| 28 |
KULA HOSPITAL |
125003 |
100 KEOKEA PLACE |
KULA |
HI |
96790 |
2017-04-21 |
425 |
F |
0 |
1 |
1M3411 |
Based on observations, interviews, and policy reviews the facility failed to utilize the pharmacy for consultation services on all aspects of the provision of pharmacy services in the facility. Findings includes: Cross to F 431 1) On 4/12/2017 at 10:40 AM interviewed Staff #116 regarding the procedure for discarding discontinued narcotics. Staff #116 stated that liquid narcotics are disposed into the drain and the controlled pills are discarded into the sharps container. The policy for disposal of discontinued narcotics was provided by Staff #116 and reviewed. The policy dated 12/12 stated: 1. The director of nursing and the consultant pharmacist will monitor for compliance with federal and state laws and regulations regarding the disposal of medications. The nursing care center should maintain approved containers to separate and securely store different types of pharmaceutical waste until it is scheduled for pick up. b. Authorized personnel who have access to medications should deposit pharmaceutical waste in the appropriately labeled container. Each container used to collect, separate and store each type of pharmaceutical waste will be labeled with the type of waste to be stored in the container. 2. Controlled Substances listed in Schedules II, III, IV and V remaining in the nursing care center after the order has been discontinued are retained in the nursing care center - until destroyed as outlined by state regulation. a. Transfer to a container for release to a pharmaceutical waste contractor, was checked off on the policy. At 1:36 PM the same day interviewed the DON regarding nursing practice for disposal of discontinued resident narcotics. The DON shared the policy for disposal of controlled drugs used on the nursing floors dated 12/12 is old, a new policy dated 5/16 is on line but has not been changed in the PharMerica policy binders used by the nursing staff. At 1:41 PM the same day interviewed Staff #108 regarding disposal of narcotics procedure. Staff #108 stated the narcotics are popped out of the blister pack and thrown into the sharps container, sometimes the pills are crushed. The liquid narcotics are poured onto a paper towel and discarded. Later that afternoon contacted the pharmacist consult (Staff #181) for the facility. When asked the recommendation and policy for disposal of controlled medications at the facility Staff #181 shared, the pharmacist does not have a role in narcotics disposal, once the medication leaves the pharmacy it belongs to the resident, nothing is returned to the pharmacy. Upon request from the facility pharmacy can advise the facility on discarding controlled medication. When informed about the practice of throwing away discontinued narcotics in the sharps containers or down the drain Staff #181 stated, we don't look at that; we are more concerned with out of date drugs. A review of the pharmacy contract titled 'Hawaii Health Systems Corporation Agreement for Goods or Services Based Upon Competitive Sealed Proposals states 2.12 Provide experienced, trained Geriatric Consultant Pharmacist to perform the following services: As per CMS requirements provide assistance with tracking, destroying; and reconciling unused controlled substances. Failure to provide pharmacy consultative services for discontinued controlled substances may potentially provide opportunity for misuse of controlled discontinued substances. 2) On 4/12/2017 at 10:40 AM reviewed the temperature log on the 3rd floor of the facility. The log titled MEDS Refrigerator/Freezer Temperature Log was printed REFRIGERATOR STANDARD: 33 degrees - 40 degrees FAHRENHEIT. The recorded refrigerator temperatures for (MONTH) (YEAR) was found to be documented at 34 degrees on (MONTH) 7 and (MONTH) 8, and at 35 degrees on (MONTH) 12, (YEAR). The refrigerator contained some of the following medications and amounts: Calcitonin Salmon Nasal Solution 1 box; Cathflor Activase a 2 mg vial; Biscodyl Suppository 13 packets; Acetaminophen Suppository 10 packets; Octreotide 50 mcg one box; Ativan vials, 4 bags with 5, 3, 5, and 5 vials per bag. The printed manufacturers label recommended temperature storage at 36 - 46 degrees for the Octreotide, Calcitonin Salmon Nasal Solution and Ativan. The temperature log was concurrently reviewed with Staff #116. Staff #116 provided a printed copy of the facility policy titled, Refrigerator/Freezer Temperature control and Maintenance. The policy stated: Refrigerator standard range if 33 degrees to 40 degrees Fahrenheit. On the same day at approximately 11:06 AM the temperature logs for the 4th and 2nd floors were reviewed. Observed that all the units were using the same standard log with the incorrect temperature range of 33 to 40 degrees Fahrenheit. The refrigerator on the second floor was observed to have the following medications and amounts: pneumococcal vaccine premeasured syringes one box; Calcitonin Salmon Nasal Spray 1 box; Influenza premeasured syringes 1 box; Tetanus 2 vials, and Ativan 3 vials. On 4/12/2017 at 1:49 PM pharmacy consultant (Staff #181) was interviewed by phone and asked about the effect of the drug temperature being at 35 degrees when the manufacturers recommendation is at 36 degrees. Staff #181 stated, one degree is not going to matter, even if the package says 36 degrees, it is OK. When asked if the manufacturer could be consulted for the medications found on the 2nd and 3rd floors stored below the manufacturers recommendation, Staff #181 stated a call would be made to the manufacturer but a response would not be available for a few days due to the time zones. Later that afternoon interviewed the DON regarding the discrepancy on the facility medication temperature log, the facility policy for refrigerated medications for storage range of 33 - 40 degrees versus the manufactures recommendation for refrigerated medications to be stored at 36 - 46 degrees. Also the concern for the efficacy of the medications stored out of temperature range. The DON shared the policy and logs were revised on 12/2016. Requested copies of the temperature logs for the past 4 months from (MONTH) (YEAR) to (MONTH) (YEAR) from all the nursing units for review. On 4/13/2017 at 3:49 AM contacted the drug manufacturers Merck, for the pneumococcal vaccine; Phizer for the Ativan vials; and Sagent Pharmaceuticals for the Octreotide vial. Each manufacturer interviewed was asked about the efficacy of the drug when stored below the recommended 36 - 46 degrees. Ativan stored below 36 degrees had no information or recommendations of use. The Octreotide drug stability studies indicated the drug was stable up to 3 months under the accelerated conditions. Accelerated conditions are described as below 36 degrees. The pneumococcal vaccine efficacy was determined by the total number of hours kept below the manufacturers recommended temperature. On 4/13/2017 at 7:30 AM obtained from the DON the collection of medication refrigerator temperature logs from (MONTH) (YEAR) to (MONTH) (YEAR) for the entire facility, which had been requested from the DON on 4/12/2017. The following temp logs provided were missing: 4 North - missing (MONTH) (YEAR) and (MONTH) (YEAR); 3rd floor - missing (MONTH) (YEAR). Review of the 2nd floor refrigerator log found that the pneumococcal vaccine had been stored below 36 degrees for 216 hours from Jan - (MONTH) (YEAR). At 7:48 AM spoke to the Merck manufacturer consultant by phone regarding the 216 hours the pneumococcal vaccine was stored below 36 degrees. Per the manufacturers recommendation, given the number of hours kept below 36 degrees the recommendation was not to administer the vaccine to any patients and remove the vaccine from inventory. The manufactures advise was shared with Staff #108 and the DON. Review of the facility policy for potency of medications titled Refrigerator/Freezer Temperature control and Maintenance date effective 12/2016 found that the policy was not signed as approved and reviewed by a PharMerica consultant. Review of the contract agreement between HHSC and the Pharmacy Corporation of America states: 2.0 Contractor Requirements. The contractor shall provide Long Term Care Pharmacy services pursuant to the provisions specified below: 2.1 Provide the facility with a comprehensive range of professional pharmaceutical services related to the use, storage, distribution and administration of medicines. Inconsistency of nursing staff practice in the proper disposal of controlled drugs; failure to update the PharMerica binder used on the floors by nursing staff on the disposal of controlled drugs; and failure to provide consultative pharmaceutical service for policy development and review in the area of medications stored in refrigerator/freezer has the potential for pharmaceutical errors. |
2020-09-01 |