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Based on the Life Safety Code (LSC) survey component. A Medicare-participating Critical Access Hospital (CAH), including all component parts or facilities of the CAH, must comply with the applicable LSC requirements.

Please refer to the life safety code deficiencies cited at: Bld: 01 K0355, K0521, K0923, K0926; Bld: 02 K0926; Bld: 03 K0926, for additional information.

Based on observation, interview, and document review, the Critical Access Hospital (CAH) failed to ensure controlled narcotic medications were reconciled in 1 of 3 offsite clinics (Pipestone), to ensure drug storage keys were secured from unauthorized access in 2 of 3 outpatient clinics (Pipestone, Jasper), to ensure a medication solution (Monsel's) was mixed, labeled and used according to manufacturer's instructions in 1 of 3 outpatient clinics (Pipestone) and to ensure multi-dose vials of anesthetic medications were properly labeled when opened/accessed in 1 of 3 outpatient clinics (Edgerton).

Findings include:

During observation on 7/17/17, at 3:30 p.m. in the west and east medication rooms located on the main floor of the Pipestone clinic, it was noted that Tramadol and other controlled narcotic medications had not been reconciled according to clinic protocol. In the west and east medication rooms, reconciliation sheets revealed July 2017's medication counts had only been verified twice by nursing personnel. In June 2017, nursing staff reconciled the controlled narcotic medications 4 times/22 clinic days. In May, nursing staff only reconciled the controlled narcotic medications 7 times/23 clinic days.

When interviewed on 7/17/17, at 3:30 p.m. the clinical director of nursing (DON) and clinical operations director (COD) agreed clinic policy required nursing staff to verify the narcotic medication count each day the clinic was open to ensure accuracy and identify potential diversion.

Review of the facility's policy dated 6/8/16, Controlled Drug Management On Patient Care Units identified it is the responsibility of all units to maintain the integrity of all controlled drugs and make a regular inventory of those drugs during the time they are stored on that unit.

During observation on 7/17/17, at 2:45 p.m. upstairs in the Pipestone clinic obstetrics and gynecology (OB/GYN) area and again on 7/19/17, at 10:00 a.m. in the Jasper clinic with the DON and COD, keys to the medication cupboards were noted to be stored in areas available to unauthorized staff. The keys to the medication cupboard were stored in the following areas: (1) in an unlocked drawer directly above the medication cupboard in the unlocked medication room and (2) in an unlocked medication refrigerator adjacent to the medication cupboard in the open hallway located next to the reception area of the Jasper clinic.

When interviewed on 7/17/17, at 2:45 p.m. both the DON and COD agreed both noted areas used for key storage were easily accessible and did not safeguard from unauthorized access to the drug storage areas.

Review of the facility's 5/26/17, Drug Handling and Storage policy revealed all drugs were to be secured with a lock. Access to those storage areas were to have been limited to pharmacy personnel and on-duty licensed nursing staff. Authorized on-duty nursing providers were responsible for safeguarding keys to drug storage areas outside the pharmacy and for transferring to the next shift.

During observations and interview on 7/17/17 at 2:45 p.m. upstairs in the in the Pipestone OB/GYN area with the clinical DON and COD, a yellow-brown paste-like substance was discovered in the medication cupboard in a specimen cup labeled with "Monsels" on it and an expiration date July of 2018. The DON was unaware what the substance/content was, but thought nursing staff mixed up a solution and left the solution thicken in the cupboard to become a paste consistency. The DON explained the substance was applied internally for some OB/GYN procedures to stop bleeding.

Interview on 7/18/17, at 8:43 a.m. with the registered pharmacist (RPh) regarding the Monsel's solution/paste in the specimen cup noted in the OB/GYN procedure room medication cupboard, revealed she had no knowledge of the rationale for the mixture of medication stored in the specimen cup. The RPh indicated this had been ordered from the manufacturer and delivered to the clinic nurse. The medication (Monsels) contained a form of Iron in a 100 milliliter (ml) bottle. Upon learning that staff had mixed the medication prior to use, the RPh placed a call to the manufacturer whose representative stated this product was distributed as a liquid and did not require any further mixing.

During a subsequent interview on 7/18/17, at 9:40 a.m. the RPh stated Monsels solution was not to be used nor reconstituted into any other form but to be used from the manufacturer's bottle. The RPh explained that some physicians preferred to use a paste version of the medication (Monsel) and if left open to air, the medication would solidify into a paste. The RPh thought this may have been the reason the substance had been mixed and placed in a specimen container.

During interview on 7/18/17, at 9:40 a.m., the clinical DON and the COD, revealed although the OB/GYN physician and nurse were on vacation, they had been able to contact the nurse by phone. They stated she revealed her process as noted: she poured the contents of the Monsel's solution from the manufacture's bottle into the specimen cup and labeled it "Monsel's with a 1 yr expiration. She explained she left the solution on the counter in the procedure room for 3 weeks so it would thicken but would add water to the mixture if it became too thick. The clinical DON and COD agreed that various patients would have been seen in the procedure room during a 3-week time period. They agreed the nurse had not followed manufacturer's instructions and the medication had not been properly labeled and stored.

Review of the facility's 5/25/16, Labeling Standard's policy indicated all drug containers should have been labeled. There was to have been a standard method for labeling and dispensation by pharmacy. The medication was to have been correctly labeled with the name, strength, total volume, date of preparation, use by date, route of administration, and its storage requirements.

Review of the 7/12/17, Medication Preparation policy indicated pharmacy staff were to have prepared the medication if necessary to ensure appropriate technique was maintained to avoid contamination during preparation.

During observation on 7/18/17, at 2:45 p.m. in the Edgerton clinic with the clinical DON and COD and certified medication aide (CMA)-A, there were 3 opened/accessed multi-dose vials located in the medication cupboard which lacked a labeled date when opened/accessed nor did a label indicate "use by date". The medications included: 1 vial of Sensorcaine and 2 vials of Lidocaine (both used as anesthetic numbing medication for procedures).

When interviewed on 7/18/17, at 2:45 p.m. CMA-A indicated all three medication vials were currently available for use and should have been properly labeled when opened and the 'use by dates' identified per policy. The clinical DON and the COD stated the vials were no longer considered multi-use and were single-use only and were to have been thrown away after use.

Review of the facility's 5/25/16 Labeling Standard's policy indicated all drug containers should have been labeled. There was to have been a standard method for labeling and dispensation by pharmacy. The medication was to have been correctly labeled with the name, strength, total volume, date of preparation, use by date, route of administration, and its storage requirements.

The United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals: If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer ' s expiration date. The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used.The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer ' s original expiration date

Based on observation, interview, and document review, the Critical Access Hospital (CAH) failed to store and prepare medications separate from urine and urinalysis testing in 2 of 2 medication rooms located in 1 of 3 outpatient clinics (Pipestone), failed to ensure staff food/drink, medication, and urine specimens were not commingled in 1 of 1 medication refrigerator located in 1 of 3 outpatient clinics (Jasper) and failed to ensure staff properly disinfect the common use glucometer equipment after patient testing for 1 of 1 patient (P1) observed who required blood sugar level testing. These practices had the potential to affect any patients who receive care at the CAH.

Findings include:

During observation on 7/17/17, at 3:30 p.m. in the west and east medication rooms on the main floor of the Pipestone clinic with the clinical DON and the COD revealed a urinalysis (UA) specimen cup filled with urine had been left on the medication counter in the west medication room. When interviewed at this time, the clinical DON and the COD indicated this was common practice as both medication rooms were adjacent to patient restrooms. It was noted that the wall separating the medication room from the bathroom had a pass-through window with a door which opened on each side, making it accessible for bodily fluids (such as urine) contained in a specimen cup to be passed from the bathroom into the medication room. The procedure was explained as: once the specimen was retrieved through the window, staff remove the specimen cup lid, access the contents and perform the testing in the medication room. After completion of the test(s), the contents are poured down the drain in the medication room sink and/or placed into a specimen bag and taken to the hospital lab for further testing. The clinical DON and COD both agreed potential cross-contamination could occur when medications and bodily fluids are prepared/tested in the same area.

Review of the 3/2/2011, Centers for Disease Control and Prevention (CDC), Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injections, https://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html, accessed on 7/19/17, indicated "Medications should be drawn up in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed. Examples of contaminated items that should not be placed in or near the medication preparation area include: used equipment such as syringes, needles, IV tubing, blood collection tubes, needle holders (e.g., Vacutainer® holder), or other soiled equipment or materials that have been used in a procedure. In general, any item that could have come in contact with blood or body fluids should not be in the medication preparation area."

During observation and interview on 7/19/17, at 10:00 a.m. in the Jasper clinic registered medical assistant (RMA)-B indicated the open bottle of water located in the medication refrigerator was staff's personal drinking bottle. RMA-B indicated staff had no choice but to store their food/drink in the medication refrigerator since they had no other available refrigerator. During further tour of the clinic and lab area, it was also noted there was no designated lab refrigerator. RMA-B confirmed lab specimens (UA, stool samples, blood products) would also be stored in the medication fridge. The clinical DON and the COD agreed it was not acceptable to co-mingle staff food and/or lab specimens.

The facility's March 2014, Laboratory Infection Control policy indicated eating and drinking was prohibited within the working laboratory.

The clinics had no specific policy related to storage of medication and/or bodily fluids.


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During observation on 7/19/17, at 11:00 a.m. registered nurse (RN)-A obtained a glucometer from the docking station located at the nursing station. RN-A entered P2's room, checked the blood sugar and immediately returned to the nursing station with the glucometer. RN-A was observed to obtain an individually packaged "PDI" "Super Sani-Cloth" and quickly wiped over the surface of the meter without allowing the meter to remain in contact with the sanitizing solution per the manufacture's recommendation of two minutes. During observation of the cleaning process the germicidal wipe was only in contact with the glucometer for under 30 seconds, (long enough to wipe over the meter's surface). On 7/19/17, at 11:00 a.m.(following completion of blood sugar check), RN-A confirmed the solution was not in contact with the meter for the recommended time period (two minutes) and if needed would have utilized the equipment for the next patient without allowing any additional drying/decontamination time.

Review of the manufacture's written instructions located on the package label of the individually packaged Sani-Cloth indicated the treated surface must have two minutes of continuous wet contact with the germicidal disposable wipe for proper disinfection of the intended surface.

When RN-A, RN-B and RN-C were interviewed on 7/19/17, at 11:15 a.m. all three verified their usual sanitizing practice included obtaining a Sani-Cloth wipe, wiping the surface of the glucometer and then allowing surface to dry. They all agreed it only took approximately 30 seconds or less to dry and confirmed they were unaware of the manufacturer's two minute contact information documented on the packet.

The infection control practitioner (ICP) was interviewed on 7/19/17, at 11:19 a.m. and indicated there was a common use glucometer available at the nursing unit. The ICP indicated it was the expectation that between patient use staff were to cleanse the equipment (glucometer) with either the individually packaged or canister Sani-Cloth wipes. It was verified she was also was unaware of the manufacturer's two minute contact information documented on the label of both the individual packets and canisters of Sani-Cloth wipes.

The facility policy titled, Infection Control-Glucose Monitor Disinfection had a review date of 3/9/17, Make sure the glucometer is off prior to disinfecting after each patient use. Wear gloves and gently wipe the meter's surface with a SANI-CLOTH Germicidal Disposable cloth. Sani-Cloth Plus Germicidal disposable is a single use product that must be discarded after each use. The policy did not address the need for contact time as indicated on the manufacture's recommendation.