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55 LAKE AVENUE NORTH

WORCESTER, MA 01655

PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION

Tag No.: A0123

Based on interviews and documentation review the Hospital (Campus #2) failed to ensure that grievances were responded to in a timely manner for one of six applicable patients (Patient #21).

Findings included:

Review of Grievances indicated that on 3/4/11 the Complainant filed a grievance regarding a staff member's treatment of Patient #21.

The Complainant was interviewed on 3/30/11 at 7:40 A.M. The Complainant said that to date there had been no further communication from the Hospital verbally or in writing regarding the complaints.

Campus #2's Policy/Procedure titled Complaint Process indicated that a grievance is a complaint that could not be resolved on the spot by staff. Patient Care Services (PCS) are notified of all grievances and is responsible for making contact with the complainant on the next business day. This communication begins with fact gathering and will set out the plan for addressing the grievance and the estimated time of response. A written response is provided within 30 days of receipt of the complaint. If the process of resolution is going to take more than 30 days then a brief letter will be sent to the complainant stating the process is continuing and the estimated time to completion.

The Director of PCS was interviewed on 3/30/11 at 10:30 A.M. and the PCS Representative assigned to Patient #21's case was interviewed on 4/5/11 at 1:35 P.M. They said the grievance was filed 3/4/11. The PCS Representative said that on 4/4/11 he/she drafted the Response Letter which was currently being reviewed. The PCS Representative said once the Letter was approved it would be mailed to the Complainant. The PCS Representative said there had been no verbal communication with the Complainant since the day the Complaint had been filed.

The Director and the PCS Representative said there were 3 representatives plus the Director to address complaints/grievances for the Hospital's 3 campuses and outlying clinics. The Director and PCS Representative said as a result of the volume letters were not always sent out in a timely manner.

Six complaints/grievances were randomly from the 2011 Patient Complaint Log for the Medical/Surgical Oncology Unit. The Director reviewed information related to the complaints/grievances and it was determined that complaints were handled on the spot and response letters to grievances were sent out within the Policy's parameters.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on interview and documentation review the Hospital failed to ensure that a physician's order was obtained daily per policy for each type physical restraint applied to one of one applicable patients (Patient #21).

Findings included:

Medical record documentation, dated 7/28/10, indicated that Patient #21 was transported to the Hospital (Campus #2) after being struck in the head by a large branch while cutting down a tree. Patient #21 had facial injuries and an obvious rupture of the right eye. Patient #21 did not have a significant medical history other than smoking cigarettes and was not on any medications.

Medical record documentation, dated 7/28/10, indicated that diagnostic testing was performed and determined Patient #21 suffered multiple facial fractures, bilateral fractures of the frontal bone, herniation of the brain to the left, a post-trauma subdural hematoma and cerebral hemorrhages. Initially Patient #21 was alert however; while in the ED he/she decompensated and required intubation (insertion of an endotracheal tube through the mouth down the throat and to trachea to provide a patent airway) and mechanical ventilation (machine that either assists with breathing or breathes for the patient). On 7/29/10 Patient #21 was taken to surgery where a craniotomy, repair of dural tears, repair of multiple facial fractures, and evacuation of the subdural hematoma were performed. Patient #21 was then transferred to the Neuro/Trauma Intensive Care Unit (ICU) in guarded condition.

Medical record documentation, dated 7/29/10 to 8/3/10, indicated that Patient #1 was frequently agitated and restless and was attempting to pull at lines, tubings, and dressings. Documentation indicated that when sedation was lifted, Patient #21's agitation and restlessness increased. Documentation indicated that nonrestrictive measures such as frequent checks, attempts to hide equipment, and verbal reminders were attempted and were not successful. Physical restraints were applied.

Review of the Hospital's Policy/Procedure titled Restraints, effective 8/12/09, and review of the Physician Order Sheet for Restraints indicated that there must be an order for each type of restraint used and the order was effective for 1 calendar day only.

Review of Patient #21's medical record documentation related to the type(s) of physical restraints used and review of physician orders for the period of 7/29/10 to 8/3/10 revealed the following:

On 7/31/10 medical record documentation indicated that Patient #21 was extubated and sedation had been lifted. Patient #21 was extremely restless and agitated and was attempting to pull at tubings and dressings. Nursing documentation indicated that wrist and ankle restraints and mitts were applied

Review of the medical record documentation indicated that a Physician Order Sheet for Restraints was not completed.

On 8/1/10 and 8/2/10 nursing documentation indicated that wrist and ankle restraints and mitts were applied. Although a Physician Order Sheet for Restraints was completed it did not include mitts.

On 8/3/10 nursing documentation indicated that Patient #21 was again extubated and sedation was lifted. Patient #21 became extremely agitated. Documentation indicated that a vest, elbow, wrist, and ankle restraints were used.

Nurse #5 was interviewed on on 4/5/11 at 10:30 A.M. Nurse #5 confirmed that vest, elbow, wrist, and ankle restraints were used.

Although a Physician Order Sheet for Restraints was completed it did not include the vest, elbow, and ankle restraints.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on interview and documentation review, the Hospital failed to ensure that a medication order was written it was intended it be administered for one of one patients (Patient #21).

Findings included:

Please refer to Standards A-0168 and A-0287 for background information regarding Patient #21's medical condition and the event of 8/3/10.

Review of the medical record, dated 8/3/10, indicated that Ativan 5 milligrams intravenous was ordered for Patient #21.

The PGY2 Resident assigned to the Neuro/Trauma ICU on 8/3/10 was interviewed on 4/6/11. The Resident said Nurse #5 reported between 2-3:00 P.M. the medication Haldol had not been effective. The Resident ordered the medication Ativan 5 milligrams and told Nurse #5 to give in smaller doses up to 5 milligrams. However, the Resident did not write the order as he/she intended for it to be given.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview and documentation review the Hospital failed to ensure that clinical alarms were responded to in a timely manner for 1 of 1 applicable patients (Patient #21).

Findings included:

Medical record documentation, dated 7/28/10, indicated that Patient #21 was transported to the Hospital (Campus #2) after being struck in the head by a large branch while cutting down a tree. Patient #21 had facial injuries and an obvious rupture of the right eye. Patient #21 did not have a significant medical history other than smoking cigarettes and was not on any medications.

Medical record documentation, dated 8/3/10, indicated that medication for sedation was discontinued and Patient #21 was extubated. Patient #21 remained connected to the monitor system for continuous monitoring of heart rate, respirations, blood pressure, oxygen saturation levels and cardiac rhythm.

Nursing documentation, dated 8/3/10, indicated that the monitor system alarm settings were: heart rate = 50 to 120; respirations = 8 to 30; systolic blood pressure = 90 to 160 and, SpO2 = 92 to 100%.

The nurse assigned to Patient #21 from 7:00 A.M. to 7:00 P.M. on 8/3/10 (Nurse #5) was interviewed on 4/5/11 at 10:30 A.M. Nurse #5 said after Patient #21 was extubated and sedation was stopped Patient #21 became very agitated. Nurse #5 was focused on Patient #21. Nurse #5 said Patient #21 was connected to the monitoring system and had a manual blood pressure cuff. Nurse #5 said the SpO2 monitor alarmed all day because Patient #21 kept removing it; despite the use of restraints. Nurse #5 never silenced the alarm. Nurse #5 said the SpO2 probe was reapplied multiple times to different sites including the ear lobes and toes. Nurse #5 checked Patient #21's vital signs and the SpO2 levels were within acceptable parameters.

The PGY2 Resident assigned to the Neuro/Trauma ICU on 8/3/10 was interviewed by telephone on 4/6/11. The Resident said Patient #21 had been very agitated after extubation and was a danger to him/herself therefore both Haldol and mechanical restraints were used. The Resident said Nurse #5 reported between 2-3:00 P.M. the medication Haldol had not been effective. The Resident ordered the medication Ativan 5 milligrams and told Nurse #5 to give in smaller doses up to 5 milligrams. However, the Resident did not write the order as he/she intended for it to be given.

Review of Physician orders and the Medication Administration Record, dated 8/3/10, indicated that Patient #21 received the following medications for agitation and pain management: Fentanyl 25 micrograms at 11:00 A.M., 1:00 P.M. and 2:00 P.M.; Zyprexa 2.5 milligrams sublingually at 1:00 P.M. (antipsychotic medication used to manage agitation); Haldol 10 milligrams intravenous (antipsychotic medication used to manage agitation) at 3:15 P.M., and Ativan 5 milligrams intravenous once 4:30 P.M. (anti-anxiety medication). Documentation indicated Ativan was administered with good effect.

Medical record documentation, dated 8/3/10 and timed 5:00 P.M. indicated that Patient #21's vital signs were as follows: the heart rate = 84 beats per minute; the respiratory rate = 25 breaths per minute; the blood pressure = 124/73, and the SpO2 level = 95% on room air. Patient #21 was in normal sinus rhythm.

Nursing documentation, dated 8/3/10 and timed 5:18 P.M., indicated that Patient #21 continued to be restless and agitated and pulling at tubes and dressings. Patient #21 required 1:1 supervision and the application of physical restraints. During the day Patient #21 had requested to go to the bathroom, was placed on the bedpan, had a bowel movement, and was incontinent of urine.

Nurse #5 said she last saw Patient #21 at approximately 5:15 P.M. and Patient #21 was okay.

Review of Patient #21's monitor system alarm history, dated 8/3/10 from 5:00 P.M. to 5:57 P.M., indicated that between the period of 5:00 P.M. and 5:57 P/M. noncritical alarms frequently sounded for heart rates ranging from 121 to 126 beats per minute, respiratory rates ranging from 32 to 40 breaths per minute, and SpO2 levels ranging from 86% to 89%. The last SpO2 level alarm documented was at approximately 5:35 P.M. for an SpO2 level of 89%. At approximately 5:57 P.M. an alarm sounded for a respiratory rate of 6-7 followed immediately by a critical alarm for apnea.

There was no evidence that nursing had responded to the alarms during this period of time.

Nurse #5 said at approximately 6:00 P.M. Patient #21's critical alarm sounded. Nurse #5 said she was in with another patient and was finishing up documenting in the electronic medical record (on the computer in the patient's room) and thought someone else had responded. Nurse #5 said she closed out the elctronic record and went to Patient #21. Nurse #5 said Patient #21 was gray in color and a Code was called. Nurse #5 said the SpO2 probe was off Patient #21's finger. Cardiopulmonary resuscitation was performed; Patient #21 was intubated and was vented.

Medical record documentation, timed 6:00 P.M., indicated that the team was called to Patient #21's room secondary to apnea. Patient #21 was being provided with breaths via an ambu bag then became pulseless and cardiopulmonary resuscitation commenced.

Medical record documentation indicated that following the Code a head CT scan was obtained that identified a slightly decreased subarachnoid hemorrhage (improved from the initial CT scan) and bilateral subdural hygromas (a collection of cerebrospinal fluid which typically is a result of head trauma). Following the Code Patient #21 developed probable seizure activity. An electroencephalogram was performed to determine Patient #21's brain activity. The electroencephalogram was indicative of anoxic brain injury and with poor prognosis. While sedation was held Patient #21 did not show signs of neurologic improvement. Meetings were held with Patient #21's family and on 8/8/10 and the family elected to have comfort measures only. Patient #21 was extubated and expired.

CONTENT OF RECORD: ORDERS,NOTES,REPORTS

Tag No.: A0467

Based on documentation review the Hospital failed to ensure that restraint documentation was completed for one of one patients (Patient #21).

Findings included:

Please refer to Standard A-0168 regarding background information for restraint use.

1) Review of the Hospital's Policy/Procedure titled Restraints, effective 8/12/09, indicated that restraints were to be checked every 2 hours.

Review of nursing documentation indicated that the electronic Nursing Care Flow Sheet had 2 areas for restraint documentation to be completed. One area identified if restraints were checked every 2 hours as required. The second area included a space to indicate patient care: the restraints were appropriately applied, circulation and skin were checked, the need for the restraints(s) was re-assessed, and release for care/repositioning.

Review of the Nursing Care Flow Sheets, dated 7/29/10 to 8/3/10, indicated that although checks were consistently documented as being completed every 2 hours; documentation under the patient care section was not consistently documented every 2 hours.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on interview, observation, and documentation review, the Hospital failed to ensure that pre-operative site marking was consistently performed on spinal surgeries for 3 of 11 applicable patients (Patients #4, #9, and #11).

Findings included:

During a tour of the OR, conducted on 3/29/11, a patient (Patient #11) having spinal surgery (entrance site was anterior cervical) was selected for observation. Observation indicated that a portable x-ray unit was brought into the OR suite and fluoroscopy images taken previously were displayed on the imaging screen for review.

Observation of Patient #11 indicated that he/she was positioned in the supine position. The Surgeon performing the procedure (Surgeon #3) said the procedure did not require a site marking and the only way to confirm the exact site was through fluoroscopy. Observation of Patient #11's anterior cervical area indicated that there was no pre-operative site marking.

The Hospital's Policy/Procedure titled Universal Protocol, effective 3/1/08, indicated that all patients having an invasive or surgical procedure that involves laterality, multiple structures or levels must have their site marked. The site will be marked with a permanent marker prior to the patient being transferred to the procedure room. Spinal surgery is a two stage marking process: 1) preoperatively the skin is to be marked at the level of the procedure and indicates anterior or posterior and right or left, and b) intra-operatively x-rays with radio-dense markers will be used to determine the exact location and level of surgery.

A sample of 10 medical records were selected for review (Patients #1-10). The review determined that:

1) On 2/9/11 Patient #4 was scheduled for a multi-level spinal fusion and resection. Review of the Perioperative Nursing Record indicated that pre-operative site marking was not performed.

2). On 2/9/11 Patient #9 was scheduled for a lumbar laminectomy and fusion. The Perioperative Nursing Record indicated that pre-operative site marking was not performed.