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Based on clinical record review and interview for 1 of 10 patients (P#1) who underwent a surgical procedure, the hospital failed to ensure medical staff accountability for the quality of medical care provided to patients when the patient was not provided with appropriate discharge instructions. The finding includes:

Patient (P) #1 had undergone a Transurethral Resection of the Prostate (TURP) on 9/10/18, performed by Medical Doctor (MD) #1. Review of hospital discharge education information dated 9/11/18 identified P#1 received educational information and instructions for Benign Prostatic Hyperplasia (BPH) however the medical record lacked educational material related to postoperative restrictions following a TURP.

On 10/1/18 at 8:46 PM, P#1 arrived in the Emergency Department (ED) of Hospital #1 with a chief complaint of bleeding/hematuria starting around 4:15 PM after lifting a heavy object.

During an interview with Compliance Officer #1 on 2/7/19 at 10:00 AM he/she indicated P#1's medical record contained discharge instructions however they were not specific to post-operative TURP.

According to a statement by MD#1, he/she discusses postoperative activity as a routine part of counseling. He/she indicated usually there is an order for no lifting anything heavy for 1 to 3 weeks. In addition MD#1 indicated a discharge education handout is provided to the patient upon discharge by either the Residents or floor nurses and he/she was not sure this had been provided.

Review of the hospital written discharge information for care after a TURP indicated the patient was to avoid lifting anything heavier than 10 pounds for 3 weeks after the procedure unless instructed otherwise by the healthcare provider.

The Discharge Planning policy indicated the RN in collaboration with other team members will instruct patients, families, significant others and designated care givers in accordance with assessment of their learning needs. Sources of education include hospital approved patient education resources and other instructional information packets.

The Condition of Surgical Services has not been met.

Based on clinical record review and interview for one of eleven patients patients who underwent cardiothoracic surgery, (Patient #12), the hospital failed to ensure that life sustaining equipment was operated correctly.


Please see A941

Based on clinical record review, facility documentation review, and interviews for one of eleven patients' who underwent cardiothoracic surgery, (Patient #12), the hospital failed to ensure that life sustaining equipment was operated correctly. The finding includes:


P#12 underwent bioprosthetic aortic valve (AV) replacement on 2/8/19 due to severe symptomatic aortic stenosis (AS). Comorbidities included hypertension and congestive heart failure.

According to the Operative report dated 2/8/19 at 8:24 AM, during the beginning stage of the procedure when P#12 was connected to the cardiac coronary bypass machine, all cannulas were de-aired and connected to the bypass circuit. During the dissection of the ascending aorta from the main pulmonary artery, air was sucked into the heart (air embolization). Corrective interventions were implemented and replacement of the aortic valve commensed. The operative report identified the complication which occurred as intra-cardiac air during bypass surgery. After the surgery, P#12 was transferred to the intensive care unit (ICU) and was hemodynamically stable.

According to the discharge summary dated 2/10/19 at 12:45 PM, postoperatively P#12 was unresponsive when off sedation. A stat head CT scan revealed tiny locules of air. An EEG showed no cortical activity. On 2/9/19 P#12's family requested that P#12 receive comfort care and hospice. P#12 was terminally extubated and pronounced expired on 2/10/19 at 12:45 PM.


During an interview with Perfusionist #1 on 2/14/19 at 12:45 PM, he/she indicated that on 2/8/19 the roller head/raceway (part of the pump that pulls blood directionally through the tubing) was set up and all checks were in place prior to the start of the procedure. When the procedure started, Perfusionist #1 (primary) placed the tubing with the VRV valve (safety valve that keeps tissue at end of tubing from collapsing and allows directional flow of fluids between the raceway and the reservoir/oxygenator) onto the machine and connected with the tubing the surgeon had handed him/her, which was placed to drain the heart. However the VRV valve in the tubing was connected to the roller head/raceway pump between the roller head and reservoir in error. TheVRV valve should have been placed between the roller head/raceway pump and the patient. When blood began flowing through the tubing the VRV valve did as intended and pressurized, squirting blood out of the valve therefore Perfusionist #1 thought the cause of the VRV valve release was that the tubing flowing through the roller head/raceway pump was placed wrong not that the VRV valve location was wrong. The pump was turned off and Perfusionist #1 flipped over and reinserted the tubing within the roller head/raceway. The machine was turned back on and the surgeon asked if Perfusionist #1 was getting air down the venous line. It was at that time Perfusionist #1 realized and identified the error in the VRV valve placement.

On 2/15/19 at 10:30 AM, the Clinical Coordinator demonstrated the proper placement of tubing on the cardiac coronary bypass machine versus how the actual tubing was placed during P#12's surgery. It was subsequently identified that at the start of P#12's procedure, just prior to being placed on cardiac coronary bypass, the tubing containing the VRV valve was placed on the wrong side of the roller head/raceway. Perfusionist #1 did not realize that the VRV valve was in the wrong place at that time therefore he/she flipped the tubing within the roller head/raceway thinking the error was in the tubing running through the roller head/raceway.

Medical Doctor (MD) was not available for interview during the onsite investigation timeframe. During an arranged interview with MD#3 on 2/20/19 at 2:40 PM, MD#3 indicated he/she became aware of a problem when he/she heard what sounded like air coming from the vicinity of the operative field. MD#3 noted air in the circuit tubing and asked Perfusionist #1 if he/she was getting air. Perfusionist #1 did not immediately respond therefore MD#3 asked anesthesia staff to check the heart and anesthesia responded that there was air in the heart. MD#3 responded by clamping the ascending aorta to prevent air from further entering the heart. MD#3 indicated when he/she asked Perfusionist #1 what occurred Perfusionist #1 had indicated one of the one-way valves in the circuit was in the wrong location.

During an interview with Perfusionist #2 (Director of Perfusion Services) on 2/14/19 he/she indicated during P#12's surgery on 2/8/19 the VRV value was placed in the wrong position causing blood to spurt out the valve. When the blood spurted out of the VRV valve Perfusionist #1 stopped the roller head, thinking the tubing was in backwards. Perfusionist #1 then reversed the tubing in the roller head causing the flow in the line to be in the wrong direction. Perfusionist #2 indicated prior to the incident hospital practice is for 2 Perfusionist in the OR during the surgery unless circumstances do not allow. The role of the second Perfusionist is to obtain additional equipment in the room and assist with vital signs and documentation. He/she indicated since the incident 2 Perfusionist are scheduled for the surgery during initiation of cardiopulmonary bypass.

According to the Clinical Perfusionist job description the Perfusionist is responsible for the selection, setup and operation of circulation equipment during any medical situation when it temporarily and artificially replaces the patient's cardiopulmonary/circulatory functions. In addition the Perfusionist should have in-depth knowledge of extracorporeal equipment. Review of the Perfusionist job description failed to identify the number of Perfusionist assigned when bypass is used and/or distinguish the roles of each Perfusionist.

Subsequent to this incident, the hospital instituted immediate corrective measures that included:

1. The bypass machine was immediately sequestered.
2. All perfusionists were notified of the event and educated to prevent reoccurance.
3. Primary perfusionist for 2/8 AVR case was placed on administrative leave.
4. All elective open heart surgery cases were placed on hold.
5. All cardiothoracic surgeries that require a left ventricle vent must have the aorta cross-clamped prior to placement of the vent. Air embolism protocol will be reviewed by surgeons.
6. Any change in direction of flow or manipulation of the pump tubing after initial test will require a repeat testing of the circuit.
7. VRV valve marker (identifies directional flow) was added to roller head cover on heart lung machine at initiation of the surgery and removed upon completion.
8. A hard stop will occur when there is any alteration in the field lines and confirmation of fluid path prior to re- initiation of flow will be established.

Future measures include:

1. Two perfusionists will be in attendance at start of case through initiation of cardiopulmonary bypass.
2. Both perfusionists will independently complete the checklist on a separate form.
3. The perfusion checklist and case summary (HCH922) will be revised to include a check that the pump tubing has the VRV valve correctly placed in the set-up.
4. Each heart lung machine to receive additional roller head for independent control of field vent / suction lines.
5. Third field vent / suction line ("blue line") to be added to custom perfusion pack by manufacturer.

The Condition of Emergency Services has not been met.

Based on clinical record reviews and interviews for three (3) of eleven (11) patients who presented to the Emergency Department (ED) for care and treatment, (Patient #1, #3, and #8) the hospital failed to ensure that the patients were assessed in a timely manner to include an Emergency Severity Index (ESI) level, vital signs and/or pain assessment during the triage process and failed to ensure that ED policies and protocols for the triage of patients was adequate to ensure timely assessment and treatment.


Please see A1104

Based on clinical record reviews and interviews for three (3) of eleven (11) patients who presented to the Emergency Department (ED) for care and treatment, (Patient #1, #3, and #8) the hospital failed to ensure that the patients were assessed in a timely manner to include an Emergency Severity Index (ESI) level, vital signs and/or pain assessment during the triage process and failed to ensure that ED policies and protocols for the triage of patients was adequate to ensure timely assessment and treatment. The findings include:


a. Patient (P) #1 had undergone a Transurethral Resection of the Prostate (TURP) on 9/10/18, performed by Medical Doctor (MD) #1. On 10/1/18 at 8:46 PM P#1 arrived in the Emergency Department (ED) with a chief complaint of bleeding/hematuria starting around 4:15 PM after lifting a heavy object. A triage nurse's note by Registered Nurse (RN) #1 dated 10/1/18 at 8:47 PM indicated P#1 reported he had a TURP procedure 3 weeks earlier. Since 4:00 PM P#1 had been passing blood and clots (from the urethra) and had difficulty urinating.

Review of the medical record failed to identify that the patient was traiged in accordance with the Emergency Severity Index (ESI) level (1 most urgent/5 least urgent). The record failed to indicate that the patient's vital signs and/or level of pain were obtained or assessed.

According to a nurse's note dated 10/1/18 at 9:23 PM, a urology practitioner called the ED requesting P#1 to be seen. The practitioner was made aware of high volume and extremely high acuity in the department at that time. The practitioner verbalized understanding. On 10/1/18 at 9:38 PM (52 minutes after arrival) P#1 left the hospital without being seen prior to triage and that procedure and treatment not carried out due to patient leaving prior to being seen by health care provider. P#1 indicated he/she was going to another hospital for care.

During an interview with RN#1 on 2/13/19 at 11:10 AM, he/she indicated when P#1 arrived to the ED, P#1 appeared slightly uncomfortable, was alert and oriented, stable ambulating, had good color and had driven him/herself to the ED. RN#1 indicated he/she reviewed P#1's symptoms and explained that the ED had a high acuity and critical patients and that P#1 would be seen as soon as possible, but to let RN#1 know if anything changed. RN#1 indicated at the time of P#1's ED encounter, the policy was not to do initial vital signs "up front" but rather as a nursing judgment call (when to do the vital signs) which could be once the patient gets placed in an ED room. RN#1 indicated that P#1 came to the triage desk several times (no more than 3) after using the restroom and RN #1's quick visual assessment indicated that P#1's condition had not changed. RN#1 indicated he/she had received a call from MD#2 inquiring as to when P#1 would be seen. RN#1 explained the acuity/volume of patients in the ED and his/her initial assessment of P#1. RN#1 indicated MD#1 did not indicate P#1 needed to be seen sooner. RN#1 indicated he/she had called back to the treatment area of the ED and briefly spoke with the charge nurse who was managing 2 cardiac arrests, a stroke alert and full rooms. The charge nurse indicated as soon as things settled and they could rearrange things, patients would be moved from the waiting area to a room.

During an interview with Medical Doctor (MD) #1 on 2/7/19 at 10:50 AM he/she indicated bleeding 3 weeks post operatively is not unusual however most cases resolve after continuous bladder irrigation and there is a small percentage that require going to the Operating Room (OR) for cautery. MD#1 indicated it was very rare that a patient would lose a life threatening amount of blood through the urinary tract.

During an interview with MD#2 on 2/7/19 he/she indicated P#1 had called the urology service twice post operatively. The first time MD#2 spoke with P#1 based on the symptoms P#1 had reported he/she instructed P#1 on some interventions to attempt to stop the bleeding and then be evaluated by MD#1 the next day. MD#2 indicated he/she told P#1 if he/she continued to have concerns P#1 should seek further evaluation. MD#2 indicated when P#1 called the second time that evening based on what P#1 reported and his/her level of alertness and sound on the phone, MD#2 did not feel P#1's situation was critical. However P#1 seemed more upset about having to wait in the ED to be evaluated. MD#2 then called and spoke to the triage nurse in the ED to see if he/she could expedite P#1 being seen. However the triage RN explained the acuity and volume of patients in the ED and indicated P#1 would be seen as soon as possible.

During an interview with the ED Manager on 2/6/19 at 9:40 AM he/she indicated that in discussing the events of 10/1/18 with the Charge Nurse, it was felt that staffing was adequate. The issue was that there were no available rooms due to multiple emergent cases in the ED at that time. Once the emergent cases were attended to and were less critical, staff would reassess the situation. The ED manager identified that he/she was aware of the process should he/she need additional staff.

During review of the medical records for P#1 with the ED Manager on 2/13/19 at 12:45 PM he/she indicated although the ED treatment area was full, vital signs and an ESI level should have been obtained in the triage area and documented as indicated in the triage policy and nursing protocol for ED nursing assessment and documentation. The ED Manager indicated that the triage policy is in the process of revision to include that vital signs need to be done immediately in triage.


Review of the "Triage of Patients Presenting in the Emergency Department" policy directed that all patients presenting to the ED would be triaged and have an intake note documented by the RN. The ESI triage system would be used to categorize the patients based on severity and resource needs. ESI triage algorithm indicated in order to establish an ESI triage level, a patients cognitive orientation, pain/distress, heart rate, respiratory rate and oxygen level needs to be assesed. The policy indicated all ED patients would receive prompt emergency care according to their urgency level. After the initial intake, Patients with an ESI of 1, 2 or 3 (resuscitation, emergent and urgent) would be placed into appropriate ED treatment rooms so that emergency measures can be initiated immediately. Patients with an ESI of 4 or 5 (less urgent/non-urgent) would be placed in an up-front provider room where care can be provided, which includes vital signs.

A nursing protocol for ED nursing assessment and documentation identified to assess the patient and assign an acuity level and complete the triage process by obtaining in part, vital signs and a pain assessment. However, the protocol failed to identify when staff should be expected to complete the triage process.

The purpose of triage in the emergency department (ED) is to prioritize incoming patients and to identify those who cannot wait to be seen. The triage nurse performs a brief, focused assessment and assigns the patient a triage acuity level, which is a proxy measure of how long an individual patient can safely wait for a medical screening examination and treatment.


b. P#3 arrived in the ED on 10/1/18 at 7:51 PM with a chief complaint of back pain after a fall at home. At 7:51 PM, RN #1 designated that the patient was an ESI level 3, was placed in a room at 8:09 PM, and evaluated by the Physician Assistant (PA) at 11:51PM. An assessment by the PA indicated as of 11:51 PM (4 hours after arrival) no vital signs were documented. A nurse's note dated 10/2/18 at 12:33 AM indicated P#3 signed the required documentation and left Hospital #1 against medical advice (AMA).


c. P#8 arrived in the ED on 10/1/18 at 8:06 PM with a chief complaint of hypertension. Review of RN #1's nurse's note dated 10/1/18 at 8:07 PM indicated P#1 reported a high blood pressure at home and that he/she had not felt well since his/her medication had been changed. P#8 reported his/her systolic BP had been >100. Review of the medical record failed to identify vital signs or an ESI level had been obtained/documented until 9:25 PM. P#8 was placed in a room at 9:27 PM (1 hour 18 minutes after arrival) and left without further evaluation at 9:30 PM.

During an interview with the ED Manager on 2/6/19 at 9:40 AM he/she indicated ideally vital signs should be obtained right away however if there was a line, the vital signs might not be taken right away and the patient would subsequently be called back to triage as soon as possible to have vital signs obtained.

During review of the medical records for P#3 and P#8 with the ED Manager on 2/13/19 at 12:45 PM he/she indicated if P#3 was triaged at 7:51 PM, it was unacceptable that as of 11:51 PM no vital signs had been obtained and documented. In addition if P#8, with a reported history of hypertension arrived to the ED at 8:06 PM complaining of a headache, vital signs and an ESI level should have been obtained and documented.