The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST MARY MEDICAL CENTER 18300 HIGHWAY 18 APPLE VALLEY, CA 92307 Dec. 23, 2019
VIOLATION: QAPI Tag No: A0263
Based on interview and record review, the hospital failed to ensure the Condition of Participation
Quality Assessment and Performance Improvement Program was met by:

1. Failing to identify expired items in the surgery, labor and delivery, neonatal intensive care, and the medical/surgical department. (Refer to A-0748)

2. Failing to identify inconsistent operating room terminal cleaning.

These failures had the potential for the spread of infection. (Refer to A-0749)

3. Failing to ensure temperature (68 degree Fahrenheit [unit of measurement] to 73 degree Fahrenheit) and humidity (20% [percent-unit of measurement] to 60%) were in safe range for storing sterile (germ free) products, on December 19, 2019 and December 20, 2019.

This failure had the potential for cross-contamination due to the packaging material becoming moist and germs from the air and surfaces affecting the packing and the sterility of the product.

4. Failing to ensure a peripherally inserted central catheter (PICC-a tube placed into a large vein that extends close to the heart to give medications and blood) site dressings were not labeled and staff did not perform daily assessments for the PICC necessity (the need for continue use of a central catheter) for two of three sampled patients (Patient 17 and Patient 18).

These failures had the potential for germs to enter Patient 17's and Patient 18's blood system causing PICC site infections and prolonged hospitalization . (Refer to A-0749)

5. Failing to ensure aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a peripherally inserted central catheter (PICC) dressing site change for one of three sampled patients (Patient 18). (Refer to A-0749)

6. Failing to identify inconsistency in their Intravenous (IV - in the vein) therapy policy and procedure for assessment of patient IV insertion sites. This failure has the potential to result in harm to patients with an IV and contributed to Patient 8 having an IV infiltration that developed large blisters in the arm that required wound care in the hospital and when the patient went home. (Refer to A-0395)

The cumulative effects of these systemic failures resulted in the hospital failing to meet the Condition of Participation Quality Assurance and Performance Improvement Program.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review the hospital failed to ensure they identified opportunities for improvement that focused on patient safety when they:

1. Failed to identify expired items in the surgery department, labor and delivery department, neonatal intensive care department and medical/surgical department.
These failures had the potential to result in patient harm, as the use of expired patient care supplies could have resulted in ineffective treatment modalities.

2. Failed to identify inconsistent operating room terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) from October 2019 through December 2019, for four of six Operating Rooms (OR 2, 3, 4, and 6).
These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable hospital acquired infection and prolonged hospitalization .

3. Aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a peripherally inserted central catheter (PICC) dressing site change for one of three sampled patients (Patient 18).

This failure had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable central line associated blood stream infection (CLASBI- bloodstream infection in a patient with a central line) and prolonged hospitalization .


4. Failed to identify inconsistency in their Intravenous (IV) therapy policy and procedure for assessment of patient IV insertion sites. This failure has the potential to result in harm to patients with an IV and contributed to Patient 8 having an IV infiltration that developed large blisters in the arm that required wound care in the hospital and when the patient went home.

Findings:

1. a. During an observation with the Labor and Delivery Unit Manager (LDM), on December 17, 2019, at 10:40 AM, in the L&D patient care supply area, the following items were expired:

One expired Bartholin gland catheter (used to treat an abscess of the Bartholin gland {glands located on both sides of the vaginal opening}) kit had a manufacturer's expiration date of November 2019, and was available for use.

One expired lubricating jelly had a manufacturer's expiration date of July 2019, and one expired lubricating jelly had a manufacturer's expiration date of March 2019, and were available for use.

During an interview with the LDM, on December 17, 2019, at 10:51 AM, the LDM stated the lubricating jelly and Bartholin gland catheter kit were expired and should have been discarded on or before the expiration dates.

b. During an observation with the Neonatal Intensive Care Unit Manager (NICUM), on December 17, 2019, 12:48 PM, in the NICU patient care supply area, the following items were expired:

One expired viral transport medium (used to collect and transport patient specimens) had a manufacturer's expiration date of November 2019, four expired viral transport medium had manufacturer's expiration dates of September 2019, one expired viral transport medium had a manufacturer's expiration date of May 2019, and were available for use.

Two expired boxes of chemical indicators (used to check for the presence of chemicals) had manufacturer's expiration dates of January 11, 2018, and were available for use.

One expired hand silk suture kit had a manufacturer's expiration date of July 19, and was available for use.

During an interview with the NICUM, on December 17, 2019, at 12:59 PM, the NICUM stated the transport mediums, silk suture kit, and chemical indicators were expired and should have been discarded.

c. During an observation with the Medical-Surgical Unit Manager (MSM), on December 18, 2019, at 10:18 AM, in the MSU patient care supply area, the following items were expired:

One expired viral transport medium had a manufacturer's expiration date of November 2019, and was available for use.

Four expired bone marrow transport mediums had manufacture's expiration dates of March 2016, and were available for use.

One expired green top vacutainer had a manufacturer's expiration date of December 2016, one expired green top vacutainer had an expiration date of November 30, 2019, and were available for use.

One expired dark green top vacutainer had a manufacturer's expiration date of February 27, 2019, one expired dark green top vacutainer had a manufacturer's expiration date of March 29, 2018, one expired dark green top vacutainer had a manufacturer's expiration date of September 8, 2018, one expired dark green top vacutainer had a manufacturer's expiration date of February 2016, one expired dark green top vacutainer had a manufacturer's expiration date of May 24, 2019, and were available for use.

One expired purple top vacutainer had a manufacturer's expiration date of August 11, 2019, one expired purple top vacutainer had an expiration date of February 24, 2019, and were available for use.

Two expired pink top vacutainers had manufacturer's expiration dates of February 2014, and were available for use.

One expired blue top vacutainer had a manufacturer's expiration date of February 2015, and was available for use.

During an interview with the MSM, on December 18, 2019, at 10:45 AM, the MSM stated viral transport mediums, bone marrow transport mediums, and vacutainers were expired and expired items should not be stocked in the MSU patient care supply areas.

In a Quality Assurance/Performance Improvement interview with the CNO (Chief Nursing Officer) and the QID (Quality Improvement Director) on December 23, 2019 at 9:45 AM, They stated they review the overall quality program, infections, re-admissions, patient satisfaction surveys, cardio-vascular, stroke and STEMI (ST Elevated Myocardial Infarctions-heart attack) goals.
They stated have a Quality Collaborative and review patient experience. They stated they did not identify that there were so many expired items, infection control issues and did not identify the discrepancy in the IV policy.

2. During a concurrent interview and record review of the "Operating Room Terminal Cleaning Logs" dated October 2019 through December 2019, with the Environmental Service Manager (EVSM), on December 19, 2019, at 9:15 AM, the EVSM stated terminal cleaning is performed daily after the last procedure to prevent the spread of infection. The EVSM stated terminal cleaning for operating rooms involved cleaning and disinfecting all exposed surfaces, including wheels and casters, of all equipment, cleaning and disinfecting the floor, and moving equipment around the room to clean the floor underneath. The EVSM stated the Operating Room Terminal Cleaning Logs indicated the following:

For OR 2, terminal cleaning was not done on November 29, 2019, and December 1, 2019.

For OR 3, terminal cleaning was not done on November 21, 2019.

For OR 6, terminal cleaning was not done on October 29, 2019.

The EVSM stated EVS staff should have performed terminal cleaning daily for Operating Rooms 2, 3, and 6.

In a Quality Assurance/Performance Improvement interview with the CNO (Chief Nursing Officer) and the QID (Quality Improvement Director) on December 23, 2019 at 9:45 AM, They stated they review the overall quality program, infections, re-admissions, patient satisfaction surveys, cardio-vascular, stroke and STEMI (ST Elevated Myocardial Infarctions-heart attack) goals.
They stated have a Quality Collaborative and review patient experience. They stated they did not identify that there were so many expired items, infection control issues and did not identify the discrepancy in the IV policy.

3. During an observation of Patient 18's PICC site dressing change, on December 18, 2019, at 2:40 PM, Registered Nurse 6 (RN 6) performed hand hygiene, put on a surgical cap, gathered the PICC dressing supplies and placed them on a clean table. RN 6 performed hand hygiene and put on a pair of sterile (germ free) gloves and covered her mouth and nose with the mask she had taken from the sterile central venous catheter kit (contain germ free supplies needed to change a PICC dressing). RN 6 cleaned the PICC double lumens (two lumens-lumens are the part of the PICC used to give IV treatments or take blood), cleaned the exposed skin which surrounded the soiled dressing, cleaned the surface of the soiled dressing, and did not perform hand hygiene prior to performing PICC lumen cap (a cover screwed onto the end of the PICC's lumen) change.

During an interview with RN 6, on December 18, 2019, at 2:55 PM, RN 6 stated she had added an extra step and cleaned the surface of the PICC soiled dressing and cleaned the exposed skin which surrounded the soiled dressing. RN 6 stated she should have performed hand hygiene prior to changing the lumen caps.

During an interview with the Vascular (blood vessels) Access Manager (VAM), on December 19, 2019, at 3:41 PM, the VAM stated RN 6 did not follow the policy and procedure for PICC site dressing change and hand hygiene should have been performed after cleaning the soiled dressing to ensure aseptic technique throughout the dressing change.

In a Quality Assurance/Performance Improvement interview with the CNO (Chief Nursing Officer) and the QID (Quality Improvement Director) on December 23, 2019 at 9:45 AM, They stated they review the overall quality program, infections, re-admissions, patient satisfaction surveys, cardio-vascular, stroke and STEMI (ST Elevated Myocardial Infarctions-heart attack) goals.
They stated have a Quality Collaborative and review patient experience. They stated they did not identify that there were so many expired items, infection control issues and did not identify the discrepancy in the IV policy.

4. During a review of the past six months of Quality Assessment and Performance Improvement meeting minutes, there was no documentation of identifying an issue with their nursing staff's IV assessments or the inconsistency of their "Intravenous Therapy" policy and procedure. The inconsistency was with how frequently the IV site assessment should be done by the nursing staff.

A review of the hospital policy and procedure titled, "Intravenous Therapy," with a revision date of September 21, 2017, showed the following:

"Policy:

A. IV therapy will be based on the Infusion Nurses Society (INS) Standards of Practice.

Procedure Guidelines:

Maintenance and Security of IV Therapy-Dressing/IV Site/Tubing:

B. Check IV site every shift and PRN ..."

The INS Standards of Practice state:

Assessment should minimally include visual assessment, palpation, and subjective information from the patient. If there is tenderness at the site, the dressing may be removed to more carefully visualize the site:

a. At least every 4 hours

i. Patients who are receiving nonirritant/nonvesicant (damaging to the tissues) infusions and who are alert and oriented and who are able to notify the nurse of any signs of problems such as pain, swelling, or redness at the site.

b. At least every 1 to 2 hours
i. Critically ill patients
ii. Adult patients who have cognitive/sensory deficits or who are receiving sedative-type medications and are unable to notify the nurse of any symptoms ..."

In a Quality Assurance/Performance Improvement interview with the CNO (Chief Nursing Officer) and the QID (Quality Improvement Director) on December 23, 2019 at 9:45 AM, They stated they review the overall quality program, infections, re-admissions, patient satisfaction surveys, cardio-vascular, stroke and STEMI (ST Elevated Myocardial Infarctions-heart attack) goals.
They stated have a Quality Collaborative and review patient experience. They stated they did not identify that there were so many expired items, infection control issues and did not identify the discrepancy in the IV policy.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review the facility failed to ensure the Condition of Participation Nursing Services was met by:

1. Failing to ensure, for seven of 30 sampled patients (Patients 1, 2, 8, 9, 10, 13, and 14), their Intravenous (IV-fluids fed into a vein through a needle or catheter) insertion sites were assessed according to the standard of nursing practice cited by the hospital's policy and procedure, "Intravenous Therapy".

This failure contributed to an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) not being detected timely, causing blisters in Patient 8's arm requiring wound care in the hospital, wound care when the patient went home, and had the potential for an IV infiltration not being caught early to prevent harm to any patient receiving IV fluids. (Refer to A-0395)

2. Failing to ensure medications were labeled according to their policy for the staff to verify prior to administration when:

a. Five oral medication syringes did not have medication labeles attached to them.

b. Eight opened unidentifiable medications were found in a dispense cup.

These failures had the potential to result in medication errors (any preventable event that may cause or lead to inappropriate use or patient harm) that could impact the patient's health and safety. (Refer to A-405)

3. Failing to ensure follow plan of care (POC) policy and procedure were followed for four out of 30 sampled patients (Patient 1, 2, 14, and 16) when:

a. For Patient 1, and 16, a care plan was not developed to provide individualized care

b. For Patient 1, 2, and 14, a pain intervention was not done after pain assessment was completed

These failures had the potential to cause Patient 1, 2, 14, and 16's inability to follow and participate in their treatment plan to achieve the desired goals. (Refer to A-0396)

The cumulative effect of these systemic problems resulted in the hospital's failure to meet the Condition of Participation Nursing Services.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure, for 7 of 30 sampled patients (Patients 1, 2, 8, 9, 10, 13, 14), their Intravenous (IV-fluids fed into a vein through a needle or catheter) insertion sites were assessed according to the standard of nursing practice cited by the hospital's policy and procedure, Intravenous Therapy.

This failure contributed to an IV infiltration (IV needle or catheter came out of the vein and fluid was going under the skin) not being detected timely, causing blisters in Patient 8's arm requiring wound care in the hospital, wound care when the patient went home, and had the potential for an IV infiltration not being caught early to prevent harm to any patient receiving IV fluids.

Findings:

1. During a review of the medical record for Patient 8, it showed the patient was admitted to the facility on on [DATE], with diagnoses that included an altered level of consciousness and a history of a previous stroke with left sided weakness.

A review of the first nursing IV Line assessment, which was in the emergency room , dated November 24, 2017 at 10:12 AM, showed the following:

Right Forearm Peripheral (Situated away from the center, as opposed to centrally located) IV. Site Observation Asymptomatic, Intact, patent (open). IV dressing description: dressing dry and intact.

A review of the IV Infusion assessment dated [DATE] at 7:57 PM, showed the following: D5NS (dextrose 5% and normal saline-sugar and salt water) rate 80 mls/hr (milliliters per hour).
A review of Patient 8's IV Assessments showed the following:

November 24, 2017 at 7:57 PM, right forearm IV site patent, intact. (8 hours and 51 minutes after the emergency room assessment)

November 25, 2017 at 8:20 AM, right forearm IV patent, intact. (12 hours and 23 minutes after the last assessment).

November 25, 2017 at 8:00 PM, right forearm IV asymptomatic, patent, intact. (11 hours and 40 minutes after the last assessment).

November 26, 2017 at 8:14 AM, right forearm IV asymptomatic, patent, intact. D5NS at 80 ml/hr. (12 hours and 14 minutes after the last assessment).

November 26, 2017 at 8:00 PM, right forearm IV asymptomatic, patent, intact. (11 hours and 46 minutes after the last assessment).

November 27, 2017 at 8:15 AM, right forearm IV asymptomatic, patent, intact. (12 hours and 15 minutes after the last assessment).

A review of the nurse's notes dated November 25, 2017 at 8:00 PM, showed the following:

"answers yes/no only sometimes, otherwise no verbal response; does not make eye contact when asked to. Follows command to squeeze hands. Pt (patient) keeps Left arm and leg in same position when staff tries to move him"

A review of the nurse's notes dated November 27, 2017 at 4:30 PM, showed "Patient found with right arm infiltrated, with large blisters. Arm restricted from ID band, IV tape and B/P (blood pressure) cuff, spoke with Team Leader, and wound care RN (registered nurse) ...dressed skin tear with petrolatum dressing (gauze with Vasoline), covered blisters with Maxorb (a type of absorbent dressing ...elevated arm on pillow paged Dr. (doctor) ..."

A review of the hospital's investigation shows the following:

"The medical record contains vs (vital signs-temperature, pulse, respirations, blood pressure) with 3 B/P taken on the right arm. (name of nurse) (RN1) stated in her interview on 12/5/17 that she took the blood pressure at 1142 (AM) and the aide took the b/p at 1552 (3:52 PM). She states she did not observe any problems with the IV until the time she charted the infiltration. Nor did the aide report any problems with the IV when she measured the blood pressure at 1552. She charted that the MD (Medical Doctor) was at the bedside at 1439 (2:39 PM) as well. (RN 1) stated that she had not seen an infiltration like this with blistering on the arms and was an uncharacteristic finding ..."

A review of the hospital policy and procedure titled, "Intravenous Therapy," with a revision date of September 21, 2017, showed the following:

"Policy:
A. IV therapy will be based on the Infusion Nurses Society (INS) Standards of Practice.
Procedure Guidelines:
Maintenance and Security of IV Therapy-Dressing/IV Site/Tubing:
B. Check IV site every shift and PRN for:
1. Change in color around puncture site
2. Moisture, fluids, or purulent (pus) drainage
3. Swelling or inflammation
4. Difference in temperature of arm
5. Palpated tenderness."

A review of the INS Position Paper showed the following:

"Recommendation for Frequency of Assessment of the Short Peripheral Catheter Site
...older adult patients (>[AGE] years old) are addressed as specialty populations in the 2011 INS Standards. In the older adult, even small infiltrates can lead to severe complications, and nursing practice policy 'may recommend observing the area every 1 to 2 hours.'

Assessment should minimally include visual assessment, palpation, and subjective information from the patient. If there is tenderness at the site, the dressing may be removed to more carefully visualize the site ... a. At least every 4 hours ...i. Patients who are receiving nonirritant/nonvesicant (damaging to the tissues) infusions and who are alert and oriented and who are able to notify the nurse of any signs of problems such as pain, swelling, or redness at the site ... b. At least every 1 to 2 hours ...i. Critically ill patients...ii. Adult patients who have cognitive/sensory deficits or who are receiving sedative-type medications and are unable to notify the nurse of any symptoms ..."

During an interview with RN 4 on December 18, 2019 at 9:20 AM, she stated if IV fluids were running she personally would check the site every 4 hours. She stated she definitely would check it at the beginning of the shift. She stated she did not always document the check every 4 hours. She stated she did not know what the hospital policy was for IV assessment.

During an interview with RN 5 on December 18, 2019 at 9:30 AM, she stated she assessed the IV every 1 to 2 hours. She stated she checked it every 2 hours. She stated they check it and document it once a shift. She stated she checked the IV every 2 hours especially if there is potassium in it. She stated "We have patient rounding every hour, I don't necessarily check the IV site every hour." She stated she did not remember what the hospital policy was for IV assessments.

During an interview with the Director of the North/South Telemetry Unit (DTU) on December 18, 2019 at 10:00 AM, she stated the INS policy and procedure 4th edition for patient IV assessment, nursing interventions and post nursing interventions: In the reference page of the hospital (IV) policy and procedure there is a clickable web address that takes you to the (INS) policy. The floor nurses would have access to that when looking at the hospital policy and procedure.

During an interview with the Director of Risk Management (RM) on December 18, 2019 at 2:00 PM, she stated she saw the issue with the conflicting directions in the intravenous policy and procedure and acknowledged the policy guidance for IV assessments was unclear and could cause confusion.

2. During a review of the medical record for Patient 9, it showed the patient was admitted to the hospital on December 15, 2019, with diagnoses that included chest pain and kidney stone.

A review of the medical record intravenous (IV-into the vein)) therapy showed the patient had an IV of D5 (dextrose 5% and NS (0.45% normal saline-salt water) at 50 ml (milliliters) per hour with 20 milliequivalents (mEq-a unit of measure) of potassium (K) from December 15, 2019 at 1:00 PM to December 17, 2019 at 4:47 PM.

A review of the IV nursing assessments showed the following:

December 15, 2019 at 7:00 AM, Left Hand asymptomatic, patent, dressing dry and intact.

December 15, 2019 at 7:30 PM, Left Hand asymptomatic, patent (December 16, 2019 at 7:00 AM, Left Hand asymptomatic, patent (open), dressing dry and intact (12 hours and 30 minutes after the previous assessment).

December 16, 2019 at 7:00 AM, Left Hand asymptomatic, patent, dressing dry and intact (11 hours and 30 minutes after the previous assessment).

December 16, 2019 at 8:00 PM, Left Hand asymptomatic, patent, dressing dry and intact (13 hours after the previous assessment).

Nursing documentation showed the IV was discontinued on December 16, 2019.

In an interview with the Medical/Surgical Unit Manager on December 19, 2019 at 9:00 AM, she stated the hospital intravenous therapy policy instructs the nurses to assess the IV insertion site once a shift (a shift is 12 hours).

A review of the hospital policy and procedure titled, "Intravenous Therapy," with a revision date of September 21, 2017, showed the following:

"Policy: A. IV therapy will be based on the Infusion Nurses Society (INS) Standards of Practice ...Procedure Guidelines: Maintenance and Security of IV Therapy-Dressing/IV Site/Tubing:

B. Check IV site every shift and PRN for:

1. Change in color around puncture site
2. Moisture, fluids, or purulent (pus) drainage
3. Swelling or inflammation
4. Difference in temperature of arm
5. Palpated tenderness."

A review of the INS Position Paper showed the following:

"Recommendation for Frequency of Assessment of the Short Peripheral Catheter Site ...older adult patients (>[AGE] years old) are addressed as specialty populations in the 2011 INS Standards. In the older adult, even small infiltrates can lead to severe complications, and nursing practice policy 'may recommend observing the area every 1 to 2 hours.'

Assessment should minimally include visual assessment, palpation, and subjective information from the patient. If there is tenderness at the site, the dressing may be removed to more carefully visualize the site:

a. At least every 4 hours ...i. Patients who are receiving nonirritant/nonvesicant (damaging to the tissues) infusions and who are alert and oriented and who are able to notify the nurse of any signs of problems such as pain, swelling, or redness at the site.

b. At least every 1 to 2 hours ... i. Critically ill patients ii. Adult patients who have cognitive/sensory deficits or who are receiving sedative-type medications and are unable to notify the nurse of any symptoms ..."

During an interview with RN 4 on December 18, 2019 at 9:20 AM, she stated if IV fluids were running she personally would check the site every 4 hours. She stated she definitely would check it at the beginning of the shift. She stated she did not always document the check every 4 hours. She stated she did not know what the hospital policy was for IV assessment.

During an interview with RN 5 on December 18, 2019 at 9:30 AM, she stated she assessed the IV every 1 to 2 hours. She stated she checked it every 2 hours. She stated they check it and document it once a shift. She stated she checked the IV every 2 hours especially if there is potassium in it. She stated "We have patient rounding every hour, I don't necessarily check the IV site every hour." She stated she did not remember what the hospital policy was for IV assessments.

During an interview with the Director of the North/South Telemetry Unit (DTU) on December 18, 2019 at 10:00 AM, she stated the INS policy and procedure 4th edition for patient IV assessment, nursing interventions and post nursing interventions: In the reference page of the hospital (IV) policy and procedure there is a clickable web address that takes you to the (INS) policy. The floor nurses would have access to that when looking at the hospital policy and procedure.

In an interview with the Director of Risk Management (RM) on December 18, 2019 at 2:00 PM, she stated she saw the issue with the conflicting directions in the intravenous policy and procedure and acknowledged the policy guidance for IV assessments was unclear and could cause confusion.

3. During a review of the medical record for Patient 10, it showed the patient was admitted to the facility on on [DATE], with diagnoses that included chest pain and gallstones (stones in the gall bladder).

A review of the nursing documentation of the intravenous (IV-into the vein) assessments showed the following:

December 15, 2019 at 5:58 PM, D5 (dextrose 5%) 0.45 NS (0.45% salt water) 20 milliequivalents (mEq - a unit of measure) KCL (potassium chloride) at 75 mls (milliliters) per hour.

December 15, 2019 at 7:20 PM, Right forearm site asymptomatic, patent (open), intact.

December 16, 2019 at 8:15 AM, right forearm site asymptomatic, patent, intact (11 hours and 55 minutes after the previous assessment).

December 16, 2019 at 10:00 PM, right forearm site asymptomatic, patent, intact (13 hours and 45 minutes after the previous assessment).

December 17, 2019 at 2:39 PM, right forearm site asymptomatic, patent, intact (14 hours and 39 minutes after the previous assessment).

December 17, 2019 at 7:40 PM, right forearm site asymptomatic, patent, intact (5 hours and 1 minute after the previous assessment).

December 18, 2019 at 11:57 AM, right forearm site asymptomatic, patent, intact (4 hours and 17 minutes after the previous assessment).

December 18, 2019 at 8:00 PM, Left forearm site asymptomatic, patent, intact. Right forearm discontinued (8 hours and 3 minutes after the previous assessment).

December 19, 2019 at 8:35 AM, Left forearm site asymptomatic, patent, intact. Right forearm discontinued (12 hours and 35 minutes after the previous assessment).

In an interview with the Medical/Surgical Unit Manager on December 19, 2019 at 9:00 AM, she stated the hospital intravenous therapy policy instructs the nurses to assess the IV insertion site once a shift (a shift is 12 hours).

A review of the hospital policy and procedure titled, "Intravenous Therapy," with a revision date of September 21, 2017, showed the following:

"Policy: A. IV therapy will be based on the Infusion Nurses Society (INS) Standards of Practice. Procedure Guidelines: Maintenance and Security of IV Therapy-Dressing/IV Site/Tubing: B. Check IV site every shift and PRN for:

1. Change in color around puncture site
2. Moisture, fluids, or purulent (pus) drainage
3. Swelling or inflammation
4. Difference in temperature of arm
5. Palpated tenderness."

A review of the INS Position Paper showed the following:

"Recommendation for Frequency of Assessment of the Short Peripheral Catheter Site
...older adult patients (>[AGE] years old) are addressed as specialty populations in the 2011 INS Standrds. In the older adult, even small infiltrates can lead to severe complications, and nursing practice policy 'may recommend observing the area every 1 to 2 hours.'

Assessment should minimally include visual assessment, palpation, and subjective information from the patient. If there is tenderness at the site, the dressing may be removed to more carefully visualize the site:

a. At least every 4 hours ...i. Patients who are receiving nonirritant/nonvesicant (damaging to the tissues) infusions and who are alert and oriented and who are able to notify the nurse of any signs of problems such as pain, swelling, or redness at the site.

b. At least every 1 to 2 hours ... i. Critically ill patients ii. Adult patients who have cognitive/sensory deficits or who are receiving sedative-type medications and are unable to notify the nurse of any symptoms ..."

During an interview with RN 4 on December 18, 2019 at 9:20 AM, she stated if IV fluids were running she personally would check the site every 4 hours. She stated she definitely would check it at the beginning of the shift. She stated she did not always document the check every 4 hours. She stated she did not know what the hospital policy was for IV assessment.

During an interview with RN 5 on December 18, 2019 at 9:30 AM, she stated she assessed the IV every 1 to 2 hours. She stated she checked it every 2 hours. She stated they check it and document it once a shift. She stated she checked the IV every 2 hours especially if there is potassium in it. She stated "We have patient rounding every hour, I don't necessarily check the IV site every hour." She stated she did not remember what the hospital policy was for IV assessments.

During an interview with the Director of the North/South Telemetry Unit (DTU) on December 18, 2019 at 10:00 AM, she stated the INS policy and procedure 4th edition for patient IV assessment, nursing interventions and post nursing interventions: In the reference page of the hospital (IV) policy and procedure there is a clickable web address that takes you to the (INS) policy. The floor nurses would have access to that when looking at the hospital policy and procedure.

In an interview with the Director of Risk Management (RM) on December 18, 2019 at 2:00 PM, she stated she saw the issue with the conflicting directions in the intravenous policy and procedure and acknowledged the policy guidance for IV assessments was unclear and could cause confusion.

4. During a review of the medical record for Patient 13, it showed the patient was admitted to the hospital on December 15, 2019, with diagnoses that included UTI (urinary tract infection) and acute kidney failure.

A review of an emergency room Intravenous (IV) Line assessment dated [DATE] at 12:09 PM, showed a right wrist Saline Lock (an IV catheter that is capped off and flushed intermittently with normal saline (salt water) to keep the blood from clogging it) was inserted.

A review of the nursing IV assessments showed the following:

December 17, 2019 at 5:55 AM, 0.9% NS (normal saline-salt water) at 125 mls (milliliters) per hour.

December 17, 2019 at 8:00 AM, Right wrist site asymptomatic, patent (open), intact. Left forearm saline lock, number of attempts (saline lock inserted) 1 attempt.

December 17, 2019 at 6:00 PM, 0.9% NS at 60 mls per hour.

December 17, 2019 at 9:53 PM, Right wrist site asymptomatic, patent, intact (13 hours and 53 minutes after the previous assessment).

December 18, 2019 at 7:00 AM, Right wrist site asymptomatic, patent, intact. IV fluids infusing. Left forearm saline lock discontinued (9 hours and 7 minutes after the previous assessment).

December 18, 2019 at 8:00 PM, Right wrist site asymptomatic, patent, intact. IV fluids infusing (13 hours after the previous assessment).

December 19, 2019 at 7:00 AM, Right wrist site patent, leaking. IV flushed and running TKO (to keep vein open) at 10 mls per hour.

December 19, 2019 at 10:11 AM, 0.9% NS at 5 mls per hour.

December 19, 2019 at 7:48 PM, Right wrist site asymptomatic, patent, intact. IV fluids infusing (12 hours and 48 minutes after the previous assessment).

During an interview with the Medical/Surgical Unit Manager on December 19, 2019 at 9:00 AM, she stated the hospital intravenous therapy policy instructs the nurses to assess the IV insertion site once a shift (a shift is 12 hours).

A review of the hospital policy and procedure titled, "Intravenous Therapy," with a revision date of September 21, 2017, showed the following:

"Policy: A. IV therapy will be based on the Infusion Nurses Society (INS) Standards of Practice. Procedure Guidelines: Maintenance and Security of IV Therapy-Dressing/IV Site/Tubing:

B. Check IV site every shift and PRN for:
1. Change in color around puncture site
2. Moisture, fluids, or purulent (pus) drainage
3. Swelling or inflammation
4. Difference in temperature of arm
5. Palpated tenderness."

A review of the INS Position Paper showed the following:

"Recommendation for Frequency of Assessment of the Short Peripheral Catheter Site
...older adult patients (>[AGE] years old) are addressed as specialty populations in the 2011 INS Standrds. In the older adult, even small infiltrates can lead to severe complications, and nursing practice policy 'may recommend observing the area every 1 to 2 hours.' Assessment should minimally include visual assessment, palpation, and subjective information from the patient. If there is tenderness at the site, the dressing may be removed to more carefully visualize the site:

a. At least every 4 hours ...i. Patients who are receiving nonirritant/nonvesicant (damaging to the tissues) infusions and who are alert and oriented and who are able to notify the nurse of any signs of problems such as pain, swelling, or redness at the site.

b. At least every 1 to 2 hours ...i. Critically ill patients ii. Adult patients who have cognitive/sensory deficits or who are receiving sedative-type medications and are unable to notify the nurse of any symptoms ..."

During an interview with RN 4 on December 18, 2019 at 9:20 AM, she stated if IV fluids were running she personally would check the site every 4 hours. She stated she definitely would check it at the beginning of the shift. She stated she did not always document the check every 4 hours. She stated she did not know what the hospital policy was for IV assessment.

During an interview with RN 5 on December 18, 2019 at 9:30 AM, she stated she assessed the IV every 1 to 2 hours. She stated she checked it every 2 hours. She stated they check it and document it once a shift. She stated she checked the IV every 2 hours especially if there is potassium in it. She stated "We have patient rounding every hour, I don't necessarily check the IV site every hour." She stated she did not remember what the hospital policy was for IV assessments.

During an interview with the Director of the North/South Telemetry Unit (DTU) on December 18, 2019 at 10:00 AM, she stated the INS policy and procedure 4th edition for patient IV assessment, nursing interventions and post nursing interventions: In the reference page of the hospital (IV) policy and procedure there is a clickable web address that takes you to the (INS) policy. The floor nurses would have access to that when looking at the hospital policy and procedure.

In an interview with the Director of Risk Management (RM) on December 18, 2019 at 2:00 PM, she stated she saw the issue with the conflicting directions in the intravenous policy and procedure and acknowledged the policy guidance for IV assessments was unclear and could cause confusion.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, and record review, the facility failed to ensure follow plan of care (POC) policy and procedure were followed for four out of 30 sampled patients (Patient 1, 2, 14, and 16) when:

1. For Patient 1, and 16, care plan was not developed to provide individualized care.

2. For Patient 1, 2, and 14, pain intervention was not done after pain assessment was completed.

These failures had the potential to cause Patient 1, 2, 14, and 16s' inability to follow and participate in their treatment plan to achieve the desired goals.

Findings:

1a. During a review of Patient 1's "Face Sheet (patient demographics)," the Face Sheet indicated, Patient 1 was admitted on [DATE] with diagnoses which included of wound necrosis (wound that contains dead tissue).

During a concurrent interview and record review on December 19, 2019, at 9:06 AM, with manager of Medical Surgical Unit (MSM) and manager of Intensive Care Unit (MIC), Patient 1's undated "ED (emergency department) Summary Report," was reviewed. MSM and MIC stated Patient 1 complaint of pain and had a wound care completed in ED. The "ED Summary Report" indicated on December 16, 2019, at 11:13 PM, Patient 1 complained of pain intensity 8 (pain scale that define 0 as no pain and 10 as the worst pain possible) and wound care intervention on December 17, 2019, at 5:46 AM. MSM and MIC stated no pain medication nor any pain intervention documented in the medical record.

During a concurrent interview and record review on December 23, 2019, at 11:12 AM, with MSM, Patient 1's POC, not dated, was reviewed. MSM stated there was "no care plan for pain" documented for Patient 1.

1b. During a review of Patient 16's "Face sheet," the Face Sheet indicated, Patient 16 was admitted on [DATE] with diagnoses which included acute [DIAGNOSES REDACTED] (brain disorders that can disrupt people's attention and consciousness), and acute kidney injury (AKI-a sudden episode of damage to the kidneys).

During a review of Patient 16's "History and Physical" (H&P), dated December 19, 2019, the "H&P" indicated, Patient 16 was "brought in from boarding care because he had been out of mental status and the staff unable to get the patient talked with them."

During a concurrent interview and record review on December 20, 2019, at 2:31 PM, with MSM, Patient 16's undated POC, was reviewed. MSM stated "there was no care plan for altered level of consciousness (ALOC)."

There were no POC that identified the specific problems to Patient 16.

During a review of the facility's P&P titled, "Plan of Care (POC)," dated September 23, 2019, the P&P indicated, "The Plan of Care (POC) is utilized to provide individualized care, define outcomes, guide care, and provide a framework for evaluation of patient responses to care ...Care plans (located in the electronic medical record) are multidisciplinary, disease specific assessments and include the following: Disease specific care plan assessment (DSCP), Ancillary care plan assessment, Additional problems assess ..."

2a. During a review of Patient 1's "Face Sheet", the Face Sheet indicated, Patient 1 was admitted on [DATE] with diagnoses which included of wound necrosis.

During a concurrent interview and record review on December 19, 2019, at 9:06 AM, with manager of Medical Surgical Unit (MSM) and manager of Intensive Care Unit (MIC), Patient 1's undated "ED (emergency department) Summary Report," was reviewed. MSM and MIC stated Patient 1 complaint of pain and had a wound care completed in ED. The "ED Summary Report" indicated on December 16, 2019, at 11:13 PM, Patient 1 complained of pain intensity 8 (pain scale that define 0 as no pain and 10 as the worst pain possible) and wound care intervention on December 17, 2019, at 5:46 AM. MSM and MIC stated no pain medication nor any pain intervention documented in the medical record.

During a concurrent interview and record review on December 19, 2019, at 10:18 AM, with the director of ED (DED), Patient 1's undated "ED Summary Report", and "Medication Administration Record (MAR)," dated December 2019, were reviewed. DED stated Patient 1 complained of pain but there was no communication from nursing staff to the physician to request any pain intervention on December 16, 2019. The MAR also indicated no pain medication was given on December 16, 2019. DED further stated there was no other types of pain intervention documented on medical record.

2b. During a review of Patient 2's "Face Sheet," the Face Sheet indicated, Patient 2 was admitted on [DATE] with diagnoses which included sepsis (life-threatening illness caused by body's response to an infection) and pneumonia (infection in the lungs).

During a concurrent interview and record review on December 19, 2019, at 3:10 PM, with MIC, Patient 2's "Pain Assessment," dated December 12, 2019, was reviewed. MIC stated the unit using the Critical Care Pain Observation Tool (CPOT) to assess patient's pain, "the lower the number the less pain patient has." The "Pain Assessment" indicated Patient 2 had pain management goal of 0. Pain level score documented as follow:

12/2/19 at 3:00 PM-pain level of 5

12/2/19 at 4:00 PM-pain level of 5

12/2/19 at 5:00 PM-pain level of 3

During a follow up concurrent interview and record review on December 19, 2019, at 3:35 PM, with MIC, Patient 2's MAR was reviewed. The MAR indicated Acetaminophen (Tylenol) was ordered for pain. MIC stated there was no documentation on the MAR dated December 2, 2019 that indicated Patient 2 received Tylenol for pain. MIC further stated there was no other types of pain intervention documented on medical record.

2c. During a review of Patient 14's "Face Sheet," the Face Sheet indicated, Patient 14 was admitted on [DATE] with diagnoses which included congestive heart failure (a chronic condition that affects the pumping power of the heart muscles."

During a concurrent interview and record review on December 20, 2019, at 10:00 AM, with DED, Patient 14's "ED Adult Intake Triage (quick examination) Assess," dated December 17, 2019, was reviewed. The triage note documented on December 17, 2019 at 7:28 PM, indicated Patient 14 complained of pain intensity 10. DED stated there was no documentation indicated Patient 14 received pain medication nor any types of pain intervention after the assessment was completed.

During a follow up concurrent interview and record review on December 20, 2019, at 10:18 AM, with DED, Patient 14's MAR was reviewed. There was documentation of no pain medication given on December 17, 2019. DED further stated pain should be re-assessed every 2 hours. Patient 14 received pain assessment on December 17, 2019 at 7:28, and 11:33 PM. DED agreed the pain assessment was not done every 2 hours.

During a concurrent interview and record review on December 20, 2019, at 10:28 AM, with MIC, Patient 14's "Pain Assessment," dated December 18, 2019, was reviewed. MIC stated Patient 14 complained of leg pain. MIC stated there was no documentation indicated Patient 14 received pain medication nor any types of pain intervention after the assessment completed.

During a review of the facility's policy and procedure (P&P) titled, "Pain Assessment and Management," dated December 19, 2019, the P&P indicated, " ...Licensed personnel are to facilitate collaboration among all disciplines of the health care team to identify issues in pain management and suggest appropriate consultations to assist in managing the patient's pain ...Interventions for pain management include pharmacological (using drugs) and nonpharmacological (without medicine) measures to relieve the patient's complaint of pain. They should be initiated whenever the patient's current pain rating exceeds their pain goal. Interventions should also be initiated when procedural pain is anticipated. Any reported pain level of greater than the patient's acceptable level of pain will be reported to the primary nurse and a pain management plan is implemented as appropriate ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the facility failed to follow their policy and procedure for safe medication storage, preparation and administration when: :

1. Five oral medication syringes did not have medication labeled attached to them.

2. Eight opened unidentifiable medications were found in the dispense cup.

3. One expired 50 milliliters (mls-unit of measurement) bag of Normal Saline (salt) solution was expired, and was available for use.

This failure had the potential to result in patients receiving deteriorated medications in the universe of 244.

4. Two opened single-dose (used in a single patient for a single case, procedure, injection) intravenous (IV-into the vein) solution bags were hanging from an IV pole for three hours, and were available for use.

This failure had the potential for increased risk of microbial (germs) growth causing a preventable bloodstream infection, and prolonged hospitalization for one of 30 sampled patients (Patient 23)

5. The facility did not assess vital signs every two minutes for 10 minutes following the initiation of epidural analgesia medication (pain medication administered through the lower back) and did not label the head of the bed, epidural infusion pump, or epidural catheter tubing for one of 30 sampled patients (Patient 25).

This failure had the potential for medication error and harm causing unintentional over sedation and respiratory depression (unusually slow breathing).

6. Aseptic technique was not maintained during medication preparation and one intravenous (IV-into the vein) infusion line (tubing) was not labeled for one of 30 sampled patients (Patient 1).

This failure had the potential for cross-contamination (germs unintentionally transferred to another person, with harmful effect) causing a preventable peripherally inserted central catheter (PICC- a tube placed into a large vein that extends close to the heart to give medications and blood) site blood infection and prolonged hospitalization .

7. Three expired 1000 ml bags of Normal Saline (salt) solutions were expired, and were available for use.

This failure had the potential to result in patients receiving deteriorated medications in the universe of 244.

8. The facility did not ensure the complete dose of Zosyn (medication to treat bacterial infection or antibiotic) was administered as prescribed for one of 30 sampled patients (Patient 1).

This failure placed Patient 1 at a greater risk for developing drug resistance (less effective of antibiotics with the change in the bacteria) to infection from incomplete dosage of antibiotics and had the potential to result in prolonged hospitalization .

These failures had the potential to result in medication errors, a preventable event that may cause or lead to inappropriate use or patient harm, that could impact the patient's health and safety.

Finding:

1. During an observation on December 17, 2019, at 11:51 AM, in the medication room of North telemetry (N tele-wirelessly monitoring of patients) unit, there were five unlabeled red oral medication syringes filled with liquid in the plastic bag along with separated erythromycin (medication to treat bacterial infection or antibiotic) labels.

During a concurrent observation and interview on December 17, 2019, at 11:53 AM, with the executive nursing director (END) and supervisor of telemetry unit (STU), in the medication room of N tele, the five unlabeled oral medication syringes were observed. When asked how the nursing staff could identify the unlabeled medication, STU stated the labels "should be attached to the syringes." The END stated "I will return them to the pharmacy now."

During a review of the facility's policy and procedure (P&P) titled, "Medication-Distribution, Dispensing and Use," dated June 27, 2019, the P&P indicated, " ...Each unit dose package must contain the following information: Name and strength of medication, dosage form, lot number, and expiration date ..."

During an interview on December 20, 2019, at 2:48 PM, with the executive director of ancillary services (EDA), in the conference room of risk management, the EDA confirmed the return of unlabeled red oral medication syringes from N tele contained erythromycin. The EDA further stated the labels should be individually attached to the edge of syringes without blocking the measurement on the tubes. When asked what process the nursing staff should have done with the unlabeled medication, the EDA stated "the nurses would not be able to associate the drug. The nurses would need to send it back to the pharmacy."

2. During an observation on December 17, 2019, at 3:06 PM, in the medication room of West telemetry (W tele) unit, there was a medication dispense cup with eight opened unidentifiable medications.

During a concurrent observation and interview on December 17, 2019, at 3:08 PM, with the director of telemetry unit (DTU) and registered nurse (RN) 2, in the medication room of W tele, the DTU and RN 2 confirmed there were eight open unidentifiable pills in the dispense cup in the medication storage bin. The DTU stated "it's not supposed to be here." RN 2 stated the medications should be in the original packages. RN 2 further stated "it's not mine. I know it's not supposed to be here. I will take care of it."

During a review of the facility's policy and procedure (P&P) titled, "Medication-Administration," dated September 23, 2019, the P&P indicated, " ...The label on the medication will be compared against the MAR (medication administration record). The secondary verification of the medication will be by way of scanning of the medication barcode and comparison with the patient MAR. Prior to administration any medication, the individual administering the medication does the following ...verifies the medication selected matches the medication order and product label (i.e. the right medication) ..."







3. During an observation with the Labor and Delivery Manager (LDM), on December 17, 2019, at 10:49 AM, in the labor and delivery patient care supply area, one expired 50 ml bag of Normal Saline solution had an expiration date of November 19, 2019, and was available for use.

During an interview with the LDM, on December 17, 2019, at 11:51 AM, the LDM stated the Normal Saline solution was expired and should have been removed from stock on or before the expiration date.

During a review of the facility's policy and procedure (P&P) titled, "Medication-Administration," revised September 23, 2019, the P&P indicated, " ...Procedure/Guidelines: A. Medication Administration ...7. Prior to administration any medication, the individual administering the medication does the following: ... d. verifies the medication is not expired, if the medication has expired, do not administer the medication; return it to pharmacy ..."

During a review of the facility policy and procedure (P&P) titled "Shelf Life Products" Revised September 23, 2019, the P&P indicated "Purpose: Following are guidelines for assuring infection control of items that are sterilized, wrapped, and placed on shelves for use throughout the medical center ...Procedures/Guidelines: A. Items having expiration dates of only month and year, must be used until last day of month indicated. B. Items having expiration date of month, date, and year, can be used until date of expiration. C. Proper rotation of stock will be done to eliminate unnecessary disposal of items ..."

4. During an observation with the Labor and Delivery Manager (LDM), on December 17, 2019, at 10:31 AM, in labor and delivery unit (LDU), two opened single-dose 1000 ml bags of Lactated Ringers solutions were stored at the Nurse's Station. The single-dose solution bags were hanging from an IV pole and spiked with IV tubing.

During an interview with Registered Nurse 9 (RN 9), on December 17, 2019, at 10:25 AM, RN 9 stated she had spiked the solution bags on December 17, 2019, at 7:30 AM, in anticipation for admissions. RN 9 stated Patient 23 was admitted to the facility at 9:57 AM (December 17, 2019) and RN 9 stated she had intended to administer one of the IV solution bags to Patient 23 (three hours after opening).

During a concurrent observation and interview with the LDM, on December 17, 2019, at 10:20 AM, the LDM discarded the two single-dose solution bags and stated after opening the solution bags, the IV fluid should have been used immediately and should not have been stored for anticipated admissions.

During an interview with the Director of Pharmacy (DOP), on December 18, 2019, at 9:05 AM, the DOP stated IV solutions are for single-dose patient use and typically lack microbial preservatives (substances added to the product to protect them from microbial growth). The DOP stated when single-dose intravenous products are opened in less than than ISO Class 5 air quality (a condition in which the air particle counts are controlled), the products must be used within one hour to prevent product contamination. The DOP stated ISO Class 5 air quality can only be found in the facility's pharmacy.

During a review of the facility's policy and procedure (P&P) titled, "Medication-Administration" revised September 23, 2019, the P&P indicated, " ...Procedure/Guidelines: B. Single-Dose Vials: 1. Use a single-does/single use vial for a single patient during the course of a single procedure. Discard the vial after this single; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etc. 2. Medications in single-dose/single-use vials lack antimicrobial preservatives and are therefore at greater risk to become contaminated and serve as a source of infection when used inappropriately. 3. If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of dosage, use a new needle and new syringe for each entry. a. USP (United States Pharmacopeia-regulatory organization) 797 states that single-dose/single-use vials opened in less than ISO Class 5 air quality be used within 1 (one) hour, with any remaining contents discarded ..."

5. During a review of Patient 25's "Admission Record" (demographic and medical information), the Admission Record indicated Patient 25 was admitted to the hospital on December 16, 2019, with diagnosis of induction of labor (the artificial start of the birth process through medical interventions).

During an observation with the Labor and Delivery Unit Manager (LDM), on December 17, 2019, at 9:30 AM, in Patient 25's room, Patient 25 was lying in bed receiving continuous epidural analgesia. Patient 25's epidural pump, epidural catheter tubing, and the head of the bed were not labeled to indicate Patient 25 was receiving an epidural infusion.

During an interview with the LDM, on December 17, 2019, at 11:26 AM, the LDM stated she did not know the epidural infusion pump, epidural catheter tubing, and head of the bed required labeling to indicate Patient 25 was receiving epidural analgesia therapy.

During a concurrent interview and review of the policy and procedure (P&P) for epidural analgesia, with the Director of Risk Management (RM), on December 17, 2019, at 3:33 PM, in the conference room, the RM reviewed the P&P and stated the epidural analgesia P&P indicates the epidural infusion pump, epidural catheter tubing, and head of the bed should have been labeled to indicate Patient 25 was receiving epidural analgesia therapy.

During a concurrent interview and record review of Patient 25's "Obstetric Nursing Flowsheet (Nursing Flowsheet)" with Registered Nurse 7 (RN 7), on December 23, 2019, at 8:15 AM, in the conference room, RN 7 stated Patient 25's epidural analgesia (pain medication) therapy was initiated on December 17, 2019, at 9:21AM and Patient 25's "Obstetric Nursing Flowsheet" did not indicate respirations (breathing rate) or oxygen saturation (oxygen in the blood) were assessed every two minutes for 10 minutes. RN 7 stated RN 10 should have assessed Patient 25's respirations and oxygen saturation every two minutes for 10 minutes after the epidural analgesic medication was initiated to ensure pain management therapy was safe and the medication did not cause slow and ineffective breathing.

During a review of the facility's policy and procedure (P&P) titled, "Epidural-Intrathecal Analgesia Temporary Continuous Infusion, Intermittent Injection (injection as needed)" revised December 4, 2017, the P&P indicated, "Purpose: to provide guideline for assessment and monitoring of patients receiving continuous and /or intermittent epidural/intrathecal analgesia ...Procedure/Guideline: ...E. Place sticker on epidural/intrathecal catheter tubing, infusion pump, head of bed and on front of patient's chart indicating epidural/intrathecal infusion ...Documentation: A. 24-hour Nursing Flow sheet (Obstetric medical record) the following: 1. Assessment of pain relief and level block. 2 BP (blood pressure) respirations, 02 (oxygen) saturation and FHR (fetal heart rate) pattern every 2 9two) minutes X (for) 10 minutes, then every 15 minutes X 4, and then every 30 minutes thereafter ..."

6. During a review of Patient 1's "Admission Sheet" (demographic and medical information), the Admission Sheet indicated Patient 1 was admitted to the facility on on [DATE], with diagnosis of wound necrosis (wound that contains dead tissue).

During an observation with the Medical-Surgical Unit Manager (MSM), on December 18, 2019, at 11:20 AM, in Patient 1's room, Patient 1was receiving IV Normal Saline (salt) solution through a peripherally inserted central catheter (PICC- a tube placed into a large vein that extends close to the heart to give medications and blood) in his right upper arm. The IV infusion tubing was not labeled to indicate when the IV tubing should no longer be used.

During an interview with the MSM, on December 18, 2019, at 11:23 AM, the MSM viewed the IV tubing and stated IV tubing are changed every 96 hours and "All IV tubing must be labeled with an expiration date." The MSM stated the nurse should have dated the IV tubing to indicate when the tubing should no longer be used.

During an observation of Patient 1's IV medication preparation, on December 18, 2019, at 2:03 PM, with the MSM, in the medication room, RN 3 was observed preparing a vial of Zozyn (medication used to treat infection) 3.375 grams (unit of measurement) to reconstitute (mix) for IV administration. RN 3 cleaned and disinfected the medication preparation area with disinfectant wipes (chemical wipes used to kill germs) and discarded the wipes. RN 3 did not perform hand hygiene or change her gloves after cleaning and disinfecting the medication preparation area. RN 3 opened the Zozyn vial and added NS into the medication vial for IV administration.

During a concurrent interview with the MSM and RN 3, on December 18, 2019, at 2:20 PM, in the medical-surgical unit, RN 3 stated she did not perform hand hygiene or change her gloves after cleaning and disinfecting the medication preparation area. The MSM stated RN 3 should have performed hand hygiene after cleaning and disinfecting the medication preparation area.

During a review of the facility policy and procedure (P&P) titled "Intravenous Therapy" revised September 21, 2017, the P&P indicated, "Purpose: A. To provide general guidelines on issues concerning the safe initiation, maintenance, and discontinuation of IV therapy and to ensure safe and appropriate administration of intravenous medications ...Policy: ...4. Initiation, maintenance, manipulation, and discontinuance of IV therapy requires strict adherence to the principles of aseptic technique and standard precautions. Wash hands before and after palpating, inserting, replacing, manipulating, or dressing and IV device or site ... D. IV Tubing: Changes: 1. Label with date, time and initials of the staff. 2. Change every 96 hours ..."

During a review of the facility policy and procedure (P&P) titled, "Prevention of Health Care Associated Infections," revised December 6, 2018, the P&P indicated, "Policy: Healthcare Associated infections significantly contribute to patient mortality and morbidity, as well as increased costs of hospitalization . Prevention of infection is a highly desirable patient outcome. Hand hygiene remains the primary method of prevention for all types of infections ..."

7. During an observation with the Surgical Service Director (SSD) and Surgical Service Manager (SSM), on December 19, 2019, at 9:09 AM, in the surgical critical core area, the surgical fluid warmer contained two expired 1000 ml bags of Normal Saline solution with expiration dates of December 10, 2019, and one expired 1000 ml bag of Normal Saline solution with an expiration date of December 12, 2019, and were available use.

During an interview with the SSM, on December 19, 2019, at 9:20 AM, the SSM stated the Normal Saline solution bags were expired and should have been removed from stock on or before the expiration date.

During a review of the facility's policy and procedure (P&P) titled, "Medication-Administration," revised September 23, 2019, the P&P indicated, " ...Procedure/Guidelines: A. Medication Administration ...7. Prior to administration any medication, the individual administering the medication does the following: ... d. verifies the medication is not expired, if the medication has expired, do not administer the medication; return it to pharmacy ..."

During a review of the facility policy and procedure (P&P) titled "Shelf Life Products" Revised September 23, 2019, the P&P indicated "Purpose: Following are guidelines for assuring infection control of items that are sterilized, wrapped, and placed on shelves for use throughout the medical center ...Procedures/Guidelines: A. Items having expiration dates of only month and year, must be used until last day of month indicated. B. Items having expiration date of month, date, and year, can be used until date of expiration. C. Proper rotation of stock will be done to eliminate unnecessary disposal of items ..."

8. During a review of Patient 1's "Face Sheet" (patient demographics), undated, the "Face sheet" indicated, Patient 1 was admitted on [DATE] with diagnosis of wound necrosis (wound that contains dead tissue).

During an observation, on December 18, 2019, at 2:15 PM, in Patient 1's room of Medical Surgical (MedSurg) unit, Patient 1 was receiving normal saline (NS-fluid solution with the same concentration as blood) solution through a peripheral inserted central catheter (PICC-an access into the vein that can be used to give medication) located in the right upper arm. RN 3 verified Patient 1's name and Zosyn with the Medication Administration Record (MAR). RN 3 hung a mini bag plus container system with the Zosyn vial filled with the mixed drug on the IV pole. RN 3 did not drain the mixed Zosyn back from the vial into the bag, and started the IV pump. RN 3 did not ensure the medication was drained into the bag before the IV pump was started.

During a concurrent observation and interview, on December 18, 2019, at 2:17 PM, with RN 3, in Patient 1's room, Patient 1 was observed to have the IV pump started with the vial filled with Zosyn and NS solution. RN 3 stated the Zosyn from the vial should have been drained into the NS solution bag prior to starting of IV pump. RN 3 further stated, "It was an honest mistake."

During a concurrent observation and interview, on December 18, 2019, at 2:18 PM, with the Supervisor of Medical Surgical unit (SMS), in Patient 1's room, the SMS confirmed the IV pump was started prior to draining the Zosyn back into the NS solution bag. The SMS stated the vial should have been emptied prior to starting of the IV pump.
During an interview, on December 18, 2019, at 3:15 PM, with the Executive Director of Ancillary Services (EDA), the EDA stated he was the Director of Pharmacy. The EDA stated staff should have emptied the vial prior to starting IV pump. The EDA further stated Patient 1 did not receive the prescribed medication, and "Yes, that was a medication error."

During a review of Patient 1's MAR, dated December 18, 2018, MAR indicated, Patient 1 received Zosyn 3.375 gram at 2:15 PM.

The manufacturer's guidelines title "[Brand Name]" user's guide, dated December 2018, indicated, " ...Reconstitution 5. For powdered drug vials: hold bag with vial down, squeeze solution into vial until half full, shake to suspend drug in solution. 6. Hold bag with vial upside down, squeeze bag to force air into vial, release to drain suspended drug from vial, repeat steps 5 and 6 until vial is empty of drug and solution is thoroughly mixed ...8. Hang container on I.V. pole and prime set per directions. Ensure that vial is empty of drug and solution ..."

During a review of the facility's policy and procedure (P&P) titled, "Medication-Administration," dated September 23, 2019, the P&P indicated, " ...The goal of drug administration is to ensure mechanisms exist such that drugs and biologicals are administered in a safe, accurate, timely, and effective manner ...H. Medication Administration via IV 1. IV medication guidelines are available electronically as a resource for registered nurse. 2. Assure proper programming of infusion pump, including: a. Concentration. b. Flow rate. c. Dose ..."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation Infection Control was met when:

1. The facility failed to ensure all available patient care supplies were not expired in three of seven sampled patient care areas (Labor and Delivery, Neonatal Intensive Care Unit, and Medical-Surgical Unit). These failures had the potential to result in patient harm, as the use of expired patient care supplies could have resulted in ineffective treatment modalities (Refer to A-0748).

2. The facility did not perform daily terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) from October 2019 through December 2019, for four of six Operating Rooms (OR 2, 3, 4, and 6). These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable hospital acquired infection and prolonged hospitalization (Refer to A-749).

3. The facility did not ensure temperature (68 degree Fahrenheit [unit of measurement] to 73 degree Fahrenheit) and humidity (20% [percent-unit of measurement] to 60%) were in safe range for storing sterile (germ free) products, on December 19, 2019 and December 20, 2019. This failure had the potential for cross-contamination due to the packaging material becoming moist and germs from the air and surfaces affecting the packing and the sterility of the product (Refer to A-749).

4. Peripherally inserted central catheter (PICC-a tube placed into a large vein that extends close to the heart to give medications and blood) site dressings were not labeled and staff did not perform daily assessments for PICC necessity (the need for continue use of a central catheter) or use an alternative method) of the for two of three sampled patients (Patient 17 and Patient 18). These failures had the potential for germs to enter Patient 17's and Patient 18's blood system causing PICC site infections and prolonged hospitalization (Refer to A-749).

5. Aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a peripherally inserted central catheter (PICC) dressing site change for one of three sampled patients (Patient 18). This failure had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable central line associated blood stream infection (CLASBI- bloodstream infection in a patient with a central line) and prolonged hospitalization (Refer to A-749).

The cumulative effect of these deficient practices resulted in the facility failing to meet the Condition of Participation for Infection Control.
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on observation, interview, and record review, the facility failed to ensure all available patient care supplies were not expired in three of seven sampled patient care areas (Labor and Delivery Unit [L&D], Neonatal Intensive Care Unit [NICU-nursery], and Medical-Surgical Unit
[MSU]).

These failures had the potential to result in patient harm, as the use of expired patient care supplies could have resulted in ineffective treatment modalities.

Findings:

1. During an observation with the Labor and Delivery Unit Manager (LDM), on December 17, 2019, at 10:40 AM, in the L&D patient care supply area, the following items were expired:

1a. One expired Bartholin gland catheter (used to treat an abscess of the Bartholin gland {glands located on both sides of the vaginal opening}) kit had a manufacturer's expiration date of November 2019, and was available for use.

1b. One expired lubricating jelly had a manufacturer's expiration date of July 2019, and one expired lubricating jelly had a manufacturer's expiration date of March 2019, and were available for use.

During an interview with the LDM, on December 17, 2019, at 10:51 AM, the LDM stated the lubricating jelly and Bartholin gland catheter kit were expired and should have been discarded on or before the expiration dates.

2. During an observation with the Neonatal Intensive Care Unit Manager (NICUM), on December 17, 2019, 12:48 PM, in the NICU patient care supply area, the following items were expired:

2a. One expired viral transport medium (used to collect and transport patient specimens) had a manufacturer's expiration date of November 2019, four expired viral transport medium had manufacturer's expiration dates of September 2019, one expired viral transport medium had a manufacturer's expiration date of May 2019, and were available for use.

2b. Two expired boxes of chemical indicators (used to check for the presence of chemicals) had manufacturer's expiration dates of January 11, 2018, and were available for use.

2c. One expired hand silk suture kit had a manufacturer's expiration date of July 19, 2019, and was available for use.

During an interview with the NICUM, on December 17, 2019, at 12:59 PM, the NICUM stated the transport mediums, silk suture kit, and chemical indicators were expired and should have been discarded.

3. During an observation with the Medical-Surgical Unit Manager (MSM), on December 18, 2019, at 10:18 AM, in the MSU patient care supply area, the following items were expired:

3a. One expired viral transport medium had a manufacturer's expiration date of November 2019, and was available for use.

3b. Four expired bone marrow transport mediums had manufacture's expiration dates of March 2016, and were available for use.

3c. One expired green top vacutainer had a manufacturer's expiration date of December 2016, one expired green top vacutainer had an expiration date of November 30, 2019, and were available for use.

3d. One expired dark green top vacutainer had a manufacturer's expiration date of February 27, 2019, one expired dark green top vacutainer had a manufacturer's expiration date of March 29, 2018, one expired dark green top vacutainer had a manufacturer's expiration date of September 8, 2018, one expired dark green top vacutainer had a manufacturer's expiration date of February 2016, one expired dark green top vacutainer had a manufacturer's expiration date of May 24, 2019, and were available for use.

3e. One expired purple top vacutainer had a manufacturer's expiration date of August 11, 2019, one expired purple top vacutainer had an expiration date of February 24, 2019, and were available for use.

3f. Two expired pink top vacutainers had manufacturer's expiration dates of February 2014, and were available for use.

3g. One expired blue top vacutainer had a manufacturer's expiration date of February 2015, and was available for use.

During an interview with the MSM, on December 18, 2019, at 10:45 AM, the MSM stated viral transport mediums, bone marrow transport mediums, and vacutainers were expired and expired items should not be stocked in the MSU patient care supply areas.

During a review of the facility policy and procedure (P&P) titled "Shelf Life Products" Revised September 23, 2019, the P&P indicated "Purpose: Following are guidelines for assuring infection control of items that are sterilized, wrapped, and placed on shelves for use throughout the medical center ...Procedures/Guidelines: A. Items having expiration dates of only month and year, must be used until last day of month indicated. B. Items having expiration date of month, date, and year, can be used until date of expiration. C. Proper rotation of stock will be done to eliminate unnecessary disposal of items ..."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the facility failed to ensure safe practices were implemented for infection control when:

1. The facility did not perform daily terminal cleaning (a cleaning method used in healthcare environments to control the spread of infections) from October 2019 through December 2019, for four of six Operating Rooms (OR 2, 3, 4, and 6).

These failures had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable hospital acquired infection and prolonged hospitalization .

2. The facility did not ensure temperature (68 degree Fahrenheit [unit of measurement] to 73 degree Fahrenheit) and humidity (20% [percent-unit of measurement] to 60%) were in safe range for storing sterile (germ free) products, on December 19, 2019 and December 20, 2019.

This failure had the potential for cross-contamination due to the packaging material becoming moist and germs from the air and surfaces affecting the packing and the sterility of the product.

3. Peripherally inserted central catheter (PICC-a tube placed into a large vein that extends close to the heart to give medications and blood) site dressings were not labeled and staff did not perform daily assessments for PICC necessity (the need for continue use of a central catheter) for two of three sampled patients (Patient 17 and Patient 18).

These failures had the potential for germs to enter Patient 17's and Patient 18's blood system causing PICC site infections and prolonged hospitalization .

4. Aseptic technique (a method used to prevent contamination with microorganisms) was not maintained during a peripherally inserted central catheter (PICC) dressing site change for one of three sampled patients (Patient 18).

This failure had the potential for cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) causing a preventable central line associated blood stream infection (CLASBI- bloodstream infection in a patient with a central line) and prolonged hospitalization .

Findings:

1. During a concurrent interview and record review of the "Operating Room Terminal Cleaning Logs" dated October 2019 through December 2019, with the Environmental Service Manager (EVSM), on December 19, 2019, at 9:15 AM, the EVSM stated terminal cleaning is performed daily after the last procedure to prevent the spread of infection. The EVSM stated terminal cleaning for operating rooms involved cleaning and disinfecting all exposed surfaces, including wheels and casters, of all equipment, cleaning and disinfecting the floor, and moving equipment around the room to clean the floor underneath. The EVSM stated the Operating Room Terminal Cleaning Logs indicated the following:

For OR 2, terminal cleaning was not done on November 29, 2019, and December 1, 2019.

For OR 3, terminal cleaning was not done on November 21, 2019.

For OR 6, terminal cleaning was not done on October 29, 2019.

The EVSM stated EVS staff should have performed terminal cleaning daily for Operating Rooms 2, 3, and 6.

During an observation with the Surgical Service Director (SSD), Surgical Service Unit Manager (SSM), and the Quality Coordinator (QC), on December 20, 2019, at 9:17 AM, in OR 4, the SSM removed the mattress from the surgical table and the mattress and table were wet. The SSD moved equipment around the room and one used syringe and one instrument cover were observed on the floor.

During a concurrent interview with the SSD, SSM, and the QC, on December 20, 2019, at 9:31 AM, the SSD stated the mattress and table should not have been wet and items should not have been observed on the floor. The SSD stated OR 4 should have been terminally cleaned on December 19, 2019, after the last procedure.

During an observation with the SSD, SSM, and the QC, on December 20, 2019, at 9:33 AM, in OR 6, the SSM removed the sheet from the surgical table and the fabric for both arm boards were ripped. The SSD removed the mattress from the surgical table and the surgical table frame contained a dried reddish brown substance. The reddish brown substance was removed with rigorous friction (scrub) and a damp cloth. The linen hamper rails and frame contained dried reddish brown substances and the SSM cleaned the dried reddish brown substances from the linen hamper rails and frame with a damp cloth. Equipment was moved around the room and one needle cap cover, one twist cap seal, one used alcohol pad, two stickers, and one box of open tissue were observed on the floor.

During a concurrent interview with the SSD, SSM, and the QC, on December 20, 2019, at 10:02 AM, the SSM stated the ripped arm boards should have been replaced prior to terminal cleaning. The SSD, SSM, and the QC stated they could not identify the dried reddish brown substance on the surgical table frame or on the linen hamper frame and rails. The SSD stated the needle cap cover, twist cap seal, used alcohol pad, two stickers, and one box of open tissue should not have been observed on the floor and OR 6 should have been terminally cleaned on December 19, 2019.

During an interview with the Infection Control Preventionist (ICP), on December 20, 2019, at 10:20 AM, in the conference room, the ICP stated staff must follow manufacture's guidelines for chemical cleaning and disinfecting which included allowing the chemical to remain wet for five minutes and then allow the surface to air dry. The ICP stated the mattress and surgical table should not have been wet and staff must perform terminal cleaning in the ORs daily to prevent hospital acquired infections.

During a review of the manufacture's instruction titled "Oxycide Daily Disinfectant Cleaner" (combination disinfection [chemical solution to destroy germs] and cleaning solution), dated 2015, the manufacture's instruction indicated " ...Combination disinfection and Cleaning: apply solution with mop, cloth, sponge, brush, scrubber, or coarse spray device or by soaking so as to wet all surfaces thoroughly. Allow to remain wet for required contact time, 3 (three), 5 (five), or 10 minutes and then either allow to air dry or if desired remove solution and entrapped soil with a clean wet mop, cloth, or wet vacuum pickup ..."

During a review of the policy and procedure (P&P) titled "Infection Control Guidelines" revised October 29, 2018, the P&P indicated, "Purpose: To prevent, control and contain infection ...Procedures/Guideline: ...Terminal Sanitation on Units: 1. Operating rooms including furniture, are clean after every procedure. 2. Operating Room (OR) suites, other invasive procedure areas, and sterile processing areas are terminally cleaned once a day by EVS personnel..."

2. During an observation with the Chief Financial Officer (CFO), Director of Clinical Expert (DCE), and Central Supply Manager (CSM), on December 20, 2019, at 3:20 PM, in the central supply storage area (CS), sterile products were observed stored on shelves and there was no thermometer located in CS to measure temperature and humidity.

During an interview with the CSM, on December 20, 2019, at 3:23 PM, the CSM stated the CS thermometer had been broken for two days. The CSM stated sterile products should be stored between 68 degree Fahrenheit to 73 degree Fahrenheit and the optimal humidity should be between 20% to 60%. The CSM stated temperature and humidity were not monitored on December 19, 2019 and December 20, 2019, to ensure temperature and humidity were maintained in safe ranges for storing sterile products.

During a concurrent observation and interview, with the CSM and CFO, on December 20, 2019, at 3:49 PM, in CS, the CSM removed a product from the storage shelf and stated central venous catheter (CVC- a tube placed into a large vein to administer medications, blood products, fluids) dressing change systems (sterile supplies used to help reduce CVC blood stream infection) are sterile products and the manufacture's label indicates CVC dressing change systems should be stored between 68 degree Fahrenheit to 77 degree Fahrenheit. The CSM stated he did not know if the temperature was maintained between 68 degree Fahrenheit to 77 degree Fahrenheit, on December 19, 2019 and December 20, 2019. The CFO stated the thermometer should have been replaced immediately on December 18, 2019.

During a review of the manufacturer's label titled "Central Venous Catheter" (undated), the manufacturer's label indicated, " ...Store between 20 degrees Celsius (unit of measurement) to 25 degrees Celsius (68 degree Fahrenheit to 77 degree Fahrenheit)."

During a review of the policy and procedure (P&P) titled "Supply Environment" revised October 8, 2014, the P&P indicated, "Purpose: Items used for patients must be stored and handled properly in order to comply with the standards of infection control and patient care ... Procedure/Guidelines: A. Warehouse/Central Supply storage areas will be maintained so that the temperature and humidity comply with the standards of the United States Pharmacopoeia (1990, 22nd revision). B. The temperature/humidity will be monitored and logged on a daily basis ...."

3. During an observation with the Medical-Surgical Manager (MSM), on December 18, 2019, at 10:53 AM, in Patient 17's room, Patient 17 was sitting in a chair watching television. Patient 17 had a PICC in her right jugular vein (large vein in the neck) and the PICC site dressing was not labeled to indicate when Patient 17's PICC dressing required changing.

During an interview with the MSM, on December 18, 2019, at 10:55 AM, the MSM stated PICC site dressings should be changed every seven days and Patient 17's PICC site dressing was not labeled. The MSM stated Patient 17's PICC site dressing should have been labeled with date, time, and staff initials, to indicate when the dressing should be changed to prevent PICC site infections.

During a concurrent interview and record review of Patient 17's "Nursing Notes" and "Progress Notes," with the Vascular (blood vessels) Access Manager (VAM), on December 19, 2019, at 3:15 PM, the VAM stated the facility's goal is to remove a PICC as soon as possible to prevent CVC site infections. The VAM stated Patient 17's clinical record should have included daily documentation for PICC necessity. The VAM stated the staff did not perform daily assessments for PICC necessity.

During an observation with the MSM, on December 18, 2019, at 11:01 AM, in Patient 18's room, Patient 18 was lying in bed, listening to music. Patient 18 had a double lumen (two lumens-lumens are the part of the PICC used to give IV treatments or take blood) PICC in her right jugular vein and the PICC site dressing was not labeled to indicate when the dressing required changing.

During an interview with the MSM, on December 18, 2019, at 11:05 AM, the MSM stated the PICC dressing was not labeled and staff did not follow the policy and procedure for labeling Patient 18's PICC site dressing. The MSM stated Patient 18's PICC site dressing should have been labeled with date, time, and staff initials.
During a concurrent interview and record review of Patient 18's "Nursing Notes" and "Progress Notes," with the VAM, on December 19, 2019, at 3:30 PM, the VAM stated staff did not perform daily assessments for PICC necessity. The VAM stated Patient 18's PICC should have been assessed daily for PICC necessity.

During a review of the policy and procedure (P&P) titled "Central Venous Catheter-Adult, Care of," reviewed December 19, 2019, the P&P indicated, " ...Policy ...F. Remove Central Lines as soon as possible. Groin lines should be relocated/removed before 24 hours. Evaluate daily the continuing need for the CVC and collaborate with physician to determine date to discontinue ...Procedure Steps: ...D ....18. Write date, time, and initial on dressing ..."
4. During an observation of Patient 18's PICC site dressing change, on December 18, 2019, at 2:40 PM, Registered Nurse 6 (RN 6) performed hand hygiene, put on a surgical cap, gathered the PICC dressing supplies and placed them on a clean table. RN 6 performed hand hygiene and put on a pair of sterile (germ free) gloves and covered her mouth and nose with the mask she had taken from the sterile central venous catheter kit (contain germ free supplies needed to change a PICC dressing). RN 6 cleaned the PICC double lumens (two lumens-lumens are the part of the PICC used to give IV treatments or take blood), cleaned the exposed skin which surrounded the soiled dressing, cleaned the surface of the soiled dressing, and did not perform hand hygiene prior to performing PICC lumen cap (a cover screwed onto the end of the PICC's lumen) change.

During an interview with RN 6, on December 18, 2019, at 2:55 PM, RN 6 stated she had added an extra step and cleaned the surface of the PICC soiled dressing and cleaned the exposed skin which surrounded the soiled dressing. RN 6 stated she should have performed hand hygiene prior to changing the lumen caps.

During an interview with the Vascular (blood vessels) Access Manager (VAM), on December 19, 2019, at 3:41 PM, the VAM stated RN 6 did not follow the policy and procedure for PICC site dressing change and hand hygiene should have been performed after cleaning the soiled dressing to ensure aseptic technique throughout the dressing change.

During a review of the policy and procedure (P&P) titled "Central Venous Catheter-Adult, Care of" reviewed December 19, 2019, the P&P indicated, "Purpose: The goal to reduce Central Line Associated Blood Stream Infections (CLABSI) include hand hygiene, maximal barrier precautions, chlorhexidine gluconate (CHG) skin antiseptic (used to destroy germs that cause disease), appropriate catheter site and administration system care, and no routine replacement ..."

During a review of the facility policy and procedure (P&P) titled "Intravenous Therapy" revised September 21, 2017, the P&P indicated, "Purpose: A. To provide general guidelines on issues concerning the safe initiation, maintenance, and discontinuation of IV therapy and to ensure safe and appropriate administration of intravenous medications ...Policy: ...4. Initiation, maintenance, manipulation, and discontinuance of IV therapy requires strict adherence to the principles of aseptic technique and standard precautions. Wash hands before and after palpating, inserting, replacing, manipulating, or dressing and IV device or site ... D. IV Tubing: Changes: 1. Label with date, time and initials of the staff. 2. Change every 96 hours ..."