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Based on observation, document review and interview, the facility failed to ensure that medications located in a crash cart and used for acute medical emergencies, have not expired leading to the potential for poor outcomes for all patients requiring interventions for medical emergencies within the facility. Findings include:

A tour of the Cardiac Rehab unit, located in the basement of the hospital, took place on 05/28/2013 at 3:00 PM with staff B (Chief Nursing Officer) and staff N (Cardiac Rehab Manager). Review of the contents in the emergency crash cart revealed two boxes of Lidocaine HCL 100 mg/50 ml that were beyond the manufacturer's expiration date. One box had expired April 1, 2013 and the second box had expired May 1, 2013. No other boxes of Lidocaine were noted to be available in the cart. Staff B and N both confirmed that the two boxes of Lidocaine were beyond the manufacturers expiration date.

Review of a form hanging on the emergency crash cart titled "Kalkaska Memorial Health Center Crash Cart Check List" read "DO MONTHLY." Documentation on the form revealed that the cart had been checked on the following dates; 11-15-12 and 3-7-13.

Staff N was asked about the frequency for checking the content of the cart for outdates and she stated that "I do it every two months or so."

Further requests for a policy regarding frequency for checking crash carts was made to staff B on 05/29/2013 at 1000. Staff B stated at this time that "In the ED (Emergency Department) I know that the crash cart is checked monthly". She later stated that "the only policy I was able to find for maintaining a crash cart, is specific to the OR (Operating Room)".
Review of the general medication policy number 036.P009 approval date 07/06/2004 titled "Medications-Administration, Dispensation, Storage, Inspection, and Control" V 2 reads on page 2 under Inspection "1. All stock medications are properly labeled and checked monthly for expiration dates by a pharmacy representative. All drugs which are due to expire within one (1) month will be pulled from stock and returned to the pharmacy for use elsewhere".


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On 5/28/2013 at approximately 11:30 during observation of the acute care department the intravenous infusion (IV) area was found to have 22 expired acetylcysteine capsules dated 10/15/12 in a basket available for use.

Interview of staff #2 revealed "we don't use that anymore and that's how it was missed."

Based on observation, interview and document review, the facility failed to ensure that equipment and supplies were monitored, maintained and replaced as needed, resulting in the potential to negatively impact all patient outcomes, who are treated at this facility. Findings include:

On 5/28/2013 at approximately 11:00 am during observation in the acute care department it was found:
1) In the crash cart 5- flex slips that expired 05/2011, 8- provodine swabs that had expired (2- expiration date of 10/2011, 3- expiration date of 08/2011, and 3- expiration date of 10/2012).
2) In the clean supply room, 3- expired evacuated containers/250 ml bottles with a manufacturers expiration date of 5/1/2013.
3) In the lab area 13- green topped lab tubes with a manufacturers expiration date of 6/2012, and 10- expired pediatric blue top lab tubes (7- dated 12/2012, 2- dated 10/2012, and 1- dated 8/2012).

On 5/28/2013 at approximately 2:00 PM during observation in the cardiac rehabilitation department the crash cart was found contain accumulated dust, and contained no documentation of monthly checks.

Interview on 5/28/2013 at approximately 2:00, of staff #2, the chief nursing officer revealed "the crash carts are expected to be checked daily in the acute care areas and monthly in the cardiac rehab area. The clean supply area and the lab area are maintained by the staff, daily and as needed". Staff #2 went on to say "the clipboards located on top of all the crash carts require signatures daily, in the acute care areas and monthly checks in the cardiac rehab".

Based on document review and interview, the facility failed to ensure that accurate records were kept in regards to the disposition of controlled substances, used in the surgical areas. The facility also failed to ensure that staff follow policy and procedure for the witnessing of waste of a controlled substance leading to potential for drug diversion. Findings include:

A review of facility policy on 05/29/13 titled "Munson Healthcare Controlled Substances - Affiliate Hospitals" policy number 062.015 version #3 reads on page 3:
"IV. Documenting Administration of a Controlled Substance
C. Floor stocked Controlled Substances (Acute Care/PACU/Procedure Room-non-Pyxis) 1.d. Signature of the nurse removing dose and any necessary co-signatures for wastage".
Page 4:
"VI. Wastage/Transfer Of Stock
D. Controlled substances or portions of controlled substances that are wasted should have the wasting witnessed by another licensed nursing professional. The wastage shall be noted on the 24 hour controlled substance administration record or disposition record with the quantity administered and quantity wasted noted and the witnessing nursing professional's signature".

Further review of the Munson Healthcare policy titled "Delivery of Anesthesia at Munson Medical Center and at Kalkaska Memorial Health Center" policy number 094.001 fails to address the procedure to be used by Anesthesia for wasting controlled substances.

On 05/29/13, a review of the agreement (contract) for anesthesia services reads on page 4 (j) Records: "The Corporation shall cooperate with the Hospital in keeping and maintaining such records as may be required by the Hospital to enable the Hospital to keep control of and determine the cost of all drugs and supplies related to anesthesia services".

On 05/29/13 at 8:00 AM during a review of the surgical areas, a request was made to staff J, (Manager of OR [Operating Room] Services), to provide documentation of the controlled substance logs utilized for the area. Staff J produced a two-page document dated 5-21-13. Page one was titled "KMCH Recovery Room Controlled Substance Inventory Record" page two contained documentation of five patient's names, who had received a controlled substance from the stored supply. According to the documentation, all five patients were administered both Versed and Fentanyl. Four of the five areas of documentation contained documented waste of Versed and three of the five areas of documentation contained documented waste of Fentanyl. The documentation lacked witness signatures for the documented waste for all five patient-named entries.

On 05/28/13 at 1000 a request was made to staff J to provide controlled substance records from January 1, 2013 to May 28, 2013. Staff J produced a folder with three types of records used in the department to monitor the controlled substance inventory (see key below). A random review of the records revealed the following:

Key:
Operating Room Controlled Substance Inventory Record (ORCSIR)
Recovery Room Controlled Substance Inventory Record (RRCSIR)
Anesthesia Controlled Substance Worksheet (ACSW)

01/03/13 the ORCSIR had an inaccurate count for the Versed 5 ml. Ending inventory count for the day showed the count to be at one; however the review of the documentation for inventory at the start of the day, medications that were added to the count during the day and what was administered during the day revealed that the correct ending inventory count should have been 20. In addition to the incorrect count, of the nine patients that were administered medications, the record lacked documentation of a witnessed waste for one record.

The ACSW for 01/03/2013 also lacked documentation for the "starting count (vials)" and the number "returned to stock (vials)"

01/09/2013 the RRCSIR shows an inventory count of 10 for Fentanyl 2cc 50 mcg. The documentation on the record reads that the first patient was administered 15 mcg and 85 mcg were wasted. Per the documentation, one whole vial plus 35 mcg were wasted, however the count went from 10 down to 9. The second patient on the record was administered 100 mcg of Fentanyl 50 mcg (2 vials) however the count only went down to 8.

The ACSW for 01/09/2013 lacks a starting count and a returned count for the day. The record contained documentation of waste for one full 5 ml vial of Fentanyl with no witness signature it also contained documentation of administration of Fentanyl 2 ml for four patients with no witness signatures for the documented waste. The record also did not have an accurate count for Fentanyl 2 ml lacking documentation of administration or waste for 1 ml.

On 01/23/13 the RRCSIR contained documentation for three patients that were administered controlled medication. All three patients were administered Lortab liquid. The medication came in 15 ml containers. Documentation on the first patient reads that 1 teaspoon (5 ml) was "given" and the count went from 6 to 5. The document does not account for the other 10 ml. Then off to the side it reads "returned." The documentation did not contain any strikes through the documentation of the amount given or the count.
On the same date a document titled Anesthesia Controlled Substance Worksheet (ACSW) shows documentation for waste of Fentanyl 2 ml for two patients with no witness signatures.

01/25/13 on the ORCSIR five patients were administered Versed and Fentanyl. Four of the five areas contained documentation for waste of Versed and one contained documentation of waste for Fentanyl. The documentation lacked witnesses signatures for the documented waste.

An interview was conducted with staff J on 05/29/2013 at 3:00 PM in regards to the inaccurate and incomplete documentation of controlled substance use and wastage on the records. Staff J confirmed the findings and stated that "the records are forwarded to the pharmacy at Munson Medical Center for review and that she had not been informed of any discrepancies". A sit down review with staff J was completed on the above records and further records for the months of February 2013, March 2013, April 2013 and May 2013. Several of the records reviewed for the above months listed contained inaccurate counts for the controlled substances and lacked witness signatures in several places for the documented waste. When staff J was queried as to the process for wasting medications she stated "two staff are suppose to sign for the waste."