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

CFR 482.13 Patient Rights

CFR 482.21 QAPI

CFR 482.28 Food and Dietetic Services

Based on document review and interview, it was determined that the facility failed to ensure that patients with mental illness are evaluated and referred for emergency services when appropriate.

Findings include:

1. During a tour of the in-patient psychiatric unit (4 East), a memorandum dated 2/1/12 and signed by Staff #23, was posted in the nurse's station, on the interior portion of a window, in plain site for all staff to acknowledge. The memorandum stated "Effective today the Urgent Care Center will close. The following processes must take place:...Falls: If the patient has not hit his head, not in need of sutures, not complaining of pain and not exhibiting any other signs or symptoms that would need immediate medical intervention he/she can wait to be seen in AM by Dr.____."

2. Staff #23 stated that another memorandum was posted to supercede the one stated above however, was unable to produce the second memorandum upon request, while on the unit.

3. The facility failed to ensure, that a psychiatric patient on 4 East, would be evaluated by a physician for appraisal of emergencies, initiate treatment or refer for other services when appropriate if a fall has occurred.

Based on review of facility policies and procedures, staff interview, and review of medical records and facility documents, it was determined that the facility failed to protect and promote the rights of each patient.

Findings include:

1. The facility failed to inform each patient of the Patient Rights in advance of furnishing patient care. (Cross refer 0117)

2. The facility failed to ensure that all patients have the right to remain free from physical restraints. (Cross refer 0154)

3. The facility failed to ensure that all patients in restraints and seclusion are monitored by trained staff that have completed the training criteria at intervals determined by hospital policy. (Cross refer 0175)

Based on staff interviews, observations, and review of facility policies and procedures, it was determined that the facility failed to inform each patient or the patient's representative, of the patient's rights, in advance of furnishing patient care.

Findings include:

Reference: Facility policy, 'Patient Rights' states, "...All patients shall be made aware of their rights within the first 24 hours of admission. They shall receive a copy of their rights and sign a statement that their rights were explained to them."

1. A tour was conducted at approximately 10:00 AM on 2/15/12 of the psychiatric in-patient unit, that housed voluntary and involuntary committed patients.

2. Staff #23 stated during interview on 2/15/12, that the census on the unit was 17 and included 5 involuntarily, committed, psychiatric patients.

3. There was no evidence in 17 of 17 medical records, of a signed copy of the 'Patient Bill of Rights' to indicate that the patients were aware of their rights and that the rights were explained to them.

4. An interview with Staff #24 on 2/15/12 indicated that the patients were only aware of their rights by viewing the 'Patient Rights' signs posted on the walls within the unit.

5. There is no evidence that the facility staff on the in-patient psychiatric unit, implemented the policy stated above.

Based on a tour and staff interview, it was determined that the facility failed to provide care in a safe setting for all patients.

Findings include:

Reference #1: Facility Policy titled 'Telemetry Procedure: Nursing Care' states, "POLICY: Interpretation and documentation of telemetry tracings shall be done by a Registered Nurse to Telemetry Technician...INSTRUCTIONS:...4. The nurse and/or telemetry technician shall set appropriate audible alarms limits and turn the alarm "ON." Alarm limits should set lower limits "50" and higher limits "120" unless patient's known rate is out of range... 14. In case of telemetry malfunction, the nurse shall: A. First check for all of the following: 1. electrodes are well attached with conductive jelly. 2. wires not loose or broken. 3. battery functional and correct voltage. 4. patient within telemetry range. B. If all the above are intact: 1. Call Biomedical Engineering immediately during weekdays. 2. Call Director of Nursing immediately on evenings and nights and the on-call Biomedical Engineer."

Reference #2: The job description titled, 'Telemetry Technician' states, "The Telemetry Technician is responsible for on-going telemetry monitoring, maintenance of all telemetry records and identification of any deviations from patient's normal cardiac rate and rhythm. All deviations are to be immediately reported by the telemetry technician to the nurse by the telephone which has been designated specifically for their purpose..."

1. On 2/14/12 at approximately 10:00 AM, a tour of 'M-3,' the telemetry unit, was conducted. The following observations were made.

a. The unit contained central monitoring equipment and staff for the telemetry patients throughout the facility.

b. It was observed during the tour of the central monitoring area, that the telemetry monitor assigned for Bed #346 B displayed in bold red letters, "Lead Off." Staff #30 confirmed during interview at approximately 10:15 AM, that if the monitor displayed any change in the patient's condition, an audible alarm would be heard from that particular monitor.

c. There was no evidence of an audible alarm from the telemetry monitor assigned to Bed #346B.

d. Upon further observations of the telemetry monitors, there was no evidence of any audible alarms sounding for any of the monitors, that displayed in bold red letters, that a problem was identified.

e. Staff #30 stated during interview on 2/14/12, that he/she had not reported the lack of audible alarms to Biomedical Engineering as per the policy stated above.

f. The tracings assigned to Bed #817A and #817B were observed to be blank for approximately 45 second intervals. Staff #30 indicated during interview, that the monitor assigned to Bed #817A and #817B had been reported to Biomedical one week prior, but the problem as of 2/14/12, still exists. There was no evidence that Staff #30 notified Biomedical Engineers of the existing problem.

g. The telemetry monitor assigned to Bed #820A was observed to have lower alarm parameters for heart rates of "120 and 39" that were in conflict with the rates of "120 and 50," as stated in Reference #1. Staff #30 stated during interview, that he/she lowered the parameters based on the patient's heart rates since admission.

h. There was no evidence that Staff #30 had knowledge of the patient's (Bed #820A) "known heart rate" prior to hospitalization, to determine if the lower range parameters were appropriate for that patient.

Based on review of 2 of 2 medical records of ED patients, review of facility policies and procedures and staff interview, it was determined that the facility failed to ensure that all patients are free of restraints of any form, imposed as a means of coercion or convenience.

Findings include:

REFERENCE: The facility policy titled, "Restraint and Seclusion," revised 2/12 states, "Indications for Restraint or Seclusion: Non Violent/Non-self-destructive Behavioral Management; used when the primary purpose is to directly support medical healing and is necessary to protect the patient from harm. Behavior is non violent, non self destructive. The Medical Use restraint standards apply to any patient of any age who receives medical-surgical care as an inpatient, in the emergency department..."

1. A review of Medical Record #38 revealed the following:

a. Patient #28 arrived to the ED on 2/6/12 at 17:39. The triage notes stated at 17:39, "brought by ambulance smell of alcohol on his breath, states he was drinking vodka today."

b. A review of an electronic physician's order dated 2/6/12 at 19:49 states "Restraints Behavioral..."

c. A review of a document titled, 'Restraint Orders' dated 2/6/12 at 7 PM states, Medical-Surgical Reasons Duration 24 hours Type Soft Wrist Left Right Soft Ankle Left Right..."

d. A review of a document titled, 'Medical/Surgical Restraint Flowsheet' dated 2/6/12, indicated with a checked off box that stated, "Pulling out tubes or drains. Harm to self."

e. There was no evidence in Medical Record #28, of any intravenous tubes, ordered or implemented. There was no evidence that Patient #28 had any drains attached.

f. There was no evidence of a Behavioral Restraint Flowsheet in the medial record.

g. There is evidence of conflicting physician orders for medical/surgical restraint use and behavioral restraint use for the same date of 2/6/12.

h. There was no evidence of the need to protect the patient or staff from harm to justify the use of restraints, as stated in the above facility policy.

2. Medical Record #40 revealed the following:

a. Patient #40 arrived at the ED on 2/5/12 at 21:39 and the triage notes stated, "brought in by ems etoh (alcohol)."

b. The Nursing 'Physical Exam' portion of the ED record stated under the 'Psychiatric' portion, "Psychiatric exam normal. Psychiatric exam included findings of patient oriented to person place and time, Normal affect, Judgement normal, Insight normal, Remote memory normal, Recent memory normal, Concentration normal..."

c. The Nursing Assessment portion of the ED record also indicated at 21:52, that the patient was assessed as, "...Anxiety; no anxiety at ease, (0), Agitation..."

d. A review of a physician order dated 2/5/12 at "10:00" PM titled, 'Restraint Orders' stated, "Behavioral Health Reasons Prevent imminent harm to self" and "Prevent disruption of treatment" were checked off. "Duration 4 hours, Type Soft Wrist Left Right Soft Ankle Left Right..."

e. The document titled 'Medical/Surgical Restraint Flowsheet' dated 2/5/12 at 10:00 PM stated under the 'Clinical Explanation Given To Prevent/Family,' "Pt is intoxicated, will not remain in bed."

f. There is no evidence in Medical Record #40 of any immediate physical safety needs to the patient or staff members, to justify the use of 4-point restraints on 2/5/12.

g. The above findings were confirmed with Staff #29 and Staff #8 on 2/16/12.

Based on review of facility policy and procedure, review of medical records of 2 of 2 ED patients who were physically restrained for management of violent or self-destructive behavior, and staff interview, it was determined that the facility failed to ensure that the condition of the patient was monitored by trained staff at an interval determined by hospital policy.

Findings include:

Reference: The facility policy titled 'Restraints and Seclusion' states revised February 2012 states on page 10, "Violent/Self Destructive Behavioral Management: The RN will:...Monitoring: An assigned staff member who is trained and competent in observing patients in restraint performs monitoring through continuous in-person observation..."

1. Staff #7 stated during interview on 2/14/12, that the ED RN's monitor patients in restraints, by placing them next to the nurses station and that no other staff member is assigned to continuously monitor the patients while in restraints.

2. Patient #39 arrived at the ED on 2/2/12 at 18:05 and the triage notes stated, "Pt brought in by ambulance for possible ETOH intoxification..."

a. A review of a physician order dated 2/2/12 at 18:05 PM for 'Restraint Orders,' stated, "Behavioral Health Reasons Prevent imminent harm to self" and "Prevent disruption of treatment" were checked off. "Duration 4 hours, Type Soft Wrist Left Right Soft Ankle Left Right..."

b. The document titled 'Medical/Surgical Restraint Flowsheet' dated 2/2/12 at 18:05 PM indicated that Patient #39 was in 4 point restraints from 6:00 PM through 9:00 PM.

c. There was no evidence that Patient #39 was continuously monitored by an assigned staff member trained and competent in observing patients while in restraints.

3. Patient #40 arrived at the ED on 2/5/12 at 21:39. The triage notes stated, "brought in by ems etoh (alcohol)."

a. A review of a physician order dated 2/5/12 at "10:00" PM titled, 'Restraint Orders' stated, "Behavioral Health Reasons Prevent imminent harm to self" and "Prevent disruption of treatment" were checked off. "Duration 4 hours, Type Soft Wrist Left Right Soft Ankle Left Right..."

b. The document, 'Medical/Surgical Restraint Flowsheet' dated 2/5/12 at 10:00 PM, indicated that Patient #40 was in 4-point restraints from 10:00 PM through 11:45 PM.

c. There was no evidence that Patient #40 was continuously monitored by an assigned staff member that was trained and competent in observing patients while in restraints.

d. The above findings were confirmed with Staff #8 and Staff #29 on 2/16/12.

Based on observation, document review and staff interview, it was determined that the facility failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

Findings include:

1. Upon review of the hospital-wide performance improvement plans for 2011 and 2012, there was no evidence of the Utilization Review Department, Medical Records Department, or Case Management/Discharge Planning Departments, identified in the on-going, data driven performance improvement plans.

a. The above findings were confirmed with Staff #11 on 2/16/12.

Based on a review of 3 medical records, review of the Medical Staff Rules and Regulations, and staff interview it was determined that the facility failed to ensure that the Medical Staff Rules and Regulations were enforced.

Findings include:

Reference: Saint Michael's Medical Staff Rules and Regulations state: Article VII, Medical Records 2. Where unlicensed house staff officers [Per Staff #8, Residents, identified by a 4 digit number after their signature] have written orders, the attending physician shall be responsible for countersigning the entries of the house staff officer within 24 hours, in addition to being responsible for countersigning operating reports and consultations.

1. Medical Record #37 contained the following orders:

a. 11/28/11, no time noted - Post Operative Orders (Total Knee Replacement) were authenticated by Resident #3634. This order was not countersigned by the attending physician.

2. Medical Record #36 contained the following orders:

a. 1/9/12, no time noted - Post Operative Orders (Total Knee Replacement) were authenticated by Resident #3634. This order was not countersigned by the attending physician.

b. 1/10/12 at 05:50 - An order to D/C Patient Controlled Analgesia (PCA) was authenticated by Resident #0680 (unclear). This order was not countersigned by the attending physician.

c. 1/10/12 at 11:30 - An order to Give omeprazole 20 mg po x 1 now was authenticated by Resident #3634. This order was not countersigned by the attending physician.

3. Medical Record #27 contained the following orders:

a. 12/13/11 at 3:00 PM - An order for a consult was authenticated by Resident #3634. This order was not countersigned by the attending physician.

b. 12/13/11 at 3:30 PM - An order for Percocet was authenticated by Resident #3634. This order was not countersigned by the attending physician.

c. 12/14/11 at 10:00 AM - An order for Dilaudid was authenticated by Resident #3634. This order was not countersigned by the attending physician.

Based on staff interview and document review, it was determined that the facility failed to administer enteral feedings as per physicians order.

Findings include:

Reference #1: The Enteral Feeding Administration and Management Policy states: "Enteral feedings will be administered to patients with a written physician order and managed as per the guidelines specified by the nutrition support team...Hang closed system formula container....Set rate on enteral feeding pump as per physicians order."

Reference #2: The Enteral Formulary Policy states: "Tube feeding must be ordered by a physician. If a TF product is ordered that is not on the formulary, an appropriate substitute will be made until order clarification can be made. An approved substitution list is used."

1. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and Staff #22, the Physician's Order Sheet was observed to contain the following diet order:

a. "Diet: Glucerna 1.5 at 70cc per hour." It was signed and dated 2/8/12 at 1:23 PM.

b. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and Staff #22, the Dietitian's "Nutrition Assessment" note dated 2/9/12 documented the patient's diet as "Glucerna 1.5 at 70cc per hour (non formulary)... Change to Glucerna 1.2 at 55 ml/hr." The Progress Notes section contained a "Nutrition (consult) Initial assessment. Recommend change feed to Glucerna 1.2 at 55ml/hr. This was dated 2/9/12 and signed by the dietitian.

c. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and Staff #22, the "Critical Care Nurse's Notes" documented the feedings as "Glucerna 1.5" on 2/8/12 and 2/9/12, as "Jevity" on 2/10/12, and as "Glucerna" on 2/11/12.

i. Staff #16 stated that "Glucerna 1.5" is not on the enteral nutrition formulary and is not available in the facility. Staff #16 stated that the approved substitute is Glucerna 1.2 and this is the feeding that was provided for the patient.

ii. Staff #16 and Staff #22 were asked to provide a copy of the diet order for administering the Glucerna 1.2 feeding at a rate of 75cc per hour. Staff #16 and Staff #22 could not locate a physician order to administer Glucerna 1.2 at a rate of 75cc per hour.

d. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and Staff #22, the "Daily Nursing Care Record," dated 2/12/12, did not list the type of enteral feeding. The "Daily Nursing Care Record" dated 2/13/12 documented "Glucerna 75/hr PEG." The Intake sheets for 2/12/12 and 2/13/12 documented that an enteral PEG feeding ran at 75 cc/hr.

i. The feeding was not given according to the physicians order of 70cc per hour.

e. On 2/14/12 at 11:15 AM, in the presence of Staff #16 and Staff
#22, Patient #23 was observed to have "Glucerna 1.2" as the enteral feeding. Staff #30 stated that the feeding was on hold, and that the PEG "dislodged about 20 minutes ago." During the interview he/she stated that the feeding was running at 75cc/hr.

i. Staff #30 was asked to provide a copy of the diet order for administering the Glucerna 1.2 feeding at a rate of 75cc per hour. Staff #30 stated that this is the diet written in the Kardex, but he/she could not locate an actual physician order to administer Glucerna 1.2 at a rate of 75cc per hour. Refer to Reference #2.

f. The above was confirmed by Staff #16 and Staff #22 on 2/14/12 at 11:30 AM.

Based on observation, document review and staff interview conducted on 2/13/12, 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 "Medications, Administration Procedure by Nurse Personnel" states, "Procedure: Administration:..3...All medications should be poured or drawn up at the patient's bedside at the time of administration."

Reference #2: Facility policy titled "Medications, Administration Procedure by Nurse Personnel" states, "Procedure: Administration...6. Administer the medication and record on the MAR [Medication Administration Record]."

Reference #3: Facility policy titled "Medications, Administration Procedure by Nurse Personnel" states, Procedure: Administration...7. Medication should never be left at bedside..."

1. Staff #13 was observed preparing and administering medications to Patient #8 on 2/13/12 at 10:45AM. The following practices were observed:

a. Mepron liquid, Ferrous Sulfate 325mg tablet, and Folic Acid 1mg tablet were removed from their packaging and placed in cups in the hallway, away from the patient's bedside. This practice is not in compliance with Reference #1.

b. Documentation of administration of the medications were initialed on the MAR by the nurse at the time they were prepared in the hallway, not after they were administered. This practice is not in compliance with Reference #2.

c. A Spiriva inhaler was found at the patient's bedside. This system requires the insertion of a capsule into the inhaler prior to administration. The nurse had inserted the capsule into the inhaler at an earlier time and had left the inhaler on the bedside table for an unknown period of time prior to administration. This practice is not in compliance with Reference
#3.

d. The nurse stated that he/she was not administering Clonidine 0.3mg because the patient's blood pressure was 108/48 and there was a hold order for low blood pressure. The physician's order for Clonidine states, "hold for SBP < 100 [systolic blood pressure less than 100]." The systolic blood pressure was 108. The medication was held, but the parameter to hold the medication was not met.

Based on observation during a tour of the Physical Therapy Gym and staff interview, it was determined that the facility failed to ensure that all equipment was properly maintained.

Findings include:

1. During a tour of the Physical Therapy Gym at 11:00 AM on 2/13/12, in the presence of Staff #8 and #9, the following were noted:

a. In the EMG room, 8 sleeves of patient MRI films were found unsecured on the floor, next to the desk.

b. This finding were confirmed by Staff #8 and #9.

Based on a review of 3 medical records, it was determined that the facility failed to ensure that all orders were dated timed and authenticated promptly.

Findings include:

Reference: Facility Medical Staff Rules and Regulations state: Article VII, Medical Records, 2. ... Inpatient Setting (on page 18) ... All orders including verbal orders in the medical record shall be legibly written, dated, timed, and authenticated.

1. Medical Record #27 contained the following orders:

a. A 12/13/11 at 9:56PM telephone order (TO) was not authenticated by the ordering practitioner.

b. A 12/13/11 at 11:35PM TO was authenticated by the ordering practitioner, but the entry was not dated or timed.

c. A 12/14/11 at 13:15 Post Anesthesia Order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

d. A 12/14/11 at 13:20 Patient Controlled Analgesia (PCA) order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

e. A 12/14/11 at 15:20 TO was authenticated by the ordering practitioner, but the entry was not dated or timed.

f. A 12/16/11, no time noted, TO for a stat x-ray was authenticated by the ordering practitioner, but the entry was not dated or timed.

2. Medical Record #36 contained the following orders:

a. A 1/19/12 at 16:00 Post Anesthesia Order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

b. A 1/19/12 at 16:00 Patient Controlled Analgesia (PCA) order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

c. A 1/9/12, no time noted, Post Operative (Total Knee Replacement) order was authenticated by the ordering practitioner. This order was countersigned by another practitioner but that entry was not dated or timed.

3. Medical Record #37 contained the following orders:

a. A 11/28/11 at 18:30 Patient Controlled Analgesia (PCA) order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

b. A 11/28/11 at 18:30 Post Anesthesia Order was authenticated by the ordering practitioner, but the entry was not a legitimate signature. This order was countersigned by another practitioner but that entry was not dated or timed.

c. A 12/14/11 at 13:15 - 1/9/12, no time noted, Post Operative (Total Hip Replacement) orders were authenticated by the ordering practitioner. This order was countersigned by another practitioner but that entry was not dated or timed.

Based on observation, document review, and staff interview conducted on 2/13/12, it was determined that the facility failed to ensure that medications not ordered for a patient were not found in the patient's medication cassette drawer.

Findings include:

1. The contents of 4 medication cassette drawers were compared with the Medication Administration Record (MAR), physician's orders and the pharmacy profile on 2/13/12 at 1:30PM. The following discrepancies were found:

a. The medication cassette drawer for Patient #9 contained one (1) unit dosed (UD) Coumadin 10mg tablet. An order for Coumadin was not found in the medical record, the MAR, or the pharmacy profile. The patient's admitting diagnosis was "Coumadin toxicity." Upon interview, Staff #3 stated that he/she was unable to determine why there was a Coumadin 10 mg tablet in the patient's medication cassette drawer.

b. The medication cassette drawer for Patient #12 contained one UD Amantadine 100mg capsule, one UD Donepezil 10mg tablet, and one Megestrol 400mg/10ml UD liquid. An order for these medications was not found in the medical record, the MAR, or the pharmacy profile. Upon interview, Staff #3 stated that he/she was unable to determine why these medications were in the patient's medication cassette drawer.

Based on observation during a tour of the Physical Therapy Gym and staff interview, it was determined that the facility failed to ensure that all drugs and biologicals are kept secured.

Findings include:

1. During a tour of the Physical Therapy Gym conducted at 11:00 AM on 2/13/12, in the presence of Staff #8 and #9, the following were noted:

a. In the EMG room, a medication storage box mounted on the wall, was found unlocked with the key in the lock.

b. The box contained four (4) vials of Lidocaine, Two (2) vials of injectable saline, and one (1) vial of Depo-Medrol.

c. No patient care was being provided in this room, at the time of this finding.

d. These findings were confirmed by Staff #8 and #9.

Based on observation, document review and interview, it was determined that the facility failed to provide organized dietary services that maintained at least the minimum standards specified in this section as evidenced by the lack of compliance with the following regulation:

482.28(a)(1) The Food Services Director/"General Manager, Food" failed to ensure daily management of the dietary services.

Based on staff interview, document review, lunch meal observations and a tour of the kitchen, it was determined that the contracted general manager failed to provide daily supervision of the Food and Nutrition Services Department.

Findings include:

Reference #1: The General Manager's position description states:
a. "Directs daily food service operations in order to provide quality products."

b. "Maintains and implements sanitary and food safety conditions and training to adhere to auditing procedures and statutory regulations."

c. "Directs daily food service operations including: menu evaluation and planning, purchasing, inventory, receiving, food preparation and storage."

d. "Maintains kitchen and storage facilities to meet/exceed sanitary conditions; monitors internal quality assurance and food safety audit process (including HACCP record keeping)."

Reference #2: NJAC 8:24-2.1(b) states, "The person in charge shall demonstrate to the health authority knowledge of food borne disease prevention, application of the hazard Analysis Critical control Point (HACCP) principles, and the requirements of this chapter."

Reference #3: NJAC 8:24-2.3(f)8 states, "Food employees shall clean their hands.....before donning gloves for working with foods."

Reference #4: NJAC 8:24-3.3(d) states, "Working containers holding food or food ingredients that are removed from their original packages for use in the retail food establishment, such as cooking oils, flour, herbs...shall be identified with the common name of the food, except that containers holding food that can be readily and unmistakably recognized..."

Reference #5: NJAC 8:24-3.5(f) states, "Potentially hazardous food shall be maintained at refrigeration temperatures (at or below 41°F)...Potentially hazardous food that is cooked to safe cooking temperatures and received hot shall be at a temperature of 135°F or above"

Reference #6: NJAC 8:24-4.2(c) states, "Temperature measuring devices shall be provided."

Reference #7: NJAC 8:24-4.5(c) states, "Surfaces such as cutting blocks and boards that are subject to scratching and scoring shall be resurfaced if they can no longer be effectively cleaned and sanitized, or discarded if they are not capable of being resurfaced."

Reference #8: NJAC 8:24-4.6(c) states, "Non food-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris."

Reference #9: NJAC 8:24-4.7 states, "After being cleaned, equipment food-contact surfaces and utensils shall be sanitized."

Reference #10: NJAC 8:24-6.2(a) states, "The floors, floor coverings, walls, wall coverings and ceilings shall be designed, constructed and installed so that they are smooth and easily cleanable..."

Reference #11: NJAC 8:24-6.5(a) states, "The physical facilities shall be maintained in good repair."

Reference #12: NJAC 8:24-6.5(b) states, "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #13: NJAC 8:24-6.6(h) states, "Toilet facilities, including toilet rooms and fixtures, shall be kept clean and in good repair."

Reference #14: NJAC 8:24-6.7(i) states, "Each hand washing sink or group of two adjacent sinks shall be provided with a supply of hand cleaning liquid, powder, or bar soap."

Reference #15: NJAC 8:24-6.7(j) states, "Each hand washing sink or group of two adjacent sinks shall be provided with the following: Individual disposable towels."

Reference #16: NJAC 8:24-6.7(n) states, "A Hand washing facility shall be maintained so that it is accessible at all times for employee use."

Reference #17: NJAC 8:24-7.2(f) states, "Chemical sanitizers and other chemical antimicrobials applied to food contact surfaces shall meet requirements specified in Tolerance exemptions for active and inert ingredients used in microbial formulations."

Reference #18: NJAC 8:24-8.11(a) states, "Immediately upon completion of the inspection, the health authority shall issue an evaluation placard of the establishment and leave the original copy of the inspection report form with the person in charge...The evaluation placard shall identify that the establishment is one of the following: 1. "Satisfactory": The establishment is found to be operating in substantial compliance with this chapter and food service personnel have demonstrated that they are aware of and are practicing sanitation and food safety principles as outlined in this chapter; 2. "Conditional Satisfactory": At the time of the inspection the establishment was found not to be operating in substantial compliance with this chapter and was in violation of one or more provisions of this chapter..."

Reference #19: The Tray Assessment policy states: "Policy: The food and Nutrition Services Department will conduct tray assessments on a regularly scheduled basis as part of Continuous Quality Improvement. Purpose: To establish procedures that ensure tray accuracy, proper food temperatures and quality food. procedure: Tray assessments will be routinely completed by management personnel, including the Food Service director, Food Service Managers, dietitians and other personnel as assigned....Action plan is developed based on score of test tray and plan is reviewed by management staff for measurable outcomes."

Reference #20: The Patient Services Gold Check audit form states: "Each week a minimum of 3 tray assessments conducted: 1 Breakfast, 1 Lunch, 1 Dinner - corrective actions and trending analysis completed routinely.

Reference #21: The Patient Satisfaction Survey policy states: "Policy: The food & Nutrition Services department will have in place a patient satisfaction survey system to measure the outcomes of all the specific criteria for quality of: food, service and accuracy for various types of diets for the patients....Procedure: The Food and Nutrition department will conduct a survey and report back the results (semi-annually)...Report outcomes to Hospital and District Manager."

1. On 2/13/12 at 10:30 AM, during observation in the main food services kitchen. in the presence of Staff #4 and Staff #17, it was determined that the General Manager failed to ensure compliance with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24, as stated in the General Manager's position Description. Refer to Reference #1.

a. On 2/13/12 at 10:30 AM, during observations in the main food services kitchen, in the presence of Staff #4 and Staff #17, the Annex building main kitchen, food storage areas, dishwasher room and various food preparation areas, were observed to have floors that were in disrepair and not maintained clean. The floor perimeters at wall junctions located under shelving, carts, equipment and tables were observed with rust like substances, food particles, cracks, holes and openings. The floor was not maintained as required in Reference #10 and #11.

b. On 2/13/12 at 10:30 AM, during observation in the main food services kitchen mechanical ware washing room, in the presence of Staff #4 and Staff #17, the dishwasher room ceiling tile grid appeared to have red and brown rust-like spots/speckles. The ceiling was not maintained as required in Reference #10 and #11.

c. On 2/13/12 at 11:30 AM, during observation in the main cafeteria in the presence of Staff #4 and Staff #19, the water fountain appeared to have red and brown rust-like residue. The water fountain was not maintained as required in Reference #11 and #12.

d. On 2/13/12 at 12:30 PM, during observations in the St. Mike's Cafe, in the presence Staff #16, the light fixtures hanging over the food service area had a heavy accumulation of dust. The light fixtures were not maintained as required in Reference #12.

e. The above was confirmed by Staff #16 on 2/13/12 at 12:30 PM.

2. On 2/13/12 at 10:30 AM, during interview with Staff #4, the most recent annual New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24," Chapter 24 Sanitation inspection report was requested for review.

a. On 2/13/12 at 11:45 AM, Staff #4 showed a Chapter 24 Sanitation inspection report dated,11/10/09. Staff #4 stated that the facility was not inspected annually by the local health department.

b. On 2/13/12, this surveyor requested that the NJDHSS (New Jersey Department of Health and Senior Services) Consumer and Environmental Health Services Division conduct a Chapter 24 inspection. The Chapter 24 Sanitation inspection was completed on 02/15/12.

c. On 02/15/12, the requested Chapter 24 Sanitation inspection was completed by the Department of Health & Human Services (Food & Drug Bureau) Newark, NJ." The facility was issued a "Conditional Satisfactory" evaluation. Refer to Reference #18.

i. The General Manager failed to ensure compliance with the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24."

d. The Chapter 24 Sanitation inspection report contained the following citations for St. Mike's Cafe:

i. "2.3(f) One food worker was observed to put on single use gloves without first washing hands before preparing food." Refer to Reference #3.

ii. "6.7(n) Hand wash facilities were observed to be used for storing personal items (purse." Refer to Reference #16.

iii. "3.5(f) Potential hazardous foods were not maintained at 135°F or above as evidenced by the observation of: chicken wings at 110°F and Beef Empanadas at 120°F." Refer to in Reference #5.

iv. "4.5 White cutting board (Continental Salad bar) observed to be in a very poor state of repair." Refer to Reference #7.

vi. "4.2 Warmer was not provided with thermometer." Refer to Reference #6.

e. The Chapter 24 Sanitation inspection report contained the following citations for the Main Kitchen:

i. "3.3(d) Food items were not labeled with common name." Refer to Reference #4.

ii. "7.2(f) Sanitizer solution concentration (QAC) too high 400 PPM." Refer to Reference #17.

iii. "6.5(b) Observed black spots on the walls in the dishwasher room." Refer to Reference #12.

iv. "6.5(b) Observed dust on the fan in the dishwasher room." Refer to Reference #12.

f. The Chapter 24 Sanitation inspection report contained the following citations for the Main Cafeteria:

i. "6.7(i) and 6.7(j) Employee hand wash sink was not equipped with soap or paper towels." Refer to Reference #14 and Reference #15.

ii. "6.5(b) Walls next to the grill observed unclean." Refer to Reference #12.

iii. "6.6(h) partitions in the women's restroom observed to be rusty." Refer to Reference #13.

3. On 2/13/12 at 12:15 PM, in the presence of Staff #16 several expired nutrition supplements were observed stored in the patient unit pantries.

a. The A-3 Pantry contained one Vivonex RTF tube feeding with a 12/6/11 expiration date.

b. The CCR Pantry contained three packets of GlutaSolve with a 2/4/12 expiration date.

c. The above was confirmed by Staff #16 on 2/13/12 at 12:30 PM.

4. On 2/13/12 at 11:15 AM, Staff #4 and Staff #16 were asked to provide for review, the Food and Nutrition Department Quality Assurance Plan, including test tray audits.

a. On 2/13/12 at 2:10 PM, Staff #16 and Staff #18 stated that the tray assessments are not completed on a regularly scheduled basis.

i. The General Manager failed to ensure compliance with the Tray Assessment policy and Gold Check audit procedure. Refer to Reference #19 and Reference #20.

b. On 2/13/12 at 2:10 PM, six (6) Gold check audits completed between September 15, 2010 and January 17, 2012 were reviewed with Staff #16 and Staff #18. Six of six Gold check audits indicated that the tray assessments were not completed.

c. On 2/13/12 at 2:10 PM, five (5) of six (6) Gold check audits did not contain a specific action plan developed for implementation and further evaluation of services.

d. One Gold Check audit dated May 2011 contained a non specific action plan stating "Action required: All managers must complete tray assessments. 1 breakfast,1 Lunch,1 Dinner. A minimum of 12 to 15 per month." The Person Responsible section contained "The entire Management Staff." A specific person responsible was not indicated.

e. On 2/13/12 at 2:10 PM, Staff #16 and #18 provided thirteen (13) lunch tray assessments, completed for October 2011, November 2011, December 2011 and January 2012, for review.

i. The Tray Assessments were not completed weekly for breakfast, lunch and dinner.

ii. Twelve (12) of thirteen (13) tray assessments completed with dates between 10/13/11 to 1/18/12, were rated unsatisfactory and did not contain a corrective action plan.

f. The above was confirmed by Staff #16 on 2/13/12 at 2:30 PM.

5. On 2/13/12 at 11:15 AM, Staff #4 and #16 were asked to provide for review, the Food and Nutrition Department Quality Assurance Plan, including patient satisfaction surveys.

a. On 2/13/12 at 2:15 PM, Staff #16 stated that patient satisfaction surveys are not completed on a semi-annual basis.

i. The General Manager failed to ensure compliance with the Patient Satisfaction Survey policy. Refer to Reference #21.

b. On 2/13/12 at 2:10 PM, the February 2011 and April 2011 patient satisfaction surveys were reviewed with Staff #16 and Staff #18.

c. The patient satisfaction surveys were not completed semi-annually for the 2011 year as required by the facility policy and procedure. Refer to Reference #21.

d. The above was confirmed by Staff #16 on 2/13/12 at 2:30 PM.

Based on staff interview and document review, it was determined that the facility failed to administer enteral feedings as per physician's order.

Findings include:

Reference #1: The Enteral Feeding Administration and Management Policy states: "Enteral feedings will be administered to patients with a written physician order and managed as per the guidelines specified by the nutrition support team...Hang closed system formula container....Set rate on enteral feeding pump as per physicians order."

Reference #2: The Enteral Formulary Policy states: "Tube feeding must be ordered by a physician. If a TF product is ordered that is not on the formulary, an appropriate substitute will be made until order clarification can be made. An approved substitution list is used."

1. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and #22, the Physician's Order Sheet was observed to contain the following diet order:

i. "Diet: Glucerna 1.5 at 70cc per hour" that was signed and dated 2/8/12 at 1:23 PM.

a. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and Staff #22, the Dietitian's "Nutrition Assessment" note dated 2/9/12 documented the patient's diet as "Glucerna 1.5 @ 70cc per hour (non formulary)...Change to Glucerna 1.2 @ 55 ml/hr." The Progress Notes section contained a "Nutrition (consult) Initial assessment under nutrition tab. Recommend change feed to Glucerna 1.2 @ 55ml/hr," dated 2/9/12 and signed by the dietitian.

b. On 2/14/12 at 10:45 AM, during review of Medical Record #23, in the presence of Staff #16 and #22, the "Critical Care Nurse's Notes" documented the feedings as "Glucerna 1.5" on 2/8/12 and 2/9/12, as "Jevity" on 2/10/12, and as "Glucerna" on 2/11/12. Refer to Reference #2.

i. Staff #16 stated that "Glucerna 1.5" is not on the enteral nutrition formulary and is not available in the facility. Staff #16 stated that the approved substitute is Glucerna 1.2 and this is the feeding that was provided for the patient.

ii. Staff #16 and #22 were asked to provide a copy of the diet order for administering the Glucerna 1.2 feeding at a rate of 75cc per hour. Staff #16 and #22 could not find a physician order to administer Glucerna 1.2 at a rate of 75cc per hour.

c. On 2/14/12 at 10:45 AM, during a review of Medical Record #23, in the presence of Staff #16 and #22, the "Daily Nursing Care Record" dated 2/12/12 did not list the type of enteral feeding. The "Daily Nursing Care Record," dated 2/13/12, indicated "Glucerna 75/hr PEG." The Intake sheets for 2/12/12 and 2/13/12 indicated that an enteral PEG feeding ran at 75 cc/hr.

i. The feeding was not given according to the physicians order of 70cc per hour. Refer to Reference #1.

d. On 2/14/12 at 11:15 AM, in the presence of Staff #16 and #22, Patient #23 was observed to have "Glucerna 1.2" as the enteral feeding. Staff #30 stated that the feeding was on hold, as the PEG "dislodged about 20 minutes ago." During the interview he/she stated that the feeding was given at 75cc/hr prior to the PEG dislodging.

i. Staff #30 was asked to provide a copy of the diet order for administering the Glucerna 1.2 feeding at a rate of 75cc per hour. Staff #30 stated that this is the diet written in the Kardex, but he/she can not find the actual physician order to administer Glucerna 1.2 at a rate of 75cc per hour. Refer to Reference #2.

e. The above was confirmed by Staff #16 and Staff #22 on 2/14/12 at 11:30 AM.

Based on observation, it was determined that the facility failed to comply with the Life Safety Code concerning exit way requirements.

Findings include:

1. On 2/1/12 at 10:30 AM, in the presence of Staff #1, in the 6th floor 'D' building south exit, the exit stair entry was not lit.

2. On 2/1/12 at 10:30 AM, in the presence of Staff #1, in the 6th floor 'D' building south exit, a cart blocked the exit stair entry.

3. On 2/1/12 at 11:05 AM, in the presence of Staff #1, in the 2nd floor 'C' building corridor, there was no exit sign.

4. On 2/1/12 at 11:25 AM, in the presence of Staff #1, in the 3rd floor 'C' building clinic, the north exit sign was not lit.

Based on observation, staff interview, review of facility policies and procedures and review of equipment manufacturer's recommendations, it was determined that the facility failed to ensure that equipment are maintained to an acceptable level of safety and quality.
Findings include:

Reference #1: N.J.A.C Title 8 Chapter 43G Hospital Licensing Standards section 8.1(e)2 states: "Methods for processing reusable medical devices shall conform with Association for the Advancement of Medical Instrumentation (AAMI) ST79:2006 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities (ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009)."

Reference #2: AAMI ST 79 section 3.3.6.6 on 'Relative Humidity' states: "Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area where the relative humidity should not exceed 70%. An independent humidity monitor should be located in each area that requires controlled relative humidity. Relative humidity should be recorded daily.

1. On 2/15/12, when Staff #26 was questioned regarding the relative humidity monitoring requirement, he/she stated that maintenance department is responsible for taking daily humidity in each room. The Maintenance Director stated that only the operating rooms' relative humidity are controlled and monitored.

Reference #3: AAMI ST 79 section 3.3.7.3 on 'Sterilization area' states: "Preferably, sterilizers should be located in a restricted access area. Sterilizers should not be located in high traffic areas or near any potential sources of contamination, such as scrub sinks, clinical sinks or hoppers, wash sinks or containers for the disposal of linen and trash."

2. On 2/15/12, Cidex OPA chemical, which is used as a high level disinfectant, was observed stored in a plastic container located under an enclosed ventilation hood located in substerile Room #5 where instruments are exposed to flash sterilization. Staff # 31 stated that 'TEE transducer tips' and laryngeal masks undergo pre-cleaning and high level disinfection in substerile Room #5.

Reference #4: AAMI ST 79 section 4.5.3 on 'Sterilization area(flash sterilization)' states, "personnel working in areas where items are flash sterilized should wear a liquid resistant face mask. Other protective and/or sterile attire might also be necessary depending on the method by which items are transferred from the sterilizer to the point of use."

3. On 2/15/12, based on interview with Staff #26, it was determined that 'Riley Flashpaks' are utilized during flash sterilization in the OR suites. OR policies and procedures have not been developed regarding proper handling, transport and attire requirements for flash sterilized items, for immediate use.

Reference #5: AAMI ST 79 section 7.2.2 on 'Manufacturer's instructions' state: "The written recommendations of the device manufacturer should always be followed."

4. On 2/15/12 at 12:30PM, a total of six (6) 'Laryngeal Mask Company Limited' Laryngeal masks were observed stored in the anesthesia workroom. The manufacturer of the 'Laryngeal Mask Company Limited' recommends "the masks are to be used a maximum of 40 times before being discarded. Continued use beyond the maximum times is not recommended as degradation of the components may result in impaired performance or abrupt failure of the device. Steam autoclave is the only method for sterilization." Staff #31 stated that he/she does not keep track of the number of usage for all reusable laryngeal masks. Staff #31 also stated that the reusable laryngeal masks are washed with soap and water and soaked at the 'Cidex OPA' solution station located in OR substerile Room #5.

5. On 2/15/12 at 12:30PM, over 10 laryngoscope blades were being stored unlabelled in open and unprocessed peel packages. The care and maintenance instructions for 'Rusch' laryngoscope blades state, "Immediately after use, blades should be rinsed in clean tap water to remove any residue. The blades should then be gently scrubbed in soapy water with a soft brush to provide a thorough physical cleaning. After cleaning, thoroughly rinse the blade and dry thoroughly using a soft towel." Upon request, Staff #31 was not able to provide any evidence to ensure that the blades have undergone proper decontamination and sterilization.

6. The manufacturer of '3M Attest 1291 Rapid Readout Biological Indicators(RRBI)' states: "Incubate the positive control and sterilized Attest 1291 RRBI for 1 hour." The final negative RRBI reading is based on review of biological monitoring records for the month of January 2012, it was determined that the facility does not record the actual time the RRBI's were placed in the incubator and when the final results were made to ensure that the final RRBI reading is made after one (1) hour.

Reference #6: AAMI ST 79 section 11.2.4. states: "Procedures for flash sterilization should be based on a documented quality process that measures objective performance data."

Reference #7: CDC's Guideline for Prevention of Surgical site Infection, 1999, section C. Recommendations, Intraoperative d.2' states "Do not flash sterilize for reasons of convenience, as an alternative to purchasing additional sets, or to save time."
7. Review of OR flash sterilization records for the month of December 2011 and interview with Staff #26 revealed that the facility does not document the reasons as to why instruments are flash sterilized.

Reference #8: N.J.A.C. 8:43G-30.1 Scope of renal dialysis standards state: "These standards shall apply to both hemodialysis and peritoneal dialysis units. In addition to the rules of this subchapter, hospitals providing inpatient renal dialysis services or an on-site, separate designated unit or service for ambulatory patients shall also comply with N.J.A.C. 8:43A-24 in accordance with N.J.A.C. 8:43G-30.3 and 30.4."

Reference #9: N.J.A.C. 8:43A-24.11 on 'Supplies and Equipment' states, "All equipment that is present in the facility shall be functional and maintained in operational condition and in sufficient numbers to adequately service all patients."

Reference #10: Fresenius' policy #FMS-CS-IS-I520-005A on 'Cannulation Site Selection and Skin Preparation' states, "Follow the steps below to select site for cannulation: 1. Wash hands and don PPE to remove bacteria and provide protection."

8. On 2/13/12 at 11:30AM, Staff #25 was observed dialyzing a patient in the Critical Care Unit. The portable Reverse Osmosis machine was hooked up directly to the handwashing sink to provide treated water to the dialysis machine, making the handwashing sink inaccessible during patient treatment.

Based on observation during tours of patient care areas and staff interview, it was determined that the facility failed to ensure that all equipment was properly maintained.

Findings include:

1. During a tour of the Physical Therapy Gym conducted at 11:00 AM on 2/13/12, in the presence of Staff #8 and #9, the following were noted:

a. The EMG machine in the EMG room, was found soiled with dust, tape, and tape residue.

b. The upper extremity bicycle, in the main gym, was found with a large amount of dust and debris on the base of the machine.

c. These findings were confirmed by Staff #8 and #9.


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2. A tour was conducted at approximately 10:00 AM on 2/15/12, of the Psychiatric In-Patient Unit, 4 West. It was observed that both top cabinet doors were coming off the hinges in the medication room.

a. Staff #27 and #28 confirmed the findings.

A. Based on observation and review of facility policies and procedures, it was determined that the facility failed to ensure the implementation of policies and procedures addressing hand hygiene.

Findings include:

Reference #1: Facility policy titled "Hand Hygiene," under Procedure states, "When to clean hands: All students, staff and faculty having direct patient care will clean hands at the following times:...Before and after patient contact, including dry skin contact; After removing gloves..."

1. On 2/13/12 at 10:55AM, during a medication pass observation, Staff #13 was observed putting on gloves without first performing hand hygiene prior to having direct patient contact.

2. On 2/13/12 at 10:58AM, during a medication pass observation, Staff #13 was observed removing gloves and not performing hand hygiene after removing the gloves.


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B. Based on document review and staff interview, it was determined that the facility failed to follow their policy for "Management of Loaner Instruments and Implants for Specialty Operative Procedures."

Findings Include:

Reference: #2: Facility policy titled, "Management of Loaner Instruments and Implants for Specialty Operative Procedures," states that a count sheet from the manufacturer should be supplied with all loaner instrument sets prior to processing.

1. On 2-13-12, at 11:00 AM Staff #5, stated that loaner instruments sets received from the vendors do not always have a count sheet present from the manufacturer.

C. Based on document review, it was determined that the facility failed to provide written documentation for the selection of nationally recognized infection control guidelines (AMMI ST 79).

Findings include:

Reference #3: " The Association for the Advancement of Medical Instrumentation (AMMI) requirements, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, " AAMI ST79. (ST79 replaces and supersedes ST 46 with 4 other AMMI standards, ST33, ST42, and ST35) Section (1.1) States, this recommended practice provides guidelines for decontamination and steam sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment.

1. On 2/15/12 at 11:15 AM, review of infection control policies failed to reveal written documentation for the selection of nationally recognized infection control guidelines.

D. Based on observation and document review, it was determined that the facility failed to maintain a Sanitary Environment.

Findings Include:

Reference: #4: Policy Titled: "Surgical/Invasive areas and Delivery Rooms- Weekly Cycle Cleaning." States: Damp wipe the overhead light fixtures, ledges, and vents with a wall washer dipped in germicidal solution.

1. On 2/15/12 at 11:30 AM, the vent in the endoscope reprocessing area had an accumulation of dust.


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E. Based on observation and interview, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

1. A tour was conducted at approximately 10:00 AM on 2/15/12, of the Psychiatric In-Patient Unit, 4 West. It was observed that the mattresses in Rooms #435A, #436A and
#438B were cracked, exposing the porous material inside, that can not be properly cleaned.

2. Staff #23 was observed applying a sheet over one of the damaged mattress.

3. Staff #27 & #28 confirmed the above.

Based on staff interview, document review, a tour of the kitchen, and lunch meal observations conducted in the presence of Staff #4 and Staff #16, it was determined that the facility Infection Prevention Committee failed to provide oversight of the Food and Nutrition Department.

Findings include:

Reference #1: The Infection Prevention Committee policy and procedure states, "The Infection Prevention Committee is comprised of representatives from clinical and non-clinical areas throughout the hospital. The committee meets bimonthly to evaluate policies, review current infection control programs, and discuss current infection control concerns. There is a planned agenda for each meeting and minutes are kept ... The committee shares information, including problems, data and relevant recommendation, with Performance Improvement Committee (PIC), Environment of Care Committee (EOC), Nursing Services, Patient Safety Committee, Administration and the Medical Staff ... Membership and Departmental Representation: ... Food and Nutrition."

1. On 2/14/12 at 1:30 PM, the Infection Control Nurse was asked if the Infection Prevention Committee monitors the Food and Nutrition Department for compliance to Infection Control procedures. The Infection Control Nurse stated that the facility does environmental rounds that include the Food and Nutrition Department, but that there is no written documentation of these rounds.

2. On 2/14/12 at 1:30 PM, the Infection Control Nurse was asked to provide a copy of the Infection Prevention Committee continuous quality improvement plan including the regular collecting and analysis of data to help determine the effectiveness of infection control practices in the Food and Nutrition Department. The Infection Control Nurse stated that a quality improvement plan to monitor the effectiveness of infection control practices in the Food and Nutrition Department is not available for review.

a. On 02/15/12, the "Department of Health & Human Services (Food & Drug Bureau) Newark, NJ" completed the New Jersey State Sanitation Code: "Sanitation in Retail Food Establishments and Food and Beverage Vending Machines (Chapter 24)" of the NJ State Sanitary Code NJAC 8:24" inspection. The facility was issued a "Conditional Satisfactory" evaluation. Refer to tag A620.

3. On 2/14/12 at 1:30 PM, the Infection Control Nurse provided the Infection Prevention Committee meeting minutes and attendance sheets form January 26, 2011 to January 25, 2012. The attendance sheets had printed on them, the Food and Nutrition Services General Manager's name. There was no signature on them indicating a representative from the Food and Nutrition Department attended the meetings.

a. The Infection Control Nurse did not know who the Food and Nutrition Services General Manager is. Staff #4 stated that the name on the attendance sheet was that of the previous Food and Nutrition Services General Manager, who left the facility in October 2009. Staff #4 started working as the General Manager at the facility in October 2009.

b. The Infection Control Nurse failed to ensure that Food and Nutrition Services actively participate in the Infection Prevention Committee.

4. The above was confirmed by the Infection Control Nurse on 2/14/12 at 1:30 PM.

Based on review of QAPI data, review of 3 in-patient medical records and staff interview, it was determined that the facility failed to review all QAPI activities of the Case Management/Social Work Department at the hospital wide QA meetings and failed to identify needs in the discharge planning process and determine corrective actions for those needs, as part of the QA process.

Findings include:

1. A tour of unit A-3, revealed the following:

a. A review of Medical Record #41 on 2/14/12, revealed that the patient was admitted on 2/10/12 and the 'Initial Patient Assessment' completed by Case Management was not completed until 2/13/12.

b. A review of Medical Record #41 on 2/14/12, revealed that the patient was admitted on 2/6/12 and the 'Initial Patient Assessment' was not completed until 2/10/12.

c. A review of Medical Record #43 on 2/14/12, revealed that the patient was admitted on 2/9/12 and was being discharge on 2/14/12. There was no evidence that the 'Initial Patient Assessment' had not been completed.

d. Staff #31 stated during interview on 2/14/12, that the Discharge/Case Management Department does not collect data on the effectiveness and timeliness of the discharge planning to determine corrective actions.

e. The above findings were confirmed with Staff #29 on 2/14/12.