HospitalInspections.org

Based on interview, record review, and review of facility policy, it was determined the facility failed to have an effective Governing Body responsible for the conduct of the facility. The Governing Body and Chief Executive Officer failed to develop and implement a written surgical policy directing contracted Invasive Radiologist to only replace malfunctioning Central Venous Catheters (CVC) and not attempt unauthorized repairs of catheters.

Record review revealed on 01/31/19, Invasive Radiologist (IR) #1 attempted a repair of Patient #1's CVC, instead of replacing the malfunctioning CVC. Manufacturer's recommendations for repair of Patient #1's CVC required the use of a CVC repair kit the manufacturer markets. Interview on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer, revealed it was the facility's policy to only perform replacement procedures of malfunctioning CVCs, and not to attempt repairs of CVCs. The facility did not stock CVC repair kits, since it was the facility's policy to only perform CVC replacements. Interview on 11/25/19 at 9:30 AM, with IR #1, revealed the unauthorized repair attempt of Patient #1's malfunctioning CVC occurred because the patient voiced he/she wished not to lose his/her current hemodialysis access site and requested a repair of the CVC be attempted just prior to the CVC surgery by IR #1. Being informed no CVC repair kits were in stock, IR #1 attempted to repair the patient's CVC by removing parts from a new CVC kit and using them to fix the patient's malfunctioning CVC. The repair attempt was against manufacturer's recommendations and the repair ultimately failed. On 08/09/19 the hubs of the repaired CVC separated from the tubing during a hemodialysis treatment session at an outside renal dialysis clinic. The failure of Patient #1's repaired CVC went undetected until a Certified Clinical Hemodialysis Technician noticed blood on the patient's shirt and under the treatment chair. Patient #1 had lost a large volume of blood. The patient was transferred to an emergency department. As a result, Patient # 1 expired due to the loss of blood (refer to A0057, A0084, A0115, A0144, A0940 and A0951).

Based on interview and record review, it was determined the Chief Executive Officer (CEO) failed to effectively manage the hospital and ensure the facility's policies were developed and implemented. Interview conducted on 12/02/19 at 2:45 PM, with the CEO, revealed the facility did not have written policy describing repair procedures of Central Venous Catheters (CVC) as this procedure was prohibited. The CEO explained it was the policy of the facility for contracted Invasive Radiologists to only conduct replacement procedures of malfunctioning CVCs; however, a written policy related to the prohibition of CVC repair procedures had not been developed and implemented prior 11/27/19. The facility had stopped supplying CVC repair kits from the manufacturer in 2014, due to their replace only policy. Record review of Patient #1's medical record revealed on 01/31/19, the patient underwent a repair procedure of his/her CVC that failed on 08/09/19, causing massive blood loss during a hemodialysis treatment. Patient #1 expired as the result of blood loss on 08/09/19.

The findings include:

Review of the facility's "Amended and Restated By Laws", dated 10/31/17, revealed the Board of Directors was responsible for the overseeing the quality of care and services provided to patients, and ensuring compliance with Medicare Conditions of Participation. According to the By Laws, the Board of Directors selected and employed a CEO. The CEO shall be responsible for implementing and enforcing policies.

Review of the Regional Market Chief Executive Officer (CEO) Job Description, revealed the position requires the CEO to be accountable for clinical integration across the system (hospital, medical group, home health, etc) and continuum of care. The CEO functions as an executive team leader for a region and the system in overall operational responsibility. The position requires collaboration with other leaders to optimize quality, safety, and patient experience for the organization. The CEO ensures adequate structures exist for oversight of quality and improvement activities.

Interview conducted on 12/02/19 at 2:45 PM, with the facility's Chief Executive Officer (CEO), revealed prior to 12/02/19, the facility did not have a written policy directing contracted Invasive Radiologist (IR) at the facility to only perform replacement procedures of mechanically malfunctioning Central Venous Catheters (CVC). The CEO reported the facility's Executive Board had been called to order earlier in the day (12/02/19) to formally adopt the facility's Central Venous Access Catheters for Hemodialysis: Cardiovascular Services Policy (Policy ID 7282023, effective 11/2019).

Review of the facility "Central Venous Access Catheters for Hemodialysis: Cardiovascular Services" Policy (Policy ID 7282023, effective 11/2019), revealed it is the institutional practice of the facility that hemodialysis catheters will not be repaired; only replaced.

Interview conducted on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer (CMO), revealed it was the policy of the facility for contracted Invasive Radiologist to only perform replacement procedures of mechanically malfunctioning CVCs; however, this practice had not been clearly written in the form of a policy or a surgical procedure practice.

Review of Patient #1's closed medical record revealed the patient had a medical diagnosis of End Stage Renal Disease and had received hemodialysis treatments at an outside renal dialysis clinic. The facility received a physician referral from Patient #1's outside renal dialysis clinic to perform a tunnel dialysis catheter exchange of the patient's Central Venous Catheter (CVC) due to mechanical malfunction of the CVC. The referring Physician reported the clamps on the CVC had broken and were leaking during hemodialysis treatments.

On 01/31/19, Patient #1 arrived to the facility and provided written informed consent for an invasive medical procedure. The patient consented to having a tunneled central venous catheter placement procedure performed. The patient's current mechanically malfunctioning CVC was to be removed and replaced with a new CVC. On 01/31/19 at 3:12 PM, the replacement procedure of the CVC was initiated. However, instead of replacing the malfunctioning CVC, Invasive Radiologist (IR) #1 performed a repair procedure using parts from a new CVC. At 3:35 PM, the repair procedure was completed. Following the procedure, Patient #1 left the facility and resumed hemodialysis treatments at the outside renal dialysis clinic.

Review of IR #1's post procedure Exam Note, dated 01/31/19, revealed the hub on the dialysis catheter was cracked and the existing hubs on the indwelling dialysis catheter were removed. New hubs were taken from a new dialysis catheter. Hubs were placed within the ends of the arterial and venous limbs of the existing catheter and secured with Dermabond. (Dermabond is a skin adhesive intended for topical application only).

On 08/09/19, Patient #1 was undergoing a hemodialysis treatment session at the outside renal dialysis clinic. During the treatment, a Certified Clinical Hemodialysis Technician (CCHT) discovered Patient #1 had blood on his/her shirt and under the dialysis chair. The CCHT discovered the replaced hub of Patient #1's CVC had disconnected from the tubing of the patient's CVC. Patient #1 was observed to be unresponsive and without a pulse. The patient was transferred to a hospital where the patient expired from massive blood loss.

On 11/25/19 at 11:06 AM, an interview was conducted with the Clinical Specialist of the manufacturer of Patient #1's CVC. During the interview, the repair procedure of the CVC, IR #1 performed on 01/31/19, was described to the Clinical Specialist. The Clinical Specialist responded by stating the repair procedure IR #1 performed was "highly irregular". He stated the manufacturer of the CVC markets a specific repair kit for the CVC of the type used by Patient #1. The Clinical Specialist stated the hubs of the repair kit are specifically designed to replace the hubs of an existing CVC. Further, no adhesives are used to secure the replacement hubs; a mechanical device secures the replacement hubs to the existing CVC tubing.

Interview conducted on 11/25/19 at 9:30 AM, with IR #1, revealed the radiologist recalled performing a repair procedure of Patient #1's CVC. IR #1 stated he recalled Patient #1 was insistent on keeping his/her current CVC and having a repair attempted. The radiologist stated he informed the patient it would be easier to replace his/her current malfunctioning CVC with a new CVC, than it would be to attempt a repair. He stated he informed the patient that since no repair kits were in stock, the only option would be to take parts from a new CVC kit and use them to do the repair, to which the patient agreed. IR #1 stated he discussed the risks and benefits of attempting to do a repair verses a replacement procedure with the patient prior to attempting the repair; however, this was not documented in the patient's medical record. When asked if he had experience conducting this type of repair procedure in the past, IR #1 stated he continued to use a repair kit in the past. Per continued interview, since there were no repair kits in stock, he was "improvising" in an attempt to meet the request of the patient. When asked why he used the topical adhesive Dermabond in an attempt to secure the new hubs to the tubing of the patient's existing CVC, IR #1 stated he was "problem solving".

Further interview on 11/25/19 at 1:30 PM, with Radiology Technician (RT) #1, he recalled being involved with the repair procedure to Patient #1's CVC. He further revealed he was aware CVC manufacturers market repair kits specifically designed to repair malfunctioning CVC's; however, the facility had not stocked a CVC repair kit "for a few years". The RT stated he was not aware of any CVC repair procedures being attempted at the facility in 2019, with the exception of Patient #1's CVC. RT #1 stated he recalled Patient #1 insisted he/she wanted to keep his/her current CVC and asked IR #1 if there was any way he could repair the catheter and not replace it.

Per interview, IR #1 instructed RT #1 to retrive a new CVC kit for a repair procedure. The Radiology Technician stated he obtained a new CVC kit and presented it to IR #1. Upon receiving the new CVC kit from RT #1, the Invasive Radiolgist opened the new kit, retrieved parts from the kit and used them to repair Patient #1's existing CVC. RT #1 stated IR #1 cut the hubs of the patient's existing CVC and then removed the clamps from the catheter. He then slid new clamps over the tubing and inserted hubs from the new CVC kit onto the tubing securing them with Dermabond skin adhesive. RT #1 denied being aware that Dermabond was intended for topical use only. RT #1 was unable to say why IR #1 decided to use that product in an attempt to secure the catheter hubs to the patient's existing CVC tubing. "He's the physicain, I assumed he knew what he was doing."

During an additional interview on 11/26/19 at 3:10 PM, with RT #1, he was asked how Patient #1 underwent a repair procedure for his/her CVC instead of a tunneled central venous catheter placement procedure as per the signed consent. RT #1 stated on 01/31/9, as the patient was being prepped for a replacement procedure, he/she stated she wanted to keep the current CVC if at all possible. Patient #1 asked IR #1 if there were any repair kits in stock. Per interview, after informing Patient #1 that there were no CVC repair kits in stock, he informed the patient, the only other option would be to take parts from a new CVC kit and use them to do the repair. RT #1 stated he had no basis to ask Patient #1 about this procedure since he had not seen a repair of a CVC performed before using parts from a new CVC kit. The RT stated he did not recall if any other staff were present when the patient asked IR #1 to attempt a repair of his/her existing CVC.

Based on interview, record review, and review of the facility's Radiology Services Agreement, it was determined the facility failed to monitor a contracted Invasive Radiology Service responsible for performing Central Vascular Catheter (CVC) placements for hemodialysis patients. This effected one (1) of ten (10) sampled patients reviewed for CVC replacement procedures.

The findings include:

Review of the facility's Radiology Services Agreement, dated July 2006, revealed the contracted radiology physician's group shall fully comply to the hospital's Medical Staff bylaws, policies and procedures, and all other reasonable rules and regulations established by the hospital and/or its Medical Staff applicable to the operation of the Department.

Review of Patient #1's closed medical record revealed diagnoses including End Stage Renal Disease and had received hemodialysis treatments at an outside renal dialysis clinic. The facility received a physician referral from Patient #1's outside renal dialysis clinic to perform a tunnel dialysis catheter exchange of the patient's Central Venous Catheter (CVC) due to mechanical malfunction of the CVC. The referring physician reported the clamps on the CVC had broken and were leaking during hemodialysis treatments.

On 01/31/19, Patient #1 arrived to the facility and provided written informed consent for an invasive medical procedure. The patient consented to having a Tunneled Central Venous Catheter placement procedure performed. The patient's current mechanically malfunctioning CVC was to be removed and replaced with a new CVC. On 01/31/19 at 3:12 PM, the replacement procedure of the CVC was initiated. However, instead of replacing the malfunctioning CVC, Invasive Radiologist (IR) #1 performed a repair procedure using parts from a new CVC. At 3:35 PM, the repair procedure was completed. Following the procedure, Patient #1 left the facility and resumed hemodialysis treatments at the outside renal dialysis clinic.

Review of IR #1's post procedure Exam Note, dated 01/31/19, revealed the hub on the dialysis catheter was cracked and the existing hubs on the indwelling dialysis catheter were removed. New hubs were taken from a new dialysis catheter. Hubs were placed within the ends of the arterial and venous limbs of the existing catheter and secured with Dermabond. (Dermabond is a skin adhesive intended for topical application only).

On 08/09/19, Patient #1 was undergoing a hemodialysis treatment session at the outside renal dialysis clinic. During the treatment, a Certified Clinical Hemodialysis Technician (CCHT) discovered Patient #1 had blood on his/her shirt and under the dialysis chair. The CCHT discovered the replaced hub of Patient #1's CVC had disconnected from the tubing of the patient's CVC. Patient #1 was observed to be unresponsive and without a pulse. The patient was transferred to a hospital where the patient expired from massive blood loss.

Interview conducted on 11/25/19 at 9:30 AM, with IR #1, revealed the radiologist recalled performing a repair procedure of Patient #1's CDC. IR #1 stated he recalled Patient #1 was insistent on keeping his/her current CVC and having a repair attempted. IR #1 stated he informed the patient it would be easier to replace his/her current malfunctioning CVC with a new CVC, than it would be to attempt a repair. He further stated he informed the patient that since no repair kits were in stock, the only option would be to take parts from a new CVC kit and use them to do the repair, to which the patient agreed. Per interview, he discussed the risks and benefits of attempting to do a repair verses a replacement procedure with the patient prior to attempting the repair; however, this was not documented in the patient's medical record. When asked if he had experience conducting this type of repair procedure in the past, IR #1 stated he had always used a repair kit in the past. Per interview, since there were no repair kits in stock, he was "improvising" in an attempt to meet the request of the patient. When asked why he used the topical adhesive Dermabond in attempt to secure the new hubs to the tubing of the patient's existing CVC, IR #1 stated he was "problem solving".

Interview conducted on 11/26/19 at 11:15 AM, with IR #2 revealed he/she was the Chair of the contracted radiology group. IR # 2 reported he/she was not aware of a written protocol prohibiting the repair of CVCs at the facility; however, it was the practice of the contracted radiologists to only perform replacements of malfunctioning CVCs. IR #2 stated the standard of practice was to evaluate each reported malfunctioning CVC and replace it under a fluoroscopy procedure. Further interview revealed the radiology group had not routinely done repairs of CVCs "for several years". Per interview, he was aware the facility did not keep CVC repair kits in stock. IR #2 stated to his/her knowledge, no other physicians in "our practice" were making repairs to hemodialysis catheters. "We replace the catheters instead of attempting to repair them."

Interview conducted on 11/26/19 at 1:00 PM, with IR #3, revealed the radiologist had been with the contracted group for two (2) years. Further, the group had always only done replacement procedures of malfunctioning CVCs, and the radiologist was unaware of any other physician attempting repairs of CVCs. Per interview, IR #3 was not aware of repair kits being kept in stock at the facility. IR # 3 was asked why it was important to follow manufacturer's recommendations if a repair of a malfunctioning CVC was attempted. The radiologist responded, "it is important because the product could fail if you don't. The patient could bleed out if the hub comes loose and the tubing is not clamped."

Interview conducted on 11/26/19 at 1:20 PM, with IR #4, revealed the radiologist had been with the contracted group since 2002. When asked how IR #4 would approach a malfunctioning CVC, the radiologist responded that a CVC repair kit would be used to do the repair. However, IR #4 stated, it was facility policy to only conduct replacement procedures of malfunctioning CVCs. Per interview, "Repair kits aren't even in stock".

Interview conducted on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer (CMO), revealed it was the policy of the facility for contracted Invasive Radiologist to only perform replacement procedures of mechanically malfunctioning CVCs; however, this practice had not been clearly written in the form of a policy or a surgical procedure practice. Per interview, the facility had not stocked CVC repair kits since 2014. Further, it was the expectation of the CMO that all malfunctioning CVCs would be replaced at the facility; as repair of CVCs was not authorized by the facility.

Based on interview, record review, and review of the facility's Patient Rights Policy, it was determined the facility failed to protect and promote each patient's rights for one (1) patient, Patient #1, who underwent an unauthorized repair of Central Vascular Catheter (CVC) instead of a replacement procedure of the CVC that the patient had signed a written consent for. This effected one (1) of ten (10) patients reviewed for CVC replacement procedures.

Record review revealed on 01/31/19, Invasive Radiologist (IR) #1 attempted a repair of Patient #1's CVC, instead of replacing the malfunctioning CVC. Manufacturer's recommendations for repair of Patient #1's CVC required the use of a CVC repair kit the manufacturer markets. Interview on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer, revealed it was the facility's policy to only perform replacement procedures of malfunctioning CVCs, and not to attempt repairs of CVCs. The facility did not stock CVC repair kits, since it was the facility's policy to only perform CVC replacements. Interview on 11/25/19 at 9:30 AM, with IR #1, revealed the unauthorized repair attempt of Patient #1's malfunctioning CVC occurred because the patient voiced he/she wished not to lose his/her current hemodialysis access site and requested a repair of the CVC be attempted just prior to the CVC surgery by IR #1. Being informed no CVC repair kits were in stock, IR #1 attempted to repair the patient's CVC by removing parts from a new CVC kit and using them to fix the patient's malfunctioning CVC. The repair attempt was against manufacturer's recommendations and the repair ultimately failed. On 08/09/19 the hubs of the repaired CVC separated from the tubing during a hemodialysis treatment session at an outside renal dialysis clinic. The failure of Patient #1's repaired CVC went undetected until a Certified Clinical Hemodialysis Technician noticed blood on the patient's shirt and under the treatment chair. Patient #1 had lost a large volume of blood. The patient was transferred to an emergency department. As a result, Patient # 1 expired due to the loss of blood (refer to A0057, A0084, A0144, A0940 and A0951).

Based on interview, medical record review and review of facility Policies, it was determined the facility failed to ensure patients received surgical services in a safe environment by conducting an unauthorized repair attempt of a Central Vascular Catheter (CVC) of a hemodialysis patient that was against manufacturer's recommendations for the product. This effected one (1) of ten (10) patients reviewed for CVC replacement procedures.

Findings Include:

Review of the facility's Notice of Patient Rights As An Individual Form, dated 02/2014 revealed each patient is to be issued a Patient Rights and Responsibility Form during the registration process.

Review of the facility's Patient Rights and Patient Responsibilities Policy, dated 12/2016, revealed facility patients have the right to receive safe and appropriate medical care to the best of the organization's ability. Patients have the right to be informed of their rights before care is provided or discontinued, whenever possible. Patients have the right to receive information including risks, benefits and reasonable alternatives in a language or method of communication that the patient can understand pertaining to the patient's health status, current diagnosis, treatment plan and prognoses in order for the patient to give informed consent or to refuse consent.

On 01/31/19, Patient #1 arrived to the facility and provided written informed consent for an invasive medical procedure. The patient consented to having a tunneled central venous catheter placement procedure performed. The patient's current mechanically malfunctioning CVC was to be removed and replaced with a new CVC. On 01/31/19 at 3:12 PM, the replacement procedure of the CVC was initiated. However, instead of replacing the malfunctioning CVC, Invasive Radiologist (IR) #1 performed a repair procedure using parts from a new CVC. At 3:35 PM, the repair procedure was completed. Following the procedure, Patient #1 left the facility and resumed hemodialysis treatments at the outside renal dialysis clinic.

Review of IR #1's post procedure Exam Note, dated 01/31/19, revealed the hub on the dialysis catheter was cracked and the existing hubs on the indwelling dialysis catheter were removed. New hubs were taken from a new dialysis catheter. Hubs were placed within the ends of the arterial and venous limbs of the existing catheter and secured with Dermabond. (Dermabond is a skin adhesive intended for topical application only).

On 08/09/19, Patient #1 was undergoing a hemodialysis treatment session at the outside renal dialysis clinic. During the treatment, a Certified Clinical Hemodialysis Technician (CCHT) discovered Patient #1 had blood on his/her shirt and under the dialysis chair. The CCHT discovered the replaced hub of Patient #1's CVC had disconnected from the tubing of the patient's CVC. Patient #1 was observed to be unresponsive and without a pulse. The patient was transferred to a hospital where the patient expired from massive blood loss.

Interview conducted on 11/25/19 at 9:30 AM, with IR #1, revealed the radiologist recalled performing a repair procedure of Patient #1's CDC. IR #1 stated he recalled Patient #1 was insistent on keeping his/her current CVC and having a repair attempted. The radiologist stated he informed the patient it would be easier to replace his/her current malfunctioning CVC with a new CVC, than it would be to attempt a repair. He stated he informed the patient that since no repair kits were in stock, the only option would be to take parts from a new CVC kit and use them to do the repair, to which the patient agreed. IR #1 stated he discussed the risks and benefits of attempting to do a repair verses a replace procedure with the patient prior to attempting the repair; however, this was not documented in the patient's medical record. A new signed informed consent form was not presented to Patient #1 informing him/her of the risks and benefits of a repair procedure for the patient's existing CVC.

Interview conducted on 12/02/19 at 2:45 PM, with the facility's Chief Executive Officer (CEO), revealed prior to 12/02/19, the facility did not have a written policy directing contracted Invasive Radiologist (IR) at the facility to only perform replacement procedures of mechanically malfunctioning Central Venous Catheters (CVC). The CEO reported the facility's Executive Board had been called to order earlier in the day (12/02/19) to formally adopt the facility's Central Venous Access Catheters for Hemodialysis: Cardiovascular Services Policy (Policy ID 7282023, effective 11/2019).

Post survey interview, conducted on 12/27/19 at 11:29 AM, with the facility's Quality and Patient Safety Director revealed facility patients who receive outpatient surgical procedures are informed of their patient rights through two different documents. Patients are present with a copy of the facility's Rights and Responsibilities for Patients document. The document informs patients that they have the right to expect they will receive safe and appropriate care to the best of the facility's capabilities. The second way outpatients are informed of their rights is through the informed consent form. The Informed Consent for Surgery or Invasive Medical Procedure form specifies the physician who will be performing the procedure and what specific surgical procedure will be performed. The form informs the patient they have the right to refuse the procedure and to ask questions of the physician prior to the procedure.

Based on interview, record review, and review of facility's Policy, it was determined the facility failed to provide surgical procedures that conform to manufacturer's recommendations of repair procedures of Central Venous Catheters (CVCs). This effected one (1) of ten (10) sampled patients reviewed for CVC replacement procedures.

Record review revealed on 01/31/19, Invasive Radiologist (IR) #1 attempted a repair of Patient #1's CVC, instead of replacing the malfunctioning CVC. Manufacturer's recommendations for repair of Patient #1's CVC required the use of a CVC repair kit the manufacturer markets. Interview on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer, revealed it was the policy of the facility to only conduct replacement procedures of malfunctioning CVCs, and not to attempt repairs of CVCs. The facility did not stock CVC repair kits since it was the facility's policy to only conduct CVC replacements. Interview on 11/25/19 at 9:30 AM, with IR #1, revealed the unauthorized repair attempt of Patient #1's malfunctioning CVC occurred because the patient voiced he/she wished not to lose his/her current hemodialysis access site and requested a repair of the CVC be attempted just prior to the CVC surgical procedure. Being informed no CVC kits were in stock, IR #1 attempted to repair the patient's CVC by removing parts from a new CVC kit and using them to fix the patient's malfunctioning CVC. The repair attempt was against manufacturer's recommendations and the repair ultimately failed. On 08/09/19, the hubs of the repaired CVC separated from the tubing during a hemodialysis treatment session at an outside renal dialysis clinic. The failure of Patient #1's repaired CVC went undetected until a Certified Clinical Hemodialysis Technician noticed blood on the patient's shirt and under the treatment chair. Patient #1 had lost a large volume of blood. The patient was transferred to an emergency department. As a result, Patient # 1 expired due to the loss of blood (refer to A0043, A0057, A0084, A0115, A0144 and A0951).

Based on interview and record review, it was determined the facility failed to deliver surgical services based on written policies governing a surgical procedure. The facility performed a Central Vascular Catheter (CVC) replacement procedure of a hemodialysis patient that was against manufacturer's recommendations for the product. This effected one (1) of ten (10) sampled patients reviewed for CVC replacement procedures.

On 01/31/19, Patient #1 provided written informed consent to have a "Tunneled Arterial Venous Catheter Placement with Possible Injection of Contrast and Angioplasty" surgical procedure. Instead, Patient #1 underwent an unauthorized repair of his/her malfunctioning CVC. The unauthorized repair of the CVC failed on 08/09/19 during a hemodialysis treatment causing the patient to lose a large amount of blood. Patient #1 was transferred to an emergency department and expired due to blood loss.

The findings include:

Interview conducted on 12/02/19 at 2:45 PM, with the facility's Chief Executive Officer (CEO), revealed prior to 12/02/19, the facility did not have a written policy directing contracted Invasive Radiologist (IR) at the facility to only perform replacement procedures of mechanically malfunctioning Central Venous Catheters (CVC). The CEO stated the facility's Executive Board had been called to order earlier in the day (12/02/19) to formally adopt the facility's Central Venous Access Catheters for Hemodialysis: Cardiovascular Services Policy (Policy ID 7282023, effective 11/2019).

Review of the facility "Central Venous Access Catheters for Hemodialysis: Cardiovascular Services" Policy (Policy ID 7282023, effective 11/2019), revealed it is the institutional practice of the facility that hemodialysis catheters will not be repaired, only replaced.

Review of Patient #1's closed medical record revealed the patient had a medical diagnosis of End Stage Renal Disease and had received hemodialysis treatments at an outside renal dialysis clinic. The facility received a physician referral from Patient #1's outside renal dialysis clinic to perform a Tunnel Dialysis Catheter exchange of the patient's Central Venous Catheter (CVC) due to mechanical malfunction of the CVC. The referring physician reported the clamps on the CVC had broken and were leaking during hemodialysis treatments.

On 01/31/19, Patient #1 arrived to the facility and provided written informed consent for an invasive medical procedure. Review the Informed Consent for Surgery or Invasive Medical Procedure form, dated 01/31/19, revealed the patient consented to having a Tunneled Arterial Venous Catheter Placement with Possible Injection of Contrast and Angioplasty procedure performed. The patient's current mechanically malfunctioning CVC was to be removed and replaced with a new CVC.

Review of the Hemodynamic Procedure Report, dated 01/31/19, revealed at 3:12 PM the procedure for replacement procedure of the CVC was initiated. However, instead of replacing the malfunctioning CVC, Invasive Radiologist (IR) #1 performed a repair procedure using parts from a new CVC. The new CVC parts consisted of two (2) clamps and two (2) hubs. At 3:35 PM, the repair procedure was completed. Following the procedure, Patient #1 left the facility and resumed hemodialysis treatments at the outside renal dialysis clinic.

Review of IR #1's Special-Interventional post procedure Exam Note, dated 01/31/19, revealed the hub on the dialysis catheter was cracked and the existing hubs on the indwelling dialysis catheter were removed. According to the note, new hubs were taken from a new dialysis catheter. Hubs were placed within the ends of the arterial and venous limbs of the existing catheter and secured with Dermabond.

On 08/09/19 Patient #1 was undergoing a hemodialysis treatment session at the outside renal dialysis clinic. During the treatment, a Certified Clinical Hemodialysis Technician (CCHT) discovered Patient #1 had blood on his/her shirt and under the dialysis chair. The CCHT discovered the replaced hub of Patient #1's CVC had disconnected from the tubing of the patient's CVC. Patient #1 was observed to be unresponsive and without a pulse. The patient was transferred to a hospital where the patient expired from massive blood loss.

Review of the manufacturer recommendations of the Hemodialysis Catheter Repair Kit marketed by the manufacturer of patient # 1's CVC, but not stocked by the facility, revealed the the repair kit is indicated for use to replace damaged connectors (hubs), clamps or repair extensions where there is a minimum of 4.5cm viable extension tubing.

On 11/25/19 at 11:06 AM, an interview was conducted with the Clinical Specialist of the manufacturer of Patient #1's CVC. During the interview, the repair procedure of the CVC IR #1 performed on 01/31/19 was described to the Clinical Specialist. The Clinical Specialist responded by stating that the repair procedure IR #1 performed was "highly irregular". He stated the manufacturer of the CVC markets a specific repair kit for the CVC of the type used by Patient #1. The Clinical Specialist stated the hubs of the repair kit were specifically designed to replace the hubs of an existing CVC. Per interview, no adhesives should be used to secure the replacement hubs, but a mechanical device secured the replacement hubs to the existing CVC tubing.

Review of the manufacturer's Labeling Specification for Dermabond revealed the product is for topical application only. Continued review revealed Dermabond topical skin adhesive is intended to be used to hold approximated skin edges of wounds from surgical incisions. Further review revealed the adhesive will slough off usually within 5 to 10 days.

Interview conducted on 11/25/19 at 9:30 AM, with IR #1, revealed the radiologist recalled performing a repair procedure of Patient #1's CDC. IR #1 stated he recalled Patient #1 was insistent on keeping his/her current CVC and having a repair attempted. The radiologist stated he informed the patient it would be easier to replace his/her current malfunctioning CVC with a new CVC, than it would be to attempt a repair. He stated he informed the patient that since no repair kits were in stock, the only option would be to take parts from a new CVC kit and use them to do the repair, to which the patient agreed. IR #1 stated he discussed the risks and benefits of attempting to do a repair verses a replace procedure with the patient prior to attempting the repair; however, this was not documented in the patient's medical record. When asked if he had experience conducting this type of repair procedure in the past, IR #1 stated he had always used a repair kit in the past. He stated since there was none in stock, he was "improvising" in an attempt to meet the request of the patient. When asked why he used the topical adhesive Dermabond in attempt to secure the new hubs to the tubing of the patient's existing CVC, IR #1 stated he was "problem solving".

Interview conducted on 11/25/19 at 1:30 PM, with Radiology Technician (RT) #1, revealed he was aware CVC manufacturers market repair kits specifically designed to repair malfunctioning CVCs; however, the facility had not stocked a CVC repair kit "for a few years". The RT stated he was not aware of any CVC repair procedures being attempted at the facility in 2019, with the exception of Patient #1. Per interview, he recalled Patient #1 insisted he/she wanted to keep his/her current CVC and asked IR #1 if there was any way he could repair the catheter and not replace it. Further interview revealed IR #1 opened a new CVC kit, retrieved parts from the kit and used them to repair Patient #1's existing CVC. RT #1 stated IR #1 cut the hubs of the patient's existing CVC and then removed the clamps from the catheter. He stated he then slid new clamps over the tubing and inserted hubs from the new CVC kit onto the tubing, securing them with Dermabond skin adhesive. RT #1 denied being aware that Dermabond was intended for topical use only and could not state why he had decided to use that product in an attempt to secure the catheter hubs to the patient's existing CVC tubing.

During subsequent interview on 11/26/19 at 3:10 PM, with RT #1, he was asked how Patient #1 underwent a repair procedure for his/her CVC instead of a Tunneled Central Venous Catheter Placement procedure, as he/she had signed consent for the replacement. RT #1 stated on 01/31/9 as Patient #1 was being prepped for a replacement procedure, the patient stated he/she wanted to keep his/her current CVC if at all possible. Per interview, Patient #1 asked IR #1 if there were any repair kits in stock. After being informed there were no repair kits in stock, IR #1 informed the patient the only other option would be to take parts from a new CVC kit and use them to do the repair. RT #1 stated he had no basis to ask Patient #1 about this procedure since he had not seen a repair of a CVC performed before using the parts from a new CVC kit. The RT stated he did not recall if any other staff were present when the patient asked IR #1 to attempt a repair of his/her existing CVC.

Interview conducted on 12/02/19 at 2:27 PM, with the facility's Chief Medical Officer (CMO), revealed it was the policy of the facility for contracted Invasive Radiologists to only perform replacement procedures of mechanically malfunctioning CVCs; however, this practice had not been clearly written in the form of a policy or a surgical procedure practice.