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MINERAL WELLS, TX 76067

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on record review and interview, the governing body failed to ensure that the medical staff was accountable to them for the quality of care provided to patients, in that 6 of 6 Patients (Patients #37, #4, #7, #8, #46, and #47) had adverse outcomes after procedures and/or treatment performed at the hospital. There was no documentation that a peer review and/or root cause analysis was completed for Patient #37, #4, #7, and #8. Patients #37, #8, #46 and #47 were transferred to a higher level of care.

Findings include:

1. Patient #37: During 4/2015, Patient #37 had an emergency cesarean section and had excessive bleeding after the cesarean section. Patient #37 returned to surgery and had a hysterectomy. The patient remained unstable and continued to hemorrhage. Patient #37 was transferred to a higher level of care. The hospital did not complete an occurrence report, conduct a Root Cause Analysis (RCA) and the physician was not referred to Peer Review.

2. Patient #4: During 2/2013, Patient #4 came to the hospital for a Day Surgery procedure to have a IUD removed because she was 8 weeks pregnant. There are discrepancies in the amount of fluid that was used during the procedure between documentation of the nurse and the doctor. The patient developed pulmonary edema and had to be intubated, placed on the ventilator and admitted to the ICU for treatment. The patient's fetus died. Prior to surgery the baby did have a sonogram heartbeat. After the procedure, the doctor was not able to obtain a fetal heart rate by sonogram. No RCA or Peer Review was conducted on this case.

3. Patient #7: On 3/25/15, Patient #7 had respiratory suppression and need for IV Narcan resuscitation to reverse the suppressive effects of the Duragesic (Fentanyl) pain patch ordered and placed on the patient in the Emergency Department (ED) for intractable left hip pain. The event occurred approximately 27 hours after the pain patch was applied and was brought to the attention of the nurse by the family who noticed the patient was unresponsive and had decreased respirations, 2-4 breaths per minute. A non-rebreather oxygen mask was applied and orders received from the patient's physician when contacted by the nurse. Patient #7 responded to the removal of the Duragesic patch, IV Narcan, and non-rebreather mask oxygenation that was ordered. The physician later documented "respiratory suppression and hypoxia...unintentional narcotic overdose." No occurrence report or RCA was completed.

4. Patient #8: On 2/20/2014, Patient #8 was admitted through Day Surgery for excision of vulvar carcinoma that resulted in excision through the right labia minora, right perineum, and perianal area and required a thigh skin flap to cover the defect. The wound dehisced on Post-op Day #3, the day after she was discharged from the hospital, and resulted in a necrotic wound. Multiple surgeries were performed that included a colostomy and reversal. Patient #8 had a large open wound for six months. She eventually developed Sepsis and Disseminated Intravascular Coagulation (DIC), was placed on mechanical ventilation, and experienced cardiac arrest. Patient #8 was transferred to a higher level of care. No Peer Review or RCA was performed on Patient #8 after multiple surgeries and hospitalizations at this hospital. This was confirmed by interview with the Director of Quality and Risk Management on 9/30/2015.

5. Patient #46 was born on 3/26/2015 by elective induction of labor. Patient #46 had "...respiratory distress syndrome with suspected meconium aspiration...At the time of delivery Patient #46 had significant occipital molding...did not have a spontaneous cry and was suctioned aggressively with thick meconium down below the cords...continued to have decreased tone...bilateral rales with intercostal retractions..." Patient #46 was transferred to a higher level of care.

6. Patient #47 was thirty-nine weeks and six days gestation and came to the hospital on 04/06/15 in active labor. The baby (Patient #48) failed to descend and had non-reassuring fetal heart rate that required emergency cesarean section. When delivered, Patient #48 had no spontaneous movement or respirations with Apgar's of 0 and 0. The ED physician was called, intubated the infant, and performed resuscitation for over an hour without any signs of life. Patient #47 was discharged on 04/08/15 and returned to the hospital on 04/10/15 with swelling. The Physician's Emergency Room (ER) Report dated 4/10/15 3:35 PM revealed: "Chief Complaint: Lower extremity swelling. Severity is described as being severe. It has become recently worse...This started 4 days ago; C section 4 days ago. Physical Exam: Lower extremities exhibit normal ROM. No lower extremity edema. (12:07 PM) Hospital has no MgSO4 (Magnesium Sulfate) so we must transfer patient. Disposition: Transferred to higher level of care. Clinical Impression-Eclampsia in the puerperium." Patient #47 was transferred on 04/10/15 to a higher level of care.

Policies Reviewed:

Bylaws of Palo Pinto County Hospital District dated 4/22/14 and signed by Staff #166 revealed: "The Board of Directors is charged with the responsibility to evaluate and supervise the conduct of the Hospital, including the care and treatment of patients the procurement and direction of personnel governed by a governing board known as the Board of Directors ensure that all patients treated by the Hospital receive quality care; to provide a means of liaison with the Medical Staff; to initiate and maintain rules and regulations for the governing of the Hospital, the Medical Staff, and employees. At least one (1) member of the active and/ or courtesy Medical Staff, the Hospital Administrator, the Quality Assurance Coordinator, the Nursing Quality Coordinator Director of Nursing Services shall review and assess any issues relative to patient care in the Hospital and shall recommend to the Board of Directors any action deemed, in the opinion of the Committee, to be necessary to address these issues. The Board of Directors, through the Quality Assurance committee, shall direct all Hospital departments, Medical Staff members and other committees to report to the Quality Assurance Committee any quality issue, unusual incidents, or perceived patient care problems. The Administrator shall cooperate with the Medical Staff and require like rendering professional services to assure patients receive the best possible care available at this facility..."
Reportable Events, Recommended by Surgery Manager, Approved by Surgical Committee, Reviewed 1/13/10 by Staff #164 06/2014 revealed: "It is the policy to report all sentinel events to Quality/ Risk Management. This policy applied to Surgical Service Staff Reportable Events; unplanned return to the Operating Room, cardiac or respiratory arrest, Day Surgery patient requiring transfusion, admission to hospital bed, transfer to alternative post anesthesia recovery area, organ failure not present on admission, unanticipated transfer to another acute care facility."

Interviews include:

An interview with Staff #3 at Palo Pinto General Hospital was conducted on 9/30/2015 9:10 AM in the administrative office. Staff #3 was asked if any doctors that had been to peer review had been referred to the Medical Board, she stated, "No doctors have been referred to the medical board. There have not been any doctors referred for Peer Review in 2014 or 2015 because we have been revamping our peer review policies and process."

PATIENT RIGHTS: GRIEVANCE PROCEDURES

Tag No.: A0121

Based on record review and interview, the hospital failed to establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital, in that, 1 of 1 patient (Patient #50) filed a written and oral complaint to the hospital. The hospital did not send the complainant a follow-up letter regarding the hospital's investigation.

Findings include:

Patient #50's spouse spoke before the Board of Director's meeting on 3/24/2015, to make her complaint regarding "abrupt discharge planning they received and the lack of compassion shown by a physician and the Discharge Planning person." On 3/25/2015, the written complaint was submitted to the hospital. Staff #2 did send the patient's spouse a letter explaining that the hospital would conduct an investigation to the allegations made and appropriate corrective action would be taken as determined by the investigation.

An interview with Staff #3 on 10/6/2015 in the Administrative office at the hospital, confirmed that the hospital had not conducted an investigation and nothing had been done about this complaint. Staff #3 stated, "It just fell through the cracks."

During an interview with Staff #3 on 10/1/2015 in the hospital's Administrative office, Staff #3 was asked for the hospital's complaint policy. A new complaint policy that was approved on 9/22/2015 was presented to the surveyors. The policy that was in effect prior to this new policy was requested on 10/1/2015, 10/5/2015 and 10/6/2015. The policy was never presented.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on record review and interview, the governing body failed to ensure that the medical staff was accountable to them for the quality of care provided to patients, in that 6 of 6 Patients (Patients #37, #4, #7, #8, #46, and #47) had adverse outcomes after procedures and/or treatment performed at the hospital. There was no documentation that a peer review and/or root cause analysis was completed for Patient #37, #4, #7, and #8. Patients #37, #8, #46 and #47 were transferred to a higher level of care.

Findings include:

1. Patient #37: During 4/2015, Patient #37 had an emergency cesarean section and had excessive bleeding after the cesarean section. Patient #37 returned to surgery and had a hysterectomy. The patient remained unstable and continued to hemorrhage. Patient #37 was transferred to a higher level of care. The hospital did not complete an occurrence report, conduct a Root Cause Analysis (RCA) and the physician was not referred to Peer Review.

2. Patient #4: During 2/2013, Patient #4 came to the hospital for a Day Surgery procedure to have a IUD removed because she was 8 weeks pregnant. There are discrepancies in the amount of fluid that was used during the procedure between documentation of the nurse and the doctor. The patient developed pulmonary edema and had to be intubated, placed on the ventilator and admitted to the ICU for treatment. The patient's fetus died. Prior to surgery the baby did have a sonogram heartbeat. After the procedure, the doctor was not able to obtain a fetal heart rate by sonogram. No RCA or Peer Review was conducted on this case.

3. Patient #7: On 3/25/15, Patient #7 had respiratory suppression and need for IV Narcan resuscitation to reverse the suppressive effects of the Duragesic (Fentanyl) pain patch ordered and placed on the patient in the Emergency Department (ED) for intractable left hip pain. The event occurred approximately 27 hours after the pain patch was applied and was brought to the attention of the nurse by the family who noticed the patient was unresponsive and had decreased respirations, 2-4 breaths per minute. A non-rebreather oxygen mask was applied and orders received from the patient's physician when contacted by the nurse. Patient #7 responded to the removal of the Duragesic patch, IV Narcan, and non-rebreather mask oxygenation that was ordered. The physician later documented "respiratory suppression and hypoxia...unintentional narcotic overdose." No occurrence report or RCA was completed.

4. Patient #8: On 2/20/2014, Patient #8 was admitted through Day Surgery for excision of vulvar carcinoma that resulted in excision through the right labia minora, right perineum, and perianal area and required a thigh skin flap to cover the defect. The wound dehisced on Post-op Day #3, the day after she was discharged from the hospital, and resulted in a necrotic wound. Multiple surgeries were performed that included a colostomy and reversal. Patient #8 had a large open wound for six months. She eventually developed Sepsis and Disseminated Intravascular Coagulation (DIC), was placed on mechanical ventilation, and experienced cardiac arrest. Patient #8 was transferred to a higher level of care. No Peer Review or RCA was performed on Patient #8 after multiple surgeries and hospitalizations at this hospital. This was confirmed by interview with the Director of Quality and Risk Management on 9/30/2015.

5. Patient #46 was born on 3/26/2015 by elective induction of labor. Patient #46 had "...respiratory distress syndrome with suspected meconium aspiration...At the time of delivery Patient #46 had significant occipital molding...did not have a spontaneous cry and was suctioned aggressively with thick meconium down below the cords...continued to have decreased tone...bilateral rales with intercostal retractions..." Patient #46 was transferred to a higher level of care.

6. Patient #47 was thirty-nine weeks and six days gestation and came to the hospital on 04/06/15 in active labor. The baby (Patient #48) failed to descend and had non-reassuring fetal heart rate that required emergency cesarean section. When delivered, Patient #48 had no spontaneous movement or respirations with Apgar's of 0 and 0. The ED physician was called, intubated the infant, and performed resuscitation for over an hour without any signs of life. Patient #47 was discharged on 04/08/15 and returned to the hospital on 04/10/15 with swelling. The Physician's Emergency Room (ER) Report dated 4/10/15 3:35 PM revealed: "Chief Complaint: Lower extremity swelling. Severity is described as being severe. It has become recently worse...This started 4 days ago; C section 4 days ago. Physical Exam: Lower extremities exhibit normal ROM. No lower extremity edema. (12:07 PM) Hospital has no MgSO4 (Magnesium Sulfate) so we must transfer patient. Disposition: Transferred to higher level of care. Clinical Impression-Eclampsia in the puerperium." Patient #47 was transferred on 04/10/15 to a higher level of care.

Policies Reviewed:

Bylaws of Palo Pinto County Hospital District dated 4/22/14 and signed by Staff #166 revealed: "The Board of Directors is charged with the responsibility to evaluate and supervise the conduct of the Hospital, including the care and treatment of patients the procurement and direction of personnel governed by a governing board known as the Board of Directors ensure that all patients treated by the Hospital receive quality care; to provide a means of liaison with the Medical Staff; to initiate and maintain rules and regulations for the governing of the Hospital, the Medical Staff, and employees. At least one (1) member of the active and/ or courtesy Medical Staff, the Hospital Administrator, the Quality Assurance Coordinator, the Nursing Quality Coordinator Director of Nursing Services shall review and assess any issues relative to patient care in the Hospital and shall recommend to the Board of Directors any action deemed, in the opinion of the Committee, to be necessary to address these issues. The Board of Directors, through the Quality Assurance committee, shall direct all Hospital departments, Medical Staff members and other committees to report to the Quality Assurance Committee any quality issue, unusual incidents, or perceived patient care problems. The Administrator shall cooperate with the Medical Staff and require like rendering professional services to assure patients receive the best possible care available at this facility..."

Reportable Events, Recommended by Surgery Manager, Approved by Surgical Committee, Reviewed 1/13/10 by Staff #164 06/2014 revealed: "It is the policy to report all sentinel events to Quality/ Risk Management. This policy applied to Surgical Service Staff Reportable Events; unplanned return to the Operating Room, cardiac or respiratory arrest, Day Surgery patient requiring transfusion, admission to hospital bed, transfer to alternative post anesthesia recovery area, organ failure not present on admission, unanticipated transfer to another acute care facility."

Medical Staff Rules and Regulations, Approved by Medical Staff 3/17/15, Approved by Board of Directors 4/28/15, and revealed: "A member of the Medical Staff shall be responsible for the medical care and treatment of each patient in the hospital."


Interviews include:

An interview with Staff #3 at Palo Pinto General Hospital was conducted on 9/30/2015 9:10 AM in the administrative office. Staff #3 was asked if any doctors that had been to peer review had been referred to the Medical Board, she stated, "No doctors have been referred to the medical board. There have not been any doctors referred for Peer Review in 2014 or 2015 because we have been revamping our peer review policies and process."

QUALIFIED DIETITIAN

Tag No.: A0621

Based on record review and interviews, the hospital failed to have a dietician that supervised the nutritional aspects of patient care for 1 of 1 patient (Patient #8) in that Patient #8 had no dietitian assessment/reassessments throughout eight months of multiple hospitalizations with surgeries (2/20/14-10/7/14) to ensure the nutritional needs of Patient #8 were met.

Findings include:

Review of records:

Patient #8 was admitted through day surgery (2/20/14) by Physician #37 who performed an extensive vulvar carcinoma resection. The wound dehisced on Post-op Day #3, the day after the patient was discharged from the hospital and resulted in a necrotic wound. This was followed at this hospital by multiple hospitalizations with necrotic tissue debridements of the surgical wound and a temporary colostomy that was later reversed.

Protein nutritional labwork (9/20/14): Total Protein 6.2 L (low, normal range 6.4-8.2); Albumin 1.7 L (low, normal range 3.5-5.0); Prealbumin 3.8 L (low, normal range 16-38). Labwork (10/1/14): Total Protein 5.7 L.

Physician #35 documented (9/24/14): "Pt severely malnourished..."

Physician #35 consulted (9/30/14): "Dehydration (Patient #8) refused to eat or drink, became profoundly hypotensive, given several fluid boluses and started on both Neo-Synephrine and dopamine. After 2 hours of resuscitation, Patient #8 appears to be more stable, hypotension and acute renal failure secondary to both dehydration and some level of infection, continue pressor support as needed, continue ventilator, fluid resuscitation at this time, in significant organ failure, condition is critical."

Patient #8 was begun on TPN (Total Parenteral Nutrition) 10/1/14 "per pharmacy protocol (Physician #35's Progress Note 10/1/14)." This was the first time the patient was on parenteral (or enteral) nutritional therapy during the eight months of multiple hospitalizations.

Patient #8's multiple hospitalizations from 2/20/14-10/7/14 had no dietitian assessments, reassessments, or pertinent information documented.

Patient #8 eventually developed Sepsis and Disseminated Intravascular Coagulation (DIC), and was transferred to a higher level of care at a different hospital in an unresponsive state.

At the higher level of care hospital, Patient #8 was placed on Total Parenteral Nutrition (TPN), progressed to N/G (nasogastric) tube feedings, and improved enough to be weaned off mechanical ventilation. Patient #8 was discharged on 10/30/14 and had hospice care.


Policies and Procedures:

Nutrition Assessment, Recommended by MS (Master of Science), RD (Registered Dietitian), LD (Licensed Dietitian), Approved by former Staff #5, Effective Date 8/1/13 revealed: "All patients identified via nutrition screening mechanism by Continuous Nutrition Monitoring criteria will receive appropriate nutrition care. Evidence-based methods of evaluation and assessing nutrition needs will be consistently utilized. Purpose-To allocate nutrition resources to patients at nutrition risk...To provide standards for evaluating and assessing patient nutrient needs; Procedure: A patient identified via Continuous Nutrition Monitoring will be seen by the Clinical Nutrition Staff within 48 hours of identification Documentation of Nutrition Status Classification will be documented in the medical record. A complete nutrition assessment will be completed if the patient's Nutrition Status Classification is determined to be severely or moderately compromised. Nutrition Assessments should be evidence-based with a consistent method of evaluating weight status, and assessing macronutrient and fluid requirements..."

(Nutrition) Reassessment and Follow-up, Recommended by MS (Master of Science) RD (Registered Dietitian), LD (Licensed Dietitian), Approved by former Staff #5, Effective Date 8/1/13 revealed: "All patients will receive ongoing assessment of nutrition status and follow-up care. Follow-up care will include a review of the following, patient's appetite, changes in weight status and nutrition-related lab values, changes in medical condition and/or treatment."

Interviews include:

Physician #35 was interviewed 10/5/15 at 3:10 PM and asked about Patient #8's nutritional needs. The physician stated Patient #8 was severely depressed and it was a constant battle to get the patient to eat and was not sure if the patient did not feel like eating or if Patient #8 had just given up. The physician was asked if physicians considered an N/G (nasogastric) tube or TPN (Total Parenteral Nutrition) feedings. Physician #35 stated she did not remember.

Staff #4 was interviewed 10/6/15 at 9:55 AM and asked to provide dietitian assessments and notes for Patient #8. Staff #4 stated the Registered Dietitian employed during the times of Patient #8's multiple hospitalizations over eight months (2/20/14-10/7/14) failed to perform any dietary assessments on the patient. Staff #4 stated, "I have to admit that we have dropped the ball on the dietitian."