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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 482.12 Governing Body

CFR 482.25 Pharmaceutical Services

Based on medical record review, staff interview, and review of facility policies and procedures, it was determined that the facility failed to ensure implementation of it's policy for code status classification and health care decisions in 4 of 7 medical records reviewed at the Morris campus, and 2 of 3 medical records reviewed at the Wayne campus. (Medical Records #M4, #M5, #M8, #M9, W#16, and #W18).

Findings include:

Reference #1: Facility policy number H-PC 02-001, titled 'CODE STATUS CLASSIFICATION' states, "POLICY 1. There shall be two categories of Code Status in --- Hospitals for patient resuscitation (Yes and No). 2. Patients are provided resuscitation services unless precluded by a legal advance directive and physician's order. 3. Any patient without a Code Status designation will receive a CPR (cardiopulmonary resuscitation) / Full Code Status. ... PROCEDURE: 1. It is the responsibility of the physician to ensure that any patient's written advance directive is considered prior to the Code Status being entered as the physician's order and that the physician considers the patient and family member /responsible party wishes. ... 3. A patient without a code status designation will default to a Category YES and the patient will receive CPR in the event of cardiac and/or pulmonary arrest."

MORRIS COUNTY

1. On 11/26/12, Medical Record #M4 was reviewed and a 'CODE STATUS ORDER' was evident. The order was signed by the physician on 11/10/12 at 6:00 AM and indicated, "CPR: NO, allow natural death (in the event of a cardiac or pulmonary arrest, DO NOT resuscitate by manual (CPR), chemical, and/or electrical means (defibrillation), and DO NOT intubate)."

a. The 'Patient Admission Assessment' form indicated in the Patient Rights section that no Advance Directive (AD) was present at the time of admission on 11/9/12 at 1900.

b. There was an AD on the chart on 11/26/12 at the time of chart review.

c. The physician progress notes for 11/10/12, [the same date of the 'No allow natural death' was ordered], was reviewed. The progress notes lacked evidence that the physician reviewed the advance directive, if it was available to him/her at the time of the order, or if he spoke to the patient/family regarding the advance directive, their wishes, and the 'NO, allow natural death' order as per policy.

2. Medical Record #M5 was reviewed on 11/26/12 and indicated on the Patient Admission Assessment' form's Patient Rights section that no Advance Directive (AD) was present at the time of admission on 10/27/12. A 'CODE STATUS ORDER' signed by the physician on 10/27/12 at 2000 that indicated "CPR: YES (In the event of cardiac or pulmonary arrest, resuscitate by manual (CPR), chemical, and/or electrical means including intubation)."

a. The physician progress notes for 11/26/12, the date of the "CPR: YES" was ordered, was reviewed. The progress note lacked evidence that the physician discussed a full code status with the family, or if the patient defaulted to a full code status per policy because he/she had no code designation.

Reference #2: Facility policy number H-PC 02-004, titled 'HEALTHCARE DECISIONS' states, "... Advance Directives ... 3. Durable Power of Attorney (DPOA) for Health Care- A document recognized by state law that delegates the authority to another person (usually called a healthcare agent, proxy, or surrogate) to make healthcare decisions for the adult patient when he/she is incapacitated. The DPOA may also describe specific wishes regarding the type of health care choices and treatments that the adult patient wishes to receive. If DPOA is in effect, the agent or surrogate must be given relevant health care information so that informed decisions can be made for the patient. ... 6. The Durable Power of Attorney for Health Care is documented on the state-approved form and signed executed in a manner consistent with state law."

Reference #3: Facility policy number H-PC 04-004, titled 'INFORMED CONSENT' states, "PURPOSE: To establish guidelines for obtaining informed consent during the hospital stay. PROCEDURE: A. Obtaining Informed Consent 1. The physician performing, ordering, or supervising the surgical or special procedure, or his/her designee shall be responsible for obtaining informed consent. 2. For purposes of obtaining informed consent only, a physician's "designee" is defined as follows: a. A licensed independent practitioner (LIP) or Allied Health Practitioner (AHP) with hospital privileges to perform the specific procedure for which consent is being obtained."

1. On 11/27/12, Medical Record #M8 was reviewed in the presence of Staff #1. A 'CODE STATUS ORDER' signed by the physician on 11/11/12 at 1520 indicated, "CPR: NO, allow natural death (in the event of a cardiac or pulmonary arrest, DO NOT resuscitate by manual (CPR), chemical, and/or electrical means (defibrillation), and DO NOT intubate)."

a. At the bottom of the form, two Registered Nurses (RNs) signed that "consent was obtained from patient's state approved guardian ----." The signatures were dated and timed 11/10/12 at 2145, the day prior to the physician's order. Registered Nurses are not credentialed to obtain consents for Code Status, as per Reference #3.

i. Staff #1 stated during interview at 11:00 AM that the physician is supposed to discuss code status with the patient, family member, or power of attorney (POA).

b. There was no evidence of a DPOA document on the chart indicating that the person the two RNs spoke to was in fact the power of attorney for Patient #M8.

c. The physician History and Physical (H&P) dated 11/11/12, [the same date of the "NO, allow natural death" was ordered], was reviewed. The H&P lacked evidence that the physician/LIP spoke directly to the POA. A notation in the H&P indicates, "The patient is a DNR per prior facility and per the guardian, ...". The physician progress notes dated 11/11/12 also lacked evidence of review of a DPOA document or discussion with the POA.

2. On 11/27/12, Medical Record #M9 was reviewed in the presence of Staff #1. A 'CODE STATUS ORDER' signed by the physician on 10/23/12 at 0700 indicated, "CPR: NO, allow natural death (in the event of a cardiac or pulmonary arrest, DO NOT resuscitate by manual (CPR), chemical, and/or electrical means (defibrillation), and DO NOT intubate)."

a. A DPOA document giving the patient's son financial DPOA was on the present on the chart, but the DPOA document did not indicate healthcare proxy.

b. The physician progress notes for 10/23/12, the date of the "NO, allow natural death" was ordered, was reviewed. The progress notes lacked evidence that the physician spoke to the patient/family regarding the patient's and their wishes, and the "NO, allow natural death" order as per policy.

WAYNE

3. On 11/28/12, Medical Record #W18 was reviewed. A 'CODE STATUS ORDER' signed by the physician on 10/9/12 at 11:30 AM indicated, "CPR: NO, allow natural death (in the event of a cardiac or pulmonary arrest, DO NOT resuscitate by manual (CPR), chemical, and/or electrical means (defibrillation), and DO NOT intubate)."

a. There was no AD or DPOA on the chart, but there was evidence that the patient indicated his son was the POA.

b. The physician H&P dated 10/9/12, the date of the "NO, allow natural death" was ordered, was reviewed. The H&P lacked evidence that the physician spoke to the POA regarding the patient's and the son's wishes, and the "NO, allow natural death" order, as per policy.

4. On 11/28/12, Medical Record #W16 was reviewed. A 'CODE STATUS ORDER' signed by the physician on 11/27/12 at 8:45 AM indicated, "CPR: NO, allow natural death (In the event of a cardiac or pulmonary arrest, DO NOT resuscitate by manual (CPR), chemical, and/or electrical means (defibrillation), and NO NOT intubate)."

a. The physician H&P dated 11/27/12, the date of the "NO, allow natural death" was ordered, was reviewed. The H&P lacked evidence that the physician spoke with the patient and/or family members regarding their wishes to "allow natural death."

Based on observation, staff interview, and review of facility policies and procedures, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to ensure that medications were dispensed and administered as ordered by the physician. Refer to Tag A500.

2. The facility failed to ensure that outdated medications were removed from active pharmacy stock. Refer to Tag A505.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that medications were dispensed and administered as ordered by the physician.

Findings include:

Reference: Facility policy titled "Dispensing of Medications" states, "...Procedure...1. The number of doses dispensed depends on the order, frequency, and time until cassette fill time. The number of doses dispensed must be sufficient to last until the next cassette exchange....3. Filling Cassettes...The patient's medication "cassettes" are filled with a supply of drugs that will last until the next cassette exchange."

RAHWAY

1. At approximately 11:30 AM on 11/29/12, patient medication cassette drawers that were returned to the pharmacy were reviewed along with medication administration records and pharmacy patient profiles. The following discrepancies were noted:

a. The returned medication cassette drawer for Patient #R33 contained two furosemide 40 mg (milligram)/4 ml (milliliter) vials.

i. No active order for furosemide was seen on the medication administration record for Patient #R33.

ii. Staff #31 found in the pharmacy profile for Patient #R33 that the order for "furosemide 40 mg IV [intravenous] Q12H [every 12 hours]" was discontinued on 11/24/12 at 9:25 AM.

iii. Upon interview, Staff #31 stated that the cassette drawer was returned to the pharmacy on 11/28/12 at approximately 3:00 PM during the 24 hour cassette exchange. Staff #31 could not explain why the two furosemide 40 mg/4 ml vials were in the cassette drawer.

b. The returned medication cassette drawer for Patient #R31 contained one tablet of losartan 50 mg, two tablets of losartan 25 mg, two calcium/acidophilus/pectin 88 mg-7.5 mg-100 mg capsules and one sucralfate 1gm (gram)/10 ml unit-dose cup.

i. Patient #R31 had an active order for losartan 25 mg once a day (hold for SBP [systolic blood pressure] less than 120), which was documented as administered on 11/27/12 at 10:00 on the medication administration record. A previous order for losartan 50 mg once a day was discontinued 11/26/12 on the medication administration record.

ii. Patient #R31 had an active order for calcium/acidophilus/pectin 88 mg-7.5 mg-100 mg three times a day, which was documented as administered on 11/27/12 at 10:00, 14:00 and 18:00 on the medication administration record.

iii. Patient #R31 had an active order for sucralfate 1 gm three times a day, which was documented as administered on 11/27/12 at 09:00, 14:00 and 18:00 on the medication administration record.

iv. Staff #31 could not explain why the extra doses of medications were in the cassette drawer.

c. These findings were confirmed by Staff #18 and #31.

WAYNE

2. At 2:00 PM on 11/28/12, a physician's order for "Diflucan 200 mg [milligram] (peg) [peg tube] OD [once daily]", written 11/27/12, was noted in Medical Record #W20.

a. A review of the medication administration record (MAR) for Patient #W20 revealed that the order for Diflucan 200 mg was not carried out. Upon interview, Staff #16 could not find an active order for Diflucan 200 mg in the pharmacy medication profile for Patient #W20.

b. At approximately 2:15 PM, a called was placed by Staff #16 to the prescribing physician to clarify the order for Diflucan. The order for Diflucan 200 mg was clarified with the physician and carried out.

B. Based on record review, staff interview and a review of the facility's policies and procedures, it was determined that the facility failed to implement policies and procedures addressing the control of medications removed from the automated dispensing machine (ADM).

Findings include:

Reference: Facility policy titled "Obtaining Medications in the Absence of a Pharmacist" (H-MM 40-008) states, "...Pharmacist review of medication orders prior to dispensing is required during the hours when a pharmacist is physically present in the facility...6. The Nursing Supervisor/Competencied Designee is required to complete the following documentation: After Hours Medication Log (H-MM F 40.008 A)."

RAHWAY

1. At approximately 2:00 PM on 11/29/12, a review of the automated dispensing machine (ADM) profile override report revealed that medications for new orders were removed from the ADM by nurses during pharmacy hours. By nursing obtaining the medication directly from the ADM, a pharmacist did not review the medication orders prior to dispensing.

a. On 11/27/12 at 09:27, lacosamide 100 mg (milligram) was removed by override by Staff #32 from the ADM for Patient #R34.

b. On 11/27/12 at 14:33, lorazepam 2 mg/1 ml (milliliter) was removed by override by Staff #32 from the ADM for Patient #R34.

c. On 11/26/12 at 12:14, carvedilol 3.125 mg was removed by override by Staff #33 from the ADM for Patient #R35.

d. Upon interview, Staff #31 confirmed that the pharmacy was open during these hours.

MORRIS COUNTY

e. On 11/24/12 at 10:34, two levetiracetam 500 mg tablets were removed by override by Staff #34 from the ADM for Patient #M36.

f. On 11/24/12 at 13:33, one baclofen 10 mg tablet was removed by override by Staff #34 from the ADM for Patient #M36.

g. Upon interview, Staff #5 confirmed that the pharmacy was open during these hours.

WAYNE

h. On 11/27/12 at 09:58 and 12:53, lidocaine hydrochloride 2% 5 ml was removed by override by Staff #29 from the ADM for Patient #W21.

i. On 11/27/12 at 10:46, albumin human 25% 50 ml was removed by override by Staff #29 from the ADM for Patient #W22.

j. Upon interview, Staff #16 confirmed that the pharmacy was open during these hours.

WAYNE

2. At 2:30 PM on 11/28/12, the After Hours Medication Log was reviewed along with the ADM profile override report to ensure that all doses removed from the ADM during the hours that the pharmacy was closed were documented according to facility Policy H-MM 40-008.

a. On 11/27/12 at 22:22, cefazolin sodium 1 gm (gram) was removed by override by Staff #30 from the ADM for Patient #W23. No documentation was made on the After Hours Medication Log.

b. These findings were confirmed by Staff #6.

A. Based on observation and staff interview, it was determined that the facility failed to ensure that outdated medications were removed from active pharmacy stock.

Findings include:

Reference: Facility policy titled "Inspection of Medication Storage Areas" (H-MM 20-005) states, "...1. Pharmacy personnel on a monthly basis will inspect the internal pharmacy unit and nursing medication storage units...6. Outdated or otherwise unusable medications in all patient care areas and in the pharmacy are identified, segregated in the pharmacy, and disposed of according to policy and procedure for expired medications (H-MM 40-010)."

RAHWAY

1. At 10:45 AM on 11/29/12, the following outdated medications were found in the active stock in the pharmacy:

a. One Tobradex ophthalmic ointment 3.5 gm (gram) tube, expired 7/11.

b. One Timolol ophthalmic solution 0.25% 5 ml (milliliter) bottle, expired 10/12.

c. One bottle of Sustiva 600 mg (milligram) tablets, expired 3/12.

d. Forty-eight lidocaine viscous 2% 15 ml oral topical solution cups, expired 9/12.

e. Fifteen guaifenesin 100 mg/5 ml oral solution cups, expired 6/12.

f. Thirty-six guaifenesin 300 mg/15 ml oral solution cups, expired 10/12.

2. The Pharmacy Medication Storage Inspection Record showed that the last inspection of the pharmacy was completed on 11/28/12.

3. These findings were confirmed by Staff #18 and Staff #31.

Based on staff interview and document review, it was determined that the therapeutic diet manual was not approved by the dietitian and medical staff at two of the three sites.

Findings include:

Morris County

1. On 11/27/12 at 11:15 AM, Staff #13 could not provide evidence that the "Nutrition Care Manual" was approved by the dietitian and medical staff for use at the Morris County Campus.

Wayne Campus

2. On 11/28/12 at 10:35 AM, Staff #17 could not provide evidence that the "Manual of Clinical Dietetics" was approved by the dietitian and medical staff for use at the Wayne Campus.

3. The above findings were confirmed by Staff #6 on 11/29/12 at 3:15 PM.

Based on observation and review of facility policy and procedure, it was determined that the facility failed to ensure that the prevention of infection among patients, personnel, and visitors was controlled.

Findings include:

Reference: Facility policy number H-IC 02-002, titled 'CONTACT PRECAUTIONS' states, "PURPOSE ... Contact Precautions is the most common Transmission Based Precaution, and is s method designed to reduce the risk of transmission of micro-organisms by direct or indirect contact. [2nd paragraph] Direct contact transmission involves skin-to-skin contact and physical transfer of micro-organisms to a susceptible host from an infected or colonized patient (turning, bathing and other patient care activities or patient to patient contact). [3rd paragraph] Indirect contact transmission involves contact of a susceptible host with a contaminated intermediate object, usually inanimate, in the patient's environment. ... PROCEDURE ... 2. Don gloves and gown prior to entering a Contact Precautions room. ... 6. Remove and dispose of gown and gloves before leaving the patient's room and perform the appropriate form of hand hygiene immediately. ... 12. Visitors: a. Educational information on Contact Precautions is available and will be included in Patient/Family teaching. Evidence of consistent non-compliance should be documented in the patient's chart along with any follow up activity."

Morris County

1. On 11/26/12 at 10:40 AM the unit was toured in the presence of Staff #1, Staff #2, Staff #3 and Staff #4. The following breeches in contact precautions and facility policy were observed amongst facility staff when entering/exiting patient rooms that had a posted contact isolation outside the door:

a. An RN was observed walking out of Room #342, taking off his/her gloves in the hallway. He/she then proceeded to the PPE cabinet located outside of Room #342 and put on a gown. This nurse did not wash his/her hands or use the alcohol based hand gel after taking off his/her gloves.

b. A physician was observed entering and exiting Room #342 without washing his/her hands or using the alcohol based hand gel. Also, this physician failed to use PPE while in the patient's room.

c. Room #352 had a visitor at the bedside. According to Staff #1, the visitor is the patient's mother and she is here everyday, all day. She has been instructed by the staff to wear a gown and gloves, but is non-compliant. There was no documented evidence of consistent non-compliance or family education in Medical Record #M2, in accordance with facility policy.

2. On 11/26/12 at 2:10 PM, a nurses aide was observed entering Room #352, a contact isolation room, to answer a call bell. The nurses aide did not have any personal protective equipment on. He/she went to the patient's bedside and turned off the call bell, which was attached to the patient's bedside rail.

a. A Respiratory Therapist (RT) was observed going into Room #351 to answer the pulse oximeter alarm. A "High Contact Isolation" sign was posted outside the room and indicated a gown, gloves, and a mask should be worn when entering the room. The RT only donned one glove to adjust the pulse oximeter machine, did not don a gown or mask per the sign posted outside the door, then proceeded to remove his/her glove, and go to the nurses station. The RT did not wash his/her hands after removing the glove.