The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|STANFORD HEALTH CARE||300 PASTEUR DRIVE STANFORD, CA 94305||Oct. 17, 2019|
|VIOLATION: COMPLIANCE WITH 489.24||Tag No: A2400|
|Based on interviews and record reviews, the hospital failed to comply with the EMTALA regulations (cross reference to A2409 and A2411).|
|VIOLATION: POSTING OF SIGNS||Tag No: A2402|
|Based on observation and interview, the hospital failed to post signs regarding the rights of individuals with emergency medical conditions (EMCs) in emergency department (ED) treatment areas and in areas likely to be noticed by patients coming to the ED by ambulance. The deficient practice had the potential to cause patients to be unaware of their right to a medical screening exam and stabilizing treatment regardless of ability to pay.
In an observation and interview on 10/15/19 at 11:01 a.m., signs regarding the rights of patients with EMCs were posted in the hallway outside the ambulatory patient entrance to the ED, and in the ED lobby waiting room. No signs regarding the rights of patients with EMCs were posted in ED treatment areas adjacent to beds A1 through A10, beds D15 through D18, the pediatric waiting area, or the pediatric triage and rapid assessment area. The surveyor asked the Patient Care Manager (PCM) if there were signs regarding the rights of patients with EMCs in the treatment areas; the PCM replied, "No, they're in the lobby by the registration desk."
In an observation and interview on 10/15/19 at 11:18 a.m., the Executive Director of Emergency Medical Services (EDEMS) stated patients arriving by ambulance arrived through the ambulance bay and were rolled down the hall by the paramedics to the ED charge nurse, who assigned a room. The hallway connecting the ambulance bay to the ED nursing station did not contain signs regarding the rights of patients with EMCs.
In an observation and interview in the Clinical Decision Unit (CDU) on 10/15/19 at 12:21 p.m., room C113 did not include a sign regarding the rights of patients with EMCs. The PCM stated patients in the CDU were cared for by ED attending physicians, nurse practitioners, and physician assistants. The EDEMS stated patients in the CDU were not admitted to the hospital but were on observation status. The EDEMS stated the CDU was part of emergency services. The EDEMS acknowledged there were no signs regarding patient rights under EMTALA (Emergency Medical Treatment and Active Labor Act) in the CDU.
In an observation and interview on 10/16/19 at 10:46 a.m., there were no signs regarding the rights of patients with EMCs in the ambulance bay or in the hall connecting the ambulance bay with the treatment areas of the ED. Two unidentified paramedics brought an unidentified patient on a gurney from the ambulance bay to the ED nursing station, then further down the same hallway to a different zone of the ED. The EDEMS acknowledged the patient who had just arrived through the ambulance bay had not passed an EMTALA sign, and that there were no EMTALA signs in the zone where the patient had been dropped off.
In an observation and interview on 10/16/19 at 12:22 p.m., the "Fast Track" and "Kappa" areas of the ED did not contain signs regarding the rights of patients with EMCs under EMTALA. The EDEMS acknowledged there were no EMTALA signs in the "Fast Track" or "Kappa" areas.
Review of the hospital policy "EMTALA - Signage Policy" (May 2019) indicated, "SHC [Stanford Health Care] and SCH [Stanford Children's Health] will post signs in the form of Exhibit A (EMTALA Sign) in the main entrance of SHC and SCH, as well as the waiting area, treatment area and other places likely to be noticed by all individuals waiting for examination and treatment of departments and clinics, including but not limited to the following: -Emergency Department..."
|VIOLATION: APPROPRIATE TRANSFER||Tag No: A2409|
|Based on interview and record reviews, the hospital failed to have a transfer form for Patient 16 and a summary of the risks and benefits for Patients 17 and 18 when they were transferred to another facility. This had the potential for patients not to be fully informed of the reasons for their transfers.
During a review Patients 17 and 18's Emergency/Transfer: Physician Assessment and Certification forms version 2/04 and concurrent interview on 10/16/19 at 12:30 p.m. with the Nursing Quality Manager, Emergency Services, she confirmed Patient 16 did not have any transfer form completed when Patient 16 was transferred to a psych facility. She also confirmed Patients 17 and 18's transfer forms did not have a summary of the risks and benefits for their transfer as discussed by the transferring physicians.
|VIOLATION: RECIPIENT HOSPITAL RESPONSIBILITIES||Tag No: A2411|
|Based on interview and record review, the hospital failed to accept the inbound transfer of 1 of 20 sampled patients (Patient 1). Patient 1 had an unstabilized emergency medical condition for which the hospital had both specialized capabilities and current capacity. The deficient practice delayed Patient 1's care and increased Patient 1's risk of dying.
Review of Patient 1's "ED [emergency department] Physician Notes" at the referring hospital dated 9/29/19 indicated the referring hospital was located in Santa Cruz, California, within the boundaries of the United States. The notes indicated Patient 1 was "brought in by EMS [ambulance] presents with hypotension [low blood pressure], altered mental status, also reports some chest and upper abdominal discomfort... XR [x-ray] Chest... Large area of consolidation [an opacity on a chest x-ray]/airspace disease in right lung... Work-up shows evidence of significant pneumonia. Patient became more interactive during observation, now complains of chest pain. Reports history of thoracic and abdominal aortic aneurysm [swelling of the largest artery in the body]. Records were reviewed. She does indeed have an aneurysm on her previous CT [computed tomography, a diagnostic imaging study in which a computer reconstructs cross-sectional images from multiple x-rays]... Will CTA [CT angiogram, an imaging study using CT and contrast, a dye injected into the blood, to visualize blood vessels] chest and abdomen..."
Review of Patient 1's "Computerized Tomography" report at the referring hospital dated 9/29/19 at 5:11 p.m. indicated, "Enlarging descending thoracic aortic aneurysm extending to the abdominal aorta and bilateral common iliac arteries [the main arteries carrying blood toward the legs formed by a fork in the aorta]. There is also evidence of thoracic aortic rupture and contrast extravastation [a collection of contrast found outside a blood vessel, suggesting bleeding], with a large mediastinal hematoma [collection of blood in the middle of the chest]. There is a large right hemothorax [blood around the lungs]."
Review of an addendum to the "ED Physician Notes" at the referring hospital dated 9/29/19 at 5:21 p.m. indicated, "I received a call... from radiology regarding concerns the patient has a bleeding thoracic aortic aneurysm. Chest x-ray abnormalities may be blood rather than consolidation. Will... discuss case with cardiothoracic surgery." Review of an addendum to the "ED Physician Notes" dated 9/29/19 at 5:28 p.m. indicated, "[cardiothoracic surgeon] called back after CT scan reviewed, notes he is concerned about the abdominal portion as well as the chest portion. We do not have vascular surgery to manage the abdominal aortic aneurysm. The aneurysm is also not amenable to endovascular repair [repair from inside the blood vessel]... Recommends transfer [to] higher level of care with cardiothoracic as well as vascular surgery. Case discussed with transfer center and Stanford to initiate likely transfer. Please update diagnosis to thoracic and abdominal aortic aneurysm, hemorrhagic [bleeding]. Condition = critical."
Review of Patient 1's "ED Physician Notes" at the referring hospital dated 9/29/19 indicated, "9/29/19 19:10:00 , phone call, Discussed with [Provider A] at Stanford. Has accepted. 9/29/19 19:40:00 , phone call, Stanford now says unable to accept patient."
Review of a "Timeline for canceled request for [Patient 1]" obtained from Stanford indicated, "09/29 1740... EMTALA [emergency medical treatment and active labor act] question asked, referring MD [doctor of medicine] answered yes... 09/29 1810... Per ANS [administrative nursing supervisor], can make E29 [name of a patient unit] ICU [intensive care unit] bed... 09/29 1913 Per [Provider A] he wants to present this to [Provider B]. Pt [patient] is homeless and is on meth [methamphetamine, a stimulant commonly used as a recreational drug], with no PCP [primary care physician] and no follow up. [Provider A] said he is not going to put a stent graft [a metal and fabric tube inserted inside a blood vessel to repair a ruptured aneurysm] in someone who will not have follow up... 09/29 1924 Per [Provider B] we can clinically deny this pt if [Provider A] will not do anything with this patient... 09/29 1930 Notified... ref TC [referring transfer center] that pt is clinically denied..."
Review of a screenshot from the hospital's transfer center intake screen indicated the "EMTALA Question" was "Does the patient have an emergency medical condition that your facility is unable to treat?"
In an interview on 10/16/19 at 10:04 a.m., Transfer Center Registered Nurse C (TCRN C) stated she was familiar with Patient 1's case, that a nurse and a communications specialist work together on a potential transfer, and that she had been the nurse assigned to Patient 1. TCRN C stated she asks the nursing supervisor if a bed is available, and if so, she connects one of the Stanford physicians to the referring physician. TCRN C stated a bed was available for Patient 1, and she was listening in the background while Provider A discussed Patient 1 with the referring physician. TCRN C stated Provider A wanted to discuss the case with Provider B, and that Provider A had indicated he would not put a stent graft in a patient who did not have follow-up care. TCRN C stated Provider B felt there was nothing that would be done differently at Stanford than at the referring hospital.
In an interview on 10/16/19 at 10:34 a.m., Medical Transportation Communications Specialist D (MTCS D) stated she had taken the initial intake regarding Patient 1, and had spoken to the referring physician, who indicated there was no vascular surgery available at the referring hospital. MTCS D stated she had asked the referring physician, "Does the patient have an emergency medical condition that your facility is unable to treat", and that the referring physician had answered yes.
In an interview on 10/16/19 at 12:06 p.m., Case Manager E (CM E) stated she was the case manager for the vascular surgery program. CM E stated in the case of an indigent, homeless patient with no PCP, she would reach out to the hospital's financial department to try to get the patient insurance and would attempt to get the patient established with a PCP in her home county. CM E stated to address homelessness, she would look at the patient's needs and eligibility and attempt to arrange respite care or a shelter placement. CM E stated the vascular surgery program had patients from "all over Northern California", including some homeless patients. The Manager of Care Coordination stated Santa Cruz county (the location of the referring hospital) had a support system for its homeless population that included county-operated medical clinics.
In an interview on 10/16/19 at 1:08 p.m., Provider B stated he was the Medical Director of the Transfer Center and had secondary, indirect involvement in Patient 1's case. Provider B stated he did not speak to the referring hospital ED or to Provider A, but had since discussed the case with Provider A. Provider B stated he spoke to TCRN C who told him Provider A's question, "If no surgery is planned, can we decline?" Provider B stated he was not involved in the decision to decline surgery, but his answer was yes, if no surgery is planned, the patient could receive care at the referring hospital. Provider B stated his understanding was that a complex surgery would require an organized social circumstance and that Provider A didn't feel comfortable.
In an interview on 10/17/19 at 11:34 a.m., Provider A stated the referring ED physician had described Patient 1 as having a leaking thoracoabdominal aneurysm, and cardiothoracic surgery at the referring hospital had seen the patient but felt they needed vascular surgery backup. Provider A stated such cases were comanaged at Stanford by the ICU team, cardiothoracic surgery, and vascular surgery. He stated depending on the patient's anatomy, there was a choice of endovascular or open repair. Provider A stated he did not have Patient 1's images and had not discussed the case with the cardiothoracic surgeons. Provider A stated in the case of a leaking thoracic aneurysm, he had prior discussions with cardiothoracic surgery indicating the mortality in such cases was 100 percent, and the question was whether to do a heroic stent. Provider A stated Patient 1 had suffered a "mortal event", based on published experience, and he had used the wrong language on the phone call with the referring physician. Provider A stated he wanted to talk to Patient 1's family about goals, and did request at the end of the call for the Medical Director to get involved because he "was not going to go straight to the OR [operating room]." Provider A stated he was not willing to operate if the mortality was 100 percent, he didn't feel he could help Patient 1, and he heard an hour later that Patient 1 went elsewhere. When the surveyor asked what published experience Provider A was referring to, Provider A replied that there was a paper in the Annals of Thoracic Surgery about 10 years prior which showed no benefit or a 97% mortality at 30 days. When the surveyor asked whether some patients opted for a 3% chance of survival rather than certain death, Provider A replied that he had attempted some heroic surgeries about 10 years ago but had turned such patients down for the past five to six years because his unpublished experience was that they had all died before hospital discharge and he had concluded it was not reasonable to offer surgery. When the surveyor asked if the hospital could provide the data Provider A was referring to, Provider A stated "a couple" patients had survived, but his experience on "a handful" of patients with hemothorax was that all had died . The Chief Medical Officer stated the hospital would pull Provider A's data.
Review of a journal article provided by the hospital in response to the surveyor's request for the article described by Provider A (Johansson G, Markstrm U, Swedenborg J. Ruptured thoracic aortic aneurysms: a study of incidence and mortality rates. J Vasc Surg. 1995;21:985-8.) indicated, "In 1980, 82 individuals... had rupture of a TAA [thoracic aortic anuerysm]. In 1989 the corresponding number was 76... Altogether only two patients with ruptured TAA underwent acute operations... both survived. Thus 156 patients died without surgical intervention. The total mortality rate in patients with ruptured TAA was 100% in 1980 and 97% in 1989... A mortality rate as low as 20% has been reported after surgical repair after rupture."
Review of a second journal article provided by the hospital (Dua A, Lavingia KS, Deslarzes-Dubuis C, Dake MD, Lee JT. Early Experience with the Octopus Endovascular Strategy in the Management of Thoracoabdominal Aneurysms. Ann Vasc Surg. 2019;doi: 10.1016/j.avsg.2019.05.043. [electronic publication ahead of print]) indicated 21 patients, including two with ruptures, underwent the Octopus procedure ("placement of multiple, stacked bifurcated grafts in the thoracic segment of a thoracoabdominal aneurysm"). Survival was 90.5% at 30 days, 88.3% at 6 months, 71.4% at one year, and 52.1% at three years. The article did not present separate survival rates for patients with ruptured aneurysms, but indicated one patient with a rupture had died before leaving the hospital.
Review of the UpToDate (an online medical reference) article, "Management of thoracic aortic aneurysm in adults" (updated 10/9/19) indicated, "The overall mortality associated with ruptured TAA is high. Only approximately one half of patients with ruptured TAA live long enough to be transferred to the emergency department for treatment. Without repair, ruptured TAA is nearly uniformly fatal. Unfortunately, regardless of the method of repair, a large portion of patients with ruptured TAA still do not survive... The outcomes of endovascular versus open surgery in the emergency setting were specifically addressed in a nonrandomized study of 60 consecutive patients with acute rupture of the thoracic aorta; 28 patients were treated surgically and 32 were treated with an endovascular stent-graft. The following findings were reported: -Perioperative mortality was significantly lower with the endovascular approach compared with open surgery (3.1 versus 17.8 percent). -At a mean follow-up of 36 months, four additional deaths occurred in patients who received stent-grafts... No additional procedure-related deaths occurred in the surgical patients."
Review of the study referenced by UpToDate (Doss M, Wood JP, Balzer J, Martens S, Deschka H, Moritz A. Emergency endovascular interventions for acute thoracic aortic rupture: four-year follow-up. J Thorac Cardiovasc Surg. 2005;129:645.) indicated the total mortality was 15.6% for patients receiving stents and 21.4% for patients receiving surgery.
Review of a journal article by Geisbsch et al (Geisbsch P, Kotelis D, Weber TF, Hyhlik-Drr A, Bckler D. Endovascular repair of ruptured thoracic aortic aneurysms is associated with high perioperative mortality and morbidity. J Vasc Surg 2010;51:299-304.) indicated, "...after endovascular treatment of ruptured thoracic aortic aneurysms... The one- and three-year survival rates were 37.3% and 29.9%..."
Review of a printout of Provider A's privileges dated 10/17/19 indicated they included "Aortic procedures (2/21/2018 - 2/20/2020)... Endovascular procedures, including balloon dilation, stenting and stent-grafting... (2/21/2018 - 2/20/2020)".
Review of a letter from the hospital to the state survey agency dated 10/18/19 indicated the hospital's vascular surgery "Services offered" included "Open and endovascular repair of thoracic and abdominal aortic aneurysms". The letter included an undated spreadsheet titled "[Provider A] Internal Data" listing 21 patients with dates of unspecified surgery between 6/17/13 and 11/27/17; the spreadsheet indicated 10 of 21 patients had died and 11 of 21 had not. The letter included transcripts of five recorded phone calls regarding Patient 1. The transcript of "Tape One" indicated MTCS D asked the ED physician at the referring hospital whether Patient 1 had an emergency medical condition the referring hospital was unable to treat; the ED physician replied, "Yes." The transcript of "Tape Two" indicated Provider A discussed Patient 1 with the "Referring MD", with TCRN C on the line. The transcript of Tape Two indicated, "[Referring MD]: ...What I have here tonight is a... female who had a known aneurism [sic], thoracic and abdominal aortic aneurism [sic]. Was found down on a bridge, she is a homeless lady. Umm uses alcohol and meth and initially it was felt she had a right-sided pneumonia, however when she came around, she said oh I have an aneurism [sic]. We CT'd it and it appears it is a hemothorax that she has and there is a leak in her thoracic component of the aneurism [sic]. [Provider A]: Has she ever been treated or followed for it, or? This is...She has not been previously treated for it [Referring MD]: No, no nothing like that... [Provider A]: yup, does she have follow-up or anything guys, or does she? So she is in the ER or she is admitted ? Or what is the deal? [Referring MD]: Correct, she is in the ER [Provider A]: Ok, yup there is going to be nothing to do. I am not going to stent graft in a homeless person so. Just bring her over we will talk to her, we will have a plan for her, probably just pull her back so just a social visit really. Unfortunately, you can't fix these if they don't have good follow up so. Ok guys, this one we just have to eat and bring her over so... And how come the CT [cardiothoracic] surgeon there, doesn't want to take care of it? Just out of curiosity? [Referring MD]: Cuz [sic] it extends down into the abdomen and so he felt inaudible [Provider A]: inaudible... or that she doesn't have insurance... yeah that's probably what it is. Yeah.. ok. Alright. Sounds good. We are happy to care for her here... Does she have any family or anything? Not really, no. [Referring MD]: I have a mother, I have a name and phone number of her mother. [Provider A]: Yeah, but she lives on her own, a drug user and everything, so. [Referring MD]: Yeah she is on the streets [Provider A]: Ok. Yeah, alright, ok sounds good... Ok guys let's just book an ICU bed nothing we can do about this one, so... We have to take this one basically? [TCRN C]: If they have CT surgery and says [sic] that they can't take care of the patient [Provider A]: Yeah I mean anybody can say that, right? that's alright. Ok we will just bring her over but there is going to be nothing I am going to do, so that's fine. Well [sic] just bring her over then, I don't know.. Shall we talk to [Provider B] and then let's see [TCRN C]: Yeah...I am going to actually present this to [Provider B] the Medical Director... [Provider A]: Of course, yeah, there is going to be nothing we are going to do so... We will baby sit her and then try to get her back to the street. I mean that's just...anybody can do that... you know... so..." The transcript of "Tape Four" indicated TCRN C discussed Patient 1 with Provider B: "[TCRN C]: ...he [Provider A] said you know I am not going to put a stent graft in somebody who doesn't have...who is not going to have follow up, so we just going to visit her [sic], talk to her and you know and... He was even telling me like... do we have to take this patient? The CT surgeon is saying that they can't take care of it, but per [Provider A]... he said you know we should maybe get [Provider B] on this, because any hospital can do this, I am not going to do anything to this patient... So, I just wanted to bring this up to you first before we deny it clinically. [Provider B]: Yeah so if, it sounds like [Provider A] has already outlined that he wouldn't put a stent graft in this patient. [TCRN C]: Yeah, mhmm [Provider B]: So then the patient doesn't need to come here to get something that they want and [Provider A] does not want to put in... we can as [Provider A] has done clinically deny the patient. They are... free to look elsewhere to find somebody who would be willing to do the procedure... They can't force [Provider A] to do a procedure they want, and he is uncomfortable with... [TCRN C]: Alright, so Ill [sic] just say clinically denied." The transcript of "Tape Five" indicated TCRN C phoned the referring hospital regarding Patient 1: "[TCRN C]:... our Medical Director clinically denied this patient... Cuz [sic] our surgeon will not do anything with this patient."