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.
|SSM HEALTH ST MARY'S HOSPITAL - ST LOUIS||6420 CLAYTON RD RICHMOND HEIGHTS, MO 63117||May 25, 2016|
|VIOLATION: CONTRACTED SERVICES||Tag No: A0083|
|Based on interview, record review, and policy review, the facility's Governing Body failed to ensure that the facility wide Quality Assessment and Performance Improvement (QAPI) Plan for 2014, 2015 and 2016 was approved and included quality measures based on high risk, high volume and problem prone areas including all clinical contractual services. The Governing Body failed to ensure that the contracted services of the Hemodialysis (a medical procedure to remove fluid and waste products from the blood) Unit and the Organ, Tissue and Eye Procurement Program (organ, tissue or eye cornea, the clear front part of the eye, transplant) were in substantial compliance. This failure had the potential to cause inadequate patient care monitoring and poor patient outcomes. The adult facility census was 300 and the pediatric facility census was 149.
1. Record review of the facility's policy titled, "Performance Improvement and Patient Safety (PIPS) Plan - 2016," dated 11/2015, showed that the program required collaborative participation from appropriate services, clinical and non-clinical, including services provided by contractors. The Board of Directors (Board) was responsible and accountable for annual approval of the PIPS Plan.
2. During an interview on 05/19/16 at 8:50 AM, Staff V, Patient Safety Quality (PSQ) Coordinator, stated that the 2016 PIPS plan was not scheduled to be reviewed by the Board of Directors until 07/2016.
During an interview on 05/19/16 at approximately 2:00 PM, Staff T, Regional Director of PSQ, stated that the PSQ Plan for 2016, including contractual services, had not been approved by the Board of Directors.
During an interview on 05/25/16 at 10:00 AM, Staff B, System Manager of Clinical Excellence and Patient Safety, stated that the Annual QAPI Plans for the last three years (2014, 2015 and 2016) had not been approved by the Governing Board.
|VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES||Tag No: A0283|
|Based on observation, interview, record review and policy review, the facility failed to identify opportunities for Quality Assessment and Performance Improvement (QAPI) and to implement changes that would lead to improvement in the high volume, high risk, and problem prone areas of:
- The Dialysis (Hemodialysis is a medical procedure to remove fluid and waste products from the blood) Unit, a contracted clinical service;
- The Organ, Tissue and Eye (an organ, tissue or eye cornea, the clear front part of the eye, transplant) Procurement program, a contracted service; and
- The Important Message From Medicare, a document required for all patients receiving Medicare services.
These failures could potentially lead to worsened medical conditions, death or violation of patients' rights.
The adult facility census was 300 and the pediatric facility census was 149.
1. Record review of the undated Dialysis Unit document titled, "Year 2015 Trend for Acute Treatments," showed the total number of patients dialyzed for the year was 3,297. The high volume unit is necessary to provide Dialysis treatments for inpatients diagnosed with renal (kidney) failure or chronic kidney disease. Patients required to undergo Dialysis often have been hospitalized for other reasons.
2. Record review of the document from Medscape, a health professional network, titled, "Starting Dialysis is dangerous," dated 05/31/16, stated that one of the highest risks to patients receiving dialysis is, "Risks of all forms of infection are many times higher once the patient is started on dialysis. Patients on dialysis are 100-fold more likely to develop methicillin-resistant Staphylococcus aureus septicemia (MRSA is a bacteria that is resistant to many antibiotics. Staph and MRSA can cause a variety of problems ranging from skin infections and sepsis to pneumonia to bloodstream infections) than the general population and 800-fold more likely than if not dialyzed with a native arteriovenous fistula (Hemodialysis fistulas are surgically created access ports between the native artery and vein in an extremity). Exposure to hospital-acquired infection is often just a component of the myriad of dangers associated with the increased amount of in-patient care. Others (risks) might include exacerbation (worsening) of malnutrition, hypostatic pneumonia (congestion due to the stagnation of blood in the dependent portions of the lungs in old persons or in those who are ill and lie in the same position for long periods), falls, and venous thromboembolism (blood clot) risk."
3. Observations on 05/16/16 at 3:15 PM showed four patients (#3, #45, #46 and #47) in the Dialysis Unit in the Dialysis treatment process. The Dialysis unit is one large room and the patients are within close proximity to each other and the nursing staff. There were curtains that could be pulled around the beds but no curtains were pulled between or around the beds. There were also no real (walls or private rooms) or 'perceived' barriers (such as tape on the floor to define an area) to identify each patients space.
4. Observation on 05/16/16 at 3:15 PM showed Patient #45 in bed one, Patient #46 in bed three, Patient #47 in bed four, and Patient #3 in bed two. The sign at the end of the bed for Patient #3, stated that she was in CONTACT ISOLATION (used to prevent the spread of diseases that can be spread through contact with open wounds).
5. Record review of the History & Physical (H&P) for Patient #46 and Patient #47 showed they both had wounds on their lower legs and/or feet.
6. Record review of Patient #3's H&P showed she was diagnosed with Resistant Acinetobacter baumannii (referred to as ACB, is an opportunistic pathogen, which is an agent that causes infection, affecting people with compromised immune systems, and is becoming increasingly important as a hospital-derived infection). The H&P also showed Patient #3 had wounds on her feet.
During an interview on 05/16/16 at 3:50 PM, Staff AA, Director of Clinical Services and Dialysis stated that a patient with Resistant ACB should not be in the Dialysis Unit and should have been dialyzed in her room. He stated that the facility had no means to alert staff what pathogen a patient had and there was no signage in use to alert visitors, staff or other patients that the patient had a highly infectious condition.
During an interview on 05/18/16 at 10:00 AM, Staff AA stated that the QAPI project for the Dialysis Unit was improved hand hygiene. He stated that he observed staff and monitored the hand hygiene and glove use. He stated that the current hand hygiene compliance was 80 percent. He stated that hand hygiene performance had not been reported to the QAPI Committee in 2016.
The facility failed to focus on the risk of possible exposure to an infectious disease for all patients with compromised immune systems, in the dialysis unit. The facility also failed to use collected data of hand hygiene to identify opportunities to implement changes that could lead to improvement in the high volume, high risk, and problem prone area of Dialysis.
7. Record review of the facility's policy titled, "Organ and Tissue Donation," revised 08/2013, showed the following:
- The Organ Procurement Organization (OPO, non-profit organization that is responsible for the evaluation and procurement of deceased -donor organs for organ transplantation) will determine suitability based on established criteria.
- An OPO representative will speak with the family about organ donation.
- Contact with the family, by the OPO, should be documented by facility staff in the medical record with donation eligibility noted.
8. Record review of the facility's document titled,"Organ and Tissue Recovery Agreement," dated 01/15/15, showed the following:
- The donor hospital will provide timely organ referrals to the OPO of all imminent deaths by notifying the donor hotline.
- Timely notification of referrals to the OPO is defined by the facility/vendor agreement as within one (1) hour of the imminent death, cardiac death, and prior to withdrawal of mechanical support.
- Referrals are made timely so that an on-site evaluation can be conducted by the OPO to determine the medical, legal and behavioral suitability of the referral.
- Donor hospitals' staff shall not rule out any patients as potential donors.
9. Record review of the US Department of Health & Human Services document titled, "Organ Procurement and Transplantation Network (OPTN)," dated 05/31/16, showed the number of waiting list candidates for Organ, Tissue and/or Eye donations are currently 120,693.
10. Record review of the facility's document titled, "Death to Referral Time," dated 2016 showed the following percentage of cases reported in under the required 60 minutes:
- January 62%;
- February 65%;
- March 75%; and
- April 86%.
During an interview on 05/18/16 at 10:10 AM, Staff B, System Manager of Clinical Excellence and Patient Safety, stated that the percentages for cases reported in a timely manner had improved for the year.
During an interview on 05/18/16 at 2:00 PM, Staff V, Patient Safety and Quality (PSQ) Coordinator, stated that she was not aware of any activities for improvement of the OPO timely referrals. She stated that it was the responsibility of someone else and that the current compliance percentages had not been reported to the Board of Directors in 2016.
The facility failed to use the collected data to identify opportunities to implement changes that could lead to improvement in the notification of referrals to the OPO.
11. Medical record review of the Important Message from Medicare Letters (IMM- notice to patients that described their discharge rights), from 05/16/16 to 05/18/16 showed that Patients #23, #24, #45, and #46 had a note written on the Patient or Representative signature line that indicated, "patient was unable to sign due to condition," and Patients #20 and #27 indicated, "verbal consent," on their signature line.
12. Record review of the facility document titled, "Delivery of the IMM," dated 09/03/2013 showed that:
- The IMM must be delivered to the enrollee in person;
- Registration must deliver the IMM to the patient at or near the time of admission; and
- If a patient is unable or refuses to sign the IMM, registration will note this.
During an interview on 05/18/16 at 2:20 PM, Staff CC, Manager of Patient Access (Registration), stated that he was not concerned that there were many admissions where the patient was not able to sign or gave verbal consent that they understood the IMM. Staff CC stated that there was not a process to follow up to determine if a patient could sign the document after the initial "unable to sign/verbal consent" comments were entered. Staff CC stated that he did not monitor for trends to determine if some registration staff had disproportionate numbers of "unable to sign" than others. Staff CC stated that there were "corporate" audits done for each registration staff members on the IMM. Staff CC stated that the auditors checked ten records a month for every registration staff member and he received a copy of those reports.
13. Record review of facility's undated policy titled, "Registration Policy Review," showed a list of items that will be audited for registration staff that included, "Patient Rights- IMM for Medicare and Medicare HMO's," (Health Maintenance Organizations- a type of medical insurance). The policy showed that five random registrations per user, per month would be audited. If the user has done less than five registrations that month, 100% of their work would be audited.
During an interview on 05/18/16 at 4:15 PM, Staff CC stated that he was not able to print the audit reports but he had his laptop with the electronic files of the audits. Staff CC opened the file and clicked on 12 random names of his registration staff files in succession. Each file showed N/A (Not Applicable) on the line item, "Patient Rights-IMM for Medicare." Staff CC stated, "I guess we're not auditing them anymore." Staff CC stated that he had 66 registration staff members.
The facility failed to collect IMM data, for this high volume area, to identify opportunities to implement changes that could lead to improvement for Medicare recipients regarding discharge rights.
|VIOLATION: QAPI PERFORMANCE IMPROVEMENT PROJECTS||Tag No: A0297|
|Based on interview, record review and policy review, the facility failed to ensure that Quality Assessment Performance Improvement (QAPI) projects (assessment conducted of a patient care problem through peer analysis, intervention, resolution of the problem, and follow-up) reflected the complexity and scope of services provided, including those provided by contract. This failure had the potential to affect all patients and prevent the facility from having an effective QAPI Program. The adult facility census was 300 and the pediatric facility census was 149.
1. Record review of the facility's policy titled, "Performance Improvement and Patient Safety (PIPS) Plan - 2016," dated 11/2015 showed:
- Annually the entity (facility) determined the number and scope of distinct quality and safety improvement priorities and projects.
- The projects were documented, including the reason for conducting them and the measurable progress achieved. The frequency and detail of data collection was approved by the Board of Directors (Board)
- The entity set priorities for its performance improvement activities that focus on high risk, high volume, and problem prone areas.
2. During an interview on 05/18/16 at 10:00 AM, Staff AA, Director of Clinical Services and Dialysis, stated that the Performance Improvement (PI) project for the Dialysis Unit was improved hand hygiene. He stated that he observed staff and monitored the hand hygiene and glove use. He stated that the current hand hygiene compliance was 80 percent. He stated that hand hygiene performance had not been reported to the QAPI Committee in 2016.
3. Record review of the undated document titled, "2016 Department Plan," for the Dialysis Unit showed that 10 hand hygiene observations per month were completed in 2016 with a compliance percentage of 80 percent.
The facility performed 1123 dialysis procedures from 01/01/16 to 04/30/16 which averages approximately 281 dialysis treatments per month. The 10 hand hygiene QAPI observations are not representative of the scope and complexity of the unit.
During an interview on 05/19/16 at 8:50 AM, Staff V, Patient Safety and Quality Coordinator, stated that she could not provide a list of 2016 Board approved PI projects for clinical services.
After several requests to submit documentation to verify substantial compliance for the facility-wide QAPI Program and the scope and services provided to patients, verification could not be provided by the facility. The Annual QAPI Plan had not been approved by the Board, therefore the number of distinct improvement projects were not approved by the Board.
|VIOLATION: INFECTION CONTROL||Tag No: A0747|
|Based on observations, interviews, record reviews and policy and procedure reviews the facility failed to have a systemic practice in place to prevent the following:
- A patient with known colonization (carrier of a germ but not showing signs and symptoms) with Resistant Acinetobacter baumannii (referred to as ACB, an opportunistic pathogen, which is an agent that causes infection), affecting people with compromised immune systems, and becoming increasingly important as a hospital-derived infection) was improperly transported and dialyzed in the Dialysis (Hemodialysis, a medical procedure to remove fluid and waste products from the blood) Unit. This failure was a breach of facility policy and procedure and exposed other patients, staff and visitors to the infectious agent. (A-0756).
The facility also failed to ensure staff:
- Properly wore surgical masks with visors when vascular access (a surgically created vein used to remove and return blood during Hemodialysis) lines were removed after a dialysis treatment (A-0749).
- Performed hand hygiene (wash hands with soap and water or use hand sanitizer) before putting on gloves or between glove changes (A-0749).
- Performed hand hygiene and changed gloves after touching a contaminated inanimate object and prior to touching the patient's bed linens, medications and cell phones during medication administration (A-0749).
-Properly followed sterile technique for a Central Venous Catheter (a catheter placed into a large vein) dressing change (A-0749).
The adult facility census was 300 and the pediatric facility census was 149.
The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.42 Condition of Participation: Infection Control. The facility was culpable (accountable and responsible) in that it had identified 28 patients with Resistant ACB in 2016 and failed to report the safety issues to administrative leadership, educate staff or to put procedures in place to prevent transmission.
Subsequently the situation constituted a condition of Immediate Jeopardy (IJ) which placed all patients of the facility at risk. The facility provided an acceptable plan of correction (POC) and implemented corrective actions to abate the IJ on 05/25/16 to prevent further risk to patients. The POC included:
- Notification to the treating nephrologist (physician who specializes in kidney care and treating diseases of the kidneys) of the patients that were exposed in the Dialysis Unit;
- Development and immediate approval of a new policy and procedure for the management of actual and/or potential infectious disease exposures.
- Development and implementation of new signage so patients with actual and/or potential infectious disease are immediately identifiable as to isolation and transport requirements.
- Staff Education beginning 05/25/16 for all staff in all departments before their next scheduled shift as to the new policy, new signage, modified hall passes, electronic health record and personal protective equipment (PPE), hand hygiene and glove use. Education will continue until 100% of all employees are educated before their next scheduled shift.
- Daily surveillance by Infection Control prevention;
- Daily drills by Department Directors or designee; and
- All corrective actions will be documented with the Interim Vice President of Nursing as the responsible person.