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Based on observation, staff interview, and review of facility documents, it was determined that the Governing Body failed to demonstrate that it is effective in carrying out the operation and management of the facility. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

482.23: Nursing Services (Cross refer Tag 0385)

482.42: Infection Control (Cross refer Tag 0747)

Based on observation and staff interview conducted on 11/30/15, it was determined that the facility failed to ensure a safe and sanitary environment for the provision of surgical services.

Findings include:

1. During a tour of the Endoscopy Clean Utility Room at 12:15 PM, the floor was observed to be soiled with dark brown and blackish residues, and contain cracked tiles.

2. At 1:45 PM, during a tour of the Operating Room Department, in the presence of Staff #4, Staff #43, Staff #45 and Staff #49, the following observations were made:

a. The hallway floor outside of OR #5 was soiled with dark brown residues.

b. The monolithic floor in OR #5 was soiled with dark brown residues and littered with debris.

i. Staff #43 stated that the room had been cleaned after the procedure.

3. These findings were confirmed by Staff #4, Staff #43, Staff #45 and Staff #49.

4. During a tour of the Operating Room Department at 1:45 PM, in the presence of Staff #4 and Staff #49, the walls in the sub-sterile area of Cardiovascular Surgery Room OR #5 were observed to be scuffed and marred, and contained exposed plaster throughout a section of the wall.

a. Exposed plaster is an uncleanable surface.

5. A Getinge Castle steam sterilizer was observed to be in the sub-sterile area of OR #5.

a. Staff #50 stated at 1:55 PM that the sterilizer is used to perform IUSS of surgical instruments.

b. At 3:20 PM, Staff #55 stated that the substerile areas of the Operating Rooms are not included in the Housekeeping schedule for terminal cleaning.

Based on observation, medical record review, a review of policies and procedures, and staff interview, it was determined that the facility failed to ensure that each order for restraint is renewed according to hospital policy.

Findings include:

Reference: Facility policy titled Restraints for Non-Violent or Non Self-Destructive Behavior states, "... Procedure: ... 2. When the restraint is initiated by the RN in response to an emergent situation, the RN immediately does the following: ... Obtains a written or electronic order for the restraint by the Attending Physician, or the Designated Physician, or Licensed Physician Assistant, or Advanced Nurse Practitioner. One of the persons listed above will respond within 1 hour ... 7. Re-evaluation and Renewal Orders: ... If the order for restraints expires, the restraint must be discontinued or the Attending Physician, or the Designated Physician, or Licensed Physician Assistant, or Advanced Nurse Practitioner must write a new order. If the restraint is discontinued and the patient must be placed back in restraint, a new order must be obtained ..."

1. During an observation in the Intensive Care Unit on 11/30/15 at 10:35 AM, Patient #32 was observed with bilateral, upper extremity wrist restraints.

2. A review of Medical Record #32 revealed the following:

a. On 11/27/15 from 1:14 AM until 3:46 AM, documented evidence in the "Restraint FS [Flowsheet]," revealed that the patient was restrained with no physician order for restraints during this two (2) hour and thirty-two (32) minute time period.

b. On 11/29/15 at 5:15 AM, documented evidence in the "Restraints FS," states, "Restraints released during AM care and discontinued afterwards."

i. On 11/29/15 at 7:00 PM, documented evidence in the "Restraint FS," revealed that the patient was being restrained at this time. There was no evidence a new restraint order was obtained at this time of restraint re-application, as per facility policy.

ii. A review of the physician orders revealed that restraints were not ordered by the physician until 11/29/15 at 22:08 PM. The patient was in restraints for three (3) hours and eight (8) minutes without a physician order for restraint.

c. On 11/30/15 at 12:01 AM, documented evidence in the "Restraint FS," states, "Restraints Discontinued ... Pt. more awake and alert, able to follow commands and communicate with staff."

(i) On 11/29/15 at 1:00 AM, documented evidence in the "Restraint FS," revealed that the patient was being restrained.

(ii) A review of the physician orders did not reveal a new physician order for restraints after being discontinued.

d. On 11/30/15 from 10:08 PM until 12/1/15 at 8:44 AM, documented evidence in the "Restraint FS," revealed that the patient was restrained without a physician order for restraints, for this eight (8) hours and thirty-six (36) minute time period.

3. During an interview on 12/1/15 at 11:14 AM, Staff #98 confirmed that the nursing process on the unit was to release and reapply the restraints as indicated by the nursing assessment, using the physician order for restraints from within that 24-hour period.

4. The above was confirmed with Staff #7.

Based on observation, staff interview, medical record review, and review of facility policies and procedures, it was determined that the facility failed to have an organized nursing service that provides medication administration and nursing interventions in accordance with current standards of practice.

Findings include:

1. The facility failed to have at least one (1) registered nurse (RN) to two (2) neonates requiring intensive care services, as required by New Jersey Administrative Code (N.J.A.C.) Title 8 Chapter 43-G Hospital Licensing Standards. (Cross Refer Tag 0393).

2. The facility failed to provide nursing care in accordance with recognized standards of practice. (Cross Refer Tag 0395).

3. The facility failed to ensure that medications are prepared and administered in accordance with facility policies, and failed to ensure the development and implementation of policies and procedures addressing the use of a syringe containing a controlled dangerous substance more than once for the same patient. (Cross Refer Tag 0405).

Based on a review of nurse staffing and staff interview it was determined that the facility failed to have at least one (1) registered nurse (RN) to two (2) neonates requiring intensive care services, as required by New Jersey Administrative Code (N.J.A.C.) Title 8 Chapter 43-G Hospital Licensing Standards.

Reference #1: New Jersey Administrative Code (N.J.A.C.) Title 8 Chapter 43-G Hospital Licensing Standards states at 19.18 (h), "The neonatal intensive care nursery shall have at least one registered professional nurse to every two neonates requiring intensive care services. ..."

Reference #2: Facility policy Patient Care Assignment states, "... PROCESS: ... 2. Assignment sheets are made out daily and retained on unit for at least two weeks. Sheets may be stored in other location after 2 weeks and will be maintained for 3 years. ..."

1. Staff #67 stated in interview on 12/1/15 that the facility considers the Intensive Care Nursery (ICN) and the Transitional Nursery/ Annex [intermediate care nursery], in which the infants are transitioning for discharge, as the whole Neonatal Intensive Care Unit (NICU).

2. On 12/2/15 nurse staffing for the Neonatal Intensive Care (NICU) for the week of 11/22/15 thru 11/28/15 was reviewed in the presence of Staff #67 and Staff #68. The secretary's census report that designates the physician ordered level of care/acuity, and the charge nurse census report with identified acuity per the facility's acuity classification system [PCC report] were also reviewed to determine the acuity [intensive or intermediate] level of the infants.

a. In interview, Staff #67 stated that on the PCC report, the acuity section identified with a number 3, 4, or 5 designates an ICN level infant. A number 1 or 2 indicates an intermediate level infant.

3. On the following dates and times, the facility did not maintain the nurse patient ratio for Intensive Care Nursery (ICN) infants at a one (1) RN to two (2) patient ratio:

a. On 11/22/15 days shift (7 AM-7 PM) the NICU census was twenty-one (21), with eight (8) Intensive Care Nursery (ICN) infants, and thirteen (13) Transitional/ Annex infants. One RN was assigned two (2) ICN infants, with the addition of a Transitional level infant for the entire shift. A second RN was assigned (2) ICN level infants with the addition of a Transitional level infant from 3 PM-7 PM.

b. On 11/22/15 night shift (7 PM-7 AM) the NICU census was twenty (20) with eight (8) ICN infants and twelve (12) Transitional/ Annex infants. Two (2) RNs were each assigned two (2) ICN infants with the addition of a Transitional level infant.

c. On 11/23/15 days shift the census was twenty (2) with eight (8) ICN and twelve (12) Transitional/ Annex infants per the Daily Shift Assignment Sheet. Upon review of the PCC [charge nurse] and census report, a ninth patient was at a ICN acuity level because he/she was intubated, per Staff #67. There was one (1) RN assigned to three (3) ICN level patients.

d. On 11/23/15 night shift the census was twenty (20) with 8 (eight) ICN and twelve (12) Transitional/ Annex infants per the Daily Shift Assignment sheet. Two (2) RNs were each assigned two (2) ICN infants with the addition of a Transitional level infant.

e. On 11/24/15 day shift the census was twenty (20) with eight (8) ICN and twelve (12) Transitional/ Annex infants per the Daily Shift Assignment sheet. One (1) RN was assigned to three (3) ICN infants. A second RN was assigned to one (1) ICN infant, and two (2) Transitional level infants.

f. On 11/24/15 night shift it could not be determined if the facility maintained a one (1) RN to two (2) infant ratio for Intensive Care level infants because the acuity level of all the infants (ICN and Transitional/ Annex [intermediate level]) is not written on the Daily Assignment sheet, and there was not an acuity report or a PCC and census report available to review.

i. The facility did not retain the daily staffing assignment sheet on the unit for at least two weeks as per facility policy in reference #2.

g. On 11/25/15 day shift the census was twenty-one (21) with nine (9) ICN and twelve (12) Transitional/ Annex infants per the Daily Shift Assignment sheet. There were two (2) RNs each assigned to three (3) ICN level patients. A third RN was assigned to one (1) ICN infant with the addition of two (2) Transitional level infants.

h. On 11/25/15 night shift it could not be determined if the facility maintained a one (1) RN to two (2) infant ratio for Intensive Care level infants because the acuity level of all the infants (ICN and Transitional/ Annex [intermediate level]) is not written on the Daily Assignment sheet, and there was not an acuity report or a PCC and census report available to review.

i. On 11/26/15 day shift and night shift it could not be determined if the facility maintained a one (1) RN to two (2) infant ratio for Intensive Care level infants because the acuity level of all the infants (ICN and Transitional/ Annex [intermediate level]) is not written on the Daily Assignment sheet, and there was not an acuity report or a PCC and census report available to review. Staff #26 confirmed in interview on 12/2/15 at 12:00 PM that an acuity report and PCC and census report for this date could not be located.

j. On 11/27/15 day shift it could not be determined if the facility maintained a one (1) RN to two (2) infant ratio for Intensive Care level infants because the acuity level of all the infants (ICN and Transitional/ Annex [intermediate level]) is not written on the Daily Assignment sheet, and there was not an acuity report or a PCC and census report available to review.

k. On 11/27/15 the night shift census was twenty (20) with ten (10) ICN and ten (10) Transitional/ Annex infants. One RN had two (2) ICN infants, with the addition of a Transitional level infant. A second RN was assigned one (1) ICN infant with the addition of two (2) Transitional level infants.

l. On 11/28/15 day shift the census was twenty (20) with ten (10) ICN and ten (10) Transitional/ Annex infants. One RN had two (2) ICN infants, with the addition of a Transitional level infant. A second RN was assigned one (1) ICN infant with the addition of two (2) Transitional level infants.

m. On 11/28/15 the night shift census was eighteen (18) with ten (10) ICN and eight (8) Transitional/ Annex infants per the Daily Staffing sheet. Review of the PCC census and acuity report indicated that only four (4) infants were at an ICN level, not ten (10) as indicated on the Daily Shift Assignment sheet. One (1) RN was assigned to three (3) ICN infants. A second RN was assigned one (1) ICN infant with the addition of two (2) Transitional level infants.

4. In interview on 12/2/15 at 11:05 AM, Staff # 68 stated the facility does not have a policy and procedure regarding mixing ICN and intermediate/Transitional level infants.

Based on medical record review, staff interview, and a review of The Nurse Practice Act for the State of New Jersey, it was determined that nursing personnel failed to provide nursing care in accordance with recognized standards of practice.

Findings include:

Reference #1: The Nurse Practice Act for the State of New Jersey states: "The practice of nursing as a registered professional nurse RN 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 policy Documentation of Skin Integrity & measurements--Inpatient states, "... Policy: Each patient is assessed for potential and actual skin breakdown on admission, per shift, ... and PRN [as needed] if patient's condition changes ... Wound Measurement ... Procedure: For Documentation: ... 3. SIZE: The wound should be measured as follows: a. Length ... c. Width ... d. Depth ... 7. PRESENT IN WOUND: Examine wound base and indicate findings ..."

1. A review of Medical Record #37, admission date 11/27/15, identified that a sacral pressure ulcer, Stage 2, had developed on 12/1/15. There was no evidence that a registered nurse measured the size of the wound in length, width and depth, and for the presence of any exudates, as required by policy.


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Reference #3: Facility policy titled Interventions for High Risk Patients (Braden Score less than or equal to 18) states, "... Documentation: ... 7. The nurse will document the following: Risk assessment on the Braden Scale at time of admission and every shift ... Select appropriate interventions implemented for prevention found at the bottom of the electronic Braden Scale Assessment form ..."

1. A review of Medical Record #37, admission date 11/27/15, lacked evidence that the registered nurses are performing identified interventions to treat and prevent pressure ulcer development.

a. Documented evidence in the "Shift Assessment," on 12/1/15 at 2030 revealed that, "Turning/Repositioning patient every 2 hours (bed/chair) ..." was identified by the registered nurse in "Ulcer Interventions."

b. The medical record lacked evidence that "Turning/Repositioning patient every 2 hours (bed/chair) ..." was performed.

2. In interview, Staff #93 confirmed that registered nurses do not document that patients are turned/repositioned after identifying the need for the intervention.

3. The above was confirmed with Staff #8.

4. On 12/2/15, a review of Medical Record #37, admission date 11/27/15, lacked evidence that the registered nurses perform interventions as per physician order.

a. The physician order dated 11/28/15, at 10:18 AM ordered the patient to be out of bed to chair.

b. The "Shift Assessment" on 11/29/15, 11/30/15, and 12/1/15 at approximately 8:00 AM documents that the patient was out of bed to chair.

c.. On interview, Staff #92, revealed that the "Shift Assessment" documentation referenced above is the plan for the nurse to get the patient out of bed, but may not actually be a performed intervention.

d. The nurses note dated 11/30/15 at 3:00 PM and 12/1/15 at 6:00 PM revealed that the patient refused to get out of bed to the chair.

5. There was no evidence in Medical Record #37 that the patient was out of bed to the chair at anytime as ordered by the physician.

A. Based observation, document review and staff interview, it was determined that the facility failed to ensure that medications are administered in accordance with facility policies.

Findings include:

Reference #1: Facility policy titled Medication Administration and Documentation states, "Procedure: ... 5. For identification verification, inpatients will be identified by name and account number ... 6. The person administering the medication will double check medication labels prior to administration, making certain to check for the "five rights" ... 8. The appropriate personnel will document on the EMAR at the time the medication was administered."

1. Staff #41 was observed administering enoxaparin 40 mg subcutaneously to Patient #2 on 11/30/15 at 10:30 AM. The policy referenced above was not adhered to as follows:

a. At the initiation of the observation, Staff #41 stated that he/she had already recorded the administration of enoxaparin in the patient's medical record. Review of the patient's medical record, on 11/30/15 at 11:23 AM, confirmed that the medication was recorded as administered at 09:31 by Staff #41.

b. Prior to the administration of enoxaparin, the nurse was not observed scanning the medication with the bedside scanner.

i. Upon interview, Staff #41 stated that he/she had scanned the drug when he/she had documented administration of the drug.

c. Upon interview, Staff #6 confirmed that scanning of the patient's wristband and the drug must be done at the time of medication adminstration, not one hour prior to administration.

2. On 11/30/15 at 10:45 AM, the drawers in a workstation on wheels (WOW), located on Unit 6W, were checked. Several of the drawers contained medications. Some of the medications were in plastic bags labeled by the pharmacy and others were loose in the drawer. All were unit-dosed. Upon interview, Staff #42 stated that he/she had removed the medications from the patient medication casette drawers and from the drug dispensing device, both of which are located in the medication room. He/she stated that he/she had taken the medications that were needed for the medication pass and placed them in the unlabeled WOW drawers, using one drawer for each patient. A comparison of the contents of each drawer to the patient's electronic medication administration record (EMAR) was performed with Staff #42. The following discrepancies between the contents of the drawers and the EMAR were identified:

a. Metoprolol tartrate 50 mg, for Patient #8, was in a drawer. The administration of metoprolol tartrtate on 11/30/15 at 10:13 AM by Staff #42 is recorded on the EMAR.

i. Upon interview, Staff #42 stated that he/she had documented administration of the medication but had not administered it because the patient's pulse was 61. The hold parameter for metoprolol was a heart rate of 55.

b. Folic acid, zinc sulfate, ferrous sulfate, docusate sodium, thiamine, cholecalciferol, ascorbic acid, furosemide, multivitamin, and magnesium gluconate unit dose packages were found in a drawer that Staff #42 stated were the medications for Patient #9. Administration of all of these medications was recorded on the EMAR at 10:05 by Staff #42.

i. Upon interview, Staff #42 stated that he/she had documented administration of the medications but had not administered them.

c. Administration of pantoprazole sodium 40 mg, meclizine 12.5 mg, diphenoxylate-atropine 2 tablets, magnesium oxide 400 mg, loperamide 2 mg, multivitamin 1 tablet, and ferrous sulfate 325 mg on 11/30/15 at 9:00 AM was not recorded on the EMAR. These drugs were not found in the WOW. Staff #42 stated that he/she had administered all of the medications but had not recorded the administration on the EMAR. He/she confirmed that he/she had not scanned the medications prior to administration.

B. Based on observation, document review, and staff interview conducted on 11/30/15, it was determined that the facility failed to ensure that medications are prepared in accordance with facility policies.

Findings include:

Reference: Facility policy titled PYXIS Medstation states, "III. A Removal: ... 6. Medications orders as "PRN" [as needed] should not be removed from the Pyxis MedStation until the patient has been assessed and need has been established. 7. Once medications are removed from the MedStation they are to be carried by the nurse to the bedside. The nurse may use the locked WOW (workstation on wheels) cart in transporting medications to patient rooms ..."

1. Medications for multiple patients were found in 2 of 2 WOWs on 11/30/15 in Unit 6W. Some of the medications were in plastic bags with a pharmacy label on the outside of the bag. Other medications were unit dose packages that did not identify a patient.

a. Upon interview, Staff #6 stated that some of the medications had been dispensed by the pharmacy and delivered to the unit in cassette drawers that were labeled with patient identifiers (including patient name). The cassettes were exhanged every 24 hours and stored in the medication room. Other medications had been obtained from the Pyxis Medstation. These medications lacked patient identifiers. He/she stated that the medications in labeled bags were dispensed by the pharmacy in order to provide medications for new orders or missing medications.

b. Policies and procedures addressing the process for the administration of medications, both from the medication cassettes and the Pyxis Medstation was requested of Staff #6 and #1. The policy referenced above was provided. This policy does not address the process to be used for obtaining medications from the various locations prior to medication administration. It only addresses the Pyxis Medstation.

c. During interview, Staff #41 stated that he/she obtains the medications that he/she needs for his/her entire medication pass (multiple patients), from both the Pyxis Medstation and the patient medication casettes, and places the medications in the WOW. He/she stated that a drawer is used for each patient. Review of the WOW confirmed this practice.

d. During interview, Staff #42 stated that he/she obtains the medications that he/she needs for his/her entire medication pass (multiple patients), from both the Pyxis Medstation and the patient casettes, and places them in the WOW. He/she stated that a drawer is used for each patient. Review of the WOW confirmed this practice.

i. PRN medications were also found in the drawers, as well as medications that were labeled for patients who had been discharged.

ii. The contents of each drawer in the WOW under the charge of Staff #42 were not for just one patient. Medications for multiple patients had been placed in the same drawer.

e. During interview, Staff #6 stated that medications are supposed to be removed from the patient medication cassettes and the Pyxis Medstation for one patient at a time and administered to the patient before removing medications for the next patient. The medications may be transported to the bedside via the WOW cart, but the cart should not be used to prepare medications for multiple patients at a time.

C. Based on document review and staff interview conducted on 12/1/15, it was determined that the facility failed to ensure the development and implementation of policies and procedures addressing the use of a syringe containing a controlled dangerous substance more than once for the same patient.

Findings include:

1. Review of Medical Records #6 and #11 revealed that one syringe/vial of a controlled dangerous substance was used to administer medication to the same patient more than once.

a. The removal of one (1) Hydromorphone 1 mg/1 ml syringe on 11/28/15 at 00:08 is recorded on the Pyxis activity report for Patient #6. The administration of Dilaudid (hydromorphone) 0.5 mg at 24:10 and 24:25 (should be 00:10 and 00:25) is recorded on the Post Anesthesia Recovery Room Record nurse's notes.

i. Since only one syringe was removed, Staff #6 stated that he/she assumes that the same syringe was used to administer a total dose of 1 mg.

b. The removal of a Fentanyl 250 mcg/5 ml single dose vial on 11/28/15 at 07:32 is recorded on the Pyxis activity report for Patient #11. The administration of Fentanyl 50 mcg IV [intravenouse] on 11/28/15at 07:30, while the patient was in the OR holding area, and the administration of a total of Fentanyl 200 mcg on the anesthesia record.

i. Since only one vial of Fentanyl was removed, Staff #6 stated that he/she assumes that the same vial was used to administer a total of 250 mcg.

c. Upon interview, Staff #6 stated that he/she did not have a policy addressing "holding onto" an opened vial/syringe during a patient's stay in the holding area or the post anesthesia care area. He/she stated that the correct practice was to discard any unused portion and obtain another vial/syringe if another dose is needed, since proper security and storage of the opened container of the controlled drug subtance could not be assured.

Based on document review and staff interview conducted on 12/1/15, it was determined that the facility failed to ensure implementation of policies and procedures addressing the accountability of controlled dangerous substances (CDS).

Findings include:

Reference: Facility policy titled Controlled Dangerous Substances-Dispensing Return and Waste states, "Procedure: ... Any partial doses, disposals, wastage, or breakage must bear the signature of the administering licensed practitioner and the counter-signature of another licensed practitioner as witness. Wastages may be logged in Pyxis MedStation with a "Counter signature" from another user using their login/password (Bio-ID) or recorded in writing in the patient's permanent medical record."

1. The removal of one (1) Hydromorphone (Dilaudid) 2 mg/1 ml syringe, a Schedule II Controlled Dangerous Substance, on 11/30/15 at 13:46 is recorded on the Pyxis Medstation report for Patient #43. The administration of "Dilaudid .4" on 11/30/15 at 14:00 is recorded on the anesthesia record in Medical Record #43. There is no evidence of wastage of the remaining 1.6 mg of Dilaudid.

2. The removal of one (1) vial of Fentanyl 250 mcg/5 ml, a Schedule II Controlled Dangerous Substance, on 11/27/15 at 18:24 and 19:05 is recorded on the Pyxis Medstation report for Patient #6 (a total of 500 mcg was removed). The administration of a total of 350 mcg of Fentanyl is recorded on the anesthesia record in Medical Record #6. There is no evidence of wastage of the remaining 150 mcg of Fentanyl.

3. These findings were confirmed by Staff #6.

Based on observation and staff interview conducted on 11/30/15, it was determined that the facility failed to ensure that medication containers are labeled by authorized personnel.

Findings include:

1. During a tour of Unit 6W at 10:45 AM, it was noted that the pharmacy label on an intravenous solution of metronidazole was placed on the over-wrap. Upon interview, Staff #6 stated that, at the time of medication administration, the pharmacy label would be removed from the over-wrap by the nurse and placed on the intravenous bag.

a. The pharmacy label includes the initials of the pharmacist who verified the accuracy of dispensing. Once initialed by the pharmacist, the label should not be removed or altered by anyone.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that drugs and biologicals are kept in a secure area and locked when not in use.

1. The WOW (workstation on wheels) cart under the control of Staff #42 was found in the corridor on Unit 6W, unlocked and unattended, on 11/30/15 at 10:30 AM. Intravenous medications (metronidazole, clindamycin, and potassium chloride) were found on top of the cart and medications were found in the drawers.

a. This finding was confirmed by Staff #6.



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B. Based on observation, review of policies and procedures, and staff interview, it was determined that the facility failed to ensure that all drugs, needles, and syringes are kept in locked storage areas.

Findings include:

Reference: Facility policy titled Medication Storage, Safety, Security & Access states, "Policy: All medication is to be stored in a safe manner and secure location. The method employed to ensure such designation may vary by the type of drugs, use/need, patient access, or level of care. Secure can mean locked in a cabinet, drawer, automated dispensing machine, or container, or under constant surveillance so unauthorized personnel do not have access ..."

1. During a tour of the Intensive Care Unit on 11/30/15 between 11:55 AM and 12:20 PM, the following was observed in unlocked drawers:

a. In a Hallway Storage Cabinet, Drawer #1:

i. Two (2) manufacturer's pre-filled syringes of Lovenox 80mg, with attached needles.

ii. One (1) B.D. 3 milliliter (ml) syringe.

b. In a Hallway Storage Cabinet, Drawer #2:

i. Two (2) B.D. 5 ml syringes.

ii. One (1) B.D. 3 ml syringe.

iii. One (1) B.D. Blunt Fill Needle 18 g x 1 ½.

c. Two mobile work stations used by respiratory therapists were observed to have respiratory medications stored in drawers that did not lock.

2. The above was confirmed with Staff #33 and Staff #34.

Based on document review, staff interview and observation, it was determined that the facility failed to ensure that the director of food services provides effective daily management of the Nutritional Services Department in accordance with the "Director of Food Services and Nutrition" job description.

Findings Include:

Reference #1: The job requirement specifications for the position of Director of Food Services and Nutrition states, "... The position directs the planning and overseas the daily operations of the food and nutrition department; coordinates other activities with other functions and participates in other organizational activities, establish and maintain high levels of quality and satisfaction in both clinical nutrition and food services ... Determines quality, food specifications and quality of food required to plan menus and maintain food cost controls in compliance with budgetary parameters ..."

Reference #2: N.J.A.C. 8:24-4.7(a) states, "Equipment food-contact surfaces and utensils shall be sanitized." 8:24-4.7(b) states, "Utensils and food-contact surfaces of equipment shall be sanitized before use and after cleaning."

Reference #3: N.J.A.C. 8:24-4.8(k) states, "A test kit or other device that accurately measures the concentration in mg/L of sanitizing solutions shall be provided." 8:24-4.8(i) states, "Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device."

Reference #4: N.J.A.C. 8:24-4.11(2) states, "Clean equipment and utensils shall be stored: (i) In a self-draining position that allows drying; and (ii) Covered or inverted."

Reference #5: N.J.A.C. 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #6: N.J.A.C. 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #7: N.J.A.C. 8:24-6.5(i), states, "Maintenance tools such as brooms, mops, vacuum cleaners, and similar items shall be stored: 1. So that they do not contaminate food, equipment, utensils, linens, and single-service and single-use articles."

Reference #8: N.J.A.C. 8:24-3.3(k), states, "During pauses in food preparation or dispensing utensils shall be stored: ... 5. In a clean, protected location if the utensils, such as ice scoops, are used only with a food that is not potentially hazardous. ..."

Reference #9: The facility policy titled, SM..6 Orientation states, "... All Staff whether clinical or supportive including contract staff, students and volunteers shall receive an orientation to specific job duties and responsibilities and their work environment as required by Federal laws and regulations. ..."

Reference #10: The facility Department Orientation Checklist states, "... The Department Orientation Checklist must be completed by the immediate supervisor for each new hire or transferee within (30) days from the date of hire/transfer. ..."

1. On 11/30/2015, in the presence of Staff #27 and Staff #30, the following deficient practices were observed:

a. Staff #31 was using sanitizer testing strips for an Oasis 46 Multi Quat Sanitizer to check the concentration of the sanitizing solution. The sanitizing strips were completely wet, discolored and without the manufacturers color coded packaging to compare the color of the test strip against the color code for level of sanitizer concentration. (Refer to Reference #3)

(i) During interview, Staff #30 confirmed that the sanitizer testing strips were not in usable condition to provide an accurate reading. (Refer to References #2 and #3)

b. A dirty mop bucket with a dirty rag soaking in dirty water was observed placed in a clean utensils and condiment area. (Refer to References #6 and #7)

c. The ice dispensing machine located in the main kitchen had a scoop for dispensing ice without a holder for the scoop. The scoop was placed on top of the water cooler adjacent to the ice machine. (Refer to Reference #8)

d. The flooring around the "tilt skillet" area was loose, causing the tile bubble around the area. (Refer to References #5 and #6)

e. The flooring outside the threshold to the vegetable refrigerator was uneven and broken. (Refer to Reference #5)

f. Wet trays were observed being stacked together after going through the kitchen warewashing machine. (Refer to Reference #4)

2. On 12/2/2015, (2) two out of (2) two (Staff #72 and Staff #73) dietary staff personnel files lacked evidence of department specific orientation. The hire date for Staff #72 and Staff #73 was 8/21/2015. (Refer to References #9 and #10)

3. The above findings were confirmed by Staff #27 and Staff #30.

Based on observation and staff interview, it was determined the facility failed to ensure that a safe and sanitary environment be maintained for patients, staff and the general public.

Findings include:

1. On 12/1/15 a tour of Unit 5W was completed in the presence of Staff #66. On the voluntary side of the psychiatric unit by the payphones, exposed dried adhesive like material was found on the floor surfaces. The substance appears to have been smeared by repeated buffing by the buffing machine giving the floor an unsanitary dirty appearance.

a. The floor surfaces in the nurses station also had exposed dried adhesive like material on its surface.

b. Staff #66 confirmed the above.

2. On December 1, 2015 thru December 2, 2015, in the presence of Staff #48, exposed dried adhesive like material was found on the floor surfaces in the following areas:

a. Inside Room #05 located on Floor #4 West.

b. Within Room #029 located on Floor #4 East.

c. Inside the Intensive Care Unit and Cardio-Vascular Intensive Care Unit.

3. On December 1, 2015 thru December 2, 2015, in the presence of Staff #48, visually dusty air-vent registers were found in the following areas:

a. Throughout all Service and Storage Rooms located on the entire Seventh Floor.

b. Within Storage Room #001 on Floor #3 West.

4. On December 1, 2015 thru December 2, 2015, in the presence of Staff #48, the wall surfaces in the following areas were damaged, exposing the gypsum material that is not a cleanable surface:

a. Inside Storage Room #044 on Floor #7 West.

b. Within Storage Room #044 on Floor #6 West.

c. In Room #036 on Floor #4 West.

d. Inside Soiled Utility Room #021 on Floor #4 West.

e. Within Neonatal Storage Room #051 on Floor #4 West.

f. At the Emergency Department Fast Track Nurse's Station.

g. Inside the former Medical Records Storage Area on Floor #3.

5. On December 1, 2015 thru December 2, 2015, in the presence of Staff #48, stained and discolored ceiling tiles were found located in the following areas:

a. Inside Trauma Services Room #003 located on Floor #5 East.

b. Within the Housekeeping Department Office.

c. In the Hospital Pharmacy.

6. These finding were confirmed by Staff #48.


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7. During a tour of the Intensive Care Unit and the Critical Care Unit on 11/30/15, the following observations were made:

a. Throughout both units, a dark brown substance was visible on the floor.

i. In interview, Staff #34 confirmed that the brown substance on the floors was adhesive that came through the floor tiles, and the facility has been unable to remove the stains.

b. Several walls were observed to have cracks, and paint that appeared to have chipped. Several walls were also observed to have holes and areas that appeared to have been spackled, but not painted.

c. Caulking around the sinks was observed to be either detached from the wall, missing or with dark residue.

d. At the nurses' stations, delamination was noted at the bottom of the outer part of the desks.

e. In the ICU Soiled Utility Room, the floor by the hopper, was yellow and rusty.

3. The above was confirmed with Staff #34.

Based on observation and staff interview conducted on 12/1/15, it was determined that the facility failed to ensure that the Life Safety from Fire requirements are met.

Findings include:

Reference: NFPA [National Fire Protection Association] Life Safety Code, 2000 edition section 19.3.2.7 Alcohol-based Hand-rub Solutions states, "... (6) The dispensers shall not be installed over or directly adjacent to an ignition source. ..."

1. During a tour of the Sterile Processing Department's Decontamination Room, in the presence of Staff #51 and Staff #52, an ABHR dispenser was observed to be installed on a wall directly above an electrical outlet.

a. Staff #52 stated that the electrical outlet was live and in use.

b. A live electrical outlet is an ignition source.

2. This finding was confirmed by Staff #51 and Staff #52.

Based on observation and interview, it was determined that the facility failed to ensure that all supplies are removed from patient care areas prior to the manufacturer's expiration date.

Findings include:

1. During a tour of the Neonatal Intensive Care Unit on 11/30/15 at 2:30 PM, the following expired items were observed available for patient use:

a. B.D. Bactec 1-5 ml Myco/F Lytic Culture vial, expiration date 7/31/15.

b. Mastisol Liquid Adhesive, 2 fluid ounces, expiration date 02/2015.

2. The above was confirmed with Staff #68.

Based on observation, 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, and failed to ensure an adequate Infection Control Program that seeks to minimize infections and communicable diseases.

Findings include:

1. The facility failed to ensure its policy for cleaning patient care equipment is implemented. (Cross Refer to Tag 0748).

2. The facility failed to ensure policies and procedures that adhere to professionally acceptable standards of practice are developed and implemented. (Cross refer to Tag 0748).

3. The facility failed to ensure that multi-dose vials access in an immediate patient care area were used for one patient and immediately discarded; and that single-dose vials are only used for one patient and immediately discarded. (Cross Refer to Tag 0749).


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4. The facility failed to ensure that an ongoing program designed to prevent, control, and investigate infections and communicable diseases is maintained. (Cross refer to Tag 0144 and Tag 0749).

A. Based on a tour of the physical therapy unit, review of facility policy and staff interview, it was determined that the facility failed to ensure all policies were implemented.

Findings include:

Reference: Facility Policy, Title:Infection Control Procedure, under C. Equipment states, "... Reusable equipment used directly by patients 8L/OR [SIC] visitors shall be washed down minimum daily with hospital approved disinfectant solution, if the patient has a draining lesion, the equipment is disinfected between patients."

1. A tour of the physical therapy unit was conducted on 12/1/15. Staff #64 was observed spraying equipment with Microcide TB disinfectant spray and wiping it off with a towel immediately after spraying the equipment.

2. The directions on the Microcide TB spray bottle states, "... Allow product to penetrate and the surface to remain wet for 3 minutes (for bloodborne Pathogens allow surface to remain wet for HIV-1, 1 minute and for HBV and HCV, 5 minutes)."

3. The facility failed to ensure staff are using the disinfectant solution as per manufacturer's directions. The equipment is not being disinfected daily or in between patients as per policy.

4. Staff #10 confirmed the above.


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B. Based on observation, staff interview and facility document review conducted on 11/30/15, it was determined that the facility failed to ensure that their policy and procedure and Infection Control activities are in compliance with OSHA regulations.

Findings include:

Reference #1: Facility policy titled Cleaning and Preparation of Endoscopes states, "Policy: ... I) Preparing the Endoscopes for Pre-Cleaning ... I. Transport the endoscope to the reprocessing area in an enclosed container or approved cinch sak. ..."

Reference #2: OSHA 29 CFR part 1910.1030(g)(1)(i)(A) states, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials ..."

1. During a tour of the Endoscopy Unit at 12:00 PM, in the presence of Staff #22 and Staff #23, it was observed that a soiled endoscope was transported from the Procedure Room to the Soiled Utility Room in a Cinch Sak.

2. The Cinch Sak was observed to be without a biohazard warning label.

a. Staff #22 stated that a single endoscope is transported in a Cinch Sak and double endoscopes are transported in a covered bin with a biohazard label.

b. The facility failed to ensure that all manners of soiled endoscope transport are in compliance with OSHA regulations.

3. Upon review of the facility policy, the policy failed to include guidance on placing a biohazard warning label on its transport containers.

4. The facility failed to ensure policies and procedure that adhere to OSHA regulations are written and implemented.

C. Based on observation, review of facility documents and staff interview conducted on 12/1/15 and 12/2/15, it was determined that the facility failed to ensure that their policy and procedure on instrument decontamination is implemented.

Findings include:

Reference #1: Facility policy and procedure titled SW-DECONTAMINATION OF SOILED INSTRUMENT AND DEVICES states, "Policy: 1. All instruments and devices shall be cleaned and/or decontaminated per the device manufacture's (sic) written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference."

1. During a tour of the SPD Department on 12/1/5 at 11:30 AM, a Stryker arthroscope was observed to be reprocessed.

a. The manufacturer's IFU for the Stryker arthroscope was requested and not received.

2. The facility failed to ensure that the manufacturer's IFU for the Stryker arthroscope was available and followed.

3. This finding was confirmed by Staff #51 and Staff #52.

Reference #2: Manufacturer's IFU for GE Voluson E8 Ultrasound system, section 10-5-4-1 General Cleaning states,"Use a fluid detergent in warm water on a soft, damp cloth to carefully wipe the entire system."

1. On 12/2/15, while touring the Antenatal Testing Unit (ATU) at 12:05 PM, a GE Voluson E8 Ultrasound system was observed.

2. In the presence of Staff #4 and Staff #87, Staff #88 stated that he/she cleans the Voluson E8 Ultrasound system with Super Sani wipes.

3. The manufacturer's IFU for the Voluson E8 Ultrasound system was requested.

a. Upon review, the IFUs indicated to use fluid detergent in warm water on a soft, damp cloth.

4. The facility failed to ensure that manufacturer's instructions for use are followed.

5. This finding was confirmed by Staff #4, Staff #87 and Staff #88.

Reference #3: Facility policy and procedure titled SW-DECONTAMINATION OF SOILED INSTRUMENT AND DEVICES states, "... Processing Area ... 6. When instruments are received in the Decontamination Area, they are to be removed from the soiled transport container/cart or biohazard bag and placed in a sink with a solution of enzymatic detergent prepared in accordance with manufacturer's instructions."

1. At 11:35 AM, during an interview in the Decontamination Room in the presence of Staff #51, Staff #52 was asked about the proper dilution of the enzymatic cleaning agent that the facility uses, "PowerCon Triple Enzyme Detergent."

2. Staff #52 responded that he/she does not know.

3. The facility failed to ensure that the manufacturer's IFU for its cleaning agents and its policy and procedure on instrument decontamination are followed.

4. This finding was confirmed by Staff #51.

D. Based on observation, review of policies and procedures, and staff interview conducted on 12/1/15, it was determined that the facility failed to implement professionally acceptable standards for hand washing.

Findings include:

Reference: Facility policy and procedure titled SYSTEM WIDE-DRESS (sic) CODE FOR STERILE PROCESSING DEPARTMENTS states, "... Procedure: ...11. Fingernails should be kept short and clean and should not extend beyond the fingertips. ..."

1. During a tour of the SPD Department at 11:30 AM, Staff #51 was observed to have fingernails that were longer than 1/4".

2. Staff #51 stated that he/she performs all duties in SPD including decontamination, prep and pack, and sterilization.

3. The facility failed to ensure compliance to its sterile processing policy.

A. Based on observation, document review and staff interview conducted on 12/1/15, it was determined that the facility failed to ensure that multi-dose vials of medications that are accessed in the immediate patient care area are discarded immediately after use on a single patient.

Findings include:

Reference #1: Center for Disease Control (CDC) question and answer guidelines for multi-dose vials , states, "Can multi-dose vials be used for more than one patient? How? Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use." And "What are examples of the immediate patient treatment area"? Examples of the immediate patient treatment area include patient rooms or bays, and operating rooms."

1. At 2:45 PM, an opened 20 ml multi-dose vial of labetalol was found stored in the anesthesia medication cart located in Procedure Room #2.

2. This findings was confirmed by Staff #43.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was removed on 12/1/15, the day of survey, upon receipt of an acceptable plan of correction.

B. Based on observation and staff interview it was determined that the facility failed to ensure all vials of medications labeled for single use are discarded after each use, and are not used for multiple patient procedures.

Findings include:

1. On 11/30/15 at 11:40 AM, the second floor Nuclear Medicine Department and Stress Test areas were toured in the presence of Staff #9 and Staff #12. In the Stress Test Room #2E013, on the counter top by the sink, a 20 ml opened bottle of Aminophylline 500 mg (25 mg/ml) was observed. the bottle had a written date of opening on it as 11-30-15 10:30 AM, with a facility staff member's initials.

2. In interview, Staff #13 stated that the facility staff use the bottle's contents for two (2) to three (3) patients, and every time for each patient, the staff wipe the rubber septum with alcohol, and use a new needle.

3. The vial of Aminophylline is labeled as single use by the manufacturer. The facility had a single dose medication opened and available for repeated patient use. Per the above staff interview, it is the facility's practice to use the single use vial of medication on multiple patients.

This finding resulted in an Immediate Jeopardy (IJ). Facility staff were made aware of the IJ, the practice stopped, and an immediate plan of correction (PoC) was requested by survey staff. An acceptable PoC was received on 12/1/15.


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C. Based on observation, a review of policies and procedures, and staff interview, it was determined that the facility failed to adhere to professionally acceptable standards for hand washing.

Findings include:

Reference #1: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states,
"Recommendations:
1. Indications for Handwashing and Hand antisepsis ... C. Decontaminate hands before having direct contact with patients ... E. Decontaminate hands before inserting ... peripheral vascular catheters, or other invasive devices ... F. Decontaminate hands after contact with a patient's intact skin ... G. Decontaminate hands after contact with ... a patient's nonintact skin ... I. Decontaminate hands after contact with inanimate objects ... in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves ..."

Reference #2: Facility policy titled Hand Washing/Hand Hygiene states, "... Policy ... --[facility name]-- Health Care System personnel will wash their hands to prevent the spread of infections: Before caring for patients, performing a procedure, donning gloves, touching wounds of any kind, eating, drinking, handling contact lenses, or using the restroom; between contacts with different patients, tasks and procedures on the same patient; after caring for patients, removing gloves, handling inanimate sources that are likely to be contaminated (bedpans, urine collection devices), contact with mucus membranes, blood and body fluids, secretions or excretions, eating, coughing, sneezing or using the rest room ..."

1. During a tour of the Critical Care Unit on 11/30/15 at 11:38 AM, Staff #35 was observed performing a finger-stick blood glucose test on Patient #33.

a. Staff #35 did not perform hand hygiene prior to performing the test.

b. At the completion of the test, Staff #35 was observed removing his/her gloves, removing the contaminated test strip from the glucometer, and returning the glucometer to its container. Staff #35 did not perform hand hygiene after completing the glucose test and removing his/her gloves.

2. During an observation in the Intensive Care Unit on 11/30/15 at 12:30 PM, Staff #32 was observed administering a respiratory treatment to Patient #35.

a. Staff #32 did not perform hand hygiene prior to patient contact.

3. The above was confirmed with Staff #33.

4. During an observation in the Same Day Stay Surgery Pre-op at approximately 12:00, Staff #104 did not perform hand hygiene after a patient physical exam.

a. In the Procedure Room, on 12/1/15 at approximately 12:25 PM, Staff #104 was observed and did not perform hand hygiene prior to the procedure and after removal of gloves.

5. During an observation in the Procedure Room, on 12/1/15 at approximately 12:15 PM, Staff #103 did not perform hand hygiene following removal of gloves x 3.

6. During an observation on 12/1/15 at approximately 12:15 PM, Staff #102 was observed wearing the same gloves during a procedure. Once the procedure was done, Staff #102 accompanied the patient to the Post-op area, and at approximately 12:45 PM removed the gloves. Staff #102 did not perform hand hygiene after glove removal.

7. There was no evidence of any hand sanitizers in the Procedure Room.

8. During an observation in OR #3, at approximately noon, Staff #100 was observed performing various tasks involving the use of gloves several times. Staff #100 did not perform hand hygiene between glove changes.

9. On 11/30/15 at 11:05 AM, the Nuclear Medicine Department was toured in the presence of Staff #9 and Staff #12. Staff #13 was observed wearing latex gloves in the hallway outside Room #2E015, then he/she went into Room #2E014, exited, moved a stretcher a patient was on, went into the Nuclear Tech office, then into and out of Room #2E013, back into Room #2E014 and came out with band-aids in his/her gloved hands, and then went back into Room #2E013.

10. Staff #13 did not change gloves or perform hand hygiene between the different points of contact, patient contact, and activities. There was not enough time in between each of his/her contacts or room appearances for hand hygiene practices to have occurred. This was confirmed by Staff #12.

D. Based on observation and document review, it was determined that the facility failed to ensure that aseptic technique was used for the preparation of medication.

Findings include:

Reference: Center for Disease Control website titled " FAQs Regarding Safe Practices for Medical Injections " states, "... 1. How should I draw up medications? ... Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."

1. On 12/3/15 during a procedure for Patient #40, Staff #100 was observed drawing medication from multiple vials using a sterile needle and syringe for each vial, without first wiping the rubber septums of the vials with alcohol.


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F. Based on observation, review of facility documentation and staff interviews conducted on 12/1/15, it was determined that the facility failed to ensure an ongoing Infection Control program for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel is implemented in the Dental/OMS Department.

Findings include:

Reference #1: OSHA (Occupational Safety and Health Administration) 29 CFR part 1910.1030(d)(2)(xiii) states, "Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping."
Reference #2: OSHA 29 CFR part 1910.1030(g)(1)(i)(A) states, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials ..."

1. During a tour of the Dental/OMS Department at 3:00 PM, a Midmark M11 Ultraclave steam sterilizer was observed in Lab Room #119.

2. Staff #89 stated, "Some instruments are sent to the hospital" and some instruments are reprocessed in Lab Room #119.

3. In the presence of Staff #4 and Staff #89, Staff #81 was asked how the soiled dental instruments are transported from the dental operatory to Lab Room #119.

4. At 3:20 PM Staff #81 stated, "I carry soiled instruments on a tray and cover them with a brown paper towel."

5. The facility failed to ensure that soiled dental instruments are transported in accordance with OSHA regulations to prevent personnel and patient exposure to potentially infectious materials.

G. Based on observation, facility document review and staff interviews conducted on 12/1/15, it was determined that the facility failed to ensure its Instrument Reprocessing practice is in conformance with AAMI ST79 guidelines. (ST 79 replaces and supercedes ST 46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009).

Findings include:

Reference #1: AAMI Sterilization in Health Care Facilities, 2014 edition, ST 79 section 10.5.1 states, "Physical monitors include time, temperature, and pressure recorders; displays; digital printouts; and gauges. ... At the end of the cycle and before items are removed from the sterilizer, the operator should examine and interpret the chart or printout to verify that all cycle parameters were met and initial it to permit later identification of the operator. ... Physical monitoring provides real-time assessment of the sterilization cycle conditions and provides permanent records by means of chart recordings or digital printouts."

1. At 3:21 PM, in the presence of Staff #4, Staff #89, the M11 Ultraclave steam sterilizer was observed to be without a printer.

2. The sterilizer records were requested from Staff #81 and Staff #82.

3. The facility records did not have evidence that the physical parameters, i.e., the exposure and drying times, temperature, and pressure, are monitored for each sterilization cycle.

4. This finding was confirmed by Staff #4 and Staff #89.

Reference #2: AAMI Sterilization in Health Care Facilities, 2014 edition, ST 79 section 10.5.3.2 Using biological indicators states, "Biological indicators should be used within PCDs ... for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use ... "

1. In the presence of Staff #4 and Staff #89, Staff #81 stated that the BIs are performed "every two weeks because sometimes we are out of supplies".

2. The facility failed to ensure that a BI is performed at least weekly.

3. Upon review of the sterilization records, there was no evidence that BI testing is done at least weekly.

4. These findings were confirmed by Staff #4 and Staff #89.

Reference #3: AAMI Sterilization in Health Care Facilities, 2014 edition, ST 79 section 10.5.2.2.2 Internal chemical indicators states, "An internal CI should be used within each package, tray, or rigid sterilization container system to be sterilized."

1. At 3:23 PM, five (5) out of five (5) sterilized paper plastic wrapped dental instruments were observed to be without an internal CI.

2. Upon review of the sterilization records, there was no evidence that internal CI testing is done with every sterilized package, tray or rigid sterilization container.

3. These findings were confirmed with Staff #4, Staff #82 and Staff #89.

H. Based on observation, lack of facility documentation and staff interview conducted on 12/1/15 and 12/2/15, it was determined that the facility failed to ensure Instrument Reprocessing training and competency for its Dental/OMS personnel.

Findings include:

1. In the presence of Staff #4 and Staff #89, Staff #81 was asked if the M11 steam sterilizer was operating as gravity displacement or prevac. He/she stated, "I do not know if it is gravity displacement or prevac."

2. Upon review on 12/2/15 at 1:30 PM, the employee personnel file for Staff #81 lacked evidence of the following:

a. A signed and dated job description

b. Training on instrument reprocessing

c. Competency on instrument reprocessing

d. A performance evaluation

3. The facility failed to ensure that personnel engaged in instrument reprocessing in the Dental/ OMS Department are trained and competent.

These findings resulted in an Immediate Jeopardy which immediately curtailed this practice on 12/1/15. The Immediate Jeopardy was removed on 12/2/15, upon receipt of an acceptable plan of correction.

I. Based on observation and staff interview conducted on 11/30/15 and 12/1/15, it was determined that the facility failed to ensure that its traffic patterns in the Operating Room are in accordance with the nationally recognized standards it has selected for its Infection Control Program.

Findings include:

Reference #1: AORN "Perioperative Standards and Recommended Practices" 2013 edition Recommended Practices for Traffic Patterns in the Perioperative Practice Setting states on page 122, "... The decontamination area and soiled linen and trash areas should be separated from personnel and patient traffic areas. Separation of clean and sterile supplies and equipment from soiled materials by space, time and traffic patterns decreases the risk of infection."

1. During the entrance interview on 11/30/15, Staff #4 stated that the facility has selected CDC, OSHA, AAMI and AORN standards for its Infection Control Program.

2. On 12/1/15, during a tour in the OR Department in the presence of Staff #4 and Staff #49, the following were observed:

a. Staff #58 and Staff #59 crossed through the Female Locker Room carrying large red bags between 10:20 AM to 10:30 AM.

b. Staff #58 and Staff #59 wore soiled gloves while touching the door knobs and other environmental surfaces into and out of the Female Locker Rooms.

c. The contaminated surfaces were not sanitized between 10:20 AM to 10:30 AM.

3. The facility failed to ensure separation of clean and soiled activities, in accordance with AORN standards.

Reference #1: OSHA 29 CFR part 1910.1030(d)(2)(i) states, "Engineering and work practice controls shall be used to eliminate or minimize employee exposure."

Reference #2: OSHA 29 CFR part 1910.1030(d)(2)(v) states, "Employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment."

1. At 10:35 AM Staff #49 stated that what was observed was the routine traffic pattern for taking out the garbage from the OR suites into the Housekeeping closet located in the unrestricted corridor of the OR.

2. Bringing large bags of bio-hazardous materials into the Female Locker Room increases the chance of employee exposure to blood borne pathogens.

3. Staff #58 and Staff #59 were observed to not sanitize their hands before re-entering the Female Locker Room.

a. There were no facilities, i.e., ABHR dispenser or handwashing sink, observed near the Housekeeping closet in the unrestricted corridor.

4. The facility failed to ensure compliance to OSHA regulations.

5. These findings were confirmed by Staff #4 and Staff #49.


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J. Based on observation, review of policies and procedures, and staff interview, it was determined that the facility failed to ensure that the glucometer is properly cleaned after each use.

Findings include:

Reference: Centers for Disease Control (CDC) website: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html titled, "Infection Prevention during Blood Glucose Monitoring and Insulin Administration," states, "... Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared ..."

1. During an observation in the Critical Care Unit on 11/30/15 at 11:38 AM, Staff #35 was observed performing a finger-stick blood glucose test on Patient #33.

a. Staff #35 did not clean and disinfect the glucometer after use.

2. In interview, Staff #4 confirmed that the facility follows CDC guidelines for infection control.


K. Based on observation, review of policies and procedures, and staff interview, it was determined that the facility failed to implement respiratory procedures related to the control and spread of infection.

Findings include:

Reference: Facility policy titled Hand Held Nebulizer (SVN) states, "... Infection Control: ... Drain nebulizer after treatment and wipe off aerosol mask ..."

1. During an interview on 11/30/15 at 12:20 PM, Staff #32 confirmed that the procedure for cleaning the nebulizer equipment after each use was to wipe the equipment with a paper towel.

2. During an observation on 11/30/15 at 12:35 PM, Staff #32 was observed removing nebulizer equipment from Patient #34, following the administration of a respiratory treatment.

a. Staff #32 placed the nebulizer equipment into a plastic bag at the bedside, without cleaning the equipment prior to storage.

3. A review of the manufacturer's instructions for the "Misty Max 10 Nebulizer," revealed the following, "... Cleaning Instructions ... Unscrew the nebulizer cap and bottle. Remove the one-piece jet by pulling and twisting the jet off the jet stem. Wash all components in warm soapy water and rinse well. Air dry or hand dry with a clean, lint free cloth ..."

4. The above was confirmed with Staff #33 and Staff #69 on 12/2/15.






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E. Based on review of facility documents, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure all personnel with negative tuberculosis (TB) screening results continue to be screened on an annual basis.

Findings include:

Reference #1: Facility policy and procedure Tuberculosis Screening and Post Exposure Investigation states, "... POLICY: Screening for tuberculosis shall be provided by Employee Health Services for all employees upon initial hire, on a repeat schedule depending upon the Infection Control TB risk assessment ... . Employees are required to participate in the TB Surveillance Program as mandated by the New Jersey Department of Health and human Services and OSHA. ... Risk Assessment - Periodic Screening ... 2. All employees whose prior TB test is negative are screened for TB with a Mantoux Tuberculin skin test (TST) using 5 t.u. PPD. This screening is scheduled according to the TB risk assessment conducted by members of the Infection Control Committee in accordance with the guidelines from the Centers for Disease Control and the New Jersey Department of Health. Risk categories are tested as follows: Risk Low to Medium Risk Frequency Annually Department All departments in which health-care workers (HCWs) have contact with patients or TB specimens. ..."

Reference #2: New Jersey Administrative Code (N.J.A.C.) Title 8 Chapter 43-G Hospital Licensing Standards states at 20.2 (d) 1. "... Employees are defined, for the purpose of this subsection, as full and part-time employees, volunteer staff and primary care providers who are salaried by the facility and/or who have clinical privileges to provide medical care at the facility.", and at 20.2 (d) 2. i., "The facility shall administer an IGRA [interferon-gamma release assay] or a Mantoux tuberculin skin test to all employees whose prior IGRA or Mantoux tuberculin skin test results were negative at least annually. Frequency of testing shall be determined by the level of risk assigned by the facility's TB plan; ..."

1. On 12/1/15 at 11:00 AM twelve (12) physician credential files (Staff #100 thru #109, #113, and #114) were reviewed in the presence of Staff #46. Within the physician credential files are the annual TB testing/screening. The credential files lacked evidence of annual TB screening or testing for Staff #113, Staff #114, Staff #101, Staff #103, Staff #104, Staff #105, Staff #106, Staff #107, Staff #108, and Staff #109.

2. On 12/2/15, Staff #75 from employee health was able to produce TB screening results from the year 2015 for Staff #113, Staff #101, and Staff #107.

3. The last date of a TB screening/ testing for the physicians without a screening/testing in the year 2015 is as follows:

a. Staff #114's last documented PPD [purified protein derivative; a TB skin test] was 11/27/14.

b. Staff #103's last screening test with Quantiferon was 3/24/14.

c. Staff #104's last PPD was 10/2014.

d. Staff #105's last PPD was 9/2014.

e. There was no evidence of a PPD or TB screening for Staff #106.

f. Staff #108's was 4/2013.

g. Staff #109's was 9/2013.

4. The facility could not show evidence of a TB screening or PPD test in seven (7) out of twelve (12) physician files reviewed.

5. Six (6) employee files were reviewed (Staff #32, #41, #42, #110, #111, and #112). Staff #110's health file lacked evidence of an annual TB screening or PPD test in 2015. His/her last PPD was in 9/2013.

Based on medical record review, a review of policies and procedures and staff interview, it was determined that the facility failed to ensure that respiratory services are delivered in accordance with medical staff directives.

Findings include:

Reference #1: Facility policy titled Start/Stop Orders states, "... Policy: All forms of respiratory therapy modalities, including mechanical ventilation, oxygen, medication delivery and arterial puncture will be initiated or changed only on written order of a physician , PA or designee [sic] ... When BiPAP equipment is not utilized by the patient for greater than 24 Hrs. due to either continued refusal or the patient's condition has improved and is no longer indicated the Respiratory Therapist will inform the RN/MD with a recommendation to discontinue therapy ..."

1. A review of Medical Record #36, date of admission 11/30/15, revealed a physician order at 5:12 AM that states, "Cpap Bipap."

a. On 11/30/15 at 8:48 AM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... Standby ... PT FOUND OFF BIPAP ON 5 L N/C [Nasal Cannula] PT STABLE AWAKE AND ALERT. BVM AT THE BEDSIDE ..."

b. On 11/30/15 at 1:29 PM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... Standby... BIPAP MACHINE STANDBY PT ON 5 L N/C PT STABLE ..."

c. On 11/30/15 at 8:10 PM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... Standby ... pt was received on 5 L n/c, bipap placed on stby [Standby] at bedside ..."

d. On 12/1/15 at 8:43 AM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... Standby ... Patient on 4 L nc, no acute distress noted ..."

e. On 12/1/15 at 3:48 PM, documented evidence in the "RT BIPAP/CPAP," states, "... Mode ... BIPAP... Pt on n/c 4 l/m. BS [breath sounds] diminished. Pt slightly tachypneic ... was ambulating in hallway [sic] ..."

f. On 12/2/15 at 12:14 AM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... BIPAP/STAND BY [sic] ... BIPAP REFUSED NO SOB [shortness of breath] FOUND RN NOTIFED [sic]. ON 4L N/C ..."

g. On 12/2/15 at 4:06 AM, documented evidence in the "RT BIPAP/CPAP" states, "... Mode ... BIPAP/STAND BY[sic] ... BIPAP REFUSED NO SOB FOUND RN NOTIFED [sic]. ON 4L N/C ..."

h. On 12/2/15 at 9:47 AM, documented evidence in the "RT BIPAP/CPAP," states, "... Mode ... BIPAP STANDBY ... PT RECEIVED ON 3L N/C BIPAP STANDBY PT NOT IN ANY RESPIRATORY DISTRESS AT THIS TIME NO CHANGES MADE AT THIS TIME ..."

2. A review of the medical record lacked evidence of a physician order for oxygen via nasal cannula.

3. During an interview on 12/2/15, at 11:08 AM, Staff #33 confirmed that there was not a physician order to place the BiPAP on standby, and that there was not a physician order to administer oxygen via nasal cannula.

4. A physician order dated 12/2/15 at 11:40 AM states, "Oxygen Therapy, 3 L/Min, Nasal Cannula prn to maintain spo2 > 95 %."

a. On 12/2/15 at 11:52 PM, documented evidence in the "RT BIPAP/CPAP" states, "pt refused bipap pt on 4 lpm [liters per minute] nc [sic]."

b. On 12/3/15 at 3:16 AM, documented evidence in the "RT BIPAP/CPAP" states, "pt refused bipap pt on 4 lpm nc [sic]."

5. Documented evidence in the medical record, revealed that the physician's order for oxygen therapy was not being followed.

Reference #2: Facility policy titled New Start Procedure states, "Policy ... Documentation will include Treatment : Prescribed Medication. Assessment and evaluation. Plan of Care. (TAP) This will then be included in the patient's chart. [sic]"

6. Review of 3 out of 3 medical records (#34, #35, #36), lacked evidence that a respiratory care practitioner established a respiratory treatment plan and respiratory therapy goals upon the initiation of respiratory therapy.

7. During an interview on 12/1/15 at 11:20 AM, Staff #32 confirmed that there was not a respiratory plan of care for Patient #34 and Patient #35.

8. During an interview on 12/1/15 at 2:45 PM, Staff #92 confirmed that there was not a respiratory plan of care for Patient #36.

9. During an interview on 12/1/15 at 3:23 PM, Staff #97 confirmed that respiratory therapists do not develop a plan of care.

10. The above was confirmed with Staff #33 and Staff #69 on 12/2/15.

Based on medical record review, a review of policies and procedures, a review of medical staff by-laws, and staff interview, it was determined that the facility failed to implement a policy for licensed respiratory care professionals to accept and record verbal orders.

Findings include:

Reference: Facility document titled Medical-Dental Staff Bylaws and Rules and Regulations, Article XIX states, "... 11 ... Verbal orders falling within the scope of practice of Respiratory Care Practitioners can be accepted and recorded by Registered or Certified Respiratory Care Practitioners licensed by the State of New Jersey ..."

1. A review of Medical Record #42, revealed the following:

a. On 12/1/15 at 7:53 AM, the "RT Ventilator FS" revealed that the Fraction of Inspired Oxygen 2% (FiO2) was documented as "50 ... continue to monitor and wean PT as per DR orders ..."

b. The physician order for respiratory states, "Ventilator Management Adult, PRVC, TV 350, RR 18, FiO2 60 %, PEEP 5 Continuous."

2. During an interview 12/1/15 at 12:00 PM, Staff #32 confirmed that the FiO2 setting was changed per verbal order from the physician and that he/she did not record the verbal order because the physician is responsible for entering the order. Staff #32 confirmed that a physician order had not been entered at this time.

3. During an interview on 12/2/15 at 10:23 AM, Staff #33 and Staff #69 confirmed the above and that there was not a facility policy addressing respiratory care practitioners accepting and recording verbal orders.