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6000 49TH ST N

SAINT PETERSBURG, FL 33709

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on review of medical records, staff interview and review of Medical Staff Bylaws it was determined the medical staff failed to ensure medical staff were held accountable for their conduct for one (#2) of four patients sampled.

Findings included:

Review of the Medical Staff Bylaws, section 2.2 Purpose and Responsibilities; the purpose and responsibilities of the Medical Staff are: 2.2.1 to provide a formal organizational structure through which the Medical Staff shall carry out their responsibilities and govern the professional activities of its members...; 2.2.2 to provide patients with the quality of care that is commensurate with acceptable standards and available community resources; 2.2.3 to collaborate with the Hospital in providing for the uniform performance of patient care processes throughout the Hospital; and 2.2.4 Medical Staff serve as a primary means for accountability to the Board concerning professional performance of Practitioners and others with clinical privileges authorized to practice at the hospital with regard to the quality and appropriateness of health care.

Review of the record for patient #2 revealed the patient arrived to the facility via EMS (Emergency Medical Services) and was admitted to the ED (Emergency Department) on 3/4/2019 at 8:00 a.m. The patient's complaint was worsening dyspnea (shortness of breath) with onset of the night before (3/3/19). Review of the physician assessment revealed the ED physician evaluated the patient immediately upon arrival at 8:02 a.m. The patient reported his SOB (Shortness of Breath) began last night and he experienced a syncope (fainting) episode. He reported his SOB continued this morning and had rapidly worsened. Physician documentation stated EMS personnel reported the patient's BP (Blood Pressure) of 72 (not within normal limits - low systolic pressure) and heart rate in the 120's (normal limits 60-100). EMS reported upon arrival to the scene the patient was found to be on all fours trying to catch his breath. The physician noted the patient was a 33 year old male with no significant respiratory history. The physician noted the patient had an Achilles cast in place that was placed 1 week ago for a torn Achilles.

Review of the ED documentation revealed laboratory and radiographic imaging was completed timely. CT scan of the chest was completed at 8:20 a.m., and revealed extensive bilateral pulmonary emboli (blockage in the arterial or venous blood flow) with two saddle emboli (refers to a large pulmonary embolism that straddles the bifurcation of the pulmonary trunk, extending into the left and right pulmonary arteries) and right upper lobe/perihilar/peribronchial consolidation, suspicious for pulmonary infarct given the extensive pulmonary emboli. Review of the ED documentation revealed the patient was administered medication to treat his presenting systems timely. Documentation revealed admission for intervention and treatment was initiated at 9:07 a.m., by the ED physician.

Review of the physician's surgical procedure note and interventional radiology (IR) notes revealed the patient was brought to the room and prepped for pulmonary angiogram and placement of bilateral infusion catheters for pulmonary embolectomy. Consent was signed by the patient prior to the procedure. Review of the IR procedure notes revealed the physician entered the room at 10:35 a.m., and the procedure time-out was called at 10:35 am. Documentation revealed the patient went into cardiac/respiratory arrest at 10:37 a.m., at which time the patient was treated and resuscitated. Documentation revealed the procedure continued and the physician inserted the first catheter to the right common femoral vein and advanced it into the left and then right pulmonary arteries where a bolus of 4 mg (milligrams) of TPA (tissue plasminogen activator: a protein involved in the breakdown of blood clots) was injected into the right and left pulmonary arteries. Next, an infusion catheter was exchanged and left in place. A second infusion catheter was then placed across the left main pulmonary artery. The two infusion catheters were secured to the skin at the right groin.

Review of the Interventional Radiologist's documentation revealed chemical thrombectomy of the main and bilateral pulmonary artery's using bolus of TPA as well as placement of infusion catheters with 0.5 mg/hour of tPA running through each catheter for at least 12 hours as well as 500 milligrams per hour of Heparin through the right common femoral sheath. The physician documented the patient would be assessed in approximately 12-24 hours for removal of the infusion catheters.

Review of the discharge summary revealed on 3/4/2019 at 7:08 p.m., the patient experienced cardiac arrest. Documentation stated ACLS (Advanced Cardiac Life Support) was immediately implemented. Physician documentation stated ACLS continued until the patient's time of death was called at 7:50 pm.

Review of the physician's orders revealed a verbal order was entered by nursing on 3/4/2019 at 1:19 p.m. The order read Heparin 500 ml (milliliters) per hr (hour), do not titrate. Documentation revealed the Heparin was premixed at a concentration of 25,000 units per 500 ml and was dispensed in a 500 ml bag. Documentation revealed the order was verbally read back and verified by the nurse. Review of the medication order revealed the ordering physician was the Interventional Radiologist that performed the procedure. Review of the medication order revealed the order was unsigned by the physician. Interview with the Director of Quality and Patient Safety at the time of the medical record review on 5/15/2019 at 9:45 a.m., stated the ordering physician refused to sign the verbal order entered into the patient's record and the IR stated to the Director of Quality and Patient Safety "that is not what I ordered."

An interview was conducted with the Director of Quality and Patient Safety on 5/15/2019 at 9:45 a.m. She stated when the Interventional Radiologist was interviewed she stated that it was her intention to infuse the Heparin at 500 units per hour and not 500 milliliters per hour. The Director of Quality and Patient Safety stated while the patient was in the procedure room a verbal order was given to the nurse for "Heparin 500 per hour." The nurse verbally repeated the order back to the physician to confirm the dosage of Heparin 500 per hour at which time the physician verified the verbal order. The Director of Quality and Patient Safety confirmed no one stated the order was in units. The nurse initiated the Heparin and the patient was transported to the CVICU. The Director of Quality and Patient Safety stated the nurse in CVICU (Cardio Vascular Intensive Care Unit) and the primary care physician also confirmed the dosage for Heparin with the ordering physician. Review of the record did not reveal evidence of the primary care physician or CVICU nurse verification of the order with the interventional radiologist.

Review of the facility's corrective action plan revealed education to all clinical nursing staff facility wide was completed for utilizing the chain of command when nursing staff needed resolution to clinical patient care or patient safety issues which included dosing concerns for high risk/high alert medications. Education also included a Heparin Administration Safety Alert provided to all nursing staff. Review of the education revealed nursing was to confirm/clarify Heparin infusion rates in units, second independent nurse check at the time of administration or rate change, and no verbal orders are to be accepted for any high risk drugs unless it is an emergent situations where immediate electronic communication is not feasible. Review of the corrective action plan revealed no evidence education was provided to the medical staff regarding the same acceptable standards of care and quality of care for patient safety. Interview with the Director of Quality and Patient Safety on 5/15/2019 at 9:45 am confirmed the findings.