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1325 S CLIFF AVE POST OFFICE BOX 5045

SIOUX FALLS, SD 57117

PATIENT RIGHTS

Tag No.: A0115

27457

Based on record review, policy review, and interview, the provider failed to ensure:
*An initial comprehensive assessment for restraints was performed for one of four sampled patients (4).
*The patients' plans of care had been updated and revised for three of four sampled patients (1, 2, and 3).
*Three of four sampled patients (1, 3, and 4) had physicians' orders for the application of restraints.
*Four of four sampled patients (1, 2, 3, and 4) had physicians' orders that were complete and accurate.
*Orders for restraints were not written on an as needed basis for one of four sampled patients (1).
*Complete clinical documentation of restraint use for four of four sampled patients (1, 2, 3, and 4) with restraints.
Findings include:

1. Interview, record review, and policy review throughout the course of the survey revealed the provider's restraint orders, assessments, and documentation were not complete and accurate. Refer to A164, finding 1; A165, findings 1-3; A168, findings 1-4; A169 finding 1; and A449 findings 1-4.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0164

Based on record review, policy review, and interview, the provider failed to ensure an initial comprehensive assessment for restraints was performed for one of four sampled patients (4).
Findings include:

1. Review of patient 4's medical record revealed:
*He was a transfer from a critical access hospital.
*He was admitted on 10/1/10 at 1:00 p.m. with a diagnosis of multifocal stroke.
*An inpatient rehabilitation admission physician's order dated 10/1/10 for a vail/net bed revealed:
-The documented reason given for the use of the vail bed the physician had given was for safety.
-The physician's signature was not timed.
-The registered nurse had noted the physician's signature at 3:00 p.m.
*An initial restraint assessment had been done on 10/1/10 at 8:00 p.m.
*An initial patient assessment that included alternatives to a restraint was not in the chart.

Interview on 9/13/11 at 1:00 p.m. with unit supervisor B revealed:
*She felt that was poor documentation of restraint use.
*A pre-admission assessment was missing from the chart.
*The pre-admission assessment would have listed alternatives to restraints used by the previous provider.
*The pre-admission assessment was used to determine the use of a restraint.

Review of the provider's June 2011 patient restraints policy revealed:
*Restraint use would be based on a comprehensive individual patient assessment.
*Alternatives to restraints would be tried prior to restraint application.
*The least restrictive form of restraint would be utilized.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0165

Based on record review, policy review, and interview, the provider failed to ensure the patients' plans of care had been updated and revised for three of four sampled patients (1, 2, and 3). Findings include:

1. Review of all of patient 1's physician's orders revealed the patient had two orders for restraints during his hospitalization:
-The first order on 9/2/11 at 12:55 a.m. read "If Ativan does not work try chest restraint."
-The second order on 9/4/11 at 1:20 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.

Interview, medical record review, and policy review on 9/13/11 at 3:05 p.m. with the director of professional practice, nurse educator G, and nurse manager H regarding the above restraints used on patient 1 revealed:
*They agreed the patient's plan of care had not been updated and revised on all of the occasions the patient had been restrained.
*They agreed the provider's reviewed June 2011 policy on restraints had not been followed. As that policy called for the patient's care plan to be updated and revised when a patient was placed in restraints.

2. Review of all of patient 3's physicians' orders revealed the patient had four orders for restraints during his hospitalization:
-The first order on 5/12/11 at 7:00 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.
-The second order on 5/13/11 at 4:06 p.m. had no specific type of restraint ordered.
-The third order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered.
-The forth order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered nor the time the order had been written.

Interview, medical record review, and policy review with the director of professional practice, unit supervisor I, and nurse manager J regarding the restraints used above on patient 3 revealed:
*They agreed the patient's plan of care had not been updated and revised on all of the occasions the patient had been restrained.
*They agreed the provider's reviewed June 2011 policy on restraints had not been followed. As that policy called for the patient's care plan to be updated and revised when a patient was placed in restraints and removed from restraints.



18559

3. Review of patient 2's medical record revealed:
*The patient had been admitted on 7/9/11 with a diagnosis of coronary disease.
*An order for a restraint dated 7/9/11 at 7:50 p.m. had:
-A check mark next to a reason of "adult critical only-implement critical care."
-No specific documentation for the type of restraint to use.
*The patient's care plan had not been revised after the patient's restraints had been removed on 7/13/11 at 4:25 p.m.

Interview on 9/14/11 at 9:00 a.m. with clinical educator A revealed patient 2's care plan had not been updated to show the patient had been extubated, and the restraints had been removed.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on record review, policy review, and interview, the provider failed to ensure:
*Three of four sampled patients (1, 3, and 4) had physicians' orders for the application of restraints.
*Four of four sampled patients (1, 2, 3, and 4) had physicians' orders that were complete and accurate.
Findings include:

1. Review of all of patient 1's physicians' orders revealed the patient had two orders for restraints during his hospitalization:
-The first order on 9/2/11 at 12:55 a.m. read "If Ativan does not work try chest restraint."
-The second order on 9/4/11 at 1:20 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.

Interview and medical record review on 9/13/11 at 1:40 a.m. with registered nurse (RN) C revealed:
*The patient had been confused related to hypoxia on 9/4/11 at 7:00 a.m. when she had reported for duty.
*Patient 1 was in a vest restraint when she had reported for duty on 9/4/11 at 7:00 a.m. She believed RN D had placed the patient in that restraint sometime around 6:00 a.m.
*She noted at around 7:00 a.m. on 9/4/11 that no physician order had been received to place patient 1 in that vest restraint. She did not call for a physician's restraint order once she noted one was not on file. She instead opted to wait for the physician's certified nurse practitioner to make rounds. The order for that restraint was not ascertained until 1:20 p.m. on 9/4/11. That incomplete order is listed above.
*She agreed patient 1 was restrained on 9/4/11 for a period of 7-8 hours without a physician's restraint order. She further agreed once the order was received it was incomplete and did not have a rationale for the use of the restraint nor the type of restraint to be used.
*She had added soft wrist restraints to both of patient 1's wrists on 9/14/11 at 6:21 p.m. as he was becoming more agitated. She did not call the physician for an order for those wrist restraints as the provider's policy did not require her to do so.

Interview and medical record review on 9/13/11 at 2:15 p.m. with RN D revealed:
*She had not gotten a physician's order for the vest restraint she had applied on 9/4/11 at around 6:00 a.m. She stated that she had assumed since the patient was previously in a vest restraint she would not need a new order.
*She had restraint training but before today she did not know how long a physician's order for a restraint was good for.
*She had not documented the time the restraint was applied on 9/4/11 nor did she update or revise the patient's plan of care to reflect the use of that restraint.

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN E revealed:
*She had taken and had recorded the 9/2/11 physician order noted above by telephone.
*She had placed patient 1 in a vest restraint around 1:00 a.m. that day and had left it in place as the patient had been confused and restless. The vest restraint was still on patient 1 when she had left around 7:00 a.m.
*She did not fill out any of the provider's restraint monitoring forms nor did she update or revise the patient's care plan to reflect the use of that restraint on 9/2/11.

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN F revealed:
*She came on duty on 9/2/11 at 7:00 a.m. and had found patient 1 was in a vest restraint. She had removed that restraint at that time as the patient was "sedated" and no longer needed to be restrained.
*She had not filled out any of the provider's restraint monitoring forms nor had she updated or revised the patient's care plan to reflect the discontinuation of the use of that restraint on 9/2/11.
*When asked by this surveyor why she had not documented the removal of the restraint and her rationale why she had removed it she stated "It just didn't get documented."

Interview, medical record review, and policy review on 9/13/11 at 3:05 p.m. with the director of professional practice, nurse educator G, and nurse manager H regarding the above restraints used on patient 1 revealed:
*The patient had been placed in restraints without a physician's order.
*The 9/2/11 at 12:55 a.m. physician's order noted above was incomplete and written in an as needed format.
*The 9/4/11 at 1:20 p.m. physician's order was not complete and was not a valid physician's order for restraint.
*The provider's reviewed June 2011 restraint policy did not require the physician to specify the type of restraint to be used. Instead the nurse in charge of the patient's care was allowed to determine what type of restraint would be used and would make the determination of what restraint or restraints were the least restrictive. They agreed based on the above policy the nurse in charge of a patient's care could apply multiple restraints without an order for each of them as long as he/she considered it was the least restrictive measure.
*They agreed the provider's reviewed June 2011 policy on restraints had not been followed.

2. Review of all of patient 3's physicians' orders revealed the patient had four orders for restraints during his hospitalization:
-The first order on 5/12/11 at 7:00 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.
-The second order on 5/13/11 at 4:06 p.m. had no specific type of restraint ordered.
-The third order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered.
-The forth order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered nor the time the order had been written.

Interview, medical record review, and policy review with the director of professional practice, unit supervisor I, and nurse manager J regarding the restraints used above on patient 3 revealed:
*The patient had been transferred from the intensive care unit (ICU) to the medical/pulmonary floor and back to the ICU over the course of his hospitalization.
*The reason the patient had been restrained during his hospitalization was related to the patient being intubated and to prevent the disruption of that treatment.
*On 5/31/11 the patient was transferred to the ICU, intubated, and soft wrist restraints were placed on both wrists. No order for those restraints existed.
*The patient had been in wrist restraints until 6/1/11 when unit supervisor I informed the nurse taking care of the patient to remove his wrist restraints. She believed the time she had told that nurse to remove the wrist restraints was around 8:00 a.m. No documentation of that removal of the wrist restraints was found.
*They all agreed the 5/12/11 order mentioned above was not a valid order.
*They all agreed the 5/13/11 order mentioned above had not triggered the provider's intubated patient restraint protocol that allowed one restraint order to be ascertained for the course of time that a patient was intubated. Per the provider's reviewed June 2011 restraint policy patients were to have a physician's order for restraints every calender day if the intubated patient restraint protocol was not indicated. They all further agreed based on the above finding the patient did not have valid physicians' orders for restraints from 5/14/11 through 5/24/11.
*They agreed the provider's reviewed June 2011 policy on restraints had not been followed.




18559

3. Review of patient 2's medical record revealed:
*The patient had been admitted on 7/9/11 with a diagnosis of coronary disease.
*An order for a restraint dated 7/9/11 at 7:50 p.m. had:
-A check mark next to a reason of "adult critical only-implement critical care."
-No specific documentation for the type of restraint to use.

Interview on 9/14/11 at 9:00 a.m. with clinical educator A revealed the above physician's order for restraints did not specify the type of restraint to use.

4. Review of patient 4's medical record revealed:
*He was a transfer from a critical access hospital.
*He was admitted on 10/1/10 at 1:00 p.m. with a diagnosis of multifocal stroke.
*An inpatient rehabilitation admission physician's order dated 10/1/10 for a vail/net bed revealed:
-The documented reason given for the use of the vail bed the physician had given was for safety.
-The physician's signature was not timed.
-The registered nurse had noted the physician's signature at 3:00 p.m.
*Seven restraint order forms had:
-The dates on the orders forms were from 10/1/10 through 10/7/10.
-The physician's signatures were not timed.
-No specific type of restraint was listed.
-The reason for the restraint was to protect a high risk patient from injury.

Interview on 9/13/11 at 1:00 p.m. with unit supervisor B revealed:
*She confirmed the patient had been listed in the vail bed until 10/14/10.
*She felt the patient had been removed from the vail bed on 10/7/10 without a discontinuation of restraint order.
*She felt that was poor documentation of restraint use.

Review of the provider's undated orientation booklet for new physicians revealed:
*Orders for a restraint must contain the date, time, and rationale of use.
*Standing or "as needed" orders were not acceptable.
*A new order must be issued no less often than once per calender day.
*If a physician was not available to issue an order a restraint use could be initiated by a registered nurse (RN). The physician must be notified and an order obtained immediately.

Review of the provider's June 2011 patient restraints policy revealed:
*The restraint orders for all non-violent, non-self destructive behavior restraints must have been provided at the onset of restraint application.
*The restraint orders should have included date, time, and rationale of use.
*The continued use of a restraint was authorized by the renewal of the original order or by a new restraint order.
*A renewal order must have been issued no less often than once per calender day.
*A physician would be notified and an order obtained immediately if they had not been available to obtain an order at the time of the restraint.

Review of the 9/21/10 restraint protocol/critical care intubated patient policy revealed:
*A physician's order was required at the time the restraint was applied.
*A new order must have been obtained when a restraint had been successfully removed.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on record review, policy review, and interview, the provider failed to ensure orders for restraints were not written on an as needed basis for one of four sampled patients (1).
Findings include:

1. Review of all of patient 1's physicians' orders revealed the patient had an as needed order for restraints during his hospitalization. That 9/2/11 at 12:55 a.m. order read "If Ativan does not work try chest restraint."

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN E revealed:
*She had taken and had recorded the 9/2/11 physician order noted above by telephone.
*She had placed patient 1 in a vest restraint around 1:00 a.m. that day and had left it in place as the patient had been confused and restless. The vest restraint was still on patient 1 when she had left around 7:00 a.m.
*She did not fill out any of the provider's restraint monitoring forms nor did she update or revise the patient's care plan to reflect the use of that restraint on 9/2/11.

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN F revealed:
*She came on duty on 9/2/11 at 7:00 a.m. and had found patient 1 was in a vest restraint. She had removed that restraint at that time, as the patient was "sedated" and no longer needed to be restrained.
*She had not filled out any of the provider's restraint monitoring forms nor had she updated or revised the patient's care plan to reflect the discontinuation of the use of that restraint on 9/2/11.
*When asked by this surveyor why she had not documented the removal of the restraint and her rationale why she had removed it she stated "It just didn't get documented."

Interview, medical record review, and policy review on 9/13/11 at 3:05 p.m. with the director of professional practice, nurse educator G, and nurse manager H regarding the above restraints used on patient 1 revealed:
*The 9/2/11 at 12:55 a.m. physician's order noted above was incomplete and written in an as needed format.
*Restraint orders were to never be written in an as needed format.
*They agreed the provider's reviewed June 2011 policy on restraints had not been followed.

CONTENT OF RECORD

Tag No.: A0449

Based on interview, record review, and policy review, the provider failed to have complete clinical documentation of restraint use for four of four sampled patients (1, 2, 3, and 4) with restraints. Findings include:

1. Review of all of patient 1's physicians' orders revealed the patient had two orders for restraints during his hospitalization:
-The first order on 9/2/11 at 12:55 a.m. read "If Ativan does not work try chest restraint."
-The second order on 9/4/11 at 1:20 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.

Interview and medical record review on 9/13/11 at 1:40 a.m. with registered nurse (RN) C revealed:
*The patient had been confused related to hypoxia on 9/4/11 at 7:00 a.m. when she had reported for duty.
*Patient 1 was in a vest restraint when she had reported for duty on 9/4/11 at 7:00 a.m. She believed RN D had placed the patient in that restraint sometime around 6:00 a.m.
*She noted at around 7:00 a.m. on 9/4/11 that no physician order had been received to place patient 1 in that vest restraint. She did not call for a physician's restraint order once she noted one was not on file. She instead opted to wait for the physician's certified nurse practitioner to make rounds. The order for that restraint was not ascertained until 1:20 p.m. on 9/4/11. That incomplete order is listed above.
*She agreed patient 1 was restrained on 9/4/11 for a period of 7-8 hours without a physician's restraint order. She further agreed once the order was received it was incomplete and did not have a rationale for the use of the restraint nor the type of restraint to be used.
*She had added soft wrist restraint to both of patient 1's wrists on 9/14/11 at 6:21 p.m. as he was becoming more agitated. She did not call the physician for an order for those wrist restraints as the provider's policy did not require her to do so.

Interview and medical record review on 9/13/11 at 2:15 p.m. with RN D revealed:
*She had not gotten a physician's order for the vest restraint she had applied on 9/4/11 at around 6:00 a.m. She stated that she had assumed since the patient had previously been in a vest restraint she would not need a new order.
*She had restraint training but before today she did not know how long a physician's order for a restraint was good for.
*She had not documented the time the restraint had been applied on 9/4/11 nor had she updated or revised the patient's plan of care to reflect the use of that restraint.

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN E revealed:
*She had taken and had recorded the 9/2/11 physician order noted above by telephone.
*She had placed patient 1 in a vest restraint around 1:00 a.m. that day and had left it in place as the patient was confused and restless. The vest restraint was still on patient 1 when she had left around 7:00 a.m.
*She did not fill out any of the provider's restraint monitoring forms nor did she update or revise the patient's care plan to reflect the use of that restraint on 9/2/11.

Interview and medical record review on 9/13/11 at 2:55 p.m. with RN F revealed:
*She came on duty on 9/2/11 at 7:00 a.m. and had found patient 1 was in a vest restraint. She had removed that restraint at that time as the patient was "sedated" and no longer needed to be restrained.
*She had not filled out any of the provider's restraint monitoring forms nor had she updated or revised the patient's care plan to reflect the discontinuation of the use of that restraint on 9/2/11.
*When asked by this surveyor why she had not documented the removal of the restraint and her rationale why she had removed it she stated "It just didn't get documented."

Interview, medical record review, and policy review on 9/13/11 at 3:05 p.m. with the director of professional practice, nurse educator G, and nurse manager H regarding the above restraints used on patient 1 revealed:
*The 9/4/11 at 1:20 p.m. physician's order was not complete and was not a valid physician's order for restraint.
*The patient's restraint monitoring documentation was not complete.
*The patient's plan of care had not been updated and revised to reflect his current restraint status and interventions.
*No documentation of the exact time of the application or of the removal of the restraints mentioned above existed.
*They agreed the documentation of the patient's restraints was not adequate and did not meet the provider's standards for documentation.

2. Review of all of patient 3's physician's orders revealed the patient had four orders for restraints during his hospitalization:
-The first order on 5/12/11 at 7:00 p.m. had no specific type of restraint ordered nor did it have a rationale for use of a restraint.
-The second order on 5/13/11 at 4:06 p.m. had no specific type of restraint ordered.
-The third order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered.
-The forth order on 5/28/11 at 11:15 a.m. had no specific type of restraint ordered nor the time the order had been written.

Interview, medical record review, and policy review with the director of professional practice, unit supervisor I, and nurse manager J regarding the restraints used above on patient 3 revealed:
*The patient had been transferred from the intensive care unit (ICU) to the medical/pulmonary floor and back to the ICU over the course of his hospitalization.
*The reason the patient had been restrained during his hospitalization was related to the patient being intubated and to prevent the disruption of that treatment.
*On 5/31/11 the patient was transferred to the ICU, intubated, and placed in soft wrist restraints on both wrists. No order for those restraints existed.
*The patient had been in wrist restraints until 6/1/11 when unit supervisor I informed the nurse taking care of the patient to remove his wrist restraints. She believed the time she had told that nurse to remove the wrist restraints was around 8:00 a.m. No documentation of that removal of the wrist restraints was found.
*No documentation of the exact time of application or removal of the restraints the patient had during the course of his hospitalization was found.
*They agreed the documentation of the patient's restraints was not adequate and did not meet the provider's standards for documentation.




18559

3. Review of patient 2's medical record revealed:
*The patient had been admitted on 7/9/11 with a diagnosis of coronary disease.
*An order for a restraint dated 7/9/11 at 7:50 p.m. had:
-A check mark next to a reason of "adult critical only-implement critical care."
-No specific documentation for the type of restraint to use.

Interview on 9/14/11 at 9:00 a.m. with clinical educator A revealed:
*The above physician's order for restraints did not specify the type of restraint to use.
*She agreed there was no documentation for the removal of the restraint.
*A nursing note should have stated the restraint had been removed.
*She assumed the restraint had been removed when the patient had been extubated on 7/13/11 at 4:25 p.m.
*Patient 2's care plan had not been updated to show the patient had been extubated and not restrained.

4. Review of patient 4's medical record revealed:
*He was a transfer from a critical access hospital.
*He was admitted on 10/1/10 at 1:00 p.m. with a diagnosis of multifocal stroke.
*An inpatient rehabilitation admission physician's order dated 10/1/10 for a vail/net bed revealed:
-The documented reason given for the use of the vail bed the physician had given was for safety.
-The physician's signature was not timed.
-The registered nurse had noted the physician's signature at 3:00 p.m.
*Seven restraint order forms had:
-The dates on the order forms were from 10/1/10 through 10/7/10.
-The physician's signatures were not timed.
-No specific type of restraint was listed.
-The reason for the restraint was to protect a high risk patient from injury.
*There was documentation of the time the patient had been placed in the vail bed.
*An initial restraint assessment had been done on 10/1/10 at 8:00 p.m.
*An initial patient assessment that included alternatives to a restraint was not in the chart.
*Restraint assessments were done every two hours from 10/1/10 at 8:00 p.m. through 10/14/10 at 8:25 a.m.
*There was no documentation for the use of a different type of bed from 10/8/10 through 10/14/10.
*There were no physician's orders for restraints from 10/8/10 through 10/14/10.

Interview on 9/13/11 at 1:00 p.m. with unit supervisor B revealed:
*She confirmed the patient had been listed in the vail bed until 10/14/10.
*She felt the patient had been removed from the vail bed on 10/7/10 without a discontinuation of restraint order.
*She felt that was poor documentation of restraint use.
*A pre-admission assessment was missing from the chart.
*The pre-admission assessment would have listed alternatives to restraints used by the previous provider.
*The pre-admission assessment was used to determine the use of a restraint.

Review of the provider's undated orientation booklet for new physicians revealed:
*Orders for a restraint must contain the date, time, and rationale of use.
*Standing or "as needed" orders were not acceptable.
*A new order must be issued no less often than once per calender day.
*If a physician was not available to issue an order a restraint use could be initiated by a registered nurse (RN). The physician must be notified and an order obtained immediately.

Review of the provider's June 2011 patient restraints policy revealed:
*Restraint use would be based on a comprehensive individual patient assessment.
*Alternatives to restraints would be tried prior to restraint application.
*The least restrictive form of restraint would be utilized.
*The restraint orders for all non-violent, non-self destructive behavior restraints must have been provided at the onset of restraint application.
*The restraint orders should have included date, time, and rationale of use.
*The continued use of a restraint was authorized by the renewal of the original order or by a new restraint order.
*A renewal order must have been issued no less often than once per calender day.
*A physician would be notified and an order obtained immediately if they had not been available to obtain an order at the time of the restraint.
*Standing or "as needed" (PRN) orders were not acceptable.
*Patient's behavior, restraint alternatives, and less restrictive measures that preceded restraint application should have been documented.
*The documentation of restraint application was not addressed.
*The patient's plan of care modified for restraint status.
*Patients in restraints should have been assessed on an on-going basis.
*The date, time, and description of the patient's behavior should have been documented when the restraint had been discontinued.
*The documentation of the restraint removal had not been addressed.

Review of the 9/21/10 restraint protocol/critical care intubated patient policy revealed:
*The protocol could have been instituted for intubated critical care patients who had met the following criteria:
-Cognitive impairment.
-Inability to follow commands.
-Lack of awareness of potential to harm self.
-Attempted to pull out tracheostomy tube.
*A physician's order was required at the time the restraint was applied.
*Intubated patients should have been routinely assessed.
*Patient's assessment should have been documented.
*The date, time, and a description of the patient's behavior should have been documented when the patient's restraint was discontinued.
*A new order must have been obtained when a restraint had been successfully removed.

Review of the December 2009 nursing documentation policy revealed:
*All entries should have been dated, timed, and signed.
*Patient notes should have been used to:
-Further explain information entered elsewhere.
-Provide a clear picture of the patient's care.
-Document any significant event.
-Any changes in diagnosis.