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Based on observation, policy review and staff interviews the Critical Access Hospital (CAH) failed to ensure annual certification and testing of the Laboratory Fume Hood (Ventilated enclosure use in laboratories to collect and exhaust contaminants).

The Fume Hood moves contaminated fumes through the duct work into an exhaust duct to be removed by a centralized blower. The failure to ensure annual certification and testing of the Laboratory Fume Hood according to the operating instructions, could potentially cause serious injury or illness through inhalation or physical contact with various bacteria and hazardous chemicals used during laboratory testing.

The Laboratory Manager stated an approximate average of 12 cultures per day are performed in the laboratory under the fume hood.

Findings include:

1. During Laboratory tour on 9/8/2016 at 1:50 p.m., an observation revealed the Fume Hood lacked a test/certification label. Staff A, Med Lab Tech, stated the fume hood lacked a label to identify when the last certification/test and thought the label should be on the fume hood. Staff A stated the fume hood should be done annually and a record kept but staff was unable to locate the log at this time.
Review of the daily maintenance log and daily maintenance log for blood bank lacked any mention of a routine cleaning, annual testing or certification of the fume hood.

Review of the Laboratory Quality Assurance policy effective 9/13 revealed Calibrations: 1. "Calibrations are performed in accordance with manufacturer's recommendations or as needed."

Review of the General Fume Hood Operating Instructions revealed, Warning: Before using this fume hood, consult the owners industrial hygienist or safety representative to make sure...2) the fume hood has been tested after installation and routinely thereafter to ensure the fume hood is providing the proper containment for the specific chemicals and processes being used...
Failure to follow these instructions could results in physical injury or illness:
13) It is recommended this fume hood be tested and certified annually by the owner according to applicable industry and government standards.

In an interview on 9/13/2016 at 8:10 a.m., the Laboratory Manager confirmed the fume hood failed to receive service since installation in 2008. The Laboratory Manager stated currently email communication for a service to test and certify the Fume Hood have been started.

On 9/12/2016 the Laboratory Manager provided a signed typed statement that included the following: 1. The laboratory is unable to provide records of annual testing and certification of the fume hood located in the Microbiology area.

Based on observation, staff interviews, and CAH policy and procedure, the provider based clinic failed to maintain an inventory log of a Schedule III medication, Stadol (Butorphanol injectable-narcotic). The Clinical Director identified an average daily census of approximate 85 patients.

Failure to maintain an inventory log of a Schedule IV medication could potentially lead to unidentified drug diversion and/or leaving patients without adequate pain medication.

Finding include:

1. During initial tour of the Hospital Based Clinic on 9/12/2016 at 12:10 p.m., observation in the locked sample drug room revealed 2 vials of Stadol 2 mg (milligrams)/ml (milliliter) in an unlocked cupboard. Staff B, Registered Nurse, (RN) identified the vial of Stadol as a narcotic used mainly for migraine headaches. Staff B stated the clinic staff failed to maintain a log on this drug for when or how much they received, how many removed for administration or how many vials are on hand at any given time. Staff B stated Pharmacy replenishes the Stadol when a nurse uses the last vial and request replacements.

Review of the medication Stadol (Butorphanol), noted this to be an opioid narcotic used in the management of chronic pain for adults in outpatient setting.

Review of the Pharmacy Examiners Chapter 10, Controlled Substances 10.34(2) noted Schedule III, IV and V records. Inventories and records of controlled substances listed in Schedules III, IV, and V shall be...in such a form that the required information is readily retrievable from the ordinary business records of the registrant.

Review of the CAH Pharmacy Policy and Procedure RX-254.07 effective date 5/16 revealed the following:
7) ...The pharmacy control number on the controlled substance administration record corresponds to the page and line number in the pharmacy perpetual inventory where the drug was signed out prior to delivery to the unit.
9) In a non-Pyxis area, controlled substances are obtained by nursing staff from the locked storage area. The nurse administering the medication must complete the controlled substance drug administration record for that medication with the administration date and time, patient name, actual quantity used, physician name and nurse that administrated.
10) When all medication have been signed off a particular controlled drug administration record/sheet, it is returned to the pharmacy where it is reviewed, filed and retained for the appropriate length of time.

During an interview on 9/13/2016 at 2:30 p.m., the Pharmacist Manager stated when the clinic needed more Stadol the nurse notified the pharmacy and a supply of one or two boxes (each box contained 10 2 ml vials), arrived at the clinic. Pharmacist Manager provided documentation of 20 vials of Stadol 2 ml/mg delivered to the Clinic on 3/23/2016. The Clinic Manager confirmed the lack of documented evidence of the medication being received and/or used.

During the 9/13/2016 interview the Pharmacist Manager confirmed the nurse administering the medication failed to complete the controlled substance drug administration record for that medication for the pharmacy to review. The Pharmacist Manager provided a signed typed statement stating: Butorphanol injection (Stadol) is stored in the clinic medication room without controlled substance medication dispensing record to track inventory use, doses administered to patients and the waste of any unused amounts with waste signatures.

Based on observation, review of policies and procedures, document review, and interview, CAH failed to follow manufacturer's directions and chemical indicator processor's directions for cleaning 1 of 1 colonoscopes (flexible cameras allowing a physician to view the colon, and detect abnormalities during a colonoscopy). The CAH operating room staff identified approximately 56 colonoscopies for the past 3 months and the staff performed approximately 19 endoscopies for the past 3 months[procedures where a physician introduces a camera into either the esophagus or stomach].

Failure to follow the manufacturer's directions for cleaning the colon/endoscopy scopes could potentially fail to remove all infectious material, or material allowing infectious organisms to grow, potentially resulting in the transmission of infectious organisms between patients, and result in the spread of infectious diseases.

Findings include:

1. Observations made of Staff F, Surgical Technician, cleaning the colonoscope in the scope cleaning room after a Patient #1's colonoscopy on 9/13/16 at 9:03 a.m., revealed Staff F placed the Colonovideoscope in the Steris I System 1 E Processor. Prior to closing the processor Staff F removed a chemical indicator test strip from a bottle of processing strips. Observation of the bottle revealed the container lacked documentation of the date when surgical technician staff opened the bottle. During an interview at the time of the observation Staff F said the test strip are used in the Steris Processor to assure sterilization of scope instruments. Staff F stated the hospital educated all surgical technician staff to date the bottle when opened and dispose any remaining strips after 6 months. Staff F acknowledged surgical technician staff failed to date the Steris System 1 E Processor strip bottle when they opened it and there were 31 of 60 test strips left.

2. During an interview on 9/3/16 at 10:15 a.m., Staff E, OR (Operating Room) Nurse Manager acknowledged surgical technician staff failed to document the test strip bottle when opened and stated she intended to remove the bottle immediately from the area and replaced it with a "dated" new test strip bottle.

3. Review of Manufacturer's Directions for chemical indicator for System 1 E Processor revealed the following in part, "...If a new bottle is being opened, record the date it was first opened and the new 6 month expiration date on the bottle."

4. Review of CAH policy/procedure titled "Steris Sterilization Usage" dated 10/15, revealed the following in part, "...The purpose is to assure proper usage and function of the Steris sterilizer and to assure sterilization of scope instruments."

5. During an interview on 9/13/16 at 1:10 PM, Staff D, Infection Control Nurse acknowledged surgical technicians failed to follow manufacturer's directions to date the Steris Test Strip bottle when opened. Staff D stated it was important to follow these directions from an infection control perspective in order to assure the instrument are sterilized appropriately and safe for use.

6. During a follow up interview on 9/13/16 at 1:15 PM, Staff E confirmed surgical technician received training stated, "In this case apparently they were remiss." When asked why it was important to date the Steris Test Strip bottles when opened, Staff E said it assures the scopes are properly sterilized and tested to prevent infections because the scope was not processed properly.

7. Review of documents presented on 9/14/16 by Staff E revealed the following in part, "...after the colonoscope is manually cleaned and leak tested it is placed in the System 1 E by the following process...the indicator strip is used as a first line quick visual that the colonoscope went through a liquid and chemical and heat sterilization...education to this process in completed on the orientation checklist under the heading of sterilization, subcategory Steris I E: indicators, sterilant, record...this is signed off when the individual demonstrates the task to the preceptor (s)."

Based on review of policies/procedures, document review, and staff interview, the CAH credentialing specialist staff failed to include 1 of 1 Physician/Ophthalmologist (Physician A), in their external peer review process to evaluate appropriateness of diagnosis and treatment furnished at the CAH prior to re-appointment.

The credentialing specialist identified 193 surgical procedures performed by Physician A for the past 10 months.

Failure to ensure an external entity evaluated the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH could potentially result in medical staff misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of Medical Staff Rules and Regulations, Section titled "Policies and Procedures Credentialing" approval date 12/15, revealed the following in part, "...In arriving at recommendations for reappointment of each medical staff member and the assignment of privileges, specific consideration shall be given to the practitioner's professional competency and clinical judgement in the treatment of patients...Reappointment policies include the periodic appraisal of the professional activities of each member of the medical staff with clinical privileges in the hospital."

2. Review of CAH policy/procedure titled "Ongoing Professional Practice Evaluation (OPPE)" effective 2/1/15, revealed the following in part, "...ongoing professional practice evaluation will be completed as part of the bi-enneal reappointment process, Each provider...will have two percent of their cases in each department per credentialing period reviewed...the reports will be returned...from the external entity quarterly...OPPE data will be collected by Credentialing Specialist per practitioner."

3. Review of peer review documentation for the past 24 months revealed the CAH failed to ensure a qualified entity completed peer review for Ophthalmology Physician A prior to reappointment.

4. During an interview on 9/14/16 at 11:20 a.m., Staff C, Credentialing Specialist acknowledged the information from the external review process was included in the practitioner's credential files and available for review by the medical staff and the governing body at the time of reappointment. Staff C acknowledged she failed to complete external peer review at the time of Physician A's reappointment. She admitted she discovered the error 2 months after medical staff and the governing board approved Physician A's reappointment.

Therefore, the medical staff and governing body lacked information from the external peer review process, including the quality and appropriateness of the diagnosis and treatment furnished by doctors at the CAH, in the physician's credential files at the time of reappointment for 1 of 1 Ophthalmology physicians.