The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

FAULKNER HOSPITAL-BRIGHAM AND WOMEN'S 1153 CENTRE STREET BOSTON, MA 02130 Dec. 14, 2011
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on observations, staff interview and review of facility quality assessment and performance improvement (QAPI) plan, the governing body failed to have a mechanism in place to ensure that 1 (acute hemodialysis) out of 8 contracted services reviewed, provided services in a safe and effective manner. Findings include:

Review of the list of contracted services provided to this hospital included dialysis nursing and technical services for acute hemodialysis patients.

A Contracted Dialysis Registered Nurse (RN) #7 was observed on 12/ 8/11 at 11:10 A.M., providing a breach in infection control technique to Patient #5. RN #7 touched the contaminated dialysis machine with bare hands. Without washing hands, R.N. #7, put on an eye shield and then went back to the dialysis machine. With bare hands, again touched the contaminated dialysis machine and readjusted the patient and tubing. Without hand hygiene, RN #7 put on a gown and a pair of gloves. RN#7 proceeded to disconnect the patient from the dialysis machine.

After observing the breaches in infection control technique by RN #7, an interview on 12/13/11 at 1:15 P.M with the Nurse Director of Intensive Care Unit (ICU)/Dialysis, who is responsible for the care provided to the acute care hemodialysis patients, stated there was no system in place to ensure the hemodialysis care provided by contract nurses to the hospital patients was performed in a safe and effective manner.

Review of the Governing Body Minutes from the first of the year 2011 to current on 12/14/11 at 8:30 A.M. lacked any written documentation that addressed how the Governing Body ensures contracted services for hemodialysis patients provide safe care to these patients.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, record review and staff interview, the hospital failed to consistently provide for a safe patient environment of care.
Findings include:
1. The hospital failed to consistently provide for patient safety during glucometer testing based on review of the hospital policy.
Observations on the 7 North Unit on 12/7/11 at 11:35 A.M., revealed a patient care technician assistant (PCT #1) failed to follow hospital procedures to ensure correct identification of a patient. PCT #1 used a hand held glucometer that was programmed to scan the identification bracelet of the patient prior to testing the patient's blood. However, instead of scanning the bar code on the patient's identification bracelet and worn by the patient, the PCT used a bar code in a loose-leaf binder in the patient's room as a means to confirm the patient's identification. This could lead to misidentification of the blood glucose results in the wrong patient record, if the wrong bar code belonging to the wrong patient were scanned.
According to the Director of Patient Safety, and review of the procedure entitled "Patient Verification," this practice was not consistent with the hospital process for patient verification.






2. The hospital failed to provide three (2 bedded) patient rooms (#208, #209, #211), on the psychiatric unit, with a call bell and individual light for each bed in these rooms. There were no nightlights observed in the bathrooms either. Patients assigned to the second bed without a lights or call bell, were at increased risk of falls due to inability to access light or assistance if needed at night to go the bathroom or if sick and in need of staff assistance.

During a tour of the 24 bed psychiatric unit on 12/13/11,at 11:30 A.M., Rooms #208, #209 and #211 were observed to each have 2 beds but only 1 call bell and 1 individual light, next to one bed only.

During interview on 12/13/11, at 11:30 A.M., the Nurse Manager, stated that initially all the rooms on the unit were singles and these three rooms were changed to doubles at some point. The hospital did not add a second call bell and individual light to each room when it became a double. She stated the hospital planned to add the necessary call bells and lights in approximately 6 months.

During interview on 12/14/11, at 1:30 P.M., the Vice President overseeing the psychiatry unit stated that the 3 rooms became doubles in 2001 and that call bells and individual lights were not added at that point for the second beds.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on staff interview and review of committee meeting minutes, the hospital failed to include available data report information for two of eight contracted services for review by the hospital's quality assessment and improvement (QAPI) program. These contracted services included the Acute Hemodialysis service and the Organ Procurement Organization. Findings include:

1. The Director of the Intensive Care Unit, (ICU) interviewed on 12/13/11 at 1:15 P.M. and interview with the Chief Nursing Officer on 12/14/11 at 9:00 A.M., revealed that data for the contracted hemodialysis service was collected. The contracted nurse for hemodialysis submitted a report of this data to the contracted service company on a quarterly basis. This data report is reviewed by the contracted service's Medical Director and their QAPI team.

The Director of the ICU who is responsible for overseeing the dialysis contracted services also reviews this quarterly data report which includes outcomes of the dialyzed patients. If there were any issues the ICU Director stated she would discuss them with the Hospital Medical Director of the ICU and would develop an action plan if needed. Although the ICU director reviewed the data, review of the hospital QAPI program minutes from 1/1/11 -12/13/11 did not contain the above contracted hemodialysis data.







2. Interview with the Director of Staff Development/Quality and Practice Innovation on 12/14/11 at 11:45 confirmed that the hospital contracts with the New England Organ Bank ( NEOB) for organ donation service. The NEOB provides data to the hospital relative to the organ procurement program.

Record review on 12/14/11 at 9:30 A.M., of the QAPI minutes from 1/1/11 through 12/14/11, revealed that the hospital collects data on the number of reported deaths, and this data is reviewed by the Director of Staff Development/Quality and Practice Innovation. However, the hospital QAPI program minutes did not indicate that this data was reported to the QAPI program.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on review of the Hospital's Internal Investigation regarding a wrong-level spine surgery performed on Patient #1-A, it was determined that the Hospital did not fully implement 2 of 5 Action Items called for in its Corrective Action Plan.

Findings include:

The Hospital reported a wrong-level spine surgery that occurred and was investigated on 10/25/11. The Report indicated that Patient #1-A was scheduled to have a L4-5 laminectomy (surgical removal of bony parts of the 4th and 5th lumbar vertebrae) and diskectomy (surgical removal of a ruptured intervertebral disk), but a L3-4 laminectomy and partial diskectomy were performed. The error was recognized when an intra-operative x-ray was obtained and the Surgeon subsequently completed the correct planned surgical procedure.

Review of the Hospital's Internal Investigation related to Patient #1-A's wrong-level spine surgery indicated that the Investigation determined that pre-operative imaging and an intra-operative x-ray were performed to identify the intended level of surgery and the correct surgical site/level was marked in accordance with the standard of care. Patient #1 had a high body mass index with abnormal spine anatomy and the surgical incision was small and deep. A second intra-operative x-ray was performed because disk findings were not what the Orthopedic Surgeon expected based on the pre-operative imaging. The second intra-operative x-ray indicated the surgery was being performed at the wrong level.

The Investigation also identified that although the Orthopedic Surgeon verbally disclosed the error to Patient #1-A, he failed to document disclosure of the surgical error to Patient #1-A.,

Review of the Hospital's Corrective Action Plan indicated the plan included the following action items: 1.) Formal discussion with the Orthopedic Surgeon regarding the case and documentaiton deficiencies, 2.) Conferencing with Operating Room Leadership Staff at Hospital #2 regarding consideration of the possible use of a fixed needle marker for all spinal surgery and a wider laminectomy incision for all patients with an increased body mass index, 3.) a formal performance improvement plan related to the Orthopedic Surgeon's documentation deficiencies, 4.) formal counseling of Staff RN #1 regarding seeking out appropriate guidance and support and 5.) formal multidisciplinary debriefings following serious events.

Review of the Corrective Action Plan implementation indicated that the following two action items were not implemented:
1.) The Operating Room Leadership Staff did not establish a date with Leadership staff at Hospital #2 to discuss the possible use of a fixed needle marker for all spinal surgeries and a performing a wider laminectomy incision for all patients with increased body mass; and
2.) The formal performance improvement plan related to the Orthopedic Surgeon's documentation deficiencies was in process, but not completed.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and staff interview, for one patient (#12) in a total sample of 30, the physician failed to ensure the patient received sertraline (antidepressant) for 3 days, despite intentions to do so.

Findings include:

Patient #12 was admitted on [DATE] with diagnoses of opioid dependence and anxiety disorder.

The physician's initial assessment on 12/5/11, indicated the patient was taking sertraline (antidepressant) 300 milligram (mg) daily. The physician's notes on 12/7/11 and 12/8/11 indicated the patient continued to take sertraline 300 mg daily for an anxiety disorder.

A review of the medical record revealed that there was not a physician's order for sertraline 300 mg. daily.

A review of the medication administration records for 12/2011 revealed the patient had not received sertraline since admission to the facility on [DATE].

During interview on 12/8/11 at 2:30 .P.M, the Nurse Manager on the detoxification unit stated the patient did not have an order for the sertraline and had not received it since admission.

During interview on 12/12/11 at 9:45 A.M., the physician stated that she had failed to write an order for the sertraline. She wrote an order on 12/8/11 and the patient received the medication on 12/9/11 before being discharged from the hospital
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and staff interview, the hospital failed to ensure a nursing care plan for each patient was (a) current and addressed each patient's needs regarding pressure ulcers for 2 patients (#4 and #19) and (b) failed to ensure each nursing care plan had goals and individualized interventions for problems identified in the nursing assessment for 3 patients ( #1, #2 and #7), out of a sample of 30. Findings include

1. For Patient #19, the plan of care was not updated to address skin breakdown which developed at the hospital.

Patient # 19 was admitted on [DATE] with failure to thrive, Diabetes and inability to ambulate.

Review of the clinical record on 12/8/11 reflected the patient was admitted with a red coccyx but skin was intact. The care plan to address skin issues had interventions initiated on 12/1/11 which included:
-keep head of bed less than 30 degrees as consistent with medical condition and other restrictions.
-reposition every hour.
-raise heels off bed with pillows.

Documentation in a nurse's note revealed on 12/3/11 the patient developed a stage II on the coccyx. There was no further assessment of the open area.

The plan of care was not updated to address actual skin breakdown.

Observation on 12/8/11 at 12:05 P.M. revealed after Registered nurse (RN) #8 removed a Mepilex dressing, an open area on the coccyx measuring approximately 1/2 inch by 1/4 inch yellow colored wound bed with serous sanguinous drainage.

During interview on 12/8/11 at 12:30 P.M. RN #8 stated that when an open area develops she applies either Critic Aid or a Mepilex dressing.

Further review of the clinical record lacked an order to apply Critic Aid or a Mepilex dressing.

2. For patient #4, the plan of care was not individualized to meet the needs of this patient.

Patient #4 was admitted to the hospital with gangrenous digits, Diabetes and bilateral below the knee amputations.

This patient was at risk for further skin breakdown based on the Braden scale assessment. The plan of care initiated on 12/5/11 had interventions that included raise heels off bed, (not appropriate for this patient who has bilateral below the knee amputations). Interview with the Nurse Director for the 6 South unit on 12/13/11 at 3:30 P.M. revealed that the plan of care interventions are automatically computer generated with the same interventions for every patient. The interventions are not individualized.







3. For Patient #1, the initial nursing assessment identified the patient as being a high risk for falls, having a colostomy, being at risk for skin breakdown, having open areas of the sacrum and left back, using a Foley catheter, being sedated on a mechanical ventilator and fed via an oral gastrostomy tube.

Review of the nursing plan of care indicated it lacked interventions and goals for falls, colostomy and catheter care and potential for infection related to the catheter and ventilator.

For skin issues, the care plan had interventions that were not individualized to the patient. The care plan under Braden -Nutrition had an intervention to offer the patient water if needed for patient hydration. Patient was sedated, intubated, nonresponsive, ordered to receive nothing by mouth and received all nutrition via a gastrostomy tube. The care plan interventions used to treat the pressure sores and goals of treatment were not individualized.

4. For Patient #2, the initial nursing assessment identified the patient as being admitted for alcohol withdrawal with seizures, being at risk for injury from falls, using restraints, a Foley catheter, under arrest and wearing leg shackles while in custody of the police. The patient's behavior was described as agitated at times .

Review of the nursing care plan indicates the plan lacked goals and interventions for falls and safety, infection prevention for the use of the catheter and no interventions to protect the skin under the shackles from breakdown.

5. For Patient #7, the initial nursing assessment indicated the patient was legally blind, high risk for falls, had depression, was admitted for congestive heart failure exacerbation and used the anticoagulant drug, Coumadin.

Review of the nursing care plan indicated it lacked interventions and goals for falls anticoagulant use, depression, visual deficits or for congestive heart failure and fluid balance.

Review of physician orders, dated 11/30/11, indicated the patient was on a strict fluid restriction, strict intake and output, daily weights and was allowed to take home sleep medications for insomnia.

6. Interview with the Chief Nursing Officer on 12/14/11 at approximately 1:30 P.M., indicated that the nursing care plans could improve to include areas identified in the nursing assessment.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on record review and interview, the Hospital failed to ensure that all medical record entries were timed and dated by the person responsible for providing or evaluation the service provided for three active patients( #3, #17, and #19 ) and two outpatients (OP #1 and OP#2), in a total sample of 34 records reviewed.

Finding include:

1. Review of the Patient record #3 indicated the Licensed Social Work consult, written on 12/5/11, was not timed as required.

2. Review of the medical record for Outpatient #1 indicated the pre operative orders,and the surgical consent were not times as required.

3. Review of the medical record for Outpatient #2 indicated the pre-operative orders, the preanesthesia evaluation and the post anesthesia evaluation were not timed as required.





4. Review of the clinical record for patient #19 on 12/8/11 revealed physicians' progress notes were not consistently timed and dated as required. For example a physician's progress note dated 12/2/11 lacked time and another medical staff progress note lacked a completed date and time.






5. For Patient #15, record review revealed on 12/ 8/11 at 11:45 A.M., the emergency room note dated 12/6/11, was signed by the physician but lacked documentation of the time the notation was entered into the medical record.

This was confirmed by the nurse manager on the 6 North unit on 12/8/11 at 3: 30 P.M.
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the Hospital failed to ensure medical records for three patients (#1, #7, #19), in a total sample of 30, properly documented informed consent forms for procedures and treatments, requiring written consent.

Findings include:

1. Per the Hospital Policy for Consent to Treat, for emergency treatment where to patient may be unable to consent, the need for proceeding with treatment must be clearly documented. The physician should take the following steps: (a) obtain a consult form a physician who is qualified to assess the patient's capacity to provide informed consent. The consult should appear in the medical record; (b) efforts should be made to obtain consent from an appropriate person on behalf of the patient such as legally appointed health care agent, legal guardian or next of kin; (c) telephone consent with the legally authorized person may be obtained with documentation in the record of the conversation, and if (d) in the event of an extreme emergency, the patient will be treated immediately.

The Request for Hospital Care and Medical Treatment form is to be explained to each patient when treatment in requested in the ER, The ER admitting staff is responsible for ascertaining that the form is completed and signed.

The Request for Medical Treatment and Admission to the Hospital is to be explained to each patient by the physician when admission to the hospital is indicated. The admitting Office staff is responsible for ascertaining that the form is compete and signed.

The Consent for Procedure form should be used for all major therapeutic and diagnostic procedures when disclosure of significant medical information, including major risks are involved, would assist a patient in making an intelligent decision as to whether to undergo the proposed procedure.

2. For Patient #1, admitted on [DATE], via the emergency room (ER) to the Intensive Care Unit (ICU), the Hospital failed to obtain general consent for treatment from the Health Care Agent and failed to document in the medical record written consent for placement of an arterial line for blood pressure monitoring and blood gas monitoring.

Patient #1 was admitted to the ICU via the ER, on mechanical ventilation with diagnosis of septic shock respiratory failure, dementia, Parkinson's disease and past cerebral vascular accident (stroke). The patient was assessed as non-verbal.

Review of the ER progress notes indicated the patient was accompanied by a family member who was identified as the health care agent and who was present all through the ER stay and admission to the ICU. Review of the physician ER progress notes indicated the ER physician "spoke at length" with the HCP but did not document any consent for treatment. Further review of the ER notes indicated the patient was intubated and mechanically ventilated shortly after arrival to the ER and placed on vasopressor therapy to maintain blood pressure.

Record review indicated that on 12/2/11, while in the ICU the patient had an arterial line placed at 9:20 P.M. Review of the pre-procedural checklist indicated that the consent was complete. Review of the medical record indicated no consent for the procedure. The ICU secretary also reviewed the record and was not able to locate a consent.

3. For Patient #7, admitted on [DATE] through the emergency room , the Hospital did not obtain written consent for admission and treatment.

Record review indicated the patient was admitted for exacerbation of congestive heart failure. Review of the record indicated on 12/12/11, no evidence of consent to hospitalization and treatment.

Record review revealed upon admission to the unit, the patient was alert and oriented to person, place and time. Although the patient was legally blind, the record indicated there was a very involved family member who was also the health care proxy.

Record review indicated there was case management meetings and the family member was in and available.

Review of progress notes did not indicate any verbal consent obtained from the patient.

As of 12/12/11, record review indicated no written consent for treatment had been obtained.

On 12/12/11/ at 11:00 A.M., the Director of Patient Safety stated there was no consent in the patient record.





4. For Patient #19 the hospital failed to obtain consent to treat and release information on admission.

Review of Patient #19 clinical record on 12/8/11 lacked signed consent to treat and release information or documentation that the patient was unable to sign.

The Director of Admissions upon interview on 12/8/11 at 1:50 P.M. stated that it was the responsibility of the admission department to obtain the written signatures of patients for consents and if unable to sign, document as such on the appropriate forms. The Director of Admissions stated that for Patient #19, the consent forms were not done as required per policy.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, and staff interviews, the Hospital failed to ensure staff consistently implemented infection control practices to prevent cross-contamination and control infections.

Findings included:
1. Observations in the Interventional Radiology (IR) Room on 12/8/11 at 11:00 A.M. revealed Patient #24 was brought to IR for the placement of a peripherally inserted central catheter (PICC). A PICC line is a long, small, flexible tube that is inserted under sterile conditions into a peripheral vein, typically in the upper arm, and advanced until the catheter tip terminates in a large vein in the chest near the heart. Patient. # 24 was on Contact Precaution (measures used to prevent the spread of pathogens including: patient placement, gloving and gowning, care of patient-care equipment and instruments/devices, hand hygiene, and environmental measures), because of the patient's history of a Multi-Drug Resistant Organism of the respiratory system (MDRO is any kind of bacteria that has become resistant to many different antibiotics.)
The patient, undergoing the PICC line insertion, also had an open tracheostomy tube (an opening in the front of the neck with a tube inserted directly into the airway.) Although the patient was on Contact Precautions a second sterile table (sterile table #2) had been set up approximately four feet away from the Contact Precaution patient. According to the Interventional Supervisor, at the completion of the procedure, environmental services would be contacted to thoroughly clean the procedure room. However, sterile table #2 had been set up and covered for the next patient's sterile procedure. Sterile table #2 was present in the procedure room during the PICC placement and before the room was thoroughly cleaned and decontaminated after the procedure for the patient on Contact Precautions.





2. The Contracted Dialysis Registered Nurse (RN) #7 was observed on 12/ 8/11 at 11:10 A.M., providing hemodialysis to Patient #5. RN #7 touched the contaminated dialysis machine with bare hands. Without washing hands, R.N. #7, put on an eye shield and then went back to the dialysis machine. With bare hands, again touched the contaminated dialysis machine and readjusted the patient and tubing. Without hand hygiene, RN #7 put on a gown and a pair of gloves. RN#7 proceeded to disconnect the patient from the dialysis machine.

Per Center for Disease Control personal protective equipment (PPE) such as gloves, be worn when touching potential contaminated equipment (dialysis machine). Hand hygiene should be performed prior to applying PPE's.

On 12/8/11 at approximtely 11:30 A.M., during interview, RN #7 said that when a patient is being dialyzed, gloves should be worn when touching the dialysis machine.

The Director of the Intensive Care Unit, (ICU) revealed upon interview on 12/13/11 at 1:15 P.M. that the contracted nurse for hemodialysis should be following proper infection control practices. Currently there are no audits being done to ensure this nurse follows proper infection control practices.










3. Review of personnel files indicated that five direct care staff did not have immunity or vaccination for Mumps as required by Hospital infection control standards for Health clearance.

Review of health records indicated the following staff lacked evidence of immunity by titer or two vaccinations for mumps: one OR nurse, three Physical Therapists and one occupational therapist.

4. During an observational tour of the operating room (OR) 2 on 12/9/11 at 10:20 A.M., three operating room staff members were observed cleaning the suite after a surgery had finished. The surveyor observed as staff cleaned and emptied trash and followed the case cart with dirty instruments to the the dirty utility room. Upon return to OR suite 2, staff were observed to be mopping the floor from the inner core door towards the outer hallway door and were at the outer hall door. The surveyor walked over to the anesthesia cart, located across the room to the right of the inner core door. This was an area that had already been mopped. Observed on the floor at the base of the anesthesia cart, was a large barrel syringe, filled with approximately 30 milliliters of a thick white fluid. A intravenous extension set was attached and the syringe was not labeled with its' contents. The Nursing Director of Perioperative Services, who was accompanying the Surveyor, picked up the syringe and disposed of it in the hazardous waste bucket after confirming it was not labeled.

Further discussion with the Director of Perioperative Services on 12/9/11 at 10:30 A.M., indicated that the cleaning staff of OR suite 2 should have noticed the syringe during a proper mopping of the OR floor and disposed of it. The Director also stated that anesthesia personnel, who most likely used the medication in the syringe during surgery, should have disposed of the syringe and its contents properly at the end of the case.