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The facility failed to ensure the Condition of Participation: CFR 482.13 Patient Rights was met by failing to ensure:

1. Based on interview and record review, the facility failed to ensure that a patient received a review of the Patients Rights upon admission to the hospital. This failure has the potential for the patient to have their rights violated.(Cross Refer to A-0116)

2. Based on observation, interview and record review, the hospital failed to assess and reassess patients for pain medications. This failure had the potential to provide inadequate pain control for patients. (Cross Refer to A-0129)

3. Based on interview and record review, the hospital failed to ensure that patient's rights were observed when informed consents for treatments did not occur. This failure has the potential for patients or their designee, to not be fully informed and participate in the decisions regarding their healthcare. (Cross Refer to A-0131)

4. Based on observation, interview and record review, the hospital failed to initiate policy and procedures to allow patients to formulate advance directives, failed to accurately document in the patient's medical record that patients had executed advance directives and the hospital failed to provide community education regarding advanced directives. These failures had the potential to deny patients the right to participate in their medical healthcare decisions. (Cross Refer to A-0132)

5. Based on observation, interview and record review, the hospital failed to ensure timely and effective pain management, this failure had the potential for patients to experience physical harm and mental anguish.(Cross Refer to A-0145)

6. Based on observation, interview and record review, the hospital failed to ensure electronic protected health information (PHI) was protected for one sampled patient. This failure has the potential to result in unauthorized access to PHI. (Cross Refer to A-0147)

7. Based on interview and record review, the hospital failed to ensure the staff implemented wrist restraints in a safe manner, when one patient sustained a dermal injury. This failure resulted in one patient's forearms sustained dermal injury. (Cross Refer to A-0167)

8. Based on interview and record review, the hospital failed to ensure staff obtained a physician's order for the application of medical restraints. This failure resulted in patient's being restrained without a doctors order and nurses practicing outside their scope of practice. (Cross Reference to A-0168)

9. Based on interview and record review, the hospital failed to ensure orders for restraints were not written on a "as needed" basis, when the hospital created, "pre-scripted" restraint orders that indicate to discontinue restraint orders when order expires. (Cross Refer to A-0169)

10. Based on interview and record review the hospital failed to ensure restraint orders used for management of violent behavior were renewed per hospital policy, this failure placed the patient at risk for injury. (Cross Refer to A-0171)

11. Based on interview and record review, the facility failed to ensure physicians or licensed independent practitioner
documented in the medical record their evaluation supporting the continued use of restraints before renewing orders. This failure placed the patient at risk of injury. (Cross Refer to A-0172)

12. Based on interview and record review, the facility failed to ensure restraint orders for,"non-violent" restraints were renewed per hospital policy. This failed practice resulted in the use of physical restraints without a physician's order. (Cross Refer to A-0173)

13. Based on interview and record review, the hospital failed to monitor and assess patients that were in restraints per hospital policy. These failures place the patients at risk for injury. (Cross Refer to A-0175)

14. Based on interview and record review, the hospital failed to provide a face to face assessment for a patient who was placed into restraints for management of violent behavior. This failure place the patient at risk of injury. (Cross Refer to A- 0179)

15. Based on interview and record review the hospital failed to ensure justification/rational to continue restraints before renewing the continued restraint order, this failure placed patients at risk of being unnecessarily restrained. (Cross Refer to A-0188)

The cumulative effect of these deficient practices resulted in the condition of participation for patient rights not being met.

Based on record review and interview, the facility failed to ensure one patient (Patient 201) of 55 sampled patients received a review of the Patients Rights upon admission to the facility.

This failure had the potential for the patient to have their rights violated.

Findings:

During an interview on 3/5/18 at 12:06 p.m., Patient 201 reported he was blind and on admission, "no one went over my patient rights."

During a record review of the "Patients Rights Acknowledgement" form for Patient 201 and a concurrent interview on 3/6/18 at 11:30 p.m., the administrator (ADM 4) acknowledged the form stated "Patient is Blind." ADM 4 acknowledged the patient should have had his patient rights read to him verbatim.

Based on interview, record review, and review of the facility's policy and procedures, the facility failed to:

1. Reassess patient's pain, pre or post medication administration, for two of 55 sampled patients (Patients 107 and 108) in accordance the facility's policy and procedure.

2. Ensure physicians' orders for patient controlled analgesia (pain control) were followed in one of 55 sampled (Patient 103) patients, when the facility did not follow up with alternative pain control when Patient 103 continued to complain of severe pain.

These failures had the potential to provide inadequate pain control for Patients 103, 107, and 108.

Findings:

The facility policy and procedure titled, "Pain Management," dated 7/11/17, indicated in part..." (Name of hospital) respects and supports the rights of patients to safe, timely, and effective pain management. We place emphasis on improving the outcomes of pain management including comfort, managing side effects and complications, and patient satisfaction." Further policy review revealed under subtitle "Procedure" indicated in part... "1. Assess and reassess for pain scale consistently as follows:... 1.3 With each new report of pain... 1.5 After each pain management intervention once sufficient time has elapsed for the treatment to reach peak effect,...2. Pain intensity will be assessed using one of the following pain scales consistently according to age and developmental level as appropriate:... 2.4 Numeric Pain Intensity Scale 2.4.1 None, Mild (1-3), Moderate (4-6), Severe (7-10)."

1a. During an interview with licensed nurse (RN 7), on 3/5/18, starting at 12 p.m., and concurrent record review of Patient 107, revealed Patient 107's physician ordered ibuprofen (non-steroidal anti-inflammatory drug) 400 milligrams by mouth every 6 hours PRN (when necessary) for pain level 1-2. Patient 107 was administered Motrin on 3/5/18, at 1 a.m., the record revealed there was no pre or post assessment done . RN 7 acknowledged the lack of pre and post pain assessment stating, "Nothing in MAR, (medication administration record)."

1b. During an interview with licensed nurse (RN 1), on 3/6/18, starting at 10:40 a.m., and concurrent record review of Patient 108's record, the record revealed Patient 108's physician ordered acetaminophen (analgesic to treat minor aches and pains) 650 milligrams for "mild" pain. The physician order for pain medication did not indicate a numeric pain level. Further record review revealed Patient 108, on 2/27/18 at 8:22 a.m., complained of pain at a level "5" (moderate pain) and was administered acetaminophen 650 milligrams. RN 1 acknowledged no pain reassessment was done and stated, "Well I guess there is a pattern."

2. During an interview with RN 1, on 3/6/18 at 10:40 a.m., and concurrent Patient 103's record review, the record indicated Patient 103 complained of leg pain on 3/5/18, at 6:11 p.m., pain level was documented in the clinical record at a 10 (severe). Patient received per doctor's order morphine (a narcotic to treat moderate to severe pain) 2 milligrams via intravenous (administering into a vein). Patient 103 was reassessed at 6:50 p.m., for relief of pain post medication administration, clinical record indicated Patient 103 pain level was at a 7, severe on pain scale. RN 1 acknowledged the medical record did not indicate initiation of physician notification of continued pain or alternative methods to relieve pain. RN 1 stated, "Could have called the doctor."

Based on interview and record review, the hospital failed to ensure informed consents for treatment occurred for eight of 55 sampled patients (Patients 201, 202, 208, 213, 214, 215, 302 and 306) when:

1. Patient 201 was not consented for the Conditions of Admission.

2. Patient 202 signed a consent with the space for the procedure left blank.

3. Patients 208, 213, 214, 215, and 302's physicians did not sign the blood consent.

4. Patient 214's consent for hemodialysis (a process of removing blood from an artery (a blood vessel that takes oxygenated blood from the heart to all parts of the body) to remove toxins and then return to the body vi a vein) was not signed by the physician.

5. Patient 215's physician did not sign the consent for general anesthesia (administration of medications which result in loss of consciousness and the ability to perceive pain).

6. Patient 306's chart had no consent for an arterial line insertion (a procedure where a thin catheter is inserted into an artery to measure blood pressures in real time and to obtain blood samples) insertion.

These failures had the potential for patients or their designee, to not be fully informed and participate in the decisions regarding their healthcare.


35399

Findings:

The facility policy and procedure titled "Informed Consent" dated 10/11/17, indicated, "A properly executed informed consent process contains at the least the following: The nature of the proposed care, treatment, services, medications, interventions or procedures."

1. During a review of the clinical record for Patient 202, the consent "Authorization For and Consent To Surgery Or Special Diagnostic Or Therapeutic Procedure" dated 3/3/18, at 7:53 p.m., was signed by Patient 202 and witnessed by Registered Nurse (RN 3). The consent did not contain the proposed surgery, intervention, or treatment to be performed.

During an interview with Patient 202 on 3/5/18, at 12:30 p.m., Patient 202 reviewed the two signed consent forms with no indication of treatment, procedure or surgery, Patient 202 indicated he did not remember what he was asked to sign for.

During an interview with RN 3 on 3/6/18, at 11:35 a.m., RN 3 reviewed the clinical record for Patient 202 and stated, "I had the patient sign the blank consent form because I wasn't sure how to spell the procedures."

2. The facility policy and procedure titled "Admitting" dated 4/17, indicated, "The Conditions of Admission (COA) contains twenty topic items with detailed legal and informational elements. While all elements need to be reviewed with the patient, listed below are the topic items requiring special attend, initialing and/or signature by the patient and the Admitting Representative."

During a review of the clinical record for Patient 201, the COA dated 3/3/18, indicated that the patient is blind and unable to sign.

During an interview with Patient 201, on 3/5/18, at 12:06 p.m., Patient 201 indicated he was able to sign his name, he just requires that someone assist him with putting the pen to the paper, however no one reviewed his patient rights with him or other areas of the consent.

During an interview with Administrator (ADM 4), on 3/6/18, at 11:30 a.m. ADM 4 acknowledged that Patient 201 should have been given the COA information and the clerk should speak verbatim (word for word) to the patient rights and the entire consent and then obtain the signature."

3. The facility policy and procedure titled "Blood Component Administration" dated 7/24/17, indicated, "The ordering physician will explain to the patient or family the reason for blood administration, including the risks, benefits and alternatives associated with blood transfusion. This information is documented on the Transfusion Information and Consent which is placed in the patient's medical record. Prior to obtaining the blood/blood product from the Blood Bank, the Registered Nurse (RN) or Licensed Vocational Nurse (LVN) will check the chart for documentation of Informed Consent by the Physician and initial the Blood Procurement Form box."

a. During a review of the clinical record for Patient 208, the Consent for Blood Transfusion dated 3/3/18, was not signed by the physician. Patient 208 received blood products.

During an interview and concurrent record review of the Consent for Blood Transfusion for Patient 208 with Registered Nurse (RN 4) on 3/6/18, at 9:30 a.m., RN 4 stated, "The blood transfusion consent should be signed by the physician."

b. During a review of the closed clinical record for Patient 213, the physician did not sign the Consent for Blood Transfusion dated 12/2/17. Patient 213 received blood products.

During an interview on 3/7/18 at 4 p.m. and concurrent record review of the Consent for Blood Transfusion for patient 213, Administrator (ADM 5) stated, "The blood consent was not signed by the physician and it should be."

c. During a review of the closed clinical record for Patient 214, the physician did not sign the Consent for Blood Transfusion dated 12/12/18 and 12/18/17. Patient 214 received blood products.

During an interview on 3/7/18 at 4:25 p.m. and concurrent record review of the Consent for Blood Transfusion for Patient 214, Administrator (ADM 5) agreed that a physician should sign the blood consents.

d. During a review of the closed clinical record for Patient 215, the physician did not sign the Consent for Blood Transfusion dated 12/6/17.

During an interview on 3/7/18 at 4:45 p.m. and concurrent record review of the Consent for Blood Transfusion for Patient 215, ADM 5 agreed that a physician should have signed the blood consent.

e. The clinical record for Patient 302 was reviewed with registered nurse (RN 6), on 3/5/18, at 5 p.m., the record revealed a Consent To Blood Transfusion, dated 2/28/18, was not signed by the physician certifying s/he had provided consent to the patient.

During concurrent interview with RN 6, she confirmed the blood transfusion consent for Patient 302 needed to be signed by the physician acknowledging the patient was consented regarding the administration of blood.

4. The facility policy and procedure titled "Informed Consent", dated 10/11/17, indicated, "The Hospital Consent to Surgery or Special Procedure form will be signed by the patient to document has received information about the procedure from the physician and consents to the proposed procedure, in the following situations: Hemodialysis."

During a review of the closed clinical record for Patient 214, the consent for hemodialysis dated 12/12/17, was not signed by the physician as having given informed consent.

During an interview and concurrent record review of the consent for hemodialysis for Patient 214, ADM 5 confirmed the consent was not signed by the physician and stated, "It should be."

5. The facility policy and procedure titled "Informed Consent", dated 10/11/17, indicated, "The Hospital Consent to Surgery or Special Procedure form will be signed by the patient to document has received information about the procedure from the physician and consents to the proposed procedure, in the following situations: anesthesia or moderate sedation."

During review of the closed clinical record for Patient 215, the Consent for Anesthesia dated 12/6/17 at 8:50 a.m., was not signed by the physician/anesthesiologist for the consent for general anesthesia (anesthesia that affects the whole body and usually induces a loss of consciousness).

During an interview and concurrent record on 3/7/18 at 4:45 p.m., review of the Consent for Anesthesia for Patient 215, ADM 5 acknowledged and stated,"The consent was not signed by the physician/anesthesiologist and it should be."

6. The facility policy and procedure titled "Informed Consent", dated 6/2017, indicated, "The hospital consent to Surgery or Special Procedure form will be signed by the patient to document that the patient has received information about the procedure from the physician and consents to the proposed procedure, in the following situations: Nonsurgical procedures that involve more than a slight risk of harm to the patient or that may cause a change in the patient's body structure (i.e...arterial line placement...)."

On 3/6/18 at 4:55 p.m., Patient 306 was observed with an arterial line (a thin catheter inserted into an artery to monitor blood pressure directly and in real-time and to obtain samples for blood samples) on the left wrist while laying in bed in the intensive care unit (ICU).

During a concurrent review of Patient 306's clinical record, the record revealed no consent for the arterial line (A-line).

During a concurrent interview, RN 6 explained that Patient 306's arterial line was placed in surgery (OR) and the procedure does not require an informed consent if placed in the OR.

During an interview and concurrent policy and procedure review on 3/7/18, at 12:30 p.m., ADM 6 acknowledged the surgery policy and procedure titled "Consent Informed," dated 7/2016, does not indicate that if an arterial line is inserted in the OR there is no need for an informed consent.


34445

Based on record review, observation, and interview, the hospital failed to initiate a mechanism via their policy and procedures to allow patients to formulate an advance directive (a written plan for medical care when a patient is unable to speak for themselves) or accurately document in the patients record that patient had executed an advance directive for 15 of 55 sampled patients (Patients 102, 104, 106, 105, 107, 103, 111, 112, 101, 201, 207, 210, 301, 308, and 303). In addition the hospital failed to provide community education regarding advanced directives per their policy and procedures.

These failures had the potential to deny patients the right to participate in their medical healthcare decisions.

Findings:

The facility policy and procedure titled, "Advanced Directives," dated 3/2/17, indicated,"The opportunity to formulate advance directives is offered to all inpatients, outpatient surgery clients who are 18 years or older, and to legally emancipated minors. Centinela Hospital Medical Center provide education on issues that concern advance directives to staff and to the community." If the patient has not executed an advance directive, make a referral to Social Services. If the patient requests help to execute a new advance directive, contact Social Services to provide information and assistance. If the patient has not executed an advance directive, initiate a referral to Social Services. Centinela Hospital Medical Center is also committed to providing education to the community regarding advanced directives. Such education is routinely provided each fall at the annual Community Health Fair."

a. During a concurrent observation and interview with Patient 102, on 3/6/18, starting at 9 a.m., Patient 102 was observed in the pre-op area laying on his back on a gurney, dressed in hospital gown, with a IV (needle in vein for receiving medication and fluids) in place in his left arm. Patient 102's speech was within normal limits, good eye contact and affect appropriate to mood. Patient 102 indicated he was scheduled for surgery to have his right eye cataract (eye lens is removed and replaced with a artificial lens) removed on same date. Patient 102's admitting information indicated Patient 102 did not have a Advance Directive, and that he had a checked off the box that indicated, "Yes" under section "Do you wish to received information on healthcare directives. If you would like further information or assistance, please contact Social Services." When Patient 102 was asked about advanced directives, Patient 102 stated, "No, I don't have one and yes I did want to get one."

During a concurrent interview with two administrators (ADM 1) and (ADM 2), on 3/6/18, starting at 9 a.m., when reviewing chart for social services referral both ADM 1 and ADM 2 acknowledged there was no referral. ADM 2 stated, "We never look at this form because it rarely happens."

b. During concurrent observation and interview on 3/5/18, starting at 2:30 p.m., Patient 104, was observed in room in a hospital patient room. Patient 104 was fully clothed in bed laying on her back. Patient explained she recently had "total knee surgery", and in the hospital for "Rehab." Patient's speech within normal limits, good eye contact, pleasant mood and affect appropriate to mood. Patient 104 denied she ever received any information on advance directives. When asked if she was asked about advanced directives at time of admission, Patient 104 stated, "No, I had one with my dad, when he was dying and I don't have one, but I am getting of the age that I should have one."

During interview with ADM 1, on 3/5/18 starting at 4 p.m., while concurrently reviewing Patient 104 medical record, ADM 1 stated, "I am not sure why she was not offered information or why this is checked off as no."

c. During concurrent observation and interview with Patient 106, on 3/5/18, starting at 12 p.m., Patient 106 was observed in a hospital patient room laying on a hospital bed, dressed in hospital gown, speech within normal limits, good eye contact, mood pleasant. Patient 106 identified the male at bedside as a "significant other (SO)." Both Patient 106 and SO who was identified as accompanying Patient 106 at time of admission, denied ever receiving any questions or information about advanced directives. SO stated, "They (admitting staff or nursing staff) never talked about it (advanced directive)."

d. During concurrent observation and interview with Patient 105, on 3/5/18, starting at 12 p.m., accompanied with licensed nurse (RN 1), Patient 105 was observed in a hospital patient room. Patient 105 stated, "Came to the hospital because they may induce me (procedure to start the delivery of a baby)." When asked about admission process and if the hospital had given her any information about advanced directives, Patient 105 went through admission paperwork at bedside and indicated she was not given any information.

During an interview on 3/5/18, starting at 12:05 p.m., while concurrently looking through Patient 105 medical record, RN 1 acknowledged there was no documents about advanced directives, stating, "They (admitting staff) should have gotten some."

e. During a record review of Patient 107, the document titled Healthcare Directive, dated 2/27/18, checked box "Yes" on requesting more information on healthcare directives. Review of notes for social worker, notes did not reveal any information given by social worker.

During an interview with a social worker (SW 1), on 3/5/18, starting at 12:30 p.m., when asked about social service involvement with labor and delivery and or postpartum (following childbirth) patients in facilitating advance directives, SW 1 stated, "The only time I do any work on Land D (labor and delivery) or postpartum is for homeless mothers, I do not recall being asked to give any information for advanced directives."

f. During a concurrent record review of Patient 103 medical record, and interview with RN 2 on 3/6/18, starting at 10:40 a.m.,the medical record indicates Patient 103 was admitted several times in the recent past with a diagnoses including CHF (congestive heart failure) and end stage renal disease (kidney failure). With Patient 103's current admission the doctor is recommending Patient 103 be placed on a heart transplant list. Review of medical record document titled Healthcare Directive, dated 2/27/18, checked box "Yes" on requesting more information on healthcare directives was checked off. Review of notes for social worker did not reveal any information given by social worker. RN 2 stated, "We have no notes from the social worker indicating anything, that's where that (advanced directives information given ) would be."

g. During a concurrent interview with ADM 3, on 3/7/18, starting at 2 p.m. and a closed record review of Patient 111, record revealed the document titled Healthcare Directive, dated 12/1/17 had a checked box "Yes" on requesting more information on healthcare directives. Review of notes for social worker did not reveal any information given by social worker. While acknowledging no social worker notes ADM 3 stated, "Based on the policy, this is a problem that we don't have any social worker notes."

h. During a concurrent interview with ADM 3, on 3/7/18, starting at 2 p.m. and a closed record review of Patient 112, record revealed the document titled Healthcare Directive, dated 12/3/17 had a checked box "Yes" on requesting more information on healthcare directives. Review of notes for social worker revealed two visits from the social worker (SW). The SW's notes did not reflect discussions about advanced directives. ADM 3 acknowledging the lack of discussion in social worker notes, stated, "Should have."

i. During a concurrent interview with ADM 2, on 3/6/18, starting at 9:30 a.m., review of operating room schedule and clinical record of Patient 101, record indicated Patient 101 was admitted to the hospital on 3/1/18. medical records revealed that Patient 101 had placed in medical record a signed advanced directive dated 1/23/18. Further record review revealed Patient 101's face sheet (form hospital uses to identify demographics, person to notify and payer information) was checked off as "N" indicating Patient 101 did not have a advanced directive. On the additional form titled Healthcare Directive, dated 3/5/18, on the question that asked, "Do you have a healthcare directive or living will: "No" check off box was indicated. While acknowledging the incorrect information in Patient 101 medical record ADM 2 stated, "We missed this, we need to get better at this."

j. During a review of the clinical record for Patient 201 the Patients Rights Acknowledgment form, dated 3/3/18, at 1:50 p.m.,was incomplete/blank under the questions regarding a Healthcare Directive. The form was signed by the admitting staff indicating "patient is blind." without obtaining patient information. During an interview with Patient 201, on 3/5/18, at 12:06 p.m., he indicated, "No one asked him about his advanced directives during the admissions paperwork, and yes he has one."

During an interview with ADM 4 on 3/6/18, at 11:30 a.m., ADM 4 acknowledged that patient 201 was not screened for Healthcare Directives by the admitting staff and should have been.

k. During a review of the clinical record for Patient 207, the Patients Rights Acknowledgment form, dated 2/28/18, at 1:50 p.m.,was incomplete/blank under the questions regarding a Healthcare Directive. The form was signed by the admitting staff indicating "muscle weakness." without obtaining patient information.

During an interview on 3/6/18 at 9:00 a.m., registered nurse (RN 4) reviewed the clinical record and agreed the Healthcare Directive questions were not completed and "should have been."

During an interview with ADM 4 on 3/6/18, at 11:30 a.m., ADM 4 agreed that the questions regarding healthcare directives should have been asked of the patient and were not done.

l. During a review of the clinical record for Patient 210, the Patients Rights Acknowledgment form, dated 3/6/18, at 3:41 a.m., was incomplete under the questions regarding a healthcare directive or a living will.

During an interview on 3/6/18, at 10:20 a.m., Patient 210 when asked if he was asked about a healthcare directive or living will,, shook his head no, When asked if he has a living will, he shook his head yes he has one. Patient 210's significant other confirmed that Patient 210 had a living will at home, but no one asked about it.

During an interview with ADM 4, on 3/6/18 at 11:30 a.m., ADM 4 acknowledged that Patient 210 was not screened for healthcare directives and should have been.

m. During an interview with ADM 6 and concurrent review of clinical records for Patients 301 and 308 on 3/7/18 at 12:50 p.m., the two records revealed patients 301 and 308 requested to receive information on healthcare directive.

Patient 301's clinical record indicated patient was in the emergency department (ED) on 3/5/18. The form Healthcare Directive dated 3/5/18, was completed indicating patient answered Yes to: "Do you wish to receive information on healthcare directives."

Patient 308's clinical record indicated patient was in the ED on 3/5/18. The form "Healthcare Directive dated 3/5/18, was completed indicating patient answered "Yes" to: "Do you wish to receive information on healthcare directives."

During a concurrent interview with ADM 6, she explained that when patients are in the ED and they request information regarding healthcare directive, the ED social worker sees the patient and provides information regarding healthcare directive to those patients. ADM 6 acknowledged there is no ED social worker documentation that either Patient 301 or 308 received information regarding advance directives. ADM 6 stated "Yes, the patients requested advanced directive information. But they were not provided with the information."

n. During an interview with social worker (SW 1) and concurrent review of Patient 303's clinical record on 3/5/18, at 3:50 p.m., the record revealed Patient 303 was admitted from the emergency department (ED) to the hospital on 2/27/18. The form Healthcare Directive dated 2/27/18, was completed indicating patient answered "Yes" to: "Do you wish to receive information on healthcare directives."

During concurrent interview with SW 1, she explained once a patient is admitted into the hospital, a social worker needs to evaluate the patient within 24-48 hours and address the advance directive concerns. Patient 303 has been in the hospital for six days and not seen by a social worker yet. SW 1 stated " Yes, I agree he (Patient 303) should have been seen within 24-48 hours of admission which would have been on 3/1/18."

During an interview with registration clerk (RC 1), on 3/7/18, at 12:15 p.m., while reviewing facility registration/ admitting forms and process, indicating healthcare directives form, RC 1 stated, "Not sure." when asked what happens if the patient would like further information on healthcare directives." RC 1 reported the admitting department does not contact social service to assist patient's request to for information about advanced healthcare directive.

During an interview with SW 2, on 3/8/18, at 9:05 a.m., while reviewing the social worker referral process, SW 2 indicated she only gets referrals from, "Fax orders from doctors or nursing." SW 2 further revealed no referrals come from the admitting department. When asked if the social worker reviews the forms for patients that request further information on their advanced directives, SW 2 stated, " I really don't even look at that form. If I see a patient and if the patient requests information I will follow up on it."

During an interview with ADM 1, on 3/8/18, at 10:15 a.m., ADM 1 confirmed that the facility has not done any community education on advanced directives.


35399

Based on record review, interview, and observation, the facility failed to ensure timely and effective pain management for two (Patients 301 and 203) of 55 sampled patients.

This failure had the potential for patients to experience physical harm and mental anguish.

Findings:

The facility policy and procedure titled, "Pain Management," dated 3/17, indicated, the "Centinela Hospital Medical Center respects and supports the rights of patients to safe, timely, and effective pain management."

a. During an interview with Patient 301, on 3/5/18, at 12:50 p.m., Patient 301 was observed moaning. Patient 301 indicated she had stomach pain and had been in pain for a long time.

Patient 301's clinical record was reviewed with administrator (ADM 6), on 3/6/18, at 1 p.m. Patient 301 initially went to the emergency department (ED) on 3/5/18, at 7:26 a.m., with complaint of abdomen pain. Patient 301 was triaged (assign a degree of urgency for treatment) at 7:28 a.m., in the ED. A numeric pain intensity scale (NPS) was used to measure patient's pain level (Pain scale rating 1-3-mild pain, 4-6-moderate pain, 7-10-severe pain). At 8:20 a.m., patient's pain level was documented as being 10/10. No pain medication was administered at the time. Patient 301 was administer tramadol (medication used for moderate to severe pain) 50 mg (milligrams) by mouth at 12:44 p.m.. ADM 6 was not able to locate in the clinical record any documentation as to the rationale for holding off on medicating Patient 301, or any nursing documentation indicating the nurse notify the physician of the patient having pain. ADM 6 stated, "Patient should have received pain medication sooner. Waiting five (5) hours without pain medication was not acceptable."

b. During an interview with Patient 203, on 3/5/18, at 2:38 p.m., Patient 203 stated, "I was in pain all night last night with 10/10 pain level in my right shoulder."

During a review of the clinical record for Patient 203, the nurses notes dated 3/4/18, at 8:53 p.m., revealed that Patient 203 had a pain level of 8/10 (a numeric pain intensity scale was used to measure patient's pain level; pain scale rating 1-3-mild pain, 4-6-moderate pain, 7-10-severe pain) to the right upper extremity. The nurses notes dated 03/04/18, at 9:45 p.m., thru 3/5/18, at 12:56 a.m., documents three attempts to reach the physician for admitting orders and escalating the problem to the charge nurse and the house supervisor. Review of the medication administration record (MAR) dated 3/5/18, indicated a pain medication order for patient 203 was not received until 1 a.m.

During an interview with an Administrator (ADM 1) on 3/7/18, at 8:10 a.m., ADM 1 stated, "It is a problem getting admitting orders timely, especially at night." ADM 1 acknowledged it is not reasonable for a patient to wait over four hours for pain medication.

The facility policy and procedure titled "Admission of Patients" dated 10/17, indicated, "Physician orders will be obtained as soon as possible"


35399

Based on observation, interview, and record review, the hospital failed to ensure the electronic protected health information (PHI) record for one (Patient 107) of 55 sampled patients was kept private and confidential.

This failure had the potential to result in the unauthorized access of the PHI record.

Findings:

The facility policy and procedure titled "Sanction Policy," dated 10/14, indicated,"Centinela Hospital Medical Center will ensure all members of its workforce comply with the security policies of the organization...Leaving your computer unattended while you are logged into a PHI program" is a breach of the policy."

During an emergency department (ED) tour and concurrent interview on 3/5/18, at 1 p.m., an administrator (ADM 6) acknowledged a mobile computer workstation with an open clinical record of Patient 107, was on the computer screen and a patient's facesheet (patient personal and medical information) sitting on top of the workstation counter top were observed. A visitor was sitting on a chair in front of the computer workstation with direct visual to the computer screen and facesheet. ADM 6 stated, "This is a patient confidentiality issue."

Based on record review and interview, the hospital failed to ensure staff implemented the wrist restraints in a safe manner to prevent injury for one of 55 sampled patients (Patient 306) and failed to report to the physician the sustained injury.

This failure resulted in reddened and swollen forearms for Patient 306.

Findings:

The facility policy and procedure titled "Restraints," dated 12/2015, indicated "Restraints will be applied with safe and appropriate techniques, evaluated frequently for continuation and ended at he earliest possible time. An assessment shall be conducted following application of physical restraint to assure that devices had been properly applied and that the patient did not sustain injury or other untoward event in the process. Any significant findings should be documented in the patient's medical record with appropriate actions subsequently taken."

During a review of Patient 306's, clinical record and interview with registered nurse (RN 6), on 3/6/18, at 4:50 p.m., record revealed patient was a 70 year female who was admitted to the hospital on 3/1/18 with confusion and altered mental status. The physician's History and Physical, dated 3/1/18, indicated patient's extremities (arms and legs) were intact. The Nursing Admission Assessment, dated 3/1/18 indicated patient's skin was intact.

The restraint monitoring flowsheet indicated restraints were applied on both wrist on 3/2/18 at 8 p.m. The flow sheet indicated the restraints were not monitored every 15 minutes as required. Nurses Notes dated 3/2/18 at 8 p.m., indicated patient is "Confused, has restraints on, is combative, kicking, hitting, and attempting to bite."

The Photographic Wound Documentation forms, dated 3/3/18 at 2:36 p.m., revealed right arm sustain a dermal injury (skin is reddened) from the fingers to the elbow area. The left arm is reddened from the knuckles to mid-forearm area. The Wound Flowsheet, dated 3/3/18, at 4:33 p.m., revealed documentation of the right forearm being "Very Reddened." The Wound Flowsheet, dated 3/3/18 at 8 p.m., revealed documentation of the left forearm having "Redness." No documentation was located in the record regarding the physician being notified of the arms dermal injuries.

During concurrent interview with RN 6, she confirmed the physician was not notified of the dermal injuries Patient 306 had sustained. RN 6 acknowledged the reddened areas on both the left and right forearm were possibly from the restraints.


35399

Based on record review and interview, the hospital failed to ensure staff obtained a Physician's order for the application of medical restraints (one or more extremities tied to limit motion) for six of 55 sampled patients (Patient 214, 216, 302, 303, 304, and 318).

This failure had the potential of patient's being restrained without a doctor's order resulting in nurses practicing out of their scope of practice.

Findings:

According to the Fundamentals of Nursing, by Wilkinson and Treas, second edition 2011, page 370, "When you apply a restraint in an emergency, obtain the order as the restraint is being applied, or as quickly as possible afterward ..."

The facility policy and procedure titled "Restraints" dated 12/15, indicated, "Orders must specify reason for restraint; and time limitation. Restraints can be initiated by a licensed independent practitioner when assessment reveals less restrictive alternatives are not sufficient to protest the patient and/or others from injury in an emergent situation. In an emergency, initiation of restraint by a qualified, competent registered nurse who has assessed the patient is permitted in the absence of a licensed independent practitioner (LIP) if the LIP is notified about the patient's physical and psychological condition, and a written or telephone order is obtained as soon as possible, but no longer than one hour after initiation"

a. During a review of the clinical record for Patient 214, on 3/7/18, at 4:25 p.m. the nursing Restraint Flowsheet indicated that a right wrist soft restraint was applied on 12/12/17, at 4 p.m. The order for the soft restraint was not obtained until 7:31 p.m. on 12/12/17.

During a concurrent interview and record review with the administrator (ADM 5) on 3/7/18, at 4:25 p.m., ADM 5 reviewed the clinical record for Patient 214 and confirmed Patient 214 was in restraints without a physician order.

b. During a review of the clinical record for Patient 216, on 3/8/18, at 9 a.m., the nursing Restraint Flowsheet indicated that soft restraints were applied to both wrists at 12 a.m. and the order for the restraints was not obtained until 5:47 a.m.

During a record review and concurrent interview on 3/8/18, at 9 a.m., ADM 5 reviewed the clinical record for Patient 216 and stated, "You should get an order for restraints within 1 hour or as soon as possible"

c. During a review of the clinical record for Patient 302, and concurrent interview with registered nurse (RN 5), on 3/6/18, at 10 a.m., acknowledged the Restraint Monitoring Flowsheet, indicated Patient 302 was in restraints on 2/28/18, from 12 a.m., to 3/1/18 until 12 a.m. RN 5 acknowledged there was no physician's order for restraints located in the clinical record.

d. During a review of the clinical record for Patient 303, and concurrent interview on 3/8/18, at 11 a.m., an administrator (ADM 8) acknowledged the clinical record revealed the Restraint Monitoring Flowsheet, indicated Patient 303 was in restraints on 2/28/18, from 8 p.m., to 3/1/18 until 1 a.m. ADM 8 acknowledged there was no physician's order for restraints in the clinical record for that time frame. ADM 8 acknowledged and confirmed Patient 303 had been in restraints without a physician's order for 5 hours after the restraints were applied.

e. During a review of the clinical record for Patient 304 and concurrent interview with on 3/6/18, at 10:24 a.m., registered nurse (RN 5) revealed the Nurses Notes, dated 3/6/18, at 7:15 a.m., indicated "Bilateral soft restrains on to prevent pulling of lines and tubes." RN 5 acknowledged no physician's order for restraints was located in the record. RN 5 reported Patient 304 has been in restraints for 4 hours and 24 minutes without a physician order.

f. During a review of the clinical record for Patient 318 and concurrent interview on 3/8/18, at 11:30 a.m., ADM 8 acknowledged the Restraint Monitoring Flowsheet indicated Patient 318 was in restraints on 3/1/18, from 2 a.m., to 3/2/18 until 4:16 a.m. ADM 8 acknowledged the first restraints order located in record was for 3/2/18 at 4:16 a.m., 26 hours after the restraints were applied.


34445

Based on record review and interview, the facility failed to ensure orders for the use of prn (as needed) restraints. Orders were not written for five of 55 (Patients 111, 114, 112, 110, and 113) sampled patients in restraints, rather the hospital created "pre-scripted" restraint orders that indicated to discontinue the restraints when the order expired.

This failure resulted in the potential for the patient to be restrained without the clinical justification for use, the duration of use, and the behavior based criteria for use.

Findings:

The facility policy and procedure titled, "Restraints," dated 4/16, "If restraints are discontinued prior to expiration of the original order, a new order must be obtained prior to reinstating or applying the restraints. If a patients released from restraint and later exhibits behavior that can only be handled through the use of restraint, a new order is required."

a. During a concurrent closed record review of Patient 111, and interview with administrator (ADM 3), on 3/7/18, starting at 2 p.m., review of telephone order to doctor 3 (MD 3) revealed a request for "Medical Non Violent Restraints," on 12/4/17 at 1 a.m., MD 3 electronically signed an order on 12/4/17, at 9:10 a.m., with the following comments: "Clinical justification : pulling tube; Type of restraints: soft wrist bilateral; Length of order: daily;
D/C (discontinue) restraint use when order expires, patient no longer meets clinical justification. I HAVE ASSESSED THE PATIENT IN PERSON AND DETERMINED THAT THE ABOVE ORDER FOR RESTRAINTS IS NECESSARY."

Further review of MD progress with ADM 3 indicated the only medical note written that day (12/4/17) was by a nurse practitioner (NP 1), NP 1's Progress Note dated 12/4/17, at 11:42 a.m., indicated Patient 111 was "In No apparent distress." NP 1's Progress Note acknowledging that Patient 111 was out of restraints for 28 hrs prior to the request for restraints, and that MD 3 had not seen Patient 111 "face to face" on 12/4/17, per MD 3 electronically signed order. ADM 3 stated, "Yes I see that, it should not have occurred." ADM 3 acknowledging the order's inappropriateness for "as needed" orders and the lack of MD 3 notes to support order ADM 3 stated, "No, that's not suppose to happen."

b. During a concurrent closed record review of Patient 114, and interview with ADM 3, on 3/7/18, starting at 2 p.m., review of telephone order to doctor 1 (MD 1) revealed request for "Medical Non Violent Restraints," on 12/31/17, at 12:11 a.m.. MD 1 electronically signed order on 12/31/17, at 8:32 a.m., with the following comments:
"Clinical justification: pulling tube; Type of restraints: soft wrist bilateral; Length of order: daily; D/C (discontinue) restraint use when order expires, patient no longer meets clinical justification. I HAVE ASSESSED THE PATIENT IN PERSON AND DETERMINED THAT THE ABOVE ORDER FOR RESTRAINTS IS NECESSARY."

Review of nursing notes with ADM 3 indicated that Patient 114 had been removed from restraints on 12/30/17, at 4 a.m. (28 hours prior to MD 1 signing order). ADM 3 acknowledged that Patient 114 was out of restraints for 28 hrs prior to the request for restraints. ADM 3 stated, "This is a big big documentation problem."

c. During a concurrent closed record review of Patient 112, and interview with ADM 3, on 3/7/18, starting at 2 p.m., review of telephone order to doctor 2 (MD 2) revealed request for "Medical Non Violent Restraints," on 12/9/17, at 1:48 a.m.. MD 2 electronically signed order on 12/9/17, at 4:25 p.m., with the following comments: "Clinical justification: pulling tube; Type of restraints: soft wrist bilateral; Length of order: daily; D/C (discontinue) restraint use when order expires, patient no longer meets clinical justification. I HAVE ASSESSED THE PATIENT IN PERSON AND DETERMINED THAT THE ABOVE ORDER FOR RESTRAINTS IS NECESSARY."

Review of nursing notes with ADM 3 indicated that Patient 112 had been removed from restraints on 12/8/17, 8 p.m. (28 hours prior to MD 1 signing order), and not reapplied through out the rest of Patient 112 admission.
Further review of MD 1 progress notes dated 12/9/17, at 2:15 p.m., indicated Patient 112 under general appearance, "No apparent distress..." There is no indication in progress notes that Patient 112 is in restraints.
Acknowledging that Patient 112 was out of restraints for 28 hrs prior to the request for restraints, ADM 3, stated, "Yes I see that, it should not have occurred."

d. During a concurrent closed record review of Patient 110, and interview with ADM 3, on 3/7/18, starting at 2 p.m., review of telephone order to doctor 4 (MD 4) revealed request for "Medical Non Violent Restraints," on 12/15/17, at 7:07 a.m.. MD 4 electronically signed order on 12/15/17, at 10:13 a.m., with the following comments:
"Clinical justification: attempting to ambulate; Type of restraints: soft wrist bilateral; Length of order: daily; D/C (discontinue) restraint use when order expires, patient no longer meets clinical justification. I HAVE ASSESSED THE PATIENT IN PERSON AND DETERMINED THAT THE ABOVE ORDER FOR RESTRAINTS IS NECESSARY."

Review of nursing notes indicate that patient had been removed from restraints on 12/15/17, at 4 a.m., (6 hours prior to MD 4 signing order), and not reapplied.

Acknowledging that Patient 110 was out of restraints for 6 hrs prior to the request for restraints, ADM 3, stated, "Not sure why they asked for restraints when the patient was not even in them."

e. During a concurrent closed record review of Patient 113, and interview with ADM 3, on 3/7/18, starting at 2 p.m., review of telephone order to doctor 5 (MD 5) revealed request for "Medical Non Violent Restraints," on 12/21/17, at 4:44 p.m., MD 5 electronically signed order on 12/21/17, at 7:12 p.m., with the following comments:
Clinical justification: pulling tube; Type of restraints: soft wrist bilateral; Length of order: daily; D/C (discontinue) restraint use when order expires, patient no longer meets clinical justification. I HAVE ASSESSED THE PATIENT IN PERSON AND DETERMINED THAT THE ABOVE ORDER FOR RESTRAINTS IS NECESSARY."

Further review of MD progress with ADM 3 indicated the only medical note written that day was by covering MD (MD 6). MD 6 note was written at 12/21/17 at 8:53 p.m. there is notation that Patient 113 was in restraints despite nursing notes indicating Patient 113 was not in restraints, MD 6 indicated Patient in, "No apparent distress."

ADM 3 acknowledge that MD 5 had not seen Patient 111 "face to face" on 12/21/17 per MD 5 electronically signed order.

ADM 3, acknowledged that orders cannot be written as "standing orders" until the order "expires", that orders were received to place patients in restraints when patients had been removed from restraints hours earlier, and that medical record documentation did not reflect that patient required restraints, that Patient 113 and Patient 111 orders indicated patients were seen by the MD but medical progress notes did not support this statement.

Based on record review and interview, the hospital failed to renew physician orders for restraints used for the management of violent behavior every four (4) hours as required for one of 55 sampled patients (Patient 306).

This failure place the patient at risk for injury.

Findings:

The facility policy and procedure titled "Restraints," dated 12/2015, indicated, "Telephone and written orders are limited to 4 hours for patients 18 and older."

During review of the clinical record for Patient 306, and concurrent interview on 3/6/18, at 3:35 p.m., registered nurse (RN 6), on 3/6/18, acknowledged behavioral restraints orders were only written every 24 hours and not every four hours as policy required.

Based on record review and interview, the hospital failed to ensure physicians or licensed independent practitioner (LIP) document in the medical record the findings of their evaluation, supporting the continued use of restraints before renewing the restraint order after 24 hours for one of 55 sampled patients (Patient 306), who was restrained for the management of violent or self-destructive behavior.

This failure placed Patient 306 at risk for injury.

Findings:

During review of the clinical record for Patient 306, and concurrent interview on 3/6/18, at 3:35 p.m., registered nurse (RN 6) acknowledged the physician's progress notes dated 3/3/18 and 3/4/18 did not include any documentation of the physician's assessment findings supporting the continued use of restraints before renewing the restraint order after 24 hours.

Based on interview and record review, the facility failed to ensure restraint orders were renewed according to the facility's policy for three of 55 sampled patients (Patients 212, 213, and 215).

This failed practice resulted in the use of physical restraints without a physician's order.

Findings:

The facility policy and procedure titled "Restraints" dated 4/16, indicated in part " ...Requirements for orders for medical and surgical restraints: orders for restraints must not exceed 24 hours ..."

a. During a record review for Patient 212, the physician order dated 12/28/17, at 12:28 a.m., indicated soft restraints were ordered to treat behaviors that included attempting to pull out tubes (medical devices such as an intubation tube). The physician renewed the restraint order on 12/29/17, at 3:31 p.m. The order expired at 12:28 a.m. on 12/29/17. There was no physician order for the renewal of the soft restraints that had been in use from 12/29/17 at 12:28 a.m. through 12/29/17 at 3:31 p.m.

During an interview with Administrator (ADM 5) on 3/7/18, at 3 p.m., ADM 5 reviewed the clinical record for Patient 212, and acknowledged the orders dated 12/29/17, 1/2/18, and 1/4/18 exceeded the 24 hour renewal policy for medical restraints.

b. During a record review for Patient 213, the physician order dated 12/4/17, at 7:31 a.m., indicated soft wrist restraints were ordered to treat behaviors that included attempting to pull out tubes (medical devices such as an intubation tube). There was no physician order for the renewal for the soft restraints in use from 12/5/17 at 7:31 a.m. through 12/6/17 at 5:17 a.m. Further record review for Patient 213 revealed there were no physician orders for soft restraints during the dates of 12/7, 12/8, and 12/10/17. Nursing Restraint Flowsheet documentation reveals that soft restraints were utilized on these dates.

During an interview and concurrent record review with Administrator (ADM 5), on 3/7/18, at 4 p.m., ADM 5 reviewed the clinical record for Patient 213 and acknowledged the lack of restraint renewal orders were out of compliance with hospital policy of every 24 hours.

c. During a closed clinical record review for Patient 215, the physician order dated 12/6/17 at 2:26 a.m. indicated soft wrist restraints were ordered to treat behaviors that included attempting to get up out of bed with an intracranial bleed (a type of bleeding that occurs inside the skull). The physician renewed the restraint order on 12/7/17 at 4:35 a.m. The order expired at 2:26 a.m. on 12/7/17. There was no physician order for the renewal of soft restraints that had been in use from 12/7/17 at 2:26 a.m. to 12/7/17 at 4:35 a.m. Further record review for Patient 215 revealed the soft restraint physician orders dated 12/7/18 at 4:35 a.m. and 1/10/17 at 12:04 a.m., resulted in expired restraint orders 12/8/17 at 4:35 a.m. through 12/8/17 at 7:04 a.m. and 12/11/17 at 12:04 a.m. through 12/8/17 at 4:36 a.m., while restraints were in use.

During an interview and record review with ADM 5 on 3/7/18, at 4:45 p.m., ADM 5 acknowledged the restraint orders for 12/7, 12/8, and 12/11/17 exceeded the 24 hour renewal policy for medical restraints.

Based on interview and record review, the hospital failed to:

1. Monitor one (Patient 306) of 55 sampled patients who was restrained for the management of violent or self-destructive behavior as per the facility's policy and procedure.

2. Monitor and assess three of 55 sampled patients (Patient 316, 317 and 215) who were restrained with the use of medical restraints (physical devices used to prevent patients from removing therapeutic medical devices).

These failures place the patient at risk of injury.

Findings:

1. The facility policy and procedure titled "Restraints", dated 12/15, indicated "One-One, Face-Face care is initiated, and continues for the first hour of restraint. After one hour, continuous observation may be archived through the use of audio and visual monitoring. The RN is responsible for ensuring that the every 15 minutes documentation of patient monitoring is completed. Specific monitoring to be done every 15 minutes includes: Status of Restraint and Environment: Nutrition and Hydration: Skin and Circulation: Hygiene and Elimination: Physical and psychological status, and Comfort."

During review of the clinical record for Patient 306, and concurrent interview 3/6/18, at 3:35 p.m., registered nurse (RN 6) acknowledged and confirmed after reviewing the entire record that the patient was not monitored for one hour after the restraints were initiated. RN 6 acknowledged and confirmed Patient 306 was not monitor by staff every 15 minutes per policy.

2. The facility policy and procedure titled "Restraints", last reviewed 12/15, under the section "Reassessment Of The Patient in Restraint", the policy indicated "2.1 Patients will be assessed/monitor at least every two (2) hours or more frequently if necessary."

a. A review of the clinical record for Patient 316, was conducted on 3/8/18. The record revealed, restraints were applied on Patient 316 on 3/7/18, at 12 p.m., and were removed on 3/8/18, after 10 a.m. There were no every two hour assessment performed between the hours of 6 p.m. to 12 a.m. (six hours).

During an interview on 3/8/18, at 10:20 a.m., administrator (ADM 8) acknowledged Patient 316 was not assessed for six hours.

b. A record review for Patient 317, conducted on 3/8/18, revealed restraints were applied on Patient 317 on 3/7/18, at 2 p.m., and were removed on 3/8/18, after 10 a.m.. There were no documentation of every two hours monitoring between the hours of 6:00 p.m., on 3/7/18, to 8 a.m., on 3/8/17 (14 hours) while Patient 317 was in restraints.

During an interview with ADM 8 on 3/8/18 at 1:55 p.m., ADM 8 confirmed there was no documentation to indicate Patient 317 was assessed or monitor for 14 hours while on restraints.


34445


c. During a review of clinical record for Patient 215, conducted on 3/7/17, at 4:45 p.m., the physician orders dated 12/6/17 at 2:26 a.m., and 12/7/17 at 4:35 a.m. indicated soft restraints to bilateral wrists. Further document review revealed every two hour assessment and monitoring of Patient 215 were not documented on the Restraint Flowsheet between 12/6/17 at 2:26 a.m. and 12/8/17 at 8 a.m.

During an interview and concurrent record review on 3/7/18 at 4:45 p.m. with Administrator (ADM 5), ADM 5 confirmed every two hour assessments for patients in restraints was not documented from 12/6/17 at 2:26 a.m. through 12/8/17 at 8 a.m.

Based on interview and record review, the hospital failed to provide a face to face assessment for one of 55 sampled patients (Patient 306), who was in restraints for the management of violent or self-destructive behavior as per the facility's policy and procedure.

This failure place Patient 306 at risk of injury.

Findings:

The facility policy and procedure titled "Restraints," dated 12/15, indicated in part, "Monitoring Requirements For Restraint Used For Violent Or Self Destructive Behavior: An licensed independent practitioner (LIP) who is primary responsible for the patient's care or an LIP designee conducts an in-person face-to-face evaluation of the patient within 1 hour of initiation. If the LIP is not able to respond, he/she must contact the Emergency Room MD to arrange coverage as a designee. The in-person face-face is conducted to review the patient's immediate status, i.e. the physical and psychological status of the patient; the patient's reaction to the intervention; the patient's medical and behavioral conditions; to make necessary revisions to the patient's plan of care, to identify alternatives to help the patient regain control; to assess the need to continue or terminate the restraints, and to sign the order."

During review of the clinical record for Patient 306 and concurrent interview with registered nurse (RN 6), on 3/6/18, at 3:35 p.m., RN 6 acknowledged and confirmed after reviewing the entire record that a face to face assessment was not performed for Patient 306.

Based on interview and record review, the hospital failed to ensure justification/rationale to continue restraints before renewing the order for restraints was documented for three of 55 sampled patients (Patient 302, 305 and 306).

This failure placed Patients 302, 305, and 306 at risk of being unnecessarily restrained .

Findings:

The facility policy and procedure titled "Restraints,"dated 12/15, indicated in part "Restraints are only used when it can be clinically justified or when warranted by the patient behavior that threatens the physical safety of the patient, staff, or others. The use of restraints is limited to those situations for which there is adequate and appropriate clinical justification. Use must be based on adequate clinical justification when other interventions would not be, or have not been, effective."

a. During a review of the clinical record for Patient 302, and concurrent interview with registered nurse (RN 5), on 3/6/18 at 10 a.m., RN 5 acknowledged and confirmed Patient 302's physician's renewal orders for restraints did not include the justification for the continuation of the restraints use on 3/2, 3/3, and 3/4/18.

b. During a review of the clinical record for Patient 305, and concurrent interview with RN 5, on 3/6/18, at 10 a.m. RN 5 acknowledged and confirmed Patient 305's physician renewal orders for restraints did not include the justification for the continuation of the restraints use on 2/17, 2/24, 2/26, 3/2, 3/3, and 3/4/18.

c. During a review of the clinical record for Patient 306, and concurrent interview with registered nurse (RN 6), on 3/6/18, at 3:50 p.m., RN 6 acknowledged and confirmed Patient 306's physician's renewal order for restraints dated 3/3/18 did not include the justification or reason for continuing the restraints.

Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation, the hospital failed to develop, implement, and maintain an effective, ongoing, data driven, hospital wide quality assessment and performance improvement (QAPI) program, that incorporated all areas of patient rights (refer to A-115), and that measured, analyzed, and tracked quality indicators, including adverse patient events (refer to A-167).

The hospital failed to have a QAPI program that included specific quality indicator data, focusing on high risk, high volume, or problem prone areas (refer to A-168, A-132, and A-131). The governing body failed to ensure the QAPI program reflected the hospital's services, involved all departments, and focused on indicators to improve health outcome and provide quality patient care and services (refer to A-799).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation, the Quality Assurance and Performance Improvement (QAPI) program failed to ensure all relevant data was captured and utilized to monitor the effectiveness and safety of services and quality of care.

Findings:

Review of QAPI documentation revealed the data showed that every 24 hours patients in restraints received a face to face visit from a health care provider and, if necessary, orders for restraints were written or renewed. However review of patient medical records revealed the face to face examination did not always precede, as required by policy and regulation, the application of restraints (refer to A-168).

Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation, the Quality Assurance and Performance Improvement (QAPI) program failed to ensure opportunities for improvement were identified.

Findings:

Instances of lack of documentation in the informed consent process had been previously presented to the governing body through the QAPI program meeting minutes as an area of concern. However there was no documentation of performance improvement projects initiated with the intention of improving the documentation of informed consent.

Based on staff interview and review of administrative records, policies and procedures, and quality assurance documentation, the hospital's governing body failed to ensure that the Quality Assurance and Performance Improvement (QAPI) program was implemented to improve quality of care and patient safety
.
Findings:

Review of the Quality Assurance and Performance Improvement (QAPI) program meeting minutes revealed that a problem with the informed consent process had been identified. There was no documentation that action to revise and improve the informed consent process had been taken. Refer to A-131.

Based on record review and interview, the facility did not meet the Condition of Participation: CFR 482.43, for Discharge Planning for one of 55 (Patient 315) sampled patients when the hospital failed to:

1. Provide a discharge planning evaluation prior to discharge, and lacked evidence that a screening process occurred to determine if sampled Patient 315 may suffer adverse health consequences upon discharge (Cross reference A-0800).

2. Arrange for transfer or make any referrals to another hospital where Patient 315's family was directed to take Patient 315 after discharge (Cross reference A-0837).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to provide discharge planning for one of 55 sampled patients (Patient 315).

This failure resulted in Patient 315 being directed to another hospital's emergency department (ED) by the physician upon discharge, with a blood pressure (B/P) of 62/33 (normal B/P is 120/80) and lightheaded, necessitating emergency interventions and hospitalization.

Findings:

The facility policy and procedure titled "Discharge Planning", dated 12/15, indicated "Discharge planning begins at the time of admission. It is an interdisciplinary process through which all members of the health care team ensure that appropriate and timely plans are made for post hospital care. The hospital personnel must complete the evaluation on a timely basis so that appropriate arrangements for post hospital care are made before discharge. Discharge planning begins at the time of admission by the case management staff using the Case Management Assessment tool."

A review of the clinical record for Patient 315 was conducted. The ED Report, dated 11/5/17, indicated Patient 315, with history of recently diagnosed ovarian cancer 1 month ago, who was brought by emergency medical system (EMS) with severe pain 10/10 (pain level 1/10, indicates no pain, pain level 10/10 indicates severe pain), temperature was 103 (F) Fahrenheit (normal temperature 98.6 F). Patient had two episodes of low blood pressure (B/P) while in the ED, at 9:48 a.m., B/P was 98/48 and at 1:49 p.m., B/P was 99/53. Temperature remained elevated per nurses notes. At 4:41 p.m., temperature was documented as being 102.7 F.

The ED Course and Medical Decision Making physician's note, dated 11/5/17 at 1:18 p.m., revealed Patient 315 was being admitted to the hospital as In-Patient due to a "Guarded" (indicates a patient whose's medical condition has become stabilized, but it is still unknown if their condition will improve or might worsen) condition. The admitting hospitalist (Physician's name) (MD 1) will assume care of Patient 315."

Further review of Patient 315's nurses notes, dated 11/5/17 at 5:10 p.m., revealed "Patient received from the ED to room 6032 (medical surgical room)...Temperature 100.8, SPO2 (amount of oxygen in blood) 90% (normal 95-100%) at room air. Patient was having brite red bleeding in her perineum (rectal area)."

The nurses note dated 11/5/17 at 6:15 p.m., indicated "Temp 101.1 orally noted. Cooling measures observed. Will continue to monitor for change of condition (COC)." The nurses note dated 11/5/17 at 7 p.m., indicated "Received a call from the charge nurse about (Patient 315) needed to transfer to direct observation unit (DOU) for close monitoring of patient's vaginal bleeding, fast heart rate and low blood pressure." Patient was received via bed... "(Physician's name) (MD 1) was with patient on transfer and said patient (Patient 315) will be discharged ASAP (as soon as possible) once the husband gets here to take her (Patient 315) to a hospital where she (Patient 315) can be treated appropriately by her doctors. (Physician's Name) (MD 1) aware of vital signs (measurements indicating the state of a patient's essential body functions) with temperature of 101.1 F."

Nurses note dated 11/5/17 at 7:05 p.m., indicated "Patient (Patient 315) was discharged accompanied by certified nursing assistant (CNA), complaining of chills, feeling cold, and warm to touch."

During an interview with the registered nurse (RN 2) on 3/7/18 at 3:35 p.m., RN 2 explained she was uncomfortable discharging Patient 315 home when the patient was "weak, pale, shaky and had a fever." RN 2 explained she attempted to convince MD 1 to transfer Patient 315 via ambulance to the hospital where she (Patient 315) was supposed to go after discharge. MD 1 insisted on discharging Patient 315 home. MD 1 stated "I'm going to discharge her home so her husband can take her to (name of another hospital) right now." MD 1 explained that if they "transfer Patient 315 by ambulance they have to call an ambulance service, call and arrange for the receiving physician and call the discharge planner to make those arrangements. This was going to take a lot of time. It was faster to have Patient 315's husband drive her to the other hospital."

During a review of Patient 315's clinical record from the ED visit at the second hospital on 11/5/17 at 8:02 p.m., the ED Final Report, dated 11/5/17 revealed "Patient 315 presented to the ED via private car. On arrival she (Patient 315) was continuing to feel very lightheaded, blood pressure was 62/33, heart rate 109, and temperature of 99.5 F. Patient 315 nearly fell down sustaining an abrasion to the side of the left leg." The report indicated "Given the high probability of imminent or life threatening deterioration of the patient's condition without intervention, the patient was immediately assessed." Patient 315 was admitted to the second hospital with diagnosis of hypotension (low blood pressure, sepsis (serious infection), ovarian cancer (cancer of the ovaries) and left leg blood clot.

Based on interview and record review, the hospital failed to ensure one of 55 sampled patients (Patient 315) was transferred or made the appropriate referral to the hospital where Patient 315 was sent after being discharged.

This failure placed Patient 315's health in jeopardy.

Findings:

The facility policy and procedure titled "Discharge Planning", dated 12/15, indicated, "Discharge planning begins at the time of admission. If a transfer to an alternate facility, such as other acute care facility, is needed, it shall be determined prior to the transfer or (referral) that the receiving facility has sufficient clinical data to ensure that it can meet the patients medical needs."

A review of the clinical record for Patient 315 was conducted. The emergency department record, dated 11/5/17, indicated Patient 315 with history of recently diagnosed ovarian cancer 1 month ago, was brought to the emergency department (ED) with severe pain and fever. Patient was admitted to the hospital.

During an interview with a registered nurse (RN 2) on 3/7/18 at 3:35 p.m., RN 2 explained she was uncomfortable discharging Patient 315 home when Patient 315 was "weak, pale, shaky and had a fever." RN 2 attempted to convince MD 1 to transfer Patient 315 via ambulance to the hospital where she was supposed to go after discharge. MD 1 insisted on discharging Patient 315 home. MD 1 stated "I'm going to discharge her home so her husband can take her to (name of another hospital) right now." MD 1 explained that if they "transfer Patient 315 by ambulance they have to call an ambulance service, call and arrange for the receiving physician and call the discharge planner to make those arrangements. This was going to take a lot of time. It was faster to have Patient 315's husband drive her to the other hospital."

Patient 315's record revealed MD 1's History and Physical, dated 11/5/17, indicated, in the physician plan, "As we do not have a GYN (female reproductive speciality) Oncologist (cancer specialist) on staff, I have recommended that the husband take her (Patient 315) to a hospital where she can receive the appropriate care."

During an interview with MD 1 on 3/7/18 at 11:30 a.m., MD 1 explained at the time of Patient 315's discharge on 1/5/17 approximately at 7 p.m. Patient 315 "appeared stable." MD 1 was asked if a patient with a hemoglobin (part of the blood responsible for transporting oxygen to tissue) of 9.2 (normal 12-16) and hematocrit (a ratio of cells to the total volume of blood) of 26.8 (normal 36-48) blood count, who has vaginal bleeding (while in the medical surgical unit), with fever of 101.1 F, who was complaining of having chills, warm to touch, feeling weak, shaky and pale was considered "stable to be sent home." MD 1 stated "Well, if you put it like that, I guess not." MD 1 was asked if she performed a physical examination on Patient 315 before being discharge. MD 1 reply "No, I did not." MD 1 was asked if perhaps transferring Patient 315 to the other hospital via ambulance would have been a better idea. MD 1 reply "Well, if you put it like that. I guess so."

During a review of Patient 315's clinical record from the ED visit at the second hospital on 11/5/17 at 8:02 p.m., the ED Final Report, dated 11/5/17 revealed "Patient 315 presented to the ED via private car. On arrival she was continuing to feel very lightheaded, blood pressure was 62/33, heart rate 109, and temperature of 99.5 F. Patient 315 nearly fell down sustaining an abrasion to the side of the left leg." The report indicated "Given the high probability of imminent or life threatening deterioration of the patient's condition without intervention, the patient was immediately assessed." Patient 315 was admitted to the second hospital with diagnosis of hypotension (low blood pressure, sepsis (serious infection throughout the body), ovarian cancer, (cancer of the ovaries) and left leg blood clot.