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Based on observation, interview, and document review, the Critical Access Hospital (CAH) was found to be out of compliance with Life Safety Code requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to Life Safety Code Inspection tags: K-0321; K-0343; K-0345; K-0363; K-0918; and K-0923.

Based on observation, interview and record review, the facility failed to implement daily reconciliation and/or timely destruction for 4 of 4 controlled narcotic medication carpuject syringes (diazepam) which were expired and located in the attached clinic (Sanford Luverne Clinic (SLC)). This has the potential to affect all patients receiving care at the clinic.

Findings include:

During observation on 5/21/18, at 11:08 a.m. in the SLC a locked narcotic box affixed to the wall at the nurses station contained four carpujects (pre-filled syringes) of controlled narcotic expired medication (diazepam) dated with an expiration date of 12/17 (5 months previously).

When interviewed on 5/21/18, at 11:10 a.m. registered nurse (RN)-C explained the noted medication (diazepam) was awaiting destruction by the clinical operations supervisor (COS)-A. RN-C stated being unsure the reason the medication had not been removed/destroyed since the expiration date December 2017. The COS was ill and unavailable for interview. RN-C indicated the process at the clinic included placing expired medications in the locked box, notifying the COS and submitting the medication log. However, documentation was lacking to indicate the medication had been removed from service nor had any medication reconciliation occurred from December, 2017 thru 5/21/18, to verify the medications had been secured and maintained.

During interview on 5/21/18, at 11:15 a.m. with RN-D regarding the noted expired medications, RN-D stated the nurse who identified the expired medications will notify the COS who talked with the pharmacist about destruction and "They handle that. We don't count it after that." RN-D stated the clinic procedure required daily counting of all other narcotic controlled medications.

During interview on 5/21/18 ,at 4:10 p.m. with clinical director of operations (CDO)-B regarding the noted expired medications revealed she was unaware these remained stored in the clinic. CDO-B stated the COS orders a form from the Drug Enforcement Agency (DEA) to destroy these drugs and they were not available at the time the medications were expired. She agreed these medications should have been counted daily until destruction per clinic procedure.

During interview on 5/22/18, at 12:08 p.m. registered pharmacist (RPh)-A indicated the expired medications should have been destroyed immediately by the COS, or the COS should have contacted RPh-A. She stated she would have destroyed the medications located in the clinic if the necessary forms were not available at the time. The time frame between removing an expired controlled narcotic medication from service and the actual destruction should entail daily documentation to prevent potential diversion.

Review of the document titled, Clinical Controlled Substance Count Sheet indicated the diazepam was removed from the in-use medications on 11/30/17. These medications had not been reconciled since this date or 173 days. reconciled.

Review of the 11/14/16 Controlled Substances-Handling-Storage of Schedule II, III, IV, and V Medications policy indicated it's purpose was to establish proper procedures for discarding and reconciling controlled (narcotic) medications. Controlled narcotic medications will be inventoried and the count verified each day of clinical operations by two licensed staff. Outdated medications should be destroyed.

Based on observation, interview, and document review, the facility failed to follow appropriate infection control technique in 1 of 1 offsite clinic (Sanford Luverne Clinic) when storing laboratory specimens. The facility also failed to monitor all patients who received services from 1 of 1 surgery department, not seen post-operatively after surgical procedures, or patients not seen by Sanford-based physicians post-operatively for potential surgical-site infection (SSI). Furthermore, the facility failed to follow appropriate infection control in the surgical suite corridor, 1 of 1 procedure room, and 1 of 1 operating room.

Findings include:

(1) Observation on 5/21/18, at 11:08 a.m. in the SLC nurses station indicated one counter was separated by a clear plexiglass partition. The left side had counter space deemed a "clean" area. the right had a sink and was deemed a "dirty" area. On the far left side clean area was a plastic basket. In that basket was a specimen cup in a clear biohazard bag, setting on top of unused biohazard bags.

Interview on 5/21/18, at 11:10 a.m. with registered nurse (RN)-C regarding the above specimen cup storage indicated that specimen cup was awaiting transportation that day to the hospital laboratory. RN-C inspected the contents of the biohazard bag and indicated it was a pap smear specimen. When asked why the specimen was stored on top of clean specimen bags and on the designated clean side of the counter, RN-C stated that was the usual method of storage, "I'm not sure, I guess we [staff] have just always put them there." RN-C agreed the specimen would be considered contaminated and should not be stored on top of clean unused specimen bags, nor on the designated clean side of the counter. RN-C immediately moved the basket to the dirty designated side of the counter.

Interview on 5/21/18, at 3:30 p.m. with the infection control coordinator (ICC)- C regarding the above SLC specimen storage indicated it was her expectation staff stored dirty specimens on the designated dirty side of the counter and not on the clean side, nor in the same basket on top of clean biohazard bags.

Interview on 5/23/18, at 8:35 a.m. with the senior accreditation specialist (SAS)-B indicated the facility had no specific policy/procedure on how staff were to appropriately store used specimen containers in the SLC. The SLC had no infection control policy/procedure. "It would be a professional standard."

(2) Review of the SSI logs and interview at that same time on 5/21/18, at 3:15 p.m. with ICC-C indicated SSI's were not tracked "specifically". If a patient who had previously received surgical services were to come back for a follow-up appointment and have laboratory or radiology tests ordered at the SLC or within the Sanford Health system, ICC-C's software program would "flag" that person for a potential SSI. When asked what criteria was used to determine how long to follow a patient, she stated the facility doesn't have any criteria per say. The software flags patients based on follow-up visits. the ICC-C indicated if a patient had no follow-up visit scheduled with the surgeon, the software would not track any other physician visit. There was no pre-determined timeframe to follow surgical patients for SSI's based on the type of surgery they had received. If a patient did not see a Sanford-based physician, they would not be tracked at all and she would have no way of knowing if that patient developed a SSI post-operatively. She agreed this was an area of concern as not all patients would be tracked under the current system or may not be tracked appropriately.

The facility had no policy/procedure specifically for tracking surgical site infections of post-operative patients.

(3) Observation on 5/22/18, at 8:15 a.m. in the 2nd preoperative (pre-op) room (PO-2) indicated P1 had arrived for his colonoscopy (diagnostic exam where a camera is used to view the colon). RN-A proceeded to begin the process to prepare P1 for his procedure with Physician (MD)-A. MD-A arrived at 8:35 a.m. and assessed P1 while wearing beige colored suede street shoes that were visibly soiled with a dark substance. MD-A completed her assessment and left the room.

Observation on 5/22/18, at 9:00 a.m. in PO-3 indicated P2 had arrived for his surgical procedure (lipoma excision [removal of fatty tumor]) and was being prepped by RN-B for his surgical procedure to be done that day by MD-A. At 9:05 a.m., MD-A assessed P2 wearing the same visibly dirty beige street shoes and marked several sites on both of P2's arms for the procedure.

Observation on 5/22/18, at 9:10 a.m. of P1 as he is being escorted into the sterile surgical corridor by RN-A indicated he was not wearing surgical booties over his personal socks and had not donned a surgical cap prior to entrance of that delineated area. At 9:13 a.m., MD-A entered the procedure room and was wearing the same soiled beige suede street shoes with no surgical booties covering the visibly dirty shoes. At 9:18 a.m., P1's colonoscopy began.

At 9:30 a.m. during P1's colonoscopy, tissue specimens needed to be obtained from P1's colon through the colonoscope. MD-A asked RN-A to hand her the biopsy forceps. The biopsy forceps was packaged in an envelope in a large coil. RN-A, while wearing clean gloves, removed the biopsy forceps from its envelope and handed it to MD-A. RN-A placed the envelope into the garbage affixed to the right side of the procedure cart. Several tissue specimen containers had been placed on top of the procedure cart prior to the procedure. RN-A opened the lid to one of the specimen containers and placed the opened cup and lid on on top the procedure cart.

Continued observation indicated MD-A uncoiled the biopsy forceps and obtained a tissue sample through the colonoscope that was inside P1's colon. MD-A removed the biopsy forceps from the colonoscope and handed it back to RN-A with the tissue sample encased in the teeth at the end of the forceps. RN-A then grasped the now contaminated biopsy forceps coil, turning left to right. The biopsy forceps visibly crossed over the top of the surgical flowsheet that was located on the procedure cart. RN-A proceeded to tap the biopsy forceps several times to loosen the tissue sample from the forceps and drop it into the specimen container that contained formailin, a liquid preservative. Once the tissue specimen had dropped into the specimen cup, RN-A placed the biopsy forceps coil into the envelope that was in the garbage. RN-A proceeded to replace the lid on the specimen container. While still wearing the same contaminated gloves, RN-A grasped her pen, and wrote information on the cup and her flowsheet. Once finished, RN-A placed the pen back onto the procedure cart. RN-A removed her contaminated gloves, placed them into the garbage can with the biopsy forceps, and donned new gloves without sanitizing her hands.

MD-A needed additional tissue specimens and requested the biopsy forceps from RN-A. RN-A grabbed the forceps that was inside the garbage can and handed it back to MD-A. RN-A opened another specimen cup, this time placing the specimen cup and lid on her surgical flowsheet. MD-A once handed the biopsy forceps back to RN-A with the tissue specimen. RN-A proceeded to tap the biopsy forceps several times to loosen the tissue sample from the forceps and drop it into the specimen container that had been placed on top of the surgical flowsheet. Once the tissue specimen had dropped into the specimen cup, RN-A placed the biopsy forceps coil back into the envelope that was in the garbage. RN-A proceeded to replace the lid on the specimen container, grasped her pen, and wrote information on the cup and her flowsheet. RN-A proceeded to move the 2 remaining specimen containers with her contaminated gloves farther back onto the cart, out of her way.

At 9:38 a.m., RN-A placed the used specimen cups inside a biohazardous bag with her contaminated gloves and placed them inside the patients plastic chart and slid the chart under the blanket covering P1. RN-A discarded her gloves, sanitized her hands and donned new gloves. RN-A then grasped the contaminated specimen cups she had moved back farther on the cart, opened the procedure cart, and placed those specimen cups back into the cart, into a box with other clean specimen cups. RN-A removed her gloves, sanitized her hands and proceeded to take P1 out of the procedure room.

Observation on 5/22/18, at 9:45 a.m. licensed practical nurse (LPN)- A began cleaning the P1's procedure room. RN-B entered the room and retrieved the specimen cups box, located inside the procedure room cart and stated P2's surgical procedure would begin shortly. Observed hanging on the wall in the procedure room was an opened Yankauer (suction catheter tip used in emergency suctioning of an airway) connected to suction tubing. It was covered loosely in its original sterile packaging, but that packaging had been opened and could easily be pulled off. LPN-A confirmed the anesthetists liked to keep this opened and available for emergencies although it was no longer sterile.

Observation on 5/22/18, at 10:05 a.m. of P2 as he was being escorted through the delineated sterile corridor by RN-B into operating room (OR)-1 indicated he also was noted not to be wearing surgical booties over his personal socks. Once inside OR-1, he was prepped for his surgery. At 10:10 a.m., that same box of specimen cups removed from the procedure room by RN-B was observed on the counter in OR-1. MD-A entered OR-1 with the same visibly dirty suede beige street shoes with no surgical booties covering them. At 10:15 a.m., the surgery began and MD-A started removing the lipomas from P2's arms. During the removal of P2's lipomas, RN-B gathered the specimen cups with his bare hands, from the same box that was removed from the procedure room. When MD-A removed the first 2 specimens, she handed them to the assisting RN who in turn dropped them into the formalin specimen cup held by RN-B with his ungloved hands. RN-B was not wearing protective eye wear. After each specimen retrieved, RN-B would close the lid, and write information on each cup, identifying its contents. RN-B then donned gloves for the remainder of the numerous specimen collections.

Interview on 5/22/18, at 10:23 a.m. with certified registered nurse anesthetist (CRNA)-C during P2's surgery regarding the Yankauer packaging observed open in the procedure room indicated she confirmed it had been opened and re-covered for staff convenience for an emergency. She was unaware it needed to remain in its sterile pouch. She agreed in its current condition, it would not be sterile, upon entering a patient's airway and would be potential for infection.

Interview on 5/21/18, with the surgical services manager, RN-B, regarding the observations noted above in the surgery department indicated it was his expectation:
(1) If a patient was only having a procedure and not surgery, they did not need to donn a surgical cap or booties, even though they crossed the delineated line designated as a sterile corridor. RN-C stated he had forgotten to ensure P2 wore surgical booties into OR-1.
(2) RN-B was unaware what shoes/coverings MD-A had been wearing as he wasn't aware of what the doctor wore for shoes. RN-B agreed suede shoes would not be appropriate personal protective equipment (PPE) attire in the OR.
(3) Specimen cups once used should not be placed on paper surgical flowsheets as these sheets were handles multiple times by staff after the procedure in the facility.
(4) Specimen cups not used during a procedure or surgery were to be disinfected with the appropriate chemical according to manufacturer's guidelines prior to placing them back inside the procedure room cart.
(5) Contaminated specimen cups were not to be placed inside a plastic chart cover as those plastic chart covers were only cleaned and disinfected once per month and not between patient use.
(6) Biopsy forceps were not to be stored in the garbage can.
RN-B indicated he did not track surgical site infections. RN-B stated that OR staff do an immediate call the following day after the procedure only to assess how well the patient tolerated the procedure.

Interview on 5/21/18, at 3:30 p.m. with the ICC-C regarding the observations in the surgical department noted above indicated it was her expectation:
(1) Both patients and staff should be wearing the appropriate PPE when entering the delineated sterile surgical area that included the procedure room and 2 OR suites. ICC- C confirmed the shoes MD-A were wearing were her street shoes and not appropriate shoes to be worn inside a surgical suite.
(2) Plastic chart covers should be disinfected with the appropriate chemical between each patient use.
(3) Specimen cups once used should not be placed on paper surgical flowsheets as these sheets were handles multiple times by staff after the procedure in the facility.
(6) Biopsy forceps were not to be stored in the garbage can.

Review of the 9/13/17, Surgical Attire policy indicated its purpose was to protect personnel from contamination and lower the contamination from the personal to the patient. Further findings included:
(1) Employee's street clothes were to be removed and stored in designated locker rooms.
(2) All possible head and facial hair should be covered when in the semi-restricted [delineated area] and restricted area [OR suites].
(3) Shoe coverings are not required as long as designated hospital shoes are worn.
(4) All non-scrubbed personnel must wear unsterile gloves when at risk of exposure to infectious material (real or potential).

Review of the 3/26/18, Principles of Sterile Technique policy indicated the edges of a sterile package or container are considered contaminated after it is opened.

Review of the 2/14/18, Tissue Specimen's policy indicated it will be the responsibility of the circulating nurse (RN) to see that each specimen is properly handled, labeled, and transported to the laboratory.

Review of the 10/5/15, Infection Control in Operating Rooms and Same Day Surgery Area policy indicated the OR/SDS [same day surgery] will participate in a surveillance program by reporting a suspected or diagnosed infection in patients to infection prevention.

Review of the 1/12/18, Infection Control Case Finding, Analysis and Reporting System Comparative Nosocomial Infection Surveillance Program policy indicated its purpose was to record and evaluate infections in patients cared for at the SLMC. Infection prevention was to utilize multiple confirmed or suspected illness. Review of positive cultures, scheduled surgeries, readmissions, emergency room visits, physician notes and keywords, antimicrobials, antidiarrheals, and cold remedies were to be reviewed in Sanford Health's electronic medical record system. There was no mention on how staff were to review any information if a patient was not a primary Sanford Health patient, or utilized a non-Sanford based healthcare system for potential post op infection complication visits. The OR supervisor was to review post-op infections to assist in identifying outbreaks, sites, pathogens, and trends. The policy made no mention of how long monitoring should occur for SSI, dependent on the type of surgery or how often it was to occur for a post-op patient at a measurable interval.

Based on interview and document review, the facility failed to provide ongoing nursing assessment for 1 of 3 pediatric emergency room patients (P10) reviewed who experienced a fall.

Findings include:

During review of emergency room records, it was noted that a 1 yr. old (P10) was treated in the emergency department (ED) for head trauma after falling down 9 steps at home into an unfinished basement. The stairs was described as wooden with cinder blocks on both sides. After an initial nursing assessment of the child was performed on 5/3/18, at 9:42 a.m., no further nursing assessments were documented. Nursing documentation identified that P10 was discharged at 11:13 a.m. without any further vital signs and/or neurological checks/assessments performed prior to discharge.

When interviewed on 5/21/18, at 3:30 p.m. the emergency room manager confirmed that documentation was lacking to indicate nursing staff had performed any nursing assessments for P10 after the initial admission to ED. She verified this was not according to facility procedure and explained an assessment should have been completed prior to discharge.

The policy titled, Documentation Guidelines, dated 3/20/18, indicated the minimum guidelines related to nursing assessments required in the ED included the following: on admission (initial), reassess (every 2 hours) and upon discharge. The policy identified these guidelines were a minimum standard; may be done more frequently as per physician order and/or as patient condition warrants.