Lovelace Women’s Hospital

“MEDICAL STAFF CREDENTIALING CFR(s): 482.22(a)(2) The medical staff must 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. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. This Standard is not met as evidenced by: 25065 Based on policy review, document review, and interview, the hospital failed to ensure the National Practitioner Data Bank (NPDB) was queried during the reappointment process for one (Physician [Phys]2) of three physician credentialing files reviewed for appointment/reappointment. This deficient practice had the potential to affect all patients receiving services of Phys2 while hospitalized. Findings include: A review of the hospital policy titled “Medical Staff Credentials Policy,” approved 08/11/22, indicated “. . . Procedure For Initial Appointment and Privileges . . . Steps to Be Followed for Initial Applicants . . . The National Practitioner Data Bank will be queried . . . Procedure For Reappointment All terms, conditions, requirements, and procedures relating to initial appointment will, as applicable, apply to continued appointment and clinical Privileges and to reappointment. . .” A review of Phys2’s credentialing file with the Medical Staff Coordinator (MedStCoor) and Medical Staff Manager (MedStMgr) presenting the file documents for review indicated Phys2’s reappointment date was 05/19/23 to 05/19/25. A review of the credentialing documents presented by MedStCoor and MedStMgr indicated there was no documentation of a NPDB query conducted at the time of the reappointment of Phys2. During an interview on 05/16/24 at 8:54 AM, MedStMgr stated he/she could not find the NPDB query for this appointment that was done by the previous coordinator. MedStMgr stated the NPDB query was required for every physician’s appointment and reappointment.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 25065 Based on policy review, document review, personnel file reviews, and interview, the hospital failed to ensure the nursing staff had documented competency evaluation for administering blood and blood products for five (Registered Nurse [RN] 2, RN3, RN4, RN5, RN6) of five RN personnel files reviewed for documented blood administration competency. This deficiency had the potential to affect all patients receiving blood and blood products while hospitalized. Findings include: A review of the hospital policy titled “New Employee Orientation Procedure - WH,” approved 01/03/22, indicated “. . . The department manager or supervisor should: . . . Prepare a plan of action for training and orientation to their new role, covering the new employee’s schedule depending upon the nature of the position. . . Coordinate clinical onboarding and documented competency relative to position requirements. . .” A review of the undated “[name of hospital system] Department Specific Orientation - Contract Staff” indicated “. . . Blood Administration Verbalize location of blood bank Verbalize process for administration: Verify order Obtain/verify consent for blood administration Verify blood product is ready under “Blood product Status Tracking” in Epic [hospital’s electronic computer documentation system] Print blood release form from EPIC, take blood release form to blood bank Two RN’s [sic] required for verification at bedside Utilize EPIC transfusion tab for product scanning and documentation Vital signs as follows: Within 15 minutes prior to transfusion, 15 minutes after product start time, then every hour until complete, then within 20 minutes of Document blood volume, answer transfusion reaction questions, document transfusion completed . . .” 1. Review of RN2’s personnel file indicated RN2 was a travel nurse from 08/28/23 - 11/25/23. A review of RN2’s “[name of hospital] Contracted Travel Nurse Unit-Based Orientation” indicated the section relative to blood administration had the preceptor/evaluator’s initials with the date 09/02/23 documented. There was no documentation of an observation of the evaluation of RN2’s competency to administer blood and blood products. 2. Review of RN3’s personnel file indicated RN3 was a travel nurse from 09/25/23 - 02/05/24. A review of RN3’s “[name of hospital] Contracted Travel Nurse Unit-Based Orientation” indicated the section relative to blood administration had the preceptor/evaluator’s initials with the date 09/28/23 documented. There was no documentation of an observation of the evaluation of RN3’s competency to administer blood and blood products. 3. Review of RN4’s personnel file indicated RN4’s date of hire was 11/20/17, and RN4 became a RN on 12/30/23. Review of RN4’s “Competency Statement” indicated “. . . DIRECTIONS: RN Position should review and complete the Core Competency Based Orientation with their preceptor. For each of the competency statements listed below, the preceptor will review orientee’s self assessment, verify the method used for validation, determines competency, and may use Performance Skills Checklist. Department Directors must work with preceptors and new employees to ensure the individual is progressing in the completion of these competencies. . .” The review indicated blood administration was not listed as one of the areas to be observed. There was no documentation of an observation of the evaluation of RN4’s competency to administer blood and blood products. 4. Review of RN5’s personnel file indicated RN5’s date of hire was 04/17/23. A review of the personnel file indicated there was no documentation of an observation of the evaluation of RN5’s competency to administer blood and blood products. 5. Review of RN6’s personnel file indicated RN6 was a travel nurse from 06/19/23 to 02/24/24. A review of RN6’s “[name of hospital] Contracted Travel Nurse Unit-Based Orientation” indicated the section relative to blood administration had the preceptor/evaluator’s initials with the date 06/21/23 documented. There was no documentation of an observation of the evaluation of RN6’s competency to administer blood and blood products. During an interview on 05/16/24 at 11:14 AM, the Human Resource Director (HR Dir) and Chief Nursing Officer (CNO) both confirmed there was no documentation of observed competencies in administering blood and blood products for the above-listed nursing staff.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 17281 Based on record review, policy review, and interviews, the facility failed to ensure blood products were transfused per the facility’s policy for two of six patients (P) (P1 and P2). Specifically, for P1 the hospital failed to ensure the initial infusion rate was according to hospital policy and for P2 the hospital failed to include complete documentation of a blood transfusion in the electronic medical record (EMR). This deficient practice had the potential to affect the quality and safety of care provided to all patients who received transfusions in the hospital. Findings include: A review of the hospital policy titled, “Blood, Blood Products Administration- NS- Patient Care,” revised on 09/16/22, indicated, “ ...Documentation in EMR: All IV [intravenous]or central line sites, verifications, start/stop times and vitals should be documented in the EMR ...and document vital signs up to 20 minutes’ post transfusion ...Observe for signs and symptom of transfusion reaction by remaining with the patient during the first 15 minutes of the transfusion. Life threatening reactions can occur after the infusion of only a small volume of blood ...All blood products should be infused at a rate of 2 ml [milliliters]/min [minute] or less during the initial 15 minutes of a non-emergent transfusion while an RN [Registered Nurse] monitors the patient for signs of transfusion reaction. An elevation in temperature or heart rate may be one of the first signs that a person is having an adverse reaction to a transfusion. The rate may be increased if no adverse reaction is noted after first 15 minutes ....” 1. Review of the “Face Sheet” located in the EMR under the “Details” tab indicated P1 was admitted to the hospital on 11/09/23 for induction of labor for pre-eclampsia (type of high blood pressure during pregnancy) without severe features. A review of the “Labor Summary and Delivery Note” dated 11/10/23 located in the EMR indicated, “ ...Controlled delivery ...There was brisk bleeding with placenta separation ...Inspection of perineum revealed deep second degree laceration ...administered TXA [Tranexamic acid -a medicine that controls bleeding] and 600 mg [milligrams]of buccal [between mouth and cheek] misoprostol [medicine that increases uterine tone and decreases postpartum bleeding.] ...and single interrupted suture for hemostasis [cessation of bleeding from a blood vessel] ...2 [two] units of PRBCs [packed red blood cells] ordered. ...” A review of the “Single Transfusion Record” located in the EMR indicated, “ ...Transfusion of leuko-reduced [packed] RBC new bag administered at 250 ml per hour on 11/10/23 at 10:01 PM ...completed transfusion at 11:38 PM. ...” A review of the “Single Transfusion Record” located in the EMR indicated, “ ...Transfusion of leuko-reduced RBC new bag administered at 250 ml per hour on 11/10/23 at 11:41 PM ...completed transfusion at 12:44 AM. ...” During an interview on 05/15/24 at 3:05 PM, the Director of Labor and Delivery (Dir L&D) stated per hospital policy, the flow rate for a blood transfusion is initially started at a slower rate to monitor the patient for any blood reaction. After about 15 minutes if there is no reaction, the flow rate can be increased. The Dir of L&D confirmed the documentation in P1’s EMR revealed the flow rate for the two units of PRBC P1 received on 11/10/23 were initially started at 250 ml per hour and not a slower rate. During an interview on 05/16/24 at 7:05 AM, RN1 stated he/she was the nurse who started both transfusions of PRBC for P1 on 11/10/23. RN1 stated when a blood product is started, hospital policy requires starting the blood transfusion at a slower rate, around 50-100 ml per hour to monitor for any transfusion reaction. RN1 was not sure what the initial flow rates were set at for the two units of PRBC P1 received on 11/10/23 but confirmed the initial flow rate should have been documented in the EMR. 2. Review of the “Face Sheet” located in the EMR under the “Details” tab indicated P2 was admitted to the hospital on 11/12/23 for induction of labor and resultant emergency cesarean section. A review of “Physician Orders” dated 11/15/23 located in the EMR indicated to transfuse one unit of leuko-reduced RBC. A review of the “Single Transfusion Record” dated 11/15/23 located in the EMR indicated, “ ...transfuse leuko-reduced RBC completed ...220 ml volume ...” Review of the “Administration Detail” section revealed, “ ...no administrations recorded.” During an interview on 05/15/24 at 2:10 PM, the Director of the Emergency Room/Intensive Care Unit (Dir ER/ICU) stated the “Single Transfusion Record” is used to document the administration of blood. The Single Transfusion Record includes the start time, stop time, flow rate, and dual verification by two nurses before the blood product is administered. The Dir ER/ICU stated P2 received a unit of PRBC on 11/15/23 and the “Single Transfusion Record” did not include the start time, stop time, flow rate, and the dual verification by two nurses. The Dir ER/ICU stated the nurse who administered the unit of PRBC on 11/15/23 no longer worked at the hospital. The Dir ER/ICU confirmed documentation of the start time, stop time, flow rate, and dual verification by two nurses of the unit of PRBC P2 received on 11/15/23 was not included in P2’s EMR.”

“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: 47480 Based on record review and interview the facility failed to ensure a medical screening exam for a patient that present to the Emergency Department and to arrange an appropriate transfer for a patient to another medical facility. This deficient practice can lead to serious injury or death of all patients seeking medical care in this facility’s Emergency Department. The findings are: A. The facility failed to perform a medical screening exam. Refer to Tag A-2406 B. The facility failed to have a process in place to ensure appropriate transfer of patients who chose to travel by personal vehicle. Refer to Tag A-2409”

“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: 47302 Based on record review and interview the facility failed to ensure that an appropriate medical screening exam was done for 2 (P[patient]1, P12) out of 20 (P1-P20) patients reviewed for seeking emergency care This deficient practice can lead to patient’s not receiving emergency care. The findings are: A. Record review of facility policy titled, “EM004 EMTALA-Medical Screening Examination and Stabilization” dated 05/19/2013 under, “Policy” it is stated, “1) Any individual who Comes to the Emergency Department will be provided an appropriate Medical Screening Examination performed by a Physician or Qualified Medical Person to determine if the individual has an Emergency Medical Condition. If an individual is determined to have an Emergency Medical Condition, [Facility Name] will provide further examination and treatment necessary To Stabilize the Emergency Medical Condition, within [Facility Name] Capability and Capacity.” B. Record review of P1’s electronic health records for visit date 08/16/2023 at 10:37 AM revealed the following: 1. Emergency medicine note dated 08/16/2023 at 11:21 AM revealed the patient presented to the emergency department with complaints of dizziness and tingling. Patient was brought in by ambulance for left sided tingling that were worsening. Patient noted to have a history of atrial fibrillation (abnormal heart rhythm) and myocardial infarction (heart attack). 2. Review of vital signs taken at 10:37 AM revealed an elevated blood pressure of 176/74. Final set of vitals taken at 2:50 PM revealed an elevated blood pressure of 197/88. 3. Review of electrocardiogram (EKG, test done to reveal the electrical currents of the heart) on 08/16/2023 at 11:37 AM revealed sinus bradycardia (slow but regular heartbeat) reviewed by the provider at 11:38 AM. 4. Review of the medications administered on 08/16/2024 revealed that patient was given a normal saline bolus (fluids given through the veins) at 2:50 PM. 5. There was no evidence that patient was evaluated for a possible stroke with tests such as an NIH stroke scale (National Institute of Health, standardized tool to assess for stroke) or CT (Computed Tomography, scan that can be done of the head to evaluate for stroke). C. Record review of P12’s electronic health records for visit date 11/18/2023 at 11:55 AM revealed: 1. Review of emergency medicine note on 11/18/2023 at 12:07 PM revealed that patient was brought in for alcohol intoxication. 2. Review of patient’s vital signs on 11/18/2023 at 12:02 PM were: elevated blood pressure 146/88, pulse 108, oxygen saturation 93%, temperature 97.5. Patient’s vital signs at 12:05 PM were blood pressure 132/86, pulse 107, oxygen saturation 90%, temperature 97.9. 3. Review of discharge instructions on 11/18/2023 at 12:13 PM revealed a blank note. Patient was provided a follow-up appointment for 11/20/2023. Patient was prescribed ibuprofen (over the counter medication given for pain) and patient was provided education on alcohol intoxication. 4. Provider’s note did not address patient’s abnormal vital signs nor were further tests ordered to evaluate patient’s condition. D. Record review of P12’s electronic health records for admission on 11/18/2023 at 11:47 PM revealed: 1. Chest X-ray ordered by S(Staff)18, clinical on 11/19/23 at 5:21 AM showed no acute findings. 2. X-ray right leg ordered by S18, clinical on 11/19/23 3:30 AM showed suspicious appearing fracture related to either acute on chronic fracture or infection. 3. Review of vital signs revealed that on 11/18/2023 at 11:45 PM patient’s vital signs were: elevated blood pressure 138/80, normal temperature 97.3, elevated heart rate 118, normal oxygen saturation 94%. Further review of flowsheets revealed that patient did require supplemental oxygen for low oxygen readings. 4. The D-dimer collected on 11/18/2023 at 3:58 AM was 1,963 (normal range <500). 5. Patient was discharged on 11/19/2023 at 6:47 AM. There is no evidence that there was a provider examination for the care provided in the emergency department. E. During an interview on 01/03/2024 at 5:05 PM with S(Staff)17, Chief Medical Officer it was confirmed that there should be a providers note for a patient that received care in the emergency department.”

“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: 47302 Based on record review and interview the facility failed to have a process in place for patients that choose to transfer via private vehicle and ensure they understand the risks involved for 1(P[patient]6) out of 5 (P3, P6, P10, P14, and P15) patients reviewed for transferring to another facility. This deficient practice could lead to unsafe conditions during transport for a patient that is requiring medical attention. The findings are: A. Record review of facility policy titled, “EMTALA-Transfers” dated 02/06/2023 on page 5 it is stated, “7) Requirements for an Appropriate Transfer. The following procedures will be followed to ensure an Appropriate Transfer of an individual with an Emergency Medical Condition that has not been Stabilized:. . . d) Transportation. The Transfer will be carried out through the use of qualified personnel and transportation equipment, as determined by the transferring Physician, including the use of necessary and medically appropriate life-support measures during the Transfer.” Continued on page 7 it is also stated, “9) Transfer of an Individual whose Emergency Medical Condition is Stabilized. An individual with an Emergency Medical Condition that has been Stabilized may be transferred in accordance with the following procedures:. . . f) Lovelace Women’s Hospital will carry out the Transfer with appropriate transportation equipment and staff in accordance with #7d of the Procedure above.” B. Record review of document titled, “Inter-Hospital Patient Transfer” dated 11/26/23 found in P6’s medical record in section 2 it is stated, “Preconditions to transfer (All Must Be Met). . . D. The patient will be transferred by qualified personnel and transportation equipment as required including the use of necessary and medically appropriate life support measures.” There is a handwritten checkmark next to “D”. Under “Mode of Transport” there is a box checked next to “Other” and it is handwritten “POV [privately owned vehicle]”. C. Record review of a provider note dated 11/26/2023 at 1:49 PM revealed that P6’s presented with a chief complaint of urinary retention, nausea, and vomiting for 2 days. 1. Under “Additional Findings” at 3:00 PM it is noted, “attempted IV (intravenous access to administer medications or fluids) access x2 unsuccessfully. . . pt (patient) reportedly not breastfeeding well and only chewing on bottle nipple. . . Pt remains drowsy.” 2. Under “Disposition” at 5:55 PM it is stated “pt transferred to [outside hospital name] PEDS-ED (pediatric emergency department). Patient’s vital signs at discharge were: blood pressure 83/61, heart rate 140, respiratory rate 26, temperature 97.4. 3. Review of nursing notes stated P6 was lethargic and decreased level of consciousness decreased skin turgor. 4. Lab work reveals leukocytosis (high white count), Carbon Dioxide 6.2 (normal 4.7-6). 5. Under “Clinical Impression” it stated, “Called [name of provider at receiving hospital] - Go to ED [emergency department] for assessment. Accepted by [name of provider at receiving hospital] Pt [patient] finished 4 oz [ounces] prior to leaving. Safe for POV. . .” No evidence of discussion of risk of transfer documented other than motor vehicle collision. D. During an interview on 01/04/2023 at 2:15 PM with S(staff)15 it was asked what the policy was for patients to transfer by private vehicle. S15 explained that there was no specific policy but their process is to discharge the patient with instructions to go to another hospital.”