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Based on observation, interview and document review, the hospital failed to ensure 2 of 2 identified incidents (P32 and P34) from Patient Incidents and Concern reports were investigated and acted on in a timely manner.

Findings include:

Patient Incidents and Concerns (also referred to as I Care and incident reports) dated 12/18/12 and 10/30/12 were reviewed. Both incidents were rated on the form as causing no injury to the patients and injury severity was rated as 0000 meaning no apparent injury. Because of the "0000" severity level, they were not investigated, although both patients were at a high risk for significant injury.

P32 received a wrong site nerve block to the ankle, according to an incident report dated 12/18/13. Although the anesthesia care provider reported the incident and noted the patient was not injured, the hospital staff did not follow up to investigate the root cause of the incident to minimize the risk of the problem happening again. The anesthesia care provider noted in the report that although the correct site was marked with a capital "A" the block was administered to the incorrect site due to "distraction." The provider cited a difficult patient work load and other work place issues as causal factors. The investigation of this incident nor the completion of the time out procedure requirement was addressed.

On 1/9/13, at approximately 12:30 p.m. the chief nurse anesthetist and perioperative director confirmed they were unaware whether anesthesia care providers and another staff person should have completed time out procedures for nerve blocks. The chief nurse anesthetist indicated a policy would be provided.

The Safe Surgery Process to Ensure Correct Patient, Correct Procedure, and Correct Site policy dated 11/28/12 to 12/28/12 directed hospital staff as follows: "Final prescriptive safety check involving anesthesia care provider and ideally performed with 2nd team member trained in performing the Anesthesia Time Out; performed just prior to anesthetic block start to verify correct patient, correct procedure and correct anesthesia block site." Page 8 of the policy noted the anesthesia care provider could ask "the patient or patient's representative to verify the procedure, block site and levels (if applicable)."

On 1/09/13, at approximately 12:15 p.m. the vice president (VP) of operations confirmed hospital staff had not followed up on the incident, but that an initial meeting should have been set up within two days following the wrong site incident. He explained that it could have been missed because the anesthesia care provider coded the severity risk as 0000, and the hospital did not follow up immediately on incidents coded as such. The VP said 0000 severity codes could be changed when the incident received follow up, and reported the hospital staff set up a meeting to discuss follow up on the report involving P32.

The second incident report (Patient Incidents and Concerns or I Care) reviewed was regarding fire safety and infection control issue in an operating room (from an anonymous reporter). The reporter informed their superior that a hole had been burnt in a surgical drape with a cautery tip. This report had not been followed up on in a timely manner. A hand written note dated 10/16/12, by the director of perioperative services, requested an (I Care ) /incident report to be filled out by the staff reporting this. No further further follow up was documented until 10/30/12.

P34 was in the inpatient operating room when a hole was burned in the drape covering the patient from the cautery tip being placed on the drape, according to a Patient Incident and Concerns report dated 10/30/12. The incident was coded as "0000--No apparent injury." The concern was not reported the day the incident occurred, and the staff person who made the report wished to remain anonymous. The report lacked a detailed description of the burn hole and in addition, the anonymous reporter alleged a possible issue with infection control problems. Although the report lacked details, the hospital did not follow up with increased monitoring regarding cautery use/surgical fires or infection control breaches.

The Fire Safety in the Operating Room (OR) policy effective 9/30/12, indicated when cautery was not in the hand of the provider during a procedure, it was to be either in the cautery holster or appropriately managed (not specified) by an intra-operative team member.

Prior to the alleged incident in the OR, the hospital had provided fire safety with the use of cautery in 7/12 and 8/12, but evidence of re-education was lacking after the anonymous report of a surgical fire was reported. The Perioperative Committee minutes dated 12/11/12, reminded staff to be sure that the cautery was managed 100% of the time; either in the hand or in the holster, however, all surgeons did not attend the committee meeting.

During a surgical observation 1/8/13, at approximately 12:04 p.m. a surgeon (MD-A) was observed to put the cautery pencil on the patient's drape twice, however, the surgical technologist ST-A quickly retrieved the cautery from the drape. The tip of the cautery was not visualized during the observation. The manufacture's instructions for the Covidien cautery device indicated the tool should have been "placed in a nonconductive, safety holster or other safe place away from flammable materials (drapes, gowns) when not in use."

On 1/08/13, at 1:40 p.m. the perioperative director confirmed she had also observed the cautery pencil being laid on the patient's drape and then being picked up by the surgical technologist. She stated the cautery pencil should have been in the provider's hand or in the cautery holster. The perioperative director further indicated there was no further documented follow up information involving P32 and P34. She confirmed the hospital's system for flagging incidents requiring immediate follow up was not working.

Based on interview and document review, the hospital failed to ensure criminal background study screening was completed as required for 1 of 10 employees (CNM-A) whose personnel records were reviewed.

Findings include:

The clinical nutrition manager's (CNM) personnel record was reviewed on 1/10/13, at 10:00 a.m. and lacked evidence of required criminal background screening. The CNM was an employee of a contracted company for more than thirty years, prior to the requirement. When the hospital contracted with the company in 2005 for services, the required background study was not completed.

The vice president of facilities and operations verified on 1/10/13, at 11:00 a.m. that there had been no background check completed for the CNM. He said had the right to request employee records as deemed necessary, and after investigating the situation, was informed that background checks of contracted employees were being requested.

The Initial Application Processing policy identified the hospital would request the criminal background study form to the Minnesota Department of Human Services (DHS) via the Internet.

Based on interview and document review, the hospital failed to ensure a history and physical (H&P) was completed for 1 of 2 obstetrical patients (P5) whose medical records were reviewed.

Findings include:

P5 was admitted to the hospital on 1/5/13, with a diagnosis of pregnancy and subsequent cesarean section that same day. P5's medical record lacked a H&P. The physician documentation on 1/5/13, indicated, "No significant change in general health status based on examination of the patient, review of Nursing Admission Database and prenatal record." The physician completed the H&P the day the patient was discharged, on 1/9/13, at 11:22 a.m.

On 1/9/13, at 12:58 p.m. a registered nurse (RN)-A verified that although a H&P should have been completed upon, or 30 days prior to admission, P5's H&P was completed after the required timeframe.

The hospital's Medical Staff Bylaws (page 6) dated 10/12, directed physicians to ensure all patients had a H&P examination performed and documented in the medical record in accordance with regulatory standards and as set forth in the hospital policy.

The facility policy and procedure on History and Physical Examination and Documentation Requirements dated 10/1/05, directed a full H&P to be completed and documented in the medical record up to 30 days before or 24 hours after admission, but prior to surgery or a procedure requiring anesthesia services.

Based on observation, interview and document review, the hospital failed to ensure all medications were securely stored to prevent access by unlicensed/unauthorized persons in 1 of 26 surgical suite areas and in 1 of 2 emergency department pods.

Findings include:

Medications were found unlocked during a tour of the hospital's 26 surgical suites. The suites were divided into three surgical areas and allowed for movement of staff from one area to another. One area was designated for inpatients, another for outpatients, and a third for eye surgeries.

Unlocked medications were found on top of a medication cart and in unlocked drawers during a tour of inpatient surgical suite #51 on 1/8/13, at 12:20 p.m. Medications observed on top of the cart included 14 vials of 1% Propofol, a bottle of Sevoflurane and a bottle of Desflurane (all medications used to maintain anesthesia during surgery). Additionally, many medications were in open anesthesia cart drawers. The chief certified registered nurse anesthetist (CCRNA) provided a list of the medications stored in the unlocked cart drawers. The list contained the following medications, as well as additional anesthesia drugs: Fentanyl (opiate analgesic), Atropine (anticholinergic/muscle relaxant/antiarrhythmic), Ephedrine (used as stimiulant), three 100 milliliters (ml) vials of Propofol 1000 milligrams (mg), and seven 50 ml vials of propofol 500 mg.

The surgical suite could be entered without observation. A health unit coordinator (HUC) sat close to the area. Other unattended persons who were observed in the inpatient surgical suite areas included vendors, maintenance and housekeeping staff, orderlies/nursing assistants, and surgical technologists.

The pharmacy policy titled Pyxis Process: Controlled Substances revised 6/12, directed staff to ensure all schedule II, III, and IV drugs were kept locked and to follow all perpetual inventory control procedures. The policy was unclear regarding securing medications not in a scheduled group, however, the hospital had an inventory control procedure.

On 1/8/13, at 2:45 p.m. the perioperative director verified all anesthesia carts should have been locked when not in use. The director stated the hospital did not have a policy or list of personnel with permitted access to medications as well as anesthesia carts in the surgical area.

On 1/8/13, at approximately 8:30 a.m. during a tour of procedure room EC-31 in the surgical eye center area, seven different eye medications were stored in an unlocked cupboard. The medications included proparacaine hydrochloride ophthalmic, tetracaine, pilocarpine 1%, and Alphagan 0.2 %.

On 1/8/13, at 9:35 a.m. the surgical eye center charge nurse (RN)-K, stated the medication cupboard should have been kept locked.


19200


During a tour of the emergency department (ED) on 1/8/13, at 10:00 a.m. a crash cart was stored that contained numerous emergency supplies and medications. The cart was located near a nursing station and across from one of the ED rooms. The cart drawers were secured with a plastic tag which could have been easily opened by twisting to to open the drawer. The ED area was closed between 1:00 a.m. and 9:00 a.m. but remained assessable, as the doors were not shut or locked, and the cart was not easily visible from the open ED areas.

The facility Medications Transportation Storage and Security policy dated 4/12, directed staff to ensure all medications stored to ensure optimal security and safety. Appendix B of the same policy addressed Medication Security Standards which indicated the ED was classified as a restricted patient/family area where only staff, patients, and immediate family were allowed. Oral and injectable medications required security in a locked area or under continued surveillance.

On 1/9/13, at 9:00 a.m. the director of the ED verified the crash cart was left unattended from 1:00 a.m. until 9:00 a.m. in the closed unit, therefore, was not secured.

Based on observation, interview, and document review, the hospital was found not in compliance with the Condition of Participation for Physical Environment (42 CFR 482.41) as as result of the Life Safety Code inspection.

Findings include:

Refer to Life Safety Code deficiencies - K18, K20, K33, K43, K52, K56, K62 and K76 for additional information.

Based on observation, interview and document review the hospital failed to ensure 1 of 1 supply carts located in the emergency department (ED) was securely locked to prevent unauthorized access.

Findings include:

A supply cart located in the emergency department (ED) containing needles and syringes was not secured and/or in view of staff at all times when a tour of the ED was conducted on 1/8/12 at 10:00 a.m. The cart was adjacent to four locked seclusion rooms that were across from a closed door area staffed by a security officer who was sometimes, but not always present.

A registered nurse (RN)-L reported that the cart should have been kept locked at all times, and that someone must have just opened it to retrieve supplies. The RN explained that the cart had a self-locking mechanism and would most likely lock momentarily, however, after four minutes, the cart still did not lock. The RN stated the self-locking mechanism appeared to not be working, and that some supply carts had recently been replaced, but not the cart in question. The RN was unsure how long the locking mechanism had not been working.

On 1/8/13, at 12:00 p.m. the director of the ED verified the self-locking mechanism was not working properly and said the cart should have been locked to prevent unauthorized access to the supplies.

The manufacturer's guidelines for the Wireless Auto-locking cart dated 2011, indicated there was a programmable auto locking system on the cart. The locking mechanism had been set to 60 seconds.

Based on observation, interview and document review, the hospital failed to maintain a sanitary environment throughout the hospital.

Findings include:

An environmental tour was conducted on 1/9/13, at 10:30 a.m. Four blue plastic garbage bins were observed on the loading dock with clean liners and were ready for use. The outsides of the bins were heavily soiled with dark-colored debris that had been dripping down the sides. The facilities director explained that the bins were used in the kitchen as part of a food composting program. It was unknown, at the time of the tour, who was responsible for cleaning the bins between uses.

On 1/9/13, at 1:00 p.m., the director of environmental services verified that the bins should have been cleaned by environmental services staff between each use. He stated that the bins would be cleaned that day. A waste receptacle cleaning policy directed staff to clean the inside and the outside of the receptacles, with a germicidal solution to remove debris, dirt or smudges.

During the environmental tour, the 8th floor nursing station microwave oven was found to be heavily soiled with food debris on the inside. A registered nurse (RN)-K explained that it was the nurses' responsibility to keep the oven clean. On 1/9/13 at 1:30 p.m. the microwave ovens on each nursing unit were observed with the director of nursing operations. The ovens on units 33 and 53 were found to be soiled with dried on food debris. On 1/10/13, at 11:30 a.m., the director of clinical quality explained that a policy that specified responsibility for cleaning the ovens and when could not be located, but it was the general consensus that it was the nurses' responsibility. He verified that the ovens were not in an acceptable state of cleanliness.

During an environmental tour of the kitchen on 1/8/13, at 10:00 a.m. with the nutrition services director, several sheet pans were found to be stored wet. When the pans were lifted from the top of the stack, water ran in a stream off the edges of the pans. The stack of pans was located in proximity to the clean end of the dish machine. A nutrition services employee (NSE-)A was working at the clean end of the machine removing the clean dishes. She explained that the procedure for handling the sheet pans was to hold them up and and tap them a bit to let water drain off before placing on the clean stack. A policy and procedure titled Handling Serviceware and Utensils indicated that items were to air dry in proper racks after washing.



12831


During the environmental tour of the inpatient perianesthesia area on 1/9/13, at approximately 12:30 p.m. oxygen cylinders for patient use were being stored next to a dirty utility hopper. The utility hopper was used to empty or rinse out bed pans, emesis basin or commode, it would have been necessary to reach over the oxygen cylinders or move them. This was an infection control issue.

The 15 small oxygen (E-size) cylinders were in the dirty utility room labeled (PS 114) observed next to the utility hopper. Three of these oxygen cylinders were lined up across the front of the hopper and one of the cylinders was touching the hopper. Twelve other cylinders were to the right of the hopper in an open-sided receptacle approximately one foot away.

The policy for Therapeutic Gases (Cylinder) Standards for storage of oxygen cylinders was last revised 3/12, however, it did not address the storage of oxygen cylinders in a clean or dirty utility area. The policy indicated only a minimal number of gas cylinders would be kept in the main respiratory therapy storage area. The policy gave an example and indicated no more than twelve oxygen "E" cylinders would be stored together.

A registered nurse (RN)-J was interviewed on 1/9/13, at 12:40 p.m. said the oxygen cylinders were used by patients when being transferred back to the floor after recovery from surgery. Orderlies retrieved a tank from the dirty utility room and attached the patient's oxygen tubing to the regulator attached to these cylinders.

The director of the perioperative area was interviewed on 1/9/13, at approximately 12:43 p.m. and confirmed the storage could have presented an infection control issue. She reported later that changes in the storage of the oxygen cylinders had been made.


18622


A sterile environment was not maintained in during a cardiac catheter procedure observation on 1/9/13, at 8:10 a.m. in the cardiac catheter surgical suite. At the time the patient was being prepped for the cardiac catheterization, the circulating RN-F was wearing a surgical scrub cap, however, the surgical cap did not cover the top third of her hairline, leaving hair exposed. In addition, the X-ray technician, (RT)-B was wearing a bracelet with multiple charms that hung down her wrist. During the procedure, the RT reached under the sterile plastic drape to take X-rays, and wore large (approximately 2-3 inch) hoop earrings that were exposed to the environment in the sterile throughout the preparation. The technician also had stands of hair outside her surgical cap, and and was stopped by the surveyor to inform her that her hair was not contained. RT-F immediately pushed the exposed hair under her surgical cap before donning sterile gloves. The catheter laboratory supervisor was interviewed immediately after the procedure on 1/9/13, at 9:20 a.m. and confirmed the observation of exposed jewelry and unconstrained hair by the two staff members.

The hospital dress code policy (revised 9/09) was reviewed and indicated the purpose of the policy was to "establish guidelines of dress, which are consistent with safety standards, infection control guidelines and promote a professional image...jewelry/accessories should be minimal, tasteful and professional."

The catheter laboratory supervisor was again interviewed on 1/10/13, at approximately 9:15 a.m. and confirmed the jewelry worn the during the procedure was more than minimal, and she stated she would re-educate the staff regarding the policy and would include covering hair.

Based on interview and document review, the facility failed to ensure a timely discharge was provided for 1 of 4 patients (P30) reviewed.

Findings include:

The STARS report of Patient Incident and Concerns dated 11/6/12, indicated P30's neurosurgeon declined writing a discharge order on Friday 10/27/12, because other staff were hired to write such orders.

P30 was admitted on 10/23/12, after experiencing frequent falls which resulted in a left parietal subdural hematoma. Additional diagnoses included Alzheimer's disease and Down's syndrome. P30 resided in a group home setting.

A social worker's note from 10/27/12, at 11:46 a.m. indicated P30 had been sitter-free for 24 hours and was "medically ready for discharge." Appropriate discharge orders were then requested by the social worker from the neurosurgeon. Transportation arrangements had been made and long term placement was agreed upon by the county social service worker and respective care provider. The social worker then received a call back from the neurosurgeon who stated he was unwilling to provide any discharge orders for P30, as he had a nurse practitioner (NP) and physician assistant (PA) who would do this work on Monday. Because of this, P30's discharge on 10/27/12, and the discharge arrangements had to be canceled.

Four days later on Tuesday, 10/30/12, at 11:00 a.m. a discharge order was written by the PA and P30 was discharged that day.

On 1/9/13, at 10:30 a.m. registered nurse (RN)-J stated that when staff was unable to obtain discharge orders from the primary physician they would contact a physician advisor who in turn would contact a hospitalist to obtain an order. RN-J vaguely recalled that a hospitalist had already completed a "sign off" for P30, therefore, would not write a discharge order for the patient on 10/27/12. RN-J did not recall any further details regarding the situation.

On 1/9/13, at 11:15 a.m. the director of business verified P30 had been charged for the additional delay days because business office charges are based on the actual date of discharge.

The Hospital Discharge Planning Process policy last reviewed 1/12, stipulated, "The purpose of this Policy is to ensure that any hospital discharge planning is done ethically and conforms with the letter and spirit of the federal law governing the Medicare program."

Based on observation, interview and document review the hospital failed to ensure hair was contained in surgical areas during 2 of 3 inpatient surgeries observed (P29 and P33) and to develop policies and procedures that addressed hair containment.

Findings include:

P29 was observed during a surgical procedure on 1/8/13, at approximately 12:00 p.m. The surgeon (MD-A) and a physician assistant (PA)-A were both wearing a surgical skull caps that did not cover the lower half of their hair nor their side burns. A surgical technologist (ST)-A was wearing a surgical cap and had pushed part of the hat behind her ears leaving hair in front of her ears unconstrained, as well as long strands of unconstrained around the nape of her neck.

On 1/8/13, at approximately 12:23 p.m. the perioperative director confirmed she noted all staffs' hair was not contained during P29's surgery.

P33's surgery was observed on 1/9/13. At approximately 11:54 a.m. the circulating nurse (RN-I) cleaned the patient's surgical site to prepare for surgery. The RN had a surgical cap that was pushed behind her ears leaving the front of her hair unconstrained in the cap, as well as hair unconstrained at the nape of her neck.

The hospital's policy for Scrubs, Wear and Use (last reviewed 6/12), did not address the containment of hair in the surgical suites. The Dress Code policy (revised 3/12), directed staff working in sterile environments must wear hospital scrubs and indicated personal hats, visors and athletic headbands/sweat/bands were not allowed. This policy did not address the containment of hair in the surgical suites.

On 1/9/13, at approximately 1:45 p.m. the perioperative director stated hair coverings had been concerning to hospital staff, and she had been had been investigating infection rates due to hair exposure. A policy had not been developed, however, to address the containment of hair in surgical areas.