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Based on observation, interview, and record review, the hospital failed to store medications according to the manufacturer's guidelines when the observed and recorded temperature for one medication freezer was not within the temperature ranges provided by the manufacturers for the two medications stored in the freezer. This failure had the potential to cause the medication to not be as potent as the manufacturer or prescriber intended which could lead to potential harm for the patients requiring those medications. Findings:

During an inspection of the pharmacy on 1/6/16, at 2:15 p.m., a freezer (ID #515060) was observed to indicate -17° Celsius (C, a measurement of temperature). Two of the medications stored in the freezer were Prostin E2 (dinoprostone, a medication used to terminate pregnancy) and Botox (onabotulinumtoxin A, a medication paralyzing muscles and used to treat muscle spasms).

A review of the medication package insert (a document from the manufacturer providing detailed information about the medication) for Prostin E2, under the section titled "How Supplied", indicated "Store in a freezer not above -20°C (-4°F)."

A review of the medication package insert for Botox, under the section titled "Storage", indicated "Unopened vials of Botox should be stored in a refrigerator (2° to 8°C)..."

During a record review of the freezer temperature log book on 1/6/16, at 2:30 p.m. the temperature recorded for the current day was "-16.8°C." During a concurrent interview, the pharmacy manager confirmed the temperatures were logged by a technician daily and stated "-16.8°C" was the temperature documented that morning.

A record review of the freezer temperature trending by the facility temperature logging system "TempTrak" on 1/6/16, at 2:35 p.m., provided by the pharmacy technician supervisor, indicated the average temperature for every month from January 2015 to December 2015 was between -16.3°C and -19.6°C. There were no months listed where the average temperature was -20°C or below.

During an observation and interview on 1/7/16 at 11 a.m., the pharmacy manager referred to the freezer and stated, "We got it fixed." The freezer was observed to indicate its temperature was -21°C.

A review of the hospital's 12/1996 policy, "Storage: General" and numbered "PTMC-PHARM-0801", indicated "Drugs shall be stored according to the provisions of the official compendia (USP/NF) {United States Pharmacopeia/National Formulary - a book of public drug standards} and/or the specifications of the manufacturer so that their integrity, stability, and effectiveness are maintained."

Based on interview and record review, the facility failed to ensure post-anesthesia evaluations (a documentation completed by an anesthesia provider regarding each patient's degree of recovery from anesthesia and the presence/absence of complications following a procedure) were not completed for two of 23 sampled patients (13 and 15). Failure to document the status of the anesthesia recovery had the potential to adversely affect the care of the patients. Findings:

On 1/7/16, a review of the surgical records for Patients 13 and 15 indicated there were no post-anesthesia evaluations documented in the records.

During an observation and interview on 1/7/16, at 11:55 a.m., the chief operating officer reviewed the records for Patients 13 and 15 and stated there were no post-anesthesia evaluations documented for the patients.

A review of the hospital's 9/2015 policy, "Anesthesia Care", indicated post-anesthesia care consisted of the appropriate management of the patients to include a record of the post-anesthetic evaluations with a notation relating to the presence or absence of anesthetic related complications.