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1500 E MEDICAL CENTER DRIVE, SPC 5474

ANN ARBOR, MI 48109

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review, the facility failed to provide information regarding sequence of medication therapies for 1 (#14) of 8 patient reviewed for informed consents for treatment, resulting in the potential for less than optimal outcomes. Findings include:

On 11/17/20 at approximately 0945, phone interview with the patient #14's mother (guardian) revealed that she and the patient were very upset about the sequence of chemotherapy and ovarian sparing medication. The mother stated that they were not informed that the ovarian sparing medication should have been given before the chemotherapy as per conversation with the Gynecological staff.

On 11/18/20 at 1300, review of patient #14's medical record revealed that the patient was a 15-year-old female recently hospitalized 11/12/20 - 11/14/20 with lupus nephritis Class 4 requiring Cyclophosphamide infusion (chemotherapy and immunosuppressive drug). Gynecology (GYN) was consulted during the admission and recommended medication be given outpatient for ovarian preservation. The patient tolerated chemotherapy well (per discharge summary) and will have another infusion in one month.

Continued medical record review of the GYN documentation revealed that they were consulted regarding discussion of fertility preservation options. The Consult documented: "Given the patient's disease status, we recommend treatment of her acute needs and would not recommend withholding or delaying treatment for fertility sparing purposes. The current treatment recommended by the primary team is to treat with Cytoxan (Cyclophosphamide) 950 mg (milligrams) monthly for 6 months. She received her first infusion yesterday." Medication options for ovarian preservation (Lupron versus Zoladex) was discussed with the patient and she agreed to future treatment. The consult continued, "We discussed the risks and benefits extensively with the patient and after thorough counseling she does agree to proceed with Zoladex. Our fertility preservation coordinator will reach out to the patient and her mother regarding insurance coverage and timing of her first injection. The first dose of Zoladex will be given as a monthly dose. If well-tolerated, then she can be switched to a 3-month dose. She only needs to be on Zoladex for the duration of her Cyclophosphamide treatment."

Further review of medical record consent revealed that the consent for treatment was signed on 11/6/20 by the patient's father/guardian prior to renal (kidney) biopsy. On 11/17/20 at 1500, interview with the Director Accreditation & Regulatory B revealed that when a consent was obtained, it was good for five years. Review of the policy/procedure for consent titled "(Facility) Informed Consent for Provision of Health Care Services, 62-10-000, revised 03/2019" documented, " ...(consent is obtained Adult or Child) upon the patient's first contact with (Facility) and every five years thereafter ..."

On 11/18/20 at approximately 1400, phone interview with the admitting/managing Pediatric Rheumatologist Physician W, revealed that she had discussed chemotherapy risks and benefits with the patient and mother. The physician stated that after the patient's renal biopsy on 11/6/20, it was determined that the patient urgently required chemotherapy for stage 4 and active symptoms. She further stated that there was no ovarian toxicity after the first dose and that the risk was with cumulative Cyclophosphamide treatment. The physician stated that she again talked to the mother on the phone yesterday to reassure the patient and family.

On 11/18/20 at 1430, review of an additional minor consent policy titled "(Facility) Consent for the Provision of Health Care Services for MINORS; Confidential Health Services Policy, 03-07-018, last revised 08/2018" documented, "General Consent to Receive Health Care Services ... which may include Surgeries and Procedures, Medications, Immunizations, Tests, Telemedicine Services, Other treatment necessary for my child's care ...I have the right to discuss my child's health care with my child's health care providers at any time. I have the right to agree to or refuse any care. I understand that my child's health care providers generally will obtain my consent after discussing specific care, therapies, and procedures with me. My child's health care providers will review known risks, expected benefits and alternatives to therapies in those discussions. I may need to give additional consent for invasive procedures and special treatments ..."

On 11/17/20 at approximately 0945, the mother/guardian had stated that the risks and benefits of the sequencing of fertility preserving options for the 15-year-old daughter was not given prior to chemotherapy treatment.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview and record review, the facility failed to evaluate and/or supervise 1 (#9) of 4 patients at risk for elopement, resulting in the potential for less than optimal outcomes. Findings include:

On 11/17/20 at approximately 1130, review of patient #9's medical record with ED Clinical Nurse Specialist F, revealed that patient #9 was a 71-year-old patient transferred from a nursing home to the emergency department (ED) via ambulance on 9/22/20 at 1419, with dental pain. The patient stated he went to the dentist and was directed to have his teeth extracted. The ED Nursing notes on 9/22/20 from 1425 to 1539 documented the patient was alert and oriented, in no acute distress. The ED Provider Note dated 9/22/20 at 1539 documented that the patient was alert and oriented, but also documented that the patient had "dementia" (impaired brain functions with memory and judgement). The last ED staff contact was documented on 9/22/20 at 1555 - 1558 by clerical staff per medical record review with ED Clinical Nurse Specialist F.

On 11/17/20 at 1130, ED Clinical Nurse Specialist F was queried about nursing assessments and documentation and she stated that it was "ongoing." Also on 11/17/20 at 1130, ED Nursing Director D stated that the facility did not have specific ED documentation policy and procedure for assessments and documentation, but utilized "Guidelines consistent with ESI" (Emergency Severity Index rank 1-5, with 1 being the most severe). The patient was classified as an ESI 3. The Director provided "ED Guideline 02-20-155, last revised 4/2020" which documented, "The patient will require 2 or more resources. Reassessment will be completed based on patient condition and response to treatment."

Further medical record review revealed that on 9/22/20 at 1730, ED Nurse AA documented: "Pt (patient) no longer on chair in room 68. Pt not with dentistry per PA (Physician Assistant). Pt no longer on unit. This RN met with security and asked them to check the cameras. Pt visualized leaving East (unit) at 1648. Pt visualized walking out to ambulance bay at 1650. The (Nursing Home) was called by (charge) RN and stated, 'the patient appears alert and oriented but is very confused.' Pt appeared alert and oriented on initial encounter, no history in the chart regarding pt's mental capacity, no paperwork sent with Pt to indicate that he was confused. Security notified of pt's mental status and (city) police was called. Charge RN and Supervisor made aware."

On 11/18/20 at approximately 1115, ED Nursing Director D stated that the nurse taking care of the patient for the visit of 9/22/20 was not available for interview. ED Nursing Director D stated that an investigation had been done. It had determined that transfer document scanning needed to be done sooner in the ED visit process so that all disciplines could have access to the patient records (e.g. from nursing home). Review of the ED Nurse Job Description provided, titled "Registered Nurse- Level C, issued 10/21/18" documented, (the nurse) "consults documentation to identify trends in patient status and enhance continuity of assessment and ongoing nursing care." The patient's dementia had not been addressed.