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925 SENECA ST

SEATTLE, WA 98101

PATIENT RIGHTS

Tag No.: A0115

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Based on observation, interview, and document review, the Hospital failed to meet the requirements for the Condition of Participation for Patient Rights.

Failure to establish and implement policies and procedures for restraint or seclusion risks physical and psychological harm, loss of dignity, and violation of patient rights which can lead to negative patient outcomes.

Findings included:

1. Failure to obtain patient consent for treatment risks patients reciving care that may not be to the patients' desires.

Cross Reference: A 0131

2. Failure to ensure orders contained the type and amount of restraint to be applied to patients increases the risk of incorrect seclusion, or restraint application, leaves the order(s) open for interpretation by staff and risks psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0159

3. Failure to document imminent physical harm to the patient , staff or others for violent restraint use risks serious physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0154

4. Failure to utilize least restrictive measures before use of restraint or seclusion risks psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0165

5. Failure to ensure that providers followed timelines for renewal of violent restraint or seclusion orders places patients at risk for harm due to inappropriate application of restraint or restraint type.

Cross Reference: A 0171

6. Failure to ensure providers saw and assessed patients that had continuous application of violent restraint or seclusion for periods greater than or equal to 24 hours risks physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0172

7. Failure to discontinue restraints at the earliest opportunity risks physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0174

8. Failure to monitor patients in restraint at designated intervals as required by hospital policy risks physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0175

9. Failure to ensure a licensed practitioner or trained registered nurse conducted a face-to-face evaluation of the patient that included all required elements within 1 hour of restraint initiation risks physical and psychological harm, loss of dignity, and violation of patient rights.

Cross Reference: A 0179

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.13 was NOT MET.
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NURSING SERVICES

Tag No.: A0385

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Based on observation, interview, and document review, the Hospital failed to meet the requirement for the Condition of Participation for Nursing Services.

Failure to ensure that patient needs are met by ongoing assessments of patients needs and providing nursing care to meet those needs risks patients not receiving care appropriate to their needs.

Findings included:

1. Failure to ensure staff completed and documented appropriate screenings and assessments risks patient harm due to delayed recognition of condition and inadequate or substandard treatment.

Cross Reference: A 0395

2. Failure to develop and implement an individualized plan of care can result in the inappropriate, inconsistent, or delayed treatment of a patient's needs and may lead to patient harm and lack of appropriate treatment for a medical condition.

Cross Reference: A 0396

3. Failure to develop and implement policies and procedures to define Standards of Care risks inappropriate and/or ineffective patient care and poor outcomes.

Cross Reference: A 0398

4. Failure to follow the hospital's medication administration processes places patients at risk for serious medication errors and patient harm.

Cross Reference: A 0405

5. Failure to follow the hospital's verbal order medication policy places patients at risk for serious medication errors and patient harm.

Cross Reference: A 0407

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.23 was NOT MET.
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PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

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Based on interview, record review, and document review of hospital policy and procedures, the hospital failed to ensure that hospital staff properly obtained consent to treat for 3 of 9 Emergency Department patients reviewed (Patient #902, #905, and #917).

Failure to properly obtain consent for treatment risks patients receiving care that may not be to the patients' desires.

Findings included:

1. On 09/20/24 between 9:20 AM and 12:00 PM, and on 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Emergency Department Director (Staff #904) and Registered Nurse (Staff #905) reviewed the medical records of patients receiving care in the hospital's Emergency Department. The review showed the following:

a. Patient #902 was a 6 year old evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a consent to treat for this visit.

b. Patient #905 was a 5 year old evaluated for a fever. The Investigator found no evidence of a consent to treat for this visit.

c. Patient #917 was a 31 year old evaluated for a peritonsillar abscess. The Investigator found no evidence of a consent to treat for this visit.

2. At the time of the reviews, Staff #904 and #905 verified the missing consents in the medical record. Staff #905 stated that patients seen in the Emergency Department should sign a consent to treat unless unable to due to their medical condition.
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USE OF RESTRAINT OR SECLUSION

Tag No.: A0154

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff evaluated and documented physical need and safety of restrained patients as required by policy for 3 of 5 records reviewed (Patients #704, #709, and #711).

Failure to ensure that staff follow approved policies and procedures for restraint use risks serious physical and psychological harm, loss of dignity, and violation of patient rights.

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, and others.

b. When a patient arrives at the hospital in restraints, the patient must be reassessed for the need for restraints.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED at 11:53 AM.

b. Patient was documented as placed in violent restraints at 12:15 PM.

c. The circumstances for violent restraints was documented as "Patient arrived in restraint."

3. Investigator #7 found no other documentation of behaviors or actions of the patient that would warrant violent restraints.

4. At the time of the observation, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others.

5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived via ambulance on 07/13/24 at 10:34 AM in restraints.

b. Restraint documentation showed violent restraints were initiated at 10:44 AM, 10 minutes after arrival.

c. The Circumstances for Violent Restraints was documented as "Arrived in ED in restraints."

6. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #709 was placed in restraints.

7. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others.

8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints.

b. Patient was documented in locking restraints at 11:20 AM.

c. The Circumstances for Violent Restraints was documented as "Arrived in ED in restraints."

9. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #711 was placed in restraints.

10. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0159

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that providers' orders for seclusion, or restraint, are patient specific and contain all components including, but not limited to, the type of restraint and the amount of restraints (5-point, 4-point, etc.) to be used for 5 of 5 charts reviewed (Patients #704, #709, #710, #711, and #712).

Failure to place complete orders increases the risk of incorrect seclusion or restraint application, leaves the order(s) open for interpretation by staff, and risks psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. Restraint and Seclusion require an order from a Physician or Licensed Provider.

b. The order must include:

i. The category (violent or non-violent).

ii. The type of device(s) to be used.

iii. The reason.

iv. The duration.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED on 08/03/24 at 11:53 AM.

b. Patient was documented as in violent restraints, beginning on 08/03/24 at 12:15 PM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM.

c. Orders for 4 hour violent restraints were placed as follows:

i. Restraint initiation by RN: violent/self-destructive on 08/03/24 at 12:57 PM.

ii. Restraint initiation by RN: violent/self-destructive on 08/03/24 at 9:25 PM.

iii. Renew restraint: violent/self-destructive on 08/04/24 at 1:51 AM, with restraint type indicating "Key Lock Cuff."

iv. Renew restraint: violent/self-destructive on 08/04/24 at 5:23 AM, with restraint type indicating "Key Lock Cuff."

v. Renew restraint: violent/self-destructive on 08/04/24 at 10:05 AM, with restraint type indicating "Key Lock Cuff."

vi. Renew restraint: violent/self-destructive on 08/04/24 at 1:29 PM, with restraint type indicating "Key Lock Cuff."

d. A provider note signed on 08/05/24 at 12:44 AM, indicating the patient was placed in 4-point restraints.

3. Investigator #7 found no indication for the amount of restraint per the order i.e. 4-point or 5-point restraint, and no restraint type for the 12:57 PM and 9:25 PM orders.

4. At the time of the review, Staff #701 verified the late orders and that the orders did not specify the amount of restraint.

5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM.

b. Patient was documented as in violent restraints beginning on 10:44 AM.

c. Orders for 4-hour violent restraints were as follows:

i. Initiate Restraint: Violent/Self-destructive with type noted as "Key Lock Cuff" on 07/13/24 at 10:44 AM.

ii. Renew restraint: violent/self-destructive on 07/13/24 at 2:44 PM, with restraint type indicating "Key Lock Cuff."

6. The remaining 11 Renew Restraint orders were ordered the same way with no amount of restraint indicated. i.e. 4 point or 5 point.

7. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint.

8.On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710. The review showed the following:

a. On 07/15/24 at 3:20 AM, Patient #710 was placed in locking restraints.

b. An order to renew "Key Lock Cuff and waist" restraints was placed on 07/15/24 at 4:01 AM.

9. At the time of the review, Staff #701 verified the order did not specify the amount of restraint.

10. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. On 09/02/24 at 11:20 AM, Patient #711 was placed in locking restraints.

b. An order to Initiate Restraint: Violent/Self-destructive with type noted as "Key Lock Cuff" on 09/02/24 at 11:20 AM.

c. An order to renew "Key Lock Cuff and waist" restraints was placed on 09/02/24 at 4:16 PM.

11. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint.

12. On 09/24/24 at 1:45 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #712 who was placed in violent restraints on 07/14/24 at 3:42 PM. The review showed the following:

a. An order to Initiate Restraint: Violent/Self-destructive with type noted as "Key Lock Cuff" on 07/14/24 at 3:42 PM.

b. An order to renew "Key Lock Cuff and waist" restraints was placed on 07/14/24 at 7:12 PM.

13. At the time of the review, Staff #701 verified the orders did not specify the amount of restraint.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0165

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure there were less restrictive measures attempted prior to placing patients in restraint or seclusion, for 3 of 5 charts reviewed (Patient #704, #709, and #711).

Failure to follow approved policies and procedures, risks psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff and others.

b. When a patient arrives at the hospital in restraints, the patient must be reassessed for the need for restraints.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED at 11:53 AM.

b. Patient was documented as placed in violent restraints at 12:15 AM.

c. The circumstances for violent restraints was documented as "Patient arrived in restraint."

3. Investigator #7 found no other documentation of behaviors or actions of the patient that would warrant violent restraints.

4. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or of behaviors that jeopardized the immediate physical safety of the patient staff or others.

5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived via ambulance on 07/13/24 at 10:34 AM in restraints.

b. Restraint initiation showed violent restraints were initiated at 10:44 AM, 10 minutes after arrival.

c. The Circumstances for Violent Restraints was documented as "Arrived in ED in restraints."

6. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #709 was placed in restraints.

7. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others.

8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints.

b. Patient was documented in locking restraints at 11:20 AM.

c. The Circumstances for Violent Restraints was documented as "Arrived in ED in restraints."

9. Investigator #7 found no clinical justification, harm to self or others, or least restrictive measures documented when Patient #711 was placed in restraints.

10. At the time of the review, Staff #701 verified there was no documentation of less restrictive measures or behaviors that jeopardized the immediate physical safety of the patient staff or others.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0171

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that there were providers orders for seclusion or restraint for 4 of 5 patients reviewed. (Patient #704, #709, #710, and #711)

Failure to place orders for restraint or seclusion every 4 hours risks psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. Violent restraint and seclusion require an order from a physician or Licensed Practitioner (LP) be placed immediately after restraints have been initiated and the scene is safe.

b. If the provider is not available at the time of the assessment indicating the need for restraint or seclusion and less restrictive measures have failed, an RN without an order, may initiate restraint to protect the patient, staff and others from harm. In this case, an order is immediately obtained from the provider as soon as the scene is safe.

c. Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff or others may only be renewed in accordance with the following limits for up to 24 hours:

i. 4 hours for adults 18 years of age or older.

ii. 2 hours for children and adolescents 9-17 years of age.

iii. 1 hour for children under 9 years of age.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record of Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED on 08/03/24 at 11:53 AM.

b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 PM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM.

c. Orders for 4-hour violent restraints were placed every 4 hours except for as follows:

i. On 08/03/24 at 9:25 PM then 4 hours and 26 minutes later on 08/04/24/at 1:51 AM.

ii. On 08/04/24 at 5:23 AM then 4 hours and 42 minutes later at 10:05 AM.

3. Investigator #7 found no further orders for the remainder of the time Patient #704 was restrained.

4. At the time of the review, Staff #701 verified the late orders. Staff #701 further verified Patient #704 was documented in restraints until 6:58 PM on 08/04/24 and should have had one more order for restraint.

5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM.

b. Patient was documented as in violent restraints beginning on 10:44 AM.

c. Orders for 4-hour violent restraints were placed every 4 hours except for as follows:

i. On 07/14/24 at 2:51 PM then 5 hours and 57 minutes later at 8:48 PM.

ii. On 07/15/24 at 6:51 AM then 4 hours and 40 minutes later at 11:31 AM.

6. At the time of the review, Staff #701 verified the late orders.

7.On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710. The review showed the following:

a. On 07/15/24 at 3:20 AM Patient #710 was placed in locking restraints.

b. An order for "Key Lock Cuff and waist" restraints was placed at 4:01 AM.

c. Patient #710 was documented as restraints discontinued on 07/15/24 at 12:12 PM.

8. Investigator #7 found no further orders for the appoximately 8 hours Patient #710 was restrained.

9. At the time of the review, Staff #701 verified the missing order.

10. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints.

b. An order for locking restraints at 11:20 AM.

c. 4 hours and 55 minutes later the next order for continued locking restraints was documented at 4:15 PM.

11. At the time of the review, Staff #701 verified the restraint order was late.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0172

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff performed a face-to-face assessment every 24 hours a patient was in restraints as directed by hospital policy for 3 of 5 patients placed in physical restraints reviewed (Patients #709, #710, and #711).

Failure to reevaluate patients in restraints every 24 hours to assess the need to continue or discontinue risks restraining a patient for longer than is needed, inappropriate and/or ineffective patient care, and poor patient outcomes.

Finding included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. All new restraint or seclusion orders require a Physician or Licensed Practitioner (LP) to evaluate the patient face-to-face within 1-hour after the initiation of the intervention.

b. The face-to-face assessment must include:

i. The patients' immediate situation.

ii. Patients' reaction to the intervention.

iii. Patients' medical and behavioral condition.

iv. The need to continue or terminate the restraint or seclusion.

c. Patients in continuous restraints or seclusion require a face-to-face assessment to be completed with each new order and at least every 24 hours.

2. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM.

b. Patient was documented as in violent restraints beginning on 07/13/24 at 10:44 AM and remained in violent restraints until 07/15/24 at 2:58 PM (a period of approximately 52 hours).

3. Investigator #7 found no documentation of a face-to-face assessment for the entirety of the restraint episode.

4. At the time of the review, Staff #701 verified there should have been documentation of a provider face-to-face every 24 hours.

5. On 09/24/24 at 12:16 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710 who was placed in restraints. The review showed the following:

a. On 07/16/24 at 7:06 PM, Patient #710 was placed in locking restraints. The patient was not released from restraints until 07/20/24 at 2:46 AM (a period of over 79 hours).

b. On 07/18/24 at 4:29 PM, a face-to-face assessment was documented by the provider.

c. On 07/18/24 at 4:32 PM, a face-to-face assessment dated 07/17/24 was documented by the provider.

d. On 07/18/24 at 4:33 PM, a face-to-face assessment dated 07/16/24 was documented by the provider.

6. Investigator #7 found no documentation of face-to-face reassessment for 07/19/24.

7. At the time of the review, Staff #701 verified the documentation dates and missing face-to-face assessments.

8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints and was documented as being placed in locking restraints at 11:20 AM.

b. At 3:29 PM on 09/02/24, the patient was transferred to the 7th floor where they remained in restraints until 09/04/24 at 7:07 AM.

9. Investigator #7 found no documentation of a face-to-face assessment dated 09/03/24 or 09/04/24.

10. At the time of the review, Staff #701 verified there was no documentation of the required 24-hour face to face assessments.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure patients were free from restraint at the earliest time possible for 2 of 5 patients reviewed (Patient #704 and #709).

Failure to follow approved policies and procedures for restraint use risks physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed staff must assess and monitor the patients condition on an ongoing basis to ensure that the patient is released from restraint at the earliest possible time. Every attempt is made to initiate the removal of the patient from restraints.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED on 07/13/24 at 11:53 AM.

b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 AM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM.

c. Patient #704's every 15 minute documentation showed the following:

i. On 08/03/24 at 1:00 PM, documentation showed "calm" until 9:35 PM when documention showed "Agitated."

ii. Agitated or calm on 08/03/24 at 9:35 PM until 11:15 PM.

iii. On 08/03/24 at 11:15 PM until 08/05/24 at 1:02 PM, documentation showed patient was either calm or sleeping.

3. At the time of the review, Staff #701 verified documentation showed the patient had not been released at the earliest possible time.

4. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM.

b. Patient was documented as in violent restraints, beginning on 07/13/24 at 10:44 AM until 07/15/24 at 2:58 PM.

c. One episode on 07/14/24 at 2:30 AM where Patient #709 had documented combative behaviors and was restrained from 3-point back to 4-point restraints. 15 minutes later the patient is documented as cooperative with no further combative episodes.

5. Investigator #7 noted every 15-minute rounding, for the majority of the restraint episode, documented the patient as calm, sleeping relaxed, restless and occasionally agitated. Investigator #7 was unable to find any clinical justification documentation to keep Patient #709 in restraints for the entire time she was restrained.

6. At the time of the review, Staff #701 verified the documentation was calm, sleeping relaxed, restless, and occasionally agitated, and with the exception of the combative episode on 07/14/24 at 2:30 AM, there was no documented behaviors that would warrant continued violent restraint use.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

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Based on document review and interview, the hospital failed to ensure that patients placed in restraints were monitored for safety per hospital policy for 2 of 5 patients reviewed (Patients #709 and #710).

Failure to monitor patients in restraints places patients at risk for physical and psychological harm, other decline in status, loss of dignity and violation of patient rights.

Findings included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following for patients in violent restraints:

a. An RN or delegate must monitor every 15 minutes and document the physiologic condition and patient behaviors.

b. An RN must assess and document at least every 2 hours:

i. Respiratory and circulation.

ii. Skin integrity.

iii. Signs of injury.

iv. Mental/cognitive status.

v. Emotional wellbeing.

vi. Behavior that may indicate continued need for restraint or readiness for discontinuation of restraint.

2. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the restraint observation record for Patient #709 who was placed in restraints. The review showed the following late rounding documentations:

a. Every 15 minute rounding:

07/13/24 at 10:44 AM placed in restraints then 35 minutes later at 11:19 AM.

11:19 AM then 56 minutes later at 12:15 PM.

12:23 PM then 112 minutes later at 2:15 PM.

3:00 PM then 21 minutes later at 3:21 PM.

3:21 PM then 39 minutes later at 4:00 PM.

4:00 PM then 44 minutes later at 4 :44 PM.

5:00 PM then 104 minutes later at 6:44 PM.

6:44 PM then 16 minutes later at 7:00 PM.

11:45 PM then 30 minutes later at 12:15 AM.

07/14/24 5:45 AM then 17 minutes later at 6:02 AM.

6:02 AM then 16 minutes later at 6:18 AM.

2:08 PM then 67 minutes later at 3:15 PM.

7:15 PM then 65 minutes later at 8:20 PM.

8:22 PM then 59 minutes later at 9:21 PM.

9:21 PM then 69 minutes later at 10:30 PM.

07/15/24 7:00 AM then no further every 15 minute documentation for the 7 hours and 46 minutes the patient remained in restraints.

b. Nursing every 2 hour rounding:

07/13/24 10:44 AM then 4 hours and 14 minutes later at 2:59 PM.

4:00 PM then 2 hours and 25 minutes later at 6:25 PM.

3. At the time of the review Staff #701 verified the every 15-minute restraint rounding and the RN every 2 hour assessments were late.

4. On 09/24/24 at 10:47 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #710 who was placed in locking restraints on 07/15/24 at 3:20 AM. The review showed the following late rounding documentations:

a. Every 15 minute rounding

07/15/24 at 4:45 AM then 35 minutes later at 5:20 AM.

6:23 AM then 50 minutes later at 7:13 AM.

8:19 AM then 45 minutes later at 9:04 AM.

9:04 AM then 54 minutes later at 10:00 AM.

10:00 AM then 60 minutes later at 11:00 AM.

11:00 AM then 60 minutes later at 12:00 AM.

b. Nursing every 2 hours rounding:

On 07/15/24 at 8:31 AM then 3 hours and 29 minutes later at 12:00 PM.

5. At the time of the review Staff #701 verified the late 15 minute rounding and the late RN every 2 hours rounding.
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PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0179

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Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that staff performed a face-to-face assessment within 1 hour after restraint application as directed by hospital policy for 4 of 5 patients placed in physical restraints reviewed (Patients #704, #709, #711, and #712).

Failure to assess patients in restraints within the first hour to assess the need to continue or discontinue risks restraining a patient for longer than is needed, inappropriate and/or ineffective patient care and poor patient outcomes.

Finding included:

1. Document review of the hospital policy titled, "Restraint and Seclusion Policy, 964.00" PolicyStat #15941773, last approved 07/08/24, showed the following:

a. All new restraint or seclusion orders require a Physician or Licensed Practitioner (LP) to evaluate the patient face-to-face within 1-hour after the initiation of the intervention.

b. The face-to-face assessment must include:

i. The patients' immediate situation.

ii. Patients' reaction to the intervention.

iii. Patients' medical and behavioral condition.

iv. The need to continue or terminate the restraint or seclusion.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was placed in restraints. The review showed the following:

a. Patient #704 arrived at the ED at 11:53 AM.

b. Patient was documented as in violent restraints beginning on 08/03/24 at 12:15 AM until 1:00 PM and on 08/03/24 at 9:30 PM until 08/04/24 at 6:58 PM.

3. Investigator #7 found no documentation of a face-to-face assessment within 1 hour of initiation of the restraint episodes.

4. At the time of the review, Staff #701 verified that there was no face-to-face documentation.

5. On 09/20/24 at 10:09 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #709 who was placed in restraints. The review showed the following:

a. Patient #709 arrived at the ED on 07/13/24 at 10:34 AM.

b. Patient was documented as in violent restraints beginning on 10:44 AM.

6. Investigator #7 found no documentation of a face-to-face assessment within 1 hour of initiation of the restraint episodes.

7. At the time of the review, Staff #701 verified there that there was no face-to-face documentation.

8. On 09/24/24 at 12:18 PM, Investigator #7 and Staff #701 reviewed the medical record for Patient #711. The review showed the following:

a. Patient #711 arrived via ambulance on 09/02/24 at 10:57 AM in restraints and was documented as being placed in locking restraints at 11:20 AM.

b. On 09/02/24 at 3:29 PM, the patient was transferred to the 7th floor where they remained in restraints until 09/04/24 at 7:07 AM.

9. Investigator #7 found no documentation of a face-to-face assessment within 1-hour of initiation of restraints.

10. At the time of the review, Staff #701 verified there was no face-to-face documentation.

11. On 09/24/24 at 1:45 PM Investigator #7 and Staff #701 reviewed the medical record for Patient #712 who was placed in violent restraints on 07/14/24 at 3:42 PM. Investigator #7 found no documentation of a face-to-face evaluation within 1-hour of restraint initiation.

12. At the time of the review, Staff #701 verified there was no face-to-face documentation within 1-hour of restraint initiation.
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RN SUPERVISION OF NURSING CARE

Tag No.: A0395

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Item #1 Pain assessment

Based on interview, record review, and review of hospital policy and procedure, the hospital failed to ensure staff members completed and documented pain assessments and reassessments for each pain management intervention for 3 out of 6 patients receiving pain medication reviewed (Patients #906, #909, and #917).

Failure to assess and reassess a patient's pain risks inconsistent, inadequate, or delayed relief of pain and risks patient harm related to delayed recognition of adverse effects of pain medication.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Pain Management: Inpatient, Emergency Department, Inpatient Surgical/Procedural Areas, and Outpatient Surgical Centers," PolicyStat ID 13662137, last approved 12/22, showed the following:

a. Patient assessment, goals, reassessment, and plan of care will be documented in the medical record.

b. Reassessment should be completed in a timely manner after each pain management intervention.

2. On 09/19/24 between 10:00 AM and 11:15 AM, Investigator #9 and Registered Nurse (Staff #909) reviewed the medical record of a patient who was admitted after a surgical procedure. The review showed the following:

a. The patient received Oxycodone (an opioid narcotic pain medication) 5 milligrams orally at 5:55 AM for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention.

b. The patient received Oxycodone 5 milligrams orally at 7:51 AM for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention.

3. At the time of the review, Staff #909 verified the missing pain assessment documentation.

4. On 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Registered Nurse (Staff #905) reviewed the medical record of a patient who was evaluated for a peritonsillar abscess (infection of the tonsils). The review showed the patient received Toradol (a medication used to treat pain) 10 milligrams intravenously for a pain score of 7 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention.

5. At the time of the review, Staff #905 verified that there was no documentation of a pain reassessment following the medication intervention.

6. On 09/24/24 between 1:30 PM and 2:30 PM, Investigator #9 and Registered Nurse (Staff #920) reviewed the medical record of a patient receiving care in the post anesthesia unit. The review showed the patient received Oxycodone 5 milligrams orally for a pain score of 5 out of 10. The Investigator found no evidence of a pain reassessment after the medication intervention.

7. At the time of the review, Staff #920 verified that there was no documentation of a pain reassessment following the medication intervention.

Item #2 Initial suicide screening

Based on interview, record review, and review of policy and procedure, the hospital failed to ensure that patients receiving care received a suicide risk assessment as directed by hospital policy and procedure for 11 of 12 medical records reviewed (Patient #906, #908, #909, #910, #1001, #1002, #1003, #1004, #1005, #1006, and #1007).

Failure to perform a suicide risk assessment, risks that patients would not receive medical treatment appropriate to their care needs.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Core Nursing Standards of Practice," PolicyStat #13687643, last approved 01/23, showed the following:

a. The Registered Nurse (RN) should screen patients for falls, skin risk, sepsis, mobility, and suicide.

b. A suicide screening should be completed upon admission and as needed.

Document review of the hospital's policy and procedure titled, "Admission, Assessment, and Reassessment of the Perinatal Patient," PolicyStat ID 13681201, last approved 02/23, showed a suicide risk assessment is to be completed on admission.

2. On 09/17/24 at 10:45 AM, Investigator #10 and the Director of Acute Care Services (Staff #1008), Quality Program Manager (Staff #1009), and a Staff Nurse (Staff #1003) reviewed the medical record of Patient #1001. The Investigator found no evidence of a suicide screening on admission.

3. At the time of the review, Staff #1003 stated that if the abuse screen questions in the admission form were "positive", the system would trigger to perform a suicide screen. Otherwise, a suicide screen was not required.

4. On 09/18/24 at 10:00 AM, Investigator #10 and the Director of Medical Units (Staff #1001), a Quality Program Manager (Staff #1009), and a Charge Nurse (Staff #1010) reviewed the medical record of Patient #1002, who had been admitted for chest pain. Investigator #10 found no evidence of a suicide screening on admission.

5. At the time of the review, Staff #1001 stated that admission suicide screens are only required for patients with a behavioral health primary diagnosis.

6. Medical record reviews of five additional patients admitted for medical treatment showed no evidence of suicide screening done on admission (Patients #1003, #1004, #1005, #1006, and #1007). At the time of the reviews, Staff #1001 verified the finding.

7. On 09/18/24 between 1:00 PM and 4:30 PM, Investigator #9 and Registered Nurse (Staff # 910) and Registered Nurse (Staff #911) reviewed the medical records of patients admitted to the obstetrical unit.

The review showed the following:

a. Patient #908 was admitted for labor. The Investigator found no evidence of a suicide screening on admission.

b. Patient #909 was admitted for labor. The Investigator found no evidence of a suicide screening on admission.

c. Patient #910 was admitted for labor. The Investigator found no evidence of a suicide screening on admission.

8. At the time of the reviews, Staff #910 and Staff #911 stated that the suicide screen is not done on admission anymore.

9. On 09/19/24 at 9:00 AM, Investigator #9 and Registered Nurse (Staff #908) reviewed the medical record of Patient #906 admitted for hip replacement surgery. The Investigator found no evidence of a suicide screening on admission.

10. At the time of the review, Staff #908 stated that a suicide screening is not done on all patients. Director of Acute Care Services (Staff #907) stated that suicide screening is not done unless a patient is admitted for a behavioral health diagnosis.

Item #3 Initial pain assessment-pediatric patients

Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure staff completed and documented initial pain assessments for 2 of 5 pediatric patients receiving care in the Emergency Department reviewed (Patients #901 and #902).

Failure to perform an initial assessment of pain creates risk that patients would not receive medical treatment appropriate to their care needs.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Pain Management: Inpatient, Emergency Department, Inpatient Surgical/Procedural Care Areas and Outpatient Surgical Centers," PolicyStat ID 13662137, last approved 12/22, showed patients are screened for pain during emergency department visits and at time of admission.

2. On 09/20/24 between 9:20 AM and 12:00 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of pediatric patients evaluated in the hospital's Emergency Department. The review showed the following:

a. Patient #901 was evaluated for a head laceration that required local anesthesia for staples. The Investigator found no evidence of a pain assessment during the visit.

b. Patient #902 was evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a pain assessment during the visit.

3. At the time of the review, Staff #904 verified the missing pain assessment documentation.

Item #4 Initial triage physical assessment-pediatric patients

Based on interview and document review, the hospital failed to ensure staff completed and documented a focused physical assessment pertinent to the chief complaint for 3 of 5 Emergency Department pediatric patients reviewed (Patient #901, #902, and #903).

Failure to perform an initial focused physical assessment creates risk that patients would not receive medical treatment appropriate to their care needs.

Findings included:

1. On 09/20/24 between 9:20 AM and 12:00 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of pediatric patients evaluated in the hospital's Emergency Department. The review showed the following:

a. Patient #901 was evaluated for a head laceration that required stapling to close. The Investigator found no evidence of a focused physical assessment of the skin/wound.

b. Patient #902 was evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a focused physical assessment of the skin, breath sounds, or cardiovascular system.

c. Patient #903 was evaluated for ear pain. The Investigator found no evidence of a focused physical assessment of the ear.

2. At the time of the review, Staff #904 verified that focused physical assessments were not documented.

Item #5 Initial falls risk assessment

Based on interview and document review, the hospital failed to ensure that hospital staff members completed and documented an appropriate initial falls risk assessment for 4 of 9 emergency department patients reviewed (Patient #901, #902, #903, and #918).

Failure to perform an appropriate falls risk assessment of the patient risks patient safety and not receiving care appropriate to their care needs.

Findings included:

1. On 09/20/24 between 9:20 AM and 12:00 PM and on 09/24/24 between 10:30 AM and 1:30 PM, Investigator #9 and Emergency Department Director (Staff #904) reviewed the medical records of patients evaluated in the hospital's Emergency Department. The review showed the following:

a. Patient #901 was a 9 year old evaluated for a head laceration after a fall. The falls risk assessment used was the Memorial ED for patients 16 years and older.

b. Patient #902 was a 6 year old evaluated for an allergic reaction with hives all over their body. The Investigator found no evidence of a falls risk assessment documented as there was not a Triage 2 note which contains that field of information.

c. Patient #903 was an 8 year old evaluated for ear pain. The falls risk assessment used was the Memorial (an evidence based risk assessment tool) ED for patients 16 years and older and the fields were blank.

d. Patient #918 was a 60 year old evaluated for dizziness. The Investigator found no evidence of a falls risk assessment.

2. At the time of the review, Staff #904 acknowledged the missing falls assessments.

Item #6 Initial neonatal pain assessment

Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure staff completed and documented neonatal pain assessments for 1 of 3 neonatal records reviewed (Patient #911).

Failure to assess and reassess a patient's pain risks inconsistent, inadequate, or delayed relief of pain and risks patient harm related to delayed recognition and treatment of pain.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Newborn Admission, Assessment, and Reassessment," PolicyStat ID 14555625, last approved 10/23, showed the following:

a. Assess newborn vital signs, heart rate, respiratory rate, temperature, and pain at 15-30 minutes, 60 minutes, and 90 minutes of age.

b. Ongoing assessments per early sepsis score and clinical assessment and routine (every 8 hours).

2. On 09/18/24 between 2:20 PM and 3:00 PM, Investigator #9 and Registered Nurse (Staff #911) reviewed the medical record of a patient admitted to the obstetrical unit. The patient delivered a newborn on 09/15/24 at 3:44 AM. The initial pain assessment documented on the newborn was on 09/15/24 at 2:54 PM (a period of approximately 11 hours after birth).

3. At the time of the review, Staff #911 verified the missing pain assessment documentation.

Item #7 Initial focused assessment

Based on interview, document review, and review of the hospital's policy and procedure the hospital failed to ensure staff completed focused assessments for 2 of 3 medical records reviewed (Patients #704 and #705).

Failure to perform focused assessments, risks deterioration of the patient's condition, poor outcomes, and death.

Findings include:

1. Investigator #7 requested a copy of the Emergency Department (ED) Standards of care and was informed the hospital does not currently have an approved Nursing Standard of Care for the ED. The last guidance used was titled, "Inpatient Nursing documentation Guidelines", no number, last approved on 07/20 with the next review date set for 07/31/23. Staff further advised there was a draft ED standard of care, but it also had not been approved yet. Review of the Inpatient Nursing documentation Guidelines showed the following:

a. In the ED, patients are to receive a triage assessment.

b. A "Physical assessment (focused)" is done once per shift.

2. On 09/19/24 at 2:49 PM, Investigator #7 and the High Acuity Unit Director (Staff #701) reviewed the medical record for Patient #704 who was seen in the ED for Suicidal Ideation and 5 lacerations to Bilateral Wrists. The review showed the following:

a. A skin assessment dated 08/03/24 at 11:24 PM showed skin Within Normal Limits (WNL).

b. A provider note dated 08/03/24 at 12:20 PM detailing the 5 laceration repairs with sutures to the bilateral wrists.

3. Investigator #7 found no additional documentation related to the 5 lacerations on the bilateral wrists. No assessment related to Psych.

4. At the time of the review Staff #701 verified there was no focused assessment documented related to the primary reason for the visit and that the skin assessment only showed "WNL".

5. On 09/20/24 at 8:36 AM, Investigator #7 and Staff #701 reviewed the medical record for Patient #705 who was seen in the ED after being involved in a Motor Vehicle Accident (MVA).

6. Investigator #7 found no evidence of a focused assessment or of any nursing interaction after the initial triage.

7. At the time of the review Staff #701 verified there was no focused assessment and no additional nursing assessments or interventions after the triage.

Item #8 Magnesium Sulfate assessment

Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure staff completed specialized assessments for obstetrical patients receiving magnesium sulfate therapy for seizure prevention for 1 of 1 patient reviewed (Patient #908).

Failure to perform assessments risks harm related to delayed recognition of condition warranting immediate care.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Nursing Assessment Guidelines for Patients with Preeclampsia- addendum," PolicyStat ID 11317724, last revised 03/22, showed the following:

a. For patients on Magnesium Sulfate for preeclampsia, deep tendon reflexes and level of consciousness will be assessed every hour, lungs will be auscultated every 2 hours.

b. After the Magnesium Sulfate is discontinued, lungs will be auscultated every 2 hours for the first 24 hours and deep tendon reflexes, and level of consciousness will be assessed every 4 hours.

2. On 09/18/24 between 1:30 PM and 2:20 PM, Investigator #9 and Registered Nurse (Staff #910) reviewed the medical record of a patient admitted for induction of labor with a diagnosis of preeclampsia and receiving Magnesium Sulfate (a medication administered to prevent a seizure). The review showed that Magnesium Sulfate was initiated on 09/16/24 at 4:25 PM and discontinued on 09/17/24 at 5:59 AM. The Investigator found no documentation of assessment of breath sounds from 09/16/24 at 8:00 PM through 09/17/24 at 7:31 AM (a period of approximately 11.5 hours).

3. At the time of the review, Staff #910 verified the missing breath sound assessments.

Item #9 Aldrete assessment

Based on interview, record review, and review of the hospital policy and procedures, the hospital failed to ensure specialized assessments were completed prior to transfer according to hospital policy for 1 of 1 cesarean section patients reviewed (Patient #908).

Failure to perform specialized assessments creates risk that patients would not receive medical treatment appropriate to their care needs and lead to unanticipated outcomes.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Obstetric Recovery Period and Postpartum Care," PolicyStat ID 16115513, last approved 07/24, showed the following:

a. For post cesarean recovery, the anesthesia provider will remain with the patient until an adequate airway is maintained, and the recovery nurse assumes care of the patient.

b. The Aldrete Sedation Assessment score will be utilized to assist with patient assessment on admission and readiness for discharge from Phase 1 or discharge to the next level of care.

c. An Aldrete score of eight or greater prior to discharge.

d. If the score is less than eight, the anesthesia care provider and/or physician must be notified prior to discharge.

2. On 09/18/24 between 1:30 PM and 2:20 PM, Investigator #9 and Registered Nurse (Staff #910) reviewed the medical record of a patient admitted for induction of labor who delivered by cesarean section. The Investigator found no evidence of documentation of an Aldrete sedation assessment in the postoperative period.

3. At the time of the review, Staff #910 verified that there was no documentation of the Aldrete score and that it was not usual practice in the department.
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NURSING CARE PLAN

Tag No.: A0396

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Based on interview, document review, and review of policies and procedures, the hospital failed to develop and implement an individualized plan of care for 6 of 9 patient care plans reviewed (Patients #906, #907, #1003, #1005, #1006, and #1007).

Failure to develop and implement an individualized plan of care can result in the inappropriate, inconsistent, or delayed treatment of a patient's needs and may lead to patient harm and lack of appropriate treatment for a medical condition.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Core Standards of Nursing Practice," Policy Stat ID 13687643, last approved 01/23, showed the following:

a. The Registered Nurse identifies expected outcomes for a plan individualized to the patient.

b. The Registered Nurse engages the patient in partnership to identify expected outcomes.

c. The Registered Nurse develops a plan that prescribes strategies to attain expected, measurable outcomes.

d. The Registered Nurse partners with the patient to implement the plan.

e. The Registered Nurse documents implementation, modifications and evaluations of goals including changes or omissions of the identified plan.

f. The Plan of Care is reviewed and updated at a minimum of every shift.

2. On 09/19/24 at 9:00 AM, Investigator #9 and Registered Nurse (Staff #908) reviewed the medical record of a current inpatient. The review showed the following:

a. The patient was admitted on 09/17/24 at approximately 4:25 PM. The Collaborative Care Plan note documented at 6:52 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

b. The Collaborative Care Plan note documented on 09/18/24 at 6:09 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

c. The Collaborative Care Plan note documented on 09/18/24 at 7:29 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

d. The Collaborative Care Plan note documented on 09/19/24 at 5:37 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

3. At the time of the review, Staff #908 verified that the Goals/Progress, Interventions/Outcomes and Evaluation areas were blank.

4. On 09/19/24 at 11:00 AM, Investigator #9 and Registered Nurse (Staff #909) reviewed the medical record of a current inpatient. The review showed the following:

a. The patient was admitted on 09/17/24 and admitted to the current unit at 10:30 PM. The Collaborative Care Plan note documented on 09/18/24 at 2:21 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

b. The Collaborative Care Plan note documented on 09/18/24 at 7:39 PM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

c. The Collaborative Care Plan note documented on 09/19/24 at 2:25 AM, was blank in the areas for Goals/Progress, Interventions/Outcomes, and Evaluation.

5. At the time of the review, Staff #909 verified that the Goals/Progress, Interventions/Outcomes and Evaluation areas were blank.

6. On 09/20/24 between 8:45 AM and 11:00 AM, Investigator #10, the Director of Medical Units (Staff #1001), and two clinical informaticists (Staff #1004 and #1005) reviewed the medical record of Patient #1003, who was hospitalized from 07/27/24 to 08/06/24. Investigator #10 found that care plan documentation was missing for multiple shifts.

7. At the time of the observation, Staff #1001 verified that documentation of care plan Goals/Progress, Interventions/Outcomes, and Evaluation is expected every shift and was missing for Patient #1003.

8. On 09/24/24 between 11:00 AM and 4:00 PM, Investigator #10, Staff #1001, the Critical Care Supervisor (Staff #1006), and a clinical informaticist (Staff #1007) reviewed the medical records of critical care unit (CCU) and progressive care unit (PCU) patients. The reviewed showed the following:

a. Patient #1005 was hospitalized from 08/13/24 to 08/22/24. Investigator #10 found that care plan documentation was missing for multiple shifts.

b. Patient #1006 was hospitalized from 08/14/24 to 08/20/24. Investigator #10 found that care plan documentation was missing for multiple shifts.

c. Patient #1007 was hospitalized from 08/06/24 to 08/09/24. Investigator #10 found that care plan documentation was missing for multiple shifts.

9. At the time of the observations, Staff #1006 verified that documentation of care plan Goals/Progress, Interventions/Outcomes, and Evaluation is expected every shift in CCU and PCU, and that this required documentation was missing for Patients #1005, #1006, and #1007.
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SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

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Item #1 Perioperative Standards of Care

Based on record review and interview, the hospital failed to develop and implement policies and procedures to define Standards of Care for Perioperative Services.

Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes.

Findings included:

1. On 09/17/24, Investigator #9 and Interim Operating Room Director (Staff #902) inspected the perioperative area. The Investigator requested a policy for Standards of Care for the Perioperative area to include the preoperative, intraoperative, and post anesthesia units.

2. On 09/19/24 at 4:00 PM after additional requests for the Standards of Care policies for the Perioperative area, Staff #902 verified that at present there was not a Standard of Care policy, and that the hospital was in the process of creating one.

3. On 09/25/24 at 10:00 AM, Investigator #9 interviewed Outpatient Surgery Center Director (Staff #906) regarding Standards of Care used at the Surgery Center. Staff #906 stated that they follow the same Standards of Care for the hospital operative area. The Investigator asked Staff #906 to provide those standards.

4. On 09/25/24 at 12:00 PM, Acute Care Director (Staff #907) stated that they were unable to locate any current outpatient surgery Standard of Care polices.

Item #2 Emergency Department Standard of Care

Based on record review and interview, the hospital failed to develop and implement policies and procedures to define standards of care for Emergency Services.

Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes.

Findings included:

1. On 09/17/24 Investigator #7 requested a copy of the Emergency Department (ED) Standards of Care.

2. On 09/20/24 at 9:00 AM, The High Acuity Unit Director (Staff #701) informed Investigator #7 that the hospital does not currently have an approved Nursing Standard of Care for the ED.

Item #3 Pediatric Triage Standards of Care

Based on record review and interview, the hospital failed to develop and implement policies and procedures to define standards of care for pediatric triage patients.

Failure to develop and implement policies and procedures risks inappropriate and/or ineffective patient care and poor patient outcomes.

Findings included:

1. On 09/20/24 during medical record review with Emergency Department Director (Staff #904), Investigator #9 requested copies of the hospital's triage policy for pediatric patients.

2. On 09/24/24 at 11:15 AM, Staff #904 stated that they did not have a pediatric triage policy.
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ADMINISTRATION OF DRUGS

Tag No.: A0405

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Based on document review and interview, the hospital failed to ensure that staff obtained complete provider orders prior to providing care including ventilator settings and management of sedation for patients requiring respiratory support for 1 of 2 patients reviewed (Patient #1006).

Failure to ensure complete orders places patients at risk for receiving care and services which were not what the provider had intended or not receiving care which the provider had intended with the potential for harm as a consequence.

Findings included:

1. On 09/24/24 at 11:00 AM, Investigator #10, the Director of Medical Units (Staff #1001), the Critical Care Supervisor (Staff #1006), and a clinical informaticist (Staff #1007), and a respiratory therapist (Staff #1011) reviewed the medical record of Patient #1006. The review showed the following:

a. Patient #1006 was admitted on 08/14/24 for a planned coronary artery bypass graft (CABG, or open-heart surgery). At the completion of surgery, the patient remained on a ventilator and sedating medications and went to the intensive care unit for recovery.

b. An order for "RT Ventilator Weaning and Discontinue" was entered by a provider on 08/14/24 at 6:14 AM. An order comment stated, "RN to page Respiratory Therapist if order is STAT", but the area for ventilator settings were blank.

c. An order for Propofol 10mcg/kg/min (a sedating medication) showed that the dose would be titrated based on goals (objective clinical measures to guide changing rate). The Goal showed "refer to order details." The order details area was blank.

d. An order for Dexmedetomidine 0.4mcg/kg/ml (a sedating medication) showed that the dose would be titrated based on goals (objective clinical measures to guide changing rate). The Goal showed "refer to order details." The order details area was blank.

e. The medication administration record showed that the rate of propofol was decreased from 50mcg/kg/min at 2:00 PM on 8/14/24 to 30mcg/kg/min at 2:15 PM, and to 0mcg/kg/min at 2:45 PM.

2. At the time of the review, Staff #1006 verified that ventilator setting orders were missing and that medications were administered and titrated without orders for a goal and parameters. Staff #1006 added that ventilator settings and sedation monitoring parameters were a standard part of post-operative CABG orders, so it was unclear how those were not included the record.
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VERBAL ORDERS FOR DRUGS

Tag No.: A0407

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Item #1 Verbal medication orders in the cardiac catheterization laboratory

Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure staff followed its policy for verbal orders for 3 of 3 cardiac catheterization patient records reviewed (Patients #912, #913, and #914).

Failure to follow the hospital's medication administration processes places patients at risk for serious medication errors and patient harm.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Medication Management Verbal or Telephone Orders," Policy Stat ID 13662117, last approved 06/22, showed the following:

a. It is the policy of Virginia Mason Medical Center to minimize verbal and telephone orders.

b. If a verbal order is necessary, it must immediately be reduced to writing, dated, identified by the names of the individuals who originated and received it, and signed by the receiver.

Document review of the hospital's document titled, "Medical Staff Rules and Regulations," dated 06/21, showed the following:

a. All orders for medications must be entered directly into the clinical information system via computerized provider order entry (CPOE) or written onto an approved pre-printed order sheet.

b. Orders must be entered or signed by an individual authorized to prescribe.

c. Verbal orders will be acted upon but require a co-signature within 48 hours.

d. Authentication for verbal orders must be completed by the prescribing physician or ARNP who is responsible for the care of the patient.

2. On 09/20/24 at 9:00 AM, Investigator #9 and Procedural Director (Staff #912) and Cardiac Catheterization Manager (Staff #913) reviewed the medical record of Patient #912 who had undergone a cardiac catheterization procedure. Investigator #9 interviewed Staff #912 regarding the process for medication administration and documentation in the catheterization lab. Staff #912 stated that the hospital uses a system that does not interface with the hospital's electronic medical record to document events during the procedure. This record is printed and scanned into the patient's electronic medical record. The record of events is completed by a person monitoring the procedure outside of the cardiac catheterization laboratory in the control room. The review showed the following:

a. The patient received a total of 100 micrograms of Fentanyl (an opioid narcotic medication) in 4 separate doses and 2 milligrams of Versed (a medication used for relaxation and to provide an amnesic effect) in 4 separate doses during the procedure.

b. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders.

c. Staff #912 stated the orders for medications are verbal orders by the physician to the nurse administering medication in the room and the scanned note is the documentation of the procedure. The provider writes the medications administered in their procedure note. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure.

3. On 09/24/24 at 2:35 PM, Investigator #9 and Procedural Director (Staff #912) reviewed the medical record of Patient #913 who had undergone a cardiac catheterization procedure. The review showed the following:

a. The patient received a total of 300 micrograms of Fentanyl in 10 separate doses and 6 milligrams of Versed in 10 separate doses. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders.

b. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure.

4. On 09/24/24 at 3:00 PM, Investigator #9 and Procedural Director (Staff #912) reviewed the medical record of Patient #914 who had undergone a cardiac catheterization procedure. The review showed the following:

a. The patient received a total of 25 micrograms of Fentanyl in 1 dose and Versed 1 milligram in 1 dose. The Investigator requested to see the medication orders entered by the nurse and signed/authenticated by the provider giving the verbal orders.

b. The Investigator found no evidence of any written and signed orders for the medications administered by the Registered Nurse as verbal orders during the procedure.

5. On 09/25/24 at 11:30 AM, Investigator #9 interviewed Interim Pharmacy Director (Staff #914) and Director of Pharmaceutical Services (Staff #915) regarding the orders for medications administered by Registered Nurses for moderate sedation in the procedural areas. Staff #915 reviewed the medications ordered for the patients above and verified that there were no orders entered for the Fentanyl and Versed administered by the Registered Nurse.

Item #2 Nurse Administered Propofol Continuous Infusion System Orders

Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure staff followed its policies for medication administration for 2 of 2 Gastrointestinal (GI) procedure patient records reviewed (Patients #915 and #916).

Failure to follow the hospital's medication administration processes places patients at risk for serious medication errors and patient harm.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Medication Management: Administration of Medication," PolicyStat ID 13654903, last approved 08/22, showed that a provider order is required before a medication is administered to a patient.

Document review of the hospital's policy and procedure titled, "Nurse Administered Propofol Continuous Infusion System," PolicyStat ID 13663006, last reviewed 06/22, showed that all changes to the Propofol (a sedative-hypnotic medication) will be with the provider's verbal order.

Document review of the hospital's document titled, "Medical Staff Rules and Regulations," dated 06/21, showed the following:

a. All orders for medications must be entered directly into the clinical information system via computerized provider order entry (CPOE) or written onto an approved pre-printed order sheet.

b. Orders must be entered or signed by an individual authorized to prescribe.

c. Verbal orders will be acted upon but require a co-signature within 48 hours.

d. Authentication for verbal orders must be completed by the prescribing physician or ARNP who is responsible for the care of the patient.

2. On 09/25/24 between 8:40 AM and 11:20 AM, Investigator #9 and Director of the Outpatient Surgery Center (Staff #916), Nurse Manager (Staff #917) and Registered Nurse (Staff #918) reviewed medical records of patients having procedures at the outpatient surgery center. Investigator #9 interviewed Staff #916 regarding the process for medication administration and documentation for GI procedures. Staff #918 stated that the hospital uses a system named Provation for documentation of the procedure and medications are ordered within the Provation system as part of the provider note. The facility uses a Nurse Administered Propofol Continuous Infusion System as long as there is an anesthesia provider present in the facility. The review showed the following:

a. Patient #915 underwent a flexible sigmoidoscopy (a procedure to look at the lower part of the intestine). Review of the document "Nurse Note" showed a total dose of Propofol 130 milligrams administered to the patient during the procedure. The note showed "Medications given per closed loop verified MD order: YES." There were an additional 4 rate changes to the Propofol infusion and 5 "PRN Propofol dose given IV" documented. Review of the document "MD note" showed a medical history, surgical history, a prepopulated order set that is not individualized to the patient, and a history and physical. After the history and physical section, the document was esigned by the provider. The Investigator requested to see where the verbal medication orders given during the procedure were signed by the provider.

b. Staff #918 stated that the provider note in Provation system was the medication orders.

c. Patient #916 underwent a colonoscopy. Review of document "Nurse Note" showed a total dose of Propofol 450 milligrams administered to the patient during the procedure. The note showed "Medications given per closed loop verified MD order: YES." There were an additional 8 rate changes to the Propofol infusion and 9 "PRN Propofol dose given IV" documented. Review of the document "MD note" showed a medical history, surgical history, a prepopulated order set that is not individualized to the patient, and a history and physical. After the history and physical section, the document was esigned by the provider approximately 70 hours after the procedure. The Investigator requested to see where the verbal medication orders given during the procedure were signed by the provider.

d. Staff #918 stated that the provider note in Provation system was the medication orders.
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