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Based on observation, record review, and interview, the hospital failed to meet the requirement of the Condition of Participation for Nursing Services as evidenced by:

1. the RN delegating the responsibility to Licensed Practical Nurses to supervise, train and evaluate the skills and competencies of unlicensed patient care providers (Medical Assistants) in the Children's Hospital Medical Practice Clinics (CHMPC) which are offsite facilities licensed under the hospital. (See findings A-0397)


2. the RN delegating complex tasks to unlicensed patient care providers (Paramedics) employed in the ED at the hospital. (See findings A-0397)


3. the hospital failing to ensure drugs and biological's were prepared and administered in accordance with scope of practice laws and hospital policies as evidenced by failing to have licensed personnel mixing and administering Xylocaine and Rocephin to pediatric patients in the primary care clinics which are offsite facilities licensed under the hospital. (See findings A-0405)


31048

Based on record review and interview, the hospital failed to ensure that the RNs:

1) Supervised, trained, and evaluated the skills and competencies of unlicensed patient care providers (Medical Assistants) employed in the CHMPC which are offsite facilities licensed under the hospital, and

2) Delegated only non-complex tasks to unlicensed patient care providers (Paramedics) employed in the ED at the hospital.

Findings:

Review of the LSBN's "Administrative Rules Defining RN Practice LAC46: XLVII §3703. Definition of Terms Applying to Nursing Practice" revealed that the RN retains the accountability for the total nursing care of the individual and is responsible for and accountable to each consumer of nursing care for the quality of nursing care he or she receives, regardless of whether the care is provided solely by the RN or by the RN in conjunction with other licensed or unlicensed assistive personnel. The RN shall assess the patient care situation which encompasses the stability of the clinical environment and the clinical acuity of the patient, including the overall complexity of the patient's health care problems. This assessment shall be utilized to assist in determining which tasks may be delegated and the amount of supervision which will be required. Any situation where tasks are delegated should meet the following criteria:

a) the person has been adequately trained for the task;

b) the person has demonstrated that the task has been learned;

c) the person can perform the task safely in the given nursing situation;

d) the patient's status is safe for the person to carry out the task;

e) appropriate supervision is available during the task implementation;

f) the task is in an established policy of the nursing practice setting and the policy is written, recorded and available to all.


Review of Louisiana State Board of Nursing's Chapter 37 Nursing Practice, 3703 Definition of Terms Applying to Nursing Practice, Revised Statute 37:913, (13) and (14) revealed the following information under the definition for "Delegating Nursing Interventions": "... iv. Contingent upon the registered nurse's evaluation of each patient's condition and also upon the registered nurse's evaluation of the competency of each unlicensed nursing personnel, registered nurses may delegate non-complex tasks to unlicensed nursing personnel. (a) A non-complex task is one that can safely be performed according to exact directions, with no need to alter the standard procedure, and the results are predictable. (b) A complex task is one that requires judgment to safely alter the standard procedure in accordance with the needs of the patient; or requires the consideration of a number of factors in order to perform the procedure; or requires judgment to determine how to proceed from one step to the next. (c) The administration of medications is a complex task because it requires the consideration of a number of factors and the formulation of judgments according to those factors."

1) RNs assigning responsibility to LPNs to supervise, train, and evaluate the skills and competencies of unlicensed patient care providers (Medical Assistants) employed in the Children's Hospital Medical Practice Clinics (CHMPC) which are offsite facilities licensed under the hospital:

Review of the CHMPC Organizational Chart, with a revision date of 03/16, revealed S25 was the Director of CHMPC clinics, and her immediate supervisor was S16Physician, Vice President and Executive Director of CHMPC. Eleven (11) primary care clinics were listed on the organizational chart with various combinations of LPNs, MAs, PSRs, File Clerks, and RNs assigned to work the 11 clinics.


An interview was conducted with S25Director of CHMPC on 04/26/16, at 12:00 p.m. She reported she was the director over the CHMPC. She reported the clinics are primary care clinics for pediatric patients. These clinics are located in and around New Orleans, Covington, Baton Rouge, and the Northshore areas. She further reported the LPNs in these clinics are under the supervision of the Director of Nurses at the hospital and the MAs are under the supervision of the physicians in the clinic.


An interview was conducted with S23LPN at Clinic A on 04/26/16 at 12:30 p.m. She reported there were 3 LPNs and 4 MAs that worked at Clinic A. She further reported the job duties are rotated equally between the MAs and the LPNs. There are usually two staff members performing triage, 1 floater (assisting where needed), 1 staff member (LPN or MA) assigned to each physician. There are 5 physicians located at Clinic A. S23LPN reported her job duties included assisting patients and physicians, drawing up medications, and administering medication (usually by intramuscular or subcuteaous route). Both the LPN and the MA draw up and administer the medications. S23LPN further reported the LPNs trained the MAs, and the only skills the MAs didn't do in Clinic A that the LPNs do are catheterizations and starting IVs (intravenous lines).


An interview was conducted with S21LPN on 04/27/16, at 1:00 p.m. She reported she had worked at Clinic A for 15 years. Her job duties entail bringing patients to their rooms, taking vital signs, handling patient calls if they have questions about dose of a medication, illness etc. S21LPN reported if she didn't know the answer to the patient's question, she would send a message (task) to the physician. S21LPN further reported S23LPN and herself trained the MAs.


An interview was conducted with S19MA on 04/26/16, at 1:15 p.m. She reported her job duties include administering immunizations and medications; testing for flu, strep, and RSV; calling in medication refills; answering phone calls; and monitoring and maintaining the lab in Clinic A. S19MA further reported she can answer some of the questions the patients have on the phone without the assistance of the physician, but some issues she has to discuss with the physician if she doesn't know the answer.


An interview was conducted with S20MA on 04/26/16, at 1:35 p.m. She reported her job duties include administering medications to the patients, including drawing up and mixing Xylocaine and Rocephin together in a syringe, and administering IM injections to the patients. She further reported with patients that are under 3 months of age, the Rocephin is diluted with sterile water, not Xylocaine due to the patient's age. When the surveyor questioned S20MA on how much diluent she diluted the Rocephin with, she reported it depended on the amount of Rocephin the physician ordered. When the surveyor asked to see what information she used to determine her diluent amount, she presented the surveyor the insert to the Rocephin vial.


An interview was conducted with S25Director of CHMPC on 04/26/16, at 1:30 p.m. She reported the clinics did not have a policy on how to mix Xylocaine and Rocephin together in a syringe and administer the medication to the patients.


An interview was conducted with S16Physician, Vice President and Executive Director of CHMPC on 04/27/16, at 3:30 p.m. He reported the LPNs in the clinic had been evaluating the MAs, assessing the skills and competencies of the MAs, and training the MAs.


Review of the personnel record for S17MA revealed she was hired on 02/13/15, and her evaluation was conducted on 06/18/15, by S23LPN. S17MA's annual Waived Testing Competency was performed by S23LPN on 05/13/15, and her Competency Checklist was performed by S23LPN on dates between 02/16/15 to 04/3/15.


Review of the personnel record for S19MA revealed she was hired on 02/13/15, and her evaluation was conducted on 06/19/15, by S23LPN. S19MA's annual Waived Testing Competency was performed by S23LPN on 05/14/15, and her Competency Checklist was performed by S23LPN on dates between 02/16/15 to 04/10/15.


Review of the personnel record for S20MA revealed she was hired on 10/02/06, and her evaluation was conducted on 06/18/15, by S23LPN. S19MA's annual Waived Testing Competency was performed by S23LPN on 05/13/15, and a partial Competency Checklist was performed by S23LPN on 10/01/2013, which was her latest Competency Checklist.


Review of the personnel record for S18MA revealed she was hired on 04/07/00, and her last evaluation was conducted on 06/17/15, by S23LPN. S18MA's annual Waived Testing Competency was performed by S23LPN (Competency was not dated) and a partial Competency Checklist was performed by S23LPN on 02/06/2014, which was her latest Competency Checklist.


Review of the competencies of skills for S21LPN, S22LPN, S23LPN, S17MA, S18MA, S19MA, S20MA revealed there were no competencies documented for mixing Rocephin and Xylocaine and administering the medication to a patient.


An interview was conducted with S25Director of CHMPC on 04/26/16, at 1:30 p.m. and she verified there were no competencies for the MAs and LPNs for mixing Rocephin and Xylocaine in the clinic.


2) RNs delegating complex tasks to unlicensed patient care providers (Paramedics) employed in the ED at the hospital:


Review of the ED Staff Roster revealed there were 3 Paramedics employed in the ED (S27Paramedic, S28Paramedic, S29Paramedic).


Review of the Job Description for the Job Title, " Emergency Department Paramedic " with a revised date of 01/14, revealed, in part: " General Summary: . . Provides care under the direction of Emergency Department nursing staff in the evaluation and treatment of patients. This includes selected invasive and non-invasive procedures, treatments, documentation, and patient/family teaching. Principal Duties and Responsibilities: 1. Initiates ordered interventions and diagnostic procedures while maintaining aseptic/sterile technique as appropriate: . . . b. Interventions: C-Spine and spinal immobilization; splints to suspected or actual fractures including hair traction splint; Orthopedic dressing-clavicle strap, cervical collars, slings, ACE wraps, knee immobilizer; Fits crutches and teaches crutch walking; Performs oral, naso-pharynx, endotracheal suctioning; Cleans wounds and applies sterile and non-sterile dressing; Initiates peripheral intravenous therapy and locks in accordance with hospital policy and ED policy; Instills saline for peripheral lock in accordance to policy. 2. Under the direction/supervision of a Registered Nurse and/or Physician, performs patient assessment after initial triage: a) Utilizes clinical judgment, reports changes; c. Establishes priorities of care. . . "


In an interview on 04/26/16, at 1:30 p.m., S9RN indicated the ED at the hospital does employ Paramedics. She also indicated the Paramedics provide care to patients in the ED under the responsibility and supervision of the Nursing Department. S9RN indicated the Paramedics in the ED perform certain delegated tasks, but do not administer medications.


In an interview on 04/26/16, at 2:15 p.m., S10MD indicated the Paramedics are under the supervision of the nursing staff, and the Paramedics do not administer any type of medications to patients in the ED. He further indicated the Paramedics do initiate intravenous access on patients, but do not give any medications through the intravenous access.



31048

Based on record review and interview, the hospital failed to ensure drugs and biologicals were prepared and administered in accordance with scope of practice laws and hospital policies as evidenced by:


1. failing to have licensed personnel mixing and administering Xylocaine and Rocephin to pediatric patients in the primary care clinics which are offsite facilities licensed under the hospital.


2. failing to have a policy and procedure on the administration of Xylocaine and Rocephin in the primary care pediatric clinics which are offsite facilities licensed under the hospital.


Findings:


1. Review of the Advisory Opinion from the Louisiana State Board of Medical Examiner, dated 07/18/12, revealed in part, it has been a long standing opinion of the board that delegation such as administration of drugs or immunizations, may be undertaken or performed by an unlicensed individual in this state who functions solely under a Louisiana licensed physician's directions and immediate supervision-i.e.., where the physician is physically present in the office or suite at all times an unlicensed assistant is providing the service and retains full responsibility to patients for training, delivery and results of all services rendered. An unlicensed individual filling such a position could not-and may not be permitted under any circumstances to act independently of a licensed physician or exercise independent medical judgment in selecting or administering drugs or immunizations. If an unlicensed individual acts beyond this scope he or she (and perhaps the physician as well) would be in violation of the Louisiana Medical Practice Act.


An interview was conducted with S20MA on 04/26/16, at 1:35 p.m. She reported her job duties include administering medications to the patients including mixing Xylocaine and Rocephin together in a syringe and administering IM injections to the patients. She further reported with patients that are under 3 months of age, the Rocephin is diluted with sterile water, not Xylocaine, due to the patient's age. When the surveyor questioned S20MA about how much diluent she diluted the Rocephin with, she reported it depended on the amount of Rocephin the physician ordered. When the surveyor asked to see what information she used to determine her diluent amount, she presented the surveyor the insert to the Rocephin vial.


An interview was conducted with S16Physician, Vice President and and Executive Director of CHMPC on 04/27/16, at 3:30 p.m. S16Physician indicated the nurses in the clinic had been providing the training to the MAs.


2. Review of the Outpatient Physician Clinic's policy for Medication Administration-All Routes, revised date of 02/24/16, revealed in part, 1. In Primary Care Clinics, MD, RNs, and MAs may administer medications. Further review of the policy revealed no procedure/information on how to mix Xylocaine and Rocephin together to administer to a patient.


An interview was conducted with S25Director of CHMPC on 04/26/16, at 1:30 p.m. She reported the clinics did not have a policy on how to mix Xylocaine and Rocephin and administer the medication to the patients.

Based on record review and interview, the hospital failed to ensure the organization of the medical record service was appropriate to the scope and complexity of the services provided as evidenced by the Medical Record Service of the main hospital not monitoring, maintaining, and ensuring the patients' medical records from the CHMPC clinics, which are offsite facilities licensed under the hospital, were complete and reviewed for documentation standards.


Findings:


Review of the hospital policy, Analysis of Medical Record in EDM, revised 03/12, revealed in part, each chart is reviewed according to documentation standards to determine if a chart has all appropriate documents and authentications.


An interview was conducted with S24HIM Supervisor on 04/27/16, at 12:50 p.m. She reported the CHMPC clinic records were not a part of the Hospital Medical Record Services.


An interview was conducted with S25Director of CHMPC on 04/27/16, at 2:00 p.m. She reported the Medical Records Department does not review the CHMPC patient records for completeness. She further reported only S16Physician monitored the CHMPC medical records for completeness.

Based on observation and interview, the hospital failed to ensure all patients' medical records were protected from water and fire damage as evidenced by patients' medical records being stored on open shelving.


Findings:


An observation was conducted on 04/26/16, at 1:00 p.m. of patients' medical records being stored on open shelving in a large room.


An interview was conducted with S25Director on 04/26/16, at 1:00 p.m. She reported the medical records on the open shelving are patients' medical records prior to implementing electronic medical records in Clinic A (an offsite facility of the hospital). She confirmed the patients' records were not protected from water and fire damage.

Based on record review and interview, the hospital failed to ensure drugs and biologicals were under the supervision of a pharmacist as evidenced by the Director of Pharmacy being unaware unlicensed personnel in the CHMPC clinics, which are offsite facilities of the hospital, were mixing Xylocaine and Rocephin and administering to patients.


Findings:


Review of the Administrative Code Title 46- Professional and Occupational Standards, PartLIII: Pharmacist; 1509. Drug Distribution Control; revealed in part, A. The hospital pharmacist-in-charge shall be responsible for the safe and efficient procurement, receipt, distribution, control, accountability, and patient administration and management of drugs.


Review of the Outpatient Physician Clinics policy for Medication Administration-All Routes, revised date of 02/24/16, revealed in part, 1. In Primary Care Clinics, MD, RNs, and MAs may administer medications. Further review of the policy revealed no policy/ procedure/information on how to mix Xylocaine and Rocephin to administer to a patient.


An interview was conducted with S25Director of CHMPC on 04/26/16, at 1:30 p.m. She reported the clinics did not have a policy on how to mix Xylocaine and Rocephin and administer the medication to the patients.


An interview was conducted with S20MA on 04/26/16, at 1:35 p.m. She reported her job duties include administering medications to the patients, including mixing Xylocaine and Rocephin together in a syringe and administering IM injections to the patients. She further reported with patients that are under 3 months of age, the Rocephin is diluted with sterile water, not Xylocaine, due to the patient's age. When the surveyor questioned S20MA on how much diluent she diluted the Rocephin with, she reported it depended on the amount of Rocephin the physician ordered. When the surveyor asked to see what information she used to determine her diluent amount, she presented the surveyor the insert to the Rocephin vial.


An interview was conducted with S30Pharmacist, Director of Pharmacy of the Hospital, on 04/27/16, at 11:15 a.m. He reported he was not aware unlicensed personnel, Medical Assistants, were mixing Rocephin and Xylocaine in the CHMPC clinics and administering the medication per injection.

Based on observation, document review, and interview, the hospital failed to ensure staff in the operating rooms were compliant with infection control standards of practice as evidenced by incorrect use of personal protective equipment for head and hair coverage in restricted areas of the surgical suites.


Findings:


Review of the Association of periOperative Registered Nurses Guidelines for Perioperative Practice, 2015 edition, revealed the Guideline for Surgical Attire, Recommendation III, included, in part: "All personnel should cover head and facial hair, including sideburns, the ears and nape of the neck, when in semi-restricted and restricted areas. Human hair can be a site of pathogenic bacteria such as MRSA. Hair acts as a filter when it is uncovered and collects bacteria. A clean, low-lint surgical head covering or hood that confines all hair and covers scalp skin and ears should be worn. The head covering or hood should be designed to minimize microbial dispersal. Skull caps (surgeon caps) fail to contain the side hair above and in front of the ears and hair at the nape of the neck and the ears, and should not be worn."


A tour of the surgical suites was conducted on 04/26/16, beginning around 12:30 p.m. An observation was made in Operating Room #1 of a surgical procedure being performed by S31Physician and S32Physician. It was observed that S31Physician had donned a skull (surgeon) cap for the procedure, and short strands of hair were protruding out from the bottom of the skull cap on the side of his head, behind his ear, and at the nape of his neck. It was further observed that S32Physician had donned a skull cap for the procedure, and short strands of hair were protruding out from the bottom of the cap onto his forehead, around the side of his head behind his ear, and at the nape of his neck. In an interview on 04/26/16, S6RN agreed that the surgeons had hair protruding out from under the skull caps and confirmed this was a breach of infection control standards of care and practices for restricted areas in the surgical suites.


An observation on 04/26/16, was made of S33ST in Operating Room #8 preparing the room (opening up supplies) for an upcoming surgical procedure. It was observed that S33ST had hair protruding out from the bottom of the head cover on the side of her head and at the nape of her neck.


In an interview on 04/26/16, S6RN agreed S33ST had hair protruding out from the bottom of her head cover on the side and at the nape of her neck, and S6RN confirmed this was a breach of infection control standards of care and practices for restricted areas in the surgical suites.