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Based on observation and interview, the Critical Access Hospital (CAH) failed to assure hypodermic needles, syringes, suture kits and intravenous supplies were stored in a safe manner in 3 of 3 (ER-1, ER-2, ER-trauma room) emergency department (ED) rooms. This had the potential to affect any patients and visitors to the ED.
Findings include:
On 8/26/14, during initial tour of the ED from 8:30 a.m. until 9:30 a.m. there was observed in all three of the ED rooms (ER-1, ER-2 and ER-trauma room) unlocked cupboards and drawers which contained suture kits, syringes and needles in a variety of sizes. Registered nurse (RN)-A confirmed patients and their visitors are left unattended at times in these ED exam and treatment rooms and verified the items noted could easily be accessed by patients and visitors.
A policy on maintaining the security of medical supplies including needles, syringes, suture kits and intravenous supplies was not provided.

Based on observation, interview and document review, the facility failed to ensure their policies were implemented to assure safety for 1 of 1 newborn (P4) currently receiving care in the hospital and 4 of 4 newborns (P11, P12, P13, and P14) reviewed who were born in the past month.

The findings include:

During a tour of the obstetrics (OB) unit on 8/26/14, at 1:30 p.m. it was noted that the OB unit was in the same area as the medical surgical patients rooms. There were 2 labor and delivery rooms that were used for delivery then after the birth of an infant, the mother and baby were moved to a post partum room located on the same corridor as the rest of the medical surgical patient rooms.

Registered nurse (RN)-C was interviewed regarding infant security during the tour of the OB area on 8/26/14, at 2:00 p.m. and stated that once the baby was delivered an identification band was placed on the infant which matched an identification band placed on the mother. RN-C stated for additional security of the infant, an Accutech BR42 tag with band was placed on the infants ankle. RN-C explained the security bracelet had conductive fiber strips that were in contact with the infants skin and if the infant was taken beyond the main nurses station an alarm sounded and all of the doors in and out of the unit were locked down. The infant alarm system also alarms if the bracelet was removed from the baby. RN-C stated the Accutech BR42 tag was placed on the baby immediately after birth along with the infant identification band. Additionally, when RN-C was asked if the facility routinely educated the new mothers on who they can safely relinquish their infant to while in the hospital RN-C stated "no." RN-C stated staff just make sure the new mother knows who her nurse is for that day and the nurse accompanies all ancillary staff into the infant and mothers room when they need to work with the infant in any manner.

There was one inpatient infant (P4) in the CAH on 8/26/14, at 2:00 p.m. During interview with the mother of P4 she confirmed that she had not been educated by the CAH staff regarding who she could relinquish her infant to. The mother of P4 stated he nursing staff made it very clear who my nurse was for the day. It was noted when the infant P4 was observed, the infant did not have the Accutech BR42 tag on. RN-C confirmed the infant P4 did not have the security tag on. RN-C stated that placing the Accutech BR42 tag on the newborn infants had been "hit and miss" because the security system had been "down." RN-C further stated she had been employed at the CAH for 2 years and had never been through a missing baby practice drill.

Review of the facility INFANT PROTECTION POLICY dated as last revised 10/12, identified the following "...To ensure that the infant is removed from mother's room by authorized staff only: 1. Mothers have been given specific instructions not to release their infant to anyone who does not have an appropriate staff badge." The policy does not include the use of the Accutech BR42 tag for infant safety.

The director of nursing (DON) was interviewed on 8/27/14, at 10:15 a.m. and stated the Accutech BR42 tag was supposed to be placed on every newborn infant shortly after delivery. The DON stated the CAH implemented the new infant security system 6-7 months ago and it had not been working very well because the sensors were too sensitive and they were having to many false alarms. The DON stated they had stopped using the infant security system for a while. The DON stated that approximately one month ago the representative of the company whom the infant security system had been purchased from had worked on the system in the CAH to make it function the way it was supposed to and the DON tested it and found that it was in working order. The DON confirmed infant P4 should have had the Accutech BR42 tag on.

Review of the Default Flowsheet Data for infant P11 who was born on 7/21/14, revealed that for the question "Security tag on" the documentation was "N/A" until discharge 7/24/14.

Review of the Default Flowsheet Data for infant P12 who was born on 7/28/14, revealed that for the question "Security tag on" the documentation was "N/A" until discharge 7/31/14.

Review of the Default Flowsheet Data for infant P13 who was born on 8/6/14, revealed that for the question "Security tag on" the documentation was "N/A" until discharge 8/9/14.

Review of the Default Flowsheet Data for infant P14 who was born on 7/19/14, revealed that for the question Security tag on the documentation was "N/A" until discharge 7/21/14.

Based on observation and interview, the critical access hospital (CAH) did not ensure medications were stored in a secure manner to prevent access by unauthorized individuals in 1 of 2 obstetrical patient rooms. This had the potential to affect any medications stored in emergency carts in either of these rooms. In addition, the CAH failed to maintain a comprehensive inventory and dispensing log for sample medications as directed by CAH policy. This had the potential to affect all patients who received care at the CAH's clinic.

Findings include:

Medications were found unlocked in an emergency cart in room 110.

During a tour of the CAH on 8/27/2014, at 9:30 a.m., accompanied by the maintenance manager, an unlocked obstetrical emergency cart was found in room 110. Unsecured medications located in the emergency cart included one 50 milliliter vial of 50% glucose, two vials of Naloxone (a narcotic reversal agent), one vial of Calcium Gluconate 10%, one container of Magnesium Sulfate 4 grams, three vials of Carbacaine, two vials of 1:1000 Epinephrine, and two intravenous solutions of oxytocin 30 units in 500 milliliters of 0.9% sodium chloride.

The Medical/Surgical Nursing Director was interviewed on 824/2014, at 11:00 a.m. and stated medications stored in the two obstetrical emergency carts should be secured at all times.

The Crash Cart: Nursing Policy, last revised 8/2012, indicated crash carts (emergency carts) should always be locked with a keyless entry lock to assure emergency equipment and medications were available.


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The CAH's inventory and dispensing log for sample medications was not comprehensive.
On 8/26/14, at 2:20 p.m. the sample medication refrigerator at the CAH's clinic was observed to contain three boxes of sample Forteo 20 micrograms (medication to treat osteoporosis). The clinic manager (CD) and registered nurse (RN)-D stated all sample medications in the refrigerator should be logged in the binder labeled Northside Medical Clinic Sample Dispensing Log. However, the CD and RN-D confirmed the log lacked documentation for the inventory and dispensing sheet for the Forteo medication.
On 8/26/14, at 2:40 p.m. the pharmacy director (PD) confirmed the clinic had not followed the CAH's policy and procedure for maintaining a comprehensive log for inventory and dispensing of sample medications. The PD stated the nursing staff at the clinic oversaw the inventory of the sample medications.
The SAMPLE MEDICATION MANAGEMENT POLICY dated 7/2013, specified sample drugs should be logged in the sample registration medication log and include the following information: name and strength of medication sample, date received, lot number of medication sample, expiration date of medication sample, quantity, and name/signature of drug representative.

Based on interview and document review, the critical access hospital (CAH) failed to ensure follow-up interventions/actions to minimize further errors/incidents had been developed / implemented to minimize reoccurrence for 13 of 13 mediation errors reviewed. These practices have the potential to affect all CAH patients.

Findings include:

Review of 13 of 13 medication errors which occurred from 1/1/14-5/3/14, revealed there was no documentation which described interventions that had been implemented to minimize reoccurrence of the errors. Additionally, on 8 of the 13 medication errors which occurred from 1/1/14-5/3/14, had no evidence that the physician had been notified according to the facility policy.

The registered pharmacist (RPh) director was interviewed on 8/27/14, at 2:00 p.m. and stated medication errors were reviewed by the director of nursing (DON), the quality improvement manager, and pharmacy director. The RPh director stated each quarter the safety committee reviewed each medication error and analyzed them for patterns and trends and implemented interventions to prevent reoccurrence of the medication error. When asked for the documentation describing the interventions implemented for the 13 medication errors which occurred from 1/1/14-5/3/14, the pharmacy director stated the interventions were not always written down and that discussion of the errors occurred during the safety meeting and then the safety committee relied on the department the error most pertained to for the implementation of the intervention to minimize reoccurrence. The pharmacist stated that all medication errors needed to be reported to the physician and confirmed that 8 of the 13 medication errors that occurred between

The director of nursing (DON) was interviewed on 8/27/14, at 10:15 a.m. and stated all med errors were reviewed quarterly by the safety committee and investigation and implementation of interventions to minimize reoccurrence occurred for only high risk medication, otherwise patterns and trends of med errors were identified and interventions were implemented to minimize reoccurrence for those medication error that had a pattern.

Review of the VARIANCE OCCURRENCE REPORTING POLICY dated as last reviewed on 9/12, identified the following: " 2. Notify the attending physician of the error. 3. Chart error and notification of doctor and corrective action taken in the nurse's notes. 3. Complete the variance report. This is sent to the nursing office/supervisor...5. Records of variances will be retained to evaluate competency of staff members and the need for pharmacological education and will be reviewed by the Safety Committee."

Based on observation, interview and record review, the facility failed to ensure hand hygiene practices were performed according to the facility policy during 1 of 1 outpatient (OP1) dressing changes observed.

The findings include:

On 8/27/14, OP1 presented to the hospital for a wound vac dressing change. During the dressing change registered nurse (RN)-B was observed with gloves on, to remove the soiled dressing and discarded the used saturated dressing, cleansed the wound and measured the wound. RN-B then removed her gloves and donned a set of new gloves prior to placing the new clean dressing on the wound. RN-B had not performed hand hygiene between changing gloves.

Review of the facility HAND HYGIENE POLICY dated as last reviewed on on 2/12, identified the following: "4. Decontaminate hands with waterless antimicrobial hand rub or antiseptic soap and water in the following circumstances: "...D. After contact with body fluids or excretions, mucous membranes, non-intact skin, or wound dressing as long as not visibly soiled. If visibly soiled, wash first with plain soap and water, followed by a waterless antiseptic hand rub."

The director of nursing (DON) was interviewed on 8/27/14, at 2:55 p.m. and confirmed hand hygiene should have been performed after changing gloves following removal of a contaminated dressing and donning clean gloves to handle clean wound vac dressing supplies for OP1.

Based on interview and document review, the Critical Access Hospital (CAH) failed to assure a comprehensive list of services furnished under agreements or arrangements had been maintained. This had the potential to affect all patients who receive services at the CAH.
Findings include:
On 8/27/14, at 11:20 a.m. the administrative assistant provided the CAH's current list of services provided through agreements or arrangements. The CAH's [undated and untitled] list identified the company's name and the services/products provided. The administrative assistant confirmed the list of agreements or arrangements provided was not an inclusive list. The administrative assistant verified some of the agreements or contracted services missing from this list were: Rice Memorial Hospital Laboratory (reference lab services), pathology services agreement with Sanford, CardinalHealth (after hour pharmacy services), Ortonville Ambulance Service, Credentialing Services Agreement with Sanford, and the Rural Health Network Agreement with Sioux Valley Hospital.

Based on interview and document review, the critical access hospital (CAH) failed to develop policies and procedures that described the limitations or prohibitions for the use of verbal orders and describe situations in which verbal orders may be used. Additionally, the CAH failed to ensure monitoring of the use of verbal orders had been completed to ensure verbal communication of orders were limited to urgent situations where immediate written or electronic communication was not feasible. This had the potential to affect all current and future patients of the CAH. Findings include:

Findings include:

The health information management (HIM) manager was interviewed on 8/24/14, at 10:30 a.m. and was asked how the CAH monitored the usage of telephone and verbal orders. The HIM manager stated the utilization of telephone and verbal orders had not been reviewed since 2011, and stated the percentage of verbal and telephone order utilization had been "low" at that time but could not provide specific metrics describing what "low" meant. The HIM manager stated verbal and telephone orders should be used infrequently as directed in the facility policy. The HIM manager explained that physicians can access the patient ordering system remotely from locations other than the hospital through computer and remote access devices. The HIM manager stated that a report of the utilization of verbal and telephone orders could be provided and provided the report on 8/25/14.

The Prevent of Verbal Orders by Patient Dept and Order Mode report form from 6/1/14-8/29/14, revealed that a total of 44,808 orders were prescribed and of those 43.68 percent of these orders were either verbal or telephone orders. The surgical department had a total number of 3,937 orders and 43.4 percent of them were either verbal or telephone orders. The emergency department had a total number of 3,240 orders and 58.5 percent of them were either verbal or telephone orders. The medical/surgical unit had a total number of 8,941 orders and 23.9 percent of them were either verbal or telephone orders. The obstetric unit had a total number of 1,399 orders and 21.2 percent of them were either verbal or telephone orders.

Review of the CAH policy PHYSICIANS ORDERS: ACCEPTING VERBAL AND TELEPHONE POLICY dated as last revised 8/13, revealed the following related to frequency of their use: "2. Orders received verbally or via telephone will be documented by the recipient. The use of verbal orders is discouraged..." The policy had not included procedures that described the limitations or prohibitions for the use of verbal orders nor described situations in which verbal orders may be used.

Based upon interview, record review and review of the medical staff bylaws, the critical access hospital (CAH) did not ensure a history and physical report and a post-procedure note were available in a timely manner for 3 of 3 outpatients who had an endoscopic procedure (P21, P22 and P23). These findings had the potential to affect any patient who had an endoscopic procedure performed by medical doctor (MD)-A).

Findings include:

A history and physical/consult report (H and P) was not available in the medical record prior to the endoscopic procedure and the procedure note was not available in the medical record in a timely manner. This would make it difficult for CAH practitioners and other staff to obtain this clinical information in the event the patient experienced complications related to the procedure which had been performed.

P-21 had an outpatient colonoscopy under intravenous conscious sedation performed by MD-A on 8/8/2014. The H and P indicated the patient had significant chronic obstructive pulmonary disease, diabetes and hypertension. Although the H and P had been dictated on 8/8/2014, by MD-A prior to the procedure, the report had not been transcribed until 8/21/2014, (thirteen days after the patient had been discharged). The procedure note, dictated by MD-A following the procedure, was dated 8/8/2014, but had not been transcribed until 8/13/2014, (five days after the patient had been discharged).

P-22 had an upper gastrointestinal endoscopy with dilation under intravenous conscious sedation as an outpatient on 8/15/2014. A review of the electronic medical record on 8/28/2014, (thirteen days following the procedure) indicated the H and P had not yet been transcribed. The post procedure note had been dictated on 8/15/2014, and had not been transcribed until 8/27/2014, (twelve days following the patient's procedure).

P-23 had an outpatient colonoscopy under intravenous sedation by MD-A on 8/15/2014. A review of the electronic medical record on 8/28/2014, (thirteen days following the procedure) revealed the H and P as well as the procedure note had not yet been transcribed.

A review of the Medical Staff By-laws, Rules and Regulations, last revised June 2010, indicated a current, thorough physical examination must be documented prior to the performance of surgery or any potentially hazardous diagnostic procedure. The by-laws also indicated if the H and P had been dictated but not yet transcribed, the practitioner must document a notation noting any abnormalities or positive findings which may require special precautions prior to the induction of anesthesia or performing the operation or diagnostic procedure. If the above requirements had not been met, the procedure was to be canceled until the practitioner stated in writing that such a delay would be detrimental to the patient.

The outpatient outreach coordinator was interviewed on 8/28/2014, at 10:40 a.m. and verified the findings. She state MD-A saw his patients in the outpatient area and dictated an H and P prior to their procedure. She stated the H and P was not transcribed prior to the procedure. She stated the physician also dictated a procedure note immediately following the procedure. She stated the physician made a brief post-procedure note which did not become a part of the medical record and was not available to CAH staff or physicians. She stated that MD-A was a consulting physician who provided outreach services to the CAH and does not live in the immediate area.

The health information manager was interviewed on 8/28/2014, at 11:15 a.m. and stated the turn around time for transcription did seem excessive. He verified the H and P, as well as the post-procedure note, would not be available in the electronic medical record or any other record if a practitioner from the CAH was required to care for one of these patients in the event of a complication related to the procedure.

Based on interview and document review, the critical access hospital (CAH) failed to ensure consistent investigation, follow up and correct action plans for 12 of 12 incident/variance reports reviewed were developed and incorporated into the CAH's quality assurance/performance improvement (QA/PI) process as directed by the CAH's performance improvement plan. This had the potential to affect all current and future patients of the CAH.
Findings include:
On 8/28/14, at 9:45 a.m. until 10:45 a.m. the CAH's patient safety variance reports were reviewed with the director of nursing (DON) and the quality improvement manager (QIM). The variance reports ranged from the time frame of 9/24/13, with the most recent being 6/19/14. The variance reports had been categorized and included some of the following:
? Four variances related to Heparin (considered a high risk blood thinning medicine) management with missed and/or misinterpreted lab values
? One variance included a near miss for conducting an imaging exam on the wrong patient
? Four variances related to missed or delayed laboratory testing, which included three related to troponin (a laboratory blood test to indicate heart muscle damage).
? One variance related to a procedure postponed due to inadequate preoperative teaching
? Two variances related to complaints of pain during a procedure
On each of the above variances on the section of the PATIENT SAFETY VARIANCE form which was to be completed by the DON and QIM there were dates that they had noted the variances, however, lacked documentation regarding follow up, investigation or recommended action plan to help prevent reoccurring incidents. The DON and QIM confirmed the above variances lacked documentation of follow up, investigation, analysis of trending and action plans to prevent further reoccurrence of the incident. In addition, the variances had not been incorporated into the CAH's QA/PI program.
The CAH's PERFORMANCE IMPROVEMENT PLAN dated 12/2013, identified an objective of the QA/PI program was to minimize the probability of events, which had an adverse effect, physical or psychological, on patients. In addition, the plan would provide the mechanisms to ensure all activities and problems related to patient and professional practice would be assessed, monitored, evaluated and improved.