The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|MEDSTAR SAINT MARY'S HOSPITAL||25500 POINT LOOKOUT ROAD LEONARDTOWN, MD 20650||Feb. 18, 2016|
|VIOLATION: MEDICAL STAFF - ACCOUNTABILITY||Tag No: A0049|
|Based on interviews with the Chief Medical Officer (CMO) and the Medical Director of Labor and Delivery (L&D) on 2/18/2016 and review of the Medical Executive Committee (MEC) documentation, the governing body was aware of the L&D and the General Operating Room (GOR) plan to utilize obstetrical technicians (OBTs) as surgical first or second assists for Caesarean -sections beginning August 2015. However the medical staff failed to ensure that quality of care had been provided to patients by allowing this plan to go forward without formal medical staff approval and without providing oversight of the process or patient outcomes.
The plan to use OBTs as surgical assists was mentioned in Medical Executive Committee (MEC) minutes in August and November 2015, but no documentation was provided confirming that this change in roles was approved by the medical staff. The CMO could not recall the content of the discussion about this issue mentioned in the MEC minutes for August and November, 2015. The Medical Director for L&D, interviewed on 2/18/16, recalled that the plan was initially presented in June of 2015 as an in-house training program that would be provided by the nurse educators of L&D and the GOR with content derived from the certified first assists in the GOR and the retiring L&D first assist. No information was found indicating that the medical staff had ever voted on or formally approved this role expansion for the OBTs.
During an interview with the CMO on 2/18/2016, the CMO stated that he became aware of L&D nurse's concerns about utilizing OBTs as surgical assistants the first week of January 2016. Meetings were held with the CMO, the interim CNO, and L&D staff to discuss concerns over this practice that had been occurring since August 2015. The CMO and interim Chief Nursing Officer (CNO) had made a decision to halt this practice on 1/20/2016, although medical record review confirms the practice continued until 1/29/16 when first assistants from the GOR could staff the L&D operating room (OR) for C-sections.
A review of the MEC minutes revealed no data or discussion about outcomes associated with this process after its implementation.
The failure of the medical staff and governing body to perform their due diligence by tacitly approving a plan to expand the role of a class of employees into supervised, yet invasive surgical assists led to a potentially unsafe situation in the L&D OR. Furthermore, the Medical Staff (MS) and Governing Body (GB) also failed to provide oversight into patient and staff outcomes. See Tag A0940 for additional information.
|VIOLATION: PATIENT RIGHTS: INFORMED CONSENT||Tag No: A0131|
|Based on interviews with staff and review of medical records, it was determined that the hospital violated the rights of women who underwent C-sections at the hospital to make informed decisions about their care by not informing them of personnel and role changes in the L&D OR. This was true for 16 of the 32 women who underwent C-sections between August 2015 and January 2016. Because the hospital failed to resolve scope of practice and training issues prior to implementing the role expansion for OBTs, patients received care from staff who were not trained in accordance with the hospital's training protocols for their C-sections without their knowledge.
Review of the operative section of the medical records revealed that OBTs are variously referred to as scrub techs, first assists, or second assists. For instance, staff D, in an interview on 2/17/16, stated that she had received " on-the-job " training as a scrub tech, and then in August, 2015, was told she was now a second assist. Review of the medical records revealed that staff D was listed as first assist on one C-section, second assist on two cases with no first assist, and a scrub tech on a fourth case. Staff E is listed in medical records as the second assist on four C-sections in which there was no first assist, and as a scrub tech on a fifth case. There is no evidence that patients were provided with an informed consent regarding who would be involved in their operative care.
|VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES||Tag No: A0283|
|Based on survey observations and staff interviews on 2/17/2016 and 2/18/2016, including the risk manager, and review of policies and training material for OBTs during C-sections, it was determined that hospital leadership had been aware of nursing staff concerns of OBTs functioning outside of their scope of practice, yet failed to develop and implement effective quality assurance (QA) oversight or interventions to ensure that staff were functioning within the confines of their licenses or certifications. The hospital also failed to ensure that nursing staff felt safe enough to report serious patient safety concerns. The findings include:
In interviews on 2/17/16 and 2/18/16, Staff A and Staff C, both nurses and charge nurses on the L&D unit, stated that nursing staff had concerns over CNAs (OBTs) functioning as first assistants during C-section. Registered nurses feared that OBTs were performing duties beyond their scope of practice, felt that the training received to work as first assists was inadequate, and stated that some nursing staff were "made" to work in roles in which staff had not worked in years. Staff A stated "Staff would complain to me as charge, so I reported those concerns to [the Director]. [The Director] is not approachable. We (other unit nurses) have been reporting our concerns for months to [the Director] and she did nothing to address our concerns." Staff C confirmed in a separate interview that she had also approached the unit director with concerns about the training and scope of practice of the OBTs but had been told that the practice would continue. Staff C had also stated that she was instructed by the unit director that she would have to perform the role of a first assistant for a C-section on a day when both scheduled OBTs had called out sick. Staff C told the Director that she had not "scrubbed in" in over 10 years and had no current competencies or recent training and was not comfortable working as an assistant. According to Staff C, the director informed Staff C that she would have to perform the role that day due to call outs. Staff C also stated she felt the director was "unapproachable" and felt that the L&D nurses' concerns never went beyond the Director. Staff C stated she feared that she would be fired if she escalated concerns over the director's head.
In an interview on 2/17/16, the unit director stated that she had first become aware of the concerns of the nurses in January 2016, after the nurses had complained to the hospital risk manager. Interview with the risk manager on 2/18/2016 confirmed that Staff C did in fact call her at home in January to report her concerns about the OBTs working as assists, the training process, and fear that the unit director was not escalating the nurse's concerns to hospital leadership. The risk manager requested that the L&D nurses meet with the CMO. A meeting was held immediately with Staff A, Staff C and the CMO to discuss nursing staff concerns in the L&D unit.
During the interview with the interim CNO and L&D Unit Director on 2/17/2016, neither could confirm if the previous CNO had verified that utilizing OBTs as surgical assists for C-sections was within their scope of practice prior to starting training and implementing this practice change.
Review of QA surveillance and reporting data revealed no evidence that the quality department had been involved in implementing staffing job description changes, in overseeing the education provided to assists, or had requested or been receiving any additional feedback about outcomes including the newborn ' initial assessment (APGARS) or the surgeons' feedback on the OBT assists training or performance.
Failure of the QAPI department and quality committees to proactively identify potential risks of the new role expansion for OBTs, including scope of practice issues, and then failure to provide QAPI oversight of the patient and staff outcomes placed patients at risk of harm. Failure to clarify and define the role confusion between the physicians and the OBTs about who was qualified to do which tasks, potentially jeopardized patient safety. In addition, the failure to follow-up on the new process in the L&D OR meant that errors and harm might have gone unreported due to the perceived punitive atmosphere on the L&D unit that caused nurses to fear reporting serious concerns.
|VIOLATION: NURSING SERVICES||Tag No: A0385|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
Based on staff interviews, review of medical records, educational tools, personnel records and other pertinent documentation for nursing services, it was determined that the hospital failed to delineate responsibilities for patient care in the Labor and Delivery (L&D) Operating Room that was within the scope of practice for certified nursing assistants (CNAs). The hospital also failed to provide administrative and QAPI oversight of a process that expanded the job duties of L&D CNAs into an invasive surgical assistant role. The nursing services at the hospital failed to confirm with the licensing and certification agency (Maryland Board of Nursing, MBON) that this expanded role was within the CNA scope of practice prior to implementing the expanded scope of work, and failed to monitor patient and staff outcomes.
Review of emails between the Nurse Director of L&D and the previous CNO/VP (Vice president) of Nursing dated 6/5/2015 indicate that the current first assistant was due to retire in August 2015, leaving a " gap for first assist. " In this email the Director stated to the CNO that the General operating room (GOR) would not be able to provide a full time first assist on weekdays and to fill that position the Nurse Director of L&D and the Nurse Director of Surgery wanted to educate the OBTs to perform the first assist duties. The email further states that most of the OBT scrub techs already fill in when the on-call first assist from the GOR is in another case or when a STAT section (emergency C-section) is called and the team can't wait for the first assist to arrive. The Nurse Director of L&D stated in this email that OBTs would "only be educated on how to retract tissues in the surgical field with instruments, apply downward pressure on the uterus to help expel the fetus from the uterus (fundal pressure), milk the umbilical cord to obtain cord blood, and cut sutures as directed by the surgeon." The previous CNO, who resigned in December 2015, approved of this plan.
A total of 44 randomly selected L&D medical records were reviewed and of those records 32 patients were identified who underwent a Cesarean Section (C-section) from 4/1/2015 through 2/17/16. Of the 32 patients that received cesarean sections, 16 were performed with the use of OBTs without appropriate training and by staff likely functioning outside of their CNA scope of practice.
Hospital job descriptions differentiate between the scrub techs and the first and second assists thusly: The scrub techs prepare the patient and the instruments on the sterile field. They will hand instruments to the surgeons, but do not touch the surgical field or the patient once the procedure is underway. The hospital uses first and second assists interchangeably and these staff use retractors to hold open the surgical field. They may use tools or sponges to control bleeding, and generally assist the surgeons with tasks within the incision or surgical field. Review of the job description for obstetrical technicians (OBTs) lists Maryland Nursing Assistant certification (CNA) as a job requirement and states that the OBTs would be trained and expected to perform the role of surgical scrub technician for cesarean sections and other surgical procedures performed in the L&D OR. This job description does not specify that an OBT may or may not perform any of the intraoperative tasks inherent in the OB surgical assistant role, for instance, assisting the surgeon with electrocautery and sutering, and applying dressings at the close of the case.
During an interview on 2/17/2016 with the L&D Nursing Director and the new interim CNO, they were asked if they could present documentation about the research performed prior to initiating this new role for OBTs as surgical assists and also to provide documentation that this practice had been confirmed as being within the scope of practice for the OBTs. No documentation was provided during the survey except for the 6/5/15 email between the previous CNO and the Nursing Director for L&D. In addition, while the plan to use OBTs as surgical assists was mentioned in Medical Executive Committee (MEC) minutes in August and November 2015, no documentation was provided confirming that this change in roles was approved by the medical staff. The Medical Director for L&D, interviewed on 2/18/16, recalled that the plan was initially presented as an in-house training program that would be provided by the nurse educators of L&D and the GOR.
When reviewing the L&D unit-based personnel files, it was difficult for the surveyors to validate the training and competency of any of the OBTs due to the disarray of the files. After taking one hour to identify the training and competencies of three OBTs, the hospital was unable to find the competency checklist for one employee, staff D.
Review of the 'Second Assisting Competency' skills validation tool for Staff H dated 9/27/15 and Staff E (both OBTs) dated 1/14/2016 lists Staff B (a contracted temporary employee who started working as a certified scrub technician at the hospital on [DATE]) as the staff person who educated, monitored, and validated the competency for Staff H and Staff E. Staff B is not a certified first assistant. The skill validations for Staff B to function as a scrub tech, as well as teach the role of 2nd assists, could not be produced by the Nurse Director of L&D. Neither Staff B's job description as a scrub tech or personnel file indicated that Staff B had been hired to provide education to staff who are to function as a first or second assist for C-sections. In addition to being a temporary contracted employee, Staff B had only worked in the hospital for three weeks before he/she starting training the OBTs on an expanded intraoperative role that Staff B was him/herself unqualified (by hospital policy) to perform. This finding was confirmed with the hospital risk manager on 2/25/16.
During interviews with the Chief Medical Officer (CMO) on 2/18/2016 and 2/23/16, the CMO could not recall the content of the discussion about this issue mentioned in the MEC minutes for August and November, 2015. According to the CMO on 2/23/16, the practice of utilizing OBTs as surgical assists ended on 1/29/16 after the hospital received a complaint from their accreditation organization.
The L&D Medical Director, in an interview on 2/18/16 stated that the assistants mainly retract tissues, suction the surgical field, and apply fundal pressure. He further stated that some of the OBTs are better than others at retracting tissue without damaging it, and at applying the right amount of force or pressure to the fundus to assist with the delivery.
Failure of nursing leadership to ensure there are sufficient numbers and types of appropriately trained and certified or licensed nursing staff to respond to the intraoperative nursing needs and care of the surgical L&D patient population and to provide the appropriate education and training within the employee's scope of practice placed patients and their newborns at risk for injury or death. Further due to the state of the personnel files it was difficult for the surveyor to understand how hospital staff could validate the training and competencies of their own staff. In addition, the apparent complicity of all levels of the organization in implementing a plan to cover the retirement of one staff person by inappropriately expanding the roles of a category of staff while having an unqualified person train these staff in their new tasks ,nursing supervision abdicated their responsibilities for ensuring patient care met minimal standards and that nursing staff had the training and competencies to perform their duties.
See also Tag A0049, and A0940
|VIOLATION: SURGICAL SERVICES||Tag No: A0940|
|Based on staff interviews, review of policies and procedures and other pertinent documentation it was determined that the hospital failed to manage the staffing and organization of the obstetrical surgical services in such a manner that ensured the health and safety of its patients. Specifically, the hospital failed to ensure that appropriate standards of practice were followed in the L&D operating suite, failed to ensure that the same standards, policies, and training used in the GOR applied to the L&D OR, and failed to require cooperation between GOR and the L&D OR staff. See Tags A0941 and A0943|
|VIOLATION: ORGANIZATION OF SURGICAL SERVICES||Tag No: A0941|
|**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**
A random selection of 44 L&D medical records were reviewed during the survey and of those records 32 patients were identified who underwent a Cesarean Section (C-section) from 4/1/2015 through 2/17/16. Based on this review, along with interviews of staff, it was determined that of the 32 cesarean sections, 16 were performed utilizing inappropriately trained surgical staff and/or by staff functioning outside of their scope of practice. In addition, interviews indicated that when staff or physicians requested qualified personnel from the GOR, they were often met with a non-collegial attitude and a reluctance to help by the GOR staff.
Review of emails between the Nursing Director of OB and former CNO dated 6/5/15 outlines "First Assistant Solutions," which was in response to a full time OB First Assistant retiring and First Assistant staff being unavailable to assist in C-sections. This document indicated that the General OR (GOR) would not be able to assist with the short staffing in L&D for the First Assistant position. The solution was to train and educate Obstetrical Technicians (OBTs) to the first assist duties. According to this document, the OBTs who serve as scrub technicians have filled in when the first assist from surgery (GOR) is already in a case in the GOR or when a stat C-section (an emergency C-section) is called and the team can't wait for the first assist to make it to the hospital. The plan indicated that the OBTs would be "trained to retract with instruments, apply fundal pressure, milk the umbilical cord, and cut sutures as directed by the surgeon." This plan to educate and train OBTs as surgical assistants had been approved by the former CNO of the hospital on [DATE].
Interviews with three first/second assist staff (staff D, E, and H) were completed on 2/17/2016. Staff B, a certified scrub tech, was also interviewed on that date. Staff B was a contracted temporary OB scrub tech since 9/9/2015. Nursing staff interviewed on 2/17/16 also included Nurses A and C. All confirmed that Staff B trained the OBTs in the role of second assisting.
Staff D was an OBT, and recently was trained by Staff B to the role of first assistant for C-sections. During the interview with Staff D on 2/17/16, Staff D stated that he/she received "on the job training" to retract tissue, push the baby on top (fundal pressure) to assist delivery, suction, maintain sterile field, hand the doctor instruments, help with counts, apply pressure to bleeding vessels (hemostasis) and cut sutures when asked by the doctor. Staff D also stated that she was educated and her skills were validated, by Staff B, the certified scrub technician. Staff D was asked if she had had concerns about this new role as assist and she replied "I did for about a week after it started, about the role, the pay, and my license if I could do this. We were told we had to do this. But now we only scrub, no more assist work."
Staff E, an OBT, was interviewed on 2/17/16. Medical record review identified that Staff E participated in 5 of the 32 C-sections previously identified from 11/23/15 through 1/18/2016. Staff E stated she was hired on 10/12/15. She was then asked to describe her training for the second assist and scrub technician roles. "There really wasn't formal training or specific tools for second assist. " Staff E was provided a copy of the didactic training PowerPoint 'Second Assisting during a C-Section' used to educate L&D staff to the role of second assist. This training had been developed by the GOR and L&D staff. Her response was that she "had not ever seen that power point before." When asked "How did you learn the role?" Staff E indicated that he/she had observed Staff B for a case, then scrubbed in for a case with Staff B, and after that, was independent. Staff E stated she/he had previous training to the role of scrub technician from previous employment and was comfortable in that role. Staff E was then asked to describe the difference between her job duties as a first or second assist that is different from scrub tech. Staff E stated that as an assist, she would hold sutures, apply fundal pressure, suction, and retract for the doctor. Staff E then confirmed that she had been working independently as a scrub tech and/or a first or second assist since December 2015. Staff E stated that she and Staff B signed off on her competency checklist a few weeks after she started working independently. The competency checklist was signed on 1/14/16.
The 'Second Assisting during Cesarean Section' Education PowerPoint, made by The General OR First Assist/Educator indicated that the first and second assists are OBTs with special training to assist during C-sections. This training for OBTs lists assisting the surgeon with draping of the patient, holding tension on skin for the surgeon to make incision, hemostasis (stopping bleeding or oozing) with laparotomy sponge, placing the Medium Richardson (retractor) in the proximal flap of the wound, placing and removing a Kocher's (hemostatic forceps) on the proximal side of the fascia (skin), placing a bladder blade (to protect the bladder while the surgeon incises the uterus), applying pressure to the fundus after removal of the retractors, and clamping and 'milking' the umbilical cord. The assistant may also be asked to hold the uterus with a laparotomy sponge if the uterus is sutured outside of the abdomen. The assistant also is taught to 'pull up on each stitch after each row ' while the surgeon sutures. These tasks are not typically within the scope of practice for a CNA.
Several L&D staff, in interviews on 2/18/16 complained that when they would call the GOR to request a qualified assist, the staff in the OR generally answered with "Don't you have techs up there?" Staff A stated that he/she had witnessed physicians requesting scrub techs or assists and being turned down by the GOR. Interviews confirmed that the hospital had only one GOR team on call at any time, so if that team was busy in the GOR, there were no back-ups available to the L&D OR. The L&D physician interviewed on 2/18/16 stated that while the L&D surgeons have the option of requesting a qualified first assist from the GOR, in practice the GOR either refuses due to staffing or the first assist is not available for several hours.
The failure of the hospital to apply appropriate surgical standards to all areas and services within the hospital that provide surgery left L&D patients and their infants at risk for injury or death.
|VIOLATION: OPERATING ROOM SCRUB NURSES||Tag No: A0943|
|Based on interviews with L&D nurses on 2/18/16, it was determined that nurses frequently functioned as RN first assists in the L&D OR even after self-identifying as unqualified to provide immediate assistance to the surgical team. The hospital also failed to ensure that nurses who had to function as scrub techs or surgical assists had updated or refreshed skills and competencies.
Staff A, interviewed on 2/18/16, stated that almost all of the RN L&D staff have been cross-trained in circulating and that some of the nurses have not scrubbed in to a case in over 10 years and were very uncomfortable being placed in the scrub tech role without having had interim skills refreshers or competency testing. Staff C, also interviewed on 2/18/16, stated that it had been over 10 years since he/she had scrubbed in to a case and when Staff C expressed misgivings to the Unit Manager, Staff C was told she "had to" scrub in as scrub tech because both OBTs had called out sick on that day. This information was validated during an interview with a physician on 2/18/16, who said that nurses who had not had a scrub role in years, with no updated competencies or training, were being "forced" to scrub in as first assists for C-sections.
The failure of the hospital to ensure that nurses were functioning within their skill sets in surgical settings, again, placed patients at risk.