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.

ADVENTHEALTH OCALA 1500 SW 1ST AVE OCALA, FL 34474 Nov. 16, 2020
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure the opportunity for improvement was implemented when collected data identified incomplete records for 2 of 2 patients, Patients #1 and #2, and failed to take actions aimed at performance improvement when a third trimester abortion was identified as having been conducted, contrary to state law, when the mother's life was not documented as being at risk for 1 of 1 patients sampled for a third trimester abortion, Patient #1.

Findings included:

Review of the report provided by the hospital, ITOP (Induced Termination of Pregnancy) Reporting for the period of 8/2018 through 10/2020, dated 3/1/2019, revealed, "Total 3rd Trimester: 1. Total Infants Born Alive: 1."

During an interview on 11/16/2020 at 9:32 AM, the Clinical Excellence Risk Management (CERM) stated, "We have no policies for abortions. We didn't have one at that time. We have one in process now. We are pulling QA [Quality Assurance] but I don't think that has been done. We don't have a record on the infant. The infant was born alive, but that record was not generated. The info we have for the baby, that is separated from the mother's record, it is these few pages here."

Review of the hospital medical record for Patient #1's admitting history and physical, dated 2/21/2019 1:56 PM, read, "History of present illness: [AGE] year old now at 24.2 weeks gestation by dates of the EDC [Estimated Date of Confinement] at 5/28/2019 and gestational age of 24.2 weeks. Patient requests therapeutic abortion for multiple congenital anomalous fetus with hydrocephaly, bilateral femoral bone regression, sacral regression, facial deformity and clubbing of right foot in addition to genetically positive for [DIAGNOSES REDACTED] 21 i.e. Down's syndrome. Assessment/Plan: 26 weeks gestation. Abnormal findings on diagnostic imagining of other specified body structures. Maternal care of benign tumor of corpus uteri, third trimester. Plan: Inpatient admission to labor and delivery. Routine blood work. Anesthesiology consult for spinal anesthesia. Advised the patient that Cytotec use for therapeutic abortion basis a high risk for rupture of the uterine scar and as a result cesarean delivery was offered."

Review of page 87 of the documentation provided by the hospital dated 1/25/2019 read, "Obstetric Ultrasound Report Patient Information: LMP (last menstrual period) 8/21/2018."

Review of the discharge summary revealed Patient #1 was discharged on [DATE] at 1:35 PM. Further review of the record revealed no nursing progress notes.

Review of Patient #1's Clinical Discharge Summary read, "DC Dx [discharge diagnosis]: 26 weeks gestation pregnancy. Abnormal findings of diagnostic imaging of other specified body structures. Maternal care for benign tumor of Corpus Uteri 3rd Trimester."

Review of the hospital documentation for Patient #2 revealed, "Sex: Female. Date of Birth: February 21, 2019. Time of Birth: 2102 [9:02 PM]. Birth Weight: 1 lbs, 7 oz [one pound, seven ounces] 652 grams. expired on [DATE] at 2:34 AM." Further review of the documentation revealed there was no birth certificate, no death certificate, no treatment notes, and no physician, physician assistant, advanced registered nurse or nursing progress notes.

During a telephone interview on 11/16/2020 at 1:08 PM, the Obstetrics and Gynecological Surgeon stated, "This was a second trimester termination. The fetus gestation was less than 24 weeks. When you put all the parameters together this patient was second trimester when she had her termination." When asked why the physician's notes read the patient was at 26 weeks, the surgeon stated, "That could be a typo, because it does happen."

During an interview on 11/16/2020 at 1:28 PM, Staff B, RM (Risk Manager) stated, "A RCA [Root Cause Analysis], was not done as we were not aware of any issues. This being a second trimester abortion it would not be reviewed. If there was an issue and a decision that had to be made it would have been above me at an Administrative level." At 2:52 PM, when asked what system was put into place by Risk Management the RM stated, "I was not made aware it was a third trimester. The decision for that would have come from above us at that time. It would have been whoever was the Administrator at that time. We didn't do an investigation for Risk Management and there is nothing for QA that I am aware of." No documentation was provided for QA related to third trimester termination and nursing progress notes.

During an interview on 11/16/202 at 2:11 PM, the Chief Medical Officer (CMO) stated, "I was told 26 weeks was the GA [gestation age] of the fetus. I didn't know the law. I wasn't aware that the state defined [third trimester] as 24 weeks. I am saying that to be honest. I didn't look at the law, so I made the decision per administration. I have a request for a termination to be conducted at 26 weeks. I called and talked to the physicians and the registered nurses they all stated the patient was at 26 weeks."

During an interview on 11/16/2020 at 2:20 PM with the CERM, a request was made for the documentation of the progress notes by the nursing staff. The CERM verified there were no nursing progress notes in the records. No additional records were provided.

Review of Patient #1's record on 1/16/2020 at 3:16 PM with Staff A, Risk Manager (RM), revealed no nursing progress notes. The nursing progress notes were requested. No additional records were provided.

During an interview on 11/16/2020 at 4:07 PM with the CERM, when asked regarding the Risk Management process and QA related to the termination being conducted at the third trimester and lack of record documentation, she stated, "I didn't know there was an issue until a couple of months ago about how the mother's life was endangered and the lack of documentation. Now we know this is against the law, and wrong. There was no policy." When asked what was put into place to make certain this does not happen again, the CERM stated, "I think the P & P [Policy and Procedure] is going to be enough. It has to go to the MEC [Medical Executive Committee] for final approval. The reason why this was not addressed sooner was that we were unaware of this concern. Once the state brought it to our attention a couple of months ago, we then saw the changes that needed to be made, this is why this was not addressed." A request was made for the patient's nursing progress notes. No additional documentation was provided.

During an interview on 11/16/2020 at approximately 4:32 PM, Staff B, RM, the QAPI Q1 and Q2 (Quality Assurance Performance Improvement Quarter 1 and Quarter 2) for 2019 were reviewed. When asked regarding the third trimester abortion not being listed on the reporting, the RM stated, "It's because we didn't look at that. That was not brought to our attention. It was handled by Administration. We don't look at that type of information for labor and delivery for that report." When asked if this should be discussed, the RM stated, "We should have, but we did not know it was a third trimester abortion. We thought it was a second trimester." When a request was made for the QA for 2020, the RM stated, "It wasn't discussed at QA in 2020." No further documentation was provided.

During an interview on 11/16/2020 at 4:42 PM with the CERM in the presence of Staff A, RM, and Staff B, RM, when asked regarding the training requirements including the law related to third trimester abortions, the CERM stated, "I agree that the CMO should be aware of the laws related to when the third trimester begins."

Review of the facility policy and procedure titled, "2019 Quality and Patient Safety Plan", read, "Purpose and Scope: the Adventist Health System's Mission, Vision and Strategic imperatives are the basis for [the facility's name] Quality and Patient Safety Plan. The Quality and Patient Safety program focuses on a framework for a safe and reliable culture and learning system. A structured framework utilizing evidence-based practices, LEAN [Leadership, Eliminate waste, Act now, Never ending] and Kaizen methodology and a commitment to excellence drives all the principles of this program. This plan specifies the authority for and the organization and coordination of all performance improvement activities for the hospital within an interdisciplinary approach. The scope of the Patient Safety plan includes situations ranging from "no harm" and frequent minor mishaps to serious outcomes and Sentinel Events. Leadership and Accountability: the Board of Directors has the ultimate authority and responsibility for fostering quality and Board delegates operational authority for the day to day responsibility for improving organizational performance and patient safety in a systematic, coordinated and continuous manner to the Medical Staff and Administration. All hospital employees, physicians and volunteer assume responsibility to promote quality and patient safety. Teamwork and Communication: Recognizing and acknowledging medical errors and risks to patient safety is the responsibility of every staff member, medical staff member and volunteer. Patient safety concerns are brought forward each day during the department's safety huddle and brought to the organizational safety huddle. Information related to process changes is communicated effectively to change behaviors to improve patient safety. Quality and Patient Safety are standing agenda items for the Board meeting, Medical Executive Committee, Medical Staff Section meetings, Administrative Council, and Leadership /Council. Improvement and Measurement: When a significant variation occurs, intense analysis is conducted with all the individuals involved, and an action plan for improvement is developed and implemented. Continuous Learning: Proactive, concurrent monitoring and real-time identification of defects/harms, allows for immediate correction or intervention. Quality and Patient Safety Goals: The over-arching goal of the Quality and Patient Safety Council is to guide the organization to deliver safe, reliable and effective care to the patients. Performance Improvement Structure: Quality and Patient Safety Council: Objectives: Receive and recommend actions for significant findings of all required quality measures. Provide direction and leadership for all quality and patient safety activities and issues. to assure compliance with all standards and regulations. Facilitate Interdisciplinary communication and collaboration. Identify opportunities for improvement and recommend processes for improvement. Reporting: Information will be disseminated throughout the organization by the respective Department Managers/Directors through daily Huddles and staff meetings. The CNO [Chief Nursing Officer] and/or Administrative Director, Quality and Patient Safety will communicate to the Medical Executive Committee (MEC) and Board of Directors. Medical Staff: The Medical Staff, through its officers, departments, divisions, committees, and individual members, has a leadership role and is responsible for actively participating in quality improvement and patients safety processes. Objective: Medical Staff Quality Review Committee (MSQRC) is responsible for involving members in quality and patient safety improvement activities directed towards evaluating important processes, patient safety and outcomes of care."
VIOLATION: CONTENT OF RECORD - OTHER INFORMATION Tag No: A0467
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the facility failed to ensure complete documented medical records for 2 of 2 patients sampled related to a termination of pregnancy, Patients #1 and #2.

Findings included:

During an interview on 11/16/2020 at 9:32 AM, with the Clinical Excellence and Risk Management (CERM) when the records were requested for Patients #1 and #2, she stated, "We don't have a record on the infant. The infant was born alive, but that record was not generated. The information we have for the baby, that is separated from the mother's record, it is these few pages here. There was no chart generated for the baby." When asked if this is the complete record for Patient #1 and Patient #2, the CERM stated, "Yes, this is all we have."

Review of the report provided by the hospital, ITOP (Induced Termination of Pregnancy) Reporting for the period of 8/2018 through 10/2020, dated 3/1/2019, revealed, "Total 3rd Trimester: 1. Total Infants Born Alive: 1."

Review of the hospital medical record for Patient #1's admitting history and physical, dated 2/21/2019 at 1:56 PM, read, "History of present illness: [AGE] year old now at 24.2 weeks gestation by dates of the EDC [Estimated Date of Confinement] at 5/28/2019 and gestational age of 24.2 weeks. Patient requests therapeutic abortion for multiple congenital anomalous fetus with hydrocephaly, bilateral femoral bone regression, sacral regression, facial deformity and clubbing of right foot in addition to genetically positive for [DIAGNOSES REDACTED] 21 i.e. Down's syndrome."

Review of the discharge summary revealed Patient #1 was discharged on [DATE] at 1:35 PM. Further review of the record revealed no nursing progress notes.

Review of the hospital documentation for Patient #2 revealed, "Sex: Female. Date of Birth: February 21, 2019. Time of Birth: 2102 [9:02 PM]. Birth Weight: 1 lbs, 7 oz [one pound, seven ounces] 652 grams. expired on [DATE] at 2:34 AM." Further review of the documentation revealed there was no birth certificate, no death certificate, no treatment notes, and no physician, physician assistant, advanced registered nurse or nursing progress notes.

During an interview on 11/16/2020 at 2:20 PM with the CERM, a request was made for the documentation of the progress notes by the nursing staff. The CERM verified there were no nursing progress notes in the records. No additional records were provided.

Review of Patient #1's record on 1/16/2020 at 3:16 PM with Staff A, Risk Manager (RM), revealed no nursing progress notes. The nursing progress notes were requested. No additional records were provided.

Review of the facility policy and procedure, titled Medical Records Management AHS Health Record Definition, with an effective date of 9/10/2010 revealed, "I. Scope: Applies to all health care staff and providers that serve [the facility's name] II. Purpose: To set the standards for all AHS acute care entities regarding the AHS Health Record. AHS Health Record is created in accordance with applicable standards as defined by the Centers for Medicare and Medicaid Services Conditions of Participation, federal regulations, state laws, and standards of accrediting agencies. III. Policy: The AHS Health Record contains the documentation of medical care provided to an individual by the AHS Healthcare Facility. It contains individually identifiable data, collected and stored on any medium, and is directly used in documenting the healthcare provided to our patients. Data/documents: Data or documents that are considered part of the AHS Health Record are: Annotations containing patient-provider or provider-provider communications regarding care or treatment of specific patients. Any other information required by the Medicare Conditions of Participation, state provider licensure statues or rules, or by any third-party payer as a condition of reimbursement. Clinical observations. Fact Sheet. Functional status assessments. Infant record. Nursing assessments. Progress notes and documentation (multidisciplinary, excluding psychotherapy notes). Vital signs. Personal Health Records: Administrative data are patient-identifiable data used for administrative, regulatory, healthcare operation, and payment (financial) purposes. Administrative data include: Birth and death certificate worksheets."