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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 482.21 QAPI
CFR 482.25 Pharmaceutical Services
CFR 482.30 Utilization Review

Based on document review and staff interview, it was determined that the facility failed to ensure that the "Informed Consent for Surgery/Procedure" policy was implemented regarding telephone consents.

Findings include:

Reference: Facility policy titled, "Informed Consent for Surgery/Procedure" states, "Policy: ... Telephone Consent: If verbal or telephone consent is obtained for either an adult or minor patients, it must be witnessed by two hospital personnel and documented in the medical record ... Additionally, when this procedure is used, the written consent must be received shortly thereafter and a copy placed in the medical record ..."

1. Review of Medical Record #2 indicates that this patient underwent a procedure/treatment on 12/20/13, 12/29/13 and 1/2/14. The consents for these procedures/treatments were obtained via telephone.

a. There was no evidence that a copy of the written consents for the procedures/treatment done on 12/20/13, 12/29/13 and 1/2/14 were present in the medical record.

b. The above was confirmed by Staff #6.

2. Review of Medical Record #32 indicated that this patient underwent a procedure/treatment on 6/24/13, and two on 6/25/13. The consents for these procedures/treatments were obtained via telephone.

a. There was no evidence that a copy of the written consents for the procedures/treatments done on 6/24/13 and 6/25/13 were present in the medical record.

b. The above was confirmed by Staff #22.

Based on document review and staff interview, it was determined that the facility failed to ensure that the Restraints policy addressed chemical restraints.

Findings include:

1. The "Restraint -Guidelines for Use" policy failed to address chemical restraints.

2. This was confirmed by Staff #1 on 1/8/14.

Based on review of facility documentation and staff interview, it was determined that the facility failed to maintain an effective, ongoing, quality assessment and performance improvement program.

Findings include:

1. The facility failed to conduct performance improvement activities that continually track adverse patient events, analyzes causes, and implements preventive actions and mechanisms, throughout the hospital, to ensure patient safety. Refer to Tags 0273, 0283, 0286, and 0297.

A. Based on staff interview and document review, it was determined that the facility failed to measure, analyze, track and monitor the dietary services quality improvement program.

Findings include:

Reference #1: The Quality Improvement policy states: "Purpose: To help identify and measure nutritional related issues to determine nutrition status of hospitalized patients. To assist in evaluating performance of Dietary staff, assist management in measure staffing effectiveness, to communicate nutritional activities with administration (To compile statistics to benchmark staffing requirements and productivity.) Procedure Monthly data will be collected and analyzed in the following areas: Clinical Productivity, Hostess rounding, Test Trays Patient Rounding."

1. On 1/7/14 and 1/8/14, Staff #37 could not provide evidence of a quality assurance plan for 2013 and 2014, including problem identification, collecting, monitoring and analyzing data, recommending, implementing and monitoring corrective actions for measurable improvement for dietary services.

2. On 1/8/14 Staff #37 provided for review, a document titled "Food and Nutrition Compliance Grid, a listing of the state licensing standards for dietary services". This document did not contain indicators, data collection, analysis or monitoring for corrective actions for a quality improvement plan.

3. On 1/8/14 Staff #37 provided for review a document titled "Performance Measurement Plan and Findings, Year 2012" for "Temperature of Food Indicator." The benchmark indicator was documented as 80.

a. The 2012 Quarterly mean scores documented for the first quarter were 86.4.

b. The 2012 Quarterly mean scores documented for the second quarter were 86.46.

c. The 2012 Quarterly mean scores documented for the third quarter were 82.6.

d. The 2012 Quarterly mean scores documented for the fourth quarter were 77.7.

e. The 2013 monthly mean scores documented for January were 77.1; February 87.5; March 79.6; April is 77.5; May 77.9; June 80.2.

i. Four of the six monthly scores reported in 2013 were below the facility benchmark of 80.

ii. Staff #37 did not provide evidence of action plans to analyze the collected data and recommend, implement and monitor corrective actions for improvement.

f. On 1/7/14 at 10:50 AM, Staff #37 stated that the food temperatures were improved and it was decided to discontinue this monitor as of June 2013.

4. The above findings were confirmed by Staff #1 on 1/08/2014 at 3:15 PM.


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B. Based on a review of facility documentation and staff interview, it was determined that the facility failed to ensure that quality indicators were measured, analyzed, and tracked.

Findings include:

1. Review of the facility's 2013 "Quality Dashboard," conducted at approximately 9:45 AM on 1/8/14 in the presence of Staff #36, revealed the following:

a. Case Management had the following indicators for which there was no evidence that data was submitted in 2013: AMI (Acute Myocardial Infarction) re-admissions within 30 days, pneumonia re-admissions within 30 days, and heart failure re-admissions within 30 days.

b. Pharmacy had the following indicators for which there was no evidence that data was submitted in 2013: ADR's (adverse drug reactions), pharmacy interventions accepted, and narcotics discrepancies - unresolved.

c. HIM (Health Information Management) had the following indicators for which there was no evidence that data was submitted in 2013: Delinquency rate: % records incomplete within 30 days, H&P (History and Physical) on in-patient chart within 24 hours, H&P within 30 days of surgery and reviewed prior to the procedure, telephone orders signed within 24 hours, written orders timed, dated, and signed, OP (operative) reports dictated within 24 hours, OP note done immediately following surgery, D/C (discharge) summary documented, suspensions, number of patients transferred for services not provided by hospital/higher level of care.

d. The following categories on the "Quality Dashboard 2013" were found to be missing data:

i. Acute myocardial infarction had no data recorded from July 2013 to December 2013.

ii. Pneumonia had no data recorded from July 2013 to December 2013.

iii. Heart failure had no data recorded from July 2013 to December 2013.

iv. Surgical Care Improvement Project had no data recorded from July 2013 to December 2013.

v. Stroke had no data recorded from July 2013 to December 2013.

vi. Venous Thromboembolism had no data recorded from July 2013 to December 2013.

vii. Global Immunization had no data recorded from July 2013 to December 2013.

viii. Case Management had no data recorded from November 2013 to December 2013.

ix. Mortality Review had no data recorded from October 2013 to December 2013.

x. Infection Prevention had no data recorded from October 2013 to December 2013.

xi. Risk Management had no data recorded from July 2013 to December 2013.

xii. Patient Satisfaction had no data recorded from June 2013 to December 2013.

xiii. Press Ganey In-patient had no data recorded from July 2013 to December 2013.

ixx. Press Ganey Emergency had no data recorded from July 2013 to December 2013.

xx. Press Ganey Ambulatory had no data recorded from July 2013 to December 2013.

xxi. HCAHPS had no data recorded from July 2013 to December 2013.

xxi. Patient Volumes had no data recorded from July 2013 to December 2013.

2. These findings were confirmed by Staff # 36.

Based on review of facility documents and staff interview, it was determined that the facility failed to ensure that data collected was used to identify opportunities for improvement and changes that will lead to improvement.

Findings include:

1. Review of the facility's 2013 "Quality Dashboard," conducted at approximately 9:45 AM on 1/8/14 in the presence of Staff #36, revealed the following:

a. Emergency Department indicators were as follows: number of ED (Emergency Department) transfers; number of patients leaving AMA (against medical advice); number of patients left prior to triage; number of patients left before being seen by a physician; number of patients return to ED within 72 hours.

i. There was no evidence that the data collected on these indicators was used to identify opportunities for improvement.

b. "Codes" contained the following indicators: number of true code blues and number of rapid response calls.

i. There was no evidence that the data collected on these indicators was used to identify opportunities for improvement.

c. These findings were confirmed by Staff # 36.

Based on review of facility documentation and staff interview, it was determined that the facility failed to ensure that medical errors and/or adverse patient events were measured, analyzed, and tracked.

Findings include:

1. Review of the facility's 2013 "Quality Dashboard," conducted at approximately 9:45 AM on 1/8/14 in the presence of Staff #36, revealed the following:

a. There was no data available on medical errors for the year of 2013.

b. There was no data available on adverse patient events for the year of 2013.

c. There was no evidence that the facility was collecting data, analyzing, and/or tracking medical errors or adverse patient events.

2. These findings were confirmed by Staff #36.

Based on review of facility documentation and staff interview, it was determined that the facility failed to document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.

Findings include:

1. On 1/8/14, Staff #5 was interviewed regarding Performance Improvement projects being conducted in the Emergency Department. He/She presented two documents titled "Quality/Performance Indicators."

a. The first document was measuring "tracking the time period duration of lab procedures."

i. All of the data was entered in July 2013.

ii. There was no evidence that the data was used to improve processes.

b. The second document was measuring "applying correct ID bands to patients."

i. All of the data was entered in August 2013.

ii. There was no evidence that the data was used to improve processes.

c. Staff #5 stated that they were comprehensive projects that involved reviews of every patient for the month indicated.

i. There was no ongoing study of the information provided in the documents.

d. These findings were confirmed by Staff #5 and Staff #36.

Based on medical record review and staff interview, it was determined that the facility failed to ensure that the "One to One (Sitter) Observation" policy regarding physician orders was implemented in one of one medical records (#33) reviewed.

Findings include:

Reference: Facility policy titled, "One to One (Sitter) Observation" stated, "... Initiation of 1:1 Observation: ... 3. One to one observation orders must be reviewed and renewed every 24 hours. 4. The Registered Nurse must inform the Physician or Licensed Independent Practitioner (LIP) when the patient's clinical status is such that one to one observation is no longer needed and the physician must write an order to discontinue the one to one observation. The RN [registered nurse] is not to discontinue one to one observation unless ordered by a physician or LIP. 5. Documentation for patient's on one to one observation must be done every shift ..."

1. A physician order dated 8/16/13 at 08:27 in Medical Record #33 stated, "Needs 1 to 1 observation please." The patient was maintained on 1:1 observation for safety according to the nurse's documentation from 8/16/13 at 08:30 until 9/5/13 07:00.

a. There was no evidence in the medical record that the order was renewed by the physician every 24 hours since 8/16/13. There was no evidence in the medical record that the order was discontinued.

2. The above was confirmed by Staff #1.

A. Based on staff interview and document review, it was determined that the facility failed to ensure that nurses practice in accordance with the New Jersey Nurse Practice Act.

Findings include:

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

1. Medical Record #31 contained orders, dated 1/5/2014, for "Oxycodone HCL 5 mg. [milligram]/APAP 325 mg. Tab [tablet] UD [unit dose] 1 Tablet PO [by mouth] Q4H [every four hours] PRN [as needed]; Morphine Sulfate Inj [injectable] 2 mg/1 ml [milliliter] IV [intravenous] Q3H [every 3 hours] PRN; Acetaminophen Tab 650mg PO Q6H PRN.

a. The above medication orders do not contain an indication for use. Although the above medications are used for pain management, the orders are not clear as to which medication to administer first, leaving the decision to the nurse. This is not in compliance with the Nurse Practice Act referenced above.

2. Medical Record #18 contained orders dated 1/6/14, for "Ibuprofen Tab 600mg PO Q6H PRN, Acetaminophen Tab 650mg PO Q6H PRN, Oxycodone HCL 5mg/APAP 325mg Tab UD 1 Tablet PO Q4H PRN." Review of the medication administration record indicated that the patient received Ibuprofen 600 mg and Oxycodone HCL 5 mg/APAP 325 mg on 1/8/14 for pain. This was confirmed by Staff #47.

a. The above medication orders do not include an indication for use. Although the above medications are used for pain management, the orders are not clear as to which medication to administer first, leaving the decision to the nurse. This is not in compliance with the Nurse Practice Act referenced above.

3. The above was confirmed by Staff #6.


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B. Based on review of medical records and facility policies and procedures, and staff interview, it was determined that the facility failed to ensure that the Respiratory Care MAR (Medication Administration Record) was completed in accordance with facility policy.

Findings include:

Reference 1. Facility policy titled "Medication Transcription and Documentation" states, "Process/Procedure: 1. RNs (Registered Nurses) are responsible for the transcription and validation of all medication. All medication orders will be verified and signed off by two RNs. Orders must include medication name, dose, route, frequency of medication and date of order. 2. All Computer Physician Order Entry (CPOE) medication orders are verified by the RN, transcribed to the MAR (Medication Administration Record) and initialed by a second RN who has also verified the order...4. All medications are documented with date, time and nurses initials...6. Nurses corresponding signature for initials must be recorded on the lower portion of the medication record. 7. Date of order and discontinuation must be recorded and initialed in designated spaces on medication record..."

Reference 2. Facility guideline titled, "Respiratory Care Medication Documentation" states, "A Nurse can only complete the MAR...If you miss a treatment a valid reason must be documented on both the MAR (use appropriate code) and the respiratory treatment notes...Any blank entries before the time you initial for the first treatment given or after a reorder should be x'd out."

1. On 1/6/14, the Respiratory Therapy MARs for Medical Record #11 and Medical Record #12, on Nursing Unit 3W, were reviewed in the presence of Staff #23 and revealed the following:

a. The physician order in Medical Record #11 states, "Levalbuterol (Xopenex) 1.25mg(milligrams)/3ML (milliliters) INHL (inhalant) Q(every)8H(hour)."

i. The physician order transcribed on the MAR states, "Xopenox[sic] Q 8 h."
The dosage of the medication and the route of administration were not transcribed.

ii. The MAR transcription for this medication contained two different sets of RN initials. There was only one set of RN initials and a corresponding signature recorded on the lower portion of the MAR.

iii. The initial box for the 1/6/14, 12:00 AM dose of Xopenox[sic], was blank. This dose was omitted without a signature and reason for omission.

b. The physician order in Medical Record #12 states, "Albuterol 3/Ipratrop 0.5 mg/3ml (Duoneb). Mix 1 package INHL Q6h ATC (around the clock). Start date/time: 12/30/2013 19:31. Stop date/time: 1/4/2014 24:00."

i. The MAR states that the Duoneb inhalation treatment was administered every 6 hours around the clock from 12/30/13 through 02:00 AM on 1/6/2014. Four inhalation treatments were administered to Patient #12 from 1/5/14 at 08:00 AM through 1/7/14 at 02:00 AM without a valid physician's order.

ii. The route of administration was not transcribed onto the MAR.

iii. There was no evidence on the MAR that this order was transcribed and verified by two RNs.

iv. The MAR did not have the corresponding dates of administration (1/5/14 and 1/6/14) written in the space above the column of initial boxes.

c. The physician order in Medical Record #12, written on 1/6/14 states, "Albuterol 3/Ipratrop 0.5mg/3ml INHL 3ml. Mix 1 package INHL Q8h. Start date/time: 1/6/2014 17:16. Stop date/time: 1/7/2014 17:47."

i. The MAR transcription for this medication contained two sets of RN initials, however, it could not be determined if the initials were from the same RN, or two different RNs.

ii. The route of administration was not transcribed onto the MAR.

iii. The order was transcribed in the PRN (as needed) order section of the MAR, however, the medication was not ordered PRN.

iv. The MAR entry for the 1/7/14, 12:00 AM Duoneb inhalation treatment was blank. This dose was omitted without a signature and reason for omission.

2. The above was confirmed by Staff #1 and Staff #23.

Based on document review and staff interview, it was determined that the facility failed to ensure that medical records were accurate.

Findings include:

1. Review of two closed medical records in the presence of Staff #1 revealed the following:

a. Medical Record #23 revealed that a physician discharge summary dictated on 12/13/13, indicated the patient's date of service was from 12/10/13 through 12/13/13. Upon further review, the content of the discharge summary was not pertinent to this patient.

b. Medical Record #33 revealed that this patient was admitted to the facility on 8/16/13 and discharged on 9/5/13. There was no evidence of an attending daily note/exam for 9/4/13 and 9/5/13. Furthermore, there was no evidence of a psychiatric physician note, as indicated in a nurse note of 9/3/13 which stated the physician was in to see the patient for evaluation.

c. The above was confirmed by Staff #1.

Based on observation, document review and staff interview conducted on 1/8/14 and 1/10/14, it was determined that the facility failed to ensure that pharmaceutical services met the needs of the patient.

Findings include:

1. The facility failed to ensure the development and implementation of policies and procedures addressing drug delivery systems utilized at the facility. Refer to Tag A0491.

2. The facility failed to ensure that the Pharmacy Director routinely evaluated the performance and competency of pharmacy personnel. Refer to Tag A0492.

3. The facility failed to ensure that drugs and biological's were controlled and distributed in accordance with applicable standards of practice. Refer to Tag A0500.

4. The facility failed to ensure that expired medications were not available for patient use. Refer to Tag A0505.

5. Upon request, Staff #31 was unable to provide evidence of a QAPI activities for pharmacy services that was integrated into its hospital-wide QAPI program.

Based on observation and staff interview conducted on 1/8/14, it was determined that the facility failed to ensure that pharmacy services developed and implemented policies and procedures addressing drug delivery systems utilized at the facility.

Findings include:

1. Upon interview, Staff #31 stated that the drug delivery system utilized on Unit 3W consisted of two methods. Many of the drugs were removed by the nurse from the Pyxis drug dispensing device. Drugs not available in the Pyxis were delivered through a 24 hour unit-dose cassette exchange.

a. Upon request, Staff #31 was unable to provide policies and procedures addressing the drug delivery system that had been implemented on Unit 3W.

2. Review of patient medication cassettes on 1/8/10 in Unit 3W revealed numerous discrepancies (Refer to Tag A500). Staff #31 confirmed that many of the "extra" medications found in the medication cassettes were available in the Pyxis drug dispensing device on the unit. Upon request, Staff #31 was unable to provide policies and procedures or evidence of practices that addressed the control and accountability for medications removed from the Pyxis drug dispensing devices.

Based on document review and staff interview conducted on 1/10/14, it was determined that the facility failed to ensure that the Pharmacy Director routinely evaluates the performance and competency of pharmacy personnel.

Findings include:

1. The competency evaluation for Staff #47, a pharmacist, was not dated. It cannot be established when it was completed.

2. Review of competency evaluations for Staff #48, a pharmacist, who has been employed for less than 3 months, revealed that the only competency done was for aseptic compounding technique. Staff #31 confirmed that he/she performed other duties, that had not been evaluated.

3. The competency evaluation for Staff #49, a pharmacist, was not dated. It cannot be established when it was completed.

4. There was no evidence that competency evaluations had been done for Staff #50, a pharmacist, in 2012 or 2013.

5. The competency evaluation for Staff #51, a pharmacist, was not dated. It cannot be established when it was completed.

6. There was no evidence that competency evaluations had been done for Staff #52, a pharmacy intern, hired in July, 2013.

A. Based on observation, document review and staff interview, it was determined that the facility failed to ensure that pharmacy services has oversite and control over the distribution of drugs and biological's.

Findings include:

1. Upon interview, Staff #31 stated that Unit 3W utilized a system of drug distribution that included the nurse removing medications from a Pyxis drug dispensing device. Any medications that were not available from the Pyxis were delivered by the pharmacy between 2:00-3:00 PM. Staff #31 stated that this system had recently been implemented. He/she stated that policies and procedures addressing this "dual" drug delivery system had not been developed.

2. On 1/8/13 at 12:00 Noon, the contents of 3 patient medication cassettes were compared with the medication administration records (MAR) and the physician's orders on Unit 3W. The contents of the cassettes did not reconcile with the physician's orders in the following instances:

a. For Patient #34:

i. There were 8 Senokot in the cassette drawer. The order was for Senokot 2 tablets at bedtime. Administration of 2 tablets was documented on the MAR on 1/7/14 at 10:00 PM. Staff #31 confirmed that there should not be any Senokot in the medication cassette drawer at this time.

ii. There was one unit-dosed (UD) amlodipine 10mg in the cassette. This medication was not on the MAR, nor was there a physician's order for it. This was confirmed by Staff #31.

iii. There was one UD doxazosin 4mg in the cassette. This medication was not on the MAR, nor was there a physician's order for it. This was confirmed by Staff #31.

iv. There was one Lovenox 40mg/0.4ml in the cassette. The medication was on hold. Upon interview, Staff #31 confirmed that this medication was removed from the Pyxis and should not be in the cassette.

v. There was one furosemide 20mg vial in the cassette. This medication was not on the MAR, nor was there a physician's order for it. This was confirmed by Staff #31.

b. For Patient #36:

i. Two (2) UD atorvastatin 40mg were in the cassette. Administration of 2 tablets on 1/7/14 at 10:00PM was recorded on the MAR. Staff #31 confirmed that there should not be any atorvastatin in the cassette at this time.

ii. Four (4) UD ondansetron 4mg were found in the cassette. This medication was not on the MAR, nor was there a physician's order for it. This was confirmed by Staff #31.

iii. One Nicotine Transdermal System 21mg was found in the cassette. This medication was not on the MAR, nor was there a physician's order for it. This was confirmed by Staff #31.

c. The medication cassette drawer for Patient #35 contained a 100ml bag on parenteral 0.9% Sodium Chloride that had been taken out of the overwrap and had a piece of tape with illegible writing on it. It could not be determined if a medication had been added to the bag. Staff #31 was unable to determine why this was in the cassette drawer.

B. Based on observation and staff interview conducted on 1/8/14, it was determined that the facility failed to ensure that the Pyxis drug dispensing devices, used for drug distribution throughout the facility, were properly maintained.

Findings include:

Reference: Facility policy titled "Medication Area Evaluations" states, "Procedure: A. All areas of the Hospital where medications are stored are to be evaluated/surveyed by a Pharmacist of (sic) his/her designee monthly or as required...C. The Pharmacist or designee shall fill out an evaluation report indicating all findings...K. Compliance results shall be trended and monitored when improvement is needed."

1. Review of pharmacy unit inspections reports on 1/10/14 revealed that they have not been done monthly. Examples include, but are not limited to the following areas:

a. Endoscopy Suite was last inspected on 3/19/13.

b. Operating Room (OR) was last inspected on 3/19/13.

c. Anesthesia 1 (Pyxis station) was last inspected on 11/27/12

d. Anesthesia 5 (Pyxis station) was last inspected on 11/27/13.

e. Anesthesia 7 (Pyxis station) and Anesthesia 4 (Pyxis station) were last inspected on 10/19/12.

f. Post Anesthesia Care Unit was last inspected on 4/2/12.

g. The Emergency Department was only inspected on 11/24/13 and 12/19/13 in 2013.

h. Unit 4W (Pediatric Unit) was last inspected on 10/9/12.

i. The Nursery was last inspected on 2/20/12.

j. Labor & Delivery was only inspected on 12/15/13 and 3/28/13 in 2013.

k. Post Partum was only inspected on 12/28/13 in 2013.

l. Intensive Care Unit was only inspected on 12/20/13 in 2013.

m. Unit 3W was only inspected 11/29/13 and 10/25/13 in 2013.

2. Upon review of drawer #6 in the Pyxis drug dispensing device located in the OR Suite, on 1/8/14 at 11:00 AM, the following discrepancies were found:

a. Dextrose 50% was stored in the same pocket as Lidocaine 2%.

b. Sensorcaine 0.5% was stored in the same pocket as Levofloxacin in 5% Dextrose.

c. Mannitol 25% was stored in the same pocket as topical benzocaine.

d. Silvadene cream was stored in the same pocket as Propofol.

e. Dextrose 50% was stored in the same pocket as lidocaine 100mg syringes.

f. Pockets for Vancomycin 500mg, aminophylline 250mg/10ml, Cetacaine topical spray, and Lidocaine 1% preservative free were empty.

3. Review of the Pyxis drug dispensing device on Unit 3 West A revealed that the pocket numbers were missing in 3 of the 6 drawers reviewed.

4. Upon interview, Staff #31 confirmed that each pocket within the Pyxis drug dispensing device should be numbered and have the same medication in it, since the device prompts the user to take the medication needed by pocket number. Mixing medications within the same pocket can increase the risk of medication errors.

5. Review of medication cassettes on Unit 3W on 1/8/14 revealed that each cassette was labeled with a room number. Staff #31 explained that pharmacy sends medications in plastic bags that are labeled with the patient's name. Review of the medication cassette drawers revealed that numerous medications found in the drawers were not in plastic bags that had been labeled by the pharmacy.

6. Upon interview on Unit 3W on 1/10/14, Staff #40 stated that the nurse will remove from the Pyxis drug dispensing device, medications that are needed for his/her medication pass for all the patients and place them in the medication cassettes. He/she would then administer the medications from the cassette. The preparation of patient medication cassette drawers is a dispensing function that should only be performed by pharmacy personnel under the supervision of a pharmacist.

Based on observation, document review and staff interview conducted on 1/8/14, it was determined that the facility failed to ensure implementation of policies and procedures addressing emergency carts.

Findings include:

Reference: Facility policy titled "Code Cart Check" states, "Policy: Each code cart shall be locked at all times. The locking mechanism shall be a numbered snap off lock..." and "Procedure/Process: 1. Each code cart will be checked on a daily basis whenever patients are present on the specific unit...2. On the first of every month, the code cart will be opened and the expiration dates of supplies will be checked and replaced as necessary."

1. The Pediatric Code Drug Box located between the Same Day Stay and the Operating Rooms was locked with a thick plastic strap that could not be easily broken. Scissors were needed to break the strap.

2. Review of the Code Cart Check List on the code cart located in Same Day Stay revealed that the Pediatric Code Cart had not been opened and checked on the 1st of every month.

a. The code cart had not been opened since 9/16/13 (there was a change in lock number at that time). It was not checked on the first of October, November, December 2013 or January 2014.

b. The code cart had not been opened from 4/2/13 until 6/2/13. It was not checked in May 2103.

3. Review of the Code Cart Check on the code cart located between the Same Day Stay and the Operating Rooms indicated that the Adult Code Cart had not been checked between 10/25/13 and 1/5/14.

4. These findings were confirmed by Staff #3.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that outdated medications were not available for patient use.

Findings include:

1. The following expired medications were found in the Operating Room (OR) Pyxis drug dispensing device on 1/8/14 at 11:00 AM:

a. Four (4) vials of diltiazem 50mg/10ml, expiration date 8/1/13.

b. Two (2) vials of diltiazem 50mg/10ml, expiration date 6/13.

c. Two (2) vials of aminophylline 250mg, expiration date 9/1/13.

d. One (1) vial of flumazenil 0.5mg/5ml, expiration date 5/13.

2. The following expired medications were found in the OR #6 Pyxis on 1/8/14 at 11:10AM:

a. Three (3) nifedapine capsules, expiration date 12/13.

b. One (1) ampule of epinephrine 1:10,000, expiration date 11/13.

c. One (1) vial of vecuronium 10mg, expiration date 11/13.

3. The following expired medications were found in the OR #4 Pyxis on 1/8/14 at 11:30AM:

a. One (1) vial of furosemide 100mg/10ml, expiration date 12/13.

b. Three (3) vials of verapamil 5mg/2ml, expiration date 5/1/13.

c. One (1) vial of vecuronium 10mg, expiration date 5/13.

d. Six (6) vials of vecuronium 10mg, expiration date 11/13.

4. These findings were confirmed by Staff #31.

B. Based on observation and staff interview conducted on 1/8/14, it was determined that the facility failed to ensure that the "use by date" is recorded on parenteral medications prepared by the pharmacist.

Findings include:

1. At 12:30 PM, the "use by date" was lacking on the pharmacy label in 8 of 18 parenteral medications.

2. This finding was confirmed by Staff #31.

A. Based on staff interview, document review, a tour of the kitchen, and lunch meal observations, it was determined that the Director of Food and Nutrition Services 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.

Findings include:

Reference #1: The Director of Food and Nutrition Services job description states: "Formulate and implement departmental policies and procedures that ensure all food preparation, food storage and food distribution areas comply with hospital, local, county, state and federal policies and sanitation standards."

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 8:24-4-2(c)2 states: "A temperature measuring device with a suitable small diameter probe that is designed to measure the temperature of thin masses shall be provided and readily accessible to accurately measure the temperature thin foods."

Reference #4: NJAC 8:24-4-2(c)3 states: "Food temperature measuring devices shall be designed to be easily readable and accurate to two degrees Fahrenheit in the intended range of use and shall be calibrated in accordance with manufacturer's specifications as necessary to ensure their accuracy."

Reference #5: NJAC 8:24-6.5(b) states: "The physical facilities shall be cleaned as often as necessary to keep them clean."

Reference #6: NJAC 8:24-6.5(a) states: "The physical facilities shall be maintained in good repair."

1. On 1/7/14, in the presence of Staff #33 and Staff #37, the following deficient practices were observed:

a. Just before the start of the lunch meal trayline at 11:30 AM, Staff #38 and Staff #39 lacked a calibrated small diameter probe thermometer to record the lunch meal food items temperatures. Staff #38 and Staff #39 had a standard tip, un-calibrated thermometer for use. Staff #38 and Staff #39 could not explain or demonstrate the appropriate thermometer calibration technique. Staff #37 stated that if a thermometer is not working correctly, the staff are to dispose of it and get a new one. Refer to Reference #3 and Reference #4.

b. The ware washing area walls and ceiling were not maintained clean. The walls and ceiling had an accumulation of dried food splatter residue on them. Refer to Reference #5 and Reference #6.

2. The above findings were confirmed by Staff #37 on 1/07/14 at 11:55 AM.

B. Based on staff interview and document review, it was determined that the facility failed to ensure that all dietary service policies and procedures were implemented.

Findings include:

Reference #1: The Calibrating Thermometers policy states, "On or about the first of each month, all pocket and/or thermo-couple thermometers will be checked and calibrated according to the manufacturer's directions."

Reference #2: The Temperature Logs policy states, "To provide the highest quality of food and to prevent the growth of undesirable microorganisms and other food spoilage, food temperatures are recorded as per the attached food logs."

Reference #3: The Cooks Temperature Log Note section states, "All hot food items must reach 165 degrees Fahrenheit or above before being placed in trayline's steam table."

1. On 1/7/14, Staff #37 could not provide evidence that thermometers are calibrated on a monthly basis, as required in Reference #1.

2. On 1/7/14, Staff #37 could not provide evidence that the cooks record food temperatures in the "Cook's Temperature Log" before being placed in the trayline's steam table, as required in Reference #2 and Reference #3 .

3. The above findings were confirmed by Staff #37 on 1/07/14 at 11:45 AM.

C. Based on staff interview and document review, it was determined that the dietary services lack a continuous quality improvement program that includes regularly collecting and analyzing data and recommending, implementing and monitoring corrective actions based on this data.

Findings include:

Reference #1: The Quality Improvement policy states, "Purpose: To help identify and measure nutritional related issues to determine nutrition status of hospitalized patients. To assist in evaluating performance of Dietary staff. assist management in measure staffing effectiveness. to communicate nutritional activities with administration (To compile statistics to benchmark staffing requirements and productivity. Procedure Monthly data will be collected and analyzed in the following areas: Clinical Productivity, Hostess rounding, Test Trays Patient Rounding."

1. On 1/7/14 and 1/8/14, Staff #37 could not provide evidence of a dietary services quality assurance plan for 2013 and 2014; including problem identification, collecting, monitoring and analyzing data, recommending, implementing and monitoring corrective actions.

2. On 1/8/14, Staff #37 provided for review a document titled, "Food and Nutrition Compliance Grid, a listing of the state licensing standards for dietary services." This document did not contain indicators, data collection, analysis or monitoring for corrective actions for a quality improvement plan.

3. On 1/8/14, Staff #37 provided for review a document titled "Performance Measurement Plan and Findings, Year 2012" for "Temperature of Food Indicator." The benchmark indicator is documented as 80.

a. The 2012 Quarterly mean scores documented for the first quarter is 86.4.

b. The 2012 Quarterly mean scores documented for the second quarter is 86.46.

c. The 2012 Quarterly mean scores documented for the third quarter is 82.6.

d. The 2012 Quarterly mean scores documented for the fourth quarter is 77.7.

e. The 2013 monthly mean scores documented for January is 77.1; February is 87.5; March is 79.6; April is 77.5; May is 77.9; June is 80.2.

i. Four of the six monthly scores reported in 2013 were below the facility benchmark of 80.

ii. Staff #37 could not provide evidence of action plans to analyze the collected data, recommend, implement and monitor corrective actions.

f. On 1/7/14 at 10:50 AM, Staff #37 stated that the food temperatures were improved and it was decided to discontinue this monitor as of June 2013.

3. The above findings were confirmed by Staff #1 on 1/08/14 at 3:15 PM.

Based on staff interview and document review, it was determined that the facility failed to ensure that the therapeutic diet manual is approved by the dietitian and medical staff.

Findings include:

1. On 1/08/14 at 10:45 AM, Staff #33 and Staff #37 could not provide evidence that the "Nutrition Care Manual" was reviewed and approved by the medical staff.

2. The above findings were confirmed by Staff #33 on 1/08/14 at 10:45 AM.

Based on document review and staff interview, it was determined that the facility failed to ensure that the hospital has in effect, a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients entitled to benefits under the Medicare and Medicaid programs.

Findings include:

The Utilization Review (UR) Committee failed to meet and carry out the UR function. Refer to Tag A-0654.

Based on document review and staff interview, it was determined that the facility failed to ensure that the Utilization Review (UR) Committee carried out UR functions as indicated in the Utilization Review Plan.

Findings include:

Reference: The document titled "Utilization Review Committee/Regulatory Compliance Policy" states under Meetings, "The Committee shall meet as a separate and distinct committee with its own agenda and minutes. The Committee shall meet as often as necessary to accomplish its functions, but no fewer than four (4) times per year."

1. On 1/6/14, Staff #16 was asked to provide for review, the 2013 Utilization Review Plan and the UR Committee meetings from January 2013 to present, January 2014.

2. Staff #16 provided the "Utilization Review Committee/Regulatory Compliance Policy" and "Utilization Management/Utilization Review Committee Meeting" minutes dated May 24, 2013 and November 14, 2013.

a. The May 24, 2013 meeting attendance sheet contained a handwritten note that stated, "Meeting canceled due to inadequate number of members attendance."

i. Staff #16 confirmed that the meeting in May was canceled due to inadequate attendance.

b. The August 2013 and November 2013 meeting was combined and was held on November 14, 2013.

3. On 1/8/14, Staff #16 stated that the UR Committee is required to meet once a quarter and the November 14, 2013 meeting was a combined meeting with August 2013.

4. There was no evidence that the UR Committee met for the first three quarters of 2013, in accordance with the Utilization Review Committee/Regulatory Compliance Policy referenced above. This was confirmed by Staff #1 on 1/8/14.

A. Based on observation, it was determined that the facility failed to ensure that a clean, safe and sanitary environment is provided in the Operating Room (OR) Suite.

Findings include:

1. On 1/7/14 at 10:50 AM, the "North American Drager" anesthesia machine located in the "Cysto" OR contained old tape residue, peeling paint and rough, not easily cleanable drawer surfaces.

2. On 1/7/14 at 11:30 AM, a "wooden arm board" was observed in poor condition with open seams and gaps.

3. The floor perimeters of an unused autoclave area, located between OR #1 and OR #2, was unclean with old paint chips and dust accumulation surrounding the old steam generator.

4. Chipping paint was observed along the wall perimeters of the storage area located between OR #5 and OR #7.



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B. Based on observation, it was determined that the facility failed to ensure that the overall hospital environment was maintained to protect the safety and well-being of patients.

Findings include:

Reference: N.J.A.C. 5:70-3, 605.1, Identified electrical hazards shall be abated.

1. On 1/6/14, in the presence of Staff #4, the facility did not repair electrical outlets as indicated by the following:

a. At 10:30 AM, in the Receiving Room, an electrical outlet was missing a cover plate exposing the wires.

b. At 10:55 AM, in the Kitchen next to the electrical panels, an electrical outlet was missing a cover plate exposing the wires.

c. At 11:25 AM, in the Emergency Department across from the Soiled Utility Room, an electrical outlet was missing a cover plate exposing the wires.

d. At 11:55 AM, in the CT Suite, an electrical outlet was not secured to the wall.

A. Based on observation and document review, it was determined that the facility failed to follow AMMI ST. 79 Guidelines for the early release of Implants.

Findings Include:

Reference: #1: AMMI ST.79: 2010, section (10.6.3) "Release criteria for implants" states, "Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistence patterns of events that are causing emergency release and that could be corrected."

Reference: #2: The facility policy titled "Release of Implants" states,
"The package or tray with the implantable device will be quarantined until the BI (Biological Indicator) is read as negative, except in an extremely rare case of a documented medical emergency."

1. On 1/6/14 at 11:00 AM, a review of the BI Implantable early release records from May 2013 to December 2013 revealed two instances where devices were released prior to a negative BI for non-emergency criteria.

a. On 5/20/13, a synthesis Mini Fragment #10 was released prior to the negative BI due to insufficient time between procedures.

b. On 11/7/13, a Stryker Hoffman 3 external fixation system was released prior to a negative BI for non-emergency criteria. This procedure was an elective surgery, not an emergency.










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B. Based on observation and staff interview, it was determined that the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases where methods for processing reusable medical devices 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).

Findings include:

Reference #1: AAMI ST 79 section 6.5.1 on "Transportation scheduling and routes" states, "The pickup and transport of soiled items from each area should be scheduled so that the items are transported and cleaned as soon as possible after becoming soiled."

Reference #2: AAMI ST 79 section 6.5.2 on "Transportation of equipment" states, "Transport system should be designed to prevent items from falling over or off during transport. Carts, reusable covers, and bins and other containers should be decontaminated after each use."

1. On 1/7/14 at 11:00 AM, one open cart containing contaminated instrument trays, waiting to be picked up by the Central Processing Department, were stored in the Soiled Storage Room of the Operating Room Suite. Staff #15 was asked on how often the soiled instruments are picked up to be transported to the Central Processing Department. He/she stated that instruments are usually picked up as soon as the procedures are completed. Policies and procedures on transportation of contaminated items was not available upon request.

Reference #3: AAMI ST 79 section 8.9.2 on "Storage facilities" states, "Sterile items should be stored in a manner that reduces the potential for contamination. In general, the temperature in storage areas should be approximately 240F (750F). There should be at least 4 air exchanges per hour and relative humidity should be controlled so that it does not exceed 70% (AIA 2006)."

1. On 1/7/14, a tour of the new OR Sterile Storage Rooms was conducted in the presence of Staff #15. During this time, it was determined through interview with Staff #15 that the temperature and relative humidity were not being monitored in the new OR Sterile Storage Rooms.






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C. Based on staff interviews, review of facility policies and procedures, and review of pertinent facility documentation, it was determined that the facility failed to ensure the implementation of an effective infection control program.

Findings include:

Reference: Facility document titled, "Meadowlands Hospital Medical Center Infection Prevention and Control Plan", states, "...The Purpose of the Infection Prevention Program is:...2. To improve process and outcomes with the principles of epidemiology for surveillance, prevention, and control of infection...The Goals of our Infection Prevention Program are to:...2. Monitor occurrence of infection and implement appropriate control measures. 3. Identify and correct problems relating to infection prevention practices...
5. Maintain compliance with state and federal regulations relating to infection prevention practices...The Scope of the Infection Prevention Program includes: 1....There is ongoing monitoring of infections of patients and personnel...5. Performance improvement - Infection control practices are assessed and actions for improvement will be done accordingly..."

1. On 1/8/14, the Infection Control Program and The Infection Prevention and Control Committee Meeting Minutes for 2013 were reviewed in the presence of Staff #22.

a. There was no evidence of follow up or resolution of issues/problems that were identified in the Infection Prevention and Control Committee Meeting minutes.

b. There was no evidence that the members of the Infection Prevention and Control Committee were regularly reporting on monitoring of infection control practices.

c. There was no evidence that the in-patient dialysis department was reporting on monitoring of infection control practices. The results of water cultures were reported to Staff #1, but dialysis was not part of the infection control plan.

2. The above was confirmed by Staff #22.

Based on document review and staff interview, it was determined that the facility failed to ensure that a discharge plan evaluation was performed as per physician order and per the Interdisciplinary Discharge Planning policy.

Findings include:

Reference: Facility policy titled, "Interdisciplinary Discharge Planning" states, "Procedure/Process: ... 3. Case Management Responsibility: ... C. Initial assessment shall be completed on all patients that meet social service high risk criteria and/or patients referred to the Case Management staff for intervention. This assessment shall be completed within 48 working hours of admission/referral ... "

1. In Medical Record #33, a physician order dated 8/16/13 at 8:14 AM states, "Social work consult now please, for living arrangement and placement."

2. There was no evidence in the medical record of an initial discharge planning evaluation completed within 48 working hours of referral.

3. The above was confirmed by Staff #1.

.

Based on medical record review, staff interview and patient/family interviews, it was determined that the facility failed to ensure that discharge planning was discussed with the patient or the patient's representative and documented in the medical record.

Findings include:

1. On 1/7/14, review of Medical Record #23 indicated that the patient was admitted to the facility on 12/30/13. The Case Management initial note dated 12/31/13, identified no discharge needs. The next note and final disposition dated 1/6/14 indicated the patient was being discharged to a rehabilitation center and that the patient/family was aware of the arrangement.

a. There was no evidence in the medical record that any subsequent discharge planning was discussed with the patient or the patient's representative prior to the final disposition.

1. On 1/8/14, review of Medical Record #34 indicated the patient was admitted to the facility on 1/2/14. The case management initial note dated 1/2/14, identified no discharge needs.

a. There was no evidence in Medical Record #34 of a discharge planning process, however, interview with Patient #34's family on 1/8/14, in the presence of Staff #22, revealed that discharge planning was discussed with the social worker.

2. On 1/6/14, review of Medical Record #8 indicated the patient was admitted to the facility on 12/28/13. The Case Management initial note dated 12/30/13, identified no discharge needs.

a. There was no evidence in Medical Record #8 of a discharge planning process, however, interview with Patient #8's family on 1/8/14, in the presence of Staff #22, revealed that discharge planning was discussed with the social worker.

3. The above was confirmed by Staff #16 and Staff #22.

A. Based on medical record review and review of facility polices and procedures, it was determined that the facility failed to ensure that the discharge planning evaluation was complete.

Findings include:

Reference: Facility policy titled, "Interdisciplinary Discharge Planning" states, "Procedure/Process: ... 3. Case Management Responsibility: B. The Case Management Department will initiate discharge planning either through high risk screening, referral from patients/families, or from members of the interdisciplinary team who identify patients needing intervention, this is done to ensure continuity of care. C. Initial assessment shall be completed on all patients that meet social service high risk criteria and/or patients referred to the Case Management staff for intervention. This assessment shall be completed within 48 hours of admission/referral. ... D. The Case Management staff is responsible for assessing the psychological, social, environmental, and financial impact of illness on patients and their families. This will be accomplished through interviews with patients and their family members. ... "

1. Medical Record #8 indicated the patient was admitted to the facility on 12/28/13. The Case Management initial assessment, completed on 12/30/13, lacked evidence that the patient's psychological, social, environmental, and financial impact of illness on patient's and their family members was assessed, as required by the above referenced policy.


2. Medical Record #23 indicated the patient was admitted to the facility on 12/30/13. The Case Management initial assessment, completed on 12/30/13, lacked evidence that the patient's psychological, social, environmental, and financial impact of illness on patient's and their family members was assessed, as required by the above referenced policy.


3. Medical Record #25 indicated the patient was admitted to the facility on 12/15/13. The Case Management initial assessment, completed on 12/17/2013, lacked evidence that the patient's psychological, social, environmental, and financial impact of illness on patient's and their family members was assessed, as required by the above referenced policy.


B. Based on review of 1 of 1 medical record, of a patient returning to a nursing home, it was determined that the facility failed to ensure that the Transfer-Return to Nursing Home policy was implemented.

Findings include:

Reference: Facility policy titled, "Transfer-Return to Nursing Home" states, "Process: ... Case Management will follow patient's medical condition and document in patient medical record every 3 days or if patient's discharge plan changes ..."

1. Medical Record #21 indicated the patient was admitted to the facility on 12/23/13. The Case Management initial assessment was completed on 12/24/13. The next Case Management final disposition note, dated 1/6/14, indicated the patient was returned to the Nursing Home.

a. There was no evidence that the Case Management staff documented in the medical record every three days, the patient's medical condition or if the patient's discharge plans changed, as required by the above referenced policy.

Based on medical record review, review of facility policies and procedures, and staff interview, it was determined that the facility failed to ensure that the Interdisciplinary Discharge Planning and the Initial Assessment/Reassessment policies were implemented for discharge planning.

Findings include:

Reference #1: Facility policy titled "Interdisciplinary Discharge Planning" states, "Procedure/Process: ... 3. Case Management Responsibility: ... Case Management staff will be responsible for documentation of all findings, recommendations and interventions... K. The discharge plan will be reviewed upon notification of any change in the patient's condition or situation. The plan shall be re-evaluated and documented in the medical record, as indicated."

Reference #2: Facility policy titled, "Initial Assessment/Reassessment" states, "... Process: ... Reassessment will be done if there is a change in patient's condition or diagnosis. Reassessments will be documented in the interdisciplinary progress notes. Documentation must be frequent enough to provide current and pertinent communications to the health care team, but no less than once a week while the care remains open. A final note will be documented detailing all resolutions and final discharge plan(s)."

1. Review of Medical Record #3 revealed the following:

a. The Hospitalist's note on 8/16/13 indicated that Patient #3 presented to the hospital on 8/16/13 with altered mental status and the diagnoses of hyponatremia, acute renal failure, elevated creatinine kinase, hypochloridemia, anemia, and drug abuse. The patient was initially seen on 8/17/13 and subsequently on 8/18/13, 8/19/13, 8/20/13, 8/21/13, 8/22/13 and 8/30/13, by a Psychiatrist. The patient was diagnosed with a Psychotic Disorder and placed on Risperdal. The Hospitalist's note dated 8/18/13 indicated the patient was to be discharged to ___ [a hospital] psychiatric ward when a bed was available.

b. The patient was medically cleared and was assessed by two psychiatric hospital screeners on 8/28/13 and 8/30/13, who determined the patient did not meet commitment criteria and was not in danger to self or others.

c. On 8/29/13 and 8/30/13, the Hospitalist's note indicated the patient was homeless and that the social worker was aware and was trying to find a shelter post discharge.

d. On 8/30/13, the Case Management note stated, "... The previous Screener who came from ... on 8/28/13 reported that the hospital should send the patient to the shelter facility. This patient has diabetes & HTN [hypertension], in addition to the psychiatric disorder. Shelter will not provide medical treatment this patient needs ..."

e. On 8/31/13, 9/1/13 and 9/2/13, the Hospitalist's note indicated the patient was cleared for discharge to a psychiatric hospital; there was no mention of the patient being discharged to a shelter.

f. On 8/31/13, the Case Management note indicated that a referral was made to another hospital for voluntary psychiatric admission.

g. On 9/3/13, the Hospitalist note indicated that the patient was being held until a bed was found at a facility (for psychiatric admission). There were no Hospitalist notes in the medical record for 9/4/13 and 9/5/13.

h. Review of a nurse's note on 9/3/13 at 4:15 PM indicated that a Dr. ____ (psychiatrist, as per Staff #1) was in to see the patient. In addition, there was communication with two hospitals for evaluation/admission to a psychiatric unit and submission of patient information. The nurse documented communication with Case Management and a Physician on the unit.

(i.) There was no evidence in the medical record of a psychiatric exam/consult by the Psychiatrist on 9/3/13, as indicated in the nurse's note, dated 9/3/13.

i. On 9/5/13, during the day shift, the nurse documented in the nurse's notes that the Psychiatrist was made aware of the patient status to be discharged and that no psychiatric ward would accept the patient, according to Case Management. In addition, the nurses note states that Case Management was conversing with the medical resident about discharge plans. In the afternoon of 9/5/13, the nurse documented that he/she spoke with Case Management and "order for d/c [discharge] to a shelter in ___ [name of shelter] arranged by social services." The discharge nursing instruction form on 9/5/13 indicated the patient was sent to a shelter with no medications or prescriptions for medications.

j. The medical record indicated that the patient was taking Protonix 40 mg. daily, Risperdone 1 mg. twice daily, Sodium Chloride 500 mg. daily, Norvasc 10 mg. daily, and Glipizide 5 mg. daily. The nurse's notes also indicate that the patient was on a one to one observation with a sitter for safety as the patient's mental status fluctuated from being calm to being agitated, with periods of confusion, and acting strangely. However, from the evening of 9/2/13 to the day of discharge on 9/5/13, the patient was calm and cooperative, with some confusion.

2. With the absence of the Hospitalist's notes of 9/4/13 and 9/5/13, the Psychiatrist's note of 9/3/13 and the Social Worker's final note, it could not be determined if the patient was provided a safe discharge.

3. In reviewing the Case Management documentation regarding findings, recommendations and interventions for discharge planning for Patient #33, there were only two entries documented, 8/30/13 and 8/31/13. There was no evidence of a final note documenting all resolutions and a final discharge plan.

4. The above referenced policies were not implemented.

5. This was confirmed by Staff #1.

Based on review of two medical records of patients who required post hospital care and staff interview, it was determined that the facility failed to ensure that the Patient Choice policy was implemented regarding the patient and/or individual acting on the patient behalf was provided a list of post acute care providers to choose from for post hospital care.

Findings include:

Reference: Facility policy titled, "Patient Choice" states, "... Procedure: The following steps shall be performed to ensure patients are given a free choice and provided a meaningful opportunity to select a post acute provider/service: Home Care, ... Sub acute Care, Rehabilitation ... The CM [case manager] staff will offer each patient or family/legal representative a list of approved providers that are appropriate for the level of care needed ... K. If a referral has been made for services post discharge, the medical record must include documentation of the patient's selection."

1. On 1/7/14, review of Medical Record #23 indicated the patient was admitted to the facility on 12/30/13 with signs/symptoms of a cerebral vascular accident. The initial Case Management assessment performed on 12/31/13 indicated that no discharge needs were identified at that time and Case Management would continue to assess and assist with discharge planning. The next note by the Case Manager, performed on 1/6/14 stated, "Final disposition." The note indicated the patient was being discharged to a rehabilitation facility and that the patient's ... [family member] was notified of the transfer.

a. There was no evidence in the medical record that the patient or family was provided with a list of rehabilitation facilities to choose from for post hospital care.

2. On 1/7/14, review of Medical Record #25 indicated the patient was admitted to the facility on 12/15/2013. The initial Case Management assessment performed on 12/17/13 indicated that no discharge needs were identified at that time and to continue with assessment and assistance with discharge planning. On 12/18/13, the Case Manager's final disposition note indicated the patient was discharged to a rehabilitation center. The patient and the patient's family were aware of arrangements/plan and agreed to it.

a. There was no evidence in the medical record that the patient or family was provided with a list of rehabilitation centers to choose from for post hospital care.

3. The above was confirmed by Staff #22.

A. Based on medical record review, review of policies and procedures and staff interviews, it was determined that the facility failed to ensure that respiratory therapy patient assessments are performed in accordance to facility policy.

Findings include:

Reference: Facility policy titled, "Charting Policy", states, "Policy: Charting shall be done on the Respiratory Therapy Treatment Notes in CAREVUE...This form shall reflect the following information:...d. Patient response to therapy, and adverse effects and other clinical observations that might provide the physician information with which to evaluate patient progress...Entries must be made after each treatment/procedure performed."

1. On 1/6/2014, 6 out of 6 medical records (#1, #2, #3, #11, #12, and #13) only had the post respiratory therapy treatment vital signs documented in the respiratory care service therapy record notes.

a. Staff #10, Staff #11 and Staff #23 stated that patient assessments are performed pre [before] and post [after] each treatment/procedure performed. The respiratory care service therapy record notes are entered into the electronic medical record post treatment/procedure.

2. Staff #10 stated that the patient's response to therapy and adverse effects of the treatment/procedure can not be fully assessed without comparing the vital signs before and after each treatment/procedure performed.


B. Based on medical record review, review of policies and procedures and staff interviews, it was determined that the facility failed to ensure that respiratory therapy patient care plans are in accordance with facility policy.

Findings include:

Reference: Facility policy titled, "Patient Assessment and Care Plan, Volume: Respiratory Therapy Department" states, "Policy:...Assessment, and Care Plan will be done within 24 hours of receipt of physician's orders. Procedure: Responsible Party
Responsibility Respiratory Care Practitioners...Formulate plan. State what, in your opinion, needs to be done to meet therapeutic goals. Indicate short or long term plans, educational needs or recommend a change of modification of therapy...Reassessment will be done every Five days that the patient is receiving therapy or when there is a significant change in the patient's condition."

1. On 1/6/2014, 6 out of 6 medical records (#1, #2, #3, #11, #12 and #13) did not indicate that the respiratory assessment and care plan included short or long term plans.

2. On 1/6/2014, 6 out of 6 medical records (#1, #2, #3, #11, #12 and #13) did not indicate that the respiratory assessment and care plan included educational needs.

3. On 1/6/2014, 4 out of 4 medical records (#1, #2, #3, and #12) did not indicate that the respiratory assessment and care plan was reviewed or revised.

4. The above findings were confirmed by Staff #10.

C. Based on medical record review, review of policies and procedures and staff interviews, it was determined that the facility failed to ensure that respiratory therapy patient/family teaching-interdisciplinary education is performed in accordance with facility policy.

Findings include:

Reference: Facility policy titled, "Patient/Family Teaching-Interdisciplinary Education Record, Volume: Respiratory Therapy Department" states, "POLICY: To document the interdisciplinary process of patient/family and teach in a collaborative and consistent manner. PROCESS:...8. Assess Learning Need - All Practitioners...All practitioners will assess learning needs of the Patient/Family. Indicate Assets/Barriers to Learning. Determine what you want patient and family to achieve...9. Response Code: Evaluate Patient/Family according to when expected outcome was achieved. Document the actual outcome of teaching Patient/Family using the code. If the Patient/Family did not meet expected outcome - mark appropriate response code. Re-evaluate reinforced teaching outcome and document."

1. On 1/6/2014, Staff #23 stated that respiratory care education begins with a referral from the physician to Respiratory Therapy Services. Staff #10, Staff #11 and Staff #23 stated that the respiratory therapist who performs the initial assessment should assess the learning needs of the patient/family and document teaching in the medical record.

a. On 1/6/2014, at approximately 2:15 PM, Staff #23 confirmed that Medical
Record #11 and Medical Record #13 did not have evidence that patient/family respiratory care education was performed by the respiratory therapist.

2. The respiratory care patient/family education form states that the topic taught was "Respiratory Care."

a. The specific respiratory care subject(s) taught (such as how to use an incentive spirometer, or how to do pursed lip breathing) is not included on the form, therefore, it can not be determined if one or more topics were addressed, or if all patient and family learning objectives were achieved.

b. The above finding was confirmed by Staff #10.

3. On 1/6/2014, 3 out of 6 medical records (#1, #2, and #3) did not have evidence that teaching was reinforced or that educational needs were re-evaluated, as indicated on the education record.

a. Staff #11 stated, "I only do it once," in reference to education for respiratory care.

b. The above finding was confirmed by Staff #10. In addition, Staff #10 stated, "I see we need to do another education when treatments change."