Ashley Medical Center

“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: 39687 Based on policy review, medical staff bylaws/rules and regulations review, record review, and staff interview, the Critical Access Hospital (CAH) failed to enforce policies to ensure compliance with 42 CFR 489.24, special responsibilities of Medicare hospitals in emergency cases, and the related requirements at 42 CFR 489.20 for 4 of 22 emergency department (ED) records (Patients #1, #2, #3, and #4) reviewed. Hospitals are required to adopt and enforce a policy to ensure compliance with the requirements at 489.24. Failure of the CAH to enforce their Emergency Medical Treatment and Labor Act policy limited the CAH’s ability to determine if the patient had an emergency medical condition, and to ensure safe care of patients transferred from the emergency department. Findings include: The CAH failed to ensure an ED provider conducted an appropriate medical screening examination within the capability of the CAH’s ED (Refer to C2406); and failed to ensure a qualified medical provider signed a certification stating the medical benefits of a transfer outweighed the risks for patients with unstabilized medical conditions (Refer to 2409).”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) and 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: 42397 Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure a qualified individual performed an appropriate medical screening examination for 1 of 22 patient records reviewed (Patient #1) of patients who presented to the CAH’s emergency department. Failure to perform a medical screening examination limited the CAH’s ability to determine if the patient had an emergency medical condition. Findings include: Review of the policy “The Ashley Medical Center Medical Screening in Emergency Room” occurred on 10/23/24. This undated policy, stated, “. . . Any patient who comes to the hospital requesting emergency services is entitled to and will receive a Medical Screening Examination performed by individuals qualified to perform such examination to determine whether an emergency medical condition exists. . . . D. How to Provide the Medical Screening Examination. . . . 3. Individuals coming to the emergency department must be provided a Medical Screening Examination beyond initial triage. . . .” Review of Patient #1’s medical record from 09/03/24 occurred on 10/22/24. Nurse’s notes dated 09/03/24 stated: * 1:15 a.m., “Patient brought in by . . . CNA [certified nurse aide], from his apartment, via wheelchair, apparently pressed the emergency button and complaining of severe pain, requesting to be brought in to ED.” * 1:17 a.m., “Routine ED admission protocol carried out. . . . stated his pain is a 9 on the left groin . . .” * 1:20 a.m., “Provider, [provider name], notified by phone.” Patient #1’s record lacked evidence of performance of a medical screening examination by a qualified individual to determine whether an emergency medical condition existed. During an interview on 10/23/24 at 8:39 a.m., provider (#3) confirmed she failed to perform a medical screening examination for Patient #1.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1-2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 39687 Based on policy review, record review, medical staff bylaws/rules and regulations review, and staff interview, the Critical Access Hospital (CAH) failed to ensure completion of the physician’s certification of transfer for 3 of 7 sampled records (Patients #2, #3, and #4) of Emergency Department (ED) patients transferred to other facilities. Failure to complete physicians’ certifications to transfer, limited the CAH’s ability to make informed decisions regarding the transfers. Findings include: Review of the policy “The Ashley Medical Center Emergency Policies” occurred on 10/23/24. This undated policy stated, “. . . Procedure: . . . Provide an appropriate transfer of an unstabilized patient to another medical facility if: A physician has signed the certification that the benefits of the transfer of the patient to another medical facility outweigh the risks. . . .” Review of the policy “The Ashley Medical Center Emergency Department Transfer Policy” occurred on 10/23/24. This undated policy stated, “Any transfer of an individual with an emergency medical condition must be initiated either by the written request from the patient or the legally responsible person acting on the patient’s behalf for such transfer or by a physician order with the appropriate physician certification. . . . Procedure: . . . 6. For a patient who has not been stabilized, a physician must have signed a certification . . . . 7. . . A stabilized patient may be transferred upon request or pursuant to pre-arranged transfers/treatment . . . if the following conditions are met: a) documentation of patient stabilization has been prepared by a physician or a qualified medical person in consultation with a physician (physician’s counter-signature is required on documentation); 8. If a physician is not physically present in the emergency department at the time a patient is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations), may sign a certification after a physician, in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. . . “ Review of the medical staff’s bylaws and rules and regulations occurred on 10/23/24. These bylaws, rules and regulations, approved by the Governing Board 02/19/07, stated, “Article III Membership, Section I Qualifications: A nurse practitioner or physician’s assistant/extender may also be a member of the medical staff, subject to all limitations imposed by his/her delineation of privileges and these By-Laws, Rules and Regulations. Allied health professionals may apply for clinical privileges with collaboration and/or supervision of a member of the medical staff.” -Review of Patient #2’s emergency department medical record occurred on 10/23/24. This record dated, 09/07/24, stated, “History of Present Illness, Chief Complaint: Stroke Code. Signs and Symptoms: patient presents to ER [Emergency Room] per EMS [Emergency Medical Staff]. EMS reports patient combative and not following commands upon arrival. Stroke code activated. . . Patient was incontinent of urine and stool in the bed. Patient moving all extremities. Upon arrival to ER patient continued to be combative, pulling IV [intravenous fluid] and monitoring wires. She was verbal, but not making any sense. Thrashing arms and legs. . . .Physical exam: General: Confused, Combative. Heart: Tachycardia [rapid heart rate]. Neurologic: Patient confused, combative, not following commands, thrashing arms and legs. Verbal but not making sense. Unable to complete full NIH [stroke scale] due to patient being combative and not following commands. Patient able to maintain airway. ED Course: Labs drawn, WBC [white blood count] 2.9 L [low], Platelets 77 L, Glucose 73 L, Liver enzymes elevated, Lactic acid 7.6 H [high], Troponin 0.37 H. EKG [electrocardiogram] done, sinus tachycardia. Assessment: Sepsis, ARF [acute renal failure], Tachycardia, Hypoglycemia [low blood sugar], Elevated Troponin, Elevated Lactic Acid, Confusion, Low platelet, and Elevated Liver Enzymes. Plan: Admit to ER. Insert IV saline lock x [times]2. 0.9% [percent] NS [normal saline] bolus x 2000ml [milliliter]. Ativan 1mg [milligram] total. . . . Results discussed with patient’s husband. CT [computed tomography Scan] head ordered but unable to complete due to patient thrashing and combative. Chest XR [xray] one view ordered, but unable to complete due to patient combativeness. Foley catheter attempted x3, unable to place. . . . 1 amp [ampule] Dextrose given for hypoglycemia. [name of receiving hospital] contacted after labs returned for patient transfer due to severity of Sepsis. [name of receiving physician] given report and did agree to accept patient for emergency transfer. . . Flight team contacted for emergent transport of patient. Medications given. . . Upon arrival flight team given report on patient. They did decide to intubate patient for flight. Patient discharged to [name of service] flight team for transfer to [name of receiving hospital] with accepting [name of receiving physician].” The record lacked evidence the provider determined patient #2 was stable for transfer. The record lacked evidence a physician co-signed a certification stating the benefits of transfer outweigh the risks. -Review of Patient #3’s emergency department medical record occurred on 10/23/24. This record dated, 05/08/24, stated, “History of Present Illness, Chief Complaint: CVA [brain bleed/clot] Stroke Code Activated. Signs and Symptoms: Patient to ER per EMS. Call into EMS around 10:30, patient at home with daughter and fell to knees beside chair. Daughter concerned patient is having a stroke. She has had previous CVA x3. Patient is not following commands and is unable to speak. Upon arrival patient maintaining airway and sent straight to CT of head. Patient’s VS [vital signs] stable. She is not verbalizing or following commands. Daughter present reports patient recently diagnosed with pneumonia and is on antibiotics. She ate breakfast around 0930 [9:30 a.m.] and was her normal. She does have right sided weakness from previous CVA. Physical Exam: Eyes: Pupils are equal, round and reactive to light. Heart: Regular rate and rhythm, Paced. ED Course: Labs drawn, 12 lead EKG, paced, CT Head without contrast: Impression: Large, remote appearing left parietal, occipital, and temporal lobe [parts of brain] infarct [blood clot]. . . . Assessment: CVA, Plan: Admit to ER. Stroke protocol orders. . . . Patient’s daughter present and updated on all results and findings. Call to [receiving hospital] and report given to [name of physician], Neurology who did agree with transfer to [name of receiving hospital]. . . Report given to [name of receiving physician], [name of receiving hospital] who accepted patient for transfer to their facility. [name of service] Flight called for transport. Patient’s family in agreement to transfer per flight. . . Report given to [name of service] Flight team and care of patient transferred to flight team. Discharged to [name of receiving hospital] per flight team. Critical care time: 1 hour.” The record lacked evidence the provider determined Patient #3 was stable for transfer. The record lacked evidence a physician co-signed a certification stating the benefits of transfer outweigh the risks. -Review of Patient #4’s emergency department medical record occurred on 10/23/24. This record, dated, 04/23/24, stated, “History of Present Illness: Chief Complaint: Weakness. Signs and Symptoms: Patient had initially presented to the clinic today for review of lab work. She was seen in the clinic yesterday and the provider that was on-call instructed her to return today and have follow-up lab work completed. . . her kidney function has worsened overnight. Patient reports that her only complaint is feeling very weak today. She states she is unable to walk while standing upright. She reports that she has had a cough and does feel short of breath when ambulating. She denies any chest pain. She states that she has had diarrhea since last Friday. She reports she is feeling slightly dizzy. She denies headache. She denies any nausea. She is cold and diaphoretic. She denies having any fevers. She states she only has a slight sore throat. She denies any pain to her ears. She reports that she only has a pressure sensation to the abdomen. Yesterday at the clinic she was given a 1000 ml of normal saline and 1 g [gram] of ceftriaxone [antibiotic] for possible UTI [urinary tract infection] and then she was sent home and instructed to come back today. Physical Exam: Labs drawn: WBC 26.5 H, Glucose 65 L. 12 Lead EKG: possible anteroseptal infarct [blood clot in heart]. CT chest/abdomen/pelvis done. Assessment: Acute Kidney Injury versus Acute Renal Failure, Hypoxia, Hypoperfusion, Hypotension, Possible sepsis, Concern for anteroseptal infarct, and Diarrhea, Dehydration and CHF [chronic heart failure] exacerbation. Plan: Admit to ER. Patient’s initial blood pressure was 150/80, within 5 minutes her blood pressure drop [sic] to 80/30. . . . Unable to obtain accurate O2 [oxygen] saturation reading due to hypoperfusion [decrease blood flow]. . . . Patient was initially placed on 4 L [liters] per nasal cannula and then was moved to 15 L of oxygen per non-rebreather. . . . Patient does show worsening of acute kidney failure. Foley catheter placed. . . . Patient is worsening. . . . Patient was updated. Call was placed to [name of receiving hospital] for accepting as we were unable to figure out what was causing patient’s acute decompensation. [name of receiving physician] was given report and did agree to accept patient. . . . Patient maintained GCS [glasgow coma scale] of 15. [name of service] flight team was called for patient transport due to her acute decompensation. . . . Upon flight team arrival they were given report. Discharge to [name of receiving hospital] per [name of service] flight team. The record lacked evidence the provider determined Patient #4 was stable for transfer. The record lacked evidence a physician co-signed a certification stating the benefits of transfer outweigh the risks. During an interview on 10/23/24 at 1:00 p.m., Provider #2 stated documentation on the discharge of an ED patient does not include the verbiage “discharge in stable or unstable condition.””

“PROTECTION OF RECORD INFORMATION CFR(s): The CAH maintains the confidentially of record information and provides safeguards against loss, destruction, or unauthorized use. This Standard is not met as evidenced by: 20497 Based on policy review, observation, and staff interview, the Critical Access Hospital (CAH) failed to securely store patient records in 1 of 1 radiology record storage area (in the computed tomography [CT] room). Failure to securely store patient records limited the CAH’s ability to ensure against loss, destruction, or unauthorized use. Findings include: Review of the policy “HIPAA Policies and Procedures Overview” occurred on 11/08/23. This undated policy stated, “. . . Patient records, medical and billing, should be stored in a secure area and not left unattended. . . .” Observation of the unlocked CT room on 11/07/23 at 10:20 a.m. showed an open shelving unit containing mammography and bone densitometry patient records. During interview on 11/07/23 at 10:20 a.m., an administrative radiology staff member (#3) confirmed the facility stored mammography and bone densitometry patient records on an open shelving unit in the CT room which does not have a lock.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 42397 Based on observation, review of manufacturer’s instructions, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed manufacturer’s instructions for the use of a chemical for cleaning and disinfecting equipment and supplies for 1 of 1 equipment processing room (central processing). Failure to follow manufacturer’s instructions for cleaning and disinfection of equipment and supplies limited the CAH’s ability to ensure proper sterilization. Findings include: Observation of the central processing room occurred on 11/06/23 at 3:10 p.m. with an administrative nurse (#1) showed a sink for preparation of water with enzymatic detergent solution (Endozime AW) for manual cleaning prior to sterilization. The sink showed a faint black line on the side of the sink approximately 2/3 of the way from the bottom. The administrative nurse (#1) stated she “rarely” performed the process and called the surgical technician (#2). During the telephone interview the surgical technician (#2) described the process used for preparation of the water with enzymatic detergent solution and stated, “I fill the sink about half full of water and add the Endozime to the line in the sink.” The surgical technician (#2) confirmed she did not measure the water or the enzymatic detergent. The Endozime AW detergent manufacturer’s instructions, reviewed on 11/06/23 at 3:15 p.m., stated, “use 1/2 ounce of solution per one gallon of water.” During an interview on 11/06/23 at 4:15 p.m., the administrative nurse (#1) confirmed the surgical technician (#2) failed to follow manufacturer’s instructions for the Endozime AW detergent and she failed to perform a competency evaluation for the surgical technician (#2) since 2017.”

“QAPI CFR(s): (b) Standard: QAPI Program Design and scope. The CAH’s QAPI program must: (2) Be ongoing and comprehensive. (3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement). This Standard is not met as evidenced by: 20497 Based on policy review, reports review, meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the Quality Assurance and Performance Improvement (QAPI) program evaluated all patient care services affecting patient health and safety for 4 of 4 quarters reviewed (1st, 2nd, 3rd, and 4th Quarters 2023). Failure to ensure all departments participate in QAPI monitoring limited the CAH’s ability to ensure the provision of quality care to the CAH’s patients. Findings include: Review of the policy titled “Quality Assurance and Performance Improvement” occurred on 11/07/23. This policy, revised 01/15/18, stated, “Policy: It is the policy of Ashley Medical Center to develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life. . . . Policy Explanation and Compliance guidelines: . . . 2. The QA Committee . . . shall: . . . b. Meet at least quarterly and as needed to coordinate and evaluate activities under the QAPI program . . . d. Regularly review and analyze data . . . 7. Program design and Scope - a. The QAPI program will be ongoing, comprehensive, and will address the full range of care and services provided by AMC [Ashley Medical Center]. . . .” Review of the CAH’s 1st, 2nd, 3rd, and 4th quarter reports and meeting minutes from 2023 occurred on 11/07/23 and indicated the following: - The 1st-4th Quarter reports and minutes failed to include reporting from anesthesia and housekeeping. - The following departments failed to include hospital monitoring in their submitted reports: social services in the 1st Quarter; social services and maintenance in the 3rd Quarter; and dietary in the 4th Quarter. - The 3rd Quarter Meeting Minutes, dated 07/28/23, indicated the QA Committee failed to meet due to an illness outbreak among staff and patients and staff education for the new electronic medical records. The CAH failed to provide evidence of a rescheduled meeting for the 3rd Quarter. The following departments failed to submit 3rd Quarter reports to the QA Committee: swing bed activities, anesthesia, central supply/operating room, emergency room/trauma, fire and safety, infection control, medical records, physical therapy, radiology, and nursing. - The 4th Quarter Meeting Minutes, dated 10/31/23, failed to include evidence of reporting or discussion of the missed 3rd Quarter Meeting and reports. During interview on 11/08/23 at 8:05 a.m., an administrative staff member (#5) confirmed the following: anesthesia and housekeeping failed to conduct QAPI monitoring for the first through fourth quarters in 2023; social services failed to monitor hospital services in the 1st and 3rd quarters, maintenance failed to monitor hospital services in the 3rd Quarter, and dietary failed to monitor hospital services in the 4th Quarter; not all departments submitted 3rd Quarter reports to the QA Committee; the QA Committee failed to reschedule the 3rd Quarter meeting; and the QA Committee failed to include the submitted 3rd Quarter reports at the 4th Quarter meeting.”

“This survey used the 2012 edition of NFPA 101, Life Safety Code, Chapter 19-Existing Health Care Occupancies and the 2012 edition of NFPA 99, Health Care Facilities Code in compliance with 42 CFR 482.41(b)(c). The facility was located in a two-story combined Hospital and Long-Term Care building of Type II (000) construction. Residential living apartments were located on the lower level of the west wing and separated by a 2-hour fire rated vertical assembly which adjoins the hospital at the lower level and long-term care at the upper level. There was no observable horizontal 2-hour rated floor/ceiling assembly dividing the residential living apartments from the long-term care facilities above. Therefore, the entire building was surveyed as existing healthcare. The building was protected by a wet automatic fire sprinkler system designed to meet the requirements of NFPA 13, Standard for the Installation of Sprinkler Systems. Note: Observation and records review determined the facility to be in compliance with the minimum requirements of the 2012 Life Safety Code and NFPA 99, Health Care Facilities Code.”