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Based on observations, record review and staff interview, the hospital failed to ensure that 5 operational satellites of the hospital were licensed by the Department of Public Health as required. Findings include:

1. The hospital was operating an oncology consultation clinic, identified as the Trussdale Clinic, located on Presidents Avenue, Fall River, Massachusetts. This clinic opened 4/2009, with patients being seen twice weekly. This satellite was not licensed by the Department of Public Health.

2. The hospital was operating a MRI clinic, identified as Alliance MRI, located at 289 Pleasant street, Fall River, Massachusetts. This clinic is in the process of a change of ownership from this vendor (Alliance MRI ) to ownership of St Anne's Hospital. This satellite was not licensed by the Department of Public Health.

3. The hospital was operating a nutritional counseling program at the Westport Family Medicine building, located at Main Road, Westport, Massachusetts. This program was operating twice monthly within a private physicians practice. This satellite program was not licensed by the Department of Public Health.

4. The hospital was operating 2 phlebotomy drawing stations, one located at 295 New Boston Road, Fall River Massachusetts, the other on South Main Street, Fall River, Massachusetts. Both of these were operating within a private physicians practices and were not licensed as satellites of the Hospital by the Department of Public Health.

5. In addition, the hospital had two pending satellites which had been constructed and were scheduled to open at the end of February and March, 2010; a medical oncology clinic and a wound clinic. No patients had been seen at either of these locations as of surveyor review.

The Vice President of Ambulatory Care confirmed during interview on 2/3/2010 that the above satellites were without a valid license, issued by the Department of Public Health.

Based on record review and staff interview, the governing body had not appointed the managing officer of the hospital. The findings are:

During the entrance interview, survey staff were introduced to the recently appointed President of the hospital. This individual was also identified as the hospital president on the organizational charts provided to survey staff; as well as on the hospital's web site. Review of the personnel file for the president contained evidence of his employment by the corporation that owned the hospital; however, there was no evidence that his appointment had been approved by the hospital's governing body. Review of meeting minutes of the governing body for the past year revealed no documentation of his appointment by the governing body. The hospital's management staff were interviewed regarding the absence of documentation regarding the appointment by the governing body. Hospital management staff subsequently confirmed that the governing body had not yet reviewed the appointment of the president. The president indicated he was not aware that the governing body had not approved his appointment.

Based on interviews and documentation review, the Hospital failed to provide 3 of 5 patients (non-sampled patients C, D and E), who had filed a complaint/grievance, with a written notice of the grievance decision that contained the name of a hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Findings included:

1. Documentation in the Hospital's Grievance Log indicated patient #C filed a verbal complaint on 10/13/09 with the Corporate Compliance Office. The patient indicated he felt violated by a medical procedure and had not given consent for the procedure.

The Patient Relations Department/Patient Advocate received the complaint on 10/13/09. The Patient Advocate met with the patient on 10/14/09. On 10/23/09, the Patient Advocate met with the patient again with 2 other members of the nursing staff and discussed the patient's concerns. According to the grievance file, closure was brought to the issue.

Documentation did not indicate a written notice of the grievance decision was provided to the patient.

On 2/8/10, the Patient Advocate confirmed that a written notice was not provided to the patient.

2. Documentation in the Hospital's Grievance Log indicated patient #D's son filed a verbal complaint on 11/30/09, with the Nursing Director of the Intensive Care Unit (ICU). The son alleged a physician in the ICU had been yelling at him regarding decisions the son had made concerning his mother's care. The son said the whole ICU heard the yelling and that he felt very disrespected.

The Patient Relations Department/Patient Advocate received the complaint on 11/1/09. On 12/4/09, the complaint was referred to the Medical Director.

On 12/7/09, the Patient Advocate called the son and apologized. The Patient Advocate related that the issues would be addressed with the identified physician and according to the grievance file, the son was satisfied.

Documentation did not indicate a written notice of the grievance decision was provided to the patient/family.

On 2/8/10, the Patient Advocate confirmed that a written notice was not provided to the patient/family.

3. Documentation in the Hospital's Grievance Log indicated patient E's daughter filed a verbal complaint on 7/1/09, alleging that she had been treated rudely by a staff person in the Emergency Department (ED) on 6/15/09, while her father was a patient there. The complaint was referred to the Manager of the ED.

The ED Manager met with the complainant on 7/8/09. They were unable to identify the staff member who had allegedly been rude. The Manager apologized to the complainant.

Documentation did not indicate a written notice of the grievance decision was provided to the patient/family.

On 2/8/10, the Patient Advocate confirmed that a written notice was not provided to the patient/family.

Based on review of hospital policies and staff interview, the hospital failed to ensure the patients were provided care in a safe setting as adult patients were routinely admitted to the pediatric unit.

The findings are:

1. On 2/3/10 at approximately 11 A.M. during a tour of the pediatric unit, it was observed that there were 6 patients on the unit. Three of the patients were adults. According to the Unit Nurse, 2 adults had been admitted to the unit due to lack of available adult inpatient beds; and, the third adult patient was there for a scheduled, out-patient visit for an infusion. There were 2 registered nurses assigned to the pediatric unit that day.

At 2:30 P.M. on 2/3/10 survey staff interviewed the out-patient who was on the pediatric unit. The patient explained that she was in for an intravenous infusion of gamma globulin. The patient stated that on her scheduled infusion days she went to patient registration, received an identification band (used for medication administration) and was usually sent to the pediatric unit for the infusion. The inpatient unit assignment was dependent on inpatient bed availability; and according to the patient, the length of time for the infusion was longer when she was assigned to the pediatric unit. She further explained that during her treatment she receives intravenous Lasix (diuretic) and at times she has not been assigned to an inpatient bed and has received the infusion in a recliner in the Pediatric day room. The patient further stated that, when she was assigned to the dayroom recliner, the bathroom available to her was located down the hallway, not readily available for her use, presenting difficulty for her when the intravenous Lasix caused her to feel urgency to void.

The Unit Nurse explained the pediatric nursing staff scheduled out-patients for infusions on the in-patient unit; and at that time, had approximately 10 patients they were routinely scheduling for infusions. Two patients were scheduled to receive intravenous infusions on 2/4/10. The nurse provided a copy of guidelines the pediatric staff used for "OUT PATIENT INFUSIONS." The guidelines did not include any screening criteria for adults being assigned for out patient services on the pediatric unit. The guidelines noted appointments should not be scheduled on weekends and no more than 2 people were to be scheduled for the same day as there may be a chance of an unexpected infusion.

The Hospital had created this subcategory of patients who were neither in-patients or out-patients; and failed to accommodate the needs of this existing patient population in the ambulatory care areas. Assignment of these adult patients to the pediatric unit did not promote a safe patient care setting for children admitted to the unit.

2. Review of Patient Care Supervisor Bed Rosters for 2/3/10 and 2/4/10 revealed adults had been admitted as in-patients to the Pediatric unit. On 2/1/10, an adult patient had been admitted to room 240-A and was discharged on 2/4/10 and on 2/2/10 another adult had been admitted to room 242-A and discharged on 2/3/10.

Review of Adult Admission Criteria to the pediatric unit revealed this only would be done in periods of high census when adult medical/surgical beds and all "swing beds" are in use. The criteria noted the adult patient would be made aware of the need to avoid contact with the pediatric patients.

Observation of the physical layout of the pediatric unit revealed there were no physical barriers separating the adult patients from the pediatric patients.

Based on record reviews and interview, for two patients (#38 and #39) out of a sample of 3 closed records reviewed for restraints, the Hospital failed to ensure the staff comprehensively assessed the use of drugs as a restraint.

Findings included:

1. Review of the Hospital's policy and procedures for "Restraints and Seclusion" failed to include a description of what constitutes the use of drugs or medications as a restraint. The Hospital's policy defined restraints as "any manual method or physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely."

The Hospital's policy description of what constituted a restraint included seclusion, medical restraints and the Behavioral Health Restraint (the restriction of patient movement for the management of violent and self-destructive behavior).

Interview with the hospital staff confirmed that Hospital's policy failed to address the regulatory standard for the use of drugs or medication as a restraint.

2. Patient #38 was admitted to the Hospital's inpatient Geriatric Psychiatry program on 12/4/09 after he was brought to the emergency room by the police department. The patient had been acting strangely and was lethargic and sleepy on admission. The patient's admission diagnoses included Bipolar disorder, manic, post-traumatic stress disorder, depression and alcohol dependence.

Review of the initial geri-psychiatric evaluation and assessment, dated 12/4/09, reported the patient had identified multiple triggers that had caused anxiousness and sleep deprivation. They included his recent move to a new apartment, that he had witnessed a recent traumatic event and he had stopped his psychiatric medication. The psychiatrist's plan was to monitor for safety and provide a safe environment. The patient would be monitored for mania, psychosis, and would be on 15 minute checks as he demonstrated no acute agitation. Psychotropic medications included Seroquel (antipsychotic) 50 mg every 6 hours as needed for anxiety and agitation, Xanax (antianxiety) 1 mg every 4 hours or as needed for anxiety or agitation, and Klonopin (antianxiety) 1 mg twice a day.

Review of the nurses' notes dated 12/5/09, 11 PM to 4:45 AM, documented the patient was restless and made frequent visits to the nurse's station. The nurses wrote the patient's behavior was delusional, he had refused all medications for sleep and that reassurance and diversional redirection failed to alter his behavior.

At 5 AM on 12/5/09, the nurse wrote that the patient appeared at the nurses's station. After a brief conversation, the patient turned and lunged at the fire alarm. The staff failed to redirect the patient, and the staff called for assistance from the hospital's security staff. In addition, the staff made an emergent call to the in-house Hospitalist, but no return call was received. The nurse wrote that the patient de-escalated and was escorted back to his room. At 5:15 AM, the nurse wrote that banging was heard from his room. The patient was found banging the smoke detector with his cane and having delusional thoughts. Multiple staff attempted several de-escalation techniques, but the patient became increasingly agitated. The staff initiated emergency restraint intervention. The nurse wrote that the security staff arrived on the unit and placed the patient in 2 point restraints and was moved to a room closer to the nurses station for closer monitoring. The nurse wrote she then contacted the physician and explained the situation. The physician ordered Haldol (antipsychotic) 10 mg IM (intramuscular), Ativan (antianxiety) 2 mg IM and Benadryl 25 mg IM be administered once for his severe agitation; and, for the house officer to evaluate the patient within one hour of administration of the medication restraint. The nurse documented that she administered the medications and initiated the restraint policy. There was no documented physician's order for the physical restraint. The nurse documented on the restraint monitoring form that "2 point physical restraints - placed by security" were used during the emergency intervention. The nurse failed to include the use of medications as an additional restraint that had been ordered by the physician.

Review of the monitoring form dated 12/5/09 revealed the patient was maintained in 2 point restraints for 45 minutes and 1 to 1 was provided by the security staff. The nursing staff monitored the patient every 15 minutes for vital signs/care, circulation, and for his condition while in the 2 point restraints. Although the nurse called the physician to conduct a face to face evaluation, the physician failed to conduct the face to face evaluation.

Interview with Staff Nurse #1 reported she had been involved in the use of emergency restraints for the patient. She stated the Security Staff had assisted in the emergency and had applied handcuffs to the patient because there were no restraints available on the unit. Staff Nurse #1 confirmed that the patient had been administered medications as defined as a medication restraint while in the 2 point restraints. Staff Nurse #1 was unaware of any specified comprehensive assessments required following the administration of a medication restraint or following the use of a medication restraint with/during an episode of a physical restraint.

Interview with the Clinical Director revealed the incident was reviewed with the Hospital's Administrative staff; and although the Hospital Administration identified problems with the incident, the Hospital failed to develop a comprehensive policy defining the use of drugs as a restraint.

3. Patient's #39 was admitted to the Geriatric Psychiatry Inpatient Unit on 12/14/09 after displaying changes in his behavior and mental status. On 12/16/09 at 2:35 PM the nurse wrote the patient became highly agitated and alternative interventions failed to de-escalate his agitated state. The physician ordered a chemical restraint that included Haldol (antipsychotic) 10 mg IM (intramuscular), Ativan (antianxiety) 2 mg IM and Benadryl 25 mg IM be administered once for his severe agitation. The nurse wrote that the three medications were administered with the security staff present.

Review of the restraint monitoring and assessment form revealed the staff failed to include any staff monitoring and assessment following the administration of the chemical restraint, with the exception of the physician's face to face visit an hour later, per the Unit's policy.

Review of the forms dated 12/16/09 revealed the patient was administered the three medications. The patient's vital signs, care, circulation and condition was not documented every 15 minutes by a trained staff person and an authorized registered nurse failed to assess the patient at least every 30 minutes following the use of the emergency restraint.

Interview with the Clinical Director confirmed that staff had not followed the emergency restraint procedure while implementing the chemical restraint for this patient. In addition, the Clinical Director confirmed that the Unit's policy failed to specify the hospital's expectation of how the staff would comprehensively assess the patient's reaction following the administration of medication used as a restraint.

Based on staff interviews, record reviews and observations, the Hospital's quality improvement program failed to adequately review environmental deficiencies in the Hospital's physical plant, in order to adequately address patient safety. The findings are:

1. During tours of the Hospital kitchen and central supply areas on 2/3, 2/4 and 2/9/10, areas in need of repair were identified. (Refer to A 620 and A 701). The leaks in the kitchen, and problems with the integrity of the kitchen flooring, had existed for at least two years. This had impacted the surgical central supply area including leaks from the ceiling.

2. During tour of the kitchen on 2/3 and 2/4/10 the dishwasher was observed leaking water, and not reaching adequate temperatures for sanitation (Refer to A 620).

3. On 2/4/10 a patient was observed being moved from the medical surgical unit into the intensive care unit for dialysis. Hospital staff interviews revealed the hospital was moving patients for dialysis into the intensive care unit due to inadequate water pressure on the medical surgical units. (Refer to A 144).

Per 2/09/10 interview with the Director of Quality, the Hospital's environment of care committee had no information about the leak in the kitchen, problems with the dishwasher, the impact on central supply or water pressure issues. The Director of Quality stated she had not been apprised of these environmental problems in the Hospital.

Based on observations, staff interviews and record reviews, the Hospital failed to allocate adequate resources to measure, assess and improve the hospital's infection control performance. The findings are:

Per interview with the Hospital's Director of Quality on 2/9/10, prior to December 2009 the Hospital had allocated one, 20 hour, position for an infection control nurse. As of November 30, 2009 and through the time of survey, the hours for infection control nurse had increased to 24 per week. Per interview with the infection control nurse on 2/9/10, the Hospital had no infection control surveillance of the satellite units. The infection control nurse also stated she was not involved in environmental surveillance and had not been aware of the environmental problems in the kitchen (Refer to A 749, A 701, A 620).

Based on observation and interview the Hospital failed to ensure that for one non-sampled patient (B) that there was immediate availability of a registered nurse for bedside care.

Findings include the following:

On 2/9/10 at 4:40 P.M., survey staff noted a handwritten sign at the nursing station on the telemetry two nursing unit (located on the second floor) indicating that the nursing staff on this unit were not to enter room 201. The sign indicated that the patient was receiving a form of radiation therapy.

The clinical leader for the telemetry unit was interviewed regarding the care of this patient. She indicated that the patient had been admitted to the hospital for radiation treatment for thyroid cancer. She further explained that the patient was being cared for by the nursing staff on the St. Mary's unit. (The St. Mary's unit was located in another area of the hospital and on another floor). The nursing staff on the St. Mary's unit were identified as the oncology nurses and had training in caring for the patient with a radium implant.

At approximately 4:45 P.M., the oncology nurse was observed leaving the patient's room on the telemetry unit. The nurse stated she was responsible for the care of this patient for the 3-11 PM. shift as well as four other patients on the St. Mary's unit. The St. Mary's Unit was located on the third floor of the hospital and there was no direct access to the telemetry unit.

The nurse stated she was able to visualize the patient via a camera which had been mounted in the patient's room on the telemetry unit with a monitor which was located on the St Mary's Unit. Additionally, the nurse stated the patient had a portable telephone and the nurse was able to contact the patient using this telephone. The nurse was unsure if the patient had the ability to contact the nurse using this telephone.

Survey staff accompanied the nurse to the St. Mary's Unit, where the monitor was observed to be mounted on the wall in the nurses' station. At that time, the patient was seated in a chair and only the patient's lower legs could be seen on the monitor. The nurse stated usually patients are in bed and can be fully visualized by the monitor. The nurse asked to be excused as she had been assigned to care for four other patients on the St. Mary's unit.

The survey staff returned to the telemetry unit and observed the patient's dinner tray on the table located outside the patient's room. It was unclear when the tray had been delivered and when the nurse would return to deliver it to the patient; as she had just left the unit to return to the St. Mary's unit.

On 2/9/10 at 5:15 P.M., the CNO (Chief Nursing Officer) was informed of the surveyors findings and concerns. The CNO stated she had knowledge of this patient's admission by e-mails she had received. The CNO stated it was the responsibility of the St.Mary's clinical director to schedule nursing staff since she knew which nurse had the appropriate training to care for this patient.

The CNO explained that the oncology unit was going to be a dedicated unit again and would be moving back to the second floor. The CNO expressed an understanding of the surveyors' concerns regarding the assignment of nursing staff to care for this patient.

On 2/11/10, the CNO informed survey staff that on 2/9/10 at 6 P.M., the nurse was transferred to the second floor to care for this patient and this would be the plan for all nurses assigned to care for this patient during this admission.

Based on observation, record review, and interview, the facility failed to ensure that nursing staff developed, and kept current a nursing care plan for 9 (#6, 9, 13, 19, 20, 25, 26, 28 and 29) of a total sample of 30 current patients reviewed.

Findings included :

1. Patient #6 was admitted with diagnoses which included hypotension and gastrointestinal bleed.

Record review on 2/9/10 revealed that the patient had resided in the intensive care unit until 2/8/10, at which time he was transferred to the telemetry floor for further care.

According to the electronic medical record, on 2/3/10 at 1803, the patient was noted to have a "reddened" area on the posterior coccyx that was assessed to be a Stage II pressure ulcer. The wound's "general appearance" was noted to be "Reddened (+)." The wound assessment indicated that there was no drainage, and although the pressure ulcer was assessed to be a Stage II wound, there was no documentation that a dressing or treatment had been initiated.

Record review revealed that the coccyx wound was assessed by nursing on 2/3/10 at 2016, and on 2/4/10 at 0054. The patient's pressure ulcer to the posterior coccyx was noted at both assessments to be "Reddened (+)" and to be a Stage II pressure ulcer. Neither of these assessments indicated the size of the wound, to include the length, width, and depth, per the hospital's policy for assessing pressure ulcers. Additionally, there was no indication that a treatment had been initiated to treat the patient's open pressure ulcer.

On 2/4/10 at 0856, the nurse documented that the posterior coccyx wound remained "Reddened (+), a Stage II pressure ulcer, with no assessment of the size of the wound. The nurse's assessment documented treatment of the wound with "Versiva" under the "Other Dressing Type" field of the wound assessment. The nurse's assessment provided no information as to the rationale for the application of the Versiva dressing. No further assessment of the wound was noted, and there was no indication that the wound nurse had been consulted.

Following the application of the Versiva dressing on 2/4/10 at 0856, the resident's wound was assessed by nursing a total of seventeen additional times, from 2/4/10 through 2/8/10 at 1639. The wound was noted at each of these assessment to present as a Stage II pressure ulcer to the posterior coccyx wound, "Reddened (+), Versiva dressing "dry and intact" and "no drainage." No additional assessment of the size, length, width, or depth of the wound was noted.

Review of the the patient's wound assessment for 2/8/10 at 2030, revealed a change in treatment from Versiva to Duoderm. The assessment of the patient's coccyx wound indicated that the wound remained "Reddened (+)". The nurse's assessment of the wound at the time the Duoderm dressing was initiated, failed to document the rationale for the change in treatment. The assessment failed to include information listed in the wound assessment part of the "Care Activity Assessments" i.e. general appearance, drainage amount, type of wound, size, stage, and drainage amount.

On 2/9/10 at 10:30 AM, the patient was observed lying in bed in Room # 216-A on the Telemetry Unit. The patient's eyes were closed, and the head of the bed was elevated at a forty-five degree angle. The patient appeared thin, with the bones of his face and extremities visible beneath the subcutaneous tissue. The patient was noted to have an air mattress control unit lying on the floor at the foot of the bed, and the mattress placed under the patient. A sign was noted at the entrance to the patient's room indicating that the patient was on isolation precautions. An isolation cart was placed at the entrance to the room with that contained disposal gowns and gloves.

Interview on 2/9/10 at 10:30 A.M., with the nurse caring for the patient, confirmed that he had a pressure ulcer on his coccyx covered with a Duoderm dressing. The nurse did not know the size, stage, or depth of the wound. When questioned regarding documentation of wound assessments, she indicated that it was all done in the electronic medical record.

When asked to review the wound assessments that had been documented in the patient's record, the nurse acknowledged that there were no assessments of the size of the wound since it first developed. The nurse also confirmed that the wound had been assessed as early as 2/3/10 to be a Stage II pressure ulcer, and acknowledged that there was no dressing documented until 2/4/10 when the Versiva dressing was initiated.

On 2/9/10 at 3:25 P.M. the resident's posterior coccyx wound was examined by the staff nurse and clinical leader on the telemetry unit, with the surveyor present. The Duoderm dressing was removed and revealed a 2.5 centimeter by 2.0 centimeter, (per nurse's assessment) Stage II pressure ulcer on the coccyx. The center of the wound was bright red at the center, pink at the edges, with noticeable depth. There was no drainage present.

Interview with the wound care nurse on 2/11/10 at 8:15 A.M., acknowledged that the hospital's policy for the care and treatment of pressure ulcers included measuring the size of the wound. The wound care nurse also acknowledged that the rationale for changes in treatments to pressure ulcers should also be included in assessment of pressure ulcers.

2. Patient #28 was a 65 year old male with metastatic non-small cell bronchogenic carcinoma, obesity and neuropathy. According to the record, the patient had been admitted to the hospital following a fall in his home. At the time of surveyor review on 2/04/10, the patient had been an in-patient for over two weeks, including a period when he was intubated and physically restrained in the ICU.

Record review on 2/04/10 at 10 AM revealed a physician entry, dated 2/03/10 at 11 PM, noting that the physician had been called to evaluate the patient who was status post a fall. The physician noted the staff should keep the patient's head elevated. The clinical record contained no additional information regarding the patient's apparent fall 12 hours prior.

The nursing clinical director and clinical leader of the St. Mary's unit were questioned at 10:45 AM regarding the specifics of the patient's fall and stated they had not been aware the patient had fallen. The clinical director reviewed the patient's medical record at that time and found no entry had been made in the clinical record by the nurse who had cared for the patient the previous evening/night. The nurse caring for the patient (nurse #2) was then interviewed and stated she had been told during shift report that the patient had been "found on the floor;" but had been given no additional information regarding the circumstances of the patient's fall. The nurse did not know if the patient's alarm had sounded, whether his bed rails had been raised and/or whether he had fallen from, or climbed out of, the bed.

The patient was observed lying in bed with three, "1/4" bed rails raised while sleeping on 2/04/10 at 11 AM.

The nursing staff failed to immediately assess the circumstances of the patient's fall, and adequately communicate the assessment of the fall to the oncoming shift, so that the nursing care plan could be reviewed and revised to prevent additional falls.

3. Patient #25 was readmitted to the Hospital on 2/1/10 with multiple medical diagnoses which included acute renal failure, congestive heart failure, hypertension and a recent history of Escherichia-coli urinary tract infection on 1/27/10.

The patient had recently been started on hemodialysis. Review of the medical record revealed that the patient was transported from her hospital room on the St. Mary's unit to the hospital intensive care unit on 2/2 and 2/4/10 for hemodialysis.

Review of the medical record revealed that on 2/2/10 at 815 (AM) there was a physician order written for the patient to be on "nursing 1:1." This was followed by an order for a psychiatric consult regarding altered mental status and to assess decision making related to medical care.

In reviewing the medical record on 2/3/10 there was no documentation found related to the status of the nursing 1:1 for this patient

The Clinical Director of the St. Mary's unit was asked about the implementation of the nursing 1:1 for this patient. She indicated that it had been determined that the patient had not needed the nursing 1:1 as she had not met the criteria. She explained that there was a form completed titled "Patient Observer Request Form" which the nursing staff completed and submits to the administrative nursing staff for approval. The Clinical Director indicated that she was unable to locate the completed form for this patient.

The nursing staff recorded in the electronic medical record on the care activity assessment form that the patient was on "constant observation" on 2/2, and 2/3/10. The Clinical Director explained that the patient was being watched closely but did not have a 1:1 nursing staff member assigned to her.

There was no indication in the medical record that the nursing staff had included the physician in the decision to not follow the order for 1:1 observation for the patient.

4. Patient #9 was admitted to the hospital on 1/25/10 with diagnosis of new onset atrial fibrillation. According to the infectious disease consult, dated 2/1/10, the consult was requested for antibiotic treatment for possible endocarditis. The patient had a history of recurrent urinary tract infection with gram-negative Citrobacter and also a history of MRSA colonization in the nares. The patient was noted to have a chronic urinary catheter in place. The consult noted that a repeat urinalysis and urine culture would be obtained.

Review of the clinical record on 2/4/10 revealed a physician's order, dated 2/1/10, for a urinalysis and urine culture be obtained "today." The electronic medical record was reviewed with the nurse assigned to the patient on 2/4/10 (nurse #3). The nurse accessed the computer screen for physician's orders which noted the urine sample remained uncollected. The nurse acknowledged this information was available for all nursing staff providing care to the patient since it was ordered on 2/1/10; and was unclear as to the reason it had not been obtained. According to the medical record, the patient's catheter was changed on 2/3/10 and the nurse stated the sample could have been obtained at that time.

5. Patient #13 was admitted to the hospital on 2/3/10 with diagnoses of tachycardia, congestive heart failure and aspiration. On 2/9/10, it was noted during review of the 2/5/10 endoscopy record that the patient had severe candida esophagitis and a PEG (percutaneous endoscopic gastrostomy) tube was inserted for enteral feedings.

The physician ordered on 2/6/10 for the tube feeding formula (Glucerna) to be advanced by 20 cc's (cubic centimeters) every shift until a maximum of 80 cc's per hour had been reached and the tube was to be flushed every shift with 100 cc's of water.

The documentation in the EMR for intake was reviewed with the Telemetry unit nurse clinical leader on 2/9/10. The clinical leader acknowledged there was no documentation of the date and time when the increases in rate of Glucerna occurred other than a notation on 2/7/10 at 1:51 A.M. that the rate was increased to 60 cc's per hour. Additionally, the clinical leader confirmed intakes were not accurately recorded as it lacked amount of water flushes and amounts of formula administered. For example, on 2/8/10 at 20:51 A.M., 2/9/10 at 4:18 A.M. and 2/9/10 at 6:16 A.M. there was no documentation of the water flushes.

The clinical record noted the patient had been weighed daily; however, it did not address the weight discrepancy documented for 2/7/10. On 2/4/10, the patient's weight was noted as 157.8, on 2/5/10 it was 158.5, on 2/7/10 it was 142.6. The Clinical Leader explained all the beds were equipped with a bed scale, that the weight recorded for 2/7/10 was not accurate and another weight should have been obtained at that time.

6. Resident #20 was admitted on 1/19/10 with a diagnosis of agitated behavior.

On 1/31/10, the physician ordered a urinalyses, culture and sensitivity (U/A, C&S) as a result of the resident exhibiting confusion and urinary frequency at night.

A review of the medical record revealed that the urine was not collected for the physician ordered laboratory test until 2/4/10. There were no nurses' notes, nursing assessments or physician notes indicating why the urine was not collected for 4 days following the physician order of 1/31/10.

During interview on 2/4/10, nursing staff on the geriatric psychiatric unit (nurse #1 and #2) indicated that the resident frequently toileted self and that the nursing staff probably had difficulty collecting the urine. There was no documentation to this effect in the medical record.

7. Patient #19 was admitted to the Geriatric Behavioral Inpatient Unit with behavioral disturbances. Review of the history and physical dated 1/20/10 revealed the patient had diagnoses that included dementia, agitation, uncontrolled hypertension and history of urinary tract infections.

Prior to the patient's hospitalization she had recently been treated with an antibiotic for a urinary tract infection. On 1/27/10, the physician ordered a urine culture to determine an infection. Interview with Staff Nurse #1 and Staff Nurse #2, determined the urine was never collected and the laboratory test was not completed. Nurse #1 and #2 could provide no information why ordered laboratory test was not completed.

Further review revealed the physician ordered a second urine culture on 2/1/10. The laboratory results for this culture revealed the patient had a positive infection and the results were reported to the physician.

8. For Resident #26, the facility failed to follow physician orders to obtain daily weights and failed to address a significant weight discrepancy.

Resident #26 was identified at nutritional risk with a history of recent weight loss (33.6 pounds) from a previous January 2010 admission for treatment of pneumonia. Medical diagnoses included altered mental status, right foot wound with MRSA infection, history of atrial fibrillation, diabetes, cardiac and peripheral vascular disease. The patient's 1/31/10 admission weight was recorded at 161.5 pounds.

On 2/4/10, a physician order included to monitor the patient's weight daily. Recorded weights for 2/5 and 2/6/10 were 161.56 and 159.6 respectively. On 2/7/10, this patient weighed 172 pounds. The patient's weight gain of 12.4 pounds was not questioned. Daily weight was not obtained on 2/8, 2/9 or on 2/10/10.

Interview with the St. Mary's unit clinical director on 2/11/10 agreed that nursing staff should have questioned and reported the weight discrepancy and /or obtained a reweigh to verify the patient's weight status. The method used to weigh this resident included the use of a built in bed scale. The clinical director had no explanation as to why the daily weight measurement was not followed.

Based on record review and interview the Hospital failed to ensure for 2 (#'s 25 and 43) of 2 records reviewed of patients receiving hemodialysis that there were physician orders written for the specific hemodialysis treatment to be provided. The total sample of current in-patients reviewed was 30.

Additionally, the Hospital failed to ensure that each contracted employee providing hemodialysis treatment had been tested for color blindness and had been evaluated by the Hospital staff.

Findings include the following:

1. Patient #25 was readmitted to the Hospital on 2/1/10 with multiple medical diagnoses which included acute renal failure, congestive heart failure, hypertension and a recent history of Escherichia-coli urinary tract infection on 1/27/10.

The patient had recently been started on hemodialysis. Review of the medical record revealed that the patient was transported from her hospital room on the St. Mary's unit to the hospital intensive care unit on 2/2 and 2/4/10 for hemodialysis.

Review of the hemodialysis run sheet for 2/2/10 and the physician orders (both the electronic and the hand written physician orders) revealed that there was no prescription written for the specifics of the hemodialysis treatment.

The hemodialysis nurse's handwritten run sheet dated 2/2/10 indicated that the patient was dialyzed for 3 hours. The dialysate solution was a 3 K, 2.5 calcium and the dialyzer was an F180NR. Under the heparinization area the nurse entered "R+D" not offering any information regarding the amount of heparin used for the process. The nurse failed to include any information on the run sheet or in the medical record that there had been any communication with the patient's physician regarding the prescription for the patient's hemodialysis treatment.

On 2/3/10 the lack of physician's orders for the hemodialysis treatment was discussed with the clinical director of the St. Mary's unit. She indicated that it was the policy of the Hospital to obtain a physician order for the specifics of the hemodialysis treatment. The contracted hemodialysis nurse was interviewed on 2/3/10 regarding the lack of a physician order. She indicated that she recalled discussing the treatment plan with the physician at some point on 2/2/10, but acknowledged that there was no written physician order for the provided treatment.

2. Patient #43 was admitted to the Hospital 2/1/10 with acute respiratory failure, shortness of breath and hypoxia. The patient also had chronic renal failure and required hemodialysis.

A review of the medical record revealed that the patient was transported from her room on the St. Mary's nursing unit to the intensive care unit for hemodialysis treatment. Review of the physician orders revealed that on 2/1/10 the physician dated, timed, and initialed the bottom of the nurse's hemodialysis run sheet. The hemodialysis nurse indicated that this was the order to confirm the information regarding the treatment that had been entered by the nurse.

The hemodialysis run sheet was initialed by the physician at 0830. The duration of treatment for this patient was from 0826 to 1045 on this date. The contracted hemodialysis nurse used this run sheet throughout the treatment. It was unclear what physician orders/notes were included in the initials of the physician at 0830.

This patient received a second hemodialysis treatment while hospitalized on 2/3/10. The physician dated, timed and initialed the box labeled physician orders/notes at the bottom of the hemodialysis run sheet at 1315. The hemodialysis treatment for this patient started at 1224. There was no indication that the contracted nurse responsible for the hemodialysis treatment reviewed written physician orders prior to the start of the treatment or recorded a conversation with the physician related to the prescribed treatment before it was initiated.

3. A review of 4 of 4 personnel files for the contracted hemodialysis nursing staff maintained by the Hospital failed to include information regarding color blindness testing. After discussing this with the clinical director responsible for overseeing the contracted hemodialysis nursing staff she contacted the contracted agency. The contracted agency was able to provide color blindness testing results for 3 of the 4 nursing staff reviewed.

Additionally, for the 4 contracted hemodialysis nursing personnel files reviewed there was no collaborative performance evaluation completed. Each of the contracted nurses reviewed had a partial evaluation prepared by the assigned manager from the contracted hemodialysis company. Interview with the hospital's clinical director responsible for overseeing the contracted hemodialysis nursing staff revealed that she had not signed any of the evaluations as she had not been involved in any of the "collaborative" evaluations.

Of the 4 evaluations reviewed there was no hospital employee involved in any of them, one was not dated by the contracted employee, one contained no dates, and another included only the first (of two) page of the evaluation.

Based on clinical record review and staff interview, the Hospital failed to have a system to promptly access or retrieve the identity of the nursing staff person responsible for the acknowledgement of physicians' orders in the electronic medical record for 30 of 30 in-patient records reviewed.

The findings are:

On 2/4/10 during clinical record review of Patient #11 it was noted the physician had ordered oral potassium based on the hospital's potassium protocol.

On 2/2/10, a blood specimen had been obtained twice that day. The potassium level at 5:15 A.M. was reported as 3.6 mEq/ L and at 11:55 A.M. it was 3.5. Review of the electronic medication administration record revealed the nurse had administered KCL (Potassium Chloride) 20 meq at 12:06 P.M. According to the potassium protocol, the patient should have received KCL 40 meq. based on the 11:55 A.M. result of 3.5.

The Clinical Director for the Telemetry unit stated she had discussed the above with the nurse caring for the patient that day. The nurse stated she did not know the patient had another blood specimen drawn after 5:15 A.M. The Clinical Director stated that based on her discussion with the nurse, the patient had received the correct dose and the nurse did not have any knowledge of another result pending as this information had not been communicated to the nurse.

Survey staff requested documentation of the nursing staff who had acknowledged the physician's order for the laboratory test. The Clinical Director stated this information was not readily retrievable as the nursing staff do not have access to this in the electronic medical record, however, staff are able to retrieve information regarding medication order acknowledgement.

The Clinical Director stated she would attempt to obtain this information. Approximately twenty four hours after discussion with the Clinical Director, a computer printout was provided of the order history. The printout noted the time, date and user password for the order entry. The Clinical Director stated the information could only be provided by the Information Technology Department. The Clinical Director acknowledged the information should be available to nursing staff as the transcription of physician orders (whether hand written or in the electronic medical record) should clearly note the registered nurse who validates (countersigns) physician's orders.

Review of the 12/10/09 Patient Care Assessment Committee meeting minutes revealed that a root cause analysis had recently been performed related to the incorrect test being done due to the (HUC) Health Unit Coordinator entering the wrong test. The root cause analysis noted the a CT guided drainage of a pelvic abscess was ordered by the physician, but a CT chest was ordered by the HUC and performed by the CT technician. The report noted the CT department called for the patient before the RN (registered nurse) had a chance to verify the orders entered by the HUC. It was determined that several electronic sessions opened simultaneously was the cause of error. Prior to implementation of the Computerized Provider Order Entry (CPOE), verification would be required via the actual patient chart.

On 2/5/10, the clinical director informed survey staff that the IT department had enhanced the electronic medical record so that nurses had the capability of obtaining the name, date and time of the person acknowledging the physicians orders; and, that this change had occured for all of the other hospitals owned by the same corporate system.

Based on observation and interview with the Director of Pharmacy, the facility failed to provide drugs and biologicals in accordance with applicable standards.

Findings include:

Observation and interview with pharmacy staff on 2/4/10 at 9 AM in the Oncology Pharmacy Satellite, the Intravenous Admixture Service is not compliant with current Standards of the United States Pharmacopoeia Chapter 797. The Intravenous Admixture Service area and preparation hoods lack the physical requirements for USP 797 Standards for preparation of sterile intravenous solutions. The hospital's pharmacists are not compliant with 247 CMR 9.01 (3) "A pharmacist shall observe the standards of the current United States Pharmacopoeia."

The facility failed to ensure that outdated and beyond use medications and biologicals were removed from patient use.

Findings include:

1. Based upon observations and interview with the Director of Pharmacy on 2/4/10 on four of nine medication storage areas (nursing units) the surveyor observed in the medication refrigerator five open multiple dose vials of Tubersol PPD (Tuberculin Purified Protein Derivative) that were not dated when opened by staff.
a. 10 AM: ICU - 2 opened vials were not dated.
b. 10:55 AM: St. Mary's (B) refrigerator - 1 opened vial was not dated.
c. 11:15 AM: Pedi - 1 opened vial not dated.
d. 11:40 AM: Telemetry #2 -1 opened vial not dated.

The manufacturer states in professional literature that once a multi-dose vial is opened the Tuberculin PPD is stable for 30 days and not to be used after 30 days. The open and not dated vials are considered beyond use date (out of date).

2. Based upon observations and interview with the Director of Pharmacy on 2/4/10 on four of nine medication storage areas (nursing units) the surveyor observed eight open, not dated bottles of Nova Glucometer Strips; four open bottles of Nova Control Solutions Low; and 5 open bottles of Nova Control Solutions High. The manufacturer states in professional literature that the bottle of Control Solution is good for only 3 months after opening. The manufacturer states in professional literature that the bottle of Glucometer Strips once opened, the StatStips test strips are stable when stored as indicated for up to 90 days or until expiration date, whichever comes first. The open and not dated bottles are considered beyond use date (out of date).
a. 10:25 AM - North 1: One opened bottle of glucometer strips was not dated.
b. 10:45 AM - GPU: One opened bottle of glucometer strips was not dated.
c. 10:55 AM - St.Mary's: 5 opened bottles of glucometer strips, 1 opened bottle of low control solution and 2 opened bottles of high control solution were not dated; two bottles of low control solution dated 11-1-09 and 2 bottles of high control solution dated 11-1-09 had expired.
d. 11:30 AM Telemetry #1: 1 opened bottle of glucometer strips, 1 opened bottle of low control solution, and one opened bottle of high control solution were not dated when opened.

Based on document review, observation and interview, the Hospital failed to maintain and/or ensure a sanitary environment and proper operation of the dish machine for effective sanitation of dishes and equipment for use during preparation, distribution and service of foods.

Findings included:

Dietary staff failed to ensure that food preparation equipment, dishes and utensils were effectively sanitized to destroy potential bacterial organisms that may cause food-borne illness.

Dietary staff failed to communicate and/or monitor the final rinse water temperature of the dishwasher machine which failed to meet the machine specifications for proper final hot water rinse temperatures of 180 degrees Fahrenheit to effectively sanitize equipment and dish ware.

The initial walk through the food service areas on 2/3/10 at 10:30 A.M. found the flooring surface throughout the kitchen heavily soiled with old food debris particularly excessive under and between heavy equipment and wall perimeters.

The dishwasher machine room area was poorly maintained. The flooring and walls were in deplorable, unsanitary condition. Food waste particles and water pooled on the tile flooring and collected where grout had worn thin and void. The wet conditions created potential safety hazards for staff and concerns for public health conditions. The existing condition of the kitchen flooring in this dish machine area impaired proper and thorough cleaning.

The concrete painted wall surface in this dish room area was dirty, scratched and soiled with a dark residue of splashed particles and residue of mildew / mold.

The dishwasher machine operation was observed on 2/3/10, just after the morning dishes were finished, and dietary staff were preparing for the start of lunch service. The wash tanks were empty, and the surveyor arranged to observe the operation after the lunch service. A subsequent visit later in the afternoon of 2/03/10 revealed that the temperature gauge for the final sanitizing rinse water did not function properly. The water temperature for the final rinse cycle failed to register over 120 degrees Fahrenheit (F). The dishwasher was not operating in accordance with the manufacture's posted template specifications for 150 degrees (F) for the wash water cycle, a 160 degree (F) rinse cycle and the 180 degree (F) final rinse water temperatures. Interview with the food service director revealed that he was unaware of any current problems with the machine or sanitizing rinse cycle temperatures.

A review of the "Dish Machine Temperature Log" revealed recorded water temperatures for the final rinse of "1000," "1200," "1300" and "1600." The food service director had no explanation at that time for the recorded numbers. Further discussion with the food service director revealed that the recorded temperatures for all three meal times for 2/1/10, 2/2/10, and 2/3/10 failed to meet the 180 degrees standard for hot water sanitizing rinse as required by the manufacturer's specifications. There was no evidence that food service distribution implemented disposable paper products for use until the dishwasher was repaired and or equipped with a chemical agent for sanitization of dishware and food service equipment.

Work order receipt dated 2/4/10 indicated that final rinse water gauge was checked and later discovered that the machine's hot water booster had malfunctioned and required additional parts for repairs. The interim plan while awaiting replacement parts for the dish machine include the conversion to a low temperature with a chemical sanitizing rinse agent which was instituted during a service visit (4:15 - 6 P.M.) on 2/4/10 by the contracted provider.

The dirty and poorly maintained floor surface was discussed with food service management which revealed that heavy power washing of the floor surface was not practical due to potential seepage through poorly grouted areas to hospital central supply and sterilization work areas.

Review of work orders from outside drain service providers revealed problematic concerns of dish machine clogs and plumbing backups in this dish machine area. The plumbing was routinely serviced (i.e. dates: 8/7/09, 7/29/09, 12/10/08, and 12/09/08 ) to remove clogs from the machine and / or floor drains. These clogs created water backup onto the flooring which often resulted in seepage through the ceiling to hospital areas existing below.

Per hospital staff interviews, maintenance request work orders to repair the kitchen wall areas and tile/grout were requested at least two years ago (10/2008) with expense quotes obtained; however, financial approval to proceed had not been approved by hospital management. The work order requests were closed without adequate repairs.

These concerns were shared with the Food Service Director during visits to the kitchen on 2/3/10 and 2/09/10 and the Environmental Engineering Plant Director on 2/11/10.

The Hospital failed to maintain the physical plant and hospital environment in good sanitary and safe condition by completing routine repairs in the kitchen / dish room areas and central supply decontamination and sterilization rooms. Routine and preventive maintenance work order requests to address these areas went unattended and were not incorporated into the hospital's QAPI plan.

Additionally, inadequate water pressure in the hospital impacted the care of patients who required hemodialysis.

The findings are:

1. Observation of the central supply area on 2/9/10 at 10:30 A.M., which included a decontamination room and a separate sterilization room for hospital equipment revealed poorly maintained conditions of cabinetry, wall surface, ceiling tiles and excess moisture from mechanical condensation.

The sink cabinetry in this decontamination room was rusty and corroded. Upon opening this under counter cabinet, the door crumbled into rust particles.

The wall surface above the sink had exposed particle board. The surface material was not properly maintained or of material to withstand proper cleaning or moisture.

The ceiling tiles (at least two) were badly stained and contained evidence of prior water leak / damage. Ceiling strapping was rusted

The ventilation duct for the equipment washer exhibited moisture condensation which dripped from the ceiling duct onto the flooring in the decontamination room. A small (4 inch) circular pool of water had accumulated in the middle of the flooring.

Work orders for repairs to the cabinetry had been requested in January of 2009. The work repairs were not completed. Interview with hospital personnel reported that periodic history of leaks from the kitchen area seeped through the flooring/drainage to the ceiling areas of the decontamination / sterilization room. There was evidence that ceiling tiles had been replaced.

During interview with the Central Supply manager on 2/04/10 at 9:15 AM, she stated there had been a "leak" into the central supply sterilization room "several months ago" from the kitchen; but, "as far as she knew, it had been taken care of." The manager was then questioned regarding what decontamination had been completed in the central sterile supply area following the leak. The manager stated "nothing needed to be done as they were not wrapping instruments when it happened."

Review of infection control committee meeting minutes of 12/11/09 reported that the Central Supply Department had to be shut down, cleaned and vacuumed due to flooded areas with broken ceiling tiles due to a dishwasher backup and leaks.

On 2/9/10 the newly hired (11/30/09) infection control nurse was interviewed regarding her knowledge of the issues in the dietary department related to the lack of adequate sanitation, dishwasher backups and the leaking from the dishroom to the Central Supply department. She indicated that she was not aware or involved in these issues. Following this interview the nurse who had been responsible for the infection control program prior to 11/30/09 was asked about her knowledge and participation related to the leaks from the dietary department into the central sterile supply area. She indicated that she remembered that there was some flooding into the central supply area from the kitchen; but had no recall of any decontamination of the area nor evaluation of potential infection control ramifications.

Per 2/09/10 interview with the Director of Quality, the Hospital's environment of care committee had no information about the leak in the kitchen, problems with the dishwasher, the impact on central supply or water pressure issues. The Director of Quality stated she had not been apprised of these environmental problems in the Hospital.

Interview with food service management and hospital staff confirmed that periodic problems with kitchen plumbing /dishwasher issues and poor flooring conditions resulted in leaks into the sterilization / decontamination area below. The hospital's infection control program and quality improvement had failed to address the safety and sanitary concerns to correct these long standing issues.

2. On 2/3/10 during tour of the ICU (Intensive Care Unit), survey staff were informed that patients requiring hemodialysis were transported from the patient care units to the ICU for treatments. The Quality Assurance nurse stated this was necessary due to the lack of adequate water pressure in the patient care units. One room of the ICU had been designated as the hemodialysis treatment room. Review of the Medical Executive Committee minutes revealed arrangements for patients to receive hemodialysis treatments in the ICU began in February 2009.

On 2/3/10, 7 patients in the ICU were on contact precautions. Four of the patients' culture results were positive for either MRSA (methicillin resistant staphylococcus aureus) or VRE (vancomycin resistant enterococcus) and culture results were still pending on 3 patients.

The hospital's plan to dialyze patients in the ICU was driven by inadequate water pressure in the hospital. The solution to the water pressure issue was to move patients from medical units to the ICU for hemodialysis, resulting in acutely compromised patients in the ICU potentially being exposed to infections from patients being transported to the ICU for hemodialysis treatments. Additionally, medical inpatients receiving hemodialysis treatments in the ICU were also potentially exposed to infections from patients in the ICU. Interview with the physician Vice President for Medical Affairs on 2/5/10 indicated his opinion that patients who required acute hemodialysis should be in the ICU; however, he stated he had not been aware prior to the day before, (2/4/10), that patients were being transported to the ICU for chronic hemodialysis.

Based on observation, record review and staff interview, the hospital failed to ensure the wireless telemetry monitoring system was maintained to ensure an acceptable level of safety and quality.

The findings are:

On 2/3/10 at approximately 9:30 A.M., the clinical leader of the Inpatient telemetry unit toured the unit with survey staff. Telemetry monitors were observed in the unit corridors. The clinical leader explained the nursing staff had the capability of monitoring 28 patients because the telemetry unit had 28 patient-worn wireless transmitters and also had monitors at the unit nursing stations.

At that time, the corridor monitor was flashing that 4 patient transmitters had a low battery. The patients were located in rooms 218, 232, 235B and 238. The patient in room 218 was on a Dobutamine intravenous drip, used to increase cardiac output in short-term treatment of cardiac decompensation.

Nursing staff were observed in the corridor and not responding to the "low battery" warning. The clinical leader explained that it was the responsibility of all the nursing staff to change the batteries if they observed the low battery warning. The clinical leader stated, the patient's heart rhythm would continue to be monitored when the low battery indication was flashing; however, if the alarm sounded, the rhythm would no longer be recorded. The clinical leader brought this to the attention of the nursing staff and requested the batteries be changed in these transmitters.

On 2/3/10, at approximately 2:45 P.M., the transmitters for two patients were noted to be flashing "low battery". Although nursing staff were observed in the corridors and at the nursing station, there was no observation of staff response to this warning.

On 2/4/10 at 8 A.M., the Chief Nursing Officer met with the surveyor and discussed the observations that were made on the telemetry unit on 2/3/10. The Chief Nursing Officer agreed if "everyone owns it no one owns it." An action plan effective 2/4/10 for Battery Replacement Telemetry Monitors was developed which noted all batteries would be replaced every morning, and this would be the responsibility of Certified Nursing Assistants during early morning rounds. The plan included a notation that the average battery life was 24 hours (with a maximum of 52) or more with an alkaline battery.

Condition for Infection Control Not Met

Based on observation, interview and record review, the Hospital failed to ensure that there was an effective hospital-wide infection control program in place to prevent, control, and address actual and potential sources for the transmission of infections.

Findings include the following:

- The Hospital failed to ensure that there was an infection control program that monitored, investigated and implemented a hospital wide surveillance system inclusive of all services and departments. Please refer to A-749.


- The Hospital's quality improvement program failed to adequately review environmental deficiencies in the Hospital's physical plant in order to adequately address the impact to patient safety in the area of infection control. Please refer to A-313.

- The Hospital nursing staff failed to ensure that urine specimens were obtained and sent to the laboratory for testing for 2 patients with recurrent urinary tract infections and for one patient who was exhibiting agitated behavior. Please refer to A-396.


- The Hospital failed to maintain and/or ensure a sanitary environment and proper operation of the dish machine for effective sanitization of dishes and equipment for use during preparation, distribution and service of foods. Please refer to A-620.


- The Hospital failed to maintain the physical plant and hospital environment in good sanitary and safe condition by completing routine repairs in the kitchen / dish room areas and central supply decontamination and sterilization rooms. Routine and preventive maintenance work order requests to address these areas went unattended and were not incorporated into the hospital's QAPI plan. Please refer to A-710.

Based on observation, record review and interview, the Hospital failed to ensure that there was an infection control program that monitored, investigated and implemented a hospital wide surveillance system inclusive of all services and departments.

Findings include the following:

1. During the initial visit to the St. Mary's medical/oncology unit on 2/3/10 it was noted that 6 of the 25 patients being cared for on the unit were on contact precautions. Interview with the Clinical Director of this unit revealed that the hospital had implemented a screening program for admissions related to the testing for MRSA (Methicillin Resistant Staphylococcus aureus) and for VRE (Vancomycin Resistant Enterococci). Three of the six patients on contact precautions had culture results pending in the laboratory. It was reported that culture results take 2 to 3 days to be reported from the laboratory.

On 2/4/10 the St. Mary's nursing care unit had 6 patients on contact precautions and 1 patient on droplet precautions. During this visit (2/4/10 at 10:20 AM) it was noted that the precaution trash in rooms 334, 337, 340, 345 and 349 was overflowing from the top of the uncovered trash bins in each of the rooms.

It was also noted at this time that the staff handed a used breakfast dietary tray from room 340 to a diet aide who placed it on the meal delivery cart to be returned to the kitchen for sanitation. (please refer to A-620)

When the St. Mary's unit was visited at 1:45 PM on 2/4/10 the precaution trash in rooms 340, 345 and 337 continued to be overflowing from the top of the uncovered trash bins in each room.

On 2/5/10 at 2:45 PM it was noted that three patients identified as being on contact precautions on the telemetry unit in rooms 218, 220, and 222 had precaution trash overflowing from the uncovered waste containers in their rooms.

2. During a visit to the St Mary's unit on 2/3/10 the staff indicated that non- sampled patient A was on contact precautions for MRSA in a foot wound.

On 2/4/10 non-sampled patient A was resting in his bed at approximately 2 PM. There was a sign on the entryway door frame which indicated that the patient was on contact precautions. It was observed that a diet assistant stood in the doorway and called out to the patient information regarding the food items on the supper menu. The surveyor heard the patient request that the diet assistant enter the room so that he could clearly hear her. The diet assistant informed the patient that she could not enter the room as he was on precautions. It was unclear why the dietary staff had not been trained in the necessary steps to take to be able to enter the patient's room and converse with him.

At approximately 2:15 PM on 2/4/10 it was noted that the staff had transferred this patient to a stretcher and placed the stretcher next to the desk at the nursing station. The unit secretary indicated that the patient was going to the ultrasound unit for a test.

The surveyor then traveled to the ultrasound unit and found the patient had been left in the hallway in the ultrasound area. At this point it was noted that the patient had a mask on his face. The surveyor was unable to determine why the mask was placed on the patient's face when the site of the MRSA had been identified as being located in a wound on the patient's foot. A review of the patient's electronic medical record revealed that the patient had no microbiology results pending.

The ultrasound technician #1 was interviewed regarding caring for this patient. He indicated that he could determine from the colored dot on the patient's identification bracelet if he had MRSA or VRE. The ultrasound technician then looked at the patient's identification bracelet and indicated that the patient had the colored dot on the bracelet to identify that the patient had MRSA.

The ultrasound technician then indicated that he had been taught to use universal precautions for all patients and would plan to care for this patient in the same manner.

During an interview with the infection control nurse on 2/9/10 the survey staff asked her about the system of using colored dots on the patient's identification bracelets to identify MRSA and VRE infections. The infection control nurse indicated that she had no knowledge of this system.

3. Patient #8 was admitted on 1/30/10 with a diagnosis of mental status changes. The patient had a fall and was taking a narcotic pain reliever and developed mental status changes. Following admission the hospital swabbed the patient's nares for MRSA and the test was positive. The resident was placed on enteric precautions. The patient was being cared for on the North 1 nursing unit.

On 2/5/10, the patient's door was observed with a "Stop" sign, a "Precaution" sign and a sign that stated "gowns" and "gloves" were required.

At 11:45 a.m., a physician was observed entering the patient's room. The physician put on gloves but did not put on a gown.

After the physician examined the patient, he disposed of the gloves in a large blue barrel and left the room requesting assistance from a nurse. Then the physician and the nurse entered the room together. The nurse began to put on a gown and gloves. At that time, the physician also put on a gown and gloves.

4. Patient #30 was admitted on 2/1/10 to the geriatric behavioral inpatient unit with diagnoses of visual hallucinations and altered mental status.

Following admission the hospital swabbed the patient's nares for MRSA and the test was positive. The resident was placed on enteric precautions.

On 2/5/10, the patients door was observed with a "Precaution" sign and a sign that stated "gowns" and "gloves" were required.

On 2/9/10 at 11:00 a.m., during interview, the patient's nurse was asked whether or not there was a special waste basket in the room for precautions. The nurse was observed going into the patient's room without a gown and checking the patient's bathroom for a waste basket. The surveyor said, "You aren't supposed to go into that room without a gown." The nurse said, "I know."

5. Patient #19 was admitted to the Geriatric Behavioral Inpatient Unit with behavioral disturbances. Review of the history and physical dated 1/20/10 revealed the patient had diagnoses that included dementia, agitation, uncontrolled hypertension and history of urinary tract infections.

Prior to the patient's hospitalization, she had recently been treated with an antibiotic for a urinary tract infection. On 1/27/10, the physician ordered a urine culture to determine an infection. Interview with Staff Nurse #1 and Staff Nurse #2, determined the urine was never collected and the laboratory test was not completed. Nurse #1 and #2 could provide no information why the ordered laboratory test was not completed.

6. The infection control nurse indicated that the infection control program has had limited involvement with the satellite units. She indicated that the satellite units have policies and procedures related to infection control however, she had not been onsite to these locations to take an active role in the implementation of the policies and procedures.

Onsite visits were conducted at 5 licensed satellites and an additional 5 unlicensed satellites. The Vice President of Outpatient Services stated that he reports monthly on the satellites. He confirmed that the reporting consists of operations data and that neither infection control logs nor surveillance tracking data is included in this reporting.

7. On 2/5/2010, during an onsite visit at a satellite clinic, (Diagnostic Imaging Services, located at 1565 North Main Street, Fall River, Massachusetts) the soiled utility room was observed. It was noted that this room contained five bags of dirty linen hat were stored on the floor, and piled on top of one another reaching to the ceiling of the room. The clinic director stated that linen was picked up weekly, and confirmed that storage of soiled linen is a problem.

8. Interview on 2/3/10 with the Clinical Director of the operating room revealed that she had no data available on the infection rates in the operating room suite. This was discussed with the infection control nurse who indicated that she had been informed of this following the surveyor's discussion with the Clinical Director.

9. On 2/3/10 during tour of the ICU (Intensive Care Unit), survey staff were informed that patients requiring hemodialysis were transported from the patient care units to the ICU for treatments. The Quality Assurance nurse stated this was necessary due to the lack of adequate water pressure in the patient care units. One room of the ICU had been designated as the hemodialysis treatment room. Review of the Medical Executive Committee minutes revealed transporting patients to the ICU for hemodialysis treatments began in February 2009.

10. On 2/3/10, 7 patients in the ICU were on contact precautions. Four of the patients' culture results were positive for either MRSA (methicillin resistant staphylococcus aureus) or VRE (vancomycin resistant enterococcus) and culture results were still pending on 3 patients.

Patient #43 was admitted to the St. Mary's nursing unit via the emergency room on 2/1/10. The patient's diagnoses at admission was acute respiratory failure. The patient had a recent admission to the hospital. According to 2/1/10 pulmonary consult, the patient had a recent hospitalization on 1/18/10 when she had evidence of acute community-acquired bronchitis.

On 2/1/10, a culture of the patient's nares was obtained. Review of the microbiology report dated 2/2/10 revealed the presence of MRSA (methicillin resistant staphylococcus aureus.)
The patient had been transported to the ICU on 2/1/10 and 2/3/10 for hemodialysis treatments.

Patient #25 was an 88 year old patient who was readmitted to the hospital on 2/1/10 with multiple medical diagnoses which included acute renal failure, congestive heart failure, hypertension and recent history of Escherichia Coli urinary tract infection of 1/27/10.

The patient had recently been started on hemodialysis via a PermaCath which was inserted on 1/23/10. Review of the medical record revealed that the patient was transported from her hospital room on the St. Mary's Unit to the ICU on 2/2/10 and 2/4/10 for hemodialysis treatments.

On 2/4/10 at approximately 1 P.M., survey staff observed the patient and her son seated in the designated hemodialysis treatment room on the ICU. The ICU staff were unaware the patient was in the room, and the hemodialysis nurse was off the unit. The hemodialysis nurse was contacted by the ICU staff and returned to the Unit.

The hospital's plan to dialyze patients in the ICU potentially exposes acutely compromised patients to infections from patients being transported to the ICU for hemodialysis treatments. Additionally, medical inpatients receiving hemodialysis treatments in the ICU also could be exposed to existing infections in the ICU.

11. On 2/9/10 the infection control nurse was interviewed regarding the infection control program in the hospital. She indicated that she had been employed at this hospital since the end of November 2009 and had been hired in a 24 hour per week position. Previous to her arrival there was a nurse assigned to direct both the infection control program and the risk management program.

The infection control nurse was interviewed regarding the hospital program of admission surveillance for MRSA and VRE screening. The infection control nurse indicated that this was a system initiative to address the hospital acquired infection rate. This hospital currently does the following:

- All admissions to the intensive care unit are cultured for MRSA,
if they continue to be patients in the ICU on Monday they are recultured.
- All patients admitted to North one are cultured. Each patient awaiting a culture result was placed on contact precautions.

Because the hospital cultures all admissions to these units and places each patient on contact precautions alone in a room while waiting for the results of these cultures, the hospital has limited its availability of beds. It was noted that on occasion the hospital had admitted adult patients to the pediatric unit. (Please refer to A-144)