Coffee Regional Medical Center, Inc.

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 46188 Based on review of Medical Staff Rules and Regulations, policy and procedures, medical records, ambulance trip report and interviews with staff, it was determined that the facility failed to provide one patient (P) (#1) of 20 sampled patients with an appropriate and ongoing medical screening examination (MSE) sufficient to address all potential emergency medical conditions (EMC). P#1 presented to the emergency department (ED) on 8/30/23 after a fall with laceration (wound to the skin and underlying tissues) to the scalp. While in the ED, P#1 was given medications for agitation and procedural sedation. P#1 was discharged before adequately recovering from the medication and suffered a cardiac arrest prior to arrival home. P#1 was transported back to the facility via EMS and transferred to a higher level of care once stabilized. P#1 eventually expired. Findings included: Cross Refer to A-2406 related to the facility’s failure to ensure that an appropriate medical screening examination was provided to P#1.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 46188 Based on review of Medical Staff Rules and Regulations, policy and procedures, medical records, ambulance trip report and interviews with staff it was determined that the facility failed to ensure that one patient (P) (#1) of 20 sampled patients received an appropriate and ongoing medical screening examination (MSE) sufficient to address all potential emergency medical conditions (EMC). P#1 presented to the emergency department (ED) on 8/30/23 at 8:16 a.m. after a fall that resulted in a laceration (wound to the skin and underlying tissues) to the scalp. While in the ED, P#1 was given medications for agitation at 8:42 a.m. and additional medicine for procedural sedation at 9:04 a.m. P#1 had not returned to baseline when he was discharged at 10:04 a.m. P#1 went into cardiac arrest while en route home and arrived back to the ED at 11:17 a.m. The facility provided stabilizing treatment and P#1 was transferred to a higher level of care and eventually expired. Findings included: A review of the facility’s “Medical Staff Rules and Regulations”, adopted 3/26/19, revealed, F, Emergency Department, Five, Guidelines for Care: a. A Medical Screening Examination (MSE) for patients presenting to the facility’s ED will be performed by members of the facility’s ED staff physician or alternatively, physician assistants (PA), or nurse practitioner (NP) working under the direct supervision of a members of the facility’s ED staff physician may perform the MSE. c. A MSE is performed to determine the patient’s emergency status and need for further treatment. The MSE will continue until the patient is stabilized and ready for discharge, admission, or transfer. A review of the facility’s policy titled, “EMTALA - Emergency Medical Treatment and Active Labor Act”, last reviewed 12/21/23, revealed Definitions: 4. Emergency Medical Condition (EMC) a. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in i. Placing the health of the individual in serious jeopardy ii. Serious impairment to bodily functions iii. Serious dysfunction of any bodily organ or part 8. Stabilized - with respect to an EMC, the term means that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during transfer of the individual from a facility. 9. To Stabilize - with respect to an EMC, to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability that no material deteriorate of the condition is likely to result from or occur during the transfer of the individual from a facility. Continued review revealed, EMTALA Procedure: 1. Medical Screening Examination (MSE) a. If any individual comes to the ED and a request is made by the individual or on the individual ’ s behalf for an examination or treatment of a medical condition, the facility will provide an appropriate MSE, within the capability of the ED, including ancillary services routinely available to the ED, to determine whether an EMC exists. 2. Emergency Medical Condition (EMC) b. If, after the MSE is performed, an individual is determined to have an EMC, the facility will do the following: i. Provide the individual with such further medical examination and treatment as is required to stabilize the EMC. IF the individual’s EMC is subsequently stabilized, the facility may either discharge the individual with follow-up instructions, admit the individual as an inpatient for continued care, or transfer to another facility depending on needs. A review of the facility’s policy titled, “Sedation” last reviewed 10/24/23, revealed that the facility has established minimum requirements for administering and monitoring moderate sedation. Continued review revealed, Definitions: · Minimal Sedation - a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. · Moderate Sedation - a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. · Deep Sedation - is a drug-induced depression of consciousness during which patients cannot be easily aroused but response purposefully following repeated or painful stimulation. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Continued review revealed, Procedure, Patient Evaluation: · A registered nurse (RN) monitor should be present to monitor the patient throughout the sedation. The moderate sedations monitor must be able to monitor and respond appropriately to the patient ’ s response to medication, including adverse drug reactions and, at a minimum, changes in: o Vital signs o Level of consciousness o Presence or lack or patent airway o Oxygen saturation o Patient ’ s response to medication Continued review revealed, Monitoring: Minimum monitoring shall include: o Blood Pressure o Pulse and respiratory rate o Oxygen saturation o Level of consciousness A standardized moderate sedation flow sheet will be completed by the monitor for all patients receiving moderate sedation. Continued review revealed, Post Procedure: Patients who receive moderate sedation will be monitored post procedure. Patients will be considered recovered when specific criteria, indicating a return to safe physiologic and psychological levels, have been achieved. A review of P#1’s medical record revealed that he presented to the facility’s emergency department (ED) on 8/30/23 at 8:16 a.m. via emergency medical services (EMS) after suffering a fall in the shower and sustaining a laceration (a wound in the skin and underlying tissues). Continued review of the medical record revealed that P#1 had a past medical history of severe intellectual disability, epilepsy (a chronic brain disorder that causes repeated seizures, which are brief episodes of involuntary movement), autistic disorder (a neurodevelopmental disorder characterized by symptoms of deficits in social communication and the presence of restricted, repetitive, and inflexible patterns of behavior that are atypical to be developmentally and socioculturally inappropriate), and impulse control disorder (a group of behavioral conditions that make it difficult to control actions or reactions). A review of an “Ambulatory Assessment” dated 8/30/23 at 8:39 a.m., by registered nurse (RN) revealed that P#1 was non-verbal and displayed aggressive behaviors such as pulling caregiver ’ s hair, kicking at staff, with a report by caregivers that this was a normal behavior for P#1. A review of the “ED Note” dated 8/30/23 at 8:46 a.m. by Medical Doctor (MD) AA revealed that P#1 had no loss of consciousness and was very combative. MD AA performed an assessment to repair the scalp laceration with a plan for P#1 to return to have staples/sutures removal in seven days. A review of the “Computerized Provider Order Entry (CPOE) Orders Report” revealed that MD AA ordered Haloperidol Lactate (also known as Haldol, an antipsychotic medication used to treat psychosis but also has a calming effect), 5 mg, Intramuscular (IM) (given by injection into a muscular area of the body), on 8/30/23 at 8:37 a.m., RN FF acknowledged the ordered on 8/30/23 at 8:40 a.m. Continued review revealed that MD AA discontinued the order on 8/30/23 at 9:00 a.m. Continued review of the CPOE revealed that MD AA ordered Diphenhydramine (an allergy medication that may cause drowsiness), 50 mg, IM, on 8/30/23 at 8:37 a.m. RN FF acknowledged the order on 8/30/23 at 8:41 a.m. Continued review revealed that MD AA discontinued the order on 8/30/23 at 9:00 a.m. Continued review of the CPOE revealed that MD AA ordered Lorazepam (also known as Ativan, an anti-anxiety medication), 2 milligrams (mg) to be administered intramuscular (IM) on 8/30/23 at 8:38 a.m. Registered Nurse (RN) FF acknowledged the ordered on 8/30/23 at 8:40 a.m. Continued review revealed that MD AA discontinued the order on 8/30/23 at 9:00 a.m. Continued review of the CPOE revealed that MD AA ordered Ketamine (a medication used for the induction and maintenance of anesthesia and can be used for short-term sedation), 350 mg IM, on 8/30/23 at 9:01 a.m. RN BB acknowledged the order on 8/30/23 at 9:50 a.m. Continued review of the CPOE revealed that MD AA ordered a computed topography (CT) scan (a non-invasive imaging procedure that uses x-ray imaging to create detailed pictures of the head) on 8/30/23 at 9:24 a.m. A review of the Medication Administration Record (MAR) revealed: Benadryl was administered on 8/30/23 at 8:42 a.m. by RN FF. Haldol was administered on 8/30/23 at 8:42 a.m. by RN FF. Ativan was administered on 8/30/23 at 8:42 by RN FF. Ketamine was administered on 8/30/23 at 9:50 a.m. by RN BB. Continued review of the MAR revealed that RN BB noted that MD AA verbally ordered B52 (combination of three medications used to treat acute agitation that typically includes Benadryl, Haldol, and Ativan) due to P#1’s agitation. RN BB noted that Ketamine was administered by RN EE at 9:04 a.m. A review of a “Physician Pre-sedation Assessment” dated 8/30/23 revealed that MD AA signed off on reviewing a set of vital signs for P#1, an American Society of Anesthesiologists (ASA) (a grading system of one through five with one identifying a person in good health and five as severe, life-threatening condition) level of two for P#1, a laceration of five cm on P#1’s crown (head), and that P#1 was combative. A review of a “Sedation Record” dated 8/30/23 revealed that the laceration repair procedure started at 9:04 a.m. and was completed at 9:20 a.m. A time-out was conducted, and P#1 received Ketamine at 9:04 a.m. administered by RN BB. Continued review revealed the following vital signs: at 9:00 a.m. P#1 had a blood pressure (BP) of 117/81 (normal is a systolic pressure less than 120 and a diastolic pressure less than 80), heart rate (HR) of 115 (normal is 60 to 100), respiration rate (RR) of 18 (normal is 12-20), oxygen saturation (pSO2) of 97% (normal is 95% to 100%), and sedation scale of five (one is anesthesia, two is deep sedation, three is moderate sedation, four is minimal sedation, and five is fully awake). A review of a “Nurses Note” dated 8/30/23 at 9:00 a.m. by RN BB revealed that per MD AA the Ketamine was okay to administer due to patient agitation after B52 administration. P#1’s caregivers were present at bedside, P#1 had even non-labored respirations and no acute distress was noted. At 9:04 a.m. P#1 had a BP of 121/87, HR of 116, RR of 20, pSO2 of 98%, and sedation scale of five. At 9:09 a.m., P#1 had a BP of 129/83, HR of 112, RR of 18, pSO2 of 97%, and sedation scale of four. At 9:13 a.m., P#1 had a BP of 128/81, HR of 106, RR of 18, pSO2 of 97%, and sedation scale of two. At 9:18 a.m., P#1 had a BP of 123/84, HR of 104, RR of 19, pSO2 of 99%, and sedation scale of two. At 9:20 a.m., P#1 had a BP of 121/83, HR of 110, RR of 19, pSO2 of 98%, and sedation scale of two. At 9:25 a.m., P#1 had a BP of 118/86, HR of 108, RR of 20, pSO2 of 98%, and sedation scale of three. At 9:30 a.m., P#1 had a BP of 130/81, HR of 109, RR of 18, pSO2 of 99%, and sedation scale of four. At 9:35 a.m., P#1 had a BP of 123/82, HR of 110, RR of 20, pSO2 of 97%, and sedation scale of five. At 9:40 a.m., P#1 had a BP of 128/80, HR of 107, RR of 20, pSO2 of 98%, and sedation scale of five. A review of a CT Head Imaging Report dated 8/30/23, read at 10:00 a.m. by a physician, revealed no intracranial trauma, no intra or extra-axial hemorrhage, and identified of scalp staples of the left frontal scalp region. Continued review of the “Nurses Note” dated 8/30/23 at 10:05 a.m. by RN BB, revealed that P#1 was arousable to verbal and painful stimuli, respirations even and non-labored. Post sedation education was provided to P#1’s caregivers. P#1 was discharged from the facility’s ED on 8/30/23 at 10:05 a.m. with caregivers via stretcher. A review of the “...EMS PCR” dated 8/30/23 at 10:25 a.m. revealed that EMS was dispatched to P#1 who was not breathing, chest compressions were performed by caregiver staff, and P#1 was lying supine on the floor of a van. Continued review revealed that an Automated External Defibrillator (AED) (a portable device used to treat a person whose heart has suddenly stopped working) was applied to P#1 and no shock was advised. Chest compressions were continued by EMS, resuscitative medications were administered, and P#1 was intubated. P#1 was transported to the facility’s ED. A review of the medical record in the “Resuscitation Record” dated 8/30/24 revealed that P#1 was intubated (an artificial airway placed through the mouth and into the lungs to assist with ventilation) at 11:11 a.m. by EMS and given Epinephrine (medication used to treat-life threatening low blood pressure), Atropine (medication used to increase and improve heart rate), Sodium Bicarbonate (medication used to treat metabolic acidosis during cardiac arrest), and Levophed (medication used to maintain blood pressure support). P#1 was reported down at 10:25 a.m. prior to hospital care. A review of an “ED Note” dated 8/30/23 at 12:24 p.m. by MD AA revealed that P#1 presented to the facility ’ s ED due to a cardiac arrest (a medical emergency that occurs when the heart suddenly stops beating and pumping blood) and was admitted to the intensive care unit (ICU) after being intubated and requiring Levophed. P#1 was admitted to the ICU on 8/30/23 at 3:21 p.m. A review of a “Discharge Summary Note” dated 8/31/23 at 3:53 p.m. by a physician, revealed that P#1 remained unresponsive with no meaningful recovery of neurological status and anoxic brain damage is highly suspected. Imaging revealed cerebral edema, and that P#1 was to be transferred to another facility for further evaluation and management. During an interview on 8/27/24 at 1:25 p.m. in the conference room, Registered Nurse (RN) BB recalled that P#1 was a patient with autistic disorder, non-verbal, and was brought in by two group home caregivers after falling and injuring his head. RN BB recalled that P#1 was very impulsive, strong, and required a lot of redirections by many staff members. RN BB recalled that medical doctor (MD) AA ordered B52, a medication cocktail of Ativan, Benadryl, and Haldol and it was administered. RN BB recalled that P#1’s caregivers were vocal in informing staff that they needed to leave the facility, when possible, to avoid the weather and were persistent in P#1 receiving additional medication as P#1 was a larger individual. RN BB recalled that MD AA verbally ordered Ketamine (medication used for the induction and maintenance of anesthesia but can also be used for pain management) which another nurse heard and administered it. RN BB recalled that she learned about this after it was administered. RN BB recalled that P#1 received all these medications prior to going to receive a head scan, then he was treated for a head laceration (a wound that occurs when the skin is torn or cut, and underlying tissues are exposed). RN BB recalled that P#1 was monitored and assessed after the laceration repair, P#1’s vital signs were back to baseline, and that P#1 was arousable and breathing. RN BB recalled that P#1 was brought out to the group home’ s van via stretcher and was safely buckled in as he left. RN BB recalled that P#1 did not ambulate into the ED and that he had trouble walking per caregivers and that this was his baseline. RN BB said that she could not recall but believes that MD AA was probably unaware that P#1 received the B52 cocktail of medication prior to ordering Ketamine. RN BB said that she thinks MD AA canceled the B52 cocktail at one point but was unsure. RN BB recalled when P#1 was brought back into the ED while experiencing a cardiac and respiratory arrest. RN BB recalled that P#1 was treated and stabilized then admitted to the intensive care unit (ICU). RN BB said that after the event, staff have received a lot of education surrounding medication administration and anesthesia, the sedation forms were changed, and that staff are no longer allowed to use verbal orders for sedation unless it is an emergency. During a telephone interview on 8/29/24 at 9:50 a.m., Medical Doctor (MD) AA recalled that P#1 was brought in by two caregivers from a group home after suffering a fall in the restroom and having a laceration on his head. MD AA recalled that the caregivers were adamant about speeding things up and trying to get home quickly as there was a hurricane warning that day and it was storming bad. MD AA recalled that P#1 had a mental disability, was non-verbal, very impulsive and physically aggressive with staff. MD AA recalled that P#1 did not ambulate in but was wheeled in by the caregivers MD AA recalled that he ordered Ativan, Benadryl, and Haldol for P#1 to assist with calming him down so that staff could provide treatment for P#1 but was deciding on whether to change it to just Ketamine. MD AA said that prior to repairing the head laceration, he canceled the Ativan, Benadryl, and Haldol because he was going to administer Ketamine. MD AA said that he did not know that the Ativan, Benadryl, and Haldol were administered prior to the Ketamine. MD AA said that if he was aware of this fact, then he would have not ordered the Ketamine. MD AA said that he was not aware that P#1 received the Ativan, Benadryl, and Haldol until after P#1 returned to the ED while experiencing respiratory arrest. MD AA recalled that he was under the understanding that P#1 only received the Ketamine. MD AA recalled that he repaired the head laceration and ordered for P#1 to have imaging of his head. MD AA recalled that P#1 was monitored by staff prior to leaving the facility and was wheeled back onto the group home van with caregivers and left the facility. MD AA recalled that P#1 then returned to the facility ’ s ED experiencing a cardiac and respiratory arrest. MD AA said that he was stabilized, treated, and then admitted to the intensive care unit (ICU) for further management.”