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Based on review of medical records, personnel files, policies, Delaware Regulations, Medical Staff bylaws and staff interview, it was determined that for 1 of 2 (50%) physicians' assistants (PAs) in the sample (Physician Assistant A), the hospital failed to ensure that the PA writing medication orders had prescriptive authority as required. Findings include:

According to the Division of Professional Regulation, 1700 Board of Medical Licensure and Discipline, Section 25.0, "Physician's Assistant...Prescriptive Authority...is a delegated medical service by the supervising physician...PAs will be assigned a provider identifier number as outlined by the Division of Professional Regulation...Controlled Substances registration will be as follows:...PAs must register with the Drug Enforcement Agency (DEA) and use such DEA number for controlled substance prescriptions...PA prescriptions for a controlled substance must include the PA's DEA number, as well as Professional Regulation provider identifier number..."

The hospital's bylaws entitled "Medical Staff Rules and Regulations" stated, "...Attending physician's supervising their Allied Health Professionals may not delegate...except to qualified Physician Assistants ...and must countersign all...orders...dictated/written by the assistant within 24 hours...PA's who have prescriptive authority in Delaware do not require cosigners for...orders..."

A. Personnel file review revealed that Physician Assistant A, appointed as a chief physician assistant, became an employee of the hospital on 5/17/10. Physician Assistant A was licensed by the State of Delaware as a PA; however, his license did not include authority to prescribe medications.

During an interview on 3/24/11 at 1:10 PM, Director of Quality Management and Performance Improvement A and Medical Credentialing Coordinator A confirmed this finding.

B. Review of medical records for Patient #'s 2 and 3 revealed the following:

1. Patient #2 - Medication orders
2/3/11 at 3:45 PM "Cardiothoracic Post-Operative Orders"
- Physician Assistant A wrote post-operative orders for 29 medications which included narcotics (controlled substances)

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:35 AM, the Director confirmed that the orders written by Physician Assistant A had not been co-signed by Physician #1, and that Physician Assistant A did not have prescriptive authority.

2. Patient #3 - Medication orders
2/28/11 "Cardiothoracic Post-Operative Orders"
- Physician Assistant A wrote post-operative orders for 32 medications which included narcotics

2/28/11 "Physician's Orders"
- Physician Assistant A wrote five (5) medication orders (timed at 8:40 PM, 10:07 PM, 10:15 PM, 11:20 PM and 11:21 PM)

3/1/11 "Physician's Orders"
- Physician Assistant A wrote 16 medication orders (timed at 12:05 AM; 12:25 AM; 2:10 AM, 2:40 AM, 3:15 AM, 3:45 AM; 4:23 AM, 4:26 AM, 4:33 AM, 5:10 AM, 7:13 AM, 6:36 PM, 6:40 PM, 10:00 PM, 10:30 PM and 11:22 PM)

3/2/11 "Physician's Orders"
- Physician Assistant A wrote two (2) medication orders (timed at 3:30 AM and 5:10 AM)

3/2/11 "Physician's Orders"
- Physician Assistant A signed a telephone order dictated by Physician #2 (timed at 5:00 AM)

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:45 AM, the Director confirmed that Physician Assistant A did not have prescriptive authority, the orders written by Physician Assistant A lacked Physician #1's co-signature and Physician Assistant A was not authorized to complete medication orders without supervising Physician #1's co-signature. In addition, the Director confirmed that Physician Assistant A had no authority to sign Physician #2's telephone order.

Based on review of medical records, personnel files, policies, Delaware Regulations, Medical Staff bylaws and staff interview, it was determined that for 1 of 2 (50%) physicians' assistants (PAs) in the sample ordering medications (Physician Assistant A), the governing body failed to ensure that the PA, working under the supervision of the physician, had prescriptive authority. Findings include:

According to the Division of Professional Regulation, 1700 Board of Medical Licensure and Discipline, Section 25.0, "Physician's Assistant...Prescriptive Authority...is a delegated medical service by the supervising physician...PAs will be assigned a provider identifier number as outlined by the Division of Professional Regulation...Controlled Substances registration will be as follows:...PAs must register with the Drug Enforcement Agency (DEA) and use such DEA number for controlled substance prescriptions...PA prescriptions for a controlled substance must include the PA's DEA number, as well as Professional Regulation provider identifier number..."

The hospital's bylaws entitled "Medical Staff Rules and Regulations" stated, "...Attending physician's supervising their Allied Health Professionals may not delegate...except to qualified Physician Assistants ...and must countersign all...orders...dictated/written by the assistant within 24 hours...PA's who have prescriptive authority in Delaware do not require cosigners for...orders..."

A. Personnel file review revealed that Physician Assistant A, appointed as a chief PA, became an employee of the hospital on 5/17/10. Physician Assistant A was licensed by the State of Delaware as a PA; however, his license did not include authority to prescribe medications.

During an interview on 3/24/11 at 1:10 PM, Director of Quality Management and Performance Improvement A and Medical Credentialing Coordinator A confirmed this finding.

B. Review of medical records for Patient #'s 2 and 3 revealed the following:

1. Patient #2 - Medication orders
2/3/11 at 3:45 PM "Cardiothoracic Post-Operative Orders"
- Physician Assistant A wrote post-operative orders for 29 medications which included narcotics (controlled substances)

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:35 AM, the Director confirmed that the orders written by Physician Assistant A had not been co-signed by Physician #1, and that Physician Assistant A did not have prescriptive authority.

2. Patient #3 - Medication orders
2/28/11 "Cardiothoracic Post-Operative Orders"
- Physician Assistant A wrote post-operative orders for 32 medications which included narcotics

2/28/11 "Physician's Orders"
- Physician Assistant A wrote five (5) medication orders (timed at 8:40 PM, 10:07 PM, 10:15 PM, 11:20 PM and 11:21 PM)

3/1/11 "Physician's Orders"
- Physician Assistant A wrote 16 medication orders (timed at 12:05 AM; 12:25 AM; 2:10 AM, 2:40 AM, 3:15 AM, 3:45 AM; 4:23 AM, 4:26 AM, 4:33 AM, 5:10 AM, 7:13 AM, 6:36 PM, 6:40 PM, 10:00 PM, 10:30 PM and 11:22 PM)

3/2/11 "Physician's Orders"
- Physician Assistant A wrote two (2) medication orders (timed at 3:30 AM and 5:10 AM)

3/2/11 "Physician's Orders"
- Physician Assistant A signed a telephone order dictated by Physician #2 (timed at 5:00 AM)

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:45 AM, the Director confirmed that Physician Assistant A did not have prescriptive authority, the orders written by Physician Assistant A lacked Physician #1's co-signature and Physician Assistant A was not authorized to complete medication orders without supervising Physician #1's co-signature. In addition, the Director confirmed that Physician Assistant A had no authority to sign Physician #2's telephone order.

Based on medical record review, policy review and staff interview, it was determined that for 1 of 2 (50%) patients in the sample (Patient #4) with communication barriers secondary to hearing impairment, the hospital utilized a minor child to provide interpreter services. Findings include:

The hospital policy entitled "Interpreting Services" stated, "...Interpreter services and persons skilled in communicating with...hearing impaired individuals shall be available to patients in the...emergency services...A minor child 15 years of age or younger should not be utilized under any circumstances..."

On 3/1/11, the State Agency received an anonymous complaint regarding the use of a minor child (age 8) to provide interpretive services (sign language) for Patient #4 during St. Francis Hospital emergency room encounters.

Patient #4's "Consent to Hospital Admission and Medical Treatment Financial Information / Authorization Form" dated 3/18/11 stated, "...You have the right to have medical treatment options clearly explained to you..."

Review of the "Emergency Provider Record" dated 3/18/11 at 9:21 PM, revealed that at the time of physical assessment, Patient #4's medical history was provided by patient and family. Nurse Practitioner A documented that Patient #4's son interpreted using sign language.

During an interview with registered nurse (RN) A on 3/25/11 at 2:55 PM, RN A reported that Patient #4's son and mother were present during the 3/18/11 emergency department encounter. RN A confirmed that Patient #4's son provided information through the use of sign language.

Based on medical record review, policy review and staff interview, it was determined that the medical record for 1 of 3 (33%) cardiovascular intensive care unit (CVICU) patients in the sample (Patient #3), was incomplete and failed to provide evidence of assessment and treatment. Findings include:

The hospital policy entitled "CVICU Nursing Care flow Sheet, Use of form 04-468" stated, "...In CVICU assessments are at least every two hours. If the assessment does not change, the assessment does not need to be written again..."

The hospital policy entitled "Blood & Blood Products Transfusion Record, Guidelines For, Use Of" stated, "...record...the donor unit number...the amount and type of blood product...the time the transfusion is initiated...the time the transfusion is completed or discontinued...vital signs are recorded by the nurse...15 minutes after the transfusion is started, hourly during transfusion and 15 minutes after completion of the transfusion...Yes...or...No is checked to indicate whether a transfusion reaction occurred...complete back of transfusion tag..."

The hospital policy entitled "Administration of Blood/Blood Components" stated, "...Two nurses...must sign the Transfusion Record (tag)...retain chart copy of transfusion tag in patient's chart..."

Patient #3 - Open heart surgery 2/28/11

Review of the medical record revealed that on 3/1/11, Patient #3 was ventilator dependent (assisted breathing), had chest tubes (used to promote drainage of air and fluid or re-expansion of the lung) and was connected to an intra-aortic balloon pump (a mechanical pump used in critical patients to increase the oxygen supply to the heart and the heart's ability to pump blood). During an interview with Director of Critical Care A on 3/28/11 at 11:40 AM, the Director described Patient #3 as "very unstable" on 3/1 - 3/2/11.

A. Review of Patient #3's patient care flow sheet and physician's orders of 3/1/11 revealed interventions/changes in the patient's condition as follows:

6:00 AM - heart rate increased and changed from sinus rhythm (normal beating of the heart) to atrial fibrillation (abnormal beating of the heart), 12 lead EKG (electrocardiogram) obtained

7:09 AM - cardiologist ordered Amiodarone (medication to control heart rate and rhythm)

7:13 AM - abnormal blood glucose levels, started on continuous intravenous (IV) insulin

8:00 AM - ventilator settings changed (breathing rate was increased and positive end expiratory pressures were increased)

11:00 AM - morphine (pain medication) administered

1:00 PM - ventilator settings changed (flow of oxygen increased from 65% to 100%)

2:00 PM - ventilator settings changed and 2 (two) continuously delivered IV medications (Epinephrine and Dopamine) to assist the heart's function/improve blood pressure were increased

4:00 PM - continuous IV administration of Levophed (medication to increase blood pressure) was increased

5:00 PM - rate of Levophed was again increasedB. Review of Patient #3's patient care flow sheet dated 3/1/11, revealed that nursing staff failed to provide documented evidence that complete neurological, respiratory, gastrointestinal and wound assessments were conducted between 6:00 AM and 6:00 PM as required, despite documented changes in the patient's condition.

C. Review of "Physician's Orders" dated 3/1/11 revealed the following orders for blood/blood products:

1. 2:30 AM - To give 1 unit of packed red blood cells (Transfusion #1)

Review of the 3/1/11 patient care flow sheet included documentation that 1 unit of packed red blood cells was initiated as a 2:00 AM intervention. The donor unit (blood product identification) number was placed on the flow sheet as a 2:30 AM intervention.

2. 3:15 AM - To give 1 unit of platelets immediately (Transfusion #2)

Review of the 3/1/11 patient care flow sheet included documentation that 1 unit of platelets was initiated at 4:00 AM. The donor unit (blood product identification) number was not documented/placed on the patient care flow sheet.

3. 6:36 PM - To give 1 unit of packed red blood cells immediately (Transfusion #3)

Review of the 3/1/11 patient care flow sheet included documentation that 1 unit of packed red blood cells was initiated as an 8:00 PM intervention. The donor unit (blood product identification) number was placed on the patient care flow sheet as either an 8:00 PM or 8:30 PM intervention.

Review of the medical record lacked evidence of a "transfusion tag", for Transfusion #'s 1, 2 and 3. The "transfusion tag" required per policy, would have provided evidence of the two required witnesses, the actual time the transfusion began and ended and any reaction that was observed or reported during the blood/blood product transfusion. In addition, there was no documentation to support that Patient #3's vital signs were obtained 15 minutes after the initiation of the blood/blood product transfusion or that vital signs were obtained 15 minutes after the completion of Transfusion #'s 1, 2 and 3.

On 3/28/11 at 11:40 AM, Patient #3's medical record was reviewed with Director of Critical Care A. The Director confirmed that nursing staff failed to document patient assessments every two hours as per policy on 3/1/11 at 6:00 AM, 8:00 AM, 10:00 AM, 12:00 PM, 2:00 PM and 4:00 PM. In addition, the Director confirmed that the required blood transfusion documentation for 3/1/11 was incomplete.

Based on review of medical records, Medical Staff bylaws, Delaware Regulations, policies and staff interview, it was determined that for 2 of 3 (67%) medical records in the sample (Patient #'s 2 and 3) containing orders written by a physician assistant (PA), the physician failed to authenticate written orders as required. Findings include:

According to the Division of Professional Regulation, 1700 Board of Medical Licensure and Discipline, Section 25.0, "Physician's Assistant...Prescriptive Authority...is a delegated medical service by the supervising physician..."

The hospital's bylaws entitled "Medical Staff Rules and Regulations" stated, "...Attending physician's supervising their Allied Health Professionals may not delegate...except to qualified Physician Assistants ...and must countersign all...orders...dictated/written by the assistant within 24 hours...PA's who have prescriptive authority in Delaware do not require cosigners for...orders..."

The hospital's bylaws entitled "Medical Staff Rules and Regulations - Coordination of Care" stated, "...the practitioner should sign, date and time telephone orders within 48 hours..."

A. Personnel file review revealed that Physician Assistant A was licensed by the State of Delaware as a PA; however, his license did not include authority to prescribe medications.

During an interview on 3/24/11 at 1:10 PM, Director of Quality Management and Performance Improvement A and Medical Credentialing Coordinator A confirmed this finding.

B. Review of medical records for Patient #'s 2 and 3 revealed that Physician Assistant A documented medication orders as follows:

1. Patient #2
2/3/11 "Cardiothoracic Post-Operative Orders"
- no authentication for 29 medications

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:35 AM, the Director confirmed that the orders written by Physician Assistant A had not been authenticated by Physician #1, and that Physician Assistant A did not have prescriptive authority.

2. Patient #3
2/28/11 "Cardiothoracic Post-Operative Orders"
- no authentication for 32 medications

2/28/11 "Physician's Orders"
- no authentication for five (5) medication orders

3/1/11 "Physician's Orders"
- no authentication for 16 medication orders

3/2/11 "Physician's Orders"
- no authentication for two (2) medication orders

3/2/11 "Physician's Orders"
- Physician Assistant A signed a telephone order dictated by Physician #2

During an interview with Director of Quality Management and Performance Improvement A on 3/25/11 at 11:45 AM, the Director confirmed that Physician Assistant A did not have prescriptive authority and was not authorized to complete medication orders without supervising Physician #1's co-signature. Director A confirmed that the orders dated 2/22, 2/28, 3/1 and 3/2/11, had not been authenticated by Physician #1 and Physician Assistant A had no authority to sign Physician #2's 3/2/11 telephone order.