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Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the facility failed to ensure nursing services were supervised by a registered nurse. Specifically, the facility failed to ensure that P#1 did not have a blood pressure taken in his left arm. This resulted in an occlusion of a fistula which subsequently caused a thrombus ( a blood clot).


Cross-reference A0397 Patient Care Assignments as it relates to the facility's failure to ensure that nursing personnel with appropriate education and competence was assigned when providing patient care in accordance with the individual needs of patients.

Cross Reference A0398 as it relates to the facility's failure to provide adequate supervision of nursing staff and to ensure that nursing personnel were aware and adhered to the facility's policies and procedures.

Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the facility failed to ensure that nursing personnel with appropriate education and competence was assigned when providing patient care in accordance with the individual needs of patients for one patient (P#1) out of 6 patients sampled.

Findings:

A medical record review revealed that Patient (P) #1 was a 72-year-old male who was seen in the emergency department (ED) on 9/2/22 at 8:09 p.m. for shortness of breath and elevated troponin (a protein that was released into the bloodstream during heart complications) levels. P#1 was admitted to the facility's General Medical/Surgery (Med/Surg) Unit on 9/3/22 at 1:13 a.m. for angina pectoris (chest pain) and gastrointestinal (GI) bleeding (bleeding in the gastrointestinal tract).

A review of MD orders dated 9/2/22 at 11:03 p.m. revealed 'Nursing Communication No IV (intravenous) sticks, blood draw, or blood pressure left upper arm (LUA).' Frequency was routine until the order was discontinued.

A review of a Physician's Note dated 9/12/22 at 9:56 a.m. revealed the following assessment plan:
1. End Stage Renal Disease (ESRD)
2. Hemodialysis (HD) (the process of purifying the blood) on Monday, Wednesday, and Friday (MWF) schedule.
3. Dialysis (process of purifying the blood), vascular (inserting a thin plastic tube into a blood vessel) access was a tunneled catheter (two inner channels, one for removing the blood to the machine and the other for returning blood to the bloodstream).
4. Arteriovenous (AV) Fistula (an abnormal connection between an artery and a vein) nonfunctional (not working).
5. Hypertension (high blood pressure)

A review of a Physician's Note dated 9/12/22 at 2:00 p.m. revealed the following: Ultrasonography Peripheral Venous (short catheter placed through the skin into a vein) arm unilateral (one-sided) right. Venous Doppler (ultrasound to check the circulation in the large veins in the legs or arms) upper extremity unilateral right.

Findings were: There was a demonstrated filling defect and lack of compression within the right distal basilic vein (large superficial vein of the upper limb). The remaining deep veins of the subclavian (an artery or vein which serves the neck and arm on the left or right side of the body), axillary (related to or located near), brachial car patent.

Impression: Findings consistent with superficial basilic venous (common access site) clot with remaining right veins patent.

Assessment & Plan: ESRD and dialysis dependent. Typically received HD on an MWF schedule. Would plan for HD today as P#1 was unable to receive HD yesterday due to a clotted access. Plan for fistulogram (x-ray procedure to see blood flow and check for blood clots or blockages in fistula) today per vascular, would plan for HD afterward.

A review of a Progress Note dated 9/12/22 at 3:49 p.m. revealed that the physician notified that P#1's fistula had no palpable (able to be touched or felt) thrill (tactile movement felt when examining a fistula) or audible bruit (audible sound of blood heard when passing through a fistula) . Therefore, orders were: fistulogram, possible angioplasty (surgical repair or unblocking of a blood vessel), thrombectomy (remove a blood clot from inside an artery or vein), and possible conscious sedation for 9/13/22.

Further review of a Progress Note dated 9/12/22 at 4:02 p.m. revealed notification by the dialysis nurse that P#1's fistula had clotted (blood material stuck together) off. A continued review of the Progress Note revealed that this was likely due to staff taking blood pressure (BP) in the left arm. Nephrology (study of the kidneys) were aware, vascular (study of blood vessels) was surgery consulted, and a fistulogram was scheduled for the following day.

A review of a Physician Progress note dated 9/13/22 revealed thrombosed (blood clot, cells stick together, that form on the wall of a blood vessel) left Cimino (surgical creation between artery and vein in the forearm) AVF (arteriovenous fistula) due to placement of BP cuff on that arm, despite P#1's protests. The Progress report indicated that an incident report should be filed.

A review of the Operative Report dated 9/13/22 at 9:35 a.m. revealed a Pre-Operative Diagnosis: Clotted AV Fistula

Procedure Performed: Mechanical thrombectomy (a surgical procedure to remove a blood clot from inside an artery or vein) and thrombolysis (breakdown of blood clots formed in blood vessels using medication), AV fistula with angioplasty (surgical repair of a blood vessel)
Findings: mild narrowing of the main runoff vein. Suspect thrombosis (clotting of the blood) was caused by the blood pressure cuff in the arm.


A review of a Nurse's Note dated 9/13/22 at 10:00 p.m. revealed attempted access to left AVF (Fistula) after thrill & bruit verified. Unable to establish venous access after two attempts. P#1 was transported back to his room. P#1's nurse was informed of P#1 not receiving HD treatment due to access issues.

A review of a Nursing Note dated 9/14/22 at 8:34 a.m. revealed no thrill palpable, or bruit heard left arm fistula. The dialysis nurse reported she could access the arterial site but not the venous site. MD indicated that P#1 would need the insertion of a permacath (tunneled hemodialysis access) today.

A review of a Case Management Note dated 9/14/22 at 3:15 p.m. revealed that P#1 was discussed in huddles that morning. Charge Nurse reported that P#1 was not stable for discharge that day as P#1 was receiving a dialysis catheter and was not medically stable due to missing the last dialysis treatment due to the shunt closing off.

A review of the Discharge Summary dated 9/16/22 revealed that P#1's hospital course was complicated by AV fistular malfunction status post thrombolysis and mechanical thrombectomy for clotted AV fistula with vascular, with poor outcome. P#1 later got an ACW tunnel catheter for HD, followed by emergent HD for uremic (high levels of waste products in the blood) encephalopathy (a disease where the brain is affected by toxins in the blood), and fluid overload.


A review of the facility's Incident Report, #83086, entered 9/12/22 by RN CC and closed 9/15/22 by CM BB, revealed the following:
Type of Incident: Vascular Access Device
Injury: Yes
Person Affected: P#1
Event Details: Blood pressure was taken in the left arm by Certified Nursing Assistant (CNA) FF, resulting in dialysis access to clot and rendering it unusable for dialysis. Dialysis Registered Nurse (RN) DD notified RN CC. Vascular surgery medical doctor (MD) MM was consulted. Clinical Manager (CM) BB was notified.
Injury Details: Left arm, Line Removed: no, MD Examination: yes
Follow-up Actions by CM BB: Spoke with CNA FF and reeducated and counseled her on the situation and the harm to the patient.


A review of the facility's policy titled "Patient Safety Plan," policy # AD-01-055, effective date December 2001, last revision date March 2017, revealed the purpose was to improve safety and reduce risk to patients through an environment that encouraged: recognition and acknowledgment or risks to patient safety and medical/health errors; the initiation of actions to reduce these risks; a focus on processes and systems; the internal and appropriate external reporting of what had been found and the actions taken; minimization of individual blame for involvement in a medical/health care error; organizational learning about medical/health care errors and preventive measures; sharing of knowledge to effect behavioral changes in health care organizations; involvement of multiple departments and disciplines in establishing the plans, processes, and mechanisms which comprise the patient safety activities.
Scope of Activities:
a. Definition: Error - An unintended act, either of omission or commission, which causes or has the potential to cause a negative patient outcome.
The scope of the Patient Safety Program included an ongoing assessment, using internal and external knowledge, databases, and experience to prevent error occurrence and maintain and improve patient safety.
Types of patient safety or medical/health care errors included in data analysis included the following:
1. Minor Harm Error with no apparent impairment of function (Level 2)-Those unintentional acts, either of omission or commission, resulting in an identified mild to moderate physical or psychological adverse outcome for the patient.
Training: Staff would receive education and training during their initial orientation process and on an ongoing basis regarding job-related aspects of patient safety, including the need and method to report medical/health care errors.

A review of the facility's policy titled "Color Coded Armbands," policy # FHS AD-04-011, effective June 2021, last revision June 2021, revealed the purpose was to have a standardized process that identified and communicated patient-specific risk factors or special needs by standardizing the use of color-coded wristbands based upon the patient's assessment, wishes, and medical status. Colored armbands may only be applied or removed by a nurse or licensed staff person conducting an assessment. The meaning of the PINK color-coded armband was' Limb Alert- No Sticks or Blood Pressure in this Limb.' During the initial patient assessment, data was collected to evaluate the needs of the patient, and a plan of care unique to the individual was initiated. Any patient demonstrating risk factors on initial assessment would have a color-coded wristband placed on the same extremity as the patient ID band by the nurse or licensed professional if the nurse was unavailable. This included all inpatient, outpatient, and emergency department, patients. The application of the band was documented in the chart by the nurse, per hospital policy. Staff Education regarding color-coded wristbands would occur during the new orientation process and be reinforced as indicated.

A review of the facility's policy "Adverse Events/Sentinel Events," policy # FHS AD-01-016, effective November 1993, last revision date May 2021, revealed the purpose was to:
1. Provide a process for quality and performance improvement renew analysis of potential adverse/sentinel events.
2. To have a positive impact on improving patient care.
3. To focus the attention of the facility on understanding the causes that underlie an adverse/sentinel event and on making changes in the organization's systems and processes to reduce the probability of such an event in the future.
4. To increase the general knowledge about adverse/sentinel events, their causes, and strategies for prevention.
A Sentinel Event was a patient safety event that reached a patient and resulted in death, permanent harm, or severe temporary harm. 'Severe temporary harm' was defined as critical, potentially life-threating harm, lasting for a limited time with no permanent residual. It required transfer to a higher level of care for a life-threatening condition or additional major surgery, procedure, or treatment to resolve the condition. These events were called "Sentinel" because they signaled the need for immediate full investigation and response. Upon identification of a patient safety event, the patient care provider would immediately report the patient safety event to the staff member's immediate supervisor or the Administrative Nursing Supervisor. Any event that constitutes a sentinel event as defined above should be reported immediately to the Risk Manager or, in her absence, the Accreditation/Compliance Coordinator or Director of Quality Management.

A review of the facility's policy titled "Arteriovenous (AV) Fistula/Graft Assessment," policy # PCS-10-009, effective July 1995, last revision date July 2020, revealed the purpose was to provide guidelines for proper maintenance of vascular access to prevent fistula/graft loss and prevent infection. Further review revealed that the expected outcome was that patients with vascular access would have appropriate care and suffer no untoward (unexpected and inappropriate or inconvenient) effects. The AV fistula and graft were vascular access devices used in patients requiring maintenance hemodialysis.

A review of the facility's policy titled "Hemodialysis," policy # PCS-10-008, no effective date, last revision date January 2022, revealed the purpose was to provide guidelines for the preparation of the patient for inpatient hemodialysis. Further review revealed that all information necessary for hemodialysis to be provided safely for hospital inpatients would be communicated to the dialysis nurse by the floor nurse via active communication prior to or upon transfer. Continued review revealed that expected outcomes were that inpatient hemodialysis patients would receive continuity of care between inpatient nursing units and the dialysis unit.

A phone interview was conducted with CNA FF on 10/26/22 at 11:30 a.m. CNA FF stated that she had worked at the facility for three years. CNA FF said she did recall P#1 when he was an inpatient in the Med/Surg Unit for a few weeks in September of 2022. CNA FF continued to say that she also recalled the day she mistakenly placed the BP cuff on P#1's left arm. She stated that it was the day that P#1 went to another department to have some tests done, and when he returned to the department, she was asked by RN CC to continue his BP checks every 15 minutes. CNA FF explained that a machine was used to auto-set the BP checks every 15 minutes for situations like this. This prevented staff from continuously disrupting the patient for continuous BP checks. She continued to explain that she asked RN CC if she could use the machine for P#1, and RN CC replied that it was okay. CNA FF said she recalled a hand-written sign on P#1's door that read in part, "no BP in left arm." She continued to explain that when she walked into P#1's room and explained that she was going to take his BP, P#1 lifted his left arm to gesture for her to take his BP in that arm. CNA FF stated that after P#1 lifted his left arm, she placed the BP cuff on his left arm. She said that at the time, she could not recall seeing a pink hospital wristband on P#1's wrist, and after placing the cuff on P#1 and setting the machine for every 15-minute check, she walked out of P#1's room. CNA FF explained that approximately one hour later, RN CC came to her and asked, "Which arm did you place the BP cuff on P#1?" CNA FF stated that as soon as RN CC asked the question, she realized she had put the cuff on the wrong arm. CNA FF said that she immediately took responsibility and apologized to RN CC. She continued to explain that later in the day, her manager, CM BB, took her aside to speak with her about the incident with P#1. CNA FF said that she told CM BB that she took responsibility for what happened, but she did not realize how bad it was until CM BB explained what happened to P#1's shunt after the BP cuff consciously took his BP every 15 minutes for over an hour. CNA FF stated that the family was irate and asked that she be removed from P#1's care; therefore, she was reassigned. CNA FF said that she did not and has not received any re-education or training regarding the duties of a CNA. She continued to explain that during her three years at the facility, she had not received any training on colored armbands and the meaning of each color. CNA FF stated that she still did not know what the colors meant or what the pink armband signified.

An interview was conducted with CM BB on 10/26/22 at 11:45 a.m. in the administration conference room. CM BB stated that she has worked at the facility for 14 years and has been in her current position for one year. CM BB stated that she recalled the situation involving P#1 and the clot in his AV fistula. She continued to say that when she arrived at the unit that day, RN CC explained that P#1 could not have his dialysis completed that day. CM BB stated that she asked RN CC why not, and that was when she found out that P#1 had been taken to the dialysis unit and was later returned to his room because P#1's shunt was clotted. She explained that RN CC told her that the dialysis nurse tried to flush the shunt but was unsuccessful. CM BB stated that RN CC explained that P#1 returned to the unit after his liver biopsy and was still groggy when CNA FF entered his room to begin his automated every 15-minute BP checks. CM BB said that when she received the incident's details from RN CC, she spoke with CNA FF the same day to hear her account about what happened that day. CM BB stated that CNA FF said that she went to P#1's room to set him up on his automated every 15-minute BP checks and acknowledged that there was a "no BP on left arm" sign on his door; however, CNA FF stated that she could not recall if P#1 had a pink colored armband on his left wrist. CM BB continued to explain that CNA FF told her that when she entered P#1's room, he extended his left arm so she could place the BP cuff on his arm. CM BB stated that CNA FF had taken responsibility for her actions which led to P#1's nonfunctional AV fistula and the tunneled catheter procedure to give vascular access for dialysis. CM BB stated that she had an extensive conversation with CNA FF about what happened and what CNA FF could do to prevent this from happening again. She stated she counseled CNA FF to stay focused and not have conversations with other staff while providing care. CM BB said that she had staff meetings in September 2022 and October 2022, where she covered nursing protocol, including bedside shift reports and signage. CM BB stated that she would make sure that the nurses were communicating with the CNAs and vice versa. CM BB said she had repeatedly educated on paying attention to things, slowing down, and not getting distracted.

An interview was conducted with RN EE on 10/26/22 at 12:00 p.m. in the administration conference room. RN EE stated that she recalled P#1 and provided care for P#1 during his inpatient stay at the facility. She continued to explain that she could recall the family being devastated and that CNA FF, assigned to care for P#1, was removed from his care. She said she did not have a conversation with CNA FF afterward because she could see that CNA FF was upset about what happened with P#1. RN EE stated that after management was notified, management spoke with CNA FF and the unit manager. CM BB conducted a huddle a few days later with the staff, and the armband situation was brought up and discussed, but nothing more was done.

An interview was conducted with RN CC on 10/27/22 at 10:30 a.m. in the administration conference room. RN CC stated that she was a travel nurse and had been assigned to the facility since April 2022. She said she did recall P#1 and the incident involving his clotted shunt for his dialysis. She recalled P#1 returning to the unit after a biopsy and being groggy from the anesthesia. RN CC explained that P#1 was on an every 15-minute BP check and could not have his BP taken on his left arm due to the fistula in this arm. She said that CNA FF, assigned to P#1, entered P#1's room to take his BP and later told RN CC that she had placed the BP cuff on the wrong arm. RN CC continued to explain that P#1 went to his dialysis appointment later the same day the BP cuff was placed on the left arm, and P#1 had to return to his room without being dialyzed. She stated the dialysis nurse (RN DD) called the unit to inform them that P#1's fistula shunt had clotted and an attempt to flush it clear was unsuccessful. She said that RN DD stated that she had consulted with vascular and determined that the AV Fistula could not be used and the patient would need to return to the unit. RN CC said after speaking with RN DD, she talked to CNA FF and asked her which arm she placed the BP cuff on. CNA FF took a minute to think about it and confirmed that she put the BP cuff on P#1's left arm, which was the wrong arm. RN CC said that P#1 had a sign on his door and a pink armband on his left wrist and was unsure how CNA FF missed those. RN CC stated that RN DD advised her that MD MM, Vascular Surgeon, was consulted. RN CC said that after she filed the incident report, she stated that CM BB had a short huddle to remind them that they needed to pay closer attention to the signs on the doors and colored armbands. She continued to explain that this was the extent of the education. There was no formal re-education specifically regarding the colored armbands. RN CC stated that when she began working at the facility, she received general hospital orientation with electronic modules. When she arrived at the floor, she was oriented to the unit.

A phone interview was conducted with RN DD on 10/27/22 at 11:00 a.m. RN DD stated that she did recall P#1 because he came to the dialysis unit with a clotted fistula. She explained that when P#1 arrived at the dialysis unit, she attempted to flush it but was unsuccessful. RN DD called the on-call vascular physician to advise him of P#1. RN DD said that when P#1 arrived at the dialysis unit, he was asleep, and his vitals were normal. She explained that when she tried to access P#1's fistula (which was not an average fistula because it was noticeable), she stated that she felt for it, but it felt faint. She continued to explain that since she could not feel it, she tried to listen for it and could not hear anything. RN DD stated that RN CC called her to check on P#1, and she advised RN CC that she was having trouble with P#1's fistula. She said she told RN CC she made three attempts to access his fistula; however, due to the clot, there was no way it would run through. RN DD explained to RN CC that she had contacted the vascular surgeon on call to consult on P#1 and that P#1 would need to return to his bed on the unit.

Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the allegation that the facility put a blood pressure cuff on P#1's left arm, which occluded the fistula and subsequently caused a thrombus was substantiated.

Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the facility failed to provide adequate supervision of nursing staff and to ensure that nursing personnel were aware and adhered to the facility's policies and procedures. This failure led to improper care for one patient (P#1) out of six sampled patients.

Finding:

A review of MD orders dated 9/2/22 at 11:03 p.m. revealed 'Nursing Communication No IV (intravenous) sticks, blood draw, or blood pressure left upper arm (LUA).' Frequency was routine until the order was discontinued.

A review of a Physician's Note dated 9/12/22 at 9:56 a.m. revealed the following assessment plan:
1. End Stage Renal Disease (ESRD)
2. Hemodialysis (HD) (the process of purifying the blood) on Monday, Wednesday, and Friday (MWF) schedule.
3. Dialysis (process of purifying the blood), vascular (inserting a thin plastic tube into a blood vessel) access was a tunneled catheter (two inner channels, one for removing the blood to the machine and the other for returning blood to the bloodstream).
4. Arteriovenous (AV) Fistula (an abnormal connection between an artery and a vein) nonfunctional (not working).
5. Hypertension (high blood pressure)

A review of a Physician's Note dated 9/12/22 at 2:00 p.m. revealed the following: Ultrasonography Peripheral Venous (short catheter placed through the skin into a vein) arm unilateral (one-sided) right. Venous Doppler (ultrasound to check the circulation in the large veins in the legs or arms) upper extremity unilateral right.

Findings were: There was a demonstrated filling defect and lack of compression within the right distal basilic vein (large superficial vein of the upper limb). The remaining deep veins of the subclavian (an artery or vein which serves the neck and arm on the left or right side of the body), axillary (related to or located near), brachial car patent.

Impression: Findings consistent with superficial basilic venous (common access site) clot with remaining right veins patent.

Assessment & Plan: ESRD and dialysis dependent. Typically received HD on an MWF schedule. Would plan for HD today as P#1 was unable to receive HD yesterday due to a clotted access. Plan for fistulogram (x-ray procedure to see blood flow and check for blood clots or blockages in fistula) today per vascular, would plan for HD afterward.

A review of a Progress Note dated 9/12/22 at 3:49 p.m. revealed that the physician notified that P#1's fistula had no palpable (able to be touched or felt) thrill (tactile movement felt when examining a fistula) or audible bruit (audible sound of blood heard when passing through a fistula) . Therefore, orders were: fistulogram, possible angioplasty (surgical repair or unblocking of a blood vessel), thrombectomy (remove a blood clot from inside an artery or vein), and possible conscious sedation for 9/13/22.

Further review of a Progress Note dated 9/12/22 at 4:02 p.m. revealed notification by the dialysis nurse that P#1's fistula had clotted (blood material stuck together) off. A continued review of the Progress Note revealed that this was likely due to staff taking blood pressure (BP) in the left arm. Nephrology (study of the kidneys) were aware, vascular (study of blood vessels) was surgery consulted, and a fistulogram was scheduled for the following day.

A review of a Physician Progress note dated 9/13/22 revealed thrombosed (blood clot, cells stick together, that form on the wall of a blood vessel) left Cimino (surgical creation between artery and vein in the forearm) AVF (arteriovenous fistula) due to placement of BP cuff on that arm, despite P#1's protests. The Progress report indicated that an incident report should be filed.

A review of the Operative Report dated 9/13/22 at 9:35 a.m. revealed a Pre-Operative Diagnosis: Clotted AV Fistula

Procedure Performed: Mechanical thrombectomy (a surgical procedure to remove a blood clot from inside an artery or vein) and thrombolysis (breakdown of blood clots formed in blood vessels using medication), AV fistula with angioplasty (surgical repair of a blood vessel)
Findings: mild narrowing of the main runoff vein. Suspect thrombosis (clotting of the blood) was caused by the blood pressure cuff in the arm.


A review of a Nurse's Note dated 9/13/22 at 10:00 p.m. revealed attempted access to left AVF (Fistula) after thrill & bruit verified. Unable to establish venous access after two attempts. P#1 was transported back to his room. P#1's nurse was informed of P#1 not receiving HD treatment due to access issues.

A review of a Nursing Note dated 9/14/22 at 8:34 a.m. revealed no thrill palpable, or bruit heard left arm fistula. The dialysis nurse reported she could access the arterial site but not the venous site. MD indicated that P#1 would need the insertion of a permacath (tunneled hemodialysis access) today.

A review of a Case Management Note dated 9/14/22 at 3:15 p.m. revealed that P#1 was discussed in huddles that morning. Charge Nurse reported that P#1 was not stable for discharge that day as P#1 was receiving a dialysis catheter and was not medically stable due to missing the last dialysis treatment due to the shunt closing off.

A review of the Discharge Summary dated 9/16/22 revealed that P#1's hospital course was complicated by AV fistular malfunction status post thrombolysis and mechanical thrombectomy for clotted AV fistula with vascular, with poor outcome. P#1 later got an ACW tunnel catheter for HD, followed by emergent HD for uremic (high levels of waste products in the blood) encephalopathy (a disease where the brain is affected by toxins in the blood), and fluid overload.


A review of the facility's Incident Report, #83086, entered 9/12/22 by RN CC and closed 9/15/22 by CM BB, revealed the following:
Type of Incident: Vascular Access Device
Injury: Yes
Person Affected: P#1
Event Details: Blood pressure was taken in the left arm by Certified Nursing Assistant (CNA) FF, resulting in dialysis access to clot and rendering it unusable for dialysis. Dialysis Registered Nurse (RN) DD notified RN CC. Vascular surgery medical doctor (MD) MM was consulted. Clinical Manager (CM) BB was notified.
Injury Details: Left arm, Line Removed: no, MD Examination: yes
Follow-up Actions by CM BB: Spoke with CNA FF and reeducated and counseled her on the situation and the harm to the patient.


A review of the facility's policy titled "Patient Safety Plan," policy # AD-01-055, effective date December 2001, last revision date March 2017, revealed the purpose was to improve safety and reduce risk to patients through an environment that encouraged: recognition and acknowledgment or risks to patient safety and medical/health errors; the initiation of actions to reduce these risks; a focus on processes and systems; the internal and appropriate external reporting of what had been found and the actions taken; minimization of individual blame for involvement in a medical/health care error; organizational learning about medical/health care errors and preventive measures; sharing of knowledge to effect behavioral changes in health care organizations; involvement of multiple departments and disciplines in establishing the plans, processes, and mechanisms which comprise the patient safety activities.
Scope of Activities:
a. Definition: Error - An unintended act, either of omission or commission, which causes or has the potential to cause a negative patient outcome.
The scope of the Patient Safety Program included an ongoing assessment, using internal and external knowledge, databases, and experience to prevent error occurrence and maintain and improve patient safety.
Types of patient safety or medical/health care errors included in data analysis included the following:
1. Minor Harm Error with no apparent impairment of function (Level 2)-Those unintentional acts, either of omission or commission, resulting in an identified mild to moderate physical or psychological adverse outcome for the patient.
Training: Staff would receive education and training during their initial orientation process and on an ongoing basis regarding job-related aspects of patient safety, including the need and method to report medical/health care errors.

A review of the facility's policy titled "Color Coded Armbands," policy # FHS AD-04-011, effective June 2021, last revision June 2021, revealed the purpose was to have a standardized process that identified and communicated patient-specific risk factors or special needs by standardizing the use of color-coded wristbands based upon the patient's assessment, wishes, and medical status. Colored armbands may only be applied or removed by a nurse or licensed staff person conducting an assessment. The meaning of the PINK color-coded armband was' Limb Alert- No Sticks or Blood Pressure in this Limb.' During the initial patient assessment, data was collected to evaluate the needs of the patient, and a plan of care unique to the individual was initiated. Any patient demonstrating risk factors on initial assessment would have a color-coded wristband placed on the same extremity as the patient ID band by the nurse or licensed professional if the nurse was unavailable. This included all inpatient, outpatient, and emergency department, patients. The application of the band was documented in the chart by the nurse, per hospital policy. Staff Education regarding color-coded wristbands would occur during the new orientation process and be reinforced as indicated.

A review of the facility's policy "Adverse Events/Sentinel Events," policy # FHS AD-01-016, effective November 1993, last revision date May 2021, revealed the purpose was to:
1. Provide a process for quality and performance improvement renew analysis of potential adverse/sentinel events.
2. To have a positive impact on improving patient care.
3. To focus the attention of the facility on understanding the causes that underlie an adverse/sentinel event and on making changes in the organization's systems and processes to reduce the probability of such an event in the future.
4. To increase the general knowledge about adverse/sentinel events, their causes, and strategies for prevention.
A Sentinel Event was a patient safety event that reached a patient and resulted in death, permanent harm, or severe temporary harm. 'Severe temporary harm' was defined as critical, potentially life-threating harm, lasting for a limited time with no permanent residual. It required transfer to a higher level of care for a life-threatening condition or additional major surgery, procedure, or treatment to resolve the condition. These events were called "Sentinel" because they signaled the need for immediate full investigation and response. Upon identification of a patient safety event, the patient care provider would immediately report the patient safety event to the staff member's immediate supervisor or the Administrative Nursing Supervisor. Any event that constitutes a sentinel event as defined above should be reported immediately to the Risk Manager or, in her absence, the Accreditation/Compliance Coordinator or Director of Quality Management.

A review of the facility's policy titled "Arteriovenous (AV) Fistula/Graft Assessment," policy # PCS-10-009, effective July 1995, last revision date July 2020, revealed the purpose was to provide guidelines for proper maintenance of vascular access to prevent fistula/graft loss and prevent infection. Further review revealed that the expected outcome was that patients with vascular access would have appropriate care and suffer no untoward (unexpected and inappropriate or inconvenient) effects. The AV fistula and graft were vascular access devices used in patients requiring maintenance hemodialysis.

A review of the facility's policy titled "Hemodialysis," policy # PCS-10-008, no effective date, last revision date January 2022, revealed the purpose was to provide guidelines for the preparation of the patient for inpatient hemodialysis. Further review revealed that all information necessary for hemodialysis to be provided safely for hospital inpatients would be communicated to the dialysis nurse by the floor nurse via active communication prior to or upon transfer. Continued review revealed that expected outcomes were that inpatient hemodialysis patients would receive continuity of care between inpatient nursing units and the dialysis unit.

A phone interview was conducted with CNA FF on 10/26/22 at 11:30 a.m. CNA FF stated that she had worked at the facility for three years. CNA FF said she did recall P#1 when he was an inpatient in the Med/Surg Unit for a few weeks in September of 2022. CNA FF continued to say that she also recalled the day she mistakenly placed the BP cuff on P#1's left arm. She stated that it was the day that P#1 went to another department to have some tests done, and when he returned to the department, she was asked by RN CC to continue his BP checks every 15 minutes. CNA FF explained that a machine was used to auto-set the BP checks every 15 minutes for situations like this. This prevented staff from continuously disrupting the patient for continuous BP checks. She continued to explain that she asked RN CC if she could use the machine for P#1, and RN CC replied that it was okay. CNA FF said she recalled a hand-written sign on P#1's door that read in part, "no BP in left arm." She continued to explain that when she walked into P#1's room and explained that she was going to take his BP, P#1 lifted his left arm to gesture for her to take his BP in that arm. CNA FF stated that after P#1 lifted his left arm, she placed the BP cuff on his left arm. She said that at the time, she could not recall seeing a pink hospital wristband on P#1's wrist, and after placing the cuff on P#1 and setting the machine for every 15-minute check, she walked out of P#1's room. CNA FF explained that approximately one hour later, RN CC came to her and asked, "Which arm did you place the BP cuff on P#1?" CNA FF stated that as soon as RN CC asked the question, she realized she had put the cuff on the wrong arm. CNA FF said that she immediately took responsibility and apologized to RN CC. She continued to explain that later in the day, her manager, CM BB, took her aside to speak with her about the incident with P#1. CNA FF said that she told CM BB that she took responsibility for what happened, but she did not realize how bad it was until CM BB explained what happened to P#1's shunt after the BP cuff consciously took his BP every 15 minutes for over an hour. CNA FF stated that the family was irate and asked that she be removed from P#1's care; therefore, she was reassigned. CNA FF said that she did not and has not received any re-education or training regarding the duties of a CNA. She continued to explain that during her three years at the facility, she had not received any training on colored armbands and the meaning of each color. CNA FF stated that she still did not know what the colors meant or what the pink armband signified.

An interview was conducted with CM BB on 10/26/22 at 11:45 a.m. in the administration conference room. CM BB stated that she has worked at the facility for 14 years and has been in her current position for one year. CM BB stated that she recalled the situation involving P#1 and the clot in his AV fistula. She continued to say that when she arrived at the unit that day, RN CC explained that P#1 could not have his dialysis completed that day. CM BB stated that she asked RN CC why not, and that was when she found out that P#1 had been taken to the dialysis unit and was later returned to his room because P#1's shunt was clotted. She explained that RN CC told her that the dialysis nurse tried to flush the shunt but was unsuccessful. CM BB stated that RN CC explained that P#1 returned to the unit after his liver biopsy and was still groggy when CNA FF entered his room to begin his automated every 15-minute BP checks. CM BB said that when she received the incident's details from RN CC, she spoke with CNA FF the same day to hear her account about what happened that day. CM BB stated that CNA FF said that she went to P#1's room to set him up on his automated every 15-minute BP checks and acknowledged that there was a "no BP on left arm" sign on his door; however, CNA FF stated that she could not recall if P#1 had a pink colored armband on his left wrist. CM BB continued to explain that CNA FF told her that when she entered P#1's room, he extended his left arm so she could place the BP cuff on his arm. CM BB stated that CNA FF had taken responsibility for her actions which led to P#1's nonfunctional AV fistula and the tunneled catheter procedure to give vascular access for dialysis. CM BB stated that she had an extensive conversation with CNA FF about what happened and what CNA FF could do to prevent this from happening again. She stated she counseled CNA FF to stay focused and not have conversations with other staff while providing care. CM BB said that she had staff meetings in September 2022 and October 2022, where she covered nursing protocol, including bedside shift reports and signage. CM BB stated that she would make sure that the nurses were communicating with the CNAs and vice versa. CM BB said she had repeatedly educated on paying attention to things, slowing down, and not getting distracted.

An interview was conducted with RN EE on 10/26/22 at 12:00 p.m. in the administration conference room. RN EE stated that she recalled P#1 and provided care for P#1 during his inpatient stay at the facility. She continued to explain that she could recall the family being devastated and that CNA FF, assigned to care for P#1, was removed from his care. She said she did not have a conversation with CNA FF afterward because she could see that CNA FF was upset about what happened with P#1. RN EE stated that after management was notified, management spoke with CNA FF and the unit manager. CM BB conducted a huddle a few days later with the staff, and the armband situation was brought up and discussed, but nothing more was done.

An interview was conducted with RN CC on 10/27/22 at 10:30 a.m. in the administration conference room. RN CC stated that she was a travel nurse and had been assigned to the facility since April 2022. She said she did recall P#1 and the incident involving his clotted shunt for his dialysis. She recalled P#1 returning to the unit after a biopsy and being groggy from the anesthesia. RN CC explained that P#1 was on an every 15-minute BP check and could not have his BP taken on his left arm due to the fistula in this arm. She said that CNA FF, assigned to P#1, entered P#1's room to take his BP and later told RN CC that she had placed the BP cuff on the wrong arm. RN CC continued to explain that P#1 went to his dialysis appointment later the same day the BP cuff was placed on the left arm, and P#1 had to return to his room without being dialyzed. She stated the dialysis nurse (RN DD) called the unit to inform them that P#1's fistula shunt had clotted and an attempt to flush it clear was unsuccessful. She said that RN DD stated that she had consulted with vascular and determined that the AV Fistula could not be used and the patient would need to return to the unit. RN CC said after speaking with RN DD, she talked to CNA FF and asked her which arm she placed the BP cuff on. CNA FF took a minute to think about it and confirmed that she put the BP cuff on P#1's left arm, which was the wrong arm. RN CC said that P#1 had a sign on his door and a pink armband on his left wrist and was unsure how CNA FF missed those. RN CC stated that RN DD advised her that MD MM, Vascular Surgeon, was consulted. RN CC said that after she filed the incident report, she stated that CM BB had a short huddle to remind them that they needed to pay closer attention to the signs on the doors and colored armbands. She continued to explain that this was the extent of the education. There was no formal re-education specifically regarding the colored armbands. RN CC stated that when she began working at the facility, she received general hospital orientation with electronic modules. When she arrived at the floor, she was oriented to the unit.

A phone interview was conducted with RN DD on 10/27/22 at 11:00 a.m. RN DD stated that she did recall P#1 because he came to the dialysis unit with a clotted fistula. She explained that when P#1 arrived at the dialysis unit, she attempted to flush it but was unsuccessful. RN DD called the on-call vascular physician to advise him of P#1. RN DD said that when P#1 arrived at the dialysis unit, he was asleep, and his vitals were normal. She explained that when she tried to access P#1's fistula (which was not an average fistula because it was noticeable), she stated that she felt for it, but it felt faint. She continued to explain that since she could not feel it, she tried to listen for it and could not hear anything. RN DD stated that RN CC called her to check on P#1, and she advised RN CC that she was having trouble with P#1's fistula. She said she told RN CC she made three attempts to access his fistula; however, due to the clot, there was no way it would run through. RN DD explained to RN CC that she had contacted the vascular surgeon on call to consult on P#1 and that P#1 would need to return to his bed on the unit.

Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the allegation that the facility put a blood pressure cuff on P#1's left arm, which occluded the fistula and subsequently caused a thrombus was substantiated.
Continued review revealed that expected outcomes were that inpatient hemodialysis patients would receive continuity of care between inpatient nursing units and the dialysis unit.

A phone interview was conducted with CNA FF on 10/26/22 at 11:30 a.m. CNA FF stated that she had worked at the facility for three years. CNA FF said she did recall P#1 when he was an inpatient in the Med/Surg Unit for a few weeks in September of 2022. CNA FF continued to say that she also recalled the day she mistakenly placed the BP cuff on P#1's left arm. She stated that it was the day that P#1 went to another department to have some tests done, and when he returned to the department, she was asked by RN CC to continue his BP checks every 15 minutes. CNA FF explained that a machine was used to auto-set the BP checks every 15 minutes for situations like this. This prevented staff from continuously disrupting the patient for continuous BP checks. She continued to explain that she asked RN CC if she could use the machine for P#1, and RN CC replied that it was okay. CNA FF said she recalled a hand-written sign on P#1's door that read in part, "no BP in left arm." She continued to explain that when she walked into P#1's room and explained that she was going to take his BP, P#1 lifted his left arm to gesture for her to take his BP in that arm. CNA FF stated that after P#1 lifted his left arm, she placed the BP cuff on his left arm. She said that at the time, she could not recall seeing a pink hospital wristband on P#1's wrist, and after placing the cuff on P#1 and setting the machine for every 15-minute check, she walked out of P#1's room. CNA FF explained that approximately one hour later, RN CC came to her and asked, "Which arm did you place the BP cuff on P#1?" CNA FF stated that as soon as RN CC asked the question, she realized she had put the cuff on the wrong arm. CNA FF said that she immediately took responsibility and apologized to RN CC. She continued to explain that later in the day, her manager, CM BB, took her aside to speak with her about the incident with P#1. CNA FF said that she told CM BB that she took responsibility for what happened, but she did not realize how bad it was until CM BB explained what happened to P#1's shunt after the BP cuff consciously took his BP every 15 minutes for over an hour. CNA FF stated that the family was irate and asked that she be removed from P#1's care; therefore, she was reassigned. CNA FF said that she did not and has not received any re-education or training regarding the duties of a CNA. She continued to explain that during her three years at the facility, she had not received any training on colored armbands and the meaning of each color. CNA FF stated that she still did not know what the colors meant or what the pink armband signified.

An interview was conducted with CM BB on 10/26/22 at 11:45 a.m. in the administration conference room. CM BB stated that she has worked at the facility for 14 years and has been in her current position for one year. CM BB stated that she recalled the situation involving P#1 and the clot in his AV fistula. She continued to say that when she arrived at the unit that day, RN CC explained that P#1 could not have his dialysis completed that day. CM BB stated that she asked RN CC why not, and that was when she found out that P#1 had been taken to the dialysis unit and was later returned to his room because P#1's shunt was clotted. She explained that RN CC told her that the dialysis nurse tried to flush the shunt but was unsuccessful. CM BB stated that RN CC explained that P#1 returned to the unit after his liver biopsy and was still groggy when CNA FF entered his room to begin his automated every 15-minute BP checks. CM BB said that when she received the incident's details from RN CC, she spoke with CNA FF the same day to hear her account about what happened that day. CM BB stated that CNA FF said that she went to P#1's room to set him up on his automated every 15-minute BP checks and acknowledged that there was a "no BP on left arm" sign on his door; however, CNA FF stated that she could not recall if P#1 had a pink colored armband on his left wrist. CM BB continued to explain that CNA FF told her that when she entered P#1's room, he extended his left arm so she could place the BP cuff on his arm. CM BB stated that CNA FF had taken responsibility for her actions which led to P#1's nonfunctional AV fistula and the tunneled catheter procedure to give vascular access for dialysis. CM BB stated that she had an extensive conversation with CNA FF about what happened and what CNA FF could do to prevent this from happening again. She stated she counseled CNA FF to stay focused and not have conversations with other staff while providing care. CM BB said that she had staff meetings in September 2022 and October 2022, where she covered nursing protocol, including bedside shift reports and signage. CM BB stated that she would make sure that the nurses were communicating with the CNAs and vice versa. CM BB said she had repeatedly educated on paying attention to things, slowing down, and not getting distracted.

An interview was conducted with RN EE on 10/26/22 at 12:00 p.m. in the administration conference room. RN EE stated that she recalled P#1 and provided care for P#1 during his inpatient stay at the facility. She continued to explain that she could recall the family being devastated and that CNA FF, assigned to care for P#1, was removed from his care. She said she did not have a conversation with CNA FF afterward because she could see that CNA FF was upset about what happened with P#1. RN EE stated that after management was notified, management spoke with CNA FF and the unit manager. CM BB conducted a huddle a few days later with the staff, and the armband situation was brought up and discussed, but nothing more was done.

An interview was conducted with RN CC on 10/27/22 at 10:30 a.m. in the administration conference room. RN CC stated that she was a travel nurse and had been assigned to the facility since April 2022. She said she did recall P#1 and the incident involving his clotted shunt for his dialysis. She recalled P#1 returning to the unit after a biopsy and being groggy from the anesthesia. RN CC explained that P#1 was on an every 15-minute BP check and could not have his BP taken on his left arm due to the fistula in this arm. She said that CNA FF, assigned to P#1, entered P#1's room to take his BP and later told RN CC that she had placed the BP cuff on the wrong arm. RN CC continued to explain that P#1 went to his dialysis appointment later the same day the BP cuff was placed on the left arm, and P#1 had to return to his room without being dialyzed. She stated the dialysis nurse (RN DD) called the unit to inform them that P#1's fistula shunt had clotted and an attempt to flush it clear was unsuccessful. She said that RN DD stated that she had consulted with vascular and determined that the AV Fistula could not be used and the patient would need to return to the unit. RN CC said after speaking with RN DD, she talked to CNA FF and asked her which arm she placed the BP cuff on. CNA FF took a minute to think about it and confirmed that she put the BP cuff on P#1's left arm, which was the wrong arm. RN CC said that P#1 had a sign on his door and a pink armband on his left wrist and was unsure how CNA FF missed those. RN CC stated that RN DD advised her that MD MM, Vascular Surgeon, was consulted. RN CC said that after she filed the incident report, she stated that CM BB had a short huddle to remind them that they needed to pay closer attention to the signs on the doors and colored armbands. She continued to explain that this was the extent of the education. There was no formal re-education specifically regarding the colored armbands. RN CC stated that when she began working at the facility, she received general hospital orientation with electronic modules. When she arrived at the floor, she was oriented to the unit.

A phone interview was conducted with RN DD on 10/27/22 at 11:00 a.m. RN DD stated that she did recall P#1 because he came to the dialysis unit with a clotted fistula. She explained that when P#1 arrived at the dialysis unit, she attempted to flush it but was unsuccessful. RN DD called the on-call vascular physician to advise him of P#1. RN DD said that when P#1 arrived at the dialysis unit, he was asleep, and his vitals were normal. She explained that when she tried to access P#1's fistula (which was not an average fistula because it was noticeable), she stated that she felt for it, but it felt faint. She continued to explain that since she could not feel it, she tried to listen for it and could not hear anything. RN DD stated that RN CC called her to check on P#1, and she advised RN CC that she was having trouble with P#1's fistula. She said she told RN CC she made three attempts to access his fistula; however, due to the clot, there was no way it would run through. RN DD explained to RN CC that she had contacted the vascular surgeon on call to consult on P#1 and that P#1 would need to return to his bed on the unit.

Based on a medical record review, a review of the facility's incident report, a review of policy and procedures, and interviews with staff, it was determined that the allegation that the facility put a blood pressure cuff on P#1's left arm, which occluded the fistula and subsequently caused a thrombus is substantiated.