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Based on record review and interviews, the Hospital was determined to be at a conditional level of non-compliance for the Conditions of Participation for Nursing Services. Findings include:

1) The Hospital failed to ensure an RN evaluated intravenous care in accordance with nationally acceptable standards of nursing practice for 6 of 9 (Patient #1, #4, #5, #6, #7, and #10), emergency department patients, in a total sample of 10. The emergency department RN improperly delegated the task of insertion of peripheral intravenous catheters to clinical assistants, who were non-licensed personnel.

2) The Hospital failed for 6 of 9 emergency department patients (Patient #1, #4, #5, #6, #7, and #10), in a total sample of 10 hospital patients, to ensure patient care assignments were consistent with standards of practice. The emergency department RN delegated the task of insertion of peripheral intravenous (PIV) catheters to non-licensed clinical assistants, which was not consistent with nationally recognized standards of practice or in accordance with CMR 244: Board of Registration in Nursing.


3) Based on record review and interview, the Hospital failed for 6 of 9 emergency department patients (Patient #1,#4, #5, #6, #7, and #10), in a total sample of 10 hospital patients, to ensure medications were administered in accordance with nationally recognized standards of practice. A subset of clinical assistants who worked in the emergency department were allowed to insert peripheral intravenous catheters, which included the administration of normal saline solution intravenously to determine patency of the catheter and placement within the vein.


See A 395, A 397, and A 409.

Based on record review and interview, the Hospital failed to ensure an RN evaluated intravenous care in accordance with nationally acceptable standards of nursing practice for 6 of 9 (Patient #1, #4, #5, #6, #7, and #10), emergency department patients, in a total sample of 10. The emergency department RN improperly delegated the task of insertion of peripheral intravenous catheters to clinical assistants, who were non-licensed personnel. Findings include:

According to 244 CMR: Board of Registration in Nursing, Nursing Activities that may not be delegated: "By way of example, and not in limitation, the following are nursing activities that are not within the scope of sound nursing judgement to delegate: (a) Nursing activities which require nursing assessment and judgement during implementation; (b) Physical, psychological, and social assessment which required nursing judgement, intervention, referral, or follow-up; (c) Formulation of the plan of nursing care and evaluation of the patient's/clients's response to the care provided; (d) Administration of medications except as permitted by M.G.L. c. 94c."

The Hospital peripheral intravenous catheter insertion policy, dated 6/25/12, indicated nurses are qualified as competent before inserting peripheral intravenous catheters. The policy indicated an assessment is required for selection of the site for insertion and includes: assessment of patient's condition, age, diagnoses, co-morbidities, condition of vasculature at the insertion site and proximal to the intended site.

The Hospital's policy, on Intermittent Peripheral Intravenous Infusion, dated 5/24/10, indicated the policy was developed in part based on the references from the Intravenous Nurses Society 2006 Standards.

According to the Infusion Nurses Society, in a Position Statement provided to the Department on 10/30/13 indicated they, "reaffirm and strongly recommends that (Nursing Assistive Personnel) NAP not be used in direct provision of infusion therapies. INS recommends that only a qualified registered nurse who is knowledgeable in the scope and practice of infusion therapy should be involved in the assessment, planning, administration, and evaluation of infusion therapies. INS believes the delegation of procedures and activities related to the direct provision of infusion therapies to NAP may result in potential adverse outcomes to the patient and the public, and may increase liability risks for the registered nurse."


1. Patient #1's emergency department record, dated 1/27/13, indicated at 6:10 P.M., the physician ordered for Patient #1 to have a peripheral intravenous catheter inserted.

The Surveyor interviewed Family Member #1 at approximately 1:30 P.M. on 11/1/13. Family Member #1 said she, another family member, and her infant, (Patient #1) were present in the emergency department for evaluation of Patient #1's fractured right arm. Family Member #1 said while in the emergency department, two staff members who were not nurses, attempted two or three times to insert in intravenous catheter in Patient #1's arm, before calling an RN, who placed the catheter in Patient #1's foot. Family Member #1 said no RN was present while the non-licensed staff attempted to insert the catheter and she did not know how the two "technicians" or words to that effect, determined where to insert the intravenous catheter.

The Surveyor interviewed the Director of the Emergency Department and the Nurse Manager of the Emergency Department at approximately 9:20 A.M. and at 3:17 P.M. on 11/6/13. The Nurse Manager and Director of the Emergency Department said the ER was staffed with RNs and approximately 40 clinical assistants and some of the clinical assistants were trained to insert peripheral intravenous catheters.

Patient #1's record did not indicate two prior unsuccessful attempts to insert Patient #1's peripheral intravenous catheter. The record indicated that on 1/27/13, a peripheral intravenous catheter was inserted by an RN in Patient #1's foot.

The Director of the Emergency Department said although not documented in Patient #1's record, an investigation regarding a concern filed on Patient #1's behalf, indicated it was clear to her that two clinical assistants attempted to insert a peripheral catheter into Patient #1's arm during the emergency department visit on 1/27/13.

The Nurse Manager said she participated in investigating and responding to concerns regarding Patient #1's care on 1/26/13 and 1/27/13 at the emergency department. The Nurse Manager said three clinical assistants who worked on 1/27/13 were considered competent to insert peripheral catheters. The Nurse Manager said she did not interview any clinical assistants in an effort to investigate or respond to the concern regarding the care Patient #1 received in the emergency department on 1/27/13.

2. Patient #4's orders, dated 11/3/13, indicated at 2:39 P.M., the physician ordered for a peripheral intravenous catheter to be inserted in Patient #4.

The clinical care note, dated 11/3/13, indicated at 3:31 P.M., a clinical assistant inserted a 24 gauge peripheral intravenous catheter into Patient #4's right lower arm. The note indicated the clinical assistant documented the area was free of infiltration, phlebitis, patency of the catheter was established by flushing it with normal saline solution (intravenously), the catheter was secured, and a dressing was applied. The record indicated the catheter was next assessed by the RN at 7:19 P.M., more than three hours after it was inserted by the clinical assistant.

3. Patient #5's orders, dated 11/1/13, indicated at 6:04 P.M., a peripheral intravenous catheter was ordered.

The clinical care note, dated 11/1/13, indicated at 6:58 P.M., a clinical assistant inserted a 22 gauge peripheral intravenous catheter in Patient #5's right arm. The care note indicated the catheter was flushed with normal saline solution intravenously. The care note indicated the insertion site was next assessed by an RN at 9:42 P.M. on 11/1/3 when the catheter was discontinued.

4. Patient #6's orders, dated 11/1/13, indicated at 11:11 A.M., the physician ordered for Patient #6 to have a peripheral intravenous catheter inserted.

The clinical care note, dated 11/1/13, indicated a clinical assistant inserted the peripheral intravenous catheter at 12:05 P.M. in Patient #6's right arm.

5. Patient #7's clinical note, dated 10/30/13, indicated that at 4:36 P.M., a clinical assistant inserted a 20 gauge peripheral intravenous catheter in Patient #7's right wrist. Review of the record did not indicate any order for the catheter, although intravenous fluids were ordered for Patient #7 at 5:00 P.M. on 10/30/13.

6. Patient #10's orders, dated 11/2/13, indicated at 9:22 A.M., the physician ordered Patient #10 to have a peripheral intravenous catheter inserted.

The clinical care note, dated 11/2/13, indicated at 9:45 A.M., a clinical assistant inserted the peripheral intravenous catheter in Patient #10's right hand.

The Surveyor interviewed Nurse #1 at 9:45 A.M. on 11/6/13. Nurse #1 said when a patient required an intravenous catheter inserted, the nurses have the option of inserting the peripheral catheter themselves, asking another RN to perform the task, call the intravenous team, or ask a clinical assistant to insert the intravenous catheter. Nurse #1 said she felt confident asking a clinical assistant to insert the intravenous catheter because they were trained to perform the task. Nurse #1 said the tasks associated with the clinical assistants inserting a peripheral intravenous catheter would include the clinical assistant choosing what size catheter to use, the location where to insert the catheter into the patient, and flushing the catheter with saline from a pre-filled syringe.

The Surveyor interviewed Clinical Assistant #1 at 12:10 P.M. on 11/7/13. Clinical Assistant #1 said he did not specifically recall Patient #1. Clinical Assistant #1 said he normally worked in the emergency department and had done so as a clinical assistant until July 2013 when he became an RN. Clinical Assistant #1 said as a clinical assistant, he was trained by the Hospital to insert peripheral intravenous catheters in the arms of patients. Clinical Assistant #1 said normally a nurse would ask for him to insert a peripheral intravenous catheter and he would go to the patient to determine where to place the catheter. Clinical Assistant #1 said sometimes he obtained and applied heat to a site he thought may be a good choice to insert the peripheral catheter. Clinical Assistant #1 said the assistants were able to decide whether or not to apply heat without the nurse's input or permission. Clinical Assistant #1 said the clinical assistant who inserted the catheter decided which size catheter to use and where to place the catheter. Clinical Assistant #1 said after insertion, the catheter was flushed with normal saline from a pre-filled syringe. Clinical Assistant #1 said the catheter was secured and a dressing was applied, and the nurse was usually informed. Clinical Assistant #1 said the clinical assistants documented they inserted the catheter, including whether the area had symptoms of infiltration (abnormal assessment finding and an indication of fluid outside the vein) or phlebitis (abnormal assessment finding defined as inflammation of the vein).

The Surveyor interviewed the Associate Chief of Nursing at 10:15 A.M. and at 1:25 P.M. on 11/6/13. The Associate Chief of Nursing said there was a subset of 6 out of 40 clinical assistants, working in the emergency department who were considered competent to insert peripheral intravenous catheters. The Associate Chief of Nursing said the clinical assistants had to have previous experience inserting catheters and complete a training and competency program. The Associate Chief of Nursing said the RN would assess the site for stability after a peripheral intravenous catheter was inserted by the clinical assistant.

The Associate Chief of Nursing said she did not know when the practice of clinical assistants inserting peripheral intravenous catheters first began, but thought it could be longer than 10 years prior to survey. The Associate Chief of Nursing said decision was made after discussion with their legal department, representatives from the department of board of nursing, and pharmacy services. The Associate Chief of Nursing said the decision was brought to, and approved by the Governing Body, but did not have records regarding when this occurred.

The Associate Chief of Nursing said the clinical assistants did not infuse any medications though the catheter and said the pre-filled syringes of saline (used to establish patency of the inserted catheter) were not considered by the hospital pharmacy to be a medication, but rather were considered to be a "delivery device" or words to that effect, and therefore not a medication.

See A 409.

Based on record review and interview, the Hospital failed for 6 of 9 emergency department patients (Patient #1, #4, #5, #6, #7, and #10), in a total sample of 10 hospital patients, to ensure patient care assignments to clinical assistants was appropriate based on their lacking licensure status. The Hospital delegated the task of insertion of peripheral intravenous (PIV) catheters to non-licensed clinical assistants, which was not consistent with nationally recognized standards of practice or in accordance with CMR 244: Board of Registration in Nursing.

Findings include:

According to 244 CMR: Board of Registration in Nursing, Nursing Activities that may not be delegated are nursing activities that are not within the scope of sound nursing judgement to delegate, and include activities which require nursing assessment and judgement during implementation.

The Hospital peripheral intravenous catheter insertion policy, dated 6/25/12, indicated it applied to all clinicians. The policy indicated nurses were qualified as competent before inserting peripheral intravenous lines. The policy indicated an assessment is required for selection of the site for insertion and includes: assessment of patient's condition, age, diagnoses, co-morbidities, condition of vasculature at the insertion site and proximal to the intended site.

The Hospital's policy, on Intermittent Peripheral Intravenous Infusion, dated 5/24/10, indicated the policy was developed in part based on the references from the Intravenous Nurses Society 2006 Standards.

According to the Infusion Nurses Society, in a Position Statement provided to the Department on 10/30/13, they, "reaffirms and strongly recommends that (Nursing Assistive Personnel) NAP not be used in direct provision of infusion therapies. INS recommends that only a qualified registered nurse who is knowledgeable in the scope and practice of infusion therapy should be involved in the assessment, planning, administration, and evaluation of infusion therapies. INS believes the delegation of procedures and activities related to the direct provision of infusion therapies to Nursing Assistive Personnel may result in potential adverse outcomes to the patient and the public, and may increase liability risks for the registered nurse."

1. Review of Patient #1's record indicated a peripheral intravenous catheter was inserted in patient #1's foot by an RN.

The Surveyor interviewed the Director of Emergency Department at approximately 9:20 A.M. and 3:17 P.M. on 11/6/13. The Director of the Emergency Department said although not documented in Patient #1's record, an investigation regarding a concern filed on Patient #1's behalf, indicated it was clear that two clinical assistants attempted to insert a peripheral catheter into Patient #1's arm during the emergency department visit on 1/27/13.

2. Record review indicated that on 11/3/13, the physician ordered for a peripheral intravenous catheter to be inserted in Patient #4 and the clinical care note, indicated that at 3:31 P.M., a clinical assistant inserted a 24 gauge peripheral intravenous catheter into Patient #4's right lower arm.

3. Record review indicated that on 11/1/13, a peripheral intravenous catheter was ordered for Patient #5. The clinical care note, dated 11/1/13, indicated a clinical assistant inserted a 22 gauge peripheral intravenous catheter in Patient #5's right arm.

4. Record review indicated that on 11/1/13, the physician ordered for Patient #6 to have a peripheral intravenous catheter inserted. The clinical care note, dated 11/1/13, indicated a clinical assistant inserted the peripheral intravenous catheter in Patient #6's right arm.

5. Record review indicated that on 10/30/13 a clinical assistant inserted a 20 gauge peripheral intravenous catheter in Patient #7's right wrist.

6. Record review indicated that on 11/2/13, the physician ordered for Patient #10 to have a peripheral intravenous catheter inserted. The clinical care note, dated 11/2/13, indicated a clinical assistant inserted the peripheral intravenous catheter in Patient #10's right hand.

The Surveyor interviewed Clinical Assistant #1 at 12:10 P.M. on 11/7/13. Clinical Assistant #1 said said as a clinical assistant, he was trained by the Hospital to insert peripheral intravenous catheters in the arms of patients. Clinical Assistant #1 said sometimes he obtained and applied heat to a site he thought may be a good choice to insert the peripheral catheter. Clinical Assistant #1 said the assistants were able to decide whether or not to apply heat without the nurse's input or permission. Clinical Assistant #1 said the clinical assistant who inserted the catheter decided which size catheter to use and where to place the catheter.

The Surveyor interviewed the Associate Chief of Nursing at 10:15 A.M. and at 1:25 P.M. on 11/6/13. The Associate Chief of Nursing said there was a subset of 6 out of 40 clinical assistants working in the emergency department who were considered competent to insert peripheral intravenous catheters. The Associate Chief of Nursing said she did not know the dates when the practice of clinical assistants inserting peripheral intravenous catheters, first began but thought it could be longer than 10 years prior to survey. The Associate Chief of Nursing said the clinical assistants had to have previous experience inserting catheters and complete a training and competency program. The Associate Chief of Nursing said the RN would assess the site for stability after a peripheral intravenous catheter was inserted by the clinical assistant.

Based on record review and interview, the Hospital failed for 6 of 9 emergency department patients (Patient #1,#4, #5, #6, #7, and #10), in a total sample of 10 hospital patients, to ensure they followed nationally recognized acceptable standards of nursing practice, when they delegated the task of insertion of peripheral intravenous catheters to clinical assistants, who were not licensed to perform the task. This practice included choosing the size of the catheter and choice for insertion; and administration of normal saline solution intravenously to determine patency of the catheter and placement within the vein.

Findings include:

The Hospital's policy, on Intermittent Peripheral Intravenous Infusion, dated 5/24/10, indicated the policy was developed in part based on the references from the Intravenous Nurses Society (INS) 2006 Standards.

According to the Infusion Nurses Society, in a Position Statement provided to the Department on 10/30/13, they "reaffirms and strongly recommends that (nursing assistive personnel) NAP not be used in direct provision of infusion therapies. INS recommends that only a qualified registered nurse who is knowledgeable in the scope and practice of infusion therapy should be involved in the assessment, planning, administration, and evaluation of infusion therapies. INS believes the delegation of procedures and activities related to the direct provision of infusion therapies to NAP may result in potential adverse outcomes to the patient and the public, and may increase liability risks for the registered nurse."

1. Patient #1's emergency department record, dated 1/27/13, indicated at 6:10 P.M., the physician ordered for Patient #1 to have a peripheral intravenous catheter inserted.

2. Patient #4's orders, dated 11/3/13, indicated at 2:39 P.M., the physician ordered for a peripheral intravenous catheter to be inserted in Patient #4. The clinical care note, dated 11/3/13, indicated at 3:31 P.M., a clinical assistant inserted a 24 gauge peripheral intravenous catheter into Patient #4's right lower arm, which included establishing patency (instillation of normal saline from a pre-filled syringe).

3. Patient #5's orders, dated 11/1/13, indicated at 6:04 P.M., a peripheral intravenous catheter was ordered. The clinical care note, dated 11/1/13, indicated at 6:58 P.M., a clinical assistant inserted a 22 gauge peripheral intravenous catheter in Patient #5's right arm. The care note indicated the catheter was flushed with normal saline solution intravenously.

4. Patient #6's orders, dated 11/1/13, indicated at 11:11 A.M., the physician ordered for Patient #6 to have a peripheral intravenous catheter inserted. The clinical care note, dated 11/1/13, indicated a clinical assistant inserted the peripheral intravenous catheter at 12:05 P.M. in Patient #6's right arm. The insertion included establishing patency (instillation of normal saline from a pre-filled syringe).


5. Patient #7's clinical note, dated 10/30/13, indicated that at 4:36 P.M., a clinical assistant inserted a 20 gauge peripheral intravenous catheter in Patient #7's right wrist. The insertion included establishing patency (instillation of normal saline from a pre-filled syringe).


6. Patient #10's orders, dated 11/2/13, indicated at 9:22 A.M., the physician ordered for Patient #10 to have a peripheral intravenous catheter inserted. The clinical care note, dated 11/2/13, indicated at 9:45 A.M., the peripheral intravenous catheter was inserted in Patient #10's right hand by a clinical assistant. The insertion included establishing patency (instillation of normal saline from a pre-filled syringe).


The Surveyor interviewed Nurse #1 at 9:45 A.M. on 11/6/13. Nurse #1 said she felt confident asking a clinical assistant to insert the intravenous catheter because they were trained to perform the task. Nurse #1 said the tasks associated with the clinical assistants inserting a peripheral intravenous catheter would include the clinical assistant choosing what size catheter to use, the location where to insert the catheter into the patient, and flushing the catheter with saline from a pre-filled syringe.

The Surveyor interviewed Clinical Assistant #1 at 12:10 P.M. on 11/7/13. Clinical Assistant #1 said said as a clinical assistant, he was trained by the Hospital to insert peripheral intravenous catheters in the arms of patients. Clinical Assistant #1 said after insertion, the catheter was flushed with normal saline from a pre-filled syringe.

The Surveyor interviewed the Associate Chief of Nursing at 10:15 A.M. and at 1:25 P.M. on 11/6/13. The Associate Chief of Nursing said there was a subset of 6 of 40 clinical assistants working in the emergency department who were considered competent to insert peripheral intravenous catheters.

Sodium Chloride (sodium chloride injection), USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for parenteral (intravenous) administration, and have legend status (defined by FDA's statement "Federal law prohibits dispensing without a prescription). According MGL Chapter 94c, normal saline pre-filled syringes are considered a Schedule IV drug which is defined as a substance which is a prescription drug; and said prescription drug has not been included in Schedules I through V.