surveyor #2 observed a medication pass on 5/4/15 at 11:40 A.M., Registered Nurse (RN) #1 administered 5 medications to Patient #11, two hours and 40 minutes after they were ordered (scheduled) by the physician.

Review of the Hospital's Policy, "Medication Administration Program and Computerized Process, revised on 4/29/15, read, "Medication should be given within the following guideline: ...Routine: Given 60 minutes before or after at the next schedule administration time."

Patient #11 was admitted to the Hospital in 4/2015, pertinent diagnoses include; End stage renal disease, diabetes mellitus and right foot osteomyelitis (a bone infection).

Surveyor #2 observed RN #1 administer Patient #11's 9:00 A.M. medications at 11:40 A.M.; Ferrous Sulfate (an iron medication) 325 milligrams (mg) by mouth, Vitamin D 5,000 international units (IU) by mouth, Aspirin (a pain medication and anticoagulant) enteric coated 81 mg by mouth, Heparin (an anticoagulant) 5,000 units subcutaneous injection (scheduled every 12 hours - 9:00 A.M. and at bedtime), and Lantus insulin 16 units subcutaneous injection (schedule at 9 A.M. and bedtime).

Surveyor #2 interviewed RN #1 and asked why she was administering this Patient's 9:00 A.M. medication at 11:40 A.M. She said that this patient was in dialysis, and they wait until the patients are out of dialysis to administer their medications. She said there is a protocol to administer the patient's medications when they return from dialysis. When this Surveyor requested the protocol, RN #1 said, "Well it's really not written, and there is no way we can scan medications into the computerized medication administration record while the Patients are in dialysis."

Surveyor #2 interviewed the Acting Chief Nurse Executive (CNE) on 5/6/15 at 10:25 A.M. She said that medications can be given in the Dialysis Unit. The Acting CNE said that Patient #11's medication should have been administered in the Dialysis Unit, since those 5 medications were ordered by the Physician to be given at 9:00 A.M. In addition, the CNE said that medications need to be administered within 1 hour of the Physician's order (or no later than 10:00 A.M.), otherwise it was a medication error.

2. Surveyor #2 observed a medication pass on 5/4/15 at 11:40 A.M. with RN #1. She failed to rotate Patient #11's Lantus Insulin and Heparin injections (an anticoagulant medication), although required by Hospital policy.

Surveyor #2 observed that Patient #11's upper right arm had large areas of ecchymosis (black and blue marks). Patient #11 said it was from the injections, but he/she declined to have injections given into his/her abdomen secondary to indentations left after injections were administered. RN #1 administered 5,000 units of Heparin in this Patient's right upper arm, and then 2 seconds later, administered Lantus Insulin 16 units in this Patient's right upper arm, 1 inch below the Heparin injection.

Surveyor #2 asked RN #1, "Where were the previous doses of Insulin and Heparin given?" She said she did not know because there was no way to check where previous injections were given. The Surveyor asked, "Did you think that giving 2 injections in the same extremity 1 inch apart was acceptable practice?" She said she probably should have given the second one in the other arm.

Surveyor #2 asked the Acting CNE, "Where do you document rotation of Heparin and Insulin?" She said that there was no place to document rotation of sites in the electronic record but she would look into it.


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3. Review of the Satellite Hospital's Medication Administration policy on 5/4/15 indicated the following requirements for medications administered via feeding tube:

"Step 4. Check feeding tube for placement.
Step 5. Flush feeding tube with 20 to 30 milliliters (mls) of warm water.
Step 6. Instill medication using a syringe. Only one medication may be administered at a time."

For Patient #20, observation of medication administration via a feeding tube, at the Hospital's Satellite on 5/4/15 at 9:30 A.M., indicated that Licensed Practical Nurse (LPN) #1 failed to follow Hospital policy.

Prior to administering any mediation, LPN #1 did not check the feeding tube for placement and then flush the feeding tube with 23 to 30 mls of warm water. Although the medications were administered one at a time, after preparing several medications for administration, LPN #1 just administered the medications, eliminating Steps 4 and 5.



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4. For Patient #7, admitted to the Main Campus Hospital in 4/2015, the Hospital failed to order medications (unable to swallow) for the correct route of administration for the patient. Diagnoses include: comatose, gastrostomy tube, tracheostomy, and ventilator dependent.

The following medications were ordered to be given po (by mouth) despite the patient being unable to swallow and on aspiration precautions:

- Renvela, 0.8 gram packet po 3 times daily (phosphate binder).
- Atorvastatin Calcium, 40 mg. (milligrams) tablets po at bedtime (cardiac medication).
- Levetiracetam solution 500 mg. po every Mon-Wed-Fri. (anti-seizure medication).
- Diltiazem HCL 60 mg. tabs, one tab every 6 hours po (antihypertensive medication).

During interview on 5/5/15 at 10:00 A.M., the Nursing Supervisor said the patient was unable to swallow and that there shouldn't have been any po medications ordered. The surveyor and Nursing Supervisor discussed that the po transcription errors could lead to medication errors which could potentially cause harm to the patient.

5. For Patient #7, the Main Campus Hospital failed to rotate/document the Insulin and Heparin injection sites as well as the fingerstick sites.

Patient #7 was admitted to the Hospital in 4/2015 with a diagnosis of Diabetes Mellitus.

Review of the clinical record indicated the patient received 6 units of Lantus Insulin subcutaneously every 12 hours and 5000 units of Heparin subcutaneously every 12 hours.

There was no documentation in the clinical record that would indicate that injection sites were rotated.

During interview on 5/6/15 at 4:00 P.M., the Acting Chief Nurse Executive said that Insulin, Heparin and finger testing sites are not documented/rotated.


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6. For Patient #16, the Main Campus Hospital failed to ensure the appropriate route of administration for one medication.

Patient #16 was admitted in 3/2015 with diagnoses including aspiration pneumonia, dysphagia and a percutaneous endoscopic gastrostomy (PEG) tube.

Review of the 5/2015 Physician's Orders indicated an order for Escitalopram Oxalate (antidepressant) 10 mg by mouth (po) daily. The start date of the medication was noted to be 4/1/15.

Review of Physician's Progress note, dated 5/6/15, indicated the patient was to remain NPO (Nothing by Mouth).

During an interview on 5/7/15 at 1:30 P.M., the DON said the patient was NPO and was not able to take any medications by mouth at this time. She said the medication was ordered incorrectly and should have indicated to give the medication through the PEG tube.

Based on observation and interview, the Main Campus Hospital failed to properly maintain the medical records in a location that provided for the security of medical records and ensured the medical records were protected from fire and water damage. Findings include:

Review of the Hospital's Medical Record Retention Policy, with a revision date of 9/2014, indicated Vibra Healthcare provides guidance regarding retention of hospital medical records. Medical records are the property of the hospital and must be retained.

A tour of the Health Information Management (HIM) Department with the Director on 5/6/15 at 8:00 A.M. indicated the following:

-In the small medical records storage room off of the Director's office, the surveyor observed several stacks of medical records stored on open, uncovered shelves and tables. The Director indicated that these records were waiting to be processed and moved to the basement storage area.

-In the medical records storage room in the basement of the Main Campus Hospital, the surveyor observed multiple, tall, metal storage shelves containing medical record files. All of these shelves were open and uncovered in the front. The surveyor also observed multiple cardboard boxes on shelves. These shelves were uncovered and open. The Director indicated the cardboard boxes contained medical records.

During an interview on 5/6/15 at 8:45 A.M., the HIM Director said that, although both medical record storage areas had sprinkler systems in place, medical records were not protected from the potential of fire and water damage.

Based on observation and interview, the Hospital failed to have the same High Risk/High Alert Medication lists at the Main Campus Site and the Hospital Satellite. In addition, the Hospital failed to immediately terminate access to controlled drugs for personnel who diverted drugs (access was not denied until 7 days after the staff member left the Hospital). The Hospital failed to report a drug diversion to the State Board of Registration in Pharmacy (BORIP) and the State's Drug Control Program (DCP), as required. Findings include:

1. High Risk/High Alert Medications are those medications involved in a high percentage of medication errors and/or sentinel events and medications that carry a higher risk for abuse, errors, or other adverse outcomes.

Review of the Main Hospital Campus' policy for High Risk/High Alert Medications, with a revision date of 7/2011, listed 16 medications along with their Special instructions.

Review of the Hospital Satellite's approved list for High Risk/High Alert Medications, dated 5/30/14, approved by Pharmacy and Therapeutics on 5/30/2014. This list had only 9 medications (different from the Hospital Policy of 7/2011) with no special instructions to minimize error.

On 5/4/15 at 11:00 A.M., the Surveyor observed that the Hospital Satellite's Medication Room had a posted list of the High Risk/High Alert Medications.

On 5/6/15 at 2:15 P.M., the Surveyor observed 4 of 4 Medication Rooms at the Main Hospital with no posted list of High Risk/High Alert Medications.

Both Directors of Pharmacy indicated at the above aforementioned times that the High Risk/High Alert Policy approved by the Pharmacy and Therapeutics, dated 5/30/14, should replace the initial list in the Hospital Policy, dated 7/2011, and be posted at both hospitals and include actions to minimize errors.

2. The Hospital Satellite failed to immediately terminate access to controlled drugs for personnel who diverted drugs and failed to report a drug diversion to the State's Board of Registration in Pharmacy (BORIP) and the State's Drug Control Program (DCP), as required.

During a Surveyor interview on 5/4/15 at 2:30 P.M. with the Director of Pharmacy, he informed the Surveyor that a Registered Nurse (RN) was terminated for drug diversion. Although the diversion was reported to the Board of Registration in Nursing, it was not reported to the DCP, as required 105 CMR 700.005(A) and the BORIP, as required by 247 CMR 6.02(10). The relevant hospital policy for Reporting Diversions of Controlled Substances is a corporate policy and is not specific to Massachusetts hospitals.

During Surveyor interview, the Director of Pharmacy said on 5/4/15 at 2:30 P.M. that the Hospital Satellite failed to immediately terminate access to medications in the automated dispensing (MedDispense) cabinets. The policy, Access to Medications, indicates that access is eliminated within 7 days of termination and does not address individuals terminated for cause. The Surveyor inquired if an RN terminated for cause, needed to be immediately locked out of the HMS (Hospital) and MedDispense (Pharmacy) systems and reported to DCP and BORIP. The Director of Pharmacy said he would address the Drug Diversion Policy to report immediately and deny access to controlled substances for personnel who divert drugs.

Based on record review, observation and interview, the Hospital failed to maintain the physical environment in a manner to ensure the safety and well being of the patients. Findings include:

1. Surveyor #2 observed the following on the Psychiatric Rehabilitation Unit on 5/4/15, from 10:35 A.M. through 10:50 A.M., with Nurse Manager (UM) #1:

2. The Women's bathroom had a ceiling vent outside a shower stall that was dusty and not working.

3. The Men's Room had 7 cracked floor tiles outside of 2 shower stalls. The radiator and the switch plate were both rusty.

4. The Restraint Room Bathroom had 2 protruding faucets approximately 4 feet above the floor, and there was toilet plumbing protruding from the wall and approximately 4 feet above the floor. Both of these created safety hazards for suicidal patients.

5. Surveyor #2 interviewed UM #1 who said that the concerns in the bathrooms and the restraint bathrooms will be addressed.

6. Observation of Room 512, Bed B on Unit 5 on 5/4/15 at 10:45 A.M. indicated that the privacy curtain had reddish brown stains on it.

7. Observation in the Bronchoscope Cleaning Room on 5/5/15 at 9:35 A.M. indicated the bronchoscope and fiberoptic scopes were hanging in a rusted cabinet with peeling green paint. The sink basin for High level disinfectant sink had multiple specks of rust which would prevent adequate disinfection. The cabinets above this high level disinfectant sink had large areas of rust and peeled paint. On top of the negative pressure machine was a dirty filter screen which had not been discarded.

During interview on 5/5/15 at 9:35 A.M.. the Directory of Respiratory Therapy said that the cabinets and disinfectant sink were old and needed replacement.


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8. On Unit 3 on 5/4/15 at 9:30 A.M., the surveyor entered Patient #7's room. The patient's family member was in the room. The surveyor asked the family member how everything was going. The family member expressed satisfaction except for a puddle of the patient's tube feeding "that had dripped onto the base of the tube feeding pole and floor and had been there for about a week." The family member told the surveyor that housekeeping was asked to clean it up, and they told her that nursing staff should be cleaning it up. Nursing staff was telling the family member that housekeeping should be cleaning it. The surveyor looked at the base of the pole and floor. There was about a six inch area of pooled tube feeding formula on the base of the pole that had dripped onto the floor.

The surveyor saw the Nursing Supervisor in the hallway outside the door to the patient's room. The Nursing Supervisor entered the room to look at the pooled formula.

The surveyor entered the room again at 11:15 A.M. and the formula had been cleaned up.

Based on observation, interview and review of policies, the Hospital failed to ensure that facilities, supplies, and equipment were maintained in a functional and safe manner for 3 of 32 Active Patients (#10, #20, and #21.) Findings include:

1. The Hospital failed to protect and ensure that the container of finger stick test strips was not left opened when not in use, per manufacturer's directions for use (MDFU).

According to the MDFU, the container of test strips read, "Remove the test strip from the vial only when ready to test. Keep the glucose test strip vial tightly closed when not in use."

Patient #10 was admitted to the Hospital in 4/2015, with pertinent diagnoses that included Diabetes mellitus, seizure disorder and Clostridium Difficile (C. diff).

Observation of a finger stick blood sugar for Patient #10 on 5/4/15 at 12:10 P.M. indicated the cover of the test strips were left open in the hallway on a bedside table, from 12:10 A.M. to 12:24 A.M. (14 minutes).

During an interview with CNA #1 at the aforementioned time, she said that she did not close the test strip container.

2. Observation on the Psychiatric Rehabilitation Unit on 5/4/15 at 10:20 A.M. with Nurse Manager (NM) #1, Surveyor #2 observed in the Woman's Room a soap dispenser above 2 handwashing sinks that was full of soap but it was not working. It could not dispense soap.

On 5/4/15 at 10:40 A.M., Surveyor #2 interviewed NM #1. He tried to dispense soap from the dispenser, and he said that it was broken and needed to be fixed.

On 5/4/15 at 10:42 A.M., Surveyor #2 interviewed Housekeeper #1. She said that the soap dispenser in the Woman's Room had been broken for a week, and she had verbally told a Maintenance Man that it needed to be fixed.

On 5/4/15 at 10:50 A.M., UM #1 said that after our tour on the unit, an electronic work order had been submitted today by the Secretary, and that this was the formal way to get things fixed.


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3. For Patient #21, observations on 5/4/15 at 9:10 A.M. of the Patient's room at the Hospital's Satellite, indicated that the Director of Respiratory Therapy for the Satellite was checking the function of the oxygen (O2) saturation monitor (indicates the level of O2 in a patient's blood). The Director of Respiratory Therapy said that the monitor was not capturing Patient #21's O2 levels properly, and the alarm to indicate a low O2 saturation was not sounding. The O2 saturation monitor was switched to a functional monitor.

4. Observations on 5/4/15 at 2:30 P.M. at the Hospital's Satellite indicated that CNA #3 was searching for a Hoyer lift (a device to safely transfer patients in and out of bed). The CNA said she needed to transfer a patient, and she had searched all the corridors, patients' rooms and bathrooms but could not locate the Hoyer lift. The CNA said it was the only one in the Satellite.

5. For Patient #20, observation of a blood glucose test on 5/4/15 at 4:45 P.M., at the Hospital's Satellite indicated that two glucometers needed to be used. One glucometer was not working due to a low battery. Therefore, CNA #2 obtained a second glucometer to perform the test.

CNA #2 said she had taken the non-functioning glucometer from the charger in the storage room. CNA #2 said she had already replaced a previous glucometer that had a low battery. Thus, two glucometers were nonfunctioning due to low batteries.

At 5:15 P.M., the Chief Clinical Officer said that staff were supposed to return the glucometers to the chargers after use. The glucometers should always be ready for use.


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6. The Main Campus Hospital failed to maintain the laundry room equipment to ensure acceptable levels of safety and quality.

During a tour on 5/6/15 at 1:40 P.M. with the Plant Operations Manager, the following concern was observed in the laundry room;

Three large window fans in the clean side of the laundry room and one in the dirty side were observed having thick layers of dust and debris.

During an interview on 5/7/15 at 12:10 P.M., the Plant Operations Manager said that fans were dirty and would be added to the monthly maintenance cleaning schedules for all needed cleaning.

Based on observations, record review, review of Hospital policies, and interviews, the Infection Control Nurse (ICN) failed to ensure that infection control policies were implemented for 7 Patients (#10, #19, #20, #21, #22, #29 and #31) from a total sample of 32 Active Patients. Findings include:

Review of the Hospital policy titled "Initiation of Transmission Based Precautions" indicated the following:

"Gowns are to be worn to prevent contamination of clothing and protect the skin of personnel from blood and body fluid exposure. Gowns especially treated to make them impervious to liquids..."

1. The ICN failed to ensure that nurses performing dialysis procedures were provided gowns that were impervious to blood and bodily fluids (fluids could not seep through the cover gowns to contaminate personnel's clothing).

Observations at the Hospital's Satellite on 5/4/15 at 10:10 A.M. in the Dialysis Procedure Room indicated that both contracted dialysis nurses were wearing yellow precautions gowns. During the observation, Registered Nurse (RN) #7 said that they (dialysis staff) had been provided blue plastic (fluid impervious) gowns in the past, but the blue plastic gowns were taken away and the yellow gowns provided. RN #7 said, "We were instructed to wear these (yellow) gowns. I don't know why the blue plastic gowns were taken away. We haven't had the blue gowns for a long time."

On 5/4/15 at 10:20 A.M., together with the Chief Clinical Officer (CCO) of the hospital Satellite, the Surveyor ran water onto a yellow gown over a sink. The water seeped through the gown. The gown was found not to be impervious to fluids.

Upon Surveyor inquiry, the ICN did not give a reason for making the change from a blue plastic impervious gown to yellow pervious gowns for the dialysis staff.

2. During interview on 5/4/15 at 11:00 A.M., the ICN said that patients with Methicillin Resistant Staphylococcus Aureus (MRSA) infections should be cohorted (roomed together) or have their dialysis at the end of the daily dialysis schedule.

Observations at the Hospital's Satellite on 5/4/15 at 10:10 A.M. in the Dialysis Procedure Room indicated that two Patients (#20 and #31) were receiving dialysis. Medical record review indicated that Patient #20 was diagnosed with a MRSA infection, and Patient #31 was not. Patient #20 was not dialysized at the end of the dialysis schedule, although required. The Hospital created a risk for cross-contamination of MRSA to Patient #31.

The ICN failed to ensure that Hospital policy for cohorting patients with like infections or scheduling procedures for infected patients last of the day, was implemented.

3. Review of the Hospital policy titled "Preventing Glucometer (a device used to obtain Patients' blood sugar levels), Cross Contamination," indicated the following:

"Clean glucometer with a PDI bleach wipe three times: before bringing (glucometer) into patient's room; at the bedside; and again outside the room."

The full procedure read, "Perform hand hygiene, don gloves, take meter out the case, clean with a PDI wipe, place meter on table, remove gloves, perform hand hygiene....Don gloves, take supplies to room, perform (glucose) test, place meter on a solid surface in the patient's room, remove gloves, perform hand hygiene. Don gloves, open a PDI bleach wipe, clean meter while walking out of patient's room, place meter on table outside patient's room (not in storage box), remove gloves, perform hand hygiene. Take a new PDI wipe, don clean gloves, disinfect meter. Assure the meter stays wet for 4 minutes (use additional wipe if necessary)."

For Patient #20, a patient with MRSA, observations of a blood sugar test on 5/4/15 at 4:45 P.M., at the Hospital's Satellite, indicated that Certified Nursing Assistant (CNA) #2 failed to adhere to Hospital policy as follows:

After disinfecting the glucometer with a PDI wipe, CNA #2 failed to wait 4 minutes to allow the glucometer to dry. CNA #2 then donned a pair of gloves without first performing hand hygiene.

Upon beginning the test, the glucometer read "low battery." CNA #2 obtained another glucometer from another staff member and used it, without first disinfecting it with a PDI wipe.

After obtaining Patient #20's blood sugar, CNA #2 documented the results on the computer keyboard with the same contaminated gloves used to obtain the Patient's blood sugar level. CNA #2 failed to remove her gloves and perform hand hygiene prior to touching the computer keyboard, although required.

CNA #2 then took both glucometers from Patient #20's room without first disinfecting them. She then placed one glucometer in the glucometer storage box without prior disinfection, thereby contaminating the storage box. CNA #2 then took the second glucometer to the charger, and placed it in the charger without prior disinfection, thereby contaminating the charger.

The ICN failed to ensure all staff adhered to Hospital policy for use and disinfection of glucometers.

4. During interview on 5/4/15 at 12:30 P.M., the Director of Respiratory Therapy (RT) at the Hospital Satellite said that, although the Centers for Disease Control and Prevention (CDC) Guidelines for Prevention of Nosocomial Pneumonia recommenced the HOB (Head of the Bed) be at 30 to 45 degree angles, he wanted all beds of vented patients to be maintained at 35 to 45 degree angles (to prevent patients from developing aspiration pneumonia).

For Patients #19, #21, and #22, at the Hospital's Satellite, observation between 11:00 A.M. and 11:30 A.M. indicated the measuring device located on each patient's bed indicated the angle of the HOB was not at 35 to 45 degrees. The HOB for these patients ranged from 28 degrees to 30 degrees.

Additionally, medical record review for the above patients indicated that documentation of the level of the HOB only read "semifowlers (semi-sitting/reclined) ." There was no documentation to indicate that the HOBs were measured to identify the actual levels of the beds.

5. According to the Centers for Disease Control and Prevention (CDC) Guidelines for Prevention of Nosocomial Pneumonia, staff use of proper hand hygiene, the HOB of ventilated patients should be maintained between 30 and 45 degrees and measured each shift, and the inside of the patients' mouths should be cleaned on a regular basis.

The RT Director said that the Hospital did not have a protocol to provide guidance to staff for preventing ventilator acquired pneumonia (VAP).

For Patient #29, a Patient at the Hospital's Main Campus, medical record review indicated that the level of the HOB was only documented as semifowlers. There was no documentation of the actual angle of the HOB.

During interview at 11:45 A.M., RT #2 said that there was no way to ensure staff actually measured the HOB by degrees, and the HOB was only documented as semifowlers position (not an accurate measurement).


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6. At the Main Campus Hospital, Surveyor #2 observed Certified Nursing Assistant (CNA) #1 obtain a finger stick blood sugar (FSBS) from Patient #10. The following breeches were observed with cross contamination:

According to the policy on Preventing Glucometer Cross Contamination, undated, it read, "Clean Glucometer with PDI Bleach Wipes."

According to the manufacturer's guidelines for the PDI sani-cloth bleach wipes, the treated surface must remain visibly wet for a full 4 minutes.

Patient #10 was admitted to the Hospital in 4/2015. Pertinent diagnoses included Diabetes mellitus, seizure disorder Clostridium Difficile (C. diff.).

On Unit 3 on 5/4/15 at 12:10 P.M., Surveyor #2 observed CNA #1 take an unassigned bedside table in the hall to set up her supplies for a FSBS. CNA #1 applied a PDI bleach wipe to the bedside table until it was glistening wet. With the bedside table still wet, she then put a large (approximate 12 inch by 6 inch) glucometer kit with supplies on top of the table (without allowing the surface to dry for adequate disinfection).

CNA #1 then washed the glucometer with a PDI wipe and immediately turned the glucometer upside down; the CNA did not allow it to air dry before and after the Finger stick was obtained. The Nursing Supervisor said, "We disinfect it upside down to prevent the bleach from running into the machine." Surveyor #2 asked was this the manufacturers guidelines, and he said, "No."

CNA #1 used a lancet to obtain 2 finger sticks from Patient #10's left 2nd and 4th fingers (since there was an inadequate amount of blood for the 1st sample). CNA #1 then put the contaminated glucometer on the bedside table on the unoccupied bed (signage on the bed stated: "This bed was cleaned and disinfected [for the next patient]."

Based on observation, review of Hospital Policies, and staff interview, the Infection Control Nurse (ICN) failed to ensure the following for 7 (#7, #10, #20, #21, #27, #30, and #32) of 32 Active Patients:

1. Staff adhered to Hospital policy for hand hygiene and disinfection of equipment, and
2. Hand hygiene at the Hospital's Satellite was accurately monitored and measured.

Findings include:

1. Review of the Hospital's Hand Hygiene Policy indicated that "hands were to be decontaminated with alcohol based hand rub or soap and water as follows:
Upon entering a patient's room; prior to donning gloves; before preparing or handling any medications; before and after direct contact with patients; before exiting a patient's room; after contact with a patient's intact skin; after contact with inanimate objects (e.g., bed, curtains, bed rails, etc.); after handling contaminated equipment; and after removing gloves."

"Monitoring (of hand hygiene) will be done through visualization, demonstrations, and random audit tools."

2. Observations of medication administration for Patients #21 and #27, at the Hospital's Satellite, on 5/4/15 from 9:10 A.M. to 9:45 A.M., indicated the following:

a. For Patient #27, Licensed Practical Nurse (LPN) #1 failed to perform hand hygiene prior to administering medications to the Patient, after the LPN handled the computer scanner to scan the Patient's medications and identification bracelet, and then touched the keyboard to document on the computer.

b. For Patient #21, observations indicated:
-LPN #1 removed his gloves after taking Patient #21's blood pressure and failed to perform hand hygiene.

-LPN #1 donned another pair of gloves without first performing hand hygiene, and handled the computer scanner to scan Patient #21's identification bracelet. With now contaminated gloves (from the scanner), LPN #1 added the medication Lasix (for fluid removal) to apple juice, and administered the solution via a feeding tube, without first changing his gloves and performing hand hygiene.

-LPN #1 then individually scanned four additional medications, individually added each medication to apple juice, and individually administered the medications to Patient #21. LPN #1 failed to change his gloves and perform hand hygiene after each time he handled the computer scanner and before he administered medications, via a feeding tube to Patient #21.

3. For Patient #32, observations at the Hospital's Satellite, at 10:10 A.M. on 5/4/15, indicated that two nurses, LPN #3 and Registered Nurse (RN) #4 failed to adhere to the hospital's hand hygiene policy, during an assessment of the Patient's skin as follows:

a. LPN #3 donned a pair of gloves without first performing hand hygiene.

b. After turning Patient #32 on the side, RN #4 needed to clean feces from the patient's buttocks before the skin assessment. RN #4 changed her gloves without first performing hand hygiene.

4. For Patient #20, observations at the Hospital's Satellite at 4:45 P.M. on 5/4/15, indicated that Certified Nurse Assistant (CNA) #2 failed to adhere to hospital policy for cleaning two glucometers.

CNA #2 obtained two glucometers, as the first glucometer was not functioning, due to a low battery. CNA #2 placed both glucometers directly on Patient #20's (a patient with a drug resistant infection) bedside table.

Hospital policy required that glucometers be cleaned/disinfected with a PDI bleach wipe three times: before bringing (glucometer) into patient's room; at the bedside; and again outside the room.

CNA #2 did not clean/disinfect each glucometer after patient use and before storing the glucometers. Without first disinfecting the functioning glucometer, CNA #2 placed the glucometer in the storage box, creating a risk for cross-contamination of the storage box and supplies. Then, without first disinfecting the glucometer, CNA #2 placed the glucometer with the low battery directly into the charger, creating a risk for cross-contamination of the charger.

5. For Patient #30, observations at the Main Hospital Campus on 5/6/15 at 11:10 A.M., indicated that Rehabilitation Aide (RA) #1 failed to adhere to Infection Control Standards of Practice when she disinfected the Endoscopy Cart after an endoscopic (examination of the inside of the body by using a lighted, flexible instrument called an endoscope) swallowing examination.

After the procedure was completed, and wearing the same cover gown and gloves used to perform the examination, RA #1 proceeded to disinfect the cart without first removing her gown and gloves, performing hand hygiene and donning clean gloves. Additionally, while in the process of disinfecting the Endoscopy Cart, RA #1 returned to Patient #30's bedside to give him the telephone, then continued disinfecting the Endoscopy Cart from the point which she was at before returning to the Patient's bedside.

RA #1 did not remove her gloves and perform hand hygiene before patient contact and before and after contact with the Patient's environment (gave the telephone to the Patient), as required by Hospital Infection Control Policy.

Additionally, while wearing contaminated gown and gloves, RA #1 reached into the PDI disinfectant container and removed an additional wipe to complete disinfecting the Endoscopy Cart, creating a risk for cross-contamination.

After Surveyor intervention, RA #1 re-disinfected the Endoscopy Cart.


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6. Surveyor #2 observed on Unit #3 on 5/4/15 at 12:10 P.M., Certified Nursing Assistant (CNA) #1 obtain a finger stick blood sugar (FSBS) from Patient #10. CNA #1 then put the contaminated glucometer on the bedside table on the unoccupied bed (signage on the bed stated "This bed was cleaned and disinfected (for the next patient)."

CNA #1 used a lancet to obtain 2 finger sticks from Patient #10's left 2nd and 4th fingers (since there was an inadequate amount of blood for the 1st sample). CNA #1 then put the contaminated glucometer on the bedside table on the unoccupied bed (signage on the bed stated "This bed was cleaned and disinfected (for the next patient)." This had the potential of cross contamination of a bedside table for another patient.

During an interview with CNA #1 on 5/4/15 at 12:10 P.M., she said that she not aware that she contaminated a bedside table for another patient.

7. Surveyor observation on Unit 5 in Room 512 bed B with the Director of Plant Operations on 5/4/15 at 10:45 A.M. indicated that the privacy curtain had reddish brown stains on it (contaminated). This bed had been vacant since 4/30/15 and was terminally cleaned. The curtains were not replaced with clean curtains for the next patient.

Review of the Contracted Housekeeping Procedure for Terminally Cleaning Patient Rooms indicated to remove cubical curtain as required.

The Surveyor interviewed the Director of Housekeeping on 5/7/15 at 1:30 P.M. who said that the curtain should have been removed as part of the cleaning process.

8. Surveyor #2 interviewed Housekeeper #1 on 5/4/15 at 10:35 A.M. and Housekeeper #2 on 5/6/15 at 10:40 A.M., both said the hospital beds are terminally cleaned (cleaned between patient occupancy) with Spic and Span Disinfectant, an EPA (Environmental Protection Agency) approved agent. This disinfectant is not sporicidal and would therefore not kill the Clostridium Difficile (C. diff) toxin (a very contagious spore on high touch surfaces).

Review of the manufacturers guidelines for the Spic and Span Disinfecting All-Purpose Spray and Glass Cleaner indicated it was an EPA approved agent. It is a bactericide and virucide (it kills bacteria and viruses), and it can kill some fungi. However, it is not sporicidal (it does not kill spores), and it would not be effective against C. diff.

Review of the contracted housekeeping's policy for Terminal Cleaning and Isolation Room Cleaning Procedure, undated, indicated to prepare and use disinfectant solution. It does not specify that the disinfectant has to be EPA approved or that it needs to be bacteriocidal, virucidal, tuberculocidal and sporicidal to address the pathogenic microorganisms in the hospital environment.

Surveyor #2 interviewed the Director of Housekeeping on 5/7/15 at 1:20 P.M., he said that the disinfectant for terminal cleaning is bleach which is sporicidal; however, this is inconsistent with what Housekeeper #1 and #2 had said earlier.

Review of the infection control surveillance data for C. diff. indicated there were 3 new cases in the first quarter of 2015 and 3 additional cases in just the 1st month of the second quarter (April 2015). The infection control action to address the increase in C. diff in the hospital was to review the room signage and increase hand hygiene audits. There was no evaluation of the environmental surface disinfectants to kill this spore (C. diff.).

9. According to the Hospital Policy, Standard Precautions, dated 10/2013, read under Hand Hygiene, "Perform hand hygiene immediately after gloves are removed, between patient contacts and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. It is necessary to perform hand hygiene between tasks and procedures on the same patient to prevent cross-contamination."

Surveyor #2 observed on 5/4/15 at 11:40 A.M., Registered Nurse (RN) #1, with clean gloved hands, contaminated her hands by using both hands to lift the lid on a trash receptacle to discard an alcohol wipe. RN #1 then administered Patient #11's two injections Lantus insulin and heparin into the patient's arm without washing hands or changing gloves.

Surveyor #2 interviewed RN #1 on 5/4/15 at 11:45 A.M., who said that she understood the infection control issue with handwashing.

10. The Hospital's Infection Control (IC) Program required annual testing of staff for Tuberculosis (TB), annual fit testing for N95 respirators (used by staff to care for patients with TB) and annual flu vaccination. Personnel file review on 5/6/15, indicated the following:

-The Director of Respiratory therapy, at the Hospital Satellite was last N95 fit tested on 12/12/13, or over two years ago. The IC Program required staff to be fit tested annually.

-Respiratory Therapist (RT) #1, at the Hospital Satellite, was last fit tested for an N95 respirator on 7/21/12, three years ago. Additionally, RT #1's file lacked documentation of annual flu vaccination since 10/11/12.

-RN #4, at the Hospital Satellite, received a TB skin test on 4/2/14. However, the test was not read for a determination of TB exposure, as required.

-Surveyor #2 reviewed Physician #2's employee record and found no evidence of a Hepatitis B vaccination status.

-Surveyor #2 reviewed Physician #6's employee record and found no evidence of the following: Medical evaluation and history of immunization status, Hepatitis B and influenza vaccination information

-Surveyor #2 interviewed Secretary #1 on 5/7/15 at 2:00 P.M. who said that she could not find the needed information in Physician #2's and #6's health record.



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11. Review of the Main Campus Hospital's policy, "Management of the Environment-Patient known or Suspected of C. difficile" included:

- "Hand sanitizers are not effective on C. Difficile. Wash with soap and water."

Review of the Main Campus Hospital's policy, "Standard Precautions" included:
- "HAND HYGIENE" - If hands are visibly soiled, wash with soap and water after touching blood, body fluids, secretions, excretions and contaminated items whether or not gloves are worn. Perform hand hygiene immediately after gloves are removed, between patient contacts and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. It is necessary to perform hand hygiene between tasks and procedures on the same patient to prevent cross-contamination."

For Patient #7, the Hospital failed to follow their policy during a dressing change observation.

Patient #7 was admitted to the Hospital in 4/2015. Diagnoses include: C. Difficile, tracheostomy, vent dependent and a Stage 3 pressure on the buttocks/sacral areas.

On 5/5/15 at 10:00 A.M., the surveyor observed the facility's Wound Nurse change the dressing on the patient's buttock/sacral area.

The Wound Nurse did not disinfect the bedside table prior to placing a clean field and dressing supplies on it. After changing the dressing on the tracheostomy, the Wound Nurse used the antiseptic gel to clean her hands and donned clean gloves. The old dressing on the buttocks/sacrum was removed. It was soiled with old stool (C. Difficile infected). The Wound Nurse disposed of the old dressing and removed her gloves. She used the antiseptic gel to disinfect her hands and donned clean gloves (She did not wash her hands with soap and water per facility policy.) During the cleaning and dressing of the wound, the patient had several episodes of loose stools. The Wound Nurse cleaned the patient each time, then used the antiseptic gel to disinfect her hands after removing her gloves, instead of washing with soap and water per facility policy. The wound was properly dressed, and the patient was repositioned in bed.

During interview on 5/5/15 at 2:30 P.M., the surveyor had reviewed the policy for C-Difficile which indicated that a disinfectant gel does not kill the spores in the stool of C-Difficile patients. The Wound Nurse said that she should have washed her hands with soap and water during the dressing change instead of using the disinfectant gel.

12. For Patient #7, hospital staff failed to change the patient's central venous catheter (CVC) dressing prior to a dialysis treatment per the Hospital's Contracted Dialysis Service policy and procedure.

The Main Campus Hospital's Contracted Dialysis Service policy and procedure, "Changing Central Venous Catheter Dressing" dated 1/16/09 included:
- Remove old dressing to assess for signs of infection. Discard old dressing and gloves in appropriate waste container.
- Wash hands and apply clean or sterile gloves.
- Using a circular motion around the catheter, rotate the germicidal soaked gauze (Chloraprep Swab) starting at the center and working outward to clean a 2 inch area around the exit site to prevent contamination.

- Repeat former step until all crusting and exudate is removed. Caution. Do not wipe over a cleaned area with the same gauze to prevent potential cross contamination.

Review Manufacturer's Directions For Use (MDFU) on the Chloraprep Swabs inserts indicates there is a dry time for at least 2-3 minutes before applying a new dressing to prevent the patient's skin from an adverse reaction (blistering).

Patient #7 was admitted to the Hospital in 4/2015 with a diagnosis of end stage renal disease.

On 5/4/15 at 11:25 A.M., the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #1 conduct Patient #7's CVC dressing change prior to the dialysis treatment. When the old dressing was removed, it was examined and discarded. The catheter entered the patient's right chest in two places. CCHT #1 wiped around both catheter insertion sites with one Chloraprep Swab, starting in the center and moving outward, then back to the insertions (recontaminating the sites and cross contaminating between sites). CCHT #1 waited for about 45 seconds for the areas to dry (and not 2-3 minutes per MDFU), then placed the small sponges over the 2 insertion sites. The area was covered with a clear dressing.

During interview on 5/4/15 at 12:15 P.M., the Dialysis Nurse Manager said that CCHT #1 should have used separate Chloraprep Swabs for each site and should not have returned to the insertion site after cleaning the periphery of the sites. The Dialysis Nurse Manager also said that the dry time was not long enough and should have been allowed to dry per MDFU.



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13. The Main Campus Hospital failed to maintain a sanitary environment to minimize the potential for transmission of infections and communicable diseases to patients and personnel.

During a tour on 5/5/15 at 10:30 A.M., the surveyor observed 4 portable oxygen tanks stored directly on the floor of the 5th floor oxygen storage room.

During a second tour of the environment with the Plant Operations Manager on 5/6/15 at 1:40 P.M., the following observations were made:

-the sorting side of the laundry room did not have an exhaust fan on to maintain a negative pressure.

-the 5th floor oxygen storage room had one portable oxygen tank stored directly on the floor and 2 others stored on top of a trash receptacle.

During an interview on 5/7/15 at 9:30 A.M., the Plant Operations Manager said that the laundry's sorting room has not been monitored for ventilation, and the exhaust fan was not being turned on by the staff. He said the ventilation will now be monitored weekly. He also said that the portable oxygen tanks should not have been stored directly on the floor and trash receptacle, and it would be monitored.

14. For Employee #16, #17 and #25, the Main Campus Hospital failed to ensure evidence of Measles, Mumps, Rubella (MMR) and Chicken Pox immunizations and/or positive titers.

Review of the Main Campus Hospital's Employee Medical Records Policy, dated 4/2007, indicated the employee medical record will contain a medical evaluation and history of immunization status.

Employee #16 was hired by the Main Campus Hospital in 5/2000 and is presently working as the Director of Food Service.

Review of the employee's Health File on 5/5/15 indicated there was no evidence of MMR and Chicken Pox vaccinations or titer testing.

Employee #17 was hired by the Main Campus Hospital in 9/2004 and is presently working a Dietitian.

Review of the employee's Health File on 5/5/15 indicated there was no evidence of MMR and Chicken Pox vaccinations or titer testing.

Employee #25 was hired by the Main Campus Hospital in 8/2003 and is presently working as the Director of Health Information Management.

Review of the employee's Health File on 5/6/15 indicated there was no evidence of MMR and Chicken Pox vaccinations or titer testing.

During an interview on 5/6/15 at 4:30 P.M., the acting Director of Human Resources said that if there wasn't evidence of immunizations in the employees medical files then the information is not available. She said the immunization evidence should be in the files as indicated in the policy.

15. For Physician #3, the Main Campus Hospital failed to maintain evidence of current Tuberculosis (TB) testing and Fit Testing.

Physician #3 was reappointed to the Main Campus Hospital on 7/1/13 for two years with department associations in Pulmonary and Critical Care Medicine.

Review of Physician #3 Health File on 5/7/15 indicated there was no current TB screening.

During an interview on 5/7/15 at 1:15 P.M., the Medical Staff Office Coordinator said she was unsure if the Physician's medical file was up to date and if the current TB testing documentation was available. She was unsure if the Physician had recent Fit Testing done

16. For Physician Assistant (PA) #1, the Main Campus Hospital failed to ensure evidence of MMR, Chicken Pox and Hepatitis B immunizations, vaccines and/or positive titers.

PA #1 was reappointed to the Main Campus Hospital on 9/27/14 for two years with a medical department association.

Review of PA #1 Health File on 5/7/15 indicated there were no current evidence of immunizations for Hepatitis B, MMR or Chicken Pox and no evidence of titer test being done.

During an interview on 5/7/15 at 1:15 P.M., the Medical Staff Office Coordinator said she was unsure if the PA's medical file was up to date and if current immunization and testing documentation were available.



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17. For Physician #1, the Main Campus Hospital failed to ensure evidence of a Hepatitis B vaccine and immunization record.

Physician #1 was hired by the Main Campus Hospital as Director of Medical Staff with re-appointment in 3/2014.

Review of the Physician's medical record indicated no evidence of a Hepatitis B vaccine and immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the Physician had a Hepatitis B vaccine and immunization record.

18. For Physician #5 the Main Campus Hospital failed to ensure evidence of a Hepatitis B vaccine and immunization record.

Physician #5 was hired by the Hospital as a Physician of Internal Medicine in 4/2014.

Review of the Physician's medical record indicated no evidence of a Hepatitis B vaccine and immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the Physician had a Hepatitis B vaccine and immunization record.

19. For Registered Nurse #2, the Main Campus Hospital failed to ensure evidence of a Hepatitis B vaccine.

Registered Nurse #2 was hired by the Hospital in 3/2014.

Review of the Nurse's Medical File on 5/6/15 indicated no evidence of a Hepatitis B vaccine.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the Registered Nurse had a Hepatitis B vaccine.

20. For Certified Nursing Assistant (CNA) #4, the Main Campus Hospital failed to ensure evidence of an immunization record.

CNA #4 was hired by the Hospital in 11/1994.

Review of the CNA's Medical File on 5/6/15 indicated no evidence of an immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the CNA had an immunization record.

21. For Registered Nurse #6, the Hospital Satellite failed to ensure evidence of an immunization record.

Registered Nurse #6 was hired as the Chief Clinical Officer by the Hospital in 5/2014.

Review of the Nurse's Medical File on 5/6/15 indicated no evidence of an immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the Registered Nurse had an immunization record.

22. For Social Worker (Employee) #29, the Main Campus Hospital failed to ensure evidence of an immunization record.

Social Worker (Employee) #29 was hired by the Hospital as the Psychiatric Unit's Program Director in 8/2012.

Review of the Social Worker's Medical File on 5/6/15 indicated no evidence of an immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the Social Worker had an immunization record.

23. For CNA (Employee) #32, the Main Campus Hospital failed to ensure evidence of an immunization record.

Employee #32 was hired by the Hospital as a Rehabilitation Technician in 10/1985.

Review of the CNA's Medical File on 5/6/15 indicated no evidence of an immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the CNA had an immunization record.

24. For Administrator #31, the Main Campus Hospital failed to ensure evidence of TB (Tuberculosis) testing and an immunization record.

Administrator (Employee) #31 was hired as the Chief Executive Officer (CEO) in 12/2014.

Review of the CEO's Medical File on 5/6/15 indicated no evidence of TB testing and an immunization record.

During interview on 5/6/15 at 3:30 P.M., the Staff Educator said that there was no evidence that the Hospital ensured the CEO (Chief Executive Officer) had TB testing and an immunization record.

Based on record review and staff interviews, the Hospital Satellite failed to provide evidence that 2 of 2 applicable sampled discharged Patients (#2 and #3) and/or their authorized persons were contacted with the option of being donors of anatomical gifts on admission or in a timely manner. Findings include:

The hospital's undated Organ and Tissue Donation Policy indicated that on admission, the patient or person authorized to make an anatomical gift on behalf of the patient shall be asked if the patient is a donor; the patient/family's donation preference will be documented in the section of the medical record as determined by the hospital, and if the patient/family wishes to sign a consent for donation on admission, they may do so utilizing appropriate consent forms. If the patient/family wishes more information regarding organ donation, they will be referred to Social Services, or their designee.

Review of the Organ Procurement Organization's Process Measures for 2014 on 5/4/15 indicated the hospital satellite had 17 deaths in 2014, but no family approaches for pre-referral for organ, eye and tissue donations in 2014.

Record review of Discharge Patient Records #2 and #3 on 5/4/15 (who expired and who were identified by the hospital satellite as potential OPO donors) indicated no evidence the patients and/or their authorized family members were contacted about the OPO process.

During interview on 5/4/15 at 1:00 P.M. (and telephone interview on 5/12/15 at 3:00 P.M.), the Director of Case Management said that the Hospital Satellite did not provide patients or their authorized persons information about organ donations or referrals.

During interviews on 5/4/15 at 5:15 P.M., the Chief Clinical Officer said that neither discharged Patients #2 and #3 were provided information about becoming an anatomical organ donor.

Please refer to A 889.

Based on record review and staff interviews, the Hospital Satellite failed to train and assign a designated requestor in the hospital to initiate requests for organ/tissue/and eye donations from patients or their authorized family members. Findings indicate:

Review of the Organ Procurement Organization's (OPO) Process Measures for 2014 on 5/4/15 indicated the hospital satellite had 17 deaths in 2014, but no family approaches for pre-referral for organ, eye and tissue donations in 2014.

For example, there was no evidence that the hospital satellite maintained organ procurement (OP) tracking identifying actual potential donors, date and time of death, date and time that the OPO was notified, the name of the person the hospital spoke to about the potential donation, the outcome of the OPO decision, and the designated referring person.

During interview on 5/4/15 at 1:00 P.M. (and telephone interview on 5/12/15 at 3:00 P.M.), the Director of Case Management said that she thought that nursing staff just called an 800 telephone number at the time of patient death.

During interviews on 5/4/15 at 5:15 P.M., the Director of Quality Management said that no one had been designated in the Hospital Satellite to initiate family contacts or referrals to the contracted Organ Procurement Organization (OPO), nor had any staff been trained by the OPO as a designated requestor, as required.

Please refer to A 891.

Based on record review and staff interviews, the Hospital Satellite failed to work with the Organ Procurement Organization (OPO) and educate staff about donation issues. Findings indicate:

During interview with the Director of Quality Management on 5/7/15 at 3:00 P.M., she said that there had not been an actual process of working collaboratively with the OP0 in educating hospital satellite staff about donation issues.

Please refer to A 892.

Based on record review and staff interviews, the Hospital satellite failed to show evidence that it worked cooperatively with the Organ Procurement Organization (OPO) in regularly reviewing and evaluating death records to improve identification of potential donors. Findings indicate:

During interview on 5/4/15 at 1:00 P.M. (and telephone interview on 5/12/15 at 3:00 P.M.), the Director of Case Management said that Hospital Satellite staff had not been provided any training about organ donation services.

During telephone interview on 5/7/15 at 3:00 P.M., the Director of Quality Management said that there had not been an actual process of working collaboratively with the OP0 such as training staff in organ donation process and reviews of the effectiveness of the service.

Based on observations, interviews, review of Infection Control (IC) quality indicators, and review of the Hospital Satellite's policies, the Hospital failed to ensure that the Infection Control (IC) Quality Assessment Performance Improvement (QAPI) program for hand hygiene at the Hospital's Satellite was accurately implemented. Findings include:

1. Review of the Hospital's Satellite's hand hygiene data, from 6/2014 to 3/2015, indicated that the average hand hygiene compliance percentage was about 93%.

Review of the Hospital's Hand Hygiene Policy indicated that "monitoring (of hand hygiene) will be done through visualization, demonstrations, and random audit tools."

During interview on 5/4/15 at 10:45 A.M., the Director of Quality and Infection Control at the Hospital Satellite said that she conducted monthly hand hygiene audits on all Satellite staff. However, the Director of Quality and Infection Control said she only "observed hand hygiene practices by sitting at the nurses' station and observing staff as they entered and left patient rooms." The Director of Quality and Infection Control said she "did not observe staff as they performed procedures in patients' rooms (e.g., dressing changes, medication administration, blood sugar testing, disinfection of equipment)."

When asked by the Surveyor for the completed hand hygiene audits, the audits were not provided. The Director of Quality and Infection Control also said that (because she had limited hand hygiene observations) her hand hygiene data was most likely not accurate.