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GOVERNING BODY

Tag No.: A0043

Based on interview and record review, it was determined that the facility failed to ensure there was an effective Governing Body to ensure Medical Staff Bylaws were followed and physicians who were granted privileges provided safe quality care to patients (Refer to A0057, A0115, A0145, A0338, and A0341).

The findings include:

On 12/22/2020, the CEO and Chief of Staff granted temporary privileges to Physician #2.

On 12/28/2020, after Patient #1 expired at the facility, RN #1 reported concerns to the CEO regarding Physician #1's care of the patient and his clinical abilities.

According to interviews, sometime on or after 12/28/2020, exact date unknown, Physician #1, #4 and #6 reported their concerns related to Physician #2 's care of patients, particularly, Patient #1.

On 03/15/2021, after the CEO had taken no action to address their concerns and they had new concerns with Physician #2's care of Patient #2, Physician #1, #4 and #9 sent a letter to the CEO requesting Physician #2's privileges be suspended and a thorough assessment of Physician #2's clinical skills because "several patients had unexpectedly died under his direct clinical management".

On 04/21/2021, the CEO and Chief of Staff gave Physician #2 temporary privileges, despite the continued concerns of physicians and nursing staff.

On 04/28/2021, Physician #2 failed to recognize Patient #5 had an elevated white blood cell count and lactic acid; subsequently, laboratory tests were not repeated and antibiotics were not initiated. Patient #5 had hypotensive episodes on 04/30/2021, 05/01/2021, and 05/02/2021; however, Physician #2 took no action to treat the patient despite numerous calls from nursing staff. The patient's white blood cell count was not repeated again until 05/02/2021, four days later when the result was 1.2 (critically low). On 05/02/2021, Patient #5 was transferred via Air-Evac at 4:55 AM; however, by that time, the patient was pale, tachypneic, and his/her blood pressure was 69/45. Patient #5 was admitted to Facility #4 with diagnoses of Acute Respiratory Failure, Severe ARDS (acute respiratory distress syndrome, which is a condition where fluid collects in the lungs), septic shock, anemia/thrombocytopenia, dilated right heart ventricle, etc. The patient remained an inpatient at Facility #4.

CHIEF EXECUTIVE OFFICER

Tag No.: A0057

Based on interview, record review, and review of facility bylaws, it was determined that the governing body failed to ensure the appointed Chief Executive Officer (CEO) was responsible for managing the facility to ensure patient safety (Refer to A0115, A0145, A0338 and A0341).

The findings include:

Review of the facility "Bylaws of the Medical Staff" dated 06/05/2019 revealed "when an Applicant with a complete application that raises no concerns is awaiting review and approval of the Medical Executive Committee and the Board, the CEO or designee, upon recommendation of the Chief of Staff, may grant the Applicant temporary privileges for no more than 120 days upon verification of ....current competence; ability to perform the privileges requested ..."

Further review revealed the "CEO or designee, with concurrence of the Chief of Staff, may at any time terminate a Practitioner's temporary privileges effective upon discharge from the hospital of the Practitioner's patient(s). However, where it is determined that the life or health of such patient(s) would be endangered by continued treatment by the Practitioner, the termination may be imposed by any person entitled to impose a summary suspension pursuant to Section 7.2 of these Bylaws and shall be immediately effective."

A review of Section 7.2 of the facility's Bylaws revealed an emergency suspension of any or all clinical privileges of a Member may be imposed by the Chief of Staff or designee, Vice Chief of Staff or designee, or the CEO "whenever failure to take such action may, in his/her opinion result in an imminent danger to the health or safety of any individual."

Continued review revelaed the duties of the Medical Executive Committe included but was not limited to: Instituting and recommending corrective action in accordance with Article 7, including termination of Medical Staff membership, where appropriate; Requesting evaluations of practitioners privileged through the Medical Staff process in instances where there is doubt about an applicant ' s ability to perform the privileges requested; Making recommendations directly to the Board regarding: the delineation of privileges for each practitioner privileged through the Medical Staff process; and Medical Staff membership; Evaluating the medical care rendered to patients in the Hospital; and Taking reasonable steps to promote ethical conduct and competent clinical performance on the part of all members, including the initiation of and participation in Medical Staff corrective action or review measures when warranted;

Review of Physician #2's privileges revealed on 12/22/2020, the CEO and Chief of Staff granted temporary privileges to Physician #2. The document stated, "These privileges are limited to Allergy and Immunology." Review of the facility physician on-call schedule revealed Physician #2 was on a rotating call schedule as the only physician on call for the facility.

Record review revealed Patient #1 was admitted to the facility on 12/27/2020 with chest pain. On 12/28/2020 at approximately 8:00 AM, nursing staff asked for physician #2's help because the patient was in distress. However, the physician did not assess the patient and left the unit. The physician did not respond to assess the patient until approximately 9:15 AM -9:30 AM, over one (1) hour later. Once in the ICU, Physician #2 ordered a paralytic medication prior to intubation and Patient #1 had cardiopulmonary arrest. Physician #2 was unable to intubate the patient after three (3) attempts at 9:43 AM. The patient was not intubated until 10:00 AM, when Physician #1 responded to the code and intubated the patient. However, Patient #1 was pronounced dead at 10:06 AM on 12/28/2020 due to Acute Cardiopulmonary Arrest.

Review of an email dated 01/04/2021, revealed Physician #1 sent an email to the CEO and facility Chief of Staff (COS) (7 days after Patient #1 expired at the facility) regarding concerns that had been raised by senior experienced staff related to care of Patient #1. Physician #1 requested a thorough internal review, analysis, and a report to be compiled related to the events that occurred with the patient's care. The email and interview also indicated Physician #1 recommended a peer review occur, from a physician on staff at the time, who was board certified in critical care and pulmonology. However, according to an interview with Physician #1 on 05/05/2021 at 3:20 PM, the CEO denied his request. Physician #1 stated he had also requested that a Medical Executive Committee (MEC) meeting be held so that staff to had the ability to "bring all the concerns to the table," regarding Physician #2's practices. Again, the CEO denied the physician's request. Physician #1 stated as a member of the MEC committee he had requested to review Physician #2's credentials and again, the CEO denied that request. Physician #1 stated he was concerned about Patient #1's care because Physician #2 had not attempted to stabilize the patient and no blood gas or chest x-ray was obtained prior to initiating intubation. Further, the physician did not have the patient in correct positioning for intubation, did not have appropriate intubation supplies in the patient's room; subsequently, Physician #2 caused a hematoma to the patient's vocal cords because there was no way he could see what he was doing. Physician #1 further stated that he, Physician #4, and Physician #6 also sat down with down with the CEO regarding concerns about the care the physician provided.

On 12/28/2020, after Patient #1 expired, interview with RN #1 at 04/28/2021 at 10:50 AM revealed she reported concerns to the CEO regarding Physician #1's care of the patient and his clinical abilities.

Further, review of a letter addressed to the governing body revealed on 02/03/2021, facility nursing staff sent an anonymous letter (The letter stated they did not list their names for fear of retaliation) regarding concerns that included Physician #2's care of Patient #1. According to the letter, the CEO was not addressing concerns at the facility and nursing staff asked the board to launch a full investigation into the CEO's behavior and facility practices.

Interview with the Case Manager on 05/03/2021 at 4:15 PM revealed the CEO immediately instructed her to investigate Patient #1's death after the patient expired on 12/28/2020. The Case Manager stated she interviewed staff and they voiced concerns related to the care the patient received. According to the Case Manager, she did not address their concerns, she just "obtained statements and turned them over to the CEO."

On 03/03/2021, Patient #2 was admitted to the facility's ICU. On 03/07/2021, at 3:00 AM, Physician #2 called the patient's family because the patient's skin was blue, the patient was lethargic and had agonal breathing (struggling/gasping to breathe that is a symptom of a severe medical emergency such as a stroke or cardiac arrest). However, no emergency resuscitative effort was initiated to stabilize the patient. The patient continued to decline and Physician #2 arranged for transport; however, did not initiate any resuscitative efforts. When EMS arrived at 6:20 AM, the patient was too unstable for transport. Air-Evac was then notified; however, they would not transport the patient either due to being too unstable. Physician #1 was notified to treat the patient even though Physician #2 was at the patient's bedside. However, by that time (8:00 AM), the patient was responsive to painful stimuli only, was severely hypotensive and hypoxic, and was mottled from the waist down. Physician #1 had to intubate the patient and administer intravenous emergency medications to stabilize Patient #2 for transport. Patient #2 was transported to Facility #3 and was diagnosed with profound shock, acute hypoxic respiratory failure, fixed dilated pupils, low heart rate, encephalopathy (concern for brain anoxic injury). Patient #2 expired at Facility #3 at 3:05 PM on 03/08/2021.

Review of the email addressed to the CEO and COS revealed on 03/15/2021, Physician #1, #4, and #9 requested the admitting privileges of Physician #2 "be immediately suspended until a full review of credentials and a thorough assessment of his clinical skills" could be conducted. The email stated, "As you are aware, there have been several patients who have unexpectedly decompensated and died under his direct clinical management. The circumstances of the unfortunate demise of these patients demand an immediate review by members of the permanent medical staff to ensure the continued safety of patients who seek medical attention at [the facility]".

According to an interview with Physician #9, an Emergency Department Physician, on 04/20/2021 at approximately 4:00 PM, the only response he received was on 04/09/2021, when the CEO handed him a notice that stated, "All patients that are admitted to [the facility] from the Emergency Department shall be admitted to the Physician On-Call as listed on the monthly Call Schedule. This policy is to be strictly adhered to for the efficient and effective continuity of care of the patient. The Emergency Department Physician does not have the authority or ability to deviate from this policy without written consent of the Chief of Staff or Chief Executive Officer." Physician #9 stated the notice was also posted in the ED.

According to Physician #9, he responded by sending the CEO and COS another email that stated, "I am again formerly asking you to provide me the medical executive committees review of the two charts [Patient #1 and Patient #2] that have been in question in the March 14th letter to [COS]. despite your undated letter that you handed me today commanding me to admit to the physician on-call, I must repeat my profound professional reluctance to admit patients to [Physician #2's] service. I have politely and professionally requested to peruse the medical executive committee's review AND APPROVAL of [Physician #2s] handling of both cases. I have spoken to one of the members of this committee ...who adamantly denies reviewing either chart. without me seeing the formal documentation, review and APPROVAL of [Physician #2's] handling of the abovementioned patients, as well as the committee's blessing that [Physician #2] continue to manage ICU patients, I must assume that no formal review and approval has been undertaken. in light of this, I am mandated by my Oath and conscious, not your letter, to do what I think is the best for the patients who entrust their care to me."

There was no documented evidence the CEO took any action to address the physicians' concerns.

Continued review of Physician #2's credentials revealed on 04/21/2021, the CEO and Chief of Staff (COS) gave Physician #2 temporary privileges for the second time, despite the continued concerns of physicians and nursing staff.

Six (6) days later, on 04/27/2021, Patient #5 was admitted with diabetic ketoacidosis, and had four (4) indicators of sepsis. Physician #2 took over the patient's care on the morning of 04/28/2021, but failed to recognize the patient had an elevated white blood cell count and lactic acid; subsequently, laboratory tests were not repeated and antibiotics were not initiated per the sepsis protocol. Patient #5 had hypotensive episodes on 04/30/2021, 05/01/2021, and 05/02/2021; however, Physician #2 took no action to treat the patient despite numerous calls from nursing staff. The patient's white blood cell count was not repeated again until 05/02/2021, when the result was 1.2 (critically low). On 05/02/2021, Patient #5 was transferred via Air-Evac at 4:55 AM; however, by that time, the patient was pale, tachypneic, and his/her blood pressure was 69/45. Patient #5 was admitted to Facility #4 with diagnoses of Acute Respiratory Failure, Severe ARDS (acute respiratory distress syndrome, which is a condition where fluid collects in the lungs), septic shock, anemia/thrombocytopenia, dilated right heart ventricle, etc. The patient remained an inpatient at Facility #4.

According to the CEO on 05/12/2021 at 1:20 PM, he was aware of physician and nursing staff concerns. The CEO stated he also communicated with the governing body that there were concerns voiced; however, no issues had been identified. He stated Physician #3 and the Chief of Staff reviewed Patient #1 and #2's medical records and had no concerns with the care and treatment provided by Physician #2 (However, there was no evidence the physicians identified that Physician #2 did not treat Patient #2's respiratory distress, did not identify the delay in Physician #2 treating #1, and did not verify Physician #2's clinical skills with intubation). However, there was no evidence the concerns were discussed during a Medical Executive Review Committee until 04/28/2021. By that time, the CEO had already given Physician #2 temporary privileges seven (7) days prior earlier, on 04/21/2021.

Interview with a member of the Governing Body on 05/13/2021 at 4:10 PM, revealed she received the anonymous letter from nursing staff. She stated she asked a lot of questions and talked to a few people, but felt like they were not forthcoming. She stated if "they don't come forward independently", she did not think the complaints were "valid". The member of the Governing Body stated she had no concerns with the CEO and felt he had made "leaps and bounds" of progress.

PATIENT RIGHTS

Tag No.: A0115

Based on interview and record review, it was determined that the facility failed to protect and promote the rights of three (3) of five (5) patients (Patient #1, #2, and #5) to ensure they were free from neglect.

The findings include:

Patient #1 was admitted to the facility on 12/27/2020 with chest pain and Physician #2 was the on call physician on 12/28/2020. Physician #2 was on the unit on 12/28/2020 at approximately 8:00 AM when nursing staff asked for the physician's help because the patient was in distress. However, the physician did not assess the patient and left the unit. Nursing staff called physician #2 after he left the unit; however, the physician did not respond to assess the patient until approximately 9:15 AM -9:30 AM after the Chief Nursing Officer called the physician and told him to come to the ICU now. Once in the ICU, Physician #2 was unable to intubate the patient after giving the patient a paralytic medication. Physician #1 and #4 responded to ICU; and physician #1 was able to intubate the patient; however, Patient #1 was pronounced dead at 10:06 AM on 12/28/2020 due to Acute Cardiopulmonary Arrest. According to interviews with Physician #4 and #1, Physician #2 did not have the clinical skills necessary to intubate the patient and caused a hematoma to the patient's vocal cords. Physician #1 stated the paralytic medication further compromised the patient's ability to breath and the patient was without oxygen too long.

On 03/03/2021, Patient #2 was admitted to the facility's ICU. On 03/06/2021, the patient developed leg pain and a nursing assessment revealed the patient's leg was cold and discolored, with a weak pulse. The patient's D-Dimer, kidney function, and potassium had elevated to abnormal levels, his/her CT scan showed CHF and bilateral pleural effusions, pericardial effusion, generalized anasarca (severe form of generalized edema), and an atrophied left kidney; the patient's vital signs were abnormal. On 03/07/2021, at 3:00 AM, the physician called the patient's family because the patient's skin was blue, the patient was lethargic and had agonal breathing. However, no emergency resuscitative effort was initiated to stabilize the patient. The patient continued to decline and Physician #2 arranged for transport; however, did not initiate any resuscitative efforts. When EMS arrived at 6:20 AM, the patient was too unstable for transport. Air-Evac was then notified; however, they would not transport the patient either due to being too unstable. Physician #1 was notified to treat the patient even though Physician #2 was at the patient's bedside. However, by that time (8:00 AM), the patient was responsive to painful stimuli only, was severely hypotensive and hypoxic, and was mottled from the waist down. Physician #1 had to intubate the patient and administer intravenous emergency medications to stabilize Patient #2 for transport. Patient #2 was transported to Facility #3 and was diagnosed with profound shock, acute hypoxic respiratory failure, fixed dilated pupils, low heart rate, encephalopathy (concern for brain anoxic injury). Patient #2 expired on 03/08/2021 at 3:05 PM.

Patient #5 was admitted to the facility on 04/27/2021 with Diabetic Ketoacidosis, and had four indications of sepsis, including elevated white blood cell count and lactic acid. Physician #2 failed to identify the sepsis indicators; subsequently, laboratory tests were not repeated and antibiotics were not initiated per the sepsis protocol. Patient #5 had hypotensive episodes on 04/30/2021, 05/01/2021 and again on 05/02/2021. However, Physician #2 took no action despite numerous calls from nursing staff. The patient's white blood cell count was not repeated again until 05/02/2021, when the result was 1.2 (critically low) A transfer was initiated on 04/30/2021 for Patient #5 due to an abnormal laboratory results and an abnormal CT. However, a bed was not available for the patient and no further attempts to transfer the patient to a higher level of care occurred until 05/02/2021 at midnight, when his/her blood pressure was 75/46. On 05/02/2021, Patient #5 was transferred via Air Evac at 4:55 AM; however, the patient was pale in color/tachypneic (fast breathing) and his/her blood pressure was 69/45 and air transport staff initiated a Levophed drip (medicine to increase blood pressure) and the patient was also intubated and placed on mechanical ventilation prior to being placed on the aircraft for transport. Patient #5 was admitted to Facility #4 with diagnoses of Acute Respiratory Failure, Severe ARDS (acute respiratory distress syndrome which is a condition where fluid collects in the lungs), septic shock, anemia/thrombocytopenia, dilated right heart ventical, etc. The patient remained an inpatient at Facility #4.

PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

Based on interview, record review and a review of facility policy, it was determined the facility failed to protect three (3) of seven (7) sampled patients from neglect, Patient #1, Patient #2, and Patient #5.

The findings include:

Review of the facility policy titled "Patient Abuse and Neglect Prevention Program" last revised June 2019 revealed neglect occurred when an individual did not receive care in one or more areas.

Review of the facility protocol for Sepsis (undated), revealed the purpose of the protocol was to identify early symptoms of sepsis and provide initial treatment of sepsis. Further review revealed symptoms for recognizing sepsis included the following: tachycardia (increased heart rate over 100); tachypnea (increased respirations above 20); hypotension (decreased blood pressure below 90/60); temperature above 100.9 or below 96.8; oliguria (low urine output); mottled skin; changes in mental status; acute respiratory syndrome; cardiac dysfunction; white blood count (WBC) above 14,000 or below 12,000; platelet counts less than 100,000 and the pressence of lactic acid in the blood above 19.8. Per the protocol, initial treatment was to be initiated within one hour of arrival to ED and the treatment included keeping oxygen saturation at 94% or greater, obtain blood cultures x 2, complete metabolic panel (CMP), complete blood count (CBC), prothrombin time (PT), international normalized ratio (INR), lactic acid level, administer fluid challenge (per physician discretion), intravenous antibiotics (per physician discretion), monitor vital signs, mental status changes, and urine output.

1. Review of Patient #1's record indicated he/she was admitted to the facility on 12/27/2020 with chest pain. According to review of the physician call schedule for December 2020, Physician #2 was the on call physician on 12/28/2020.

Interview with Registered Nurse (RN) #1 on 04/28/2021 at 10:50 AM revealed Physician #2 was in the Intensive Care Unit (ICU) on 12/28/2020 at approximately 8:00 AM when nursing staff asked for the physician's help because the patient was in distress. However, according to the RN, the physician did not assess the patient and left the unit to see other patients.

Continued interview with RN #1 revealed nursing staff called Physician #2 after he left the unit because Patient #1 continued to be in distress. However, the physician did not respond to assess the patient until approximately 9:15 AM -9:30 AM, after the Chief Nursing Officer called the physician and told him to come to the ICU "now", over an hour after RN #1 first asked for Physician #2's assistance. Further interview with the RN and review of the patient's medical record revealed, once the physician returned to the ICU, and was preparing to intubate the patient, Patient #1's vital signs "dropped" and a code blue was initiated. The nurse stated the Physician #2 ordered "paralytics" (medications to sedate the patient) which was not normally utilized for intubation attempts. Then, Physician #2 was unable to intubate the patient. The RN was unable to recall how many attempts the physician made to intubate Patient #1, because she was "doing chest compressions." According to the RN, Physician #1 and #4 then responded to ICU; and Physician #1 was able to intubate the patient. However, Patient #1 was pronounced dead at 10:06 AM on 12/28/2020, due to Acute Cardiopulmonary Arrest.

According to interviews with Physician #4 on 05/12/2021 at 3:40 PM and Physician #1 on 05/02/2021 at 3:20 PM, Physician #2 did not have the clinical skills necessary to intubate Patient #1 and caused a hematoma to the patient's vocal cords. Physician #4 stated Physician #2 did not ensure the patient was appropriately positioned so the patient's airway could be visualized and before paralytic medications were administered to the patient. Physician #4 also stated once arriving to the ICU to assist with the intubation, he had to take time to have staff assist him in properly positioning the patient, before he could attempt to intubate the patient on 12/28/2020. Physician #4 stated he felt Physician #2 damaged the patient's airway, causing a hematoma. He stated, "There's no way anyone could have visualized the patient's cords to intubate" because of the way the patient was lying in the middle of the bed. The physician also stated, "What physician would administer paralyzing medications to a 200 plus pound patient without having the patient properly positioned to see the cords in preparation for an intubation."

Interview with Nurse Practitioner (NP) #2 on 04/30/2021 at 11:15 AM revealed after Patient #1 expired at the facility, RN #1 informed her that she felt like Physician #2 "just left her" because after she notified the physician that Patient #1 was in distress, he never assessed the patient and just left the ICU to go to another unit of the hospital.

Interview with RN #1 on 04/28/2021 at 10:50 AM revealed she felt like Physician #2 neglected Patient #1. The RN stated, "What doctor leaves an ICU patient without even looking them?" especially after a nurse has told him the patient is in distress, "that's neglect." RN #1 also stated she felt Patient #1 could have had a better outcome if Physician #2 would have "looked at the patient at 8 o'clock when I first asked him too instead of letting the patient get so much worse until" the patient was "begging to be intubated because [he/she] couldn't breathe."
Interview with Physician #2 on 05/10/2021 at 11:45 AM revealed when he arrived to conduct provider rounds on 12/28/2020, even though he was the on call provider as of 8:00 AM that day, he was not aware that he needed to see Patient #1. He stated he went into the ICU and a nurse notified him that Patient #1 was hypertensive, having trouble breathing, and spitting up blood so "I ordered a CT." The physician stated he did not evaluate the patient's status at that time, and went to another floor of the hospital to do rounds. He stated he should have asked more questions about why the nurse was telling him about this patient's distress, so he could have realized that he needed to see the patient sooner. The physician stated he recalled receiving a call "later" that the patient was too sick to go to CT, and was notified again regarding the patient's condition. He stated when he went to the ICU to evaluate the patient, he found the patient was hypertensive, breathing "fast" and the patient requested to be intubated. The physician stated he discussed the process with NP #4 and attempted to get help from the ER doctor; however, he was unable to assist. Physician #2 stated he then went in to intubate the patient. He was unable to recall how many attempts he made, but was unsuccessful. The physician stated he observed blood on the tip of the tube after intubation was attempted, but was unsure where the blood came from. He stated Physician #4 was also unsuccessful at intubating the patient and Physician #1 eventually came and was able to successfully intubate the patient. However, attempts to revive the patient were unsuccessful.

2. Review of Patient #2's record revealed the patient was admitted to the facility's ICU on 03/05/2021 at 4:00 AM with diagnoses, which included Withdrawal Symptoms from Methamphetamine, Seizure Activity and Exacerbation of Chronic Obstructive Pulmonary Disease. Review of the record indicated Physician #2 assumed care/treatment of Patient #2 on 03/06/2021.

Further review of Patient #2's record and interview with RN #7 on 04/29/2021 at 3:00 PM revealed Patient #2's right leg was blue/purple in color, was cold to touch and only had a weak pulse on 03/06/3021. The RN also stated the patient's D-Dimer level (lab result that could indicate a blood clot) was abnormal. She stated she notified the physician. Further interview and review of the patient's medical record indicated Patient #2 was "crying out in pain" to his/her right leg on 03/06/2021 at 3:40 PM and Physician #2 was notified. According to the RN, Physician #2 came and evaluated the patient's leg. She stated he asked the patient if he/she had a history of a "bad back". When the patient replied "yes", Physician #2 told the patient his/her leg pain was coming from his/her back.

Further Review of Patient #2's record and interview with RN #5 at 8:00 PM on 05/02/2021 revealed she cared for Patient #2 during the night shift (7PM-7AM) beginning on 03/06/2021. She stated the patient's right leg was "dusky blue" and cold to touch, with a faint palpable pulse to his/her right foot. She stated she reported the abnormal findings to Physician #2 and stated, "He saw the patient's leg. I couldn't understand why he didn't further evaluate the leg with a Doppler study to see what was wrong. Especially because the D-Dimer was positive." RN #5 stated at 9:30 PM on 03/06/2021, Patient #2's heart rate dropped to 50 (normal range 60-100), his/her blood pressure was 160/94, respirations were 22 (normal range 12-16) and temperature was 98.1. She stated Physician #2 was in the ICU and was notified of the patient's decreased heart rate; however, the physician gave no new orders to address the patient's decline.

According to RN #5, Patient #2's heart rate remained 45-50 beats per minute, throughout the shift. She stated she notified the physician several times and Physician #2 was at the patient's bedside periodically throughout the shift; however, no new orders were received to address the patient's abnormal heart rate. Interview and continued review of the patient's medical record revealed at 12:00 AM on 03/07/2021, facility #2 was contacted for transfer; however, no beds were available and Physician #2 was notified. No other attempts were made at that time to obtain a bed Patient #2 at another facility.

Review of the record and continued interview with RN #5 indicated at 2:41 AM on 03/07/2021, the patient's potassium (an electrolyte that effects how the heart muscles work) was seven (7) (normal range 3.5-5.3) and his/her D-Dimer level had increased to greater than 12.50. Physician #2 was notified and the physician stated he would come to evaluate the patient.

Review of the record and further interview with RN #5, revealed at 2:45 AM on 03/07/2021, Physician #2 arrived to evaluate the patient. Record review indicated at 3:00 AM, Patient #2's bilateral lower extremities were now cool to touch/blue in color, the patient was lethargic, he/she had "agonal respirations" (struggling/gasping to breathe that is a symptom of a severe medical emergency such as a stroke or cardiac arrest) and his/her heart rate was 45. Patient #2's blood pressure was 152/89, and the patient's oxygen level was 90% on oxygen at 2 liters via nasal cannula. The record indicated Physician #2 contacted the patient's family and informed them of the change in his/her condition; however, the physician took no action to address the patients' respiratory/cardiac deterioration. RN #5 stated the physician called the patient's family because the patient's skin was blue, the patient was lethargic, and had agonal breathing. The patient continued to decline and Physician #2 arranged for transport; however, did not initiate any resuscitative efforts.

Further review of Patient #2's medical record revealed that at 4:14 AM on 03/07/2021, Facility #3 was contacted in attempts to obtain a bed for the patient. According to the record, a bed was confirmed for Patient #2 at 5:09 AM, and EMS was notified for transport at 5:30 AM. However, continued interview with RN #5 revealed Patient #2's condition continued to deteriorate, his/her heart rate remained 45-50 beats per minute and even though Physician #2 remained at the patient's bedside, he took no action to stabilize the patient.

Further interview with RN #5 and review of the record, indicated EMS arrived to the facility to transport the patient at 6:20 AM on 03/07/2021; however, they felt the patient was "unstable for transport." Physician #2 was notified and instead of taking steps in attempts to stabilize the patient, he instructed staff to "fly" the patient to the receiving facility. The record indicated Physician #2 remained at the patient's bedside and air transport was notified at 6:35 AM.

Patient #2's medical record and interview with RN #7 on 04/29/2021 at 3 PM revealed she arrived for her shift, received report, and evaluated the patient at 7:15 AM on 03/07/2021. The nurse stated she was unable to obtain a blood pressure or an oxygen saturation reading on the patient. Interview and record review also indicated the patient's heart rate was 40, his/her skin was discolored/cool to touch, and the patient continued to have agonal breathing. RN #7 stated Physician #2 was at the patient's bedside; however, he made no attempts to stabilize the patient's deteriorating condition. RN #7 stated she "couldn't understand why" Physician #2 was not doing anything to treat the patient's low heart rate and low blood pressure." According to the record, Patient #2 was placed on a 100% non-rebreather mask for oxygen delivery at 7:25 AM on 03/07/2021, and he/she would only respond to painful stimuli.

Continued review of the record indicated at 7:45 AM on 03/07/2021, the patient's blood pressure was 60/30 (normal range below 120/80), his/her oxygen level was 86% with 100% oxygen being administered, and a Dopamine drip (medication to increase heart rate and blood pressure) was initiated for the patient.

Interview with RN #6 on 05/05/2021 at 11:15 AM revealed she was house supervisor when Patient #2 was transferred from the facility on 03/07/2021. She stated she went to the ICU at approximately 7:15 AM on 03/07/2021 to evaluate Patient #2, when she observed the patient to be non-responsive, his/her heart rate was "in the 40's" and Physician #2 was at the bedside; however, nothing was being done to treat his/her critical condition. According to the RN, Patient #1 was "mottled" from the waist down to his/her lower extremities and she asked Physician #2 why he was not addressing/treating Patient #2's low heart rate. She stated she told the physician that "we needed to" treat the patient. However, Physician #2 informed the RN that the patient "had been this way a while" and that he/she was stable. The physician also told the RN "they [air evac] were on their way to get the patient." RN #6 stated she suggested a medication drip be started in attempts to stabilize Patient #2's abnormal vital signs, the RN stated the physician ordered the medication as she suggested (Dopamine that was initiated at 7:45 AM). RN #6 also stated she suggested that Patient #2 be intubated because he/she was in "respiratory distress". However, Physician #2 told the nurse again that a transport team was on their way. According to the RN, she suggested a second time Patient #2 be intubated due to his/her respiratory distress; however, the physician refused to treat the patient's ongoing respiratory distress. Record review and further interview revealed when the air transport team arrived at 7:50 AM, Patient #2 was again too unstable for transfer and they refused to transport the patient.

Continued interview with RN #6 revealed on the third request to render aide to Patient #2, she told Physician #2 that Patient #2 was too unstable and that the transport team had already refused to transport him/her. She stated she told the physician that "No one will transport [the patient] until" he/she is intubated and stabilized for transport. The RN stated after the third request he instructed the nurse to contact Physician #1 to assist with intubation and Physician #2 had made no attempts to intubate the patient.

According to the record, Physician #1 intubated Patient #2 at 8:00 AM, and ordered Epinephrine (emergency medication to increase heart rate) 1 ampule and an Epinephrine drip to be initiated in attempts to stabilize Patient #1. Physician #1 also ordered a Diprivan (medication to sedate the patient after intubation) drip, a normal saline fluid bolus, and one ampule of Sodium Bicarbonate (medication to treat metabolic acidosis and/or circulatory deficits) be administered to the patient. According to the record, at 8:15 AM on 03/07/2021, Patient #2's blood pressure was 75/40 and his/her heart rate had increased to 61. At 8:20 AM, Patient #2's blood pressure was 78/54 and the patient's heart rate was 62. Air-Evac transported the patient from the facility at 8:50 AM on 03/07/2021.

Review of Patient #2's hospital record at Facility #3 indicated he/she was admitted at approximately 10:28 AM on 03/07/2021 with diagnoses, which included Shock possible septic versus cardiogenic (heart failure), fixed dilated pupils (symptom of brain injury), acute hypoxic respiratory failure (not enough oxygen in the blood) with concerns for an anoxic brain injury (lack of oxygen to the brain which results in brain death), pericardial effusion (buildup of fluid around the heart) and bradycardia (low heart rate). Documentation also revealed that Patient #2's lower extremities were both mottled (red/purple) in color and he/she was found to have Deep Vein Thrombus (blood clots) in both lower extremities. The patient was also in multi-organ failure. According to the hospital record, Patient #2's clinical condition continued to deteriorate and he/she had cardiac arrest and expired on 03/08/2021 at 3:05 PM.

Interview with Physician #2 on 05/10/2021 at 11:45 AM revealed he cared for Patient #2 on 03/06/2021 and 03/07/2021. He stated he thought the patient's low heart rate was because his/her potassium was elevated; therefore, he stated because he had ordered medication to treat the patient's high potassium, he felt he was treating the low heart rate. Physician #2 acknowledged Patient #2 was in respiratory distress with agonal breathing at 3:00 AM on 03/07/2021 and nothing was done to treat the patient; however, stated he should have had Physician #1 intubate Patient #2 "sooner," instead of waiting on the transport team to render services for Patient #2's respiratory distress.

Interview with the Chief of Staff (COS) on 05/10/2021 at 8:30 AM revealed she was aware that staff, including physicians had voiced concerns with Physician #2's care/treatment of Patient #1 and Patient #2. She stated she had reviewed both patient records and had not identified any real concerns and did not feel like Physician #2 had neglected either patient. However, according to the COS, she had not identified that the Physician #2 did not treat Patient #1 timely, nor address the concerns that the physician's intubation skills were questioned. Further, the COS did not identify that Physician #2 did not treat Patient #1's deteriorating condition, including respiratory distress, on 03/07/2021 for approximately five (5) hours.

3. Review of medical record revealed Patient #5 arrived to the ED on 04/27/2021 at 12:02 PM via Emergency Medical Services (EMS) with a chief complaint of high blood glucose and sleeping for two days. Further review revealed vital signs of blood pressure 88/56 (normal range 90/60 to 120/80), heart rate 110 (normal range 60-100), oxygen saturation 97% (normal range 95%-100%) on room air and temperature 97.2, tympanic (electronic temperature taken via the ear canal).

Review of Patient #5's ED record revealed the physician ordered laboratory testing at 12:44 PM. The laboratory results were reported at 12:47 PM and 1:00 PM. Patient #5's blood glucose level was at a critical level of 1664 (normal range below 100), the white blood count was 24.4 (normal range 4.5 to 11) and the lactic acid was at a critical level of 101.3 (normal range 4.5 to 19.8).

Continued review of Patient #5's medical record revealed the hospital admitted the patient to the Intensive Care Unit (ICU) under the services of Physician #2 on 04/27/2021 at 4:26 PM with a diagnosis of Diabetic Ketoacidosis.

Based on the above Sepsis Protocol, Patient #5 met four (4) early identification symptom criteria for sepsis (tachycardia, hypotension, elevated WBC, elevated lactic acid); however, further review of the record revealed no evidence the hospital screened the patient per the above sepsis protocol.

Review of physician orders revealed Patient #5 did not receive antibiotic therapy per the protocol until three (3) days after admission when Physician #2 ordered Levaquin 250 milligrams (mg) via intravenous infusion on 04/30/2021 at 10:50 PM.

Interview with Physician #2 on 05/09/2021 at 11:40 AM revealed he was aware of the hospital's sepsis protocol. Physician #2 stated Patient #5 should have received antibiotics per protocol for the elevated WBC and high lactic acid levels. Per the physician, Patient #5 should have been treated with antibiotics and the antibiotics should have been initiated in the ED. When asked why Patient #5 did not receive antibiotics for three (3) days after admission from the ED, he responded if Patient #5 had been identified with sepsis in the ED, he would have viewed the treatment approach for sepsis differently.

Review of Patient #5 nursing notes dated 04/30/2021 at 6:44 PM, revealed Physician #2 was present and planned to transfer Patient #5 to another facility. Further review revealed Patient #5 was accepted to another facility at 7:15 PM but was awaiting a bed to become available at the receiving facility before transferring the patient. No further attempts or correspondence to arrange transfer of Patient #5 were made until 12:55 AM on 05/02/2021, when Patient #5 had became critically hypotensive and was in respiratory distress.

Review of Patient #5 nursing notes dated 04/30/2021 at 4:30 PM, revealed RN #7 noted Patient #5 had a blood pressure of 80/35 and notified the on-call Nurse Practitioner (NP) #2. Orders were received to increase Patient #5's intravenous fluids of Normal Saline to 150 milliliters (ml) per hour. Further review revealed again on 04/30/2021 at 6:15 PM, RN #7 noted Patient #5 blood pressure to be 81/56 and Physician #2 was present. Verbal orders were received from Physician #2 to increase intravenous fluids of Normal Saline to a rate of 175 ml per hour.

Review of nursing notes dated 05/01/2021 at 11:35 PM revealed RN #3 notified Physician #2 of Patient #5's continued and worsening hypotension when the patient had a blood pressure of 71/38. Review of physician orders dated 05/01/2021 at 11:35 PM revealed an order was received by RN #3 from Physician #2 for an Arterial Blood Gas (ABG); however, no orders were given by Physician #2 to address Patient #5's worsening hypotension. Continued review revealed Physician #2 ordered Patient #5 to be placed on Bi-Pap (Bilevel Positive Airway Pressure) at 11:36 PM to assist with increased respiratory effort, with no additional orders to address Patient #5's severe hypotension.

Review of Patient #5 blood pressure record dated 05/01/2021 AT 11:39 PM revealed a documented blood pressure of 71/44. On 05/02/2021, the patient's blood pressure continued to be low at 70/41 at 1:50 AM and 76/49 at 4:17 AM.

Continue review of the record revealed Physician #2 arrived to the facility's ICU at 2:00 AM to evaluate Patient #5, nearly two and a half hours after he was contacted by RN #3 of the patient's deteriorating condition. Review of physician orders dated 05/02/2021 at 2:08 AM revealed an order for a Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), International Normalized Ratio (INR), Troponin and D-Dimer lab test.

Review of lab reports dated 05/02/2021 at 2:08 AM revealed a WBC of 1.2 (critically low), with the previous WBC 24.4 on 04/27/2021 when Patient #5 was admitted to the facility. Review of the record revealed no WBC was ordered nor obtained between 04/27/2021 and 04/30/2021.

Further record review revealed Patient #5's physician ordered to transfer the patient to another facility at 3:20 AM on 05/02/2021 and Air Evac was contacted to transport the patient at 3:30 AM. Review of Patient #5 nursing notes dated 05/02/2021 at 4:00 AM revealed the Air Evac team arrived to the facility to transfer patient.

Review of the Air ambulance record on 05/02/21 revealed Patient #5 was pale, tachypneic and had a blood pressure of 69/45 prior to air transfer. Further review revealed Patient #5 was intubated by Air Evac ambulance team and placed on mechanical ventilation prior to being placed on the aircraft for transport. In addition, transport staff initiated Levophed (medication to increase blood pressure) intravenous vasopressor medication prior to take-off at 4:55 AM.

Review of the hospital record for Patient #5 from Facility #4 revealed the patient was admitted to Facility #4 on 05/02/2021with diagnoses of Acute Respiratory Failure, Severe ARDS (acute respiratory distress syndrome which is a condition where fluid collects in the lungs), septic shock, anemia/thrombocytopenia, dilated right heart ventical, etc. The patient remained an inpatient at Facility #4.

Interview with RN #7 on 05/05/2021 at 5:50 PM revealed she had cared for Patient #5 on 04/30/2021 from 7:00 AM to 7:00 PM and she made Physician #2 aware of Patient #5's hypotension. She stated although it was discussed by Physician #2 that Patient #5 possibly needed an intravenous vasopressor (medication to increase blood pressure), he did not order this type medication for the patient.

Interview with RN #3 on 05/09/2021 at 10:40 AM revealed she cared for Patient #5 on 05/01/2021 from 7:00 PM until 4:55 AM on 05/02/2021when Patient #5 was transferred from facility. The RN stated she notified Physician #2 at approximately 11:35 PM on 05/01/2021 Patient #5 was hypotensive and had decreased oxygen saturation with respiratory distress, but did not receive orders from Physician #2 to address the resident's low blood pressure or hypotension. Further interview revealed as an ICU nurse, she felt Patient #5's blood pressure was critically low and it would be standard practice to treat the blood pressure with medication. She continued by stating Patient #5 was transferred from the facility via Air Evac ambulance at approximately 4:55 AM.

Continued interview with Physician #2 on 05/09/2021 at 11:40 AM revealed he provided care to Patient #5 from 04/27/2021 until transfer from the facility on 05/02/2021. He stated he initially treated Patient #5's hypotension by increasing fluids. He further stated he was notified by RN #3 at approximately 11:35 PM on 05/01/2021, Patient #5 was hypotensive. Physician #2 stated he did not treat the Patient #5's hypotension with medication but should have ordered an intravenous medication drip to improve the patient's blood pressure. The physician stated a repeat CBC should have been ordered/obtained the morning following Patient #5's admission and daily thereafter. Physician #2 stated he was aware of the Patient's elevated WBC when he saw the patient after admission; however, Physician #2 had no explanation as to why a repeat WBC was not ordered for three (3) days after admission or why the WBC was not obtained when labs were drawn on 04/30/2021 at 11:20 AM. Physician #2 stated he was aware of Patient #5's decline in condition and the patient required intubation prior to being transported via Air Evac to another hospital.

QAPI

Tag No.: A0263

Based interview, record review and review of facility policy, it was determined the facility failed to develop, implement, and maintain an effective ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

The findings include:

Review of Patient #1's medical record revealed the patient presented to the facility's ED on 12/27/2020 with chest pain, shortness of breath, hypertension, and tachycardia; Review of Patient #2's medical record revealed the patient presented to the facility ED with moderate respiratory distress, and methamphetamine overdose on 03/04/2021; Review of Patient #3's medical record revealed the patient presented to the facility ED on 04/04/2021 with shortness of breath and weakness. However, none of the patients' vital signs were obtained/monitored per protocol in the ED.

Review of Patient #5's medical record revealed although Patient #5 met four (4) sepsis criteria, indicating the patient should have been screened for sepsis, staff failed to screen Patient #5 for sepsis or implement the sepsis protocol as required by the facility's sepsis protocol.

According to interviews with Quality Assurance and Performance Improvement members including Board Member #1 on 05/13/2021 at 4:10 PM, the Laboratory Director on 05/10/2021 at 4:40 PM, and with the Quality Manager on 05/11/2021 at 5:10 PM, and review of QAPI meeting minutes for meetings conducted in March 2021 and April of 2021, the facility was aware that staff were not obtaining/documenting vital signs in the ED and the facility's sepsis protocol was not being implemented when indicated.

However, there was no evidence found to indicate the facility took any corrective action or conducted monitoring to ensure staff obtained/documented ED patients' vital signs and that patients were screened for sepsis when the patient's condition and clinical assessment met the criteria for sepsis screening.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on interview, record review and review of facility policy, it was determined the facility failed to make improvements and changes based on collected data when it was identified that vital signs were not being obtained appropriately in the Emergency Department (ED) and the facility's sepsis protocol was not consistently being implemented. In addition, the facility also failed to take actions aimed at performance improvement, and to maintain an effective ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

The findings include:

Review of the facility's "2020 Quality Improvement Plan" reviewed 03/03/2020 revealed the facility's Quality Improvement program would provide a planned, systemic, organization wide approach to process, design, and measure organizational performances and patient outcomes. According to the policy, the QAPI program committee was composed of a member of the Board of Directors, a member of the medical staff, the Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and other members as designated. The policy stated the QAPI (Quality Assessment and Performance Improvement committee was responsible to collect data to determine the facility's level of performance and areas of possible improvement in the facility's existing processes. The policy also stated the committee should take action to correct identified problems and monitor the effectiveness of actions taken to correct the identified concerns.

Review of Patient #1's record revealed the patient presented to the facility ED on 12/27/2020 at approximately 11:30 PM with chest pain, shortness of breath, hypertension, and tachycardia. However, review of the patient's record revealed no evidence staff obtained/documented the patient's vital signs upon arrival to the ED or for approximately two (2) hours after arrival. The patients first documented set of vital signs occurred at 1:14 AM.

Review QAPI documentation revealed administration provided staff with education on 01/05-06/2021 and again on 02/08-09/2021 because "ED documentation is horrible". The education related to staff failing to obtain and/or document vital signs in the medical record. However, review of subsequent QAPI meetings revealed no evidence the facility implemented an action plan or that on-going monitoring occurred to ensure the problem did not persist in the facility.

Review of Patient #2's record revealed the patient presented to the ED with moderate respiratory distress and a methamphetamine overdose on 03/04/2021 at approximately 11:35 PM. However, review of the patient's record revealed only one set of vital signs were obtained at 11:44 PM. However, staff treated Patient #2 for approximately four (4) hours in the ED.

Review of QAPI meeting minutes dated March 16, 2021 and April 13, 2021, revealed the facility had identified concerns with staff failing to implement the facility's sepsis protocol. In the April 13, 2021 QAPI meeting minutes, Nurse Practitioner (NP) #4 recommended sepsis charts be reviewed more often than just when the facility reviewed core measures. Continued review of the minutes revealed NP #4 would meet with the staff to discuss the issue. However, there was no evidence that the facility implemented an action plan or ongoing monitoring to correct the facility's concerns with implementation of the facility's sepsis protocol.

Interview with Board Member #1 on 05/13/2021 at 4:10 PM revealed she regularly attended the facility's QAPI meetings. She stated she recalled discussions during the March 2021 and April 2021 QAPI meetings of "things falling off in the ED" but was unable to recall what areas of concern the committee discussed. However, Board Member #1 acknowledged that the committee did not discuss an action plan or develop monitoring tools during the meetings related to the facility's concerns in the ED.

Interview with the Laboratory Director on 05/10/2021 at 4:40 PM revealed she attended the QAPI meetings in March and April of 2021, and the committee discussed the failure of staff to implement the facility's sepsis protocol. However, the Laboratory Director stated the facility had not implemented a plan to correct the problem and was not monitoring the concern or conducting audits of the sepsis protocol.

Interview with the Case Manager on 05/03/3031 at 4:15 PM revealed she reviewed Patient #1's medical record at the direction of the CEO, after staff voiced concerns related to the care Physician #2 provided to the patient on 12/28/2020. Further interview with the Case Manager and review of her documented findings revealed she identified staff failed to document any vital signs for the patient for approximately three hours after the patient arrived to the ED. The Case Manager stated she had provided a summary of her findings to the CEO in December 2020. In addition, the Case Manager stated she attended the facility QAPI meetings and recalled discussing staff failures to implement the facility's Sepsis Protocol. The Case Manager also stated she attended an "informal meeting, a few weeks ago", unable to recall exact date, with NP #4 who was the facility's CNO, and other staff regarding the need to gather more information and implement staff education related to the facility's identified failures. However, she stated after the informal meeting took place NP #4 was off for a medical procedure and to her knowledge, no further action was taken.

Interview with Registered Nurse (RN) #11 on 05/13/2021 at 12:05 PM revealed she was the facility's infection control nurse for approximately one year until March 2021. She stated the facility's failure to implement the sepsis protocol and the failure to document patient's vital signs in the ED was an "ongoing conversation" at the facility. She stated the problems were discussed in "numerous" QAPI meetings, however, she was unaware of any action plan or ongoing monitoring that was implemented to correct the problems.

Interview with the Quality Manager on 05/11/2021 at 5:10 PM revealed she had been the director since January 2021. She stated the facility was aware that staff was not implementing the facility's sepsis protocol consistently, and the QAPI team had discussed the concern. However, the Quality Manager stated the facility had not implemented any action or conducted monitoring to evaluate the concern. The Quality Director stated she did not recall any discussions related to the facility's failure to document patient vital signs in the ED records, and also stated she frequently reviewed patient records in the facility, but had not identified that as a concern.

Interview with NP #4 on 05/20/2021 at 3:07 PM revealed she conducted training with staff in January and February 2021, related to concerns identified in the facility, which included staff failing to document vital signs for ED patients and failing to implement the facility's sepsis protocol. However, NP #4 stated she was unaware of any action plan developed to monitor the facility's identified concerns.

Interview with the CNO on 04/29/2021 at 2:15 PM revealed she had been the CNO since 04/28/2021. She stated prior to accepting the CNO position, she conducted record reviews at the facility and administrative staff was aware of the concerns related to staffs' failure to document vital signs for patients in the ED, and their failure to implement the sepsis protocol. She stated she had not attended any QAPI meetings as of yet, so she was not sure if the concerns were discussed during the meetings. However, she stated she was not aware of any action plans that were in place, or any ongoing monitoring at the facility related to documentation of vital signs in the ED or implementing the facility's sepsis protocol.

Interview with the CEO on 05/10/2021 at 8:05 PM revealed he was aware of concerns related to the staff not implementing the facility's sepsis protocol in the ED. He stated a mandatory meeting with nursing staff occurred in January 2021 and February 2021 and he told the nursing staff "they were either lazy or stupid", because the concerns remained ongoing in the facility. The CEO stated nursing staff were "reluctant to do and document as they should." The CEO also stated the committee had discussed the concerns during the last three QAPI meetings at the facility. However, he was unaware of any action plan being implemented or developing any audit tools to track the facility's progress related to the concerns.

MEDICAL STAFF

Tag No.: A0338

Based interview, record review and review of Physician #2's credentials it was determeined that the facility failed to have an organized medical staff that operated under bylaws approved by the governing body; and which is responsible for the quality of medical care provided to patients by the hospital.

The findings include:

Review of Physician #2's credentials revealed on 12/22/2020, the CEO and Chief of Staff granted temporary/disaster privileges to Physician #2.

Interview with RN #1 revealed on 12/28/2020, after Patient #1 expired at the facility, she reported concerns to the CEO regarding Physician #1's care of the patient and his clinical abilities.

According to interviews, sometime on or after 12/28/2020, exact date unknown, Physician #1, #4 and #6 reported their concerns related to Physician #2's care of patients, particularly, Patient #1.

Review of Patient #2's medical record revealed Physician #2 failed to treat the patient's respiratory distress and continuous decline. At approximately 3:00 AM on 03/07/2021, Patient #2 had agonal breathing (struggling/gasping to breathe that is a symptom of a severe medical emergency such as a stroke or cardiac arrest); however, the physician did not take any action to treat the patient's respiratory distress. Patient #2 continued to decline and EMS and Air-Evac refused to transfer the patient because he/she was not stable. However, Physician #2 took no action to stabilize the patient until the house supervisor insisted the patient be intubated.

On 03/15/2021, after the CEO had taken no action to address their concerns and they had concerns with the care of Physician #2's care of Patient #2, Physician #1, #4, and #9 sent a letter to the CEO requesting Physician #2's privileges be suspended and a thorough assessment of Physician #2's clinical skills because "several patients had unexpectedly died under his direct clinical management".

According to the CEO, Physician #4 and the Chief of Staff reviewed Patient #1 and #2's medical records and had no concerns. However, there was no evidence a review took place until 04/28/2021. In the meantime, on 04/21/2021, the CEO and Chief of Staff gave Physician #2 temporary privileges, despite the continued concerns of physicians and nursing staff.

Review of the facility Bylaws revealed no evidence that temporary privileges could be granted twice. In addition, according to the Bylaws, "The CEO or designee, with concurrence of the Chief of Staff, may at any time terminate a Practitioner's temporary privileges ....However, where it is determined that the life or health of such patient(s) would be endangered by continued treatment by the Practitioner, the termination may be imposed by any person entitled to impose a summary suspension pursuant to Section 7.2 of these Bylaws and shall be immediately effective."

A review of Section 7.2 of the facility's Bylaws revealed an emergency suspension of any or all clinical privileges of a Member may be imposed by the Chief of Staff or designee, Vice Chief of Staff or designee, or the CEO "whenever failure to take such action may, in his/her opinion result in an imminent danger to the health or safety of any individual."

Interview with the CEO revealed despite multiple physician and nursing concerns with Physician #2's care of patients, no action was taken to ensure the physician was competent to safely provide care to patients.

On 04/27/2021, four (4) days after Physician #2 was granted temporary privileges for the second time, Patient #5 was admitted with diabetic ketoacidosis, and had four (4) indicators of sepsis. Physician #2 took over the patient's care on the morning of 04/28/2021, but failed to recognize the patient had an elevated white blood cell count and lactic acid; subsequently, laboratory tests were not repeated and antibiotics were not initiated per the sepsis protocol. Patient #5 had hypotensive episodes on 04/30/2021, 05/01/2021, and 05/02/2021; however, Physician #2 took no action to treat the patient despite numerous calls from nursing staff. The patient's white blood cell count was not repeated again until 05/02/2021, when the result was 1.2 (critically low). On 05/02/2021, Patient #5 was transferred via Air-Evac at 4:55 AM; however, by that time, the patient was pale, tachypneic (fast breathing), and his/her blood pressure was 69/45. On arrival, Air-Evac intubated the patient and initiated intravenous medications to treat the patient's hypotension (low blood pressure) (Refer to A0341).

MEDICAL STAFF CREDENTIALING

Tag No.: A0341

Based on interview, record The facility failed to have an organized medical staff that operated under bylaws approved by the governing body, which is responsible for the quality of medical care provided to patients by the hospital. In addition, the facility failed to ensure medical staff could examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations.

The findings include:

Review of the facility "Bylaws of the Medical Staff" dated 06/05/19 revealed temporary privileges could be granted in two (2) circumstances which were (1) to fulfill an important patient care, treatment and service need; (2) when a new applicant with a complete application that raises no concerns is awaiting review and approval of the Medical Executive Committee (MEC) and the Board. The Bylaws did not address granting temporary privileges to a physician twice.

Further review revealed "when an Applicant with a complete application that raises no concerns is awaiting review and approval of the Medical Executive Committee and the Board, the CEO or designee, upon recommendation of the Chief of Staff, may grant the Applicant temporary privileges for no more than 120 days upon verification of ....current competence; ability to perform the privileges requested ..."

Special requirements of supervision and reporting may be imposed on any Practitioner granted temporary privileges. Temporary privileges shall be immediately terminated by the CEO or designee with concurrence of the Chief of Staff upon notice of any failure by the Practitioner to comply with such special conditions.

The CEO or designee, with concurrence of the Chief of Staff, may at any time terminate a Practitioner's temporary privileges effective upon discharge from the hospital of the Practitioner's patient(s). However, where it is determined that the life or health of such patient(s) would be endangered by continued treatment by the Practitioner, the termination may be imposed by any person entitled to impose a summary suspension pursuant to Section 7.2 of these Bylaws and shall be immediately effective."

A review of Section 7.2 of the facility's Bylaws revealed an emergency suspension of any or all clinical privileges of a Member may be imposed by the Chief of Staff or designee, Vice Chief of Staff or designee, or the CEO "whenever failure to take such action may, in his/her opinion result in an imminent danger to the health or safety of any individual."

Review of Physician #2's credentialing documentation revealed on 12/22/2020, the CEO and Chief of Staff granted Temporary privileges to Physician #2. The document stated, "These privileges are limited to Allergy and Immunology." Review of the physician's clinical privileges dated 12/22/2020 revealed a box was checked that stated, "recommend privileges with the following conditions/modifications"; however, no information was included indicating what conditions/modifications were recommended.

Review of the facility's physician call schedule revealed Physician #2 rotated call with Physician #1 and #3 as the on-call physician for the facility and was the only physician on call on average of fifteen (15) days per month for the hospital medical/surgical unit and the intensive care unit.

Interview with Registered Nurse (RN) #1 on 04/28/2021 at 10:50 AM and review of a facility investigation revealed on 12/28/2020, after Patient #1 expired at the facility, RN #1 reported concerns to the CEO regarding Physician #2's care of the patient and his clinical abilities.

According to the interview with RN #1, she cared for Patient #1 on 12/28/2020 when the patient had cardiac arrest and later expired. She stated Physician #2, Nurse Practitioner (NP) #1 and NP #2 were in the ICU at approximately 8:00 AM, when Physician #2 was notified of the patient's deteriorating condition, including a heart rate of 150's/160's and the patient was in respiratory distress. The RN stated she told the physician that she "needed help" to stabilize Patient #1. However, the RN stated Physician #2 never "even looked" at the patient to assess his/her condition, he "just ordered a CT [Computerized Tomography or CT scan]". RN #1 stated the physician left the ICU to go to another area of the hospital to see other patients, stating he would be back later to see the patient. The RN stated the CT scan of the patient's chest was ordered as directed; however, radiology staff refused to transport the patient for the CT scan because he/she was too unstable. RN #1 stated Patient #1's condition continued to deteriorate and staff called the other hospital floor to inform Physician #2 that he was needed in ICU. However, Physician #2 failed to respond. Subsequently, RN #1 contacted the Chief Nursing Officer (CNO), at the time of the patient's deteriorating condition and the need for physician intervention.

According to RN #1, the CNO contacted the physician and informed him that he was needed in ICU "now". The physician, as well and NP #1 and NP #2 returned to the ICU; however, no one saw/assessed the patient. RN #1 stated NP #1 ordered Lopressor (medication to lower blood pressure and heart rate) 5 mg, to be administered to the patient at approximately 8:30 AM. A second dose was also administered at 8:35 AM; however, the patient's heart rate remained high. Further interview with RN #1 revealed Patient #1's condition continued to deteriorate and the patient requested to be intubated. She stated Physician #2 was again notified of the patient's condition and was present in the ICU; however, he, nor any other provider did not come in to assess the patient. The RN stated at approximately 9:30 AM, Physician #2 remained in the ICU at the nurse's station, but still not assessed the patient. RN #1 stated the patient's condition continued to worsen and she felt the patient needed to be intubated. She asked another staff member to contact Physician #1 for intubation. However, Physician #2 instructed the other nurse to "hang up the phone and call the ER" for that physician to assist. According to the RN, the ED physician was unable to assist because a critical patient was in route to the ED. Then, Physician #2 came in to evaluate the patient for intubation. RN #1 stated while Physician #2 was preparing to intubate the patient, Patient #1's vital signs "dropped" and a code blue (cardiopulmonary arrest) was initiated. The nurse stated the Physician #2 ordered "paralytics" (medications to sedate the patient), which was not normally utilized for intubation attempts. Then, Physician #2 was unable to intubate the patient. The RN was unable to recall how many attempts the physician made to intubate Patient #1, because she was "doing chest compressions." RN #1 stated the ED physician (Physician #4) arrived soon after the code was called to assist with intubation; however, he was also unsuccessful at intubating the patient. According to the RN, Physician #1 also responded to the code, and he attempted one time and was successful in intubating the patient. However, attempts to resuscitate the patient were unsuccessful and Patient #1 was pronounced deceased at 10:06 AM.

Further interview with RN #1 revealed she had never had a physician "leave her and not assess a patient that was in distress." RN #1 stated she immediately contacted the Chief Executive Officer (CEO) after the patient had expired on 12/28/2020 and asked the CEO when was the last time Physician #2 had cared for "sick people and when was the last time he intubated a patient." However, the RN stated the questions and concerns voiced related to Physician #2 had not been addressed. RN #1 stated she also voiced concerns with Physician #2's care of the patient to NP #2 on 12/28/2020.

Interview with NP #4 on 05/03/2021 at 1:35 PM revealed she was the acting CNO when Patient #1 received care/treatment in the facility and confirmed RN #1 notified her of Patient #1's deteriorating condition on 12/28/2020. The NP stated she observed Patient #1 was in respiratory distress, breathing 48/50 breaths a minute, and was in cardiac distress. She stated she contacted the physician, who had went to make rounds, and informed him he was needed in the ICU. She stated he came "straight down" to the ICU and questioned why the patient had not gone for a CT scan. The CNO stated she told the physician that the patient "would arrest if we took" him/her to CT. The NP stated Physician #2 then asked her "what do you think?" NP #4 told Physician #2 that the patient was in distress and needed to be intubated. However, the NP stated when her conversation took place with the Physician regarding Patient #1's care needs, she was not aware that the physician had not "layed eyes on the patient." She stated she explained the facility's process on intubation and that the ED physician was normally called to assist with intubation; however, the ED physician was awaiting arrival of an ill patient and was unable to assist. She stated Physician #2 attempted intubation twice and was unable to intubate the patient. The NP stated Physician #4 came to ICU to assist and before attempting to intubate Patient #1, Physician #4 stated that Patient #1 "had a large hematoma" (a collection of blood outside of the blood vessels) observed in his/her airway. She stated Physician #4's intubation attempts were also unsuccessful. According the NP, Physician #1 then arrived to assist with the patient's intubation and Physician #4 informed Physician #1 of the hematoma he had observed in the patient's airway.

Further interview with NP #4 revealed Physician #1 successfully intubated the patient after one attempt; however, stated "it was too late" and Patient #1 was pronounced deceased at 10:06 AM. NP #4 also stated RN #1 became tearful after Patient #1's death and the RN requested to speak to the CEO. She stated RN #1 told the CEO that Physician #2 "killed" the patient. According to NP #4, the CEO told the NP/CNO that he wanted the patient's death investigated. The NP stated the Case Manager investigated Patient #1's death, and the case was later reviewed by the Chief of Staff and the Vice Chief of Staff (exact date unknown). According to NP#4, no "real concerns" were identified as a result of the investigation.

Interview with the Case Manager on 05/03/2021 at 4:15 PM revealed the CEO immediately instructed her to investigate Patient #1's death after the patient expired on 12/28/2020. The Case Manager stated she interviewed staff and they voiced concerns related to the care the patient received. She stated she "obtained statements and turned them over to the CEO." According to the Case Manager, she did not substantiate, nor unsubstantiate any concerns because she "wasn't a doctor".

Review of statements collected by the Case Manager revealed RN #1 had concerns because Physician #2 left the ICU after being informed the patient was in distress. She was also concerned that after the physician was contacted twice, he returned to the ICU; however, "stood in ICU for 15 minutes before coming to the patient's room." The nurse's statement also indicated she was concerned because the physician ordered paralytics (medication to sedate the patient) to be administered to the patient prior to intubation and when Physician #2 was unable to intubate the patient successfully, the patient became "bradycardic and then asystole" (no heart beat). The nurse also stated concerns because Physician #2 refused assistance from a senior physician at the facility, Physician #1, to assist with intubating the patient.

Continued review of the statements obtained by the Case Manager revealed Physician #4 stated when he responded to the ICU, he was unable to intubate the patient because he/she was in a "soft bed," and "was not in the best position for intubation and had a larger neck."

Interview with Physician #4 on 05/12/2021 at 3:40 PM revealed he had voiced concerns to the CEO on more than one occasion, regarding Physician #2's care/treatment of Patient #1. The physician stated when he arrived to assist with intubation for Patient #1, the patient was in a "horrible position" and had no "back board" under him/her. He also stated the patient was lying down in the middle of the bed, and he had to have staff assist him in repositioning the patient before attempting intubation. According to Physician #4, "There's no way anyone could have visualized the patient's cords to intubate" the way the patient was lying in the bed. The physician also stated, "What physician would administer paralyzing medications to a 200+ pound patient without having the patient properly positioned to see the cords in preparation for an intubation?" Physician #4 stated he was also concerned because after the event, he looked at the patient's medical record and Physician #2 had not conducted any tests to "bridge the patient for an intubation." He stated Physician #2 had not obtained blood gasses in attempts to see if a bipap machine (a machine used for patients requiring breathing assistance) could have relieved the patient's inability to breath, or to "really know what was actually going on with the patient's respiratory status." Physician #4 also stated he, along with Physician #1 and #6, sat down with the CEO and reported their concerns related to Physician #2's care of patients, particularly, Patient #1. Physician #4 stated he did not feel the concerns had been investigated. He also stated Physician #1 had informed the CEO of concerns a "few months before we sat down with him"; however, the voiced concerns had not been addressed by the CEO.

Further review of the Case Manager's investigation, revealed Physician #1 informed the Case Manager during her investigation that Patient #1 had a hematoma of the larynx (voice box) which made intubation more difficult.

Interview with Physician #2 on 05/10/2021 at 11:45 AM revealed he was granted emergency privileges at the hospital on 12/22/2020. He stated when he arrived to conduct provider rounds on 12/28/2020, even though he was the on call provider as of 8:00 AM that day, he was not aware that he needed to see Patient #1. He stated he went into the ICU and a nurse notified him that Patient #1 was hypertensive, having trouble breathing, and spitting up blood so "I ordered a CT." The physician stated he did not evaluate the patient's status at that time, and went to another floor of the hospital to do rounds. He stated he should have asked more questions, about why the nurse was telling him about this patient's distress, so he could have realized that he needed to see the patient sooner. The physician stated he recalled receiving a call "later" that the patient was too sick to go to CT, and was notified again regarding the patient's condition. He stated when he went to the ICU to evaluate the patient, he found the patient was hypertensive, breathing "fast" and the patient requested to be intubated. The physician stated he discussed the process with NP #4 and attempted to get help from the ER doctor; however, he was unable to assist. Physician #2 stated he then went in to intubate the patient. He was unable to recall how many attempts he made, but was unsuccessful. The physician stated he observed blood on the tip of the tube after intubation was attempted, but was unsure where the blood came from. He stated Physician #4 was also unsuccessful at intubating the patient and Physician #1 eventually came and was able to successfully intubate the patient. However, attempts to revive the patient were unsuccessful.

Interview with Physician #1 on 05/05/2021 at 3:20 PM revealed he voiced concerns verbally to the CEO regarding the care Physician #2 provided to Patient #1 (exact date unknown). Continued interview and review of an email sent to the CEO and facility Chief of Staff (COS) indicated on 01/04/2021 (7 days after Patient #1 expired at the facility) Physician #1 informed the CEO and COS that concerns had been raised by senior experienced staff related to the care of Patient #1. Physician #1 requested a thorough internal review, analysis, and a report to be compiled related to the events that occurred with the patient's care. The email and interview also indicated Physician #1 recommended a peer review occur, from a physician on staff at the time, who was board certified in critical care and pulmonology. However, Physician #1 stated his request was denied. Physician #1 stated he had also requested that a Medical Executive Committee (MEC) meeting staff to have the ability to "bring all the concerns to the table," regarding Physician #2's practices. Again, the CEO denied the physician's request. Physician #1 stated as a member of the MEC committee, he had requested to review Physician #2's credentials and again, that request was denied by the CEO. Physician #1 also stated he was concerned about Patient #1's care because Physician #2 had not attempted to stabilize the patient, and no blood gas or chest x-ray was obtained prior to initiating intubation.

Review of MEC meeting minutes dated 01/20/2021 revealed two (2) cases were presented for the committee to review; however, no details were provided.

Review of Patient #2's record revealed he/she arrived to the facility ED at approximately 11:30 PM on 03/04/2021 with complaints of shortness of air and methamphetamine abuse with involuntary movements to his/her entire body. According to Patient #2's record, he/she was transferred to the ICU at approximately 4:00 AM on 03/05/2021, with diagnosis that included Withdrawal Symptoms from Methamphetamine, Seizure Activity and Exacerbation of Chronic Obstructive Pulmonary Disease. Review of the record indicated Physician #2 assumed care/treatment of Patient #2 two days after admission, 03/06/2021.

Interview with RN #2 at 2:35 PM on 04/28/2021 revealed he was assigned to care for Patient #2 during the night shift (7AM-7PM) on 03/06/2021 when the patient experienced a change in condition. Review of Patient #2's medical record revealed on 03/06/2021 at 12:40 AM, the patient's blood pressure was 194/101 and Physician #2 was notified. According to the record, medications were ordered to treat the patient's elevated blood pressure and the physician ordered laboratory tests. Further interview with RN #2 and record review indicated Physician #2 came to the ICU to evaluate the patient and the RN informed the physician of Patient #2's laboratory results, which indicated at 1:45 AM on 03/06/2021, that the patient's D-Dimer (test that could indicate presence of a blood clot) was positive at 5.106 (normal range 0.100-0.500) and his/her white blood cell count had went up to 17.8 (normal range 4.8-10.8) when it had been normal at 10.7 on 03/05/2021, the day prior. According to the RN, Physician #2 ordered laboratory work to be repeated the next morning and Plavix 75 mg (an antiplatelet medicine) to address the patient's positive D-Dimer; however, no new orders were received related to the patient's elevated white blood cell count, which was an indication of a possible infection.

According to the record at 4:10 AM on 03/06/2021, new orders were received from the physician to transfer Patient #2 to another facility. Continued interview with RN #2 revealed a larger medical center (Facility #1) was contacted; however, no beds were available and the physician was notified that the patient had been placed on a "waiting list." The nurse stated the physician preferred that the patient go to Facility #1, and no further orders were given to attempt to find the patient a bed at another hospital.

Continued review of Patient #2's record revealed on 03/06/2021 at 11:36 AM Physician #2 was notified that Patient #2's repeat D-Dimer level continued to be abnormal at 4.946 and a CT was ordered of the patient's chest. Review of Patient #2's CT results completed on 03/06/2021 at 12:40 PM indicated, "Cardiomegaly [enlarged heart] with congestive failure and bilateral pleural effusions [unusual amount of fluid around the lungs], Pericardial effusion [buildup of extra fluid in the space around the heart] is noted, Generalized anasarca [swelling], small and atrophied [wasting away] left kidney." However, the physician took no action related to the concerns identified from the CT scan.

Further review of Patient #2's medical record revealed on 03/06/2021 at 3:40 PM, RN #7 informed Physician #2 that the patient was "crying out in pain" to his/her right leg. The patient's right leg was cool to touch, blue/purple in color, and only a faint pulse was palpable to his/her right foot. According to the nurse, Physician #2 asked if she had a bedside Doppler and stated he would come evaluate the patient.

However, RN #7 stated when Physician #2 came to see the patient at 4:05 PM on 03/06/2021, he never asked for the Doppler when he went to evaluate the patient. RN #7 stated she accompanied the physician to Patient #2's room. Physician #2 observed the patient's right leg and asked the patient if he/she had a history of a "bad back." The RN stated the patient replied, "Yes," and Physician #2 informed the patient the pain in his/her leg was "coming from" his/her back. The physician ordered a pain medication, Norco 5 mg to be administered for pain.

Review of Patient #2's record and interview with RN #5 at 8:00 PM on 05/02/2021 revealed she cared for the patient during the night shift (7PM-7AM) beginning on 03/06/2021. She stated the patient's right leg was "dusky blue" in color and cold to touch, with a faint palpable pulse to his/her right foot. The RN stated the physician was aware and saw the patient's leg. According to the RN, she could not understand why he did not further evaluate the leg with a Doppler study to see what was wrong, "especially because the D-Dimer was positive." RN #5 stated Patient #2 was observed to be "lethargic" at 8:45 PM on 03/06/2021, so she evaluated the patient's blood glucose and it was determined to be low at 23 (normal range 90-110). The nurse stated the physician was notified and medication was given to increase his/her blood glucose, which returned to normal. The RN stated Physician #2 came to the ICU to evaluate the patient at 9:30 PM, at which time Patient #2's heart rate had dropped to 50 (normal range 60-100), his/her blood pressure was 160/94, respirations were 22 (normal range 12-16) and temperature was 98.1. She stated the physician was notified of the patient's decreased heart rate; however, no new orders were received to address the patient's heart rate.

According to interview with RN #5, the patient's heart rate remained 45-50 beats per minute. She stated Physician #2 remained at the patient's bedside' however, no new orders were given to address the patient's heart rate was given. Continued interview with RN #5 and review of the record revealed at 12:00 AM on 03/07/2021, staff contacted Facility #2 for transfer; however, no beds were available and the physician was made aware. No further direction was provided to nursing staff to attempt to find the patient a bed at another facility.

According to Patient #2's medical record, at 1:30 AM on 03/07/2021, Patient #2's blood glucose dropped again to 58, and new laboratory tests were ordered. Review of the record and interview with RN #5 indicated at 2:41 AM, the patient's potassium (an electrolyte that effects how the heart muscles work) level came back and was elevated at seven (7) (normal range 3.5-5.3) and his/her D-Dimer level had increased to greater than 12.50. Physician #2 was notified and new orders were received to address the patient's low blood glucose. The physician stated he would come to evaluate the patient and did not address the patient's potassium, nor increasing D-Dimer.

Continued review of Patient #2's medical record revealed at 2:45 AM on 03/07/2021, Physician #2 arrived to evaluate the patient. Continued interview with RN #5 and review of the record revealed at 3:00 AM, Patient #2's condition had further deteriorated and the patient's bilateral lower extremities were cool to touch/blue in color. The patient was lethargic, had "agonal respirations" (struggling/gasping to breathe that is a symptom of a severe medical emergency such as a stroke or cardiac arrest) heart rate was 45, blood pressure was 152/89, respirations were 24, and his/her oxygen level was 90% on oxygen at 2 liters via nasal cannula. The record indicated Physician #2 contacted the patient's family and informed them of the change in his/her condition; however interview with the RN and review of the record revealed no evidence any actions were taken to address the patient's respiratory/cardiac deterioration and no action to address the patient's increasing D-Dimer.

According to Patient #2's medical record, Physician #2 ordered an insulin drip (1 unit per hour) to be administered to Patient #2 on 03/07/2021 at 4:00 AM, over one hour later, to address his/her elevated potassium level, even though the patient's glucose had previously dropped below normal on two occasions. He also ordered a Kayexalate (medication to treat a high potassium level) enema 15 grams to be administered one time to treat the potassium level.

Continued interview with RN #5 revealed she questioned the physician's order for an insulin drip, because the patient had experienced previous low blood sugar readings; however, the physician informed the nurse he frequently treated high potassium levels in that manner.

At 4:14 AM on 03/07/2021, facility staff contacted Facility #3 in an attempt to obtain a bed for the patient, and according to the record, a bed was confirmed for the patient at 5:09 AM. EMS was notified for transport at 5:30 AM. Continued interview with RN #5 revealed the patient's condition continued to deteriorate. The patient's heart rate remained 45-50 beats per minute. Physician #2 remained at the patient's bedside; however, no new orders were received in attempts to stabilize the patient.

According to the patient's medical record and further interview with RN #5, EMS arrived at the facility at 6:20 AM on 03/02/2021; however, they felt the patient was too "unstable for transport." Physician #2 was notified and orders were received to "fly" the patient to the receiving facility. The record indicated air transport was notified at 6:35 AM and the physician was again at the patient's bedside at 6:40 AM on 03/07/2021.

Patient #2's record and interview with RN #7 on 04/29/2021 at 3:00 PM revealed she arrived for her shift, received report, and evaluated Patient #2 at 7:15 AM on 03/02/2021. She stated she was unable to obtain a blood pressure or an oxygen saturation reading on the patient. Documentation also indicated the patient's heart rate was 40, his/her skin was discolored and cool and Patient #2 continued to have agonal breathing. Physician #2 was at the patient's bedside; however, no orders were received in an attempt to stabilize the patient. RN #7 stated she "couldn't understand why [the physician] wasn't doing anything to treat the patient's low heart rate and blood pressure." At 7:25 AM on 03/07/2021, Patient #2 was placed on a 100% non-rebreather mask (at the house supervisor's request) for oxygen delivery and the patient was "only" responding to painful stimuli.

Continued review of Patient #2's medical record indicated at 7:45 AM on 03/07/2021, Patient #2's blood pressure was 60/30, his/her oxygen reading was 86% with 100% oxygen being administered to the patient, and a Dopamine drip (Medication to increase heart rate and blood pressure) was initiated for the patient, also at the request of the house supervisor. At 7:50 AM on 03/07/2021, the record revealed Air-Evac staff came to transport the patient; however, they contacted their director and refused to transport Patient #2 because the patient "needs to be stabilized" for transfer. The patient's record indicated Physician #1 was contacted to intubate the patient.

According to the record at 8:00 AM on 03/02/2021, Physician #1 intubated the patient and ordered Epinephrine (emergency medication to increase heart rate) one (1) ampule be administered one time and the physician also ordered an Epinephrine drip to be initiated in attempts to stabilize the patient. Physician #1 ordered a Diprivan (mediation to sedate the patient after intubation) drip be started and also ordered a normal saline fluid bolus, and one (1) ampule of Sodium Bicarbonate (medication to treat metabolic acidosis and/or circulatory deficits) to be administered to the patient. According to the record, at 8:15 AM, Patient #2's blood pressure was 75/40 and his/her heart rate had increased to 61. At 8:20 AM, Patient #2's blood pressure was 78/54 and his/her heart rate was 62; Air-Evac transported the patient from the facility at 8:50 AM on 03/07/2021.

Review of Patient #2's hospital record indicated he/she was admitted to Facility #3 at approximately 10:28 AM on 03/07/2021 with diagnoses, which included Shock possible septic versus cardiogenic (heart failure), fixed dilated pupils (symptom of brain injury), acute hypoxic respiratory failure (not enough oxygen in the blood) with concerns for an anoxic brain injury (lack of oxygen to the brain which results in brain death), pericardial effusion (buildup of fluid around the heart) and bradycardia (low heart rate). Documentation also revealed that Patient #2's lower extremities were both mottled (red/purple) in color and he/she was found to have Deep Vein Thrombus (blood clots) in both lower extremities. The patient was also in multi-organ failure. According to the hospital record, Patient #2's clinical condition continued to deteriorate and he/she had cardiac arrest and expired on 03/08/2021 at 3:05 PM.

Interview with RN #6 on 05/05/2021 at 11:15 AM revealed she was the house supervisor when Patient #2 was cared for and transferred from the facility on 03/07/2021. She stated she went to ICU at approximately 7:15 AM to evaluate the patient because she had been informed a patient was being transferred. She stated Patient #2 was unresponsive, his/her heart rate was "in the 40's", and Physician #2 was at the bedside. RN #6 stated the physician, however, was doing nothing to stabilize the patient. RN #6 stated the patient was "mottled" from the waist, down his/her lower extremities. She stated she asked Physician #2 why he was not addressing/treating the patient's low heart rate, and told him "we needed to". She stated the physician replied that the patient "had been this way a while" and that he/she was stable. RN #6 stated she suggested a medication drip be started in attempts to stabilize the patient. She stated the physician ordered the medication (Dopamine). The nurse also stated she suggested that the patient be intubated as the patient was in "respiratory distress". However, the physician stated again that a transport team was on their way. She stated she suggested a second time that the patient be intubated in attempts to stabilize the patient; however, the physician refused again to intubate the patient. RN #6 stated on the third request for intubation, she told the physician that Patient #2 was unstable and reminded him that the transport team had already refused to transport Patient #2. She stated she told the physician that "no one will transport [the patient] until" he/she was intubated and stabilized for transport. The RN stated after the third request, Physician #2 instructed her to contact Physician #1 to assist with intubation. She stated Physician #2 made no attempts to intubate the patient, even though the patient was in distress. The nurse stated she informed the CNO at the time (NP #4) of what "had happened" with Patient #2's course of treatment provided/not provided by Physician #2.

Interview with Physician #4 on 05/12/2021 at 3:40 PM revealed he was working the ED on 03/07/2021 when Patient #2 was transferred. He stated RN #6 returned to the ED after assisting with care/treatment of the patient and he stated, "The nurse looked traumatized." He stated he questioned what was wrong with the nurse and she informed him of Patient #2's condition and stated Physician #2 "was doing nothing" to attempt to stabilize the patient. Again, Physician #4 stated concerns were taken directly to the CEO regarding the care provided by Physician #2; however, no action had been taken to ensure the safety and wellbeing of patients at the facility.

NURSING SERVICES

Tag No.: A0385

Based on interview, record review and review of facility policies, it was determined the facility failed to ensure nursing staff supervised and evaluated patient care in accordance with acceptable standards of nursing practice and hospital policy for five (5) of seven (7) sampled patients (Patient #1, Patient #2, Patient #3, Patient #5 and Patient #6).

Record review revealed Patient #1 presented to the facility with chest pain, shortness of breath, hypertension, and tachycardia. However, the patient's vital signs were not monitored per protocol. The patient was admitted to the ICU and during the night of 12/27-28/2020, the patient's blood pressure and heart rate were elevated and not responsive to treatment; however, the nurse failed to notify the patient's physician. When another nurse began caring for the patient at approximately 7:30 AM on 12/28/2020, the nurse found the patient in distress.

Record review revealed on 03/07/2021, at 4:00 AM Patient #2's physician ordered an insulin drip to treat the patient's elevated potassium and ordered for the patient's blood glucose to be checked every hour. However, a blood sugar was not obtained every hour as ordered, even though at approximately 1:30 AM (prior to the insulin drip) the patient's blood sugar was 58 and required treatment for hypoglycemia. The only documented blood sugars after the insulin was initiated was at 5:44 AM when the patient's blood sugar was low at 56 and at 7:09 AM when it was 117.

Record review revealed on 04/09/2021, at 1:07 AM, Patient #3 became unresponsive, had agonal breathing, and had cardiac arrhythmias. The patient's physician arranged for transfer of the patient and confirmed bed availability at the receiving hospital on 04/09/2021 at 5:15 AM; however, nursing staff failed to initiate notification to Emergency Medical Services (EMS) for a transport until 6:40 AM. However, the nurse noted the line was busy and did not reach EMS until 7:25 AM, approximately two hours after the transfer was arranged. The patient was not transferred from the facility until 10:40 AM on 04/09/2021.

Record Review revealed the facility admitted Patient #6 to the medical floor on 12/20/2020 at 11:50 PM with orders for continuous telemetry monitoring (heart monitoring) after presenting to the Emergency department (ED) with complaint of pain and swelling in legs, torso and neck that began one day prior. Nursing staff failed to follow protocol to obtain an initial heart rhythm strip when Patient #6 was placed on telemetry monitoring and failed to monitor and notify the physician of critical tachycardia (elevated heart rate above 100) and telemetry event alarms. Patient #6 developed respiratory distress and supraventricular tachycardia (SVT) and required transfer to the Intensive Care Unit (ICU) on the morning of 12/21/2020, where he/she was treated for SVT. Patient #6 left the facility on 12/21/2020 against medical advice and returned to the ED on 12/23/2020 and was pronounced dead on arrival to facility.

Record review revealed Patient #5 was admitted to the facility on 04/27/2021 with Diabetic Ketoacidosis. On 04/30/2021, a computerized tomography (CT) scan revealed the patient had an ileus and a physician's order was written for the patient to have nothing by mouth (no food, drink, etc). However, the facility failed to follow the physician's orders and continued to administer food to the patient.

Refer to A0395.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview, record review and review of facility policies, it was determined the facility failed to ensure nursing staff supervised and evaluated patient care in accordance with acceptable standards of nursing practice and hospital policy for five (5) of seven (7) sampled patients (Patient #1, Patient #2, Patient #3, Patient #5 and Patient #6).

The findings include:

Review of the facility's policy System for Informing the Physician of Patient Changes in Condition, revised July 2009 and 04/12/2021, revealed it was the responsibility of the nursing staff to notify the attending or on-call physician if a patient experienced a pertinent change in vital signs or level of orientation. In addition, staff were to notify the physician if a patient was determined to have abnormal lab values, X-ray findings, or experienced a cardiac arrhythmia (irregular heart rate), chest pain or respiratory distress. However, the policy did not direct staff regarding how soon they should notify the physician when they identified a significant change in a patient's condition including one or more of the previously listed abnormalities.

Interview with the Chief Executive Officer (CEO) on 05/10/2021 at 8:05 PM revealed nursing staff should inform the patient's physician immediately when a change in a patient's condition occurred.

Review of the facility's Emergency Department Cardiac Chest Pain Protocol, not dated, revealed the purpose of the protocol was to ensure patients were provided with immediate and appropriate care when experiencing chest pain. The protocol also stated staff would monitor a patient's vital signs every fifteen (15) minutes if the patient presented to the facility with chest pain.

Review of facility policy titled, "Telemetry Policy and Procedure", dated 06/2019, revealed the purpose is to provide continuous electrocardiogram (ECG) monitoring for patients on the medical floor to provide early detection of arrhythmias/dysrhythmias (abnormal heart rhythms) and evaluation of cardiac function. Further review revealed nursing staff on the medical surgical unit were to print a tracing strips each shift on every telemetry patient and the medical surgical nurse was responsible to notify the floor of any abnormal or irregular tracings. Per the policy, the medial surgical unit nurse was to notify the floor immediately if a life threatening arrhythmia was detected.

Review of facility policy titled, "Transcription of Physician's Orders", dated April, 2021, revealed the purpose was to ensure accurate and timely transcription, implementation, and authentication of physician's orders. Further review revealed physician orders may be placed via computer, handwritten or given verbally to a licensed nurse or pharmacist. Per the policy, verbal orders are discouraged, not routinely used, and should be utilized on a limited emergent basis.

1. Review of an Emergency Medical Services (EMS) "Run Sheet" for Patient #1 dated 12/27/20 at 11:00 PM, revealed, EMS was transporting Patient #1 to the facility with complaints of chest pain and anxiety, which the patient had been experiencing for approximately four (4) hours prior to calling EMS. Further review of the EMS Run Sheet revealed at 11:21 PM, the patient's blood pressure was 170/108 mmHg (normal range less than 120/80mmHg); heart rate was 118 beats per minute (normal range 60-100 beats per minute); and temperature was 97.5 degrees Fahrenheit (normal 98.6 degrees Fahrenheit). In addition, the Run Sheet revealed Patient #1 was receiving supplemental oxygen at 2 liters per minute via nasal cannula.

Review of Patient #1's medical record revealed the patient arrived at the facility's Emergency Department (ED) on 12/27/2020 at 11:33 PM via EMS, with complaints of chest pain and anxiety, which the patient had been experiencing for approximately four (4) hours prior to arrival. Further review of the ED record revealed the patient also complained of shortness of breath and was exhibiting hypertension, and tachycardia. However, there was no evidence to indicate staff obtained Patient #1's vital signs upon arrival to the ED. Further review of the record revealed Patient #1 was administered Nitroglycerine (a medication to treat chest pain and lower blood pressure) at 11:42 PM and Morphine (pain medication) 4 milligram was also administered to Patient #1 at 12:00 AM on 12/28/2020 , both without evidence of staff obtaining the patient's vital signs. Continued review of the record revealed the first documentation of Patient #1's vital signs was at 1:14 AM on 12/28/20, approximately two (2) hours after arrival to the facility, approximately one (1) hour and thirty-two (32) minutes after administration of Nitroglycerine, and approximately one (1) hour and fourteen (14) minutes after administration of Morphine.

Further review of the ED record revealed Patient #1's vital signs documented at 1:14 AM on 12/28/2020 included a blood pressure of 181/108 mmHg, and a pulse rate of 118 beats per minute and at 1:16 AM, staff applied a Clonidine Patch (a transdermal medication to treat high blood pressure) to Patient #1. However, the patient's systolic blood pressure remained above 180 mmHg and diastolic blood pressure remained above 100 mmHg until the facility admitted the patient to the Intensive Care Unit (ICU) at approximately 2:15 AM on 12/28/2020 with diagnoses including Chest Pain, Worsening Shortness of Air, Pneumonia and Tachycardia.

Interview with RN #3 on 05/01/2021 at 10:50 PM revealed she cared for Patient #1 while the patient was in the ED during the late night of 12/27/2020 and early morning of 12/28/2020. RN #3 stated staff were supposed to print off the patient's vital sign readings from the monitor and place them in the patient's medical record, but she had forgot to do this for Patient #1.

Review of Patient #1's ICU record revealed on 12/28/2020 at 2:23 AM, the patient's blood pressure was documented as 179/122 mmHg, and the patient's heart rate was 139 beats per minute. At 3:05 AM, staff documented the patient's blood pressure and heart rate remained elevated and Physician #3, the physician treating Patient #1, order staff to administer the patient a one-time dose of intravenous Labetalol (a medication to treat high blood pressure). Review of the patient's medication record revealed staff administered the medication to Patient #1 at 3:27 AM. However, there was no documentation found in Patient #1's medical record of what the patient's blood pressure and heart rate reading were when staff called the patient's physician or before staff administered the medication to the patient. Continued review of Patient #1's ICU record revealed at 3:41 AM, the patient's blood pressure was 185/113 mmHg and the patient's heart rate was 135 beats per minute. Further review of the ICU record revealed the patient's blood pressure and heart rate continued to be elevated and was documented as blood pressure 169/103 mmHg and heart rate 135 beats per minute at 3:56 AM and blood pressure 164/96 mmHg and heart rate 132 beats per minute at 4:26 AM. However, there was no evidence found to indicate staff notified the Patient's physician of the continued elevation of Patient #1's blood pressure and heart rate after administration of the Labetalol.

Interview with Physician #3 on 05/06/2021 at 5:25 PM revealed staff only notified him of Patient #1's elevated blood pressure and heart rate one time on 12/28/2020, when the patient was in the ICU. Physician #3 stated he recalled ordering an IV medication to treat the patient's elevated blood pressure and heart rate, and would have expected staff to call him back within one (1) hour of administration when the medication was not effective. However, Physician #3 stated staff never contacted him again in regards to Patient #1.

Continued review of Patient #1's ICU record revealed at 5:11 AM, the patient's blood pressure was 160/101 mmHg and heart rate was 138 beats per minute, at 5:41 AM the patient's blood pressure was 168/101mmHg and heart rate was 127 beats per minute, and at 6:11 AM the patient's blood pressure was 154/104 mmHg and heart rate was 141 beats per minute. Further review of the record revealed staff documented at 6:50 AM "Pt remains hypertensive and tachycardic at this time", and that Nurse Practitioner (NP) #2, was notified and ordered staff to administer Labetalol IV STAT (immediately) to Patient #1. However, there was no documentation in the record of what the patient's vital signs were when staff contacted NP #2, why Physician #3 was not contacted instead of NP #2 since he was Patient #1's treating physician, or if staff informed NP #2 that Physician #3 had previously ordered the patient that same medication which was administered at 3:27AM, and it had not been effective. Review of Patient #1's medication record revealed staff administered the IV STAT Labetalol at 6:55 AM.

Interview with Registered Nurse (RN) #2 on 04/28/2021 at 2:35 PM revealed he admitted Patient #1 to the ICU on 12/28/2020 at 2:15 AM and continued to care for the patient until 7 AM on 12/28/2020. RN #2 stated he was concerned about Patient #1 because the patient's blood pressure and heart rate remained elevated and the patient was complaining of chest pain. RN #2 stated he informed Physician #3 of the patient's condition and abnormal vital signs at approximately 3:00 AM and the physician ordered an IV medication to lower the patient's heart rate and blood pressure. RN #2 stated he realized after approximately one (1) hour of administering the medication, that it was not effectively treating the patient's elevated blood pressure and heart rate, but stated he took no action to inform Physician #3 of the ineffectiveness of the medication. RN #2 stated he waited until "closer to shift change" to notify NP #2 about Patient #1's high blood pressure and heart rate. However, RN #2 could not recall why he waited to contact a provider or why he called NP #2 and not Physician #3 who was treating Patient #1. RN #2 went on to state when he spoke to NP #2 he did not inform her that he had contacted Physician #3 earlier at approximately 3:00 AM about Patient #1's elevated blood pressure or that the patient had already received Labetalol at 3:27 AM, but continued to have an increased blood pressure and heart rate. RN #2 stated he administered the Labetalol medication IV ordered by NP #2, and gave report to RN #1 who took over care of Patient #1 at approximately 7:00 AM on 12/28/2020.

Interview with NP #2 on 04/30/2021 at 11:15 AM revealed RN #2 contacted her on 12/28/2020 at approximately 7:00 AM and informed her that Patient #1's blood pressure and heart rate was elevated and she gave RN #2 a medication order to administer to the patient. However, NP #2, stated RN #2 did not inform her that Patient #1's blood pressure and heart rate had been elevated since arrival to the facility, that Physician #3 had already been notified previously during the shift and ordered medication to be administered to the patient, or that the medication ordered by Physician #3 was not bringing the patient's elevated blood pressure and heart rate under control. NP #2 stated RN #2 should have informed her of the Patient's course of treatment since arriving to the facility including any medications previously administered

Interview with RN #1 on 04/28/2021 at 10:50 AM, and review of RN #1's documentation revealed on 12/28/2020 at 7:30 AM Patient #1's heart rate was 168 beats per minute and the patient was "Very short of air." RN #1 stated when she received report from RN #2, on Patient #1, the only thing she recalled being told by the off going nurse was that the patient had received Labetalol IV during the night for an elevated blood pressure and heart rate. However, RN #1 stated when she initially assessed Patient #1 at approximately 7:30 AM on 12/28/2020, the patient's blood pressure and heart rate were both still elevated, the patient was anxious, short of breath, coughing up blood and the patient's lungs sounded like he/she "was drowning." RN #1 also stated Patient #1 had a decreased oxygen saturation, despite the patient receiving oxygen via nasal cannula. RN #1 stated she recalled notifying respiratory therapy and placed Patient #1 on an oxygen mask rather than a nasal cannula, administering fifty (50) percent oxygen in an attempt to treat the patient's respiratory distress. However, Patient #1's condition continued to deteriorate and the patient requested intubation after stating "I can't breathe, please don't let me die". RN #1 stated she notified Physician #2 who was in the ICU and overseeing the care of Patient #1 at that time, and NP #1 of Patient #1's deteriorating condition. However, neither Physician #2, nor NP #1 came to the patient's bedside and physically evaluated the patient, but NP #1 ordered IV Lopressor (medication to lower blood pressure and heart rate) to be administered to the patient at approximately 8:30 AM and a second dose was also administered at 8:35 AM. Although RN #1 stated the patient's blood pressure came down "some", the RN stated the patient's heart rate remained elevated. However, there was no documentation of the patient's blood pressure or heart rate in the medical record, and RN #1 stated she failed to document the vital signs. RN #1 also stated Digoxin (a medication to treat an irregular heart beat) was also administered to the patient however, she failed to document the dosage of the medication or the time the medication was administered and again, failed to document Patient #1's vital signs in the medical record or the patient's response to the medication. RN #1 stated she should have documented all medications Patient #1 received and each time she obtained the patient's vital signs. In addition, RN #1 stated she should have also documented the patient's ongoing decline and all interventions attempted to stabilize Patient #1, however, RN #1 stated, "Everything happened so fast." Continued interview with RN #1 revealed Patient #1's condition continued to deteriorate and the patient's vital signs "dropped off to nothing". RN #1 stated she yelled out that Patient #1 was in cardiac/respiratory arrest, and Physician #2 came to the bedside and attempted to intubate Patient #1 but was unsuccessful. RN #1 stated despite resuscitative measures being provided, Patient #1 was pronounced deceased at 10:06 AM. RN #1 stated NP #1 did not arrive to Patient #1's bedside until after the patient had been pronounced deceased.

Interview with NP #4 on 05/03/2021 at 1:35 PM revealed she was acting Chief Nursing Officer (CNO) when the facility cared for Patient #1. NP #4 stated staff should have obtained and documented Patient #1's vital signs upon arrival to the ED, and every five (5) minutes as long as they remained abnormal while in the ED. She also stated staff should have obtained and documented the patient's vital signs in the ICU every five (5) minutes or at a minimum every fifteen (15) minutes as long as the patient's vital signs remained unstable. NP #4 also stated staff should have document the patient's vital signs any time staff notified the physician of abnormalities and any time the patient was administered a medication, which would affect the patient's vital signs. NP #4 also stated staff should have notified the physician when Patient #1's blood pressure and heart rate remained elevated during the night on 12/28/2020 and when it was apparent the medication administered to Patient #1 was not effectively treating the patient's elevated blood pressure and heart rate.

2. Interview with the Chief Nursing Officer (CNO) on 04/29/2021 at 2:15 PM revealed the facility did not have a written insulin protocol. However, she stated patients being administered intravenous (IV) insulin should have their blood glucose levels obtained and documented at a minimum of every hour, unless the patient's physician ordered otherwise.

Review of Patient #2's medical record revealed the patient arrived to the facility's ED at approximately 11:30 PM on 03/04/2021 with complaints of shortness of air and methamphetamine abuse with involuntary movements to the entire body. Continued review of the record revealed no evidence the patient's vital signs were obtained upon arrival to the ED. The first documented vital signs in Patient #2's medical record were documented at 11:44 PM on 03/04/2021 and the patient's blood pressure was 179/73 mmHg, heart rate was 120 beats per minute, temperature was 98 degrees Fahrenheit, and respirations were 20 breaths per minute. Further review of the ED record revealed at 12:00 AM on 03/05/2021, Patient #2 was administered intravenous Valium (a sedating medication to treat anxiety), and at 1:47 AM staff administered oral Valium to Patient #2. In addition, at 12:16 AM staff administered the patient intravenous Benadryl (a medication to treat allergies that can cause drowsiness). However, there was no evidence staff obtained Patient #2's vital signs other than at 11:44 PM, for the entire time (4.5 hours) the Patient was in the ED, despite being administered medication three (3) times. In addition, there was no documentation of the patient's response to the medications or if it was effective in treating Patient #2's condition. Continued review of Patient #2's record revealed the facility transferred the patient to the ICU on 03/05/2021 at 4:00 AM.

Review of Patient #2's ICU medical record there was no documentation of what the patient's vital signs were upon entering the ICU and the first vital signs documented in the patient's record was at 8:12 AM on 03/05/2021, four (4) hours after the Patient #2 was admitted to the ICU. Review of the vital signs documented for the patient at 8:12 AM, revealed blood pressure was 141/95 mmHg and heart rate was 111 beats per minute, respiratory rate was 24 breaths per minute, temperature was 97.5 and oxygen saturation was 95 percent.

Interview with RN #3 on 05/01/2021 at 10:50 PM revealed she cared for Patient #2 in the facility ED on 03/04/2021 and 03/05/2021. RN #3 stated she was supposed to print off the patients vital signs from the monitor and place in them in the patient's medical record. However, she stated she had forgotten to do so for Patient #2. Continued interview with the RN #3 revealed she administered the Valium and Benadryl to Patient #2 because the patient was "thrashing around in bed." The RN stated she had failed to document the effectiveness of the medications she had administered to Patient #2.

Further review of Patient #2's record revealed RN #7 documented the patient was "crying out in pain" related to pain to the right leg on 03/06/2021 at 3:40 PM and the patient's physician was notified. Interview with RN #7 on 04/29/2021 at 3:00 PM, revealed Patient #2's right lower leg was blue/purple in color, cold to touch, and had a faint pulse. However, RN #7 failed to document the condition and her assessment of the patient's right lower extremity in the patient's medical record. RN #7 stated she was aware of the need to document a change in a patient's condition in the record, and was unsure why she had not included her assessment findings in Patient #2's record.

Continued review of Patient #2's record revealed on 03/07/2021 at 4:00 AM, Physician #2 ordered staff to administer an insulin drip to Patient #2 and subsequently staff were to monitor the patient's blood glucose level every hour. However, review of nursing documentation revealed no evidence of what time staff initiated the patient's insulin drip, that staff monitored the patient's blood glucose levels as ordered, and no indication of when staff discontinued the patient's insulin drip. The only blood glucose levels documented in the medical record for Patient #2 on 03/07/2021 were at 5:44 AM the patient's blood glucose level was 56 (normal range 70-130) and 7:00 AM the patient's blood glucose level was 115 and at 7:09 AM the patient's blood glucose level was 117.

Interview with RN #5 on 05/02/2021 at 8:00 PM revealed she received the orders to initiate the insulin drip for Patient #2 on 03/07/2021. However, she stated she could not recall what time she initiated the insulin drip for the patient, what the patient's blood glucose level was when staff initiated the insulin drip or if she monitored the patient's glucose level hourly as ordered. RN #5 stated she should have documented in the patient's medical record when the drip was initiated and what the patient's blood glucose was at the time, however stated she must have failed to do so.
Further interview with RN #7 revealed she cared for Patient #2 during the day shift from 7AM-7PM, on 03/07/2021. She stated Patient #2 had an insulin drip infusing at the start of the shift on 03/07/2021, and she could not recall if she monitored the patient's glucose level hourly as ordered. However, RN #7 acknowledged the medical record provided no evidence that she checked the patient's glucose level at any time during the shift. She also stated to the best of her recollection, Air-Evacuation (medical helicopter) staff discontinued the drip when they were preparing to transport the patient to another facility at approximately 8:00 AM on 03/07/2021. RN #7 stated she should have obtained and documented hourly blood glucose checks as ordered and should have documented when the Air-Evacuation staff discontinued the insulin drip for Patient #2.

Interview with NP #4 at 1:35 PM on 05/03/2021 revealed she was the CNO when Patient #2 was cared for in the facility. She stated nursing staff were to document assessment findings, including any change in condition in the patient's medical record. She also stated staff should closely monitor a patient's blood glucose levels anytime the patient is receiving insulin intravenously.

3. Review of Patient #3's medical record revealed the patient arrived at the ED on 04/08/2021 at 12:00 PM with complaints of shortness of breath, weakness and alcohol intoxication. Subsequently, the facility admitted Patient #3 to a medical floor in the facility on 04/08/2021 at 2:15 PM with diagnoses including alcohol intoxication and possible rhabdomyolysis.

Continued review of Patient #3's record indicated on 04/09/2021, at 1:07 AM, Patient #3 became unresponsive, had agonal breathing (gasping for breath), and cardiac arrhythmias. According to the record Cardiopulmonary Resuscitation (CPR) was initiated and the facility transferred Patient #3 to the ICU. Staff were able to stabilize Patient #3, and the facility arranged to transfer Patient #3 to another hospital able to provide a higher level of care.

Further review of Patient #3's record revealed transfer diagnoses included an Acute Stroke, and the receiving facility confirmed the patient's bed at the receiving hospital on 04/09/2021 at 5:15 AM. However, according to Patient #3's medical record RN #11, who was caring for Patient #3, did not attempt to notify EMS of Patient #3's transfer until 6:40 AM on 04/09/2021. However, RN#11 documented that the telephone line was busy. Further review of the record revealed the facility did not notify EMS of Patient #3's need for transport until 10:00 AM, approximately five hours after the facility had arranged for the patient's transfer. Continued review of the record revealed Patient #3 left the facility at 10:40 AM on 04/09/2021.

Interview with Administrative staff on 05/10/2021, at 8:05 PM, revealed RN #11 was hospitalized and unable to give an interview.

Interview with Physician #4 on 05/12/2021 at 3:40 PM revealed he had written orders to transfer Patient #3 for a suspected stroke on 04/09/2021. Further interview revealed after caring for Patient #3 and arranging for the patient's transfer, he returned to the facility ED to evaluate patients and stated staff did not inform him that there was a delay in transferring Patient #3, but they should have.

Interview with the Chief Executive Officer (CEO) on 05/10/2021 at 8:05 PM revealed nursing staff were to inform the physician when a change in a patient's condition occurred. In addition, the CEO also stated nursing staff in all clinical settings were to obtain and document vital signs, changes in patient conditions and ineffectiveness of medications in the medical record. In addition, the CEO stated staff should arrange emergent transfers immediately. Further, the CEO stated nursing staff should follow facility protocols/policies in regards to insulin drip administration and other medications administered in the facility, and stated the information obtained from patient assessments should be included in the medical record. The CEO also stated administration had identified concerns with nursing documentation in the facility and had provided education, however stated nursing staff remained "reluctant to do and document as they should." The CEO stated he was unaware of any further actions taken to correct or monitor the concerns related to nursing services in the facility.

4. Review of Patient #6's medical record revealed the patient presented to the Emergency Department (ED) on 12/20/2020 at 5:46 PM with a chief complaint of pain and swelling in the legs, torso and neck for the past day. The patient's vital signs were blood pressure 168/90, pulse 83, respirations 22, oxygen saturation 98% room air, temperature 97.3 (temporal). Further review revealed Patient #6 was admitted to Medical floor under care and services of Physician #3 with diagnoses of Hyponatremia (low sodium), Dehydration, Hyperkalemia (high potassium), and prolonged QT (delayed electrical recharge between heartbeats).

Review of Patient #6's ECG dated 12/20/2020 at 8:17 PM revealed sinus tachycardia (normal heart rhythm with increased rate) at a rate of 116 beats per minute.

Continued review of Patient #6's medical record revealed he/she arrived to the medical floor at 12:27 AM on 12/21/2020 with initial vital signs of blood pressure 160/70, pulse 80, respirations 22, oxygen saturation 97% room air, temperature 97.8, and was order to receive continuous telemetry monitoring. Further review of the record revealed no initial telemetry strip was obtained by nursing staff when Patient #6 was placed on telemetry as the hospital policy required.

Interview with State Registered Nurse Aide (SRNA) #7, on 05/18/2021 at 1:05 PM, revealed telemetry strips were supposed to be printed each shift and if an event alarm occurs, a strip should be printed, and the physician notified. Further interview revealed strips were placed in a telemetry log book on the medical floor and event strips were placed in the patient chart. SRNA #7 stated nurses usually monitor telemetry but no specific staff is assigned.

Review of Patient #6's vital signs on 12/20/2020 reflect one set of vital signs taken at 4:00 AM following the initial set of vital signs taken at 12:27 AM upon admission to the medical floor. The vital signs were recorded as a blood pressure of 109/91, pulse rate 60, respirations of 20, oxygen saturation of 90% and temperature of 98.2.

Attempts to contact the author of Patient #6's vital signs taken at 4:00 AM on 12/21/2020 were unsuccessful, as the facility had no contact information and the author was employed a very short time at the facility as an orderly. In addition, the facility was unable to provide the full name of the author/orderly.

Interview with RN #13, on 05/12/2021 at 3:25 PM, revealed Patient #6 began complaining of shoulder pain, shortness of breath, and became restless at approximately 1:00 AM on 12/21/2020. RN #13 stated he called the on-call Physician #8 (also the ER physician). The RN stated he could not remember why he called Physician #8 instead of the patient's physician (Physician #3). The RN stated Physician #8 gave orders for a chest x-ray, arterial blood gases (ABG) and to administer three (3) liters of oxygen via nasal cannula to the patient; however, there was no documentation Patient #6 was not seen by Physician #8. He further stated Patient #6 looked very sick and he was a graduate nurse and was not comfortable caring for the patient. He stated he notified his House Nursing Supervisor (RN #3) after contacting Physician #8 (at approximately 1:00 AM). The RN stated he told the House Nursing Supervisor Patient #6 should be placed in the intensive care unit (ICU) as the patient had developed a critically high heart rate of approximately 140-150 beats per minute. When asked if he notified the physician about the increased heart rate, he stated he could not recall, but he had notified Physician #3 of the change in condition and results of ABG at 1:45 AM. The RN stated he could not recall if he obtained a telemetry event alarm strip when Patient #6 had a change in heart rate; however, the RN stated the patient telemetry alarmed all night due to the increased heart rate. He stated just before shift change at approximately 6:45 AM, the oncoming nurse (RN #10) identified Patient #6 was in distress with a critically high heart rate and critical rhythm, and finally got the patient moved to the ICU, where he/she received treatment. RN #13 stated at the time he cared for Patient #6, he had not been trained on telemetry nor was he certified in advanced cardiac life support (ACLS) to identify arrhythmias/dysrhythmias.

Review of Patient #6's physician orders dated 12/21/2020 revealed an order for chest x-ray and an Arterial Blood Gases (ABG) was placed by on-call Physician #8 at 1:00 AM related to shortness of breath. Further review revealed Physician #8 placed an additional order for a lactic acid at 2:07 AM.

Interview with Physician #8, on 05/18/2021 at 4:05 PM, revealed he was contacted related to Patient #6's respiratory distress at approximately 1:00 AM on 12/21/2020. He stated he did not recall why he was called instead of the patient's physician (Physician #3). He stated typically the nurse would have contacted Physician #3, unless it was a rapid response in the facility where the emergency room physician would be present. He stated he did not recall going to the medical floor to evaluate Patient #6 on 12/21/2020, and did not recall the event specifically. The physician stated he did not remember being notified of the patient's critically high heart rate. Physician #8 stated if he was notified of the critically high heart rate, he would have went to see the patient.

Review of Patient #6's ABG lab result dated 12/21/2020 at 1:45 AM revealed Patient #6 had a blood pH 7.33 (reference range 7.35-7.45), pCO2 19 (reference range 35-45) , bicarb 10 (referemce range 22-28) , and SO2 94 (reference range 94-100). Review of Patient #6 radiology report dated 12/21/2020 revealed a chest x-ray resulted at 2:37 AM indicating cardiomegaly (enlarged heart) and congestive heart failure with patchy pneumonia noted in the right upper lung lobe.

Review of nursing notes dated 12/21/2020 at 1:45 AM revealed RN #13 notified Physician #3 of ABG results and received no new orders. Further review revealed no documentation Physician #3 was notified of Patient #6 increased heart rate. Continued review of Patient #6 nursing notes dated 12/21/2020 revealed no documentation of physician notification of radiology results obtained at 2:37 AM.

Review of Patient #6's laboratory report dated 12/21/2020 at 2:40 AM revealed a lactic acid level 62.6 (reference range 4.5 to 19.8).

Review of Patient #6's nursing notes dated 12/21/2020 at 3:45 AM revealed RN #13 notified Physician #3 of lactic acid results and received new orders to administer Levaquin 250 milligram (mg) antibiotic intravenously. Further review revealed no documentation Physician #3 was notified of Patient #6 increased heart rate.

Review of Patient #6's medical record revealed no telemetry strips were recorded on 12/21/2020 and no event alarm strips were recorded on 12/21/2020 by nursing staff.

Review of Patient #6's physician notes dated 12/21/2020 at 9:00 AM revealed Physician #8 was called by Physician #3 to assist with Patient #6 having SVT at bedside in ICU and oversaw treatment for Patient #6 while assisted by NP #1.

Interview with Physician #3, on 05/19/2021 at 9:45 AM, revealed he was not notified that Patient #6 had developed a critically increased heart rate on 12/21/2020. He stated he expected nursing staff to be competent to notify him of a change in the patient's condition and to be competent to monitor telemetry patients. He further stated if he had been aware of the patient having an increased heart rate, he would have ordered an ECG to further evaluate the patient. Physician #3 stated he expected nursing staff to follow telemetry protocol and to print a telemetry strip of an ev

EMERGENCY SERVICES

Tag No.: A1100

Based on interview, record review and review of facility policies, it was determined staff failed to implement policies and procedures to ensure three (3) of seven (7) sampled patients in the emergency department received appropriate medical care (Patient #1, Patient #2, and Patient #5).

Record review revealed Patient #1 presented to the facility on 12/27/2020 with chest pain, shortness of breath, hypertension, and tachycardia and Patient #2 presented to the facility ED with moderate respiratory distress, and methamphetamine overdose on 03/04/2021. However, the patients' vital signs were not monitored per protocol in the facility ED.

Record review revealed Patient #5 arrived to the facility ED on 04/27/2021 and presented with signs and symptoms of sepsis. According to the ED Physician, the patient met four sepsis criteria indicating he/she should have been screened for Sepsis. However, staff failed to screen or implement the sepsis protocol as required for Patient #5 while in the ED.

Refer to A1104.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on interview, record review and review of facility policies, it was determined staff failed to implement policies and procedures to ensure three (3) of seven (7) sampled patients in the emergency department received appropriate medical care (Patient #1, Patient #2, and Patient #5)

The findings include:

Review of the facility protocol for Sepsis (undated), revealed the purpose of the protocol was to identify early symptoms of sepsis and provide initial treatment of sepsis. Further review revealed symptoms for recognizing sepsis included the following: tachycardia (increased heart rate over 100); tachypnea (increased respirations above 20); hypotension (decreased blood pressure below 90/60); temperature above 100.9 or below 96.8; oliguria (low urine output); mottled skin; changes in mental status; acute respiratory syndrome; cardiac dysfunction; white blood count (WBC) above 14,000 or below 12,000; platelet counts less than 100,000 and lactic acid levels above 19.8. Per the protocol, initial treatment was to be initiated within one hour of arrival to ED and the treatment included keeping oxygen saturation at 94% or greater, obtain blood cultures x 2, complete metabolic panel (CMP), complete blood count (CBC), prothrombin time (PT), international normalized ratio (INR), lactic acid level, administer fluid challenge (per physician discretion), intravenous antibiotics (per physician discretion), monitor vital signs, mental status changes, and urine output.

Review of the facility's Emergency Department Cardiac Chest Pain Protocol, not dated, revealed Emergency Department (ED) staff would monitor a patient's vital signs every fifteen (15) minutes if the patient presented to the facility with chest pain.

1. Review of medical record revealed Patient #5 arrived to the ED on 04/27/2021 at 12:02 PM via Emergency Medical Services (EMS) with a chief complaint of high blood glucose and sleeping for two days. Further review revealed vital signs of blood pressure 88/56 (normal range 90/60 to 120/80), heart rate 110 (normal range 60-100), oxygen saturation 97% (normal range 95%-100%) on room air and temperature 97.2, tympanic (electronic temperature via ear canal).

Review of Patient #5's ED Triage nursing documentation record dated 04/27/2021 at 12:30 PM revealed the patient presented with non-labored breathing, tachycardic (rapid heart rate) with normal sinus heart rhythm at a rate of 110 beats per minute and hypotensive with blood pressure of 88/56. Further review revealed no documented evidence of a sepsis screen completed during triage despite Patient #5 displaying two (2) sepsis indicators upon arrival to the ED.

Review of Patient #5's ED record revealed the physician ordered laboratory testing at 12:44 PM. The laboratory results were reported at 12:47 PM and 1:00 PM. Patient #5's blood glucose level was 1664 (normal range below 100) a critical lab value, a white blood count of 24.4 (normal range 4.5 to 11) and a lactic acid level of 101.3 (normal range 4.5 to 19.8) a critical lab value.

Review of Patient #5's ED provider note dated 04/27/2021 at 2:57 PM revealed Physician #6 cared for the patient while in the ED. Further review revealed Physician #6 noted Patient #5 was hypotensive with a blood pressure of 73/41, tachycardic with a rate of 120 beats per minute upon his assessment and was difficult to establish intravenous access, requiring central vein catheter placement. Upon initial assessment and review of lab results, Physician #6 concluded Patient #5 was in severe metabolic acidosis, had a glucose level of 1160, extremely high lactic acid levels, leukocytosis (high white blood cell count) and had hyperkalemia (elevated potassium levels). Physician #6 noted the case was discussed with Physician #2. Patient #5 was accepted by Physician #2 on 04/27/2021 at 2:26 PM and the patient was admitted to the Intensive Care Unit (ICU) with a diagnosis of Diabetic Ketoacidosis.

Based on the above Sepsis Protocol, Patient #5 met four (4) early identification symptom criteria for sepsis (tachycardia, hypotension, elevated WBC, elevated lactic acid); however, the patient was not screened for sepsis and potential sepsis was not identified.

Interview with RN #12 on 05/06/2021 at 4:13 PM revealed she had worked as an ED nurse in the facility for the past six (6) years and provided care in the ED on 04/27/2021 to Patient #5. Per the RN, the sepsis screening is completed by the triage nurse for every ED patient and the screening is documented in the electronic charting system. She further stated patients with two or more symptoms of sepsis would trigger the triage nurse to complete a sepsis screen protocol on the electronic charting assessment. She stated Patient #5 should have been screened for sepsis in the ED when he/she presented with tachycardia and hypotension symptoms.

Interview with Physician #6 on 05/11/2021 at 4:30 PM revealed he cared for Patient #5 on 04/27/2021 in the ED. He stated that this was his first shift at the facility and he was unaware of the hospital's sepsis protocol. Per Physician #6, he suspected Patient #5 was septic as the patient had hypotension, dehydration, elevated WBC, extremely high lactic acid and was in diabetic Ketoacidosis. Physician #6 stated he should have ordered antibiotics for Patient #5 and the patient should have received the antibiotics while in the ED. The Physician stated he did not know why he did not order antibiotics for Patient #5.

Review of Patient #5's physician orders revealed no antibiotic therapy was ordered until 04/30/2021 at 10:50 PM by Physician #2, approximately three (3) days after admission to the facility.

Review of Patient #5's blood pressure record revealed continued episodes of hypotension on 04/28/2021 at 4:19 PM with recorded blood pressure (BP) of 86/50, on 04/29/2021 at 10:59 AM of 88/54, 04/30/2021 at 5:11 AM, of 79/38. Continued review revealed Patient #5 continued to have hypotension with blood pressure level of 73/33 on 05/01/2021 at 10:43 PM.

Continued review of Resident #5's record revealed the patient continued to decline and had critically low WBC (white blood count) of 1.2 on 05/02/2021. The patient was intubated by the Air Ambulance team on 05/02/2021 and transferred to another hospital.

Review of Patient #5's hospital record revealed the patient was admitted to Facility #4 on 05/02/2021 with diagnoses of Acute Respiratory Failure, Severe ARDS (acute respiratory distress syndrome which is a condition where fluid collects in the lungs), septic shock, anemia/thrombocytopenia, dilated right heart ventical, etc. The patient remained an inpatient at Facility #4.

Interview with Physician #2 on 05/09/2021 at 11:40 AM revealed he was aware of the hospital's sepsis protocol. Physician #2 stated Patient #5 should have received antibiotics per protocol for the elevated WBC and high lactic acid levels. Per the physician, Patient #5 should have been treated with antibiotics and the antibiotics should have been initiated in the ED. When asked why Patient #5 did not receive antibiotics for three (3) days after admission from the ED, he responded if Patient #5 had been identified with sepsis in the ED, he would have viewed the treatment approach for sepsis differently.

Interview with the facility Case Manager on 05/11/2021 at 4:20 PM revealed the facility was aware of screening and documentation issues related to sepsis screening protocol not being consistently implemented by nursing and physician staff in the ED. She stated she assisted and attended meetings in attempts to gather education and training to provide to ED nursing staff and physicians to improve sepsis screening and identification upon triage when patients present to the ED.

2. Review of an Emergency Medical Services (EMS) "Run Sheet" for Patient #1 dated 12/27/20 at 11:00 PM, revealed, EMS was transporting Patient #1 to the facility with complaints of chest pain, which the patient had been experiencing for approximately four (4) hours. Further review of the EMS Run Sheet revealed at 11:21 PM, Patient #1 had an elevated blood pressure of 170/108 mmHg (normal range less than 120/80mmHg) and an elevated heart rate of 118 beats per minute (normal range 60-100 beats per minute) in route to the facility.

However, review of Patient #1's ED record revealed staff failed to obtain the patient's vital signs upon arrival to the ED at 11:33 PM. In addition, although staff administered Patient #1 Nitroglycerine (a medication to treat chest pain and lower blood pressure) at 11:42 PM and Morphine (pain medication) at 12:00 AM on 12/28/2020, the facility to document vital signs before administration of the medication. Continued review of Patient #1's ED record revealed the first documentation of Patient #1's vital signs was at 1:14 AM on 12/28/20, approximately two (2) hours after arrival to the facility, approximately one (1) hour and thirty-two (32) minutes after administration of Nitroglycerine, and approximately one (1) hour and fourteen (14) minutes after administration of Morphine.

Interview with RN #3 on 05/01/2021 at 10:50 PM revealed she cared for Patient #1 while the patient was in the ED during the late night of 12/27/2020 and early morning of 12/28/2020. RN #3 stated she was supposed to print off the patient's vital sign readings from the monitor and place them in the patient's medical record, but she had forgotten to do this for Patient #1.

3. Review of Patient #2's medical record revealed the patient arrived to the facility's ED at approximately 11:30 PM on 03/04/2021 with complaints of shortness of air and methamphetamine abuse with involuntary movements to the entire body. Continued review of the record revealed no evidence staff obtained the patient's vital signs upon arrival to the ED. The first documented vital signs in Patient #2's medical record were documented at 11:44 PM on 03/04/2021, fourteen (14) minutes after the patient arrived to the ED. Review of the vital signs obtained for Patient #2 at 11:44 PM revealed the patient's blood pressure was elevated at 179/73 mmHg and the patient's heart rate was elevated at 120 beats per minute. Further review of the ED record revealed at 12:00 AM on 03/05/2021, Patient #2 was administered intravenous Valium (a sedating medication to treat anxiety), and at 1:47 AM staff administered oral Valium to Patient #2. In addition, at 12:16 AM staff administered the patient intravenous Benadryl (a medication to treat allergies that can cause drowsiness). However, there was no evidence staff obtained Patient #2's vital signs other than at 11:44 PM, for the entire time (4.5 hours) the Patient was in the ED, despite being administered medication three (3) times. In addition, there was no documentation of the patient's response to the medications or if it was effective in treating Patient #2's condition while the patient remained in the ED.

Interview with RN #3 on 05/01/2021 at 10:50 PM revealed she cared for Patient #2 in the facility's ED on 03/04/2021 and 03/05/2021. RN #3 stated she was supposed to print off the patient's vital signs from the monitor and place in them in the patient's medical record. However, stated she had forgotten to do so for Patient #2. Continued interview with the RN #3 revealed she administered the Valium and Benadryl to Patient #2 because the patient was "thrashing around in bed", but had not documented the effectiveness of the medications she administered to Patient #2 when the patient was in the ED.

Interview with NP #4 on 05/03/2021 at 1:35 PM revealed she had previously functioned as the facility's Chief Nursing Officer (CNO). NP #4 stated staff should obtain and document patients vital signs immediately upon arrival to the ED in emergent situations and per emergency protocols established for the ED.

Interview with the Chief Executive Officer (CEO) on 05/10/2021 at 8:05 PM revealed nursing staff in all clinical settings including the ED were to obtain and document vital signs as directed in the policies and procedures and emergency protocols established for the ED.