HospitalInspections.org

Based on a review of medical records, hospital policies and procedures, interviews with administrative and direct care staff, tours of the facility and review of relevant documentation, it was determined that the governing body failed to demonstrate that it is effective in carrying out its' responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the facility's lack of compliance with the Medicare Condition of Participation for hospitals, specifically:

42 CFR 482.21- QAPI (Quality Assurance Performance Improvement).

42 CFR 482.25- Pharmaceutical Services.

Based on observation, staff interviews, and review of facility documentation, 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 evaluate all of its' contracted services as part of the QAPI program. Please refer to Tag 0084.

2. The facility failed to evaluate its' pharmaceutical services. Please refer to Tag 0490.

3. The facility failed to incorporate patient complaints and grievances into the hospital's QAPI program. Please refer to Tag 0119.

4. The facility failed to evaluate its' dietary service. Please refer to Tag 0620.

Based on Quality Assurance Performance Improvement (QAPI) review, review of the facility's contracted services, and staff interview it was determined that the facility failed to evaluate all of their contracted services as part of their QAPI program.

Findings include:

1. On 3/6/13 and 3/7/13 the facility's contracted services and QAPI was reviewed. There was no evidence the facility performed QAPI evaluations of the following contracted services:

a. pharmacy

b. housekeeping

c. dietary

d. laboratory

e. physical therapy

f. laundry

2. On 3/7/13 at 11:30 AM Staff #1 confirmed that the facility has not done QAPI evaluations of the above contracted services.

Based on review of patient complaints, Quality Assessment and Performance Improvement Program (QAPI) review and staff interview, it was determined that the facility failed to incorporate patient grievances, as well as other complaints that are not defined as grievances, into the hospital's QAPI program.

Findings include:

1. On 3/7/13 at 12:15 PM patient complaints and resolutions were reviewed.

a. Staff #1 reported that the facility has not had any written grievances for 2012.

2. There was no tracking and trending of the complaints, or QA available for review.

3. Staff #1 confirmed that complaints/grievances are not aggregated and incorporated into the facility's QAPI program.

Based on observation, document review and staff interview, it was determined that the facility failed to ensure that pharmacy provided services in a safe and effective manner.

Findings include:

1. The facility failed to ensure implementation of policies and procedures addressing floor stock. Refer to Tag A491.

2. The facility failed to ensure that medications that can be packaged in unit dose containers were included in the 24 hours unit dose cassette exchange. Refer to Tag A491.

3. The facility failed to ensure that medications prescribed for one patient are not used for another patient. Refer to Tag A500.

4. The facility failed to ensure that medications packaged by the pharmacy are given an expiration date in accordance with the standards as stated in the United States Pharmacopeia. Refer to Tag A501.

5. The facility failed to implement policies and procedures addressing review of the formulary. Refer to Tag A511.

6. The facility failed to implement policies and procedures to ensure accurate records of scheduled drugs. Refer to Tag A494.

7. The facility failed to ensure implementation of policies and procedures addressing the storage of controlled dangerous substances. Refer to Tag A503.

A. Based on observation, document review, and staff interview conducted on 3/6/13, it was determined that the facility failed to ensure implementation of its policy and procedure addressing floor stock.

Findings include:

Reference: Facility policy titled "Floor Stock" states, "Procedure: East Mountain Hospital maintains a selection of commonly used and treatment appropriate medications. Medications included in floor stock are used for emergency, PRN, state or standing orders...The attached form #7144 is the current list of floor stock..."

1. The following medications found in the facility's inventory of floor stock are not listed on Form #7144:

a. Five (5) Abilify 10 mg tablets

b. Five (5) phenytoin sodium Ext. 100 mg capsules

c. Eleven (11) ziprasidone HCl 20 mg capsules

d. Thirteen (13) lamotrigine 25 mg tablets

e. Six (6) Invega 3 mg tablets

f. Ten (10) Zyprexa 10 mg tablets

g. Ten (10) Zyprexa Zydis quick disintegrating 10 mg tablets

h. One (1) Geodon injectable vial 20 mg/ml

i. Seven (7) nicotine Transdermal patches 14 mg/patch

j. Eleven (11) nicotine Transdermal patches 21 mg/patch

k. One (1) Lantus insulin 100 unit/10 ml vial

l. One (1) Chloral Hydrate 500 mg/5 ml bottle

B. Based on observation, document review, and staff interview, it was determined that the facility failed to ensure that all medications that can be packaged in unit dose containers were included in the 24 hour unit dose cassette exchange.

Reference: Facility policy titled "Pharmacy Services Provided by an External Pharmacy" states, "Delivery Procedure: A Raritan Valley courier will make daily cassette exchanges which will contain a 24 hour supply of medication...Bulk items, which are not available in unit of use packaging, i.e. creams, inhalers, eye drops, etc., must be stored separately in the cabinet (in the medication room) and not in the patient's cassette drawers."

1. During an inspection of the medication room on 3/6/13, it was noted that the following medications, which are packaged in unit dose containers or can be packaged in unit dose containers, were dispensed by the pharmacy in bulk containers.

a. One box of 25 individually wrapped (unit dose) containers of albuterol sulfate .042% were dispensed for Patient #16.

b. One box of 30 Metamucil packets with the pharmacy label ripped off. Upon interview Staff #9 stated that this had been dispensed patient specific.

c. One box of 24 Guaifenesin 400 mg capsules with the pharmacy label ripped off. Upon interview Staff #9 stated that this had been dispensed patient specific.

d. One 240 milliliter bottle of Lactulose Syrup with the pharmacy label ripped off. Upon interview Staff #9 stated that this had been dispensed patient specific.

Based on observation and staff interview on 3/6/13, it was determined that the facility failed to implement policies and procedures to ensure accurate records of scheduled drugs.

Findings include:

Reference: Facility policy titled "Integrity of Controlled Substance Inventory" states, "...It is the policy of this hospital to monitor and maintain an accurate inventory of controlled substances...The Director of Nursing will perform medication room inspections that will include the monitoring of controlled drug documentation, storage, and waste. These inspections will occur once per week with appropriate follow-up, based on findings (change in policy, staff education, etc.)."

1. At 10AM in the presence of Staff #9, a bottle containing 40 ml (milliliter) of chloral hydrate 500 mg (milligram)/ 5 ml, a Class IV controlled substance, was noted in the medication room cabinet.

a. The --[name of contracted pharmacy]-- Pharmacy Controlled Drug Substances Record (Control #8147) assigned to the bottle of chloral hydrate stated the quantity of medication remaining was 35 ml. Thus, the inventory record and amount of drug on hand did not reconcile and was not accurate.

2. Upon interview, Staff #4 could not provide evidence that the weekly medication room inspections by the Director of Nursing were completed in accordance with facility policy (Reference #2).

3. This finding was confirmed with Staff #1, #4 and #9.

Based on observation, document review and staff interview conducted on 3/6/13, it was determined that the facility failed to ensure that medications prescribed for one patient are not used for another patient.

Findings include:

Reference: Facility policy titled "Administration of Medications" states, "Procedure:...Prescriptions written for one patient are not to be used for another patient."

1. On 3/6/13 at 10:30 AM the following medications were found in the medication room cabinets. In each instance, the pharmacy label had been ripped off or the patient had been discharged. This medication was available for administration to another patient.

a. Tinactin spray

b. One box of Mucinex DM capsules

c. Guaifenesin 400 mg capsules, box of 24

d. Metamucil packets, box of 30

e. Lactulose syrup 240 milliliters

f. Lantus Solostar insulin pens, box of 4

g. NovoLog FlexPen insulin pens, box of 3

2. This finding was confirmed by Staff #9.

Based on observation, document review and staff interview, it was determined that the facility failed to ensure that unit-dose medications that had been packaged as such by the pharmacist were labeled with an expiration date that complied with repackaging standards as stated in the United States Pharmacopeia (USP).

Findings include:

Reference: The Food and Drug Administration website http://www.fda.gov/ohrms/dockets/98fr/05d-0174-gdl0001.pdf states "The U.S. Pharmacopeia (USP) contains standards on expiration dating and beyond-use dating in its General Notices and Requirements section... The USP states: For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers, the beyond-use date shall be one year from the date the drug is packaged into the single-unit or unit-dose container or the expiration date on the manufacturer's container, whichever is earlier, unless stability data or the manufacturer's labeling indicates otherwise."

1. During a tour of the medication room on 3/6/13, it was noted that many of the unit-dose medications had a beyond use date of greater than one year. These medications had been repackaged by the provider pharmacy.

2. On 3/6/13 evidence from the provider pharmacy that would support a beyond use date of one year was requested.

3. On 3/7/13 a letter from the provider pharmacy was presented to the surveyor by Staff #1. The letter stated, "Effective March 6, 2013, [the pharmacy] will package each medication with an expiration date not exceeding 1 year. Medications that have a manufacture (sic) expiration of less than a year will be packaged with that expiration date as per the manufacturer expiration date."

a. The provider pharmacy was unable to provide evidence that would support a beyond use date of greater than one year. All the unit-dose medications at the facility were labeled with a beyond use date that was not in compliance with USP standards.

Based on observation and staff interview on 3/6/13, it was determined that the facility failed to ensure implementation of policies and procedures addressing the storage of controlled dangerous substances.

Findings include:

Reference: Facility policy titled "Controlled Substance Storage" states, "...All Controlled Substances are to be stored in a locked cabinet in the hospital medication room. Class II Substances will be stored separately in a locked cabinet within the controlled substance cabinet."

1. During a tour of the medication room at 10 AM, the lock on the cabinet door where Class II controlled substances are stored was found to be broken. Thus, Class II controlled substances were not stored in compliance with facility policy.

2. These findings were confirmed with Staff #1, #4 and #9.

A. Based on document review and staff interview, it was determined that the facility failed to ensure implementation of policies and procedures addressing the drug formulary.

Findings include:

Reference: Facility policy titled "Formulary" states, "Procedure:...The formulary will be reviewed no less than four times per year by the Pharmacy and Therapeutics Committee.

1. Review of meeting minutes of the Pharmacy and Therapeutics Committee for the year 2012 revealed that the formulary was not on the agenda for any of the meetings held in 2012.

2. This finding was confirmed by Staff #1.


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B. Based on observation, record review and staff interview on 3/7/13, it was determined that the facility failed to ensure implementation of policies and procedures addressing the drug formulary.

Findings include:

Reference: Facility policy titled "Medication-Outside Formulary" states, "...Should a medication outside of the formulary of East Mountain Hospital be ordered by any LIP [licensed independent practitioner], pharmacy will notify EMH [East Mountain Hospital] and the prescribing individual and offer a suitable equivalent product. If there is none available or it is felt the medication ordered would be in the best interest of a client this will be noted in the Nursing Staff Progress section of the client's chart."

1. At 11:30 AM, one Levemir (insulin detemir) 10 ml (milliliter) vial and one Humalog (insulin lispro) 10 ml vial, both dispensed by the pharmacy for Patient #16, were noted in the medication refrigerator.

a. Levemir and Humalog are not on the facility formulary provided by Staff #1.

b. Upon interview, Staff #9 and #10 could not provide documentation in the nursing staff progress notes that EMH or the prescribing individual was notified regarding the non-formulary status of Levemir and Humalog at the facility.

Based on staff interview, document review, lunch meal observations and a tour of the pantry, it was determined that the contracted Food Services Manager/Clinical Dietitian failed to provide daily supervision of the Food and Nutrition Services Department.

Findings include:

Reference #1: The Food Services Manager/Clinical Dietitian's position description states:

a. "This position assumes the full time responsibility for both food service and clinical aspects of...Hospital."

Reference #2: The "Pantry Food Storage" policy states "To provide a clean and safe food storage area for patient food items...Microwave must be wiped down after each meal and as needed."

1. On 3/06/12 at 10:00 AM, in the presence of Staff #3, the pantry microwave was observed to have food residue on the interior walls and ceiling.

a. The Food Services Manager/Clinical Dietitian failed to ensure that the microwave is wiped down after each meal as stated in the "Pantry Food Storage" policy. Refer to Reference #1 and Reference #2.

b. The above was confirmed by Staff #3 on 3/06/12 at 2:30 PM.

Reference #3: The "Meal Rounds & Meal Monitoring" policy states "Meal Rounds will be conducted three times weekly or more frequently as needed."

1. On 3/06/12 at 10:15 AM, Staff #3 did not provide for review, the requested meal round audits/tray assessments completed from 1/1/13 to date of visit 3/6/13.

a. On 3/06/12 at 10:15 AM, Staff #3 stated that the most recent meal round audit/tray assessment available for review was dated 12/27/12.

b The Food Services Manager/Clinical Dietitian failed to ensure meal rounds are conducted three time a week as stated in the "Meal Rounds & Meal Monitoring" policy. Refer to Reference #1 and Reference #3.

c. The above was confirmed by Staff #3 on 3/06/12 at 2:30 PM.

Based on review of the facility's Utilization Review (UR) Committee's meeting minutes and staff interview, it was determined that one of the two independent physicians on the UR committee that are not professionally involved in the care of the patients, is not regularly attending the UR committee meetings.

Findings include:

Reference: Facility's Utilization Review Plan states "UTILIZATION REVIEW COMMITTEE ... [3rd paragraph] The EMH Utilization Review Committee is composed of two physicians, the EMH Executive Director [Staff #1], the Director of Social Services, the director of Nursing, the Director of Utilization Management and a Utilization Coordinator, the Compliance Officer, the Director of Compliance and Audit and the Risk Manager. The --facility's-- Chief Medical Director will be invited to attend and participate in regularly scheduled quarterly meetings."

1. On 3/7/13 at 10:35 AM the UR committee meeting minutes were reviewed in the presence of Staff #11. Staff #11 stated in interview that Staff #13 and Staff #14 are the primary physician reviewers because they do not have any involvement with the treatment of this facility's patients.

2. The meeting minutes and committee participants attendance were reviewed. It was observed that Staff #14 did not attend five of the last six UR meetings. The last six meetings were held on 9/13/11, 11/29/11, 2/21/12, 5/15/12, 8/7/12, [11/13/12 canceled due to Super Storm Sandy], and 3/5/13. Staff #14 only attended the 5/15/12 meeting.

3. Staff #14 confirmed the above.