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Based on record review, observation, and interview the CAH (Critical Access Hospital) failed to follow the written policies governing Pharmacy Services when preparing (admixing) antibiotic solutions for IV (intravenous) therapy for medications ordered for patients as evidenced by the nurses failing to adhere to aseptic practice and pharmacy protocols.

Findings:
A review of the CAH Pharmacy Department policy titled, "Medication Administration", provided by administration as a current policy, revealed in part: Medications will be prepared immediately prior to administration. Medications will be administered by the person preparing the medication. LPN's (Licensed Practical Nurses) who have documented competency may hang piggy backs to existing infusions.

A review of the CAH Pharmacy Department policy titled, "Preparation and Sterilization of IV Admixtures", provided by administration as a current policy, revealed in part: Aseptic technique involves manipulating sterile products without compromising their sterility and maintaining conscientious work habits. Sterile Compounding Areas: wash hands and arms before compounding. Scrub hands, nails, wrists, forearms to elbows for at least 30 seconds with a brush, warm water, and appropriate bactericidal soap. Before preparing IV admixtures, the work surface should be thoroughly cleaned with alcohol. All admixtures should be labeled with a BUD (beyond use date) /expiration date.

A review of the Staff L's 2018 Drug Room Education and Competency Assessment: Aseptic Technique, dated 10/22/18, was performed by Staff X and included observations and evaluations. Staff L's skills observed and evaluated by Staff X and marked with "M" (skill standard met) included in part: Entry into controlled area performed with minimal contamination of gloved hands. Removed any supply items not needed from hood/isolator. Disinfected work surfaces with designated cleaning. Arranged items more than 6 inches within aseptic area and 5 inches from each side. Performs manipulations only in direct compounding area of the hood, meticulously conducting aseptic processes so that exposed critical sites are always directed into the air stream.

An observation on 01/15/19 of the Medication (Drug) Room revealed an 18 inch by 18 inch squared off area marked by red tape, which was the designated area for IV preparations with admixtures. There was no hood or isolator observed in the Medication (Drug) Room.

An observation on 01/15/19 at 11:00 a.m. of the Drug Medication Room revealed a prepared IV antibiotic solution located in the red squared off area on the counter. A review of the label on the IV antibiotic solution revealed no BUD noted. There was no nurse observed in the medication room at this time.

In an interview on 01/15/19 at 11:05 a.m. with Staff L she indicated she had prepared the antibiotic IV infusion (as observed by the surveyor on the counter earlier) earlier for a patient's infusion for later that morning. Staff L indicated that the red squared off area was the designated area for preparing IV infusions for patients with admixtures.

An observation on 01/16/19 at 2:20 p.m. of Staff L preparing an antibiotic (admixture) IV infusion for a patient, revealed the following: Staff L disinfected the designated red squared off area with an EPA (environmental protection agency) disinfectant wipe for 45 seconds instead of the 2 minutes per the manufacturer's IFU (instructions for use). Staff L washed her hands only with soap and water for less than 30 seconds and did not use a brush. She did not don any gloves before preparing the IV antibody infusion. Staff L reconstituted the antibiotic by withdrawing 10 ml (milliliter) from the IV solution bag and then reentered the IV solution bag again to inject the reconstituted antibiotic admixture. After completing the process, she indicated that she did not have to put a BUD on the label since she was planning to administer it within 30 minutes. There was no hood or isolator observed being used during this observation.

In an interview on 01/17/19 at 2:30 p.m. with Staff X she indicated that she performed the 2018 Competency Assessment on Staff L for aseptic technique in the preparation of IV infusions with admixtures. Staff X indicated that she marked a "M" on her assessment sheet as an observation under a hood even though the CAH did not have a hood or an isolator. Staff X indicated that the red squared off designated area was sufficient. Staff X further indicated that Staff L should have donned gloves and that Staff L should not have used the IV solution in the bag as the solvent for the antibiotic.

Based on observation, interview and record review the CAH:
a) Failed to have a facility-wide system in place for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in all of the CAH's services, as evidenced by failing to have infection control active surveillance components that included data collection and analysis, monitoring, and evaluation of preventive intervention in the following CAH services; Radiology, Nursing Services, Laboratory, and Rehabilitation Therapy Services, and
b) Failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases in all areas of the CAH as evidenced by multiple observations of infection control breaches.

Findings:
a) Failed to have a facility-wide system in place for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in all of the CAH's services, as evidenced by failing to have infection control active surveillance components that included data collection and analysis, monitoring, and evaluation of preventive intervention in the following services; Radiology, Nursing Services, Laboratory, and Rehabilitation Therapy Services.

On 01/16/19 at 2:45 p.m. with Staff F, a review was conducted of the Infection Control Program binder. There was no documented evidence in the Infection Control Program binder of active surveillance activities being conducted in the following CAH services; Radiology, Nursing Services, Laboratory, and Rehabilitation Therapy Services.

In an interview on 01/16/19 at 4:20 p.m. with Staff F he indicated that he was not conducting active surveillance activities that included data collection and analysis, monitoring, and evaluation of preventive intervention in the following CAH services; Radiology, Nursing Services, Laboratory, and Rehabilitation Therapy Services at this time. Staff F indicated that his last annual infection control risk assessment was conducted at least 3 years ago. Staff F had no further documented evidence to present.


b) Failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases in all areas of the CAH as evidenced by multiple observations of infection control breaches.

The following infection control breaches were identified in various departments/services within the CAH:

1) On 01/15/19 at 10:00 a.m. an observation in the U/S (ultrasound) room in the Radiology Department revealed the transvaginal ultrasound probe had been processed in theTrophon 2 (High Level Disinfecting solution) on 11/07/18 according to the date on the package.

A review of the CAH's Radiology Department policy titled, "Cleaning and Disinfecting Ultrasound Transducers", provided by administration as a current policy, revealed in part: After the transvaginal probe is removed from the Trophon 2 (High Level Disinfecting solution), it should be placed in a protective probe cover. If not used within 7 days, the (Trophon 2 High Level Disinfectant) process should be repeated.

In an interview on 01/15/19 at 10:20 a.m. with Staff D he indicated that the transvaginal ultrasound probe was last processed on 11/07/18 and should be reprocessed every 5 days if not used. Staff D indicated that he had not reprocessed the transvaginal ultrasound probe since the last reprocessing date noted on the package.


2) On 01/15/19 an observation of additional infection control breaches were identified:
- A dirty cleaning brush located in the Clean Linen Room
- A cardboard box on the floor in the Clean Linen Room containing clean patient supplies
- A red plastic biohazard bag containing soiled biohazard materials on the shelf in the Soiled Linen Room, instead of being placed in the designated Biohazard Room
- A trash can in a patient room, who was on droplet precautions, being located in the back corner of the room for staff to place PPE (protective personal equipment) in prior to exiting the room
- No designated isolation cart outside of a patient room, who was on contact precautions
- A non-disposable stethoscope being located in a patient room, who was on contact precautions, instead of the designated disposable stethoscope
- No designated red pack (containing the disposable stethoscope, blood pressure cuff, and thermometer) located in a patient room, who was on contact precautions
- Expired cottage cheese x2 in the patient's nourishment refrigerator in the Patient Supply Room. Individual loose ice creams in the freezer compartment with no expiration date on them
- Outdated supplies (electrocardiogram pads x2, calcium alginate dressing x4) located in the Patient Supply Room
- A sterile staple skin remover that had been opened and put back into the container in the sterile supply drawer
- A blood pressure cuff hanging from the blood pressure machine that was worn and torn in several areas
- Opened and used ointments in a treatment drawer in the Patient Supply Room

In an interview on 01/15/19 at 3:30 p.m. with Staff (B,H) they indicated that the CNA's (certified nursing assistants) were responsible for checking expired and outdated patient supplies in the Patient Supply Room and checking outdates in the Patient Nourishment Refrigerator and that all patient food items should be dated with expiration dates.

In an interview on 01/16/19 with Staff U, she indicated that all foods items for patient use should have an expiration date on them. An observation in the Dietary Department freezer revealed the ice cream box was dated with an expiration date and not the individual ice creams themselves. Staff U indicated that each individual ice cream should have been dated with the expiration date present on the box.



3) On 01/15/19 - 01/17/19 throughout the survey, there were multiple observations and interviews regarding the use of the CAH's EPA (environmental protection agency) disinfectant cleaner.

A review of the manufacturer's IFU (instructions for use) for the EPA disinfectant cleaner utilized in the CAH revealed the following: Unfold a clean wet wipe and thoroughly wipe the surface allowing the surface to remain wet for a full 2 minutes. Reapply as needed to allow the area to remain wet for the full 2 minutes. Let air dry.

In interviews on 01/15/19 - 01/17/19 with multiple staff from Nursing, Radiology, Rehabilitation Therapy, and Environmental Services, Staff ( D, J, K, L, N, T, O, Q, R, S, W) indicated that the EPA wipe did not stay wet for the entire 2 minutes with using only one EPA wipe unless they used another EPA wipe. The above staff also indicated that they did not use another EPA wipe and that they allowed the area to dry after using only one EPA wipe, regardless if it was wet for a full 2 minutes.



4) A review of the CAH Infection Control Department policies revealed no policy on glucometer cleaning/disinfecting. Staff F only provided the surveyor with a printout for the cleaning protocol for the glucometer printed from the manufacturer's procedure manual. This printout was not a current policy of the CAH's Infection Control department.

A review of the glucometer's manufacturer's IFU (instructions for use), as provided by Staff F, revealed in part: All glucometers will be cleaned and disinfected using *Clorox Germicidal wipes or equivalent. Use a fresh wipe each time. Wipe all surfaces, top, bottom, and sides, avoiding the bar code scanner and electrical connection. All to air dry before using on next patient.

In an interview on 1/16/19 at 3:20 p.m. with Staff F, he indicated that there was no CAH infection control policy on glucometer cleaning and disinfecting, so he pulled up the manufacturer's IFU and presented it to the surveyor. He further indicated that the EPA disinfectant noted on the manufacturer's IFU was not the one currently used by the CAH for glucometer disinfection.



5) A review of the CAH Rehabilitation Department policy titled, "Therapy Services-Hot Packs", provided by administration as a current policy, revealed in part: Check the hydrocollator unit for proper water temperature and water level. The water temperature should not exceed 165 degrees Fahrenheit. Remove the appropriate size pack from the hydrocollator unit. Place a towel over the patient area to be treated and then the hot pack wrapped in towels. A further review of the policy revealed no routine laundering instructions for the hot pack covers or laundering instructions if they came in contact with patient skin or when they became soiled. Staff H later provided the surveyor with a printout with the cleaning instruction for the "Terry Hot Pack Covers" from the manufacturer. The printout revealed in part: All covers are machine washable. Use mild detergent in cold water, gentle cycle and lay flat to dry. Do not put in dryer. This printout was not a current policy of the CAH's Rehabilitation Department.

An observation of the Rehabilitation Department hydrocollator revealed no evidence of the water temperature being monitored by the therapy staff and no temperature probe was noted to be located in the water. A further observation revealed no documented evidence of when the terry hot pack covers were routinely laundered.

In an interview on 01/17/19 at 9:15 a.m. with Staff O, she indicated that she periodically performed a manual temperature check on the water temperature in the hydrocollator every 2-3 months, but she was unable to find the last time she checked the temperature of the water in the hydrocollator. She was asked about the laundering of the terry hot pack covers. Staff O indicated that the department had 8 covers and she takes them home to launder them every week and then hangs them on racks or on cloth baskets in her house to dry.



6) In an interview on 01/16/19 at 4:20 p.m. with Staff V he was asked about the reprocessing of the laryngoscope blades when used in patient care. Staff V indicated that when they are used, he washes them with soap and water and then wraps them in an EPA disinfectant wipe for several minutes and after they dry he returns them to the crash cart. He indicated that when respiratory was on site, they would take care of disinfecting the used laryngoscope blades.

In an interview on 01/16/19 at 4:35 p.m. with Staff E she was asked about the reprocessing of the laryngoscope blades when used in patient care. Staff E indicated that the used laryngoscope blades are disinfected for 30 minutes in 70% alcohol before they are returned to the crash cart.

A review of the CMS 2015 Hospital Infection Control Worksheet, Section 3.A. Reprocessing of Semi-Critical Equipment revealed in part: Semi-Critical equipment are objects that contact mucous membranes or non-intact skin and require, at a minimum, HLD (High Level Disinfection) prior to reuse (i.e., laryngoscope blares).

A review of the Spaulding Classification for Medical Devices indicated that semi-critical devices in contact with mucous membranes or non-intact skin (i.e., laryngoscope blares) require HLD (High Level Disinfection).


In an interview on 01/16/19 at 4:45 p.m. with Staff F, the above multiple infection control breaches were discussed with him. Staff F indicated that he was not aware of the above infection control breaches identified by the surveyor.

Based on record review and interview the CAH Radiology Department failed to adhere to their written policy governing radiologic requirements when performing CT (computerized tomography) with contrast as evidenced by failing to have at least 2 co-workers in attendance during all CT procedures involving the injection of contrast material and failing to document test dose observations.

Findings:
A review of the CAH Radiology Department policy titled, Protocol for IV (intravenous) injection of contrast material during CT scan procedures, provided by administration as a current policy, revealed in part: Observation of the IV site by the (radiology) technician for the first 10-20 seconds of the injection. The policy further revealed: Anytime a CT is done with contrast, at least 2 co-workers will be in attendance. After hours, a licensed person will accompany the (radiology) technician.

A review of the CT log from 09/26/18 to present revealed that 36 of 79 CT procedures with contrast were performed with no documented evidence of 2 persons being in attendance during those procedures. A review further revealed no documented evidence that a test dose observation was documented.

In an interview on 01/16/19 at 12:10 p.m. with Staff (D, J, K) they were asked about the CT with contrast log sheet and where only one person was documented during the procedure. They indicated that they try to have 2 (two) people present, but at times there was only one person present. Staff (J, K) indicated that this occurred mostly on the night shift. Staff D indicated that a test dose is automatically performed through the CT contrast machine, but the technicians do not document it anywhere on the CT log.