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Based on record review and interviews, the Facility failed to promote and protect patient rights for 3 of of 5 ESRD patients (Patient #1, #2, #3), in a total sample of 10. Findings include:

The Hospital failed to ensure their designees were provided the information necessary to make in informed decision prior to having invasive procedures performed at the Hospital. The Hospital failed to ensure they contacted the person authorized to make health care related decisions on a patient's behalf, prior to performing procedures which required informed consent.

See A0131 and A0132.

Based on record review and interviews, the Hospital failed to provide surgical services that were in accordance with acceptable standards of practice for 3 of of 5 ESRD patients (Patient #1, #2, #3), in a total sample of 10. Findings include:

1. The Hospital failed to ensure they contacted the person authorized to make health care related decisions on a patient's behalf, prior to performing invasive and surgical procedures which required informed consent.

See A0995

Based on record review and interviews, the Facility failed for 3 of of 5 ESRD patients (Patient #1, #2, #3), in a total sample of 10, to ensure their designees were provided the information necessary to make in informed decision prior to having invasive procedures performed. The Hospital failed to ensure they contacted the person authorized to make health care related decisions on a patient's behalf, prior to performing procedures which required informed consent. Findings include:

Hospital #1's Informed Consent Policy, dated 3/1/13, indicated that any major diagnostic, invasive, and therapeutic procedure offered to a patient must be presented with sufficient information to assist the responsible individual in making decision regarding the nature, merit, risk, and benefits involved to the proposed patient. The policy indicated the physician or their designee will obtain informed consent and documentation of the consent will be documented on the Consent for Surgery, Invasive Procedure or Treatment form. The policy indicated informed consent may be granted by the patient or the patient's legally designated representative. The policy indicated informed consent may be waived in the event of an emergency where a delay in care could create a life threatening situation, or significant irreversible damage, for example loss of a limb.

The policy indicated procedures requiring informed consent included, all procedure performed in the operating room and central line placements.

1. The Health Care Proxy, dated 12/02/00, indicated Patient #1 designated Family Member #1 as the person authorized to make health care related decisions on Patient #1's behalf, in the event Patient #1 was unable to do so. The Health Care Proxy Form, dated 4/13/11, indicated that on this date, a physician determined Patient #1 was unable to make health care decision due to developmental delays.

A.) The Department of Surgery Surgical Wait List, 6/11/13, indicated Patient #1 was placed on the surgical wait list on 6/11/13. The Surgical Wait List indicated the status of the surgery was considered to be urgent, which was defined as to occur within one week. The Surgical Wait List indicated Patient #1 had poor flow through the dialysis vas catheter and the procedure to be performed was for the catheter to be changed.

The Consent for Surgery, Invasive Procedure or Treatment form, signed by Vascular Surgeon #1 on 6/13/13, indicated Patient #1 had Health Care Proxy (Agent) who was identified by name. Documentation on Request for the Administration of Anesthesia form (located on the back of the Consent for Surgery, Invasive Procedure or Treatment Form) indicated that at 2:45 P.M. on 6/12/13 a voicemail message was left for someone documented on the form as being Patient #1's Health Care Proxy (Agent) and at 8:00 A.M. on 6/13/13, a second attempt was made to contact the person identified on the form. The name of the family member identified on the form was not Patient #1's Health Care Agent or Alternate Agent. There was no indication Patient #1's Health Care Agent was informed of the scheduled procedure or consented for Patient #1 to have the procedure. The Consent indicated though they were unable to reach the family member, who was incorrectly identified as Patient #1's HCP (Health Care Proxy/Agent), they proceeded with the catheter change because Patient #1's surgery was, "deemed an emergency" by Vascular Surgeon #1.

The operative report, dated 6/13/13, indicated Patient #1's catheter was not placed properly and Patient #1 had the catheter replaced.

B.) The dialysis treatment record, dated 8/26/13, indicated on this date, Patient #1, who was known to the Facility, had problems establishing adequate blood flow rates and as Vascular Surgeon #1 was already in the building, he was called to request to have the catheter changed over a wire. The note indicated Patient #1 was transferred to the operating room to have the catheter changed by Vascular Surgeon #1.

Surveyor #1 interviewed the Nurse Practitioner at 2:45 P.M. on 10/9/13. The Nurse Practitioner said they had another patient scheduled for a catheter change on 8/26/13. The Nurse Practitioner said the patient did not show up for the scheduled procedure. The Nurse Practitioner said on 8/26/13, Patient #1's dialysis catheter was not functioning and because Vascular Surgeon #1's schedule was open she called to determine whether Vascular Surgeon #1 would change Patient #1's catheter.

The Consent for Surgery, Invasive Procedure or Treatment form, dated 8/26/13, indicated Patient #1 was to have a change in hemodialysis catheter at the right subclavian over a wire or a new site. The form indicated Patient #1 was unable to have hemodialysis due to the catheter not functioning. The form indicated the person giving consent for the procedure was identified by name, but was not reached and a voice mail was left. The person indicated was not Patient #1's Health Care Agent or Alternate Agent. The consent form indicated they were unable to contact and, "will be as an emergency."

The Nurse Practitioner said Patient #1's prior dialysis treatment was the previous Friday (8/23/13), but on 8/26/13 had excellent urine output, and stable vital signs. The Nurse Practitioner said she never contacted Patient #1's Health Care Agent, because she thought it was the responsibility of the Surgeon to obtain the information. The Nurse Practitioner said based on Patient #1's condition on 8/26/13, she did not feel Patient #1's catheter needed to be changed emergently and it could have waited until the Health Care Agent was contacted and gave consent. The Nurse Practitioner said after the procedure, Patient #1 returned to the dialysis unit, but was unable to be dialyzed.

Surveyor #1 and Surveyor #2 interviewed Vascular Surgeon #1 at 3:00 P.M. on 10/2/13. Vascular Surgeon #1 said he attempted to contact Patient #1's Health Care Agent as did the Physician's Assistant and the Nurse Practitioner, but they were unable to reach the Agent. Vascular Surgeon #1 said he proceeded with Patient #1's catheter placement without obtaining consent from Patient #1's Health Care Agent because he felt Patient #1's condition was life threatening because Patient #1 required dialysis. Vascular Surgeon #1 identified the individual who was contacted. The person identified was not Patient #1's Health Care Agent or Alternate Agent, as documented on Patient #1's Health Care Proxy document.

Surveyor #1 and Surveyor #2 interviewed the Surgical Physician's Assistant at 10:15 A.M on 10/2/13. The Physician's Assistant said he was called by someone at the dialysis unit that Patient #1 needed a new dialysis catheter. The Physician's Assistant said he informed Vascular Surgeon #1 who put Patient #1 on the operating room schedule. The Physician's Assistant said he documented attempting to contact Patient #1's "Guardian" but did not recall having made the call himself. The Physician's Assistant said normally if a patient or their representative can not provide consent, the physician is notified and he would notify Vascular Surgeon #1 who would make the decision to proceed with the catheter change.

Surveyor #1 interviewed Family Member #1 (Patient #1's Health Care Agent) at 4:45 P.M. on 10/1/13. Family Member #1 said he was never contacted by anyone at the Facility at any time. Family Member #1 said he was not informed of the 6/13/13 or 8/26/13 catheter changes and never consented for Patient #1 have any catheter changes completed at Hospital #1. Family Member #1 said he learned of the 8/26/13 procedure after Patient #1 had the procedure and was transferred to Hospital #2.

2. Review of the Supplemental Findings of Fact, dated 4/2/13, indicated Patient #2 had a Guardian since 10/12/06.

A) The Surgical Wait List Form, dated 5/8/13, indicated Patient #2 was to have a revision of the AV (arteriovenous) fistula in Patient #2's right arm, and the procedure was scheduled for 5/20/13.

The Consent for Surgery, Invasive Procedure or Treatment form, dated 5/20/13, indicated they were unable to reach Patient #2's Guardian. The Form indicated Patient #2 signed the consent for the procedure and for the administration of Anesthesia.

B) The Surgical Wait List form, dated 7/8/13, indicated Patient #2 had an occluded (blocked) AVF (arteriovenous fistula) and the status of the procedure was considered to be urgent, which was defined as to be scheduled within one week.

The Consent for Surgery, Invasive Procedure or Treatment Form, dated 7/8/13, indicated Pateint #2 had a new dialysis catheter placed. The Consent indicated they were unable to reach Patient #2's Guardian at the numbers provided and there was no indication the Guardian consented to the procedure before it was completed. The Consent for the Administration of Anesthesia Form was not completed.

C) The Surgical Wait List Form, dated 8/23/13, indicated Patient #2 was to have a new dialysis catheter placed, and the procedure was considered a priority, which was defined as being within two weeks. The Surgical Wait List Form indicated Vascular Surgeon #1 deemed the case an emergency. The Request for Administration of Anesthesia form, indicated on 8/23/13, Patient #2's Guardian was contacted and consented by telephone for anesthesia to be administered to Patient #2.

The Consent for Surgery, Invasive Procedures or Treatment Form, dated 8/26/13, indicated several attempts were made to reach Patient #2's Guardian to consent on the day of the procedure, but they were unable to contact the Guardian.

3. The Health Care Proxy Form indicated that on 8/25/11, Patient #3 designated a family member as being authorized to make health care related decision on his/her behalf. The Proxy included an out-of-state telephone number to reach the Agent.

The Letters of Guardianship for an Incapacitated Person indicated that on 8/29/12, a Permanent Guardian was appointed for Patient #3 and the person appointed was not the same person who Patient #3 appointed as his/her Health Care Agent. The Guardianship indicated the Guardianship authorized the revocation of Patient #3's Health Care Proxy.

The Department of Surgery Surgical Wait List, dated 5/24/13, indicated Patient #3 was scheduled to have procedures performed to evaluate the functioning of Patient #3's AV fistula, which included a possible revision of the fistula. The Surgical Wait List Form indicated the procedure was considered to be a priority, which was defined as being within two weeks. The Surgical Wait List Form included for information regarding a patient's guardianship to be documented, but the section of the form was left blank.

The Consent for Surgery, Invasive Procedure or Treatment Form, (without a date), indicated Patient #3 authorized Vascular Surgeon #1 to perform a revision of Patient #3's left forearm AV fistula. There was no signature from the Guardian documented on the form or that attempts were made to obtain consent from Patient #3's Guardian prior to the procedure being performed. The form indicated Vascular Surgeon #1 was unable locate Patient #3's Guardian (sister) and the decision was to proceed with the procedure, however Patient #3's legal Guardian was not a family member as indicated. The Request for the Administration of Anesthesia Form (located on the back of the Surgical Consent Form) was blank.

Vascular Surgeon #1's progress note, dated 5/30/13, at 10:30 A.M., indicated the Guardian's telephone number was not in service and indicated the person they referred to as the Guardian was Patient #3's family member.

The Operative Report, dated 5/30/13, indicated Patient #3 had a procedure for treatment of a non-functioning fistula in the left forearm.

Based on record review and interviews, the Facility failed for 3 of of 5 ESRD patients (Patient #1, #2, #3), in a total sample of 10, to ensure their designees were provided the information necessary to make an informed decision prior to having invasive procedures performed. The Hospital failed to ensure they contacted the person authorized to make health care related decisions on a patient's behalf, prior to performing procedures which required informed consent. Findings include:

1) Patient #1 had a dialysis catheter changed on 6/13/13 and 8/26/13, and Patient #1's Health Care Agent did not consent to the procedure.

2) Patient #2 had procedures performed on 5/20/13, 7/8/13, and 8/26/13, and the Guardian did not provide consent for the procedures.

3) Patient #3 had a procedure performed on 5/30/13, but Patient #3's Guardian was not contacted prior to the procedure and did not give consent for the procedure to be done.

Based on record review and interviews, the Facility failed for 3 of of 5 ESRD patients (Patient #1, #2, #3), in a total sample of 10, to ensure their designees were provided the information necessary to make in informed decision prior to having invasive procedures performed. The Hospital failed to ensure they contacted the person authorized to make health care related decisions on a patient's behalf, prior to performing procedures which required informed consent. Findings include:

Hospital #1's Informed Consent Policy, dated 3/1/13, indicated that any major diagnostic, invasive, and therapeutic procedure offered to a patient must be presented with sufficient information to assist the responsible individual in making decision regarding the nature, merit, risk, and benefits involved to the proposed patient. The policy indicated the physician or their designee will obtain informed consent and documentation of the consent will be documented on the Consent for Surgery, Invasive Procedure or Treatment form. The policy indicated informed consent may be granted by the patient or the patient's legally designated representative. The policy indicated informed consent may be waived in the event of an emergency where a delay in care could create a life threatening situation, or significant irreversible damage, for example loss of a limb.

The policy indicated procedures requiring informed consent included, all procedure performed in the operating room and central line placements.

1. The Health Care Proxy, dated 12/02/00, indicated Patient #1 designated Family Member #1 as the person authorized to make health care related decisions on Patient #1's behalf, in the event Patient #1 was unable to do so. The Health Care Proxy Form, dated 4/13/11, indicated that on this date, a physician determined Patient #1 was unable to make health care decision due to developmental delays.

A.) The Department of Surgery Surgical Wait List, 6/11/13, indicated Patient #1 was placed on the surgical wait list on 6/11/13. The Surgical Wait List indicated the status of the surgery was considered to be urgent, which was defined as to occur within one week. The Surgical Wait List indicated Patient #1 had poor flow through the dialysis vas catheter and the procedure to be performed was for the catheter to be changed.

The Consent for Surgery, Invasive Procedure or Treatment form, signed by Vascular Surgeon #1 on 6/13/13, indicated Patient #1 had Health Care Proxy (Agent) who was identified by name. Documentation on Request for the Administration of Anesthesia form (located on the back of the Consent for Surgery, Invasive Procedure or Treatment Form) indicated that at 2:45 P.M. on 6/12/13 a voicemail message was left for someone documented on the form as being Patient #1's Health Care Proxy (Agent) and at 8:00 A.M. on 6/13/13, a second attempt was made to contact the person identified on the form. The name of the family member identified on the form was not Patient #1's Health Care Agent or Alternate Agent. There was no indication Patient #1's Health Care Agent was informed of the scheduled procedure or consented for Patient #1 to have the procedure. The Consent indicated though they were unable to reach the family member, who was incorrectly identified as Patient #1's HCP (Health Care Proxy/Agent), they proceeded with the catheter change because Patient #1's surgery was, "deemed an emergency" by Vascular Surgeon #1.

The operative report, dated 6/13/13, indicated Patient #1's catheter was not placed properly and Patient #1 had the catheter replaced.

B.) The dialysis treatment record, dated 8/26/13, indicated on this date, Patient #1's who was known to the Facility, had problems establish adequate blood flow rated and as Vascular Surgeon #1 was already in the building, he was called to request to have the catheter changed over a wire. The note indicated Patient #1 was transferred to the operating room to have the catheter changed by Vascular Surgeon #1.

Surveyor #1 interviewed the Nurse Practitioner at 2:45 P.M. on 10/9/13. The Nurse Practitioner said they had another patient scheduled for a catheter change on 8/26/13. The Nurse Practitioner said the patient did not show up for the scheduled procedure. The Nurse Practitioner said on 8/26/13, Patient #1's dialysis catheter was not functioning and because Vascular Surgeon #1's schedule was open she called to determine whether Vascular Surgeon #1 would change Patient #1's catheter.

The Consent for Surgery, Invasive Procedure or Treatment form, dated 8/26/13, indicated Patient #1 was to have a change in hemodialysis catheter at the right subclavian over a wire or a new site. The form indicated Patient #1 was unable to have hemodialysis due to the catheter not functioning. The form indicated the person giving consent for the procedure was identified by name, but was not reached and a voice mail was left. The person indicated was not Patient #1's Health Care Agent or Alternate Agent. The consent form indicated they were unable to contact and, "will be as an emergency."

The Nurse Practitioner said Patient #1's prior dialysis treatment was the previous Friday (8/23/13), but on 8/26/13 had excellent urine output, and stable vital signs. The Nurse Practitioner said she never contacted Patient #1's Health Care Agent, because she thought it was the responsibility of the Surgeon to obtain the information. The Nurse Practitioner said based on Patient #1's condition on 8/26/13, she did not feel Patient #1's catheter needed to be changed emergently and it could have waited until the Health Care Agent was contacted and gave consent. The Nurse Practitioner said after the procedure, Patient #1 returned to the dialysis unit, but was unable to be dialyzed.

Surveyor #1 and Surveyor #2 interviewed Vascular Surgeon #1 at 3:00 P.M. on 10/2/13. Vascular Surgeon #1 said he attempted to contact Patient #1's Health Care Agent as did the Physician's Assistant and the Nurse Practitioner, but they were unable to reach the Agent. Vascular Surgeon #1 said he proceeded with Patient #1's catheter placement without obtaining consent from Patient #1's Health Care Agent because he felt Patient #1's condition was life threatening because Patient #1 required dialysis. Vascular Surgeon #1 identified the individual who was contacted. The person identified was not Patient #1's Health Care Agent or Alternate Agent, as documented on Patient #1's Health Care Proxy document.

Surveyor #1 and Surveyor #2 interviewed the Surgical Physician's Assistant at 10:15 A.M on 10/2/13. The Physician's Assistant said he was called by someone at the dialysis unit that Patient #1 needed a new dialysis catheter. The Physician's Assistant said he informed Vascular Surgeon #1 who put Patient #1 on the operating room schedule. The Physician's Assistant said he documented attempting to contact Patient #1's "Guardian" but did not recall having made the call himself. The Physician's Assistant said normally if a patient or their representative can not provide consent, the physician is notified and he would notify Vascular Surgeon #1 who would make the decision to proceed with the catheter change.

Surveyor #1 interviewed Family Member #1 (Patient #1's Health Care Agent) at 4:45 P.M. on 10/1/13. Family Member #1 said he was never contacted by anyone at the Facility at any time. Family Member #1 said he was not informed of the 6/13/13 or 8/26/13 catheter changes and never consented for Patient #1 have any catheter changes completed at Hospital #1. Family Member #1 said he learned of the 8/26/13 procedure after Patient #1 had the procedure and was transferred to Hospital #2.

2. Review of the Supplemental Findings of Fact, dated 4/2/13, indicated Patient #2 had a Guardian since 10/12/06.

A) The Surgical Wait List Form, dated 5/8/13, indicated Patient #2 was to have a revision of the AV (arteriovenous) fistula in Patient #2's right arm, and the procedure was scheduled for 5/20/13.

The Consent for Surgery, Invasive Procedure or Treatment form, dated 5/20/13, indicated they were unable to reach Patient #2's Guardian. The Form indicated Patient #2 signed the consent for the procedure and for the administration of Anesthesia.

B) The Surgical Wait List form, dated 7/8/13, indicated Patient #2 had an occluded (blocked) AVF (arteriovenous fistula) and the status of the procedure was considered to be urgent, which was defined as to be scheduled within one week.

The Consent for Surgery, Invasive Procedure or Treatment Form, dated 7/8/13, indicated Pateint #2 had a new dialysis catheter placed. The Consent indicated they were unable to reach Patient #2's Guardian at the numbers provided and there was no indication the Guardian consented to the procedure before it was completed. The Consent for the Administration of Anesthesia Form was not completed.

C) The Surgical Wait List Form, dated 8/23/13, indicated Patient #2 was to have a new dialysis catheter placed, and the procedure was considered a priority, which was defined as being within two weeks. The Surgical Wait List Form indicated Vascular Surgeon #1 deemed the case an emergency. The Request for Administration of Anesthesia form, indicated on 8/23/13, Patient #2's Guardian was contacted and consented by telephone for anesthesia to be administered to Patient #2.

The Consent for Surgery, Invasive Procedures or Treatment Form, dated 8/26/13, indicated several attempts were made to reach Patient #2's Guardian to consent on the day of the procedure, but they were unable to contact the Guardian.

3. The Health Care Proxy Form indicated that on 8/25/11, Patient #3 designated a family member as being authorized to make health care related decision on his/her behalf. The Proxy included an out-of-state telephone number to reach the Agent.

The Letters of Guardianship for an Incapacitated Person indicated that on 8/29/12, a Permanent Guardian was appointed for Patient #3 and the person appointed was not the same person who Patient #3 appointed as his/her Health Care Agent. The Guardianship indicated the Guardianship authorized the revocation of Patient #3's Health Care Proxy.

The Department of Surgery Surgical Wait List, dated 5/24/13, indicated Patient #3 was scheduled to have procedures performed to evaluate the functioning of Patient #3's AV fistula, which included a possible revision of the fistula. The Surgical Wait List Form indicated the procedure was considered to be a priority, which was defined as being within two weeks. The Surgical Wait List Form included for information regarding a patient's guardianship to be documented, but the section of the form was left blank.

The Consent for Surgery, Invasive Procedure or Treatment Form, (without a date), indicated Patient #3 authorized Vascular Surgeon #1 to perform a revision of Patient #3's left forearm AV fistula. There was no signature from the Guardian documented on the form or that attempts were made to obtain consent from Patient #3's Guardian prior to the procedure being performed. The form indicated Vascular Surgeon #1 was unable locate Patient #3's Guardian (sister) and the decision was to proceed with the procedure, however Patient #3's legal Guardian was not a family member as indicated. The Request for the Administration of Anesthesia Form (located on the back of the Surgical Consent Form) was blank.

Vascular Surgeon #1's progress note, dated 5/30/13, at 10:30 A.M., indicated the Guardian's telephone number was not in service and indicated the person they referred to as the Guardian was Patient #3's family member.

The Operative Report, dated 5/30/13, indicated Patient #3 had a procedure for treatment of a non-functioning fistula in the left forearm.