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|NORTH SHORE MEDICAL CENTER||1100 NW 95TH ST MIAMI, FL 33150||April 18, 2014|
|VIOLATION: COMPLIANCE WITH 489.24||Tag No: A2400|
|Based on reviews of clinical records, Policies and Procedures, Emergency Department central and transfer logs, State licensure, Medical Staff Rules and Regulations, Physician On-Call lists and interviews, it was determined the facility failed to provide an appropriate transfer of a patient in labor as evidenced by failure to provide documentation that the patient was informed of and understood the risk versus benefit of transfer, failed to provide a physician 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, failure to ensure the receiving facility has available space and qualified personnel for the treatment of the individual and has accepted the individual, and failure to send to the receiving facility all medical records (or copies thereof) related to the emergency condition with which the individual has presented that are available at the time of the transfer.
The facility failed to provide an appropriate transfer of an individual who required specialized capabilities for obstetrical services for 1 of 14 sampled patients (Patient #1). Refer to findings at tag A2409.
|VIOLATION: APPROPRIATE TRANSFER||Tag No: A2409|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on reviews of clinical records, Policies and Procedures, Emergency Department central and transfer logs, State licensure, Medical Staff Rules and Regulations, Physician On-Call lists, Facility self report, and interviews, it was determined the facility failed to provide an appropriate transfer of a patient in labor as evidenced by failure to provide documentation that the patient was informed of and understood the risk versus benefit of transfer, failed to provide a physician 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, failure to ensure the receiving facility has available space and qualified personnel for the treatment of the individual and has accepted the individual, and failure to send to the receiving facility all medical records (or copies thereof) related to the emergency condition with which the individual has presented that are available at the time of the transfer. The facility failed to provide an appropriate transfer of an individual who required specialized capabilities for obstetrical services for 1 of 14 sampled patients (Patient #1).
The facility has an ongoing corrective action plan in place at the time of survey, 4/18/2014.
The finding includes:
Review of the Complaint Administration Units (CAU) narrative summary dated 4/18/14 reveals a self-reported possible EMTALA (emergency medical treatment and labor act) violation submitted by the transferring facility, Florida Medical Center - A campus of North Shore Medical Center (FMC) concerning the transfer of a woman in labor to a receiving hospital on [DATE]. The complaint summary notes the following:
The caller is the Risk Manager (RM) at the facility in question (FMC) and is self-reporting a possible EMTALA violation. On 4/3/14, Patient #1 arrived at the emergency room (ER) complaining of lower abdominal pains. She was 31 weeks pregnant with twins at the time. Patient #1 was able to make her own decisions and was insured by Medicaid. She suffered from no other medical conditions. Florida Medical Center does not offer labor & delivery or NICU (neonatal intensive care) services. Patient #1 was triaged, examined by Dr. L... (ED Physician on duty, staff #9) and an ultrasound (Doppler) was completed. The ultrasound revealed both twins had an active heartbeat. Patient #1 was diagnosed with having contractions 5-7 minutes apart and being in active labor. After a complete examination, Dr. L... confirmed the patient was stable & could be transported to another facility for more treatment. During the same time Patient#1 was at the facility two code blues & a stroke alert occurred, so Dr. L... made the decision to go ahead and transfer Patient #1 to a receiving Hospital. Dr. L... is a fairly new physician working in the ER, so he gave the okay to call 911, so Patient #1 could be transferred to a receiving Hospital. Patient #1 was transferred safely to a receiving Hospital. On 4/4/14, the CEO at FMC received a call from the receiving Hospital's CEO. She was notified that Patient #1 was sent by ambulance to the receiving Hospital without Dr. L... contacting the ER physician at the receiving Hospital for acceptance. Patient #1 was also transferred with no medical records. The CEO at the receiving Hospital informed the CEO at FMC that Patient #1 delivered the twins an hour after arriving at the receiving Hospital, and all of them were doing well. The CEO at the receiving Hospital notified the CEO at FMC that he felt they dumped the patient on them. On 4/7/14, the CEO at FMC completed an investigation in the ER & spoke with the ER Medical Director & ER Nursing Manager. The results were that Dr. L... and other staff involved misunderstood the transferring of a patient to another facility. The ED Medical Director and Nurse Manager spoke with Dr. L... and the other parties involved about the incident. An in-service is being planned for the ER staff so they will be made aware of the protocol for transferring patients so possible EMTALA violations do not occur in the future. She did notify the receiving Hospital's Risk Manager that she would be self-reporting the incident.
Review of the clinical record of Patient #1 revealed she arrived to the Emergency Department (ED) at FMC by Walk-in / private vehicle on 4/3/14 at 3:22 AM, with a presenting complaint of abdominal pain for 2 hours and contraction pains, 31 weeks pregnant with concerns of no fetal movement. Patient #1 has a history of reported abdominal pains times 2 hours, with a pain level of 4/10 (10 being worst), without bleeding or urinary tract infection.
Review of Patient #1's clinical record revealed she presented to the ED and was triaged appropriately at 3:44AM. The record notes she is Gravida 1, 1 full term birth and vital signs are stable. Triage assessment completed, in no apparent distress, cooperative, quiet, pain now 10/10, aching. Acuity assessed as ESI (emergency severity index) 3.
At 4:08 AM the patient is noted uncomfortable and anxious, VS stable.
At 4:25 Doppler ultrasound notes Twin A 138, Twin B 142, contractions 5-7 minutes.
At 4:27AM a saline lock is inserted with NS 150 ml/hr.
Medical screening exam is documented as done at 4:44 AM by the ED physician (Dr. L...). The notes documents discussion with patient regarding exam findings and diagnostic results supporting the diagnosis and need to transfer to another facility. The fetal heart tones are noted at 138 and 142 beats/min., contractions every 5-6 minutes. Per protocol since greater than 20 weeks and in active labor, 911 was called. Patient transferred without any problems.
The record notes a call to 911 at 4:20AM for transfer to nearest facility for obstetrical treatment and patient transferred to receiving Hospital at 4:38AM. Another note documents the patient left the ED at 4:45AM. At 4:44AM the record notes an order to transfer to receiving Hospital, Diagnosis pregnancy. Reason for transfer is noted as higher level of care, accepting physician is noted as "Hospital Name"(receiving Hospital). There is no documentation in the record of any communication with the receiving Hospital or that the hospital accepted the patient in transfer.
There is no documentation in the record that the Assessment and Certification Form was completed (physician 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), the Patient transfer form is signed but incomplete lacking the physicians name, recommendation or risk vs benefit of transfer, and there is no documentation that pertinent medical records were copied and sent with the patient.
Additionally the Emergency Medical Services record titled, "_______Sheriffs Fire Rescue- Trip Information " report dated 4/3/14 indicates that the transferring facility (FMC) did not provide any medical record in the transport from FMC to the receiving facility. The Report also notes the patient (#1) was picked up at 4:37AM of 4/3/14 and arrived at the receiving Hospital at 4:48AM on 4/3/14.
The facility Risk Manager was interviewed during the record review and could not show evidence of staff following facility policy and protocol for accessing specialty care for Patient #1 prior to her transfer out on 4/3/14. She noted and review of the physician roster concurred that OB/gyne physicians are on call in the ED.
The Risk Manager stated that an internal investigation dated 4/7/14 found that the ED Physician, ID # 9, did not communicate with the accepting facility, complete the Risk versus Benefit form found in Patient #1's clinical record, and did not send any medical record with Patient #1 to the receiving facility.
The Risk Manager states that Patient #1 was stabilized and treated before transfer to receiving Hospital. She stated at the time Patient #1 presented to the ED, the ED department was experiencing a heavy work load with two cardiac arrests and a 3rd cardiac code in-house (CVICU), and that the attending ED Physician " Was fairly new to the facility as an ED Physician " . The Risk manager states the acuity at the time of the transfer and the three cardiac codes contributed to the lack of communication to the receiving facility and failure to send medical records to the receiving facility.
An interview and records review with the PBX supervisor at approximately 2:00 PM on 4/18/14 revealed the following: The PBX supervisor, staff ID # 13, provided the surveyor with the 4/3/14 log noting a code blue in the ED at 2:22AM and 2:29AM on 4/3/14 and another code in the CVICU at 4:10AM to which the ED physician responded.
Interview with the Risk Manager confirmed and review of the ED physician roster concurred that Dr. L... was the only ED physician on duty from 9PM on 4/2/14 to 7AM on 4/3/14.
Review of the facility policy and procedures (P&P) entitled: Hospital-Wide Policy & Procedure (P&P). Cobra (Medical Screening Examination) concerning ED access and emergency medical treatment and labor act (EMTALA) transfers revealed:
? Page # 8 of 12 section " b " The individual may be transferred if a physician has documented in the " Physician Assessment and Certification Form " that the transfer will not create a medical hazard for the individual.
? Page #8 of 12 section " D " lines # 2 and #3 indicate the representative of the receiving facility must confirm that the receiving facility has available space and qualified personnel to treat the individual, the receiving facility must agree to treat the individual. Additionally the receiving Physician must agree to accept and treat the Patient; the receiving physician will be documented on the transfer record.
? #4 the hospital will send the receiving facility copies of all pertinent medical records ...
Review of the facility Florida license #4133 dated effective 3/12/13 to expiration date 1/10/15 indicates the facility is licensed for Emergency Medicine, and Gynecology, and is not licensed for Obstetrics, Pediatrics or NICU (neonatal intensive care).
Review of the Medical Staff Rules & Regulations, Section M, reveals FMC Campus specifics: patients under the age of 18 may not be admitted , if a patient is less than 16 weeks gestation and presents to NSMC, FMC campus for emergency medical treatment and requires admission, the patient must be admitted by the appropriate on call service according to her medical problem ....with the understanding the obstetrician on call will agree to consult.
An interview was conducted with the Risk Managers (RM) on 4/18/14 at 10:51 AM. This interview verifies the Complaint Administration Units (CAU) narrative (CCR# ) dated 4/18/14 noted above. (Originally received on 4/16/14 as an emergency access complaint.)
The RM provided evidence and stated Patient #1 was seen, treated and stabilized while in the Emergency department (ED) on 4/3/14 prior to transfer to receiving Hospital via Emergency Medical Services (EMS) on 4/3/14 at 4: 45 AM.
This interview and documentation review further indicates the following:
? No communication was documented between the transferring facility (FMC) ED and receiving facility ED.
? No Physician Assessment and Certification Form for transfer was completed. The clinical record revealed an incomplete Transfer Form without the Staff/Physician name that informs Patient #1 of this potential risk of transfer. Additionally the date and time of being informed is omitted from the form with a blank line present.
? No evidence of the receiving facility having excepted Patient #1.
The Risk Manager acknowledges the absence of the transfer documentation.
The Risk Manager presented documentation that the facility is currently conducting a Corrective Action Plan that includes the following:
? Counseling to the Charge nurse, Physician and Nurses who were involved in the event.
? Online EMTALA education courses assigned to staff involved in the event and all current ED staff. Review of documentation presented revealed 30 of 67 ED staff had completed the on line training module and 37 are in process.
? Risk Management EMTALA presentation to the ED staff scheduled for in-services on 4/21/14.
? Creation of an EMTALA transfer Checklist posted by the ED work station and included in each Transfer packet.
? Ongoing education in daily and shift meetings with the ED Manager.
The corrective action plan is noted to be ongoing during this investigation survey.
In addition to the RM, six (6) staff interviews ( #6, #7, #8, #9, #10, and #11) were conducted throughout the day with the staff that have knowledge of the events concerning Patient #1 on 4/3/14 and were subsequently involved in the investigation of the ED transfer. The interviews included ED RN #6, CEO #7, ED Nurse Manager #8, ED Physician Dr L... #9, ED Medical Director #10, and ED night shift charge nurse #11.
An interview was conducted via telephone on 4/18/14 at 9:50 AM with the ED Physician (# 9) who provided care for Patient # 1 on 4/3/14. He verified that no communication occurred between FMC and the receiving Hospital prior to the transfer of Patient #1 on 4/3/14, and no risk vs benefit form or physician assessment and certification form was completed. He verified there was no documentation that the receiving Hospital accepted the transfer. He further stated that there were two codes in the ED and one stroke alert during the time Patient #1 was seen in the ED, and due to this, he instructed the staff to call 911 and transport Patient #1 to Receiving Hospital for obstetrical care. He further stated Patient #1 was stable at the time of transfer. Additionally the ED physician stated he was in-serviced on the EMTALA requirements after this event on 4/3/14 and currently fully understands the appropriate transfer protocol and his responsibility.
In a telephone interview with the Chief Executive Officer (CEO) (#7) on 4/18/14 at 1:55 PM she stated that she received a call from the CEO at the receiving Hospital on the morning of 4/4/14 informing her of the alleged EMTALA violation and she verified that no communication between FMC and the receiving Hospital occurred prior to Patient #1's transfer, and no medical record were sent to receiving facility with Patient #1. She stated that this was an unusual breakdown in process in this case and an isolated incident. She asked the team to research and complete an action plan "to make sure we have a process in place to prevent further occurrences".
An interview was conducted on 4/18/14 at 9:32 AM with the ED Nurse Manager (staff # 8). She verified that there was no communication between the sending or receiving facility prior to the transfer of Patient #1 on 4/3/14, no risk versus benefit or transfer form was completed, and no medical records were sent with Patient #1 at transfer.
An interview was conducted on 4/18/14 at 9:25 AM with the ED Medical Director (# 10). He confirmed that he was aware of the incident concerning Patient #1 and that she was transported by EMS to Plantation hospital on [DATE] without the appropriate ED Physician to Physician communication to the accepting facility, no completed physician certification or transfer form, and without the patient's medical records. Additionally the Medical Director stated, " I feel there was a miscommunication in this transfer event and the nurse thought it was like a transfer alert, and sent the patient without the Physician's further interactions and documentation. "
A telephone interview was conducted on 4/18/14 at 3:26 PM with the ED Charge Nurse who was on duty 4/3/14 (#11) who stated she is aware after the event that there was no communication between the transferring and receiving facilities, and no medical records were sent to the receiving facility with Patient #1. She further states that she was only in contact with Patient #1 for a few minutes, and did call the 911 services to transport Patient #1 to the receiving facility.
A telephone interview was conducted on 4/18/14 at 3:20 PM with the ED Nurse assigned to Patient #1 on 4/3/14 (staff #6) who stated she is not aware of any transfer documents concerning Patient #1 as she states she only did the Doppler ultrasound.
These interviews concurred that the facility did not communicate to the receiving facility and acknowledged that the Physician Assessment and Certification form was not completed for Patient #1, and that Patient #1's medical records were not sent to the receiving facility with the patient at transfer.
Each of the above staff stated they were in-serviced concerning ED access and EMTALA regulatory requirements, and that the facility has a system of online learning modules that they are to complete individually and a Transfer check-off list document has been developed to ensure the future transfers are conducted appropriately.
Further interview with the Risk Manager (RM) revealed the ED staff meet at change of shift and have daily staffings with the ED Nurse Manager (staff # 8), at which time the online EMTALA training is discussed. Per documentation so far, 30 staff have completed the training and 37 are in process (incomplete). This is for all non physician staff. Per interview with the ED Nurse Manager at approximately 3PM on 4/18/14, staff has until May to complete the training. The transfer checklist and documents needing to be completed is posted in the staff lounge as well as available for use for upcoming transfer situations.
Additionally the RM stated she will be presenting an EMTALA training commencing on 4/21/14 to ED staff, ARNPs (advanced registered nurse practitioners) and physicians.
The RM presented an e-mail from the ED Medical Director to administration relating his informal discussion with the ED Physician, Dr. L..., staff #9, concerning "the EMTALA situation" and Patient #1 and a formal discussion with Dr. L... and administrative staff to develop a process to avoid any future concerns. The email notes the " EMTALA Transfer checklist established and posted and discussion at huddles, EMTALA education in Process."
Per the RM, the ED Physician has been referred to Quality and they will decide how to proceed. A Peer Review Referral form dated 4/7/14 was reviewed relating to Patient #1, noting 31 week twin gestation female arrived with abdominal pain/cramping. transferred to receiving Hospital without appropriate EMTALA requirements.
The Transfer Checklist was reviewed as well as the Assessment and Certification form and Transfer Form that must be completed as noted on the checklist and in policy.
The evidence indicates the facility self-report and investigation concerning this alleged EMTALA violation on 4/3/14 were appropriately conducted, and the facility has in place a system and standard of Quality assurance evidenced in the review of Quality Assurance (QA) Committees, Medical Staff By-laws, Physician's Credentials, Staff personnel records, and facility policies and procedures related to emergency services and patient transfer. Additionally the facility has a current corrective action plan that includes ongoing training to ED Physicians and ED Nursing staff, QA committee review and auditing of ED records.