The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

WILLOUGH AT NAPLES, THE 9001 TAMIAMI TRAIL EAST NAPLES, FL 34113 July 24, 2013
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on record review, observation and interview, the facility failed to ensure that 10 (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10) of 10 sampled patients were given accurate information when signing a release relating to their medications, confiscated by the facility upon admission. Patients are unable to exercise their rights relating to medications held by the facility.

The findings include:

1. On 7/24/13, review of the Nursing Policy/Procedure Manual revealed a Policy/Procedure dated 10/01/11 (NUR - 7:107) entitled "Patient Medication Brought to Facility." The procedure states: "1. Patients are advised by Admissions of what medications if any to bring with them, as the facility provides most medications. Patients are also advised by Admissions to bring an empty bottle of their prescriptions or list so the physician may be aware of their current medications. 2. The admitting nurse will collect and record all patient medications on the Medication Inventory form. These medications will be stored in the pharmacy.
3. Upon discharge, the medication will be given to the patient with the exception of controlled substances which are destroyed by the pharmacy upon receipt."
The policy states medications are stored in the pharmacy. There is no documentation that the patient is advised of the medications being stored in the Unit 200 medication room in an unlocked file cabinet.

Upon interview on 7/24/13 at 4:30 p.m. the DON acknowledged that the policy did not accurately reflect what was being done with these medications relating to storage.


2. On 7/24/13 review of "Medication Brought in by Patient Release" forms (attached as Page 2 to the "Nursing Screen and Assessment") revealed that Patients #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10 signed a release form upon their admission to the facility.
The release stated: "I agree to have any medications not approved by the Medical Director or Psychiatrist picked up within three (3) days of my admission or authorize The Willough at Naples staff to destroy and dispose of them."

Upon interview on 7/24/13 at 10:40 a.m. , the facility Medical Director stated that any controlled substances, that would be detrimental to the patient upon discharge, would be destroyed upon discharge of the patient.

Upon interview on 7/24/13 at 4:30 p.m., the Director of Nursing (DON) stated the the patient/family/significant other is not apprised of what medications are "not approved" by the Medical Director or Psychiatrist and not provided with the opportunity to make arrangements for a 3-day pick up of the medications and/or not provided with the opportunity to give authorization for the facility to destroy the medications.

Review of the medical records found no documentation that information regarding unapproved medications was provided to patients by the facility.

4. On 7/24/13, confiscated medications were observed in 2 unlocked file cabinets located in the 200 Unit Medication Room. All of the medications collected on admission (including controlled substances) were still in the facility, in a sealed plastic bag for all 10 patients.

Upon interview at 4:30 p.m. on 7/24/13, the Director of Nursing (DON) acknowledged that the policy did not accurately reflect what was being done with these medications. In addition, the form used to inventory the medications (without a title) states "Medication to be stored in Pharmacy Dept." This form is signed by the patient indicating that the pharmacy is storing the medications. There is no documentation that the patient is advised of the medications being stored in the Unit 200 Medication Room in an unlocked file cabinet.

5. On 7/24/13 at 4:30 p.m., the "Nursing Screen and Assessment" form was also discussed with the DON. The section "Medications Brought in by Patient Release" states the following:

"I agree to have any medications not approved by the Medical Director or Psychiatrist picked up within three (3) days of my admission or authorize The Willough at Naples staff to destroy and dispose of them. All controlled substances will be destroyed in accordance with The Willough at Naples policies. Medications that have been prescribed and discontinued during your stay will not be returned and will be disposed of in accordance with the Willough at Naples policies. All other medications may be returned at the time of your discharge. It is your responsibility to pick up these medications prior to your departure from The Willough at Naples. No medications will be mailed after your departure. All medications will be disposed of in accordance with The Willough at Naples policies." This section is signed/dated by the patient (on day of admission) and has the signature/date of a witness.

The DON acknowledged that the patient/family/significant other is not apprised of what medications are "not approved" by the Medical Director or Psychiatrist so that the patient can make arrangements for a 3-day pick up or give authorization to the facility to destroy and dispose of the medications. When asked who destroys the medication and when, the DON stated the medications are brought to the pharmacy at discharge of the patient. When asked if she was a witness to the destruction of these medications (including controlled substances), the DON stated "No."

.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on record review, observation and interview the facility failed to ensure a system to track the movement of controlled substances brought into the facility by patients ("end user"/not dispensed by the hospital) upon admission from point of entry into the hospital to the point of departure. Pharmacist responsibility and accountability for these scheduled drugs including record keeping is not delineated in policies and procedures,

The findings include:

1. Upon interview on 7/24/13 at 12:30 p.m., the contracted Pharmacist Director/Consultant stated he did not know how to dispose of "end user" controlled medications (those not dispensed by the hospital). He said he was advised by the Drug Enforcement Administration (DEA) that the hospital could not dispose of controlled substances that were not dispensed by the hospital (under their DEA number). He continued to state that prior to 7/1/13, he was disposing of these controlled substances at Conventa. He stated Conventa is licensed to accept controlled substances and has an incinerator. The Pharmacy Director acknowledged that no specific records were kept regarding the disposal of "end user" controlled substance medications. He stated, "the disposal was noted on the inventory sheet completed by the nursing department."

2. The Pharmacy Director stated that he was advised by the DEA that a disposal service, contracted with the facility as of 7/1/13, could not dispose of "end user" controlled substances. The contracted service could only dispose of controlled substances dispensed under the facility (hospital) DEA number. The Pharmacy Director again acknowledged that he did not know how to dispose of "end user" controlled substances; and there were no policies/procedures in place to do the same within his department.

3. On 7/24/13 at 4:45 p.m., the contract with "Stericycle" dated 7/1/13 was reviewed with the facility Administrator present.
The Administrator explained that the company is DOT, EPA and DEA approved to manage and dispose of hazardous waste, including controlled/non-controlled medication. The Administrator acknowledged that the disposal service contract did not include a copy of the Controlled Substance Registration Certificate. The Administrator said he would contact the disposal service regarding the Controlled Substance Registration Certificate.

4. On 7/25/13 at 12:30 p.m., via telephone, the Stericycle contract was again discussed with the Administrator. The Administrator stated he was informed that Stericycle had a "dual DEA number" and was capable of handling/destroying "end user" controlled medications. He stated he would forward this information to the surveyor. This information was received on 7/26/13. The Drug Enforcement Administration was consulted regarding the same. On 7/29/13, via e-mail, the DEA response was "Stericycle will only destroy controlled substances ordered under the hospital DEA #, not 'user medication'."

5. In an interview on 7/24/13 at 11:00 a.m., the Director of Nursing (DON), confirmed that patient's medications, confiscated by the facility on admission (including controlled substances), are managed and stored by the nursing department in 2 unlocked file cabinets in the 200 Unit Medication Room. The DON continued to state, at this time, that these medications are given to the pharmacy when not returned to the patient at discharge; and there is no specific procedure/policy related to this transfer of "management and storage." The DON acknowledged she was not involved with the destruction of "end user" controlled and non-controlled substances.

In a fax transmission dated 7/25/13, the Administrator offered the following information:
"Disposal: There are times, with the patient's permission or their insisting, that we dispose of controlled home medications (using an informed consent form). Prior to July 2013, the disposal process occurred with the involvement of our in-house pharmacy. In late June of 2013, we were advised by our Pharmacist that the disposal process with patient's home medications required modification. In consultation with our corporate Medical Director it was decided that all "end user" medications needed to have management and storage outside of the licensed pharmacy in a monitored location."

.
VIOLATION: CONTROLLED DRUGS KEPT LOCKED Tag No: A0503
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review, observation and interview the facility failed to ensure that 2 (Patients #4 and #10) of a sample of 10 patients had their confiscated controlled substances stored in a secure/locked area.

The findings include:

The facility policy entitled "Controlled Substances", dated 7/7/04, states "5.1 The nurse who receives these materials (controlled substances) shall verify and sign for all controlled substances dispensed and place them immediately in the locked compartment provided for this purpose in the nursing unit medication cabinet."

1. Review of the medical record for Patient #4 revealed that she was admitted to the facility on [DATE], with two controlled substances in her possession. A medication inventory sheet was completed on 7/4/13, identifying Fioricet 50 milligram (mg)/325mg/40mg tablets, 19 count and Suboxine 8mg filmstrips, 73 count.

On 7/24/13, at 11:00 a.m., a sealed plastic bag, identifying these medications as part of its contents for Patient #4, was observed in an unlocked filing cabinet located in the locked medication room on the 200 wing unit. The Director of Nursing (DON) was present at this time. She acknowledged that the file cabinet was not and could not be locked. She continued to state that the medication room was kept under double lock at all times.

This medication room was observed again at 12:00 p.m. on this date. Patient #4's sealed bag of medications, listing 2 controlled substances (Fioricet and Suboxine) was observed again in an unlocked file cabinet. A Drug Enforcement Administration (DEA) agent and the DON were present at this time. The DEA agent advised the DON that the unlocked file cabinets (2), containing "end user" medications including controlled substances, needed to be locked.

At 4:30 p.m., this medication room was observed again. The medication room was found to be unlocked. The DON, present at this time, acknowledged that the medication room was unlocked, not secured and unattended. The file cabinet, with #4's sealed bag of medications (including 2 listed controlled substances), was again found to be unlocked.

2. Review of the medical record for Patient #10 revealed that she was admitted to the facility on [DATE], with 1 controlled substance in her possession. A medication inventory sheet was completed on 7/14/13, identifying Alprazolam 0.25mg, 169 and 1/2 pills.

On 7/24/13 at 11:00 a.m., a sealed plastic bag, identifying this medication as part of its contents for Patient #10, was observed in an unlocked filing cabinet located in the locked medication room on the 200 wing unit. At 12:00 p.m., the same was observed in this same location. At 4:30 p.m., a third observation found the medication room unlocked and the file cabinet, containing this medication, continued to be unlocked. Now, this controlled substance was not secured in any manner.

A count of patients, with confiscated medications in sealed bags in 2 unlocked filing cabinets in this location, was done at 4:30 p.m. on this date. It revealed a total of 47 patients with sealed bags of medications; some containing controlled substances.

.