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AU MEDICAL CENTER 1120 15TH STREET AUGUSTA, GA 30912 July 13, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
Based on medical record review, facility policies, and staff interviews, the facility's Governing Body failed to ensure nursing care services were administered in a safe and effective manner for one (1) Patient #1, which resulted in the death of the patient.

Findings:

Cross reference A0385 as it relates to the failure of the facility to provide nursing care and services in a safe and effective manner.
Cross reference A0115 as it relates to the failure of the facility to protect and promote each patient's rights.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on medical record review, facility policies, and staff interviews, the facility failed to maintain a patient's right to receive care in a safe setting, for one (1) patient (#1), which resulted in the death of the patient.

Findings:

Cross reference A0385 as it relates to the failure of the facility to provide nursing care and services in a safe and effective manner.

Cross reference A0043 as it relates to the failure of the governing body to ensure that the protect and promote each patient's rights.
VIOLATION: NURSING SERVICES Tag No: A0385
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on a review of facility's policies, patient records, staff and patient interviews and observations during a facility tour, it was determined that the facility failed to implement an effective system for the safe preparation and administration of medications resulting in the death of Patient #1. The patient died as a result of receiving medication that had been mixed in the solution.

Findings:
Cross reference A0043 as it relates to the failure of the governing body to ensure that they protect and promote each patient's rights.
Cross reference A0115 as it relates to the failure of the facility to protect and promote each patient's rights.

A review of Patient #1's medical record revealed that he/she was a seventy-nine (79) year old admitted to the facility on [DATE] as a direct admit from another facility with a diagnosis of [DIAGNOSES REDACTED][DIAGNOSES REDACTED] (increase fats) and heart failure (chronic condition in which the heart doesn't pump blood properly). Continued review of Patient #1's chart revealed that medical physical exam revealed pitting (skin remains indented after being pressed) edema, clear lungs sounds, electrocardiogram (EKG) showing cardiac rhythm of left bundle branch block (heart block) and vital signs (VS) 149/90, 83, 16, 100% oxygen saturation. Medical orders included telemetry (continuous cardiac monitoring), oxygen as needed, heparin intravenous drip, and trending troponins (blood specimen which measure cardiac enzymes).

Continued medical chart review revealed that on 06/04/18 at 02:52 p.m., Patient #1 underwent a percutaneous coronary intervention (non-surgical procedure used to treat narrowing of the coronary arteries) in the cardiac catherization department. Medical chart review revealed Patient # 1 returned to the assigned unit post-procedure with a mixed bag of normal saline (NS) and Levophed (medication which treats heart failure and low blood pressure). Further chart review revealed that on 06/05/18 there as was a significant decrease in Patient #1's blood pressure. At 01:00 a.m. the patient's blood pressure was 57/40 and heart rate was 21 with oxygen saturation at 100%. An order was written for NS intravenous (IV) bolus (fast) infusion. Patient # 1's medical record revealed that the pre-mixed NS bag containing the medication Levophed was administered at 01:10 a.m. The patient's blood pressure increased to 185/105, heart rate was 127, with 88% oxygen saturation at 01:15 a.m. A code (emergency resuscitation notification) was called at 01:40 a.m. and Patient #1 was placed on a mechanical ventilator with continued twenty minute resuscitative efforts. Patient #1's clinical status did not improve and after a steady decline and he/she expired on [DATE] at 05:28 a.m.

A tour was conducted immediately after the entrance conference, starting at 2:00 p.m. accompanied by Employee #2, Director of Cardiac Catherization department, personnel Regulatory Affairs and Patient Safety Lead. It was observed that the cardiac catherization department was clean, well lit, and adequately staffed. Director of Cardiac Catherization stated that only pre-mixed medications are now in the Pyxis (automated) medication system. A tour of the coronary care unit (CCU) revealed a clean environment, well lit hallways and patient rooms.

A review of the facility's policies and procedure revealed the following:-

Bylaws of AU Health System, INC, no issue date, revised 01/25/2018, revealed that the Board of Directors shall have supervision, control, and direction of the management, affairs, and property of the corporation, shall determine the policies of the corporation and any changes thereto. The Board of Directors shall provide the risk management functions of the corporation in order to prevent injuries, losses or damages from occurring.

Policy# 384 titled Patient Rights and Responsibility, issued 07/01/2000, revised 10/12/17, revealed that AU Medical Center (AUMC) is committed to providing quality medical care to every patient. The policy further revealed patient rights to request and receive medically appropriate treatment and services within the Medical Center's capacity and capabilities and to appropriate assessment and management of symptoms, including pain.

Policy entitled 'Departmental Scope of Service Statement, Department of Pharmacy', issued 04/2016, reviewed 04/27/16, revealed that the AU Medical Center Department of Pharmacy is responsible for the medication-use process for patients of all ages including neonatal, pediatric, adolescent, adult and geriatric across the continuum of care. Policy review further revealed that the goal of a quality drug distribution system is to provide medications in a ready-to-administer (unit dose) form in an accurate, timely and efficient manner. Appropriate checks and balances are built into the system so that the pharmacist is in a position to make the ultimate decision as to whether a medication is prepared correctly (i.e., the order is interpreted, labeled, and prepared accurately) and to verify that the medication is appropriate for the individual patient and situation. Minimizing the risk of medication errors is an important outcome of a safe drug distributing system. Continued policy review further revealed that the department of pharmacy staff members collaborate with other allied health disciplines (e.g. medical, nursing, respiratory, dieticians, etc.) to provide comprehensive and high quality pharmacy patient care services to patients, families, and caregivers.

Policy# 3591 titled Leadership of Nursing Services in Support of Professional Nursing Practice, no issue date, reviewed 11/08/17, revealed that the staff nurse is a registered nurse who reports directly to the Nurse Manager (NM) or Assistant Nurse manager (ANM) and is responsible for the planning, implementing and evaluating direct patient care. Policy review further reveals, as a patient care manager, a staff nurse is accountable for the delivery of care using the patient's plan of care which is assessed daily. The professional staff nurse is responsible for delivery of the highest level of patient care by complying with established standards of nursing practice.

Policy# 920 titled Medication Administration, issued 04/01/2009, revised 08/08/16, revealed that the policy exists to promote patient safety and high quality patient care by delineating guidelines for the safe administration of medications. Medications will be administered only with a legal medical order. A legal order is recognized as an order written on paper or entered electronically by a physician (credentialed faculty, fell ow, resident, or intern), physician assistant (PA), nurse practitioner (NP), nurse midwife, dentist, podiatrist or optometrist with prescriptive authority. Medications are administered in compliance with federal and state laws, standards of professional practice and hospital policies by authorized and qualified personnel (including but not limited to licensed independent practitioners, licensed practical nurses, registered nurses, respiratory therapists, pharmacists and physical therapists within their scope) who have been deemed competent to administer medications to patients as well as those individuals under the supervision of authorized and qualified personnel. The policy further revealed that all medications will be administered using the five rights of medication administration (i.e., right patient, right medication, right dose, right route and right time). The right action (i.e., appropriate reason), right form, right response and right documentation may also be confirmed during the medication administration process. Further policy review revealed that prior to administration, two patient identifiers will be actively acquired to positively identify patients prior to medication administration. The patient's armband will be considered the primary patient identifier.

Policy# 310 titled Safe Medication Practice, issued 07/01/2000, revised 09/12/16, revealed that prescribers, pharmacists, nurses and other healthcare professionals will seek resolution whenever there is a question with regard to the appropriateness or safety of medication use or need for clarification. All medications will remain labeled until they reach the patient's bedside to permit a final check of drug name, dose, route and time. Prior to medication administration, the nurse or other healthcare professional will verify the patient's identification (e.g., armband for inpatients), medication, dose, route and time. The nurse will utilize barcode scanning technology to scan the medication as well as the patient's barcode to document administration on the medication administration record.
A review of facilities policy# 3299 titled Nursing Documentation, no issue date, reviewed 09/22/2016, revealed that the nursing care documentation guidelines will be adhered to in order to assure care is provided to and documented for each patient based on a nursing assessment. The goal of the assessment is to determine the care, treatment and services that will meet the patient's initial and continuing needs. Policy review further reveals that nurse to nurse handoff reports will be done using the SBAR (S-Situation, B-Background, A-Assessment, R-Recommendation) Nurse to Nurse Handoff tool in the electronic health record or a paper SBAR Handoff tool. Continued policy review revealed that SBAR has become the Joint Commission's stated industry best practice for standardized communication in healthcare. SBAR promotes quality and patient safety, primarily because it helps individuals communicate with each other with a shared set of expectations. The care team uses SBAR to share patient information in a clear, complete, concise and structured format, improving communication efficiency and accuracy. SBAR is primarily for nurse to nurse transitions of care (i.e. shift change, patient transfer between nursing units).

An interview with Patient #9 on 07/11/18 at 08:00 a.m. on the Coronary Care Unit revealed that he/she has been admitted for twenty-four (24) hours due to a fast heart rate. He/she stated that the Patient Rights were reviewed with him/her, nursing care has been wonderful and he/she may be discharged on [DATE]. He/she stated that staff answer the call light in a timely manner and all medications given has been explained to him/her.

An interview with Patient #10 on 07/11/18 at 08:20 a.m. on the Coronary Care Unit revealed that he/she was admitted on [DATE] due to a high potassium (element found in the body). He/she stated that the Patient Rights were reviewed with him/her and that the nursing care has been good. He/she stated that staff answer the call light in a timely manner and all medications given has been explained to him/her.

An interview with Employee #5 (Registered Nurse, RN) on 07/11/18 at 07:40 a.m. in the Executive Administration Conference Room revealed that he/she has been employed at the facility for seven (7) years. He/she stated that on 06/05/18 he/she started the shift at 07:00 p.m. and received report from the day shift RN. Employee #5 stated that report initiated at the nurse's station, then he/she with the day shift RN, both went to Patient #1's bedside to check the intravenous fluid pump and he/she (Employee #5), saw intravenous fluid Normal Saline (NS) five hundred 500 milliliter bag hanging and infusing at a keep vein open (KVO) rate. Employee #5 denied seeing any label/labels on the NS bag at that time. Employee #5 stated that Patient #1's room was fully illuminated. Employee #5 further described Patient #1's condition, as awake and alert with some irregularity in blood pressure and complaint of nausea (desire to vomit). Employee #5 medicated Patient #1 with anti-nausea medication and a pre-sedative prior to a medical procedure. Employee #4 stated that Patient #1 was fine after the procedure and continued to monitor the hematoma (swelling) which had occurred following the completion of the procedure earlier in the day. Employee #5 further stated that he/she spoke with the Resident (physician) covering the Coronary Care Unit (CCU) at that time, and a medical order was written for an intravenous five hundred (500) milliliter (ml) bolus of Normal Saline(NS). He/she denied use of a scanner (device used when administering medication) and did bolus two fifty (250) milliliters of NS, at 01:10 a.m. from the bag already hanging on the intravenous pole. Employee #5 further stated that he/she had retrieved a one (1) liter (L) bag NS from the medication Pyxis (automated medication dispensing system), and while changing the NS 500 ml bag to the 1 L NS, noticed at that time the silk tape on the back of the NS 500 ml bag with the written label Levophed (medication which treats heart failure and low blood pressure) gtts (drops) 16 mg/500 ml NS. Employee #5 stated that he/she immediately went to get another RN to assist him/her in the verification of the written label. Employee #5 stated that Patient #1 had complained of chest pain and a code (emergency resuscitation notification) was called.

An interview with Employee #8 (Medical Director) on 07/11/18 at 09:49 a.m. in the Executive Administration Conference Room revealed that he/she was made aware of the incident involving Patient #1 during a Daily Safety Brief meeting, which was responded to by a swarm which involves all leadership personnel to investigate the occurrence. He/she described the Cardiac Catherization procedure room as a sterile environment. Per pharmacy recommendations the procedure room now utilizes only two (2) concentration of pre-mixed medications in stock. Employee #8 further explained the current action plan of standardizing colors of medication labels for intravenous bag and tubings.

An interview with Employee #2 (Director Critical Care) on 07/11/18 at 10:09 a.m. in the Executive Administration Conference Room revealed he/she has been employed at the facility since 1998 and has been in the current position for one (1) year. He/she stated that he/she was first made aware of the incident involving Patient #1 during a Daily Safety Brief meeting. He/she stated that he/she contacted the Risk Manager, all senior leadership, all clinical team and Patient #1's family. Employee #2 stated that as part of the Root Cause Analysis action plan, a Practice Alert was conducted with staff in the critical care areas, some of which were on-going. He/she also described expansion plans for the Coronary Critical Unit (CCU) to which would include bigger rooms and better lighting.

An interview with Employee #3 (Registered Nurse- RN) on 07/11/18 at 10:21 a.m. in the Executive Administration Conference Room revealed that he/she has been employed at the facility since 04/17/17. He/she stated prior to the procedure, Patient #1 had been stable and was to have a high-risk stent placement. He/she stated the Cardiologist requested extra staff to be available. Employee #3 described the cardiac instrument called a Impella which propels blood flow and reduces the work load off the heart. Employee #3 stated it was the usual custom for the Cardiologist to verbally instruct the nursing staff on any medications he/she wanted to have prepared prior to the procedure start. Employee #3 further stated that he/she then prepared the Levophed (medication which treats heart failure and low blood pressure) medication using four (4) 4 mg vials mixed in a 500-ml bag of Normal Saline (NS). He/she further explained that he/she used a 500 ml NS bag due to a national shortage of NS 250 ml bags. He/she stated that no labels were available in the procedure room and that it was the custom to use tape. Employee #3 stated that he/she wrote the name of the drug Levophed and the dose and placed the label on the front of the NS bag, however when he/she hung the bag onto the intravenous (IV) pole, light coming through the bag obscured the writing on the label. Employee #3 stated that he/she then placed the label onto the back of the NS bag, spiked the bag with the IV tubing and programmed the IV pump however, did not connect it to Patient #1. Employee #3 stated the procedure began and at a point, Patient #1's blood pressure reading was in the seventies (70s) and the Cardiologist stated to get ready to start the IV Levophed infusion. Employee #3 further stated that he/she did connect the IV tubing to Patient #1, but never started the infusion. Patient #1 received a one (1) liter IV NS. He/she stated that Patient #1 developed a hematoma post procedure and that he/she maintained pressure at the procedure site. Employee #3 stated that after continued monitoring and with the Cardiologist assistance, Patient #1 was transported back to the Coronary Care Unit (CCU) where several CCU RNs came to assist in returning to Patient#1 to bed and maintain pressure to the hematoma site. Employee #3 further stated that he/she provided education on care of Patient #1's hematoma to the CCU RNs and due to being focused on the Patient #1's hematoma he/she did not remember to mention the Levophed NS bag.

An interview with Employee #4 (Pharmacist) and Employee #9 (Pharmacy Manager) on 07/11/18 at 10:45 a.m. in the Executive Administration Conference Room revealed Employee #4 has been employed for twenty-nine (29) years and was first made aware of the incident involving Patient #1 the day of its occurrence on 06/05/18. Employees #4 and #9 both stated that an immediate meeting was held in the pharmacy and once they learnt the drug involved was norepinephrine (Levophed - medication which treats heart failure and low blood pressure), it was immediately pulled and replaced with pre-mixed medications and a new medication policy put into effect. Employee #9 further stated that medication labels typically were handled by central distributing department and that they were in the process of standardizing the label system. Employees #4 and #9 states they continue to be involved with the Root Cause Analysis meetings.

An interview with Employee #7 (Interim Director Clinical Quality) on 07/11/18 at 11:00 a.m. in the Executive Administration Conference Room revealed that he/she has worked via contract since May 2018. He/she stated that he/she first became aware of the incident involving Patient #1 during Daily Safety Brief which is a team of all senior leaders and managers. He/she further stated that the safety lead conducted an investigation and completed an on-line reporting via safety intelligence. A Root Cause Analysis (RCA) was initiated with weekly meetings. Employee #7 stated that the RCA square which is endorsed by the Joint Commission (JC) is a thorough investigative tool. The RCA identifies opportunities for improvements and the action plan includes a Cardiologist and Anesthesiologist.
An interview with Employee #6 (Registered Nurse-RN) on 07/11/18 at 11:10 a.m. in the Executive Administration Conference Room revealed that he/she has been employed for a year and a half. He/she stated that he/she was aware of Patient #1 when he/she returned from the procedure. He/she stated that he/she recalled that Patient #1 had developed a hematoma and that the staff was attending to that. He/she further stated that there was a 500-ml bag which looked like a saline bag laying on the bed. Employee #6 further stated that he/she removed the bag from the bed and hung it onto an intravenous (IV) pole and it was not connected to Patient #1. He/she stated that it was routine for patients returning from the procedure room to have an IV and that labels have always been in use. He/she stated that after rendering assistance he/she did not have any further contact with Patient #1.

A review of seven (7) personnel files (1,2,3,4,5,6 and 7) revealed all contained evidence of current licensure, department orientation, annual competency and health exams.
A review of one (1) credentialing file (Employee #8) revealed current licensure, DEA certificate, insurance, appointment, privileges and peer reviews.
Review of nine (9) additional medical records (# 2, 3, 4, 5, 6, 7, 8, 9, and 10) revealed that all patients had signed consent forms and Patient Rights and responsibilities. All nine (9) had evidence of clinical assessments and re-assessments, appropriate diagnostic-specific treatment plans and completed medication administration records.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on medical record review, facility policies, and staff interviews, the facility failed to maintain policies and procedures that minimize drug errors, for one (1) patient (#1), which resulted in the death of the patient.

Findings:

Cross reference A0385 as it relates to the failure of the facility to provide nursing care and services in a safe and effective manner.

Cross reference A0043 as it relates to the failure of the governing body to ensure that the protect and promote each patient's rights.