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Tag No.: A0043
Based on observations, interviews, and record reviews, the facility:
Failed to ensure that the medical staff was accountable for the quality of care provided to patients as evidenced in failure to insure that any individual providing patient care services is a member of the medical staff (refer to A-0049);
Failed to insure that evidence of current licensure, current training and professional education were available, maintained, and reviewed for 2 of 11 facility staff; representing themselves as either physicians or physician assistants (PAs), records reviewed. (Staff A & B) (refer to A-0341);
Failed to to protect patients right to confidentiality of medical record during emergency department (ED) visits to the hospital (refer to A-0147); and
Failed to protect patients right to privacy during emergency department (ED) visits to the hospital. (refer to A-0143).
The effect of these systemic practices resulted in the hospital's failure to have a consistent practice(s) related to assuring that any individual providing or representing themselves to provide patient care services was a member of the medical staff and the facility is found to be out of compliance with 42 CFR 482.12 - Condition of Participation: Governing Body.
Tag No.: A0049
Based on record review and interview, the facility failed to ensure that the medical staff was accountable for the quality of care provided to patients as evidenced in failure to insure that any individual providing patient care services is a member of the medical staff.
Findings:
Staff A ("A"), a seventeen year old, posed as an observer, a physician assistant (PA), PA student from 08/20/2011 to 08/28/2011, in the emergency department (ED) of the facility (on the night shift).
During an interview with the Chief Nursing Officer (CNO) on 09/07/2011 at 10 a.m., it was confirmed the facility was made aware of that "A" was in the ED posing as a PA student.
Interviews on 09/07/2011 at 10:15 a.m. and 09/08/2011 at 4:55 p.m. with ED physician (staff F), it was confirmed he met "A" on 08/08/2011 in the ED. "A" asked him if he could come to the ED as an observer and shadow him. He stated he told "A" to contact the ED Medical Director (staff C) for permission. He also asked "A" to write the Medical Director a note. He informed "A" that he would have to get clearance through the Medical Staff Office. He stated he had conversation with the Medical Director on 08/12/2011 and that both he and the Medical Director had told "A" to get the clearance and paperwork from the Medical Staff Office. He stated "A" was first observed in the ED on the night shift on 08/20/2011. He confirmed that "A" had a facility badge which indicated "A" worked for Surgical Management, a physician group, with a second badge which hung below the main badge with large letters "PA". He stated that all clinical staff in the ED such as physicians, PAs, and registered nurses had the second badge with MD, PA, or RN in large letters. The badges described were observed on clinical staff in the ED during the interview. He stated "A" told him he had the clearance but confirmed he did not ask for the clearance form and that "A" did not present the clearance. He stated "A" observed in the ED on 08/20, 08/21, 08/25, 08/26, and 08/27/2011 on the night shift. He stated that when "A" was with him, he observed and did not provide patient care. He did confirm "A" could observe care provide by ED staff and observe what staff was documenting in the patient record. He stated that he told "A" to work with the PAs in the ED on 08/25/2011 because he felt they could provide more information to "A". He stated he was not present with "A" when "A" was with the ED PAs.
During interviews on 09/07/2011 at 5 p.m. and on 09/08/2011 at 3:20 p.m. with staff C, the Medical Director of the ED, he stated he had met with "A" during the week of 08/12/2011. He stated "A" was requesting to do a clinical PA rotation. He stated he told "A" the ED no longer provided PA clinical rotations, but agreed to allow a one (1) day observation with physician F. He confirmed he told "A" to get clearance from the Medical Staff Office. He also confirmed he had not received any clearance from the Medical Staff Office.
Review of the credentialing files for PA student, staff A, did not show a credential file, and did not have a verification letter or notice related to an approval by the medical staff.
During an interview with the Director of Medical Staff Service on 09/08/2011 at 11:40 a.m., she confirmed that she had never met "A" and that the Medical Staff office had not received a request from "A". She did confirm that the badges for the medical staff, including medical doctors (MDs) and PAs were made in the Human Resources (HR)department. She confirmed that sometimes medical staff go to HR on their own. She stated that when that happens, the HR staff call the Medical Staff office for confirmation of their credentials. She stated that although this was the practice, there was no written policy for the practice. She could not provide any evidence documenting when it occurred.
During interview with members of the HR department, including the Vice President of HR (staff S), an HR generalist (staff Q), and HR Assistant (staff R), it was confirmed that "A" had received a courtesy badge when he stated working in the medical office located on the facility campus. The VP of HR confirmed that the facility provided the courtesy badges to allow physicians' office staff access to the hospital. She could not provide a policy concerning the practice and confirmed no background check or verification was completed on the staff who were not employed by the facility. The HR Generalist (staff Q) stated "A" came to HR on 08/24/2011 and asked to have his badge changed. She checked the system and found his name. She stated the original badge stated his name and under it "Surgical Management", which was the office practice where he worked. He told her he had a new position, PA. She confirmed she made the change in the system. She stated she was interrupted and did not print the badge. The HR Assistant (staff R) stated she did print the badge. She stated that it was the practice to give the second badge with the large letters "PA" to anyone receiving a PA badge but she could not recall if she gave him the second badge. The Vice President, Generalist, and Assistant all confirmed it was their practice to call the Medical Staff Office to verify credentials for PAs. They confirmed there was not a written policy concerning the phone verification, and that they did not document when they did call. Both the HR Generalist and the HR Assistant confirmed they did not call when they gave "A" the badge.
During an interview on 09/07/20111 at 6:15 p.m., ED PA (staff E) said staff "A" was in the ED during the week of August 24th 2011. He confirmed "A" had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirmed "A" had examined patients, assessed breath sounds, assisted in restraining a combative patient, and assisted in holding a pediatric patient who was being sutured. Staff E did confirm "A" had access to patient demographic and clinical information by watching other staff members enter information in patient records.
During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse, staff N, said the first time he saw PA student "A", was on 08/26/2011 at around 7 p.m. The ED charge nurse said "A" had access to view patient information and personal health information on screen while shadowing another staff member. The ED charge nurse also said "A" would also have had access to patient demographic information sheets and patient stickers. The ED charge nurse said he witnessed "A" performing ear examinations, eye examinations, neurological examinations, and listening to patients' lungs for breath sounds.
During a phone interview on 09/08/2011 at 1:45 p.m., the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.
During an interview on 09/09/11 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients "A" may have interacted with during the times he was present in the ED.
Tag No.: A0115
Based on observations, interviews, and record reviews, the facility:
Failed to inform two patients and/or patient representative of the patient's rights related to "An Important Message from Medicare" within two days of admission (refer to A-0117);
Failed to provide patient's with notification of the hospital grievance process (refer to A-0121);
Failed to provide one patient response to a filed grievance in a timely manner (refer to A-0122);
Failed to provide one patient with advanced directive assistance (refer to A-0131);
Failed to protect patients right to privacy during emergency department (ED) visits to the hospital. (refer to A-0143); and
Failed to to protect patients right to confidentiality of medical record during emergency department (ED) visits to the hospital (refer to A-0147);
The severity and effect of these systemic practices resulted in the hospital's failure to have a consistent practice(s) related to patient's rights throughout the hospital and the facility is found to be out of compliance with 42 CFR 482.51 - Condition of Participation: Patient Rights.
Tag No.: A0117
Based on observation, interview, and record review, the facility failed to ensure two of seven Medicare patients (#12 & 17) signed and received a copy of the "An Important Message from Medicare" document within two days of admission.
Findings included:
1. Patient #12, age 71, was admitted on 09/01/2011 with pneumonia. Review of the medical record documented the patient did not sign the document "An Important Message from Medicare" (MI) until 09/07/2011, six days after admission.
During an interview on 09/07/2011 at 10:35 a.m., the licensed practical nurse (LPN) said that normally the Medicare notification is signed and a copy is placed on the front of the patient's medical record. This is done by the registration department.
During an interview on 09/07/2011 at 11:30 a.m., the registered nurse (RN) case manager (staff KK) said case management provides the copy of the "Medicare Important Message" two days prior to the patient being discharged, not within two days of admission, has the patient sign, and places a copy on the medical record.
2. Patient #17, age 69, was admitted on 08/30/2011 for open heart surgery. Review of the medical record showed no copy of the "An Important Message from Medicare" within two days of admission. On 09/09/2011 at 11 a.m., the director of registration, staff DD, reviewed the electronic record, finding an entry of some unknown type of documentation dated 09/07/2011 but could not locate a signed copy of the "An Important Message from Medicare" in the patient's medical record. Staff DD said it is the responsibility of the registration coordinator to get the signed during the registration process.
During an interview on 09/07/2011 at 12:30 p.m., the registration coordinator said all patients sign the consent, receive patient right's packets, MI information sheet, and are asked about advanced directives at the time of admission. All signed copies are placed on the medical record. The process was changed, but not recently. The last change in process was about two years ago.
Tag No.: A0121
Based on record review and interview, the facility failed to provide patient's with notification of the hospital grievance process.
Findings included:
Review of the "Patient Information Guide" given to patients in the registration department at the time of admission showed on page nine the instructions for filing a complaint the following, "If you have a complaint regarding your care, please discuss it with the staff member most directly involved in your care. If you are unable to resolve it at this level then you may talk or write to the department director or follow the hospital grievance process." The patient information guide did not show any information explaining the hospital grievance process.
Review of the policy "Patient Grievance", dated as revised 08/2008, read that the procedure is as follows, "Patients and/or patients' representative are provided with information, at the time of admission about the Grievance process."
During an interview on 09/07/2011 at 12:40 p.m., the Patient Access supervisor (staff NN) said she was not sure where the written notice is located, "A lot of times the patients come back to the registration department and complain about care and services." Staff NN said she then refers the patient to the patient advocate.
Tag No.: A0122
Based on record review and policy, the facility failed to provide 1 of 5 patients response to a filed grievance in a timely manner (#20).
Findings included:
Review of the grievance filed by the husband of patient #20 showed a grievance filed on 08/17/2011 related to the patient complaining about an unknown observer during a cardiac catheterization procedure. Review of the letter of response to the patient showed it was dated 09/07/2011, twenty-one days later. The facility grievance policy read that response is expected to be within seven days.
Review of the policy "Patient Grievance", dated as revised 08/2008, read, "A written response will be provided on average a timeframe of 7 days when possible . . . . respond to the patient or their representative, upon receiving the grievance, to let them know that the complaint is being addressed and they will receive a follow up response once the investigation is concluded. Every effort will be made to respond within 7 days."
Tag No.: A0131
Based on record review and interview, the facility failed to provide 1 of 7 patients with advanced directive assistance in a timely manner (#13).
Findings included:
Review of the policy "Advanced Directives", dated as revised 08/2008, read that the procedure for a patient who desires to execute an advanced directive and asks for forms is to, "contact the Patient Advocate or Risk Manager. The patient Advocate or Risk Manager will provide the patient with a copy of the health Care Advanced Directives pamphlet provided by the State of Florida Agency for Health Care."
Patient #13, age 80, was admitted on 08/26/2011 with pneumonia. Review of the medical record review showed the patient has been in the hospital since 08/26/2011 and there is documentation patient #13 does not have an advanced directive. On 08/26/2011, the medical record read that the patient requested information for an advanced directive.
During an interview on 09/07/2011 at 11 a.m., the patient nurse advocated confirmed the medical record showed the patient's request for additional information related to advanced directives on 08/26/2011 but she has not yet consulted with the patient or family. The patient nurse advocate said she usually sees patients within one day of admission, but this patient had not been seen yet.
Tag No.: A0143
Based on interview and record review, the facility failed to protect patients right to privacy during emergency department (ED) visits to the hospital.
Findings included:
Staff A, a seventeen year old, posed as an observer, a physician assistant (PA) or PA student, from 08/20/2011 to 08/28/2011, in the ED of the hospital on the night shift. It is unknown how many patients he might have had contact with prior to discovery.
During an interview on 09/09/2011 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients staff A might have interacted with during the times he was present in the ED.
During an interview on 09/07/2011 at 6:15 p.m. ED PA (staff E) said staff A was in the ED during the week of August 24th 2011. He confirmed staff A had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirmed staff A had examined patients, assessed breath sounds, assisted in restraining a combative patient, and assisted in holding a pediatric patient who was being sutured. Staff E did confirm staff A had access to patient demographic and clinical health information by watching other staff members enter information in patient records.
During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse (staff N) said the first time he saw staff A was on 08/26/2011 at around 7 p.m. The ED charge nurse said staff A had access to view patient health information and personal information on screen while shadowing another staff member. ED charge nurse also said staff A would also have had access to patient demographic information sheets and patient stickers. ED charge nurse said he witnessed staff A performing ear examinations, eye examinations, neurological examinations, and listening to patients' lungs for breath sounds.
During a phone interview on 09/08/2011 at 1:45 p.m., the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.
Review of the credentialing files for staff A did not show a credential file and did not contain a verification letter or notice related to an approval by the medical staff.
Tag No.: A0147
Based on interview and record review, the facility failed to protect patient's right to confidentiality of medical record during emergency department (ED) visits to the hospital.
Findings included:
Staff A, a seventeen year old, posed as an observer, a physician assistant (PA) or PA student, from 08/20/2011 to 08/28/2011, in the ED of the hospital on the night shift. It was unknown how many patients he may have had contact with prior to discovery.
During an interview on 09/09/2011 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients staff A might have interacted with during the times he was present in the ED.
During an interview on 09/07/2011 at 6:15 p.m., ED PA (staff E), confirmed that Staff A was in the ED during the week of August 24th 2011. He confirmed staff member A had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirm staff member A had access to patient demographic and clinical information by watching other staff members enter information in patient records. He stated he did not observe staff member A enter information in the electronic records, but was observed to be writing information in a personnel notebook.
During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse, staff N, said the first time he saw staff A was on 08/26/2011 at around 7 p.m. The ED charge nurse said staff A had access to view patient medical information and personal information the computer screen while shadowing another staff member. Staff N also said staff A would have also had access to patient demographic information sheets and patient stickers.
Review of the medical record face (demographic) sheet showed the document would have a patient's social security number, date of birth, address, phone number, and insurance specific information included. The patient sticker has the patient's name, date of birth, and age included.
During a phone interview on 09/08/2011 at 1:45 p.m. the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.
Review of the credentialing files for staff A did not show a credential file and did not contain a verification letter or notice related to an approval to be a hospital observer or physician assistant or physician assistant student by the medical staff or staff A.
Tag No.: A0341
Based on record review and interview, the facility failed to insure that evidence of current licensure, current training and professional education were available, maintained, and reviewed for 2 of 11 facility staff representing themselves as either physicians or physician assistants (PAs) (staff A & B).
Findings:
Review of medical staff credentials did not provide evidence of ACLS certification for physician B from 02/23/2010 through 05/12/2010. The physician's privileges include requirement for current ACLS certification.
Interview with the Director of Medical Staff Services on 09/09/2011 at 11 a.m. confirmed that the privileges required ACLS and that the certification had expired on 02/23/2010 and was not renewed until 05/12/2010.
During and interviews on 09/07/2011 at 5 p.m. and 09/08/2011 at 3:20 p.m. with Staff C, the Medical Director of the ED, he stated he had met with staff A during the week of 08/12/2011. He stated staff A was requesting to do a clinical PA rotation. He stated he told staff A the ED no longer provide PA clinical rotations, but agreed to allow a one (1) day observation with physician F. He confirmed he told staff A to get clearance from the Medical Staff Office. He also confirmed he had not received any clearance from the Medical Staff Office.
Review of the credentialing files for staff A did not show a credential file, and did not contain a verification letter or notice related to an approval by the medical staff. During an interview with the Director of Medical Staff Service on 09/08/2011 at 11:40 a.m., she confirmed that she had never met staff A and that the Medical Staff office had not received a request from staff A. She did confirm that the badges for the medical staff, including medical doctors (MDs) and PA S were made in the Human Resources (HR) Department. She confirmed that sometimes medical staff go to HR on their own. She stated that when that happens the HR staff call the Medical Staff office for confirmation of the credentials. She stated that although this was the practice there was no written policy for the practice. She could not provide any evidence documenting when it occurred.
Interviews on 09/07/2011 at 10:15 a.m. and 09/08/2011 at 4:55 p.m. with ED physician F; confirmed he met staff A on 08/08/2011 in the ED. Staff A asked him if he could come to the ED as an observer and shadow him. He stated he told staff A to contact the ED Medical Director (staff C) to get permission. He also asked staff A to write the Medical Director a note. He informed staff A that he would have to get clearance through the Medical Staff Office. He stated he had conversation with the Medical Director on 08/12/2011 and that both he and the Medical Director had told staff A to get the clearance and paperwork from the Medical Staff Office. He stated staff A first observed in the ED on the night shift on 08/20/2011. He confirmed that staff A had a facility badge which indicated staff A worked for "Surgical Management", a physician group, with a second badge which hung below the main badge with large letters PA. He stated that all clinical staff in the ED such as physicians, PAs, and registered nurses had the second badge with MD, PA, or RN in large letters. The badges described were observed on clinical staff in the ED during the interview. He stated staff A told him he had the clearance but confirmed he did not ask for the clearance from and that staff A did not present the clearance. He stated staff A observed in the ED on 08/20, 08/21, 08/25, 08/26, and 08/27 2011 on the night shift. He stated that when staff A was with him he observed and provide no patient care. He did confirm staff A could observe care provide by ED staff and observe what staff were documenting in the patient record. He stated that he told staff A to work with the PAs in the ED on 08/25/2011 because he felt they could provide more information to staff A. He stated he was not with staff A when staff A was with the ED PAs.
Review of records and interview failed to confirm Staff A was involved in any invasive care.
Record review and interview confirmed " A " provided cardiopulmonary resuscitation (CPR) on one patient. Patient #2 arrived in the ED on 08/25/2011 at 3:04 p.m. She arrived by ambulance with CPR in progress. The record reflected that she had taken over 30 Hydrocodone pills. CPR was continued in the ED and she was successfully resuscitated at 3:12 p.m. with rhythm of Sinus Tach 136, B/P 68/43 was continued on ventilator. Between 3:34 and 7:19 p.m., the patient ' s heart rate was between 100 and 120, and was between B/P 88/60 to 100/62.
At 7:19 p.m., she went into ventricular fibrillation (V-Fib), and CPR was initiated. The patient was successfully resuscitated at 7:32 p.m. with Sinus Tachycardia. The vital signs from 7:32 p.m. until transferred to floor at 9:10 p.m. were Sinus Tachycardia 101-105 and B/P 87/40-113/68. The patient expired the next day 09/26/2011 at 5:30 p.m. The hematology consultation ' s clinical impression was Hydrocodone overdose, liver failure, coagulopathy, and severe anemia. She was critically ill with extremely poor prognosis.
There were no clinical issues with either case, care documented was consistent with current standards of practice. Interview with CNO 09/09/11 at 10 p.m. confirmed the records were accurate and the policies were operational.
During interview on 09/15/2011 at 9:15 a.m., physician SS, an ED physician, stated he recalled staff A was in the ED on the night of 08/25/2011, most of the time with PA staff D. Other than the code involving patient #2, he did not observe staff A providing any patient care. He confirmed staff A provided CPR during the Code on patient #2 on 08/25/2011. He stated that staff A was performing CPR correctly and that when he, staff SS assessed the pulse with a Doppler, the CPR was producing an effective femoral pulse.
During interview on 09/07/2011 at 7 p.m., staff Z, an ED nurse, stated he confirmed the police record that CPR was performed by staff A. A second interview was requested but the staff was unavailable.
A second interview on 09/15/2011 at 7:15 a.m. confirmed patient #2 was in the ED when he, staff Z came on duty at 7 p.m. on 08/25/2011. Staff Z was not assigned to patient #2 but went to the room when the respiratory therapist called him about 7:15 p.m. The patient had experienced a second cardiac arrest. Staff Z started CPR. Staff A relieved him at about 7:20 p.m. He stated that staff A continued CPR until the patient was successfully resuscitated.
During interview by phone on 09/15/2011 at 11 a.m. Staff VV, a respiratory therapist, confirmed staff A performed CPR on patient 2. Had no other contact with " A " .
During interview by phone on 09/15/2011 at 11:30 a.m., Staff D, an ED PA, confirmed staff A was in the ED on 3 nights. She confirmed he shadowed her and that when shadowing her, he watched her examine patients. She confirmed staff A had a hospital badge identifying him as a PA. She said staff A was also with MD staff F and PA staff E. She stated she did not observe staff A provide and care or complete any patient examinations.
Interview at 11:45 a.m. on 09/15/2011 with staff X, CNO, and staff W, the Director of Quality, confirmed that the facility did not have any evidence that staff A was certified in CPR.