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ALAMANCE REGIONAL MEDICAL CENTER 1240 HUFFMAN MILL RD BURLINGTON, NC 27216 Dec. 11, 2014
VIOLATION: COMPLIANCE WITH 489.24 Tag No: A2400
Based on policy and procedure review, medical record reviews, and staff interviews, the hospital failed to comply with 489.24 as evidenced by the Dedicated Emergency Department (DED) physician failing to ensure an appropriate transfer; by failing to complete a written physician's certification for transfer documenting the medical benefits and/or increased risks associated with the transfer for the specific Emergency Medical Condition (EMC) of the patient transferred to another hospital.

The findings include:

~ Cross refer to 489.24(e)(1)(2) Risks and Benefits, Tag A2409.
VIOLATION: APPROPRIATE TRANSFER Tag No: A2409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy and procedure review, closed medical record reviews, and staff interviews, the hospital's Dedicated Emergency Department (DED) physician failed to ensure an appropriate transfer; by failing to complete a written physician's certification for transfer documenting the medical benefits and/or increased risks associated with the transfer for the specific Emergency Medical Condition (EMC) of the patient in 3 of 4 (2 of 3 ED and 1 of 1 Obstetrical) DED patients that were transferred to another hospital (#24, #6, #13).

The findings include:

Review of current hospital policy "E.M.T.A.L.A. Compliance..." Policy No: H-PC-800-01, Revised 01/2011, revealed "LEGAL DUTIES IMPOSED: ...If an emergency medical condition does exist, the Hospital must: 1. stabilize the medical condition, or if unable to stabilize, 2. transfer the patient to a hospital that is capable of stabilizing the medical condition. BASIC LEGAL REQUIREMENTS: ...If an emergency medical condition exists, the patient must either be stabilized, or if unable to be stabilized, the patient must be transferred to a hospital that is capable of stabilizing condition. ...PROCEDURE: ...Provide an appropriate transfer of an unstabilized individual to another medical facility if: The individual (or person acting on his or her behalf) after being informed of the risks and the hospital's obligations requests a transfer. A physician has signed the certification that the benefits of the transfer of the patient to another facility outweigh the risks ..."

1. Hospital A (transferring facility), closed DED Labor and Delivery (L&D) record review on 12/10/2014 for Patient #24 revealed the patient presented to the L&D on 12/06/2014 at 1142 with a chief complaint of 32 weeks pregnant, back pain, and contractions. Review of MSE documentation by Physician F dated 12/06/2014 at 1303 revealed the patient was G (Gravida)1 P (Para) 0 with estimated date of confinement 12/29/14, and Cesarean Section scheduled for 12/22/14, and has high risk pregnancy conditions that involve personal [DIAGNOSES REDACTED], Club Feet status post repair, Chronic Fecal/Urine Incontinence, Mild mental retardation, Past Substance Abuse, and Chronic urinary tract infections, who presents at 36 weeks with Contractions and vaginal leakage (incontinence or amniotic fluid in question), presenting by EMS to (Hospital A). Prenatal Care at (Hospital D), with planned delivery by Cesarean Section there. Patient expresses strong desire to return to (Hospital D) for any further care at this time. In fact, patient fervantly [sic] refuses exam although does allow us brief and limited exam to ensure no immediate concern for delivery. Review of Impression - Early Preterm Labor vs. False Labor, Question of premature rupture of membranes. Plan - EFM/NST (electronic fetal monitoring/nonstress test). Comments - Discussed with (Hospital D) MFM (maternal-fetal medicine). Accepting of transfer due to high risk condition and patient desire. Stable for transfer. Review of a "Documents Review Report (printed and given to patient to sign)" of the "Patient Transfer-To Outside Acute Care Facility" form (Pages 1-2) electronically completed for Patient #24 on 12/06/2014 at 1313 revealed an "Assessment (TO BE COMPLETED BY PHYSICIAN)" section (Page 1). Review revealed "Benefits of Transfer" were "Close proximity to advanced medical facility in event of worsening condition; Patient requests and has had plans for delivery there at (Hospital D), due to high risk maternal-fetal medicine concerns" only. Review of the section "Notice of Risk (TO BE COMPLETED BY PHYSICIAN)" (Page 1) revealed the section was blank. Review revealed the form was electronically signed by Physician F at 1303 (Page 1). Review of the "Patient Consent to Transfer" section (Page 1) revealed "I hereby consent to the transfer to another facility. I understand that it is in the opinion of the physician responsible for my care that the benefits to transfer outweigh the risk of transfer. Accepting institution (Hospital D). Review revealed the hand written signature of the Patient/Responsible Party (Page 2) without a witness signature (not dated or timed). Record review revealed the patient left the L&D via ambulance at 1407 for transfer to Hospital D (receiving facility). Record review failed to reveal documentation in the patient's medical record indicating benefits and increased risks of transfer specific to the patient's emergency medical condition of Early Preterm Labor vs. False Labor, Question of premature rupture of membranes were explained.

Interview on 12/11/2014 at 0943 with DED Management Staff #1 revealed the ED physician makes the decision to transfer patients to outside facilities. Interview revealed the patient and/or guardian is required to be consulted and involved in the decision making process regarding the transfer. Interview revealed the appropriate facility must be contacted to ensure they have a bed and an accepting physician. Interview revealed once there is an accepting physician and facility, the "paperwork process" starts. Interview revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed in the computer. Interview revealed the top of the form is completed by the physician and the bottom portion is completed by the nurse. Interview revealed once the form is completed, it is printed and taken to the patient and/or guardian for review and to be signed. If the patient is unable to sign, two nurses sign the form. Interview revealed the signed forms are scanned into the electronic medical record. Interview revealed the ED physician is responsible for explaining the risk and benefits of the transfer to the patient and/or guardian. Interview revealed it is the responsibility of the physician to document on the form if the patient is stable or unstable; and to complete the risk and benefits section of the form. Interview revealed there are no risks specific to the patient's emergency medical condition listed in the Notice of Risk section. Interview revealed a standardized statement auto-populates into the section. Interview revealed the statement is the same for all patients. Interview revealed there is not a space to free-text risks of transfer related to the patient's specific emergency medical condition. After the form is completed, printed, and signed by the patient the form is reviewed by the charge nurse for completeness. Interview revealed the charge nurse reviews the form in the computer only. Interview revealed the charge nurse does not review the signed printed forms. Interview revealed if the charge nurse had been reviewing the printed forms, it would have been expected to see the risks documented on the form. Interview confirmed the printed Patient Transfer-To Outside Acute Care Facility forms signed by Patient #24 nor the medical record contained any available documentation indicating the benefits and increased risks of transfer specific to the patient's emergency medical condition of Early Preterm Labor vs. False Labor, Question of premature rupture of membranes were explained.

Interview on 12/11/2014 at 0910 with Information Technology (IT) RN Analyst #1 revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed electronically by the physician, nurse, and unit clerk. Interview revealed the electronic form was built to mirror the original paper form. Interview revealed the top portion of the form (Initial Diagnosis/Chief Complaint, Assessment, and Notice of Risk) is completed by the physician and the bottom portion (Transfer Information, Consent for transfer, Copies of Records Sent, Vital Signs) is completed by the nurse and unit clerk. Interview revealed once the form is completed, it is printed and taken to the patient to be signed. Interview revealed the signed forms are then scanned into the medical record. Interview revealed the physician completes the "Benefits of Transfer" section by placing checks in boxes adjacent to standardized benefits listed on the computer screen or they may check the box for "Other" and free-text additional benefits on a blank line. Interview revealed the physician also completes the "Notice of Risk" section by clicking on a circle on the computer screen that will auto-populate the section with a standardized risk statement. Interview revealed the statement can not be modified by the physician. Interview revealed the statement is the same for all patients. Interview revealed there is not a blank line to free-text specific risks. Interview revealed the statement is not specific to each individual patient's emergency medical condition. Interview confirmed the "Documents Review Report (printed and given to patient to sign)" of the "Patient Transfer-To Outside Acute Care Facility" form for Patient #24 did not contain any standardized notice of risk statements under the "Notice of Risk" section. Interview revealed "there was an IT printing issue" when the forms were printed. Interview revealed "I have a suspicion it was the sequence of how the note was filled out in the computer by the staff." Interview revealed when viewed on computer, the standardized Notice of Risk statement is present for each patient. Interview revealed "screenshots" of the completed Notice of Risk statements could be printed from the computer.

Review of electronic medical record "computer screenshots" provided by Information Technology (IT) RN Analyst #1, dated 12/11/2014 at 0950 for Patient #24 revealed sections (completed individually by the physician, nurse, and unit clerk) of the "Patient Transfer - To Outside Acute Care Facility" forms. Review revealed under the "Notice of Risk (TO BE COMPLETED BY PHYSICIAN)" section the standardized statement "Based on the above and my personal judgment, I hereby certify that based on the information available to me AT THE TIME OF TRANSFER, the medical benefits reasonably expected from the provision of appropriate medical care at another medical facility outweigh the increased risk of the transfer to the individual and in the case of a women in labor, the unborn child. The risk of transfer has been fully explained to the patient or their responsible party including the risk of discomfort during transport, possible worsening of condition during transport, potential accident during transport, and the risk that no further treatment/improvement is possible. Review failed to reveal any available documentation indicating that the benefits and increased risks of transfer specific to the patient's emergency medical conditions were explained to each patient.

2. Hospital A (transferring facility), closed DED record review on 12/10/2014 for Patient #6 revealed the patient (MDS) dated [DATE] at 1350 with a chief complaint of bloody urine, patient here for hematuria after dirt bike accident yesterday. Patient flipped his dirt bike....hurts on right side and peed blood about one hour ago. Review of MSE documentation by Physician G revealed the patient was seen at 1500. Review revealed a chief complaint of fall from dirt bike, now with blood in urine and abdominal pain. Review of lab data revealed, WBC (white blood count) 15.5 (reference range 3.8-10.6); HGB 12.7 (reference range 13.0-18 grams/deciliter); Alkaline Phosphatase 272 (reference range 45-117 Units/Liter), AST [ALT] 48 (reference range 10-36 Units/Liter); urinalysis 3+ blood, 25,000 RBC [red blood cells] (reference range 0-5/HPF). Review of CT Scan revealed, right renal laceration, small amount pelvic free fluid. Review of Progress notes revealed "D/W (discussed with) [Hospital B] ER will transfer via ground." Review revealed a clinical impression of Traumatic Renal (kidney) Laceration. Review of a "Documents Review Report (printed and given to patient to sign)" of the "Patient Transfer-To Outside Acute Care Facility" form (Pages 1-3) electronically completed for Patient #6 on 11/28/2014 at 1658 revealed an "Assessment (TO BE COMPLETED BY PHYSICIAN)" section (Page 1). Review revealed "Benefits of Transfer" were "Physician specialties needed are not available" only. Review of the "Notice of Risk (TO BE COMPLETED BY PHYSICIAN)" section (Page 1) revealed "Based on the above and my personal judgment, I hereby certify that based on the information available to me AT THE TIME OF TRANSFER, the medical benefits reasonably expected from the provision of appropriate medical care at another medical facility outweigh the increased risk of the transfer to the individual and in the case of a women in labor, the unborn child. The risk of transfer has been fully explained to the patient or their responsible party including the risk of discomfort during transport, possible worsening of condition during transport, potential accident during transport, and the risk that no further treatment/improvement is possible. Review revealed the form was electronically signed by Physician G at 1658. Review of the "Patient Consent to Transfer" section (Page 2) revealed "I hereby consent to the transfer to another facility. I understand that it is in the opinion of the physician responsible for my care that the benefits to transfer outweigh the risk of transfer. Accepting institution (Hospital B). Further review revealed on page 3, "The transfer information above has been reviewed with the patient/responsible party by a staff member. The original will be signed and placed in the medical record and a copy will be forwarded with the patient to the receiving acute care facility." Review revealed the hand written signature of the Patient/Responsible Party witnessed by a RN (not dated or timed). Record review revealed the patient left the DED via ambulance at 1714 for transfer to Hospital B (receiving facility). Record review failed to reveal documentation in the patient's medical record indicating that the benefits and increased risks of transfer specific to the patient's emergency medical condition of Traumatic Renal Laceration were explained.

Interview on 12/11/2014 at 0943 with DED Management Staff #1 revealed the ED physician makes the decision to transfer patients to outside facilities. Interview revealed the patient and/or guardian is required to be consulted and involved in the decision making process regarding the transfer. Interview revealed the appropriate facility must be contacted to ensure they have a bed and an accepting physician. Interview revealed once there is an accepting physician and facility, the "paperwork process" starts. Interview revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed in the computer. Interview revealed the top of the form is completed by the physician and the bottom portion is completed by the nurse. Interview revealed once the form is completed, it is printed and taken to the patient and/or guardian for review and to be signed. If the patient is unable to sign, two nurses sign the form. Interview revealed the signed forms are scanned into the electronic medical record. Interview revealed the ED physician is responsible for explaining the risk and benefits of the transfer to the patient and/or guardian. Interview revealed it is the responsibility of the physician to document on the form if the patient is stable or unstable; and to complete the risk and benefits section of the form. Interview revealed there are no risks specific to the patient's emergency medical condition listed in the Notice of Risk section. Interview revealed a standardized statement auto-populates into the section. Interview revealed the statement is the same for all patients. Interview revealed there is not a space to free-text risks of transfer related to the patient's specific emergency medical condition. After the form is completed, printed, and signed by the patient the form is reviewed by the charge nurse for completeness. Interview revealed the charge nurse reviews the form in the computer only. Interview revealed the charge nurse does not review the signed printed forms. Interview revealed if the charge nurse had been reviewing the printed forms, it would have been expected to see the risks documented on the form. Interview confirmed the printed Patient Transfer-To Outside Acute Care Facility forms signed by Patient #6's Guardian nor the medical record contained any available documentation indicating the benefits and increased risks of transfer specific to the patient's emergency medical condition of Traumatic Renal Laceration were explained.

Interview on 12/11/2014 at 0910 with Information Technology (IT) RN Analyst #1 revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed electronically by the physician, nurse, and unit clerk. Interview revealed the electronic form was built to mirror the original paper form. Interview revealed the top portion of the form (Initial Diagnosis/Chief Complaint, Assessment, and Notice of Risk) is completed by the physician and the bottom portion (Transfer Information, Consent for transfer, Copies of Records Sent, Vital Signs) is completed by the nurse and unit clerk. Interview revealed once the form is completed, it is printed and taken to the patient to be signed. Interview revealed the signed forms are then scanned into the medical record. Interview revealed the physician completes the "Benefits of Transfer" section by placing checks in boxes adjacent to standardized benefits listed on the computer screen or they may check the box for "Other" and free-text additional benefits on a blank line. Interview revealed the physician also completes the "Notice of Risk" section by clicking on a circle on the computer screen that will auto-populate the section with a standardized risk statement. Interview revealed the statement can not be modified by the physician. Interview revealed the statement is the same for all patients. Interview revealed there is not a blank line to free-text specific risks. Interview revealed the statement is not specific to each individual patient's emergency medical condition.

3. Hospital A (transferring facility), closed DED record review on 12/10/2014 for Patient #13 revealed the patient (MDS) dated [DATE] at 1822 with a chief complaint of fall. Patient was on ladder hanging a curtain and fell . Review of MSE documentation by Physician H revealed the patient was seen at 1841. Review revealed a chief complaint of fall. fell from height of 2 feet. Moderate pain. Review of x-rays results revealed, left leg, extensively comminuted proximal tibia and fibial plateau fracture. Review revealed at 1901 "spoke with (Physician name), ortho advises to splint leg + (and) transfer to (Hospital B)." Review revealed at ~2230 no beds at (Hospital B). (Physician name) accepts (Hospital E) ER." Review revealed a clinical impression of Comminuted Proximal Left Tibia and Left Tibial Plateau Fracture. Review of a "Documents Review Report (printed and given to patient to sign)" of the "Patient Transfer-To Outside Acute Care Facility" form (Pages 1-3) electronically completed for Patient #13 on 10/01/2014 at 0004 revealed an "Assessment (TO BE COMPLETED BY PHYSICIAN)" section (Page 1). Review revealed "Benefits of Transfer" were "Physician specialties needed are not available" only. Review of the section "Notice of Risk (TO BE COMPLETED BY PHYSICIAN)" (Page 1) revealed the section was blank. Review revealed the form was electronically signed by Physician H at 2327 (09/30) [Page 2]. Review revealed no "Patient Consent to Transfer" section. Further review revealed on page 3, "The transfer information above has been reviewed with the patient/responsible party by a staff member. The original will be signed and placed in the medical record and a copy will be forwarded with the patient to the receiving acute care facility." Review revealed the hand written signature of the Patient/Responsible Party witnessed by a RN (not dated or timed). Record review revealed the patient left the DED via ambulance at 0015 (10/01) for transfer to Hospital E (receiving facility). Record review failed to reveal documentation in the patient's medical record indicating that the benefits and increased risks of transfer specific to the patient's emergency medical condition of Comminuted Proximal Left Tibia and Left Tibial Plateau Fracture were explained.

Interview on 12/11/2014 at 0943 with DED Management Staff #1 revealed the ED physician makes the decision to transfer patients to outside facilities. Interview revealed the patient and/or guardian is required to be consulted and involved in the decision making process regarding the transfer. Interview revealed the appropriate facility must be contacted to ensure they have a bed and an accepting physician. Interview revealed once there is an accepting physician and facility, the "paperwork process" starts. Interview revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed in the computer. Interview revealed the top of the form is completed by the physician and the bottom portion is completed by the nurse. Interview revealed once the form is completed, it is printed and taken to the patient and/or guardian for review and to be signed. If the patient is unable to sign, two nurses sign the form. Interview revealed the signed forms are scanned into the electronic medical record. Interview revealed the ED physician is responsible for explaining the risk and benefits of the transfer to the patient and/or guardian. Interview revealed it is the responsibility of the physician to document on the form if the patient is stable or unstable; and to complete the risk and benefits section of the form. Interview revealed there are no risks specific to the patient's emergency medical condition listed in the Notice of Risk section. Interview revealed a standardized statement auto-populates into the section. Interview revealed the statement is the same for all patients. Interview revealed there is not a space to free-text risks of transfer related to the patient's specific emergency medical condition. After the form is completed, printed, and signed by the patient the form is reviewed by the charge nurse for completeness. Interview revealed the charge nurse reviews the form in the computer only. Interview revealed the charge nurse does not review the signed printed forms. Interview revealed if the charge nurse had been reviewing the printed forms, it would have been expected to see the risks documented on the form. Interview confirmed the printed Patient Transfer-To Outside Acute Care Facility form signed by Patient #13 nor the medical record contained any documentation indicating the benefits and increased risks of transfer specific to the patient's emergency medical condition of Comminuted Proximal Left Tibia and Left Tibial Plateau Fracture were explained.

Interview on 12/11/2014 at 0910 with Information Technology (IT) RN Analyst #1 revealed the "Patient Transfer-To Outside Acute Care Facility" form is completed electronically by the physician, nurse, and unit clerk. Interview revealed the electronic form was built to mirror the original paper form. Interview revealed the top portion of the form (Initial Diagnosis/Chief Complaint, Assessment, and Notice of Risk) is completed by the physician and the bottom portion (Transfer Information, Consent for transfer, Copies of Records Sent, Vital Signs) is completed by the nurse and unit clerk. Interview revealed once the form is completed, it is printed and taken to the patient to be signed. Interview revealed the signed forms are then scanned into the medical record. Interview revealed the physician completes the "Benefits of Transfer" section by placing checks in boxes adjacent to standardized benefits listed on the computer screen or they may check the box for "Other" and free-text additional benefits on a blank line. Interview revealed the physician also completes the "Notice of Risk" section by clicking on a circle on the computer screen that will auto-populate the section with a standardized risk statement. Interview revealed the statement can not be modified by the physician. Interview revealed the statement is the same for all patients. Interview revealed there is not a blank line to free-text specific risks. Interview revealed the statement is not specific to each individual patient's emergency medical condition. Interview confirmed the "Documents Review Report (printed and given to patient to sign)" of the "Patient Transfer-To Outside Acute Care Facility" form for Patient #13 did not contain any standardized notice of risk statements under the "Notice of Risk" section. Interview revealed "there was an IT printing issue" when the forms were printed. Interview revealed "I have a suspicion it was the sequence of how the note was filled out in the computer by the staff." Interview revealed when viewed on computer, the standardized Notice of Risk statement is present for each patient. Interview revealed "screenshots" of the completed Notice of Risk statements could be printed from the computer.

Review of electronic medical record "computer screenshots" provided by Information Technology (IT) RN Analyst #1, dated 12/11/2014 at 0951 for Patient's #13 revealed sections (completed individually by the physician, nurse, and unit clerk) of the "Patient Transfer - To Outside Acute Care Facility" forms. Review revealed under the "Notice of Risk (TO BE COMPLETED BY PHYSICIAN)" section the standardized statement "Based on the above and my personal judgment, I hereby certify that based on the information available to me AT THE TIME OF TRANSFER, the medical benefits reasonably expected from the provision of appropriate medical care at another medical facility outweigh the increased risk of the transfer to the individual and in the case of a women in labor, the unborn child. The risk of transfer has been fully explained to the patient or their responsible party including the risk of discomfort during transport, possible worsening of condition during transport, potential accident during transport, and the risk that no further treatment/improvement is possible. Review failed to reveal any available documentation indicating that the benefits and increased risks of transfer specific to the patient's emergency medical conditions were explained to each patient.

In summation the findings revealed Patient's #24, #6, and #13, presented to the DED of Hospital A with three (3) different types of emergency medical conditions: 1.. Early Preterm Labor vs. False Labor, Question of premature rupture of membranes; 2. Traumatic Renal Laceration; and 3. Comminuted proximal left tibia and left tibial plateau fracture; and were subsequently transferred to other hospitals. Review of each patient's individual "Patient Transfer Form - To Outside Acute Care Facility" form revealed identical standardized "Notice of Risk" statements. Record review failed to reveal any available documentation indicating that the benefits and increased risks of transfer specific to the patient's emergency medical conditions were explained to each patient.

NC 1392