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METHUEN, MA 01844

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on record review, physician and staff interview, one of one Patient's scheduled for a Stereotactic Radiosurgery in April 2010 did not have the Crew Frame removed by the Neurosurgeon according to the Hospital's Rules and Regulations and Hospital Policy.

The findings are as follow:

The Patient was scheduled as an outpatient for the two phase procedure the Stereotactic Radiosurgery.

Review of the literature for Tumor Registrars Association Newsletter of New England (T.A.N.E) for Stereotactic Radiosurgery as written by the Radiation Oncologist indicated the high doses of radiation were delivered by directing radiation beams in three dimensional fashion. The first phase of the patient's procedure involved the surgical placement of a Crew Frame using four pins drilled into the Patient's forehead and back of the head. The procedure took place in the operating room The second phase of the procedure involved taking the patient to radiation oncology for the delivery of the radiation by bolting the patient's head Crew Frame to the table. The literature indicated after completion of the patient's procedure the patient then returned to the operating room for removal of the head crew frame and dressing application by the Neurosurgeon.

Review of the Patient's record and interview by telephone with the Neurosurgeon on 07/27/10 at 4.25 PM indicated had the Neurosurgeon applied the Crew Frame as the Patient was administered conscious sedation and a local anesthetic on 04/20/10 at 10:19 AM.

Review of the Operative Note indicated the Patient tolerated the procedure well. The Patient was then taken for a head Computerized Tomography (CT). The Neurosurgeon then identified the specific nerve for the Radiation Oncologist to treat with the radiation beams.

Review of the Surgical Day Care Nursing Assessment indicated on 04/20/10 at 11:27 AM, the Patient returned for further monitoring.

At approximately 1:30 PM on 04/20/10, the Patient was brought to Radiation Oncology for the second phase the radiation treatment for a complaint of left trigeminal nerve pain.

Review of the Hospital's Policy for Stereotactic Radiosurgery indicated at the completion of the delivery of radiation, the neurosurgeon was to remove the frame from the patient in the treatment room and bandage the patient's head and apply pressure; if there was any bleeding.

The Radiation Oncologist was interviewed in person on 07/27/10 at 11:45 AM. The Radiation Oncologist said the Patient had the stereotactic radiation done over a period of approximately 40 minutes. The team consisted of the Radiation Oncologist, Physicist,and Radiology Technician. The Patient then returned to Surgical Day Care Center for monitoring.

Review of the Discharge Summary for the radiation treatment as documented by the Radiation Oncologist(undated) indicated the Patient tolerated the procedure well and the CRW (crew) Frame was removed and the Patient returned again to Surgical Day Care.

The Hospital's Risk Manager said the Radiation Oncologist was not credentialed for the Crew Frame removal and the priviledges were to be reviewed by the VP of Medical Affairs.

Continued review of the Operative Note by the Neurosurgeon dated 04/20/10 as dictated at 11:54 AM indicated following the delivery of radiation, the Crew Frame was removed and a dressing was placed. The Patient tolerated the procedure well. However, the Radiation Oncologist removed the Crew Frame in Radiation Oncology in the afternoon and the Patient was returned once again to Surgical Day Care on 04/20/10 at 4:36 PM.

There was no further documentation in the Surgical Day Care Center Nursing Assessment, the Neurosurgeon returned to re-evaluate the Patient on 04/20/10 between 4:36 PM to 5:30 PM when the Patient was discharged home.

The Neurosurgeon did not follow the Hospital's Policy which required the Crew Frame be removed in an appropriate surgical treatment room by a neurosurgeon or appropriate qualified designated physician.

PATIENT RIGHTS: GRIEVANCE PROCEDURES

Tag No.: A0121

Based on record review and staff interview, the Surgical Day Care nursing staff and Emergency Department staff failed to adequately respond to one of one Patient's who expressed a verbal complaint in April 2010.

The findings are as follow:

The Patient was scheduled for a two phase procedure (Stereotactic Radiosurgy) in April 2010.

Review of the Hospital's Guidelines for the Surgical Patient idnicated the patient was to make arrangements for an adult to drive the patient after the procedure and to remain with the patient during the immediate home care period. The post procedure guidelines indicated the patient may travel by taxi however a responsible adult was to accompany the patient in addition to the taxi driver. The Patient was both verbally instructed by telephone of the procedures to follow prior to the day of surgery and written instructions were sent by mail to the Patient.

Review of the Pre-Admission Testing Assessment dated for both 04/16/10 and 04/19/10 and the Pre-Surgical Assessment dated 04/20/10 at 7:12 AM indicated the Patient arrived for the procedure by an elder van unaccompanied and without a designated responsible individual to drive the Patient home and to remain with the Patient for a minimum of 24 hours following discharge from the Surgical Day Care Center.

Registered Nurse #1 was interviewed in person on 07/27/10 at 1:15 PM and the Charge Nurse/Clinical Leader was interviewed in person on 07/27/10 at 10:20 AM. Registered Nurse #1 telephoned the Patient for Pre-Admission Testing Assessment. Both said the Patient reported not having a designated responsible person and was unable to identify an individual to remain with the Patient post procedure. The Charge Nurse/Clinical Leader said the Patient arrived by a elder van and was unable to provide the name of an individual who would accompany the Patient home and remain with the Patient.

There was no documentation on the day of the procedure that either the Neurosurgeon or Anesthesiologist were notified the Patient had not made the appropriate arrangements prior to the administration of conscious sedation and the application of the head Crew Frame for a designated person to accompany the Patient post procedure on 04/20/10.

Review of the Telephone Follow-Up Call Record dated 04/21/10 at 10:05 AM indicated Registered Nurse #2 documented the Patient reported being upset for not being admitted to the Hospital overnight and was told by the Neurosurgeon the Patient would be admitted.

Review of an Emergency Department (ED)Report dated 04/22/10, the Patient complained of being angry with the Neurosurgeon for discharging the Patient on 04/20/10 from the Surgical Day Care Center.

Review of the Hospital's Policy for Patient Complaints and Grievances indicated the purpose of the policy was to implement an effective system to address concerns about any aspect of care of service. The patient had the right to voice a verbal complaint.The Hospital's Policy indicated whenever a patient or patient's representative requests that his/her complaint be handled as a formal complaint or grievance or when the patient requests a response from the hospital, the complaint is considered a grievance.

The Hospital's staff did not appropriately report the Patient's complaints for a lack of responsible person to accompany the Patient and remain with the Patient post procedure to the Director of Surgical Day Care or the Anesthesiologist prior to the start of the procedure. The Hospital staff did not report the Patient's complaint for further appropriate investigation about not being hospitalized as expressed during an ED visit on 04/22/10.

Both the Hospital's Risk Manager and Director of Surgical Day Care Center said they were unaware of the Patient's complaints and there was no incident report filed.

CONTENT OF RECORD: ORDERS,NOTES,REPORTS

Tag No.: A0467

Based on record review and staff interview, one of one Patient's scheduled for an Outpatient Procedure in the Radiation Oncology Department lacked any documentation following the removal of a Crew Frame by the Registered Nurse assigned to the treatment area in April 2010.

The findings are as follow:

Review of the Patient's medical record indicated on 04/20/10 at approximately 4:36 PM, the Patient returned to the Radiation Oncology Department for the removal of the Crew Frame.

The Radiation Oncologist and the Program Director for Oncology said the Registered Nurse assisted the Radiation Oncologist with the Crew Frame removal procedure and the application of a head dressing.

Review of the Job Description for the Radiation Oncology Registered Nurse indicated the responsibilities included providing thorough, timely and accurate documentation of all pertinent data, therapeutic interventions and the patient responses including assessment according to established standards.

There was no documentation by the Registered Nurse in Radiation Oncology the Patient had returned to the Department for the Crew Frame removal. The Registered Nurse in attendance was not identified in the Patient's record.

There was no documentation of the Patient's vital signs nor documentation for the Patient's response to the Crew Frame removal procedure in Radiation Oncology.

OPERATIVE REPORT

Tag No.: A0959

Based on record review and staff interview, one of one Patient's medical records reviewed indicated the Operative Report included documentation by the Neurosurgeon for the removal procedure for a Crew Frame in April 2010. The Neurosurgeon did not remove the Patient's Crew Frame.

The findings are as follow:

Review of the Patient's record and interview by telephone with the Neurosurgeon on 07/27/10 at 4.25 PM indicated had the Neurosurgeon applied the Crew Frame following administration of conscious sedation and a local anesthetic on 04/20/10 at 10:19 AM.

Review of the Operative Note indicated the Patient tolerated the procedure well. The Patient was then taken for a head Computerized Tomography (CT). The Neurosurgeon then identified the specific nerve for the Radiation Oncologist to treat with the radiation beams.

Review of the Surgical Day Care Nursing Assessment indicated on 04/20/10 at 11:27 AM, the Patient returned for further monitoring.

At approximately 1:30 PM on 04/20/10, the Patient was brought to Radiation Oncology for the second phase the radiation treatment for a complaint of left trigeminal nerve pain.

Review of the Hospital's Policy for Stereotactic Radiosurgery indicated at the completion of the delivery of radiation, the neurosurgeon was to remove the frame from the patient in the treatment room and bandage the patient's head and apply pressure; if there were any bleeding.

The Radiation Oncologist was interviewed in person on 07/27/10 at 11:45 AM. The Radiation Oncologist said the Patient had the stereotactic radiation done over a period of approximately 40 minutes. The team consisted of the Radiation Oncologist, Physicist,and Radiology Technician. The Patient then returned to Surgical Day Care Center for monitoring.The Patient later returned to Radiation Oncology and the Radiation Oncologist removed the Crew Frame in the Radiation Oncology Department

Review of the Discharge Summary post radiation treatment as documented by the Radiation Oncologist(undated) indicated the Patient tolerated the procedure well and the CRW (crew) Frame was removed and the Patient returned again to Surgical Day Care.

Continued review of the Operative Note by the Neurosurgeon dated 04/20/10 and dictated at 11:54 AM indicated following the delivery of radiation, the Crew Frame was removed and a dressing was placed. The Patient tolerated the procedure well. However, the Radiation Oncologist removed the Crew Frame in Radiation Oncology in the afternoon and the Patient was returned once again to Surgical Day Care on 04/20/10 at 4:36 PM.

There was no further documentation in the Surgical Day Care Center Nursing Assessment, the Neurosurgeon returned to re-evaluate the Patient between 4:36 PM to 5:30 PM when the Patient was discharged home.

The Neurosurgeon did not follow the Hospital's Policy which required the Crew Frame be removed in an appropriate surgical treatment room by a neurosurgeon or appropriate qualified designated physician.

OUTPATIENT SERVICES PERSONNEL

Tag No.: A1079

Based on record review and staff interview, three of three applicable Patient Telephone Follow-Up Call Records reviewed lacked the necessary documentation to ensure the Patient's (A, B and C) were immediately evaluated post surgical procedure for a potential change in condition.

The findings are as follow:

PATIENT A:

Patient A was scheduled for Stereotactic Radiosurgery in April 2010. Patient A was monitored in the Surgical Day Care Center.

Review of the telephone follow-up call documentation made on 04/21/10 indicated at 10:05 AM indicated the Patient reported loosing consciousness and was on the floor dressed in clothing. Registered Nurse #2 documented the Patient's condition as good.

Registered Nurse #2 was interviewed in person on 07/27/10 at 12:30 PM. Registered Nurse #2 said Patient A was not able to report the length of time spent lying on the floor. Registered Nurse #2 said the Neurosurgeon's office staff were notified of Patient A's complaint and recommended Patient A be seen by the Primary Care Physician.

Registered Nurse #2 did not instruct Patient A to be immediately evaluated by a physician nor provide assistance for Patient A to seek immediate medical attention.

The VP of Medical Affairs was interviewed on the day of survey. The VP of Medical Affairs said Patient A should have been immediately evaluated in the ED.

On 04/22/10, Patient A was brought to the ED by ambulance for a medical evaluation for possible lung infiltrate.

PATIENT B:

Patient B was scheduled for a lancing of the right small finger on 06/22/10. Patient B was monitored in the Surgical Day Care Center.

Review of the telephone follow-up call documentation by Registered Nurse #4 indicated Patient's spouse reported Patient B was not good, unable to walk secondary to dizziness and incoherent (not able to understand or clearly communicate) since the day of the procedure. Patient B reportedly had a fever, chills and surgical drainage. Registered Nurse #4 did not instruct the spouse of Patient B to seek immediate medical attention nor provide assistance for Patient B's spouse to seek immediate medical attention. Instead, the spouse assured Registered Nurse #4 that a call would be placed to a physician.

There was no documentation that the Surgeon was notified of the reported condition of Patient B.

Registered Nurse #4 indicated Patient B was in fair condition.

Registered Nurse #4 was not available for interview on the days of survey.

PATIENT C:

Patient C, a minor, had an unknown surgical procedure three days prior to the follow up call.

Review of the telephone follow-up call documentation indicated the Parent reported the Patient C/child had a swollen penis which was purple in color and the child was urinating. Documentation indicated the Pediatrician's office was called by the Parent. Patient' C's condition was documented as good.

There was no documentation for any instructions provided to the Parent of Patient C nor documentation the Pediatrician responded. There were no follow up calls to the Parent documented to ensure the child had been evaluated.

The Director of Surgical Day Care said there had been inadequate oversight for the concerns raised during the post-procedure follow-up calls.

The Director of Surgical Day Care did not meet the responsibilities of the position to ensure that appropriate measures were taken to provide appropriate adviseto patients or their responsibile individuals in seeking medical attention post-surgical procedure with complaints of a change in condition.

There was no indication there was an appropriate review or monitoring for the quality of post-procedure follow-up calls and the reported concerns voiced by patients reported for Quality Assessment and Improvement.