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.

ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL ONE ROBERT WOOD JOHNSON PLACE NEW BRUNSWICK, NJ 08901 Dec. 21, 2018
VIOLATION: NURSING SERVICES Tag No: A0385
Based on medical record review, review of facility documentation, and staff interview, it was determined that the facility failed to have an organized nursing service.

Findings include:

1. The facility failed to ensure that morphine for comfort care was administered in accordance with the orders of the practitioner responsible for the patient's care, State law, and acceptable standards of practice. (Cross refer to Tag A 405, part A)

2. The facility failed to ensure that all medications were administered in accordance with physician's orders, facility policy, and acceptable standards of practice. (Cross refer to Tag A 405, part B)

3. The facility failed to ensure that standing orders and protocols were implemented in accordance with facility policy and Federal law. (Cross refer to Tag A 406)
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on medical record review, review of facility protocol, and staff interview, it was determined that the facility failed to ensure that morphine for comfort care is administered in accordance with the orders of the practitioner responsible for the patient's care, State law, and acceptable standards of practice.

Findings include:

Reference #1: The New Jersey Board of Nursing Statutes 45:11-23 indicates, " ... (b) The practice of nursing as a registered professional nurse is defined as diagnosing and treating human responses to actual or potential physical and emotional health problems, through such services as casefinding, health teaching, health counseling, and provision of care supportive to or restorative of life and wellbeing, and executing medical regimens as prescribed by a licensed or otherwise legally authorized physician or dentist. ..."

Reference #2: Facility protocol titled, "Guideline: Comfort Care Order Set Protocol" indicates, "... Physician Orders: As indicated on the order set the patient may receive continuous infusion of opioids (morphine or dilaudid) as well as bolus doses of opioids for symptom relief. ... If the patient requires more than 2 bolus doses per hour then the hourly drip rate should be increased by 25% [percent] ... As the drip rate increases the bolus dose will also need to be increased so that it is maintained at 50% of hourly infusion. ..."

1. A review of 13 out of 18 medical records for patients receiving morphine for comfort care on SICWest [Surgical Intensive Care West] revealed that the patients received dosages of morphine greater than the dosage prescribed by the physician, as follows:

a. Medical Record #1 contained a physician's order for morphine infusion dated 2/24/16, which indicated, "... Initial Dose Rate: 2 mg/hr [milligram per hour], 2 ml/hr [milliliter per hour], ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 2/24/16 at 3:00 PM at the ordered rate of 2 mg/hr. At 5:00 PM, the hourly rate was increased to 4 mg/hr by the Registered Nurse (RN). The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase from 2 mg/hr to 4 mg/hr was a 100% increase and not a 25% increase in accordance with physician orders and the Comfort Care Protocol.

(ii) At 10:00 PM, the morphine hourly rate was increased to 6 mg/hr and a nursing progress note indicated, "... 3 mg of morphine IV [intravenous] were given and the morphine drip was increased to 6mg [sic] per hour." The bolus dose of 3 mg was greater than 50% of what the hourly rate should have been if the morphine had been infusing in accordance with the physician's order indicating an hourly rate of 2 mg/hr. Additionally, the increased infusion rate of 6 mg was not appropriate because the medical record lacked evidence that two (2) bolus doses had been administered within the previous hour. Therefore, the criteria allowing for an increase in the hourly rate as specified in the physician's order was not met and the rate should not have been increased. Finally, the hourly infusion rate of 6 mg/hr was a 400% increase from the ordered rate of 2 mg/hr and not a 25% increase in accordance with physician orders and the Comfort Care Protocol.

(iii) At 11:00 PM, the morphine hourly rate was increased to 8 mg/hr and a nursing progress note indicated, "... the patient was noted to be comfortable yet (his/her) oxygen saturation was in the middle 60's. ... The morphine drip was further increased to 8mg per hour to maintain adequate level of comfort. ..." The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within an hour prior to the rate increase. Therefore, the criteria allowing for an increase in the hourly rate as specified in the physician's order was not met and the rate should not have been increased. Additionally, an hourly rate of 8 mg/hr was a 300% increase from the ordered rate of 2 mg/hr and not a 25% increase in accordance with physician orders and the Comfort Care Protocol. Finally, the nursing note also indicates that the rate was increased while the patient was documented as being "comfortable."

(iv) An "Expiration Note" revealed that Patient #1 expired at 11:06 PM, six (6) minutes after the morphine was increased to 8 mg/hr. The medical record lacked evidence that the patient ever received two (2) bolus doses of morphine within one (1) hour. Therefore, the morphine should have been infusing at 2 mg/hr at the time of death in accordance with the physician's order. At the time the patient expired, the morphine was infusing at a rate four (4) times the rate ordered by the physician.

(v) The above was confirmed with Staff #1, Staff #2, Staff #3, Staff #4, Staff #8 and Staff #9 on 12/5/18 at 1:05 PM.

(vi) The above was confirmed again on 12/12/18 with Staff #2, Staff #3, and Staff #12 and on 12/13/18 at 11:30 AM with Staff #14.

b. Medical Record #4 contained a physician's order for morphine infusion dated 2/5/16, which indicated, "... Initial Dose Rate: 1 mg/hr, 1 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated by the RN on 2/5/16 at 5:00 AM with an infusion rate of 10 mg/hr, not 1 mg/hr as ordered by the physician. This rate was ten (10) times higher then the ordered infusion rate. The patient expired 18 minutes later at 5:18 AM.

(ii) The above was confirmed with Staff #14 on 12/13/18 at 11:30 AM.

c. Medical Record #6 contained a physician's order for morphine infusion dated 2/14/16, which indicated, "... Initial Dose Rate: 1 mg/hr, 1 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated by the RN on 2/14/16 at 2:00 PM with an infusion rate of 5 mg/hr, not 1 mg/hr as ordered by the physician. This rate was five (5) times higher then the ordered infusion rate. The patient continued to receive 5 mg/hr of morphine until he/she expired at 5:27 PM.

(ii) The above was confirmed with Staff #14 on 12/13/18 at 11:30 AM.

d. Medical Record #3 contained a physician's order for morphine infusion dated 11/15/18, which indicated, "... Initial Dose Rate: 2 mg/hr, 2 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 11/15/18 at 6:00 PM at the prescribed infusion rate of 2 mg/hr. At 7:00 PM, the hourly rate was increased to 5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase from 2 mg/hr to 5 mg/hr was a 150% increase and not a 25% increase in accordance with physician orders and the Comfort Care Protocol.

(ii) At 8:00 PM, the hourly rate of the morphine infusion was increased to 8 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within an hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. The hourly infusion rate of 8 mg/hr was a 300% increase from the ordered rate of 2 mg/hr, and not a 25% in accordance with physician orders and the Comfort Care Protocol.

(iii) An "Expiration Note" revealed that Patient #3 expired at 10:08 PM. The medical record lacked evidence of the hourly rate that the morphine was infusing after the increase to 8 mg at 8:00 PM. However, documented evidence supports that the hourly infusion rate was at least four (4) times the ordered rate of 2 mg/hr at the time the patient expired. The medical record lacked evidence that the criteria allowing for the increase was met in accordance with physician orders and the Comfort Care Protocol.

(iv) The above findings were confirmed with Staff #2, Staff #4, Staff #11, Staff #12 and Staff #14 on 12/12/18 at 2:30 PM.

(v) The above findings were confirmed again with Staff #14 on 12/13/18 at 11:30 AM.

e. Medical Record #40 contained a physician's order for morphine dated 9/23/18, which indicated, "morphine infusion... Initial Dose Rate 2 mg/hr ... Additional Instructions ORDER TO BE IMPLEMENTED WHEN WITHDRAWAL OF LIFE SUPPORT INITIATED Titrate to pain score of 0 or to maintain resp [respiratory] rate below 12 ..." The physician's order lacked evidence of an increment in which the hourly rate should be increased during titration.

(i) The medical record lacked evidence that the physician's order was clarified by the nursing or pharmacy staff.

(ii) Documented evidence revealed that the morphine infusion was initiated at the prescribed rate of 2 mg/hr on 9/23/18 at 5:00 PM, and was increased by an increment of 2 mg/hr by a RN without a physician's order as follows:

9/23/18 at 6:00 PM, the hourly rate was increased to 4 mg/hr.
9/23/18 at 7:00 PM, the hourly rate was increased to 6 mg/hr.
9/24/18 at 12:00 AM, the hourly rate was increased to 8 mg/hr.
9/24/18 at 9:00 AM, the hourly rate was increased to 10 mg/hr.
9/24/18 at 11:00 AM, the hourly rate was increased to 12 mg/hr.
9/24/18 at 2:00 PM, the hourly rate was increased to 14 mg/hr.

(iii) A nursing note dated 9/24/18 at 5:09 PM, indicated that Patient #3 expired. The medical record lacked evidence of the hourly rate that the morphine was infusing after the increase to 14 mg at 2:00 PM. However, documented evidence supports that the hourly infusion rate was at least seven (7) times the ordered rate at the time the patient expired.

(iv) The above was confirmed with Staff #1, Staff #14, and Staff #28 on 12/17/18 at 11:20 AM.

f. Medical Record #48 contained a physician's order for morphine infusion dated 8/28/18, which indicated, "... Initial Dose Rate: 1 mg/hr, 1 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 8/28/18 at 6:55 PM at the prescribed infusion rate of 1 mg/hr. At 10:05 AM, the hourly infusion rate was increased by 100% of the ordered rate to 2 mg/hr by the RN. Five (5) minutes later at 10:10 AM, the hourly rate was increased by 150% of the ordered rate to 2.5 mg/hr by the RN. The rate was increased for a third time within one (1) hour at 10:45 AM to 3 mg/hr by the RN. The increase from 1 mg/hr to 3 mg/hr was a 200% increase and not a 25% in accordance with physician orders and the Comfort Care Protocol. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased.

(ii) At 11:50 AM, the hourly rate was increased to 4 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 4 mg/hr was a 300% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iii) At 3:00 PM, the hourly rate was increased to 5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within an hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate as specified in the physician's order was not met and the rate should not have been increased. Additionally, the hourly rate increase to 5 mg/hr was a 400% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iv) At 3:50 PM, the hourly rate was increased for the second time within one (1) hour to 6 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 6 mg/hr was a 500% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iv) At 4:30 PM, the hourly rate was increased to 7.5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 7.5 mg/hr was a 650% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(v) At 5:00 PM, the hourly rate was increased to 9 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 9 mg/hr was a 800% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(vi) At 7:00 PM, the hourly rate was increased to 12.5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 12.5 mg/hr was a 1150% increase from the ordered rate of 1 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(vii) An "Expiration Note" revealed that Patient #48 expired on [DATE] at 1:29 AM while receiving 12.5 mg/hr of morphine. The medical record lacked evidence that the patient ever received two (2) bolus doses of morphine within one (1) hour. Therefore, the morphine should have been infusing at 1 mg/hr at the time of death in accordance with the physician's order and the Comfort Care Protocol. At the time the patient expired the morphine was infusing at a rate twelve and one-half (12 1/2) times the rate ordered by the physician.

(viii) The above was confirmed with Staff #14 on 12/17/18.

g. Medical Record #45 contained a physician's order for morphine infusion dated 7/14/18, which indicated, "... Initial Dose Rate: 12 mg/hr, 12 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 7/14/18 at 12:23 PM at the prescribed rate of 12 mg/hr. Upon medical record review, Staff #14 stated that the only documentation in the medical record of the hourly drip rate was on 7/14/18 at 8:00 PM, when documented evidence indicated that the morphine was infusing at 15 mg/hr. The medical record lacked evidence of the time the hourly rate was increased. However, the medical record lacked evidence that the patient had received two (2) bolus doses of morphine within a one (1) hour timeframe as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased.

(ii) The medical record lacked additional evidence of the hourly rate in which the morphine was infusing. Patient #45 expired the following day on 7/15/18 at 4:15 PM.

(iii) The above was confirmed with Staff #14 on 12/17/18 at 12:05 PM.

h. Medical Record #46 contained a physician's order for morphine dated 7/16/18, which indicated, "... Initial Dose Rate: 2 mg/hr, 2 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 7/16/18 at 12:00 PM at the prescribed rate of 2 mg/hr. At 1:00 PM, the hourly infusion rate was increased to 4 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase from 2 mg/hr to 4 mg/hr was a 100% increase and not 25% in accordance with physician orders and the Comfort Care Protocol.

(ii) At 2:00 PM, the infusion rate was increased to 5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 5 mg/hr was a 150% increase from the ordered rate of 2 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iii) At 8:00 PM, the infusion rate was increased to 6 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 6 mg/hr was a 200% increase from the ordered rate of 2 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iv) At 9:00 PM, the infusion rate was increased to 7 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 7 mg/hr was a 250% increase from the ordered rate of 2 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(v) An "Expiration Note" revealed that Patient #46 expired on [DATE] at 12:30 AM while receiving 7 mg/hr of morphine. The medical record lacked evidence that the patient had ever received two (2) bolus doses of morphine within one (1) hour. Therefore, the morphine should have been infusing at 2 mg/hr at the time of death in accordance with the physician's order and the Comfort Care Protocol. At the time the patient expired, the morphine was infusing at a rate three and one-half (3 1/2) times the rate ordered by the physician.

(vi) The above was confirmed with Staff #14 on 12/17/18 at 11:50 AM.

i. Medical Record #47 contained a physician's order for morphine dated 8/8/18, which indicated, "... Initial Dose Rate: 2 mg/hr, 2 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the patient was extubated and the morphine infusion was initiated on 8/9/18 at 12:46 AM. The morphine infusion was initiated by the RN at an hourly rate of 8 mg/hr, not 2 mg/hr as ordered by the physician.

(ii) The morphine infusion remained at 8 mg/hr until the patient expired, on 8/9/18 at 3:59 AM. At the time the patient expired, the morphine was infusing at a rate four (4) times the rate ordered by the physician.

(iii) The above was confirmed with Staff #14 on 12/17/18.

j. Medical Record #42 contained a physician's order for morphine dated 6/11/18, which indicated, "... Initial Dose Rate: 2 mg/hr, 2 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated by the RN on 6/11/18 at 3:00 PM at an hourly rate of 5 mg/hr, not 2 mg/hr as ordered by the physician.

(ii) The morphine infusion remained at 5 mg/hr until the patient expired three (3) hours later at 6:00 PM on 6/11/18. At the time the patient expired, the morphine was infusing at a rate two and one-half (2 1/2) times the rate ordered by the physician.

(ii) The above was confirmed with Staff #14 on 12/17/18.

k. Medical Record #41 contained a physician's order for morphine dated 7/28/18, which indicated, "... Initial Dose Rate: 8 mg/hr, 8 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 7/28/18 at 1:45 PM at the prescribed rate of 8 mg/hr. At 2:00 PM, the infusion rate was increased to 12 mg/hr. The patient had received a bolus dose at 1:15 PM prior to the initiation of the continuous infusion and again at 2:00 PM. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour once the infusion was initiated. Therefore, the criteria allowing for an increase in the hourly rate as specified in the physician's order and the Comfort Care Protocol was not met. The rate should not have been increased. Additionally, the hourly rate increase from 8 mg to 12 mg was a 50% increase and not a 25% increase in accordance with physician's order and the Comfort Care Protocol.

(ii) The morphine infusion remained at 12 mg/hr until the patient expired on [DATE] at 6:49 PM.

(iii) During an interview on 12/17/18, Staff #14 and Staff #28 confirmed that the rate was increased by greater than 25% as ordered by the physician and specified in the comfort care protocol.

l. Medical Record #15 contained a physician's order for morphine dated 9/3/18, which indicated, "... Initial Dose Rate: 2 mg/hr, 2 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 9/3/18 at 12:00 PM at the prescribed rate of 2 mg/hr. At 1:00 PM, the rate was increased to 4 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase from 2 mg/hr to 4 mg/hr was a 100% increase and not a 25% increase in accordance with physician orders and the Comfort Care Protocol.

(ii) At 2:00 PM, the rate was increased to 6 mg/hour by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 6 mg/hr was a 200% increase from the ordered rate of 2 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iii) At 3:00 PM the rate was increased to 8 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 8 mg/hr was a 300% increase from the ordered rate of 2 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iv) An "Expiration Note" revealed that Patient #15 expired on [DATE] at 6:08 PM. The medical record lacked evidence of the hourly rate that the morphine was infusing after the increase to 8 mg at 4:00 PM. However, documented evidence supports that the hourly infusion rate was at least four (4) times the ordered rate of 2 mg/hr at the time the patient expired. The medical record lacked evidence that the criteria allowing for the increases was met in accordance with physician orders and the Comfort Care Protocol.

(iv) The above was confirmed with Staff #14 on 12/14/18 at 3:00 PM.

m. Medical Record #37 contained a physician's order for morphine dated 8/21/18, which indicated, "... Initial Dose Rate: 4 mg/hr, 4 ml/hr, ... Additional Instructions: TITRATION GUIDELINES:If [sic] the patient receives 2 bolus [sic] of morphine in 1hour [sic] then the hourly drip rate should be increased by 25%. As the drip rate is increased the bolus dose should be increased so that it is maintained at 50% of hourly infusion. ..."

(i) Documented evidence revealed that the morphine infusion was initiated on 8/21/18 at 10:00 AM at the prescribed rate of 4 mg/hr. At 2:00 PM, the hourly rate was increased to 5 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased.

(ii) At 4:00 PM, the rate was increased from 5 mg/hr to 8 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 8 mg/hr was a 100% increase from the ordered rate of 4 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(ii) At 6:00 PM, the rate was increased to 10 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 10 mg/hr was a 150% increase from the ordered rate of 4 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iii) At 9:00 PM, the rate was increased to 15 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 15 mg/hr was a 275% increase from the ordered rate of 4 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(iv) At 11:00 PM, the rate was increased to 20 mg/hr by the RN. The medical record lacked evidence that the patient had received two (2) bolus doses of morphine within one (1) hour prior to the rate increase as indicated in the physician's order and the Comfort Care Protocol. Therefore, the criteria allowing for an increase in the hourly rate was not met and the rate should not have been increased. Additionally, the hourly rate increase to 20 mg/hr was a 400% increase from the ordered rate of 4 mg/hr and not 25% in accordance with physician orders and the Comfort Care Protocol.

(v) The above was confirmed with Staff #14 on 12/14/18 at 3:10 PM.

(vi) A nursing progress note indicated that Patient #37 expired on [DATE] at 9:24 AM. The morphine infusion rate was last documented on 8/22/18 at 5:30 AM as 20 mg/hr. The medical record lacked evidence of the rate between 5:30 AM and the time of death. However, documented evidence supports that the hourly infusion rate was at least five (5) times the ordered rate of 4 mg/hr at the time the patient expired. The medical record lacked evidence that the criteria allowing for the increase was met in accordance with physician orders and the Comfort Care Protocol.

2. A review of one (1) out of (1) medical records for patients actively receiving morphine for comfort care on 12/12/18 during a State complaint investigation, revealed that the patient was receiving dosages of morphine greater than the dosage ordered by the phy
VIOLATION: WRITTEN MEDICAL ODERS FOR DRUGS Tag No: A0406
Based on observation, medical record review, review of facility policy, review of facility protocols, and staff interview, it was determined that the facility failed to ensure that standing orders and protocols are implemented in accordance with facility policy and Federal law.

Findings include:

Reference #1: Facility policy titled, "Medication Orders" indicates, "... PROCEDURE: ... Standing Orders: Standing orders are not acceptable. ..."

Reference #2: Facility protocol titled, "Advanced Triage for Pediatric Topical LET (Lidocaine, Epinephrine, Tetracaine) Protocol" indicates, "... POLICY: ... The following guidelines are to be followed when initiating the Pediatric Topical LET Protocol, which includes the application of LET prior to the Emergency Department [ED] physician evaluating the patient. * The Pediatric Topical LET Protocol will be initiated by a Registered Nurse (RN). The protocol will be included in the RN's Orientation and competencies will be met yearly. * Topical LET may be used for providing anesthesia when treating minor lacerations."

1. The protocol referenced above is not in compliance with the facility policy referenced above, which indicates that standing orders are not acceptable.

a. During an interview on 12/17/18 at 10:55 AM, Staff #11, Staff #29, Staff #30, and Staff #31 were questioned about how the protocol for medication administration without a physician's order in the Pediatric ED differs from standing orders, which were not allowed as per facility policy. Staff members were unable to provide an explanation of how the protocol differs from standing orders.

2. The "LET" protocol lacked evidence of the process by which the prescriber authenticates the order, which was initiated by the RN.

a. On 12/17/18, Medical Record #18 was reviewed. As of 12/17/18, a physician had not signed the order for topical LET entered and administered by Staff #31 on 12/13/18.

(i) This finding was confirmed with Staff #14.

b. During an interview with Staff #11, Staff #29, Staff #30, and Staff #31 on 12/17/18 at 10:55 AM, Staff #31 stated that a physician should be signing orders entered by a RN using the LET protocol after the medication is given.

3. The LET protocol indicates "Topical LET may be used for providing anesthesia when treating minor lacerations." It does not indicate if it must be used, thus permitting inconsistent practices.

a. During an interview on 12/18/18 at 1:40 PM, Staff #53, a RN in the Pediatric ED, stated that he/she does not follow the LET protocol. Staff #53 stated that he/she waits until the physician has evaluated the patient because the physician might order an injectable medication in the place of the topical solution.

4. During an interview on 12/13/18 at 1:58 PM, Staff #31 stated that he/she had initiated the LET Protocol on Patient #18 at 1:00 PM.

a. Upon review of Medical Record #18, in the presence of Staff #31, it was noted that the record lacked evidence of an order for the administration of topical LET solution.

b. At the time of the medical record review at 1:58 PM, Staff #31, a RN, then entered a physician's order for topical LET solution and documented in the medication administration record that the medication had been administered at 1:00 PM.

5. The "Advanced Triage for Pediatric Topical LET (Lidocaine, Epinephrine, Tetracaine) Protocol" indicates, "... POLICY: ... The following guidelines are to be followed when initiating the Pediatric Topical LET Protocol, which included the application of LET prior to the Emergency Department physician evaluating the patient. The Pediatric Topical LET Protocol will be initiated by a Registered Nurse (RN). The protocol will be included in the RN's Orientation and competencies will be met yearly. ..."

a. A review of the personnel file for Staff #31 lacked evidence of a competency evaluation related to the LET protocol.

b. During an interview on 12/18/18 at 3:39 PM, Staff #4 confirmed that Staff #31 did not have a competency evaluation for the LET protocol.

6. Two (2) medical records for patients identified by pharmacy as having topical LET removed from the Automatic Dispensing Cabinet (ADC) under their profile while in the Pediatric ED were requested and reviewed as follows:

a. Topical LET was removed from the ADC for Patient #57 on 12/12/18 at 7:20 PM.

(i) The medical record lacked evidence of a physician's order to administer topical LET.

(ii) The medication administration record lacked evidence that the topical LET solution had been administered.

b. Topical LET was removed from the ADC for Patient #58 on 10/5/18 at 2:41 PM.

(i) A triage note indicated that topical LET was applied during triage.

(ii) The medical record lacked evidence of a physician's order to administer topical LET.

c. The above was confirmed with Staff #1 on 12/20/18 at 10:20 AM.

7. Additional protocols for care in use by the Pediatric ED were requested and reviewed, as follows:

a. The "Advanced Triage for Pediatric Sickle Cell Crisis Protocol" indicates, "... PROCEDURE: The following guidelines are to be followed when initiating the Pediatric Sickle Cell Protocol, which included ordering of diagnostic tests prior to the Licensed Independent Practitioner (LIP) seeing the patient. ... FEVER CRISIS ... 5. Initiate an order for IV antibiotics STAT as outlined below: ... IV Ceftriaxone 50mg/kg/dose (Maximum dose of 2 grams). ..."

b. The "Advanced Triage: Pediatric Neutropenic Protocol" indicates, "... PROCEDURE: The following guidelines are to be followed when initiating the Pediatric Neutropenic Protocol, which includes ordering of Laboratory Tests prior to the Licensed Independent Practitioner (LIP) seeing the patient ... 6. Initiate an order for IV antibiotics STAT as outlined below:
Cefepime 50mg/kg/dose (maximum dose of 2g) ..."

c. The protocols referenced above lacked evidence of the process by which the prescriber authenticates the order initiated by the RN.

d. Interviews with Pediatric ED staff revealed that staff were inconsistent with the implementation of the above protocols.

(i) During an interview on 12/17/18 at 10:55 AM, Staff #31 stated that a physician enters orders for intravenous antibiotic administration, not the RN, as directed by protocol.

(ii) During an interview on 12/18/18 at 1:40 PM, Staff #53, a RN in the Pediatric ED, stated that he/she does not follow the Advanced ED Triage Protocols related to the administration of intravenous antibiotics. Staff #53 stated that he/she does not initiate a physician's order until the patient has been evaluated by a physician.

(iii) During an interview on 12/18/18 at 1:44 PM, Staff #54, an attending physician in the Pediatric ED, stated that a physician enters the order for intravenous antibiotics, not a RN. Staff #54 stated that the pharmacy will not accept an order for intravenous antibiotics entered by a RN without a physician's order.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that the hospital has pharmaceutical services that meet the needs of the patients.

Findings include:

1. The facility failed to ensure that all pharmacy records have sufficient detail to follow the flow of pharmaceuticals throughout the hospital and maintain control over medications. (Cross refer to Tag A 491)

2. The facility failed to ensure implementation of policies and procedures addressing the accurate recording of the wastage of Controlled Drug Substances (CDS). (Cross refer to Tag A 494)

3. The facility failed to ensure implementation of policies and procedures that pharmacy medication management inspections are conducted in all areas where medications are stored. (Cross refer to Tag A 500)

4. The facility failed to ensure the development and implementation of policies and procedures that address the monitoring for and the reporting of controlled drug losses. (Cross refer to Tag A 509)
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on document review and staff interview conducted on 12/21/18, it was determined that the facility failed to ensure that all pharmacy records have sufficient detail to follow the flow of pharmaceuticals throughout the hospital and maintain control over medications.

Findings include:

1. Review of the Anesthesia Record for Patient #64, dated 12/20/18, revealed that the patient was administered Propofol 200 mg (milligrams) at 8:00 AM and 30 mg at 8:15 AM.

a. Review of the corresponding CareFusion Device Event Narrative Report for Patient #64, for the medication, Propofol 200 mg, indicated that only one (1) vial of Propofol 200 mg was removed for this patient.

b. Upon interview at 1:35 PM, Staff #9 and Staff #35 were unable to explain where the additional Propofol 30 mg that was administered to Patient #64 at 8:15 AM was obtained.

2. Review of the CareFusion Device Event Narrative Report for the medication "Lantus" in the Emergency Department, dated 12/20/18 to 12/21/18, revealed the following:

a. On 12/21/18 at 12:02 AM, the medication was removed from the automated dispensing device and administered for a patient. There was no documented transaction for return of the medication.

b. On 12/21/18 at 1:08 AM, the medication was removed from the automated dispensing device for Patient #63.

(i) Review of the Medication Administration Record for Patient #63 indicated that he/she was administered Lantus at 1:03 AM on 12/21/18.

(ii) Upon interview at 1:35 PM on 12/21/18, Staff #9 and Staff #35 were unable to explain how the medication was administered to Patient #63 before the medication was removed from the automated dispensing device.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on medical record review, document review, and staff interview, it was determined that the facility failed to ensure implementation of policies and procedures addressing the accurate recording of the wastage of Controlled Drug Substances (CDS).

Findings include:

Reference: Facility policy titled "Controlled Substance Management Policy" indicates, "Procedure: ... 6. All doses of CS [Controlled Substances] removed from the sealed container must be properly administered, or if administration is not possible, that dose or any partial dose must be destroyed in full view of a witness who must co-sign on the ADC [Automatic Dispensing Cabinet]. ... Pharmacy ... The Pharmacy Department is responsible for ordering, storing, distributing and controlling all drugs included in controlled drug schedules II-V. A perpetual inventory will be maintained by the Pharmacy for all Schedule II-V drugs. ... Nursing ...
Those with authorized access to CS [controlled substances] are responsible for removing, administering, documenting usage and waste, performing inventory verification and maintaining security of these drugs on the nursing unit as outlined above. ..."

1. Review of Medical Record #59 revealed that 14.9 ml of Hydromorphone PCA injection 1mg/1ml (milligram per milliliter), a Schedule II CDS, were recorded as wasted on the (PCA) Infusion Pump Administration Record on 12/7/18 at 8:00 AM. The wastage was not recorded in the ADC.

2. Review of Medical Record #60 revealed that 14.9 ml of Morphine 1mg/1ml PCA injection, a Schedule II CDS, were recorded as wasted on the (PCA) Infusion Pump Administration Record on 11/7/18 at 9:45 PM. The wastage was not recorded on the ADC.

3. Review of Medical #61 revealed that Morphine Infusion, a Schedule II CDS, was discontinued when the patient expired on [DATE] at 1:28 PM. There was no evidence of documentation of the amount of Morphine remaining and the wastage of the remaining Morphine.

4. Review of Medical Record #62 revealed that a reservoir volume of 57.9 ml of epidural Fentanyl 0.0005% (a Schedule II CDS) with Bupivacaine 0.05% solution was recorded on the Patient-Controlled Analgesia (PCA) Infusion Pump Administration Record, dated 11/8/18, at the time of discontinuation. The date and time of discontinuation was not recorded on the record. The wasting of 80 ml of the epidural solution was recorded in the ADC on 11/12/18 at 08:11. The records do not reconcile.

5. The above findings were confirmed by Staff #37 and #35 on 12/17/18 at 2:00 PM.





6. A review of Medical Record #1 revealed that a continuous infusion of morphine sulfate 100 mg [milligram] in 100 ml [milliliter] of 5% Dextrose was initiated on 2/24/16 at 3:00 PM.

a. Documented evidence indicates that the morphine infused at the following rates:

(i) 3:00 PM: 2 mg/hr (milligram per hour)

(ii) 4:00 PM: 2 mg/hr

(iii) 5:00 PM: 4 mg/hr

(iv) 6:00 PM: 4 mg/hr

(v) 7:00 PM: 4 mg/hr

(vi) 8:00 PM: 4 mg/hr

(vii) 9:00 PM: 4 mg/hr

(viii) 10:00 PM: 6 mg/hr

(ix) 11:00 PM: 8 mg/hr

b. Patient #1 expired on [DATE] at 11:06 PM. The medical record lacked evidence that the remainder of the 100 mg morphine that was not infused was wasted and destroyed by nursing staff after Patient #1 expired.

7. A review of Medical Record #3 revealed that a continuous infusion of morphine sulfate 100 mg in 100 ml of normal saline was initiated on 11/15/18 at 6:00 PM.

a. Documented evidence indicates that the morphine infused at the following rates:

(i) 6:00 PM: 2 mg/hr

(ii) 7:00 PM: 5 mg/hr

(iii) 8:00 PM: 8 mg/hr

b. Patient #3 expired on [DATE] at 10:08 PM. The last documented morphine infusion rate was at 8:00 PM. The medical record lacked evidence that the remainder of the 100 mg morphine that was not infused was wasted and destroyed by nursing staff after Patient #3 expired.

8. A review of Medical Record #4 revealed that a continuous infusion of morphine sulfate 100 mg in 100 ml of 5% Dextrose was initiated on 2/5/16 at 5:00 AM.

a. Documented evidence indicates that the morphine infused at the following rates:

(i) 5:00 AM: 10 mg/hr

b. Patient #4 expired on [DATE] at 5:18 AM. The medical record lacked evidence that the remainder of the 100 mg of morphine, that was not infused, was wasted and destroyed by nursing staff after Patient #4 expired.

9. A review of Medical Record #6 revealed that a continuous infusion of morphine sulfate 100 mg in 100 ml of 5% Dextrose was initiated on 2/14/16 at 2:00 PM.

a. Documented evidence indicates that the morphine infused at the following rates:

(i) 2:00 PM: 5 mg/hr

(ii) 3:00 PM: 5 mg/hr

(iii) 4:00 PM: 5 mg/hr

(iv) 5:00 PM: 5 mg/hr

b. Patient #6 expired on [DATE] at 5:27 PM. The medical record lacked evidence that the remainder of the 100 mg of morphine, that was not infused, was wasted and destroyed by nursing staff after Patient #6 expired.

10. During an interview on 12/13/18 at 12:06 PM, Staff #9 confirmed that the pharmacy records lacked evidence that the unused morphine from Patient #1, Patient #3, Patient #4, and Patient #6 was wasted upon the patient's expiration.

B. Based on medical record review, review of staff education, review of facility policy, and staff interview, it was determined that the facility failed to maintain accurate records for the administration of controlled substances.

Findings include:

Reference #1: Facility policy titled, "High Alert Medications" indicates, "... PROCEDURE: ... B. RWJ New Brunswick: ... 2. Appendix B, Table 2 also contains a list of identified high alert medications for verification by two Nurses to help prevent errors. Certain medications require a double check via dual nurse signatures/verification at: a. Initiation of infusion b. Dose/rate change (for drips that are being actively titrated: dose/rate verification will take place once the goal of the medicated infusion therapy is achieved) c. Change of a bag d. Change of shift ... Appendix B: RWJUH New Brunswick ... Table 2 ... High Alert Medications for Verification ... Continued medicated infusions .... Medications ... Morphine ... Verification Procedure: WHEN 1. Initiation of a high risk medicated infusion. 2.Dose/rate [sic] change (for drips that are being actively titrated: dose/rate verification will take place once the goal of the medicated infusion therapy is achieved) 3.Change [sic] of a bag 4.Change [sic] of shift ... Documentation ... Double-verification of continuous medicated infusions should be completed on the appropriate medication infusion document(s). ...."

Reference #2: Facility education provided to RNs titled, "Documenting Continuous Infusions In SCM" indicates, "... You must scan all medicated and continuous infusions before hanging, and at every bag change ... You must document hourly rates in the vital signs flowsheet. ... Finally, you must also document volume in the I&O flowsheet (Per ordered I&O frequency) ..."

1. During an interview with Staff #14 on 12/14/18 at 11:49 AM, he/she stated that a continuous infusion of morphine should be documented by nursing staff in several locations in the medical record. Staff #14 stated that when the infusion is initiated, it is signed in the medication administration record. Then every hour while it is infusing, the rate is documented on the vital signs flowsheet. The volume infusing is documented on the I&O flowsheet every hour. Staff #14 stated that any changes to the infusion are documented on the infusion record.

a. Staff #14 confirmed that all nurses in the facility receive education on this documentation process.

2. Documented evidence in Medical Record #1 revealed that a continuous infusion of morphine was initiated on 2/24/16 at 3:00 PM. The hourly infusion rate was increased on 2/24/16 at 5:00 PM, 10:00 PM, and 11:00 PM.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation and with each rate change.

b. The above was confirmed with Staff #2 on 12/12/18 at 11:06 AM and again with Staff #3 on 12/13/18 at 11:18 AM.

3. Documented evidence in Medical Record #3 revealed that a continuous infusion of morphine was initiated on 11/15/18 at 6:00 PM. The hourly infusion rate was increased at 7:00 PM and 8:00 PM.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation and with each rate change.

(i) The above was confirmed with Staff #3 on 12/13/18 at 11:18 AM.

b. The "Vital Signs Flowsheet" lacked evidence of the hourly rate that the morphine was infusing after the rate was increased at 8:00 PM until the patient expired at 10:08 PM.

(i) The above finding was confirmed with Staff #2, Staff #4, Staff #11, Staff #12 and Staff #14 on 12/12/18 at 2:45 PM and again with Staff #14 on 12/13/18 at 11:30 AM.

c. The medical record lacked evidence that the volume of fluid infusing was documented in the "I&O [intake and output] Flowsheet" hourly from the time the infusion was initiated until it was discontinued.

(i) The above finding was confirmed with Staff #14 on 12/13/18 at 11:30 AM.

4. Documented evidence in Medical Record #4 revealed that a continuous infusion of morphine was initiated on 2/5/16 at 5:00 AM.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation.

b. The above was confirmed with Staff #3 on 12/13/18 at 11:30 AM.

5. Documented evidence in Medical Record #6 revealed that a continuous infusion of morphine was initiated on 2/14/16 at 2:00 PM.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation.

b. The "Vital Signs Flowsheet" lacked evidence of the hourly rate in which the morphine was infusing from the time of initiation until the patient expired at 5:27 PM.

c. The above was confirmed with Staff #3 on 12/13/18 at 11:30 AM.

6. Documented evidence in Medical Record #15 revealed that a continuous infusion of morphine was initiated on 9/3/18 at 12:00 PM. The hourly infusion rate was increased on 9/3/18 at 1:00 PM, 2:00 PM, an 3:00 PM.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation and with each rate change.

b. The above was confirmed with Staff #14 on 12/14/18 at 3:00 PM.

7. Documented evidence in Medical Record #37 revealed that a continuous infusion of morphine was initiated on 8/21/18 at 10:00 AM. The hourly infusion rate was increased on 8/21/18 at 2:00 PM and 4:00 PM.

a. The "MEDICATED INFUSION WORKSHEET" lacks evidence that two (2) RNs verified the morphine dosage upon initiation and with each rate change above.

b. The above was confirmed with Staff #14 on 12/14/18 at 3:10 PM.

8. Documented evidence in Medical Record #45 revealed that a morphine infusion was initiated on 7/14/18 at 1:25 PM. On interview, Staff #14 confirmed that the only documentation in the medical record of the hourly drip rate was on 7/14/18 at 8:00 PM, when documented evidence indicated that the morphine was infusing at 15 mg/hr.

a. The medical record lacked evidence of a "MEDICATED INFUSION WORKSHEET" used by nursing staff to document that two (2) RNs verified the morphine dosage upon initiation and with the rate change to 15 mg/hr.

b. Patient #45 expired on [DATE] at 4:15 PM. The "Vital Signs Flowsheet" lacked evidence of hourly documentation of the morphine infusion rate from initiation until the time the patient expired.

c. The medical record lacked evidence that the volume of fluid infusing was documented in the "I&O [intake and output] Flowsheet" hourly from the time the infusion was initiated until it was discontinued.

d. The above was confirmed with Staff #14 on 12/17/18 at 12:05 PM.

9. Documented evidence in Medical Record #11 revealed a physician's order for morphine infusion dated 10/12/18. The order had a "Stop date" and time of 10/15/18 at 3:54 PM upon the patient's expiration on 10/15/18 at 9:53 AM.

a. The last documented infusion rate was on 10/14/18 at 4:00 PM in the I&O Flowsheet. The medical record lacked evidence of an hourly infusion rate documented on the "Vital Signs Flowsheet" or hourly volume of morphine infused on the "I&O Flowsheet" from 4:00 PM until the time the patient expired.

b. The above was confirmed with Staff #14 on 12/14/18 at 11:35 PM.

10. Documented evidence in Medical Record #14 revealed a physician's order for morphine infusion dated 11/27/18. The order had a "Stop date" and time of 11/28/18 at 8:24 PM upon the patient's expiration on 11/28/18 at 2:45 PM.

a. The last documented infusion rate was 1 mg/hr on 11/28/18 at 6:00 AM. The medical record lacked evidence of an hourly infusion rate documented on the "Vital Signs Flowsheet" or hourly volume of morphine infused on the "I&O Flowsheet" from 6:00 AM until the time the patient expired.

b. A nursing progress note dated 11/28/18 at 10:15 AM, indicates, "Interdisciplinary Note: received [sic] verbal orders from Dr. [name] for tylenol suppository and to increase morphine drip by 1 mg/hr."

(i) The "Vital Signs Flowsheet" and the "I&O Flowsheet" lacked evidence that the morphine infusion rate was increased and the "MEDICATED INFUSION WORKSHEET" lacked evidence that two (2) RNs verified that the morphine infusion rate had been increased.

c. The above was confirmed with Staff #14 on 12/14/18 at 11:35 AM.

11. Documented evidence in Medical Record #40 revealed a physician's order for morphine infusion initiated on 9/23/18 at 4:30 PM. The "Intake Output Records" form indicated that the rate was increased at 6:00 PM from 2 mg/hr to 4 mg/hr.

a. The "MEDICATED INFUSION WORKSHEET" lacked evidence that two (2) RNs verified the morphine dosage upon the rate increase.

b. The "Intake Output Records" form indicated that the hourly rate was increased to 8 mg/hr on 9/24/18 at 12:00 AM. This rate change was not verified by two (2) RNs on the "MEDICATED INFUSION WORKSHEET" until 9/24/18 at 7:00 AM.

12. Documented evidence in Medical Record #43 revealed a physician's order for morphine infusion was initiated on 9/6/18 at 8:00 AM.

a. The "Vital Signs Flowsheet" lacked evidence of hourly documentation of the morphine infusion rate from initiation until the time the patient expired on [DATE] at 2:35 PM.

b. The above was confirmed with Staff #14 on 12/17/18.

13. Documented evidence in Medical Record #44 revealed an "Intake Output Records" form which indicates that the patient's continuous infusion of morphine was increased from 3 mg/hr to 5 mg/hr on 7/30/18 at 10:00 AM.

a. This rate change was not verified by two (2) RNs on the "MEDICATED INFUSION WORKSHEET" until 7/30/18 at 11:00 AM.

b. The above was confirmed with Staff #14 on 12/17/18.

14. Documented evidence in Medical Record #48 revealed a physician's order for continuous morphine infusion was initiated on 8/28/18 at 8:00 AM.

a. The "MEDICATED INFUSION RECORD" indicates that the hourly infusion rate was increased from 2.5 mg to 3 mg at 10:45 AM.

(i) At 11:00 AM, the "Intake Output Records" form indicates that the hourly rate was 2.5 mg/hr; this was inconsistent with the above documented rate change.

b. The "MEDICATED INFUSION RECORD" indicates that the hourly infusion rate was increased from 3 mg/hr to 4 mg/hr at 11:50 AM.

(i) At 12:00 PM, the "Intake Output Records" form indicates that the hourly rate was 3 mg/hr; this was inconsistent with the above documented rate change.

c. The above was confirmed with Staff #14 on 12/17/18.

15. Documented evidence in Medical Record #9 revealed a physician's order for continuous morphine infusion that was initiated on 10/2/18 at 7:00 PM.

a. The "Intake Output Records" form lacks evidence of the hourly volume of morphine infusing from 10/2/18 at 8:00 PM until 10/4/18 at 8:00 AM.

b. The above was confirmed with Staff #14 on 12/14/18 at 11:35 AM.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on observation, staff interview, and document review conducted on 12/20/18, it was determined that the facility failed to ensure implementation of policies and procedures that pharmacy medication management inspections are conducted in all areas where medications are stored.

Findings include:

Reference: Facility policy titled, "Storage and Security of Medications in Patient Care Areas" states, "Policy: ...6. Pharmacy Medication Management Inspections will be conducted on all medication areas once every other month."

1. During an observation in the perfusion pump room at 12:27 PM, a cabinet containing medications was found.

a. Upon interview, Staff #9 stated that the pharmacy medication management inspection is not conducted in this area.
VIOLATION: REPORTING ABUSES/LOSSES OF DRUGS Tag No: A0509
Based on staff interviews and document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the monitoring for and the reporting of controlled drug losses.

Findings include:

1. On 12/18/18 at 2:00 PM, the facility was unable to provide a policy and procedure that addressed the monitoring of controlled substance usage for possible loss or diversion upon request.

2. On 12/18/18 at 2:00 PM, the facility was unable to provide a policy and procedure that addressed the reporting of suspected or confirmed controlled substance losses to the appropriate authorities upon request.

3. On 12/18/18 at 2:00 PM, Staff # 35 confirmed these findings.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, facility document review, and staff interview, it was determined that the facility failed to ensure the provision of a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

1. The infection control officer, or officers, failed to ensure maintenance of a sanitary hospital environment. (Cross refer to Tag A 749, part A)

2. The facility failed to ensure there is a separation between clean and contaminated work areas and activities. (Cross refer to Tag A 749, part B)

3. The facility failed to ensure that instruments are cleaned and/or disinfected properly after use to prevent the formation of biofilm. (Cross refer to Tag A 749, part C)

4. The facility failed to conform to AAMI [Association for the Advancement of Medical Instrumentation] guidelines for instrument reprocessing for 3 of 3 processed instrument containers. (Cross refer to Tag A 749, part D)

5. The facility failed to ensure that rigid sterilization container systems are clean prior to sterilization. (Cross refer to Tag A 749, part E)

6. The facility failed to ensure infection control procedures for hand hygiene are implemented according to facility policy. (Cross refer to Tag A 749, part F)

7. The facility failed to ensure a functional and sanitary environment for the provision of surgical services in accordance with acceptable standards of practice. (Cross refer to Tag A 749, Part G)

8. The facility failed to ensure that reusable instruments are sterilized in accordance with manufacturer's instructions for use and Association for the Advancement of Medical Instrumentation (AAMI) guidelines. (Cross refer to Tag A 749, Part H)

9. The facility failed to ensure implementation of policies and procedures that medications are prepared in a sanitary environment with an acceptable standards of practice. (Cross refer to Tag A 749, part I)

10. The facility failed to ensure that injectable medications, labeled for single use, are prepared and administered according to acceptable standards of practice. (Cross refer to Tag A 749, part J)

11. The facility failed ensure that the sterility of needles and syringes are maintained. (Cross refer to Tag A 749, part K)
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
A. Based on tours of six (6) of six (6) patient care units and interviews with administrative staff, it was determined that the infection control officer, or officers, failed to ensure maintenance of a sanitary hospital environment.

Findings include:

1. On 12/19/18, a tour of Unit 2 East, an orthopedic post-surgical unit, revealed the following:

a. Pantry:

(i) An unfinished piece of wood, approximately two (2) feet long, was attached to the rear of the ice machine, creating an uncleanable surface.

(ii) Dust and a package of saltine crackers was observed beneath the refrigerator.

b. Nurses Station:

(i) Heavy dust, paper scraps, and grit were observed on the floor beneath a "Shred-it" box.

(ii) Heavy dust and grit were observed on the floor around a monitor and a printer.

c. Room E-219 (housekeeping closet): soiled, wet, "Swiffer-type" pads were observed on handles, in a mop bucket containing approximately 1 inch of water.

2. On 12/19/18, a tour of Unit 4 West, a medical/telemetry unit, revealed the following:

a. Nurses Station: Heavy dust, grit, paper scraps, wrappers, and a crumpled EKG strip were observed behind a monitor on the floor.

b. Medication Room:

(i) Medication refrigerator: Dust and grit were observed in the folds of the rubber gasket on the door.

(ii) Heavy dust, grit, medication packaging, paper scraps, needle covers, one-half of a tan tablet, and stained tiles were observed on the floor beneath and behind the refrigerator.

(iii) Four (4) drawers in a cabinet were observed to have grit, plastic caps, hair, and other refuse in the corners.

3. On 12/19/18, a tour of the Transitional Care Unit revealed the following:

a. Nurses Station: Dust, crumpled paper, and grit were observed on the floor behind a gray metal cabinet.

b. Pantry Area:

(i) The refrigerator was observed to have a cracked gasket on the right side of the door. Food particles and grit were inside of the cracks.

c. Clean Utility Room:

(i) Two (2) oxygen canister carts were observed to have clumps of dust atop the bases and beneath the carts. There was a clump of dust on one of the wheels on one of the carts.

(ii) A cabinet contained a pair of soiled slippers in a plastic bag atop a bin containing a packaged respiratory mask, a sterile 500 ml canister, two (2) sterile V.A.C. Granufoam Dressing packages, and one (1) packaged SURGIFLO Hemostatic Matrix Kit.

d. Soiled Utility Room: A mop bucket contained approximately one-half (1/2) inch of water at the bottom and a thick green substance at the bottom of the interior and in the corners of the bucket. Staff #35, the Director of Environmental Services, stated that there should be no water in the bucket and that whatever the green substance is, it should not be in the bucket.

4. On 12/19/18, a tour of the Nurses Station in the Transitional Care Unit revealed that there was a heavy accumulation of dust and grit on the base of the rear of the EKG printer.

5. On 12/19/18, a tour of the SBMU (South Building Medical Unit) revealed:

a. Nurses Station:

(i) There was a heavy accumulation of dust on, and beneath a TRIPP-LITE universal power source.

(ii) The exterior wall of the counter had a clump of dust hanging on it.

(iii) The code cart had two (2) electrode packages atop the cart with tape and tape/glue residue on the exterior of the packages. There was grit stuck to the packages.

b. Pantry Room:

(i) A plastic bin with a brown stain on it, in a cabinet drawer, contained sugar packets. There was a heavy accumulation of sugar crystals and other particulate on the bottom of the bin. The drawer in which the bin was placed had a raised brown stain on the bottom and a brown, powdery particulate on the interior.

(ii) Refrigerator: The egg bin had grit in it.

6. On 12/19/18, a tour of the Respiratory Care Unit revealed:

a. Pantry: A bin containing sugar, coffee packets, and Sweet 'N Low was observed to have a heavy accumulation of sugar crystals and coffee granules at the bottom of it.

b. The code cart had two (2) electrode packages atop the cart with tape and tape/glue residue on the exterior of the packages. There was grit stuck to the packages.





7. On 12/14/2018 at 11:42 AM, during a tour of the Coronary Care Unit (CCU) in Room 3N14, a vacant patient room that was clean and ready for a patient, the following was observed:

a. In the cabinet containing patient supplies, there was a bin of opened and partially emptied skin care products and prescribed topical creams from the previous patient.

b. On the wall next to the sink, there was a gaping hole exposing a black-brown, non-cleanable surface.

c. These findings were confirmed with Staff #3 and Staff #42 at 1:00 PM.





B. Based on observation, staff interviews conducted on 12/20/18, and a review of nationally recognized guidelines, it was determined that the facility failed to ensure there is a separation between clean and contaminated work areas and activities.

Findings include:

Reference: ANSI/AAMI (Association for the Advancement of Medical Instrumentation) ST79:2017 section 7.9 The Association for the Advancement of Medical Instrumentation (AAMI) Standards and Recommended Practices, 2015 edition section 3.2.2, 'Functional workflow patterns' indicates, "The sterile processing department/area should include ... e) systems to contain contaminants and minimize employee exposure to bloodborne and other potentially infectious organisms; ..."

1. On 12/20/18 at 11:57 AM, during a tour of the Decontamination Room, six (6) decontamination sinks contained adhesive labels within the sinks, marking the water levels of water.

a. The adhesive labels had curled edges exposing the adhesive side of the label, preventing proper cleaning.

2. The above finding was confirmed with Staff #45, Staff #32 and Staff #47 on 12/20/18 at 12:01 PM.

C. Based on observation, staff interviews conducted on 12/20/18, and a review of nationally recognized guidelines, it was determined that the facility failed to ensure that instruments are cleaned and/or disinfected properly after use to prevent the formation of biofilm.

Findings include:

Reference: ST 79, section 6.3, "Care and handling of contaminated reusable items at point of use," indicates, "...To prevent the formation of biofilm, definitive cleaning should occur as soon as possible."

1. On 12/20/18 at 12:17 PM, during a tour of the decontamination room, two (2) sinks were observed to contain soiled instruments soaking in clear liquid.

a. Upon interview, at 12:17 PM, Staff #45 stated that he/she was unsure what the instruments were soaking in, but stated that he/she thought they were soaking in an enzymatic solution.

b. Upon interview, at 12:25 PM, Staff #32 stated that he/she was unsure what the instruments were soaking in, but stated that he/she thought they were soaking in plain water.

c. Upon interview, on 12/20/18 at 12:18 PM Staff #45, could not identify how long the instruments were soaking.

d. Upon interview, on 12/20/18 at 12:26 PM Staff #32, could not identify how long the instruments were soaking.

2. Upon interview, Staff #32 confirmed that if the instruments soak in an enzymatic solution, a biofilm could form after excessive soaking, making it difficult to properly clean the instruments.

D. Based on observation, staff interviews conducted on 12/20/18, and a review of nationally recognized guidelines, it was determined that the facility failed to conform to AAMI [Association for the Advancement of Medical Instrumentation] guidelines for instrument reprocessing for three (3) out of three (3) processed instrument containers.

Findings include:

Reference: AAMI guidelines, ST 79, Section 8.4.3, "Inspection," indicates, "Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging."

1. On 12/20/18 at 10:55 AM, upon inspection of three (3) processed instrument containers, containing sterilized instruments, reddish brown stains were noted on the white lining of the containers.

2. On 12/20/18 at 11:09 AM the above finding was confirmed with Staff #32 and Staff #47.

E. Based on observation, staff interview, and review of nationally recognized guidelines, it was determined that the facility failed to ensure that rigid sterilization container systems are clean prior to sterilization.

Findings include:

Reference: Advancement of Medical Instrumentation (AAMI), ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities section 7.5.2.2. Rigid sterilization container systems 7.5.2.2.1 General considerations indicates, "...Rigid sterilization container systems should be cleaned a) before sterilization, either manually or mechanically; ...Rationale: ...Damaged components of container systems could interfere with the sterilization process or allow contamination of the contents..."

1. Upon inspection on 12/20/18 at 11:15 AM, six (6) instrument containers contained tape and tape residue, rendering them an uncleanable surface.

2. On 12/20/18 at 11:20 AM, the above finding was confirmed with Staff #32 and Staff #45.





F. Based on observation, staff interview and document review conducted on 12/20/18, it was determined that the facility failed to ensure infection control procedures for hand hygiene are implemented according to facility policy.

Findings include:

Reference #1: Facility policy titled, "Hand Hygiene for Healthcare Workers" indicates, "Procedure: 1. Hand hygiene with either waterless hand sanitizer or soap and water is required: ...d. Before donning and after removing gloves."

Reference #2: Facility policy titled, "Environmental Cleaning of Operating Rooms" indicates, "Policy:...All personnel must follow Hand Hygiene for Healthcare Workers New Brunswick at all times. When cleaning is complete, remove gloves and clean hands."

1. During an observation of the post procedure room turnover in Operating Room (OR) #5 at 11:22 AM, the following was revealed:

a. Staff #55 failed to perform hand hygiene after removing gloves and before donning gloves.

b. Staff #56 failed to perform hand hygiene after removing gloves and before donning gloves.

c. At 11:56 AM, Staff #57 stated that he/she had completed cleaning and turning over the room. With soiled gloves on, Staff #57 touched the handles of the door and left the room.

2. This was confirmed by Staff #2 at 12:00 PM on 12/20/18.

G. Based on observation, staff interview, document review conducted on 12/20/18, it was determined that the facility failed to ensure a functional and sanitary environment for the provision of surgical services in accordance with acceptable standards of practice.

Findings include:

Reference: AORN Perioperative Standards and Recommended Practices; "RP: Environmental Cleaning" indicates, "... Recommendation II. A safe environment should be re-established after each surgical procedure. ..."

1. During observation of a post-procedure room turnover in Operating Room (OR) #5 at 11:22 AM, in the presence of Staff #2 and Staff #59, the following was observed:

a. Staff #56 dropped the disinfectant wipes on the soiled floor. He/she then picked up a few wipes from the soiled floor and started to clean the bed with the soiled wipes.

b. Staff #56 wiped the surfaces of the mats then placed the mats onto the surfaces of the surgical table that had not been cleaned and disinfected.

c. Staff #60 was observed wiping a back surgical table, without first clearing off the table.

d. Staff #56 was observed setting the bed with clean sheets at the same time Staff #57 was mopping the floor. With soiled gloves, Staff #57 was observed touching the clean bed and moving the bed.

e. Staff #56 was observed taking surgical suctioning equipment out of the room. He/she then brought clean surgical suctioning equipment back into the room, that had not been cleaned.

f. Staff #56 was observed wiping the surfaces of a piece of surgical equipment. While wiping the surfaces of the equipment, he/she placed clean items on the floor. The floor had not been cleaned. Staff #56 then placed the items from the uncleaned floor on to the cleaned surgical equipment.

2. In Operating Room #5, it was noted that the Bair Hugger equipment had a cracked screen.

3. In Operating Room #18, it was noted that the mattress on the surgical bed was torn and the wall vent screen was broken.

4. These findings were confirmed by Staff #2 and Staff #59 at 12:00 PM on 12/20/18.

H. Based on staff interview and document review conducted on 12/21/18, it was determined that the facility failed to ensure that reusable instruments are sterilized in accordance with manufacturer's instructions for use and Association for the Advancement of Medical Instrumentation (AAMI) guidelines.

Findings include:

Reference: ANSI/AAMI ST 79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities section 7.3 Manufacturer's written IFU [Instructions for Use] indicates, "The device manufacturer's current written IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning."

1. During a review of sterilization record sheets, dated 12/18/18, the following was noted:

a. An Ear, Nose and Throat (ENT) Lewey Retractor was sterilized at the temperature of 272 degrees Fahrenheit.

(i) The manufacturer's instructions for use indicates, "...The following steam sterilization cycles may be used for instruments: Temperature 270 degrees Fahrenheit or 273 to 279 degrees Fahrenheit."

b. The Clavicle Implant was sterilized at the exposure temperature of 272 degrees Fahrenheit, exposure time of 10 minutes and dry time of 50 minutes.

(i) The manufacturer's instructions for use indicates, "...Exposure Temperature: 270 degrees Fahrenheit or 273 to 279 degrees Fahrenheit.
Exposure Time: 8 minutes
Dry Time: 30 minutes"

2. The above findings were confirmed by Staff #2 and Staff #15 on 12/21/18 at 2:30 PM.

I. Based on observation, staff interview, and document review conducted on 12/20/18, it was determined that the facility failed to ensure implementation of policies and procedures that medications are prepared in a sanitary environment with an acceptable standards of practice.

Findings include:

Reference #1: The Center for Disease Control website
<http://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions-d-f.html> indicates, "Clean medication preparation areas when visibly soiled; if medication preparation takes place in the patient treatment area (outside a designated medication room), clean this area after each patient encounter: Ensure the medication preparation area is free of any items contaminated with blood or body fluids (e.g., used equipment such as syringes, needles, IV tubing, blood collection tubes, and needle holders)."

Reference #2: Facility policy titled, "Environmental Cleaning of Operating Rooms" indicates, "...Procedures: ...4. Scheduled Cleaning: Clean all areas and equipment that are not terminally cleaned according to an established schedule as shown in the table below. Pyxis Machine (exterior) Between case/Daily."

1. During an observation of the post procedure room turnover on 12/20/18 at 11:22 AM, Staff #56 and Staff #57 were observed cleaning Operating Room (OR) #5. Staff #56 and Staff #57 failed to clean the exterior of the anesthesia pyxis machine.

a. Upon interview at 11:58 AM, Staff #58 confirmed that she/he prepared medications on the exterior tabletop of the anesthesia pyxis machine.

2. This finding was confirmed by Staff #2 and Staff #59 at 12:00 PM on 12/20/18.





J. Based on observation, staff interviews, and document review conducted on 12/18/18, it was determined that the facility failed to ensure that injectable medications, labeled for single use, are prepared and administered according to acceptable standards of practice.

Findings include:

Reference #1: Facility policy titled, "Expiration Dating-Sterile Single and Multiple-Dose injectable vials, Topical Solutions, Oral Bulk Solutions, and Topical Solid Preparations" indicates, "... Injectable drugs procured in containers designated as "single-use" shall be discarded immediately after use."

Reference #2: Facility policy titled, "Expiration Dating-Sterile Single and Multiple-Dose injectable vials, Topical Solutions, Oral Bulk Solutions, and Topical Solid Preparations" indicates, "... Preparation of Injectable Medication Syringes: Any medication drawn into a syringe, outside of the Pharmacy, must be administered to the patient immediately. If the medication cannot be administered immediately, the syringe must be labeled appropriately with the drug name, concentration, patient name, preparation date and time, and administered within 1 hour. If not administered within 1 hour the syringe must be discarded appropriately."

Reference #3: The Diprivan manufacturer's package insert indicates, "Strict aseptic technique must always be maintained during handling. Diprivan is a single access parenteral product... which contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms... However, Diprivan can still support the growth of microorganisms as it is not an antimicrobially preserved product under USP standards.... Diprivan must be prepared for use just prior to initiation of each anesthetic/sedative procedure."

1. On 12/18/18 at 11:06 AM, in Procedure Room #1 located in the Endoscopy Suite, one (1) vial of Diprivan 500 mg (milligram) per 50 mL (milliliter) and one (1) 5 mL vial of Lidocaine 2%, both labeled as "single-use," were found needle punctured and partially used, stored inside the bottom drawer of the anesthesia Pyxis. These single-use vials were not discarded immediately after use, as per Reference #1.

a. This surveyor observed the cleaning of Procedure Room #1 prior to entering.

b. This finding was confirmed by Staff #12, Staff #38, and Staff #39 on 12/18/18 at 11:06 AM.

2. On 12/18/18 at 11:06 AM, in Procedure Room #1 located in the Endoscopy Suite, two (2) pre-drawn syringes containing a white liquid were found inside the bottom drawer of the anesthesia Pyxis.

a. One (1) syringe contained ten (10) mL and was labeled: "Diprivan 10 mg/mL, Date 12/18/18, Staff initials, 1330."

b. One (1) syringe contained fifty (50) mL and was labeled: "Diprivan 10 mg/mL, Date 12/18/18, Staff initials, 1330." This syringe had a stop-cock and unwrapped tubing attached.

(i) Upon interview, Staff #39 stated that "1330" was the beyond use time for the syringes.

(ii) Staff #39 stated that the single-use Diprivan pre-drawn syringes had a beyond use time of six (6) hours.

(iii) Staff #39 confirmed that the syringes were drawn up in the Procedure Room on 12/18/18 at 11:10 AM.

(iv) Staff #39 could not confirm the exact time the syringes were pre-drawn. He/she stated that they were prepared "approximately thirty (30) minutes ago," which was before Procedure Room #1 was cleaned.

c. This finding was confirmed by Staff #12, Staff #38, and Staff #39 on 12/18/18 at 11:10 AM.

These findings resulted in an Immediate Jeopardy which immediately stopped these practices. The Immediate Jeopardy was removed on 12/18/18, upon receipt of an acceptable plan of correction.

K. Based on observation, staff interviews, and document review conducted on 12/18/18, it was determined that the facility failed ensure to that the sterility of needles and syringes is maintained.

Findings include:

Reference: APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care (2016) indicates, "Never store needles and syringes unwrapped because sterility cannot be ensured..."

1. On 12/18/18 at 11:06 AM, in Procedure Room #1 located in the Endoscopy Suite, two (2) un-wrapped empty syringes were found stored inside the bottom drawer of the anesthesia Pyxis.

a. This finding was confirmed by Staff #12, Staff #38, and Staff #39 on 12/18/18 at 11:10 AM.