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Based on the Life Safety Code (LSC) survey. 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:

K0223, K0321, K0712, K0901, K0914, K0918, for additional information.

Based on observation, interview, and document review, the critical access hospital (CAH) was not in compliance with §458.635 Condition of Participation for Provision of Services due to the failure of the CAH to establish and effectively operationalize CAH policy regarding infant abduction.

Findings include:

See C271: The CAH failed to ensure a safe environment in the maternal child unit in an effort to prevent the risk of infant abduction as directed by the CAH policy. This had the potential to affect all infants born at the CAH.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure a safe environment in the Maternal Child Unit in an effort to prevent the risk of infant abduction as directed by the CAH policy. This had the potential to affect all infants born at the CAH. In addition, the facility failed to ensure a policy had been developed which directed registered nurse and certified orthopaedic technician intraoperative surgical incision closure. This deficient practice had the potential to affect all current and future surgical patients of the CAH.

Findings include:

On 8/15/17, from 8:30 a.m. until 9:07 a.m. an initial tour of the Maternal Child Unit (MCU) was conducted with the director of inpatient services (registered nurse [RN]-N). There currently were no patients in the MCU. The following was observed:

-There were two double door entrances into the MCU which were badge access for entry. There was a phone located on the wall outside of the MCU which instructed visitors to call to gain entrance however, visitors, staff and patients could exit these doors freely.
-The MCU was shaped like a square "U" with the nurses' station located at the bottom of the "U". The nurses' station was located as such that it did not have visualization of either entrance. Visitors were "buzzed" into the MCU from the nursing station area.
-The nurses' station had a badge access entry. RN-N stated the door to the nurses' station was kept shut when there were patients in the MCU, and when the nurses' station was being left unattended.
- Inside of the nurses' station was a small nursery. The nursery entrance had a door on it, however, no lock was on the door. RN-N stated usually the nursery door was left open, and it was rare that an infant was in the nursery because the infants roomed in with the mothers.
-Across and to the right of the nurses' station (in partial view through the nurses' station window) was an unmarked elevator. RN-N stated this elevator was locked and could not be used to exit the MCU. The surveyor pushed the elevator button and the doors opened. RN-N pushed the "G" and "B" buttons on the inside elevator panel. Upon reaching the "G" level, the elevator doors opened right outside of the CAH's kitchen. The elevator doors closed and upon reaching the "B" level, the elevator doors opened and the surveyor and RN-N exited the elevator. RN-N confirmed this area was the CAH loading dock which had double exit doors located approximately 100 feet from the elevator. These exit doors could be exited freely out into the CAH's back parking lot. RN-N and the surveyor returned to the elevator, pushed the elevator button to go up; elevator doors opened and the surveyor and RN-N were able to return to the MCU.
-Located to the right of the elevator on the MCU (out of view from the nurses' station) was an exit door. This door was unlocked, and when opened did not alarm. The surveyor and RN-N went down one flight of stairs which went to a door right outside of the CAH kitchen. The surveyor and RN-N went down another two flights of stairs which opened up to the same loading dock area noted above (with access to the open exit doors to the back CAH parking lot). This door locked when closed.

On 8/15/17, at 9:07 a.m. RN-N confirmed there were no audio or video surveillance cameras in or outside of the MCU. RN-N confirmed the MCU staff did not have a specific/different name badge or marking on their name badge that would identify them as being MCU staff members. RN-N stated they have placed infants on 72 hour holds (emergency protective care) and if they believed there was a risk for infant abduction, they would staff one nurse with one baby. RN-N confirmed that even if an infant was placed on a 72 hour hold, they did encourage the newborn to room in with the mother to promote breastfeeding and bonding. RN-N stated at times the mother of a newborn that was placed on a 72 hour hold was discharged, and the newborn had to stay until placement could be found. RN-N stated they allowed the mother to stay in the room with the newborn even after she had been discharged.

On 8/15/17, at 11:50 a.m. RN-K confirmed when MCU only had one patient; the MCU nurse assigned to the MCU patient also was assigned one or two patients in the medical/surgical unit. RN-K stated this happened frequently.

On 8/15/17, at 1:47 p.m. RN-N confirmed nothing in writing was distributed to the new mothers/parents of a newborn regarding how to keep the infant safe while in the MCU. RN-N stated the MCU nursing staff did this verbally with the mother/parents however, nothing was documented in the newborn or mother's medical record that infant security information had been discussed with the mother/parents. RN-N verified that there was nothing that was posted in the MCU unit or in the patient rooms that provided information regarding infant security. RN-N stated she was unaware of the last time a missing person/infant drill had been conducted.

On 8/15/17, at 1:55 p.m. RN-I stated visitors had to be buzzed into the MCU area as the double doors were locked. RN-I stated if the mother was comfortable with leaving the infant in the mother's room with other visitors, the mother could leave and go for a walk leaving the infant with them. RN-I confirmed two ID bands were placed on the infant right after birth (one on the infant's wrist and one on the ankle) and matching ID bands were placed on the wrists of the mother and another on an adult of the mother's choice. RN-I confirmed there were no cameras in the MCU or directly outside of the MCU. RN-I stated visitors had to be buzzed into the MCU by the RN at the nursing station when they wanted to enter the MCU. RN-I verified the entrance doors were not visible from the nurses' station, and there was the potential to have an unwanted visitor follow someone in. RN-I stated every time RN-I was assigned to the MCU, and there was only one mother/newborn that were stable, RN-I would be assigned 1-2 patients on the medical/surgical unit which was located down the hall. RN-I stated this would potentially leave the MCU without a staff person present. All MCU phone calls were then transferred to the medical/surgical nurses' station. If a visitor requested to enter the MCU, a nurse would have to physically go down and let them in. RN-I verified that nothing in writing was provided to new mothers/parents regarding infant security, nor was anything posted in the patient rooms or MCU. RN-I stated mothers/parents were told to not let their infant go to just anyone. RN-I stated any information that was discussed with the mother/parents with regards to infant security was not documented in the medical record. RN-I stated she had not participated in a missing person/infant drill.

On 8/16/17, at 8:12 a.m. another tour of the MCU was conducted with RN-N, the safety coordinator (SC) and the director of building and grounds (DBG). The following was confirmed:
-The ICU and both MCU entrances were badge access so that visitors had to be "buzzed" in to enter. However, all of these exits could be freely exited as they had motion sensors that would automatically open the doors when anyone was in close proximity of the door.
-The linen, clean and dirty utility rooms, and the door connecting ICU and MCU could be freely entered and exited. SC confirmed the CAH had budgeted to install badge access readers on the doors entering into the ICU from these rooms to limit access into ICU.
-The DBG confirmed the exit door near the elevator was an emergency exit door and when opened did not alarm. DBG verified this exit door had never had an alarm on it. SC verified that the CAH's Missing Person policy dated 2/2017, was not being followed as this policy indicated that emergency exit doors in the MCU would have audible alarms.
-The elevator was locked, however, the doors opened and even though the "G" button in the elevator could not be selected the "B" button could. DBG confirmed when this elevator was locked, anyone could enter this elevator and descend to the "B" (basement) level. The surveyor, RN-N, SC, and DBG entered the opened elevator, DBG pushed the "B" button which went down to the basement, and the elevator opened up to the loading dock area. DBG confirmed the exit doors in the loading dock were unlocked. DBG stated the exit doors in the loading dock were locked daily from 6:00 p.m. until 4:30 a.m. when they started to get deliveries. However, DBG confirmed anyone could exit the loading dock doors at any time. Since the elevator was locked, when this group attempted to re-enter the elevator, the doors would open however; none of the buttons when pushed would allow the elevator to go up.
-SC and DBG verified there were no surveillance cameras in the loading dock area, MCU elevator or in MCU.
-SC, DBG, and RN-N confirmed the CAH didn't have a schedule to routinely check that the elevator was in the locked position.

On 8/16/17, at 11:42 a.m. SC stated a table top missing person/infant abduction scenario had been conducted at the emergency management committee on 2/1/16. SC verified the scenario was a generic scenario which had been pulled from the Federal Emergency Management Agency (FEMA) website. SC confirmed there had not been an MCU nurse involved in this table top exercise. SC stated at the time of the review of this exercise the CAH felt they had a security system in place to prevent infant and child abduction because the doors to the MCU were locked, and no changes were made following this exercise. SC stated she now realized the MCU area was not as secure as they thought. SC confirmed that she was not aware of any missing infant drills/simulations that had been conducted at the CAH.

On 8/16/17, at 12:45 p.m. RN-N verified the CAH lacked a security policy for infant/newborn safety. RN-N stated all new employees review the emergency codes which include missing person; and all staff reviewed these annually.

On 8/16/17, at 1:41 p.m. RN-N confirmed the CAH had had 69 births in 2016, and year-to-date for 2017, the CAH had had 39 births. RN-N reviewed the missing person policy dated 2/17, and verified the CAH was not following the below areas of the policy:
-Information regarding visitation policies and importance of never leaving the infant unattended was provided to the parents. RN-N felt this was being done, however, was not documented in the medical record.
-Visitors were not being identified and designated by the patient, as support persons at the time of admission to the MCU by being provided a visitor badge.
-Visitors were not given a visitor badge to wear.
-The emergency exit door in the MCU did not have an audible alarm on it when exited.

On 8/17/17, at 10:43 a.m. RN-L and RN-J stated the MCU was a locked unit, and visitors needed to be buzzed in to enter. The infant, mother and one other adult were given matching ID bands. The infant was to be transported in the bassinet. RN-L and RN-J stated they informed new parents that they make sure staff identify themselves when working with the infant, and all staff should have an ID badge on. RN-L and RN-J confirmed this education was not documented in the medical record. RN-J confirmed she had seen visitors attempt to use the elevator in the MCU.

On 8/17/17, at 11:07 a.m. patient (P)5 and family member (FM)-A were interviewed. P5 had just given birth earlier on 8/17/17. P5 and FM-A confirmed the nursing staff had explained to them staff had to let visitors in to MCU. They both had armbands that matched their infant, and they stated they were to make sure staff had an ID badge on. Also at this time, a visitor was observed seated in a chair across from P5. This visitor lacked a visitor badge that identified herself as a visitor.

On 8/17/17, at 11:27 a.m. RN-L and RN-J confirmed that it was not the practice of the CAH to hand out visitor badges to visitors. RN-L stated they had talked about it at one time, but had not implemented this practice.

The CAH's Missing Person policy dated 2/2017, directed the following special considerations for the Labor/Delivery/Nursery (MCU) department:
-The following Information regarding visitation policies and importance of never leaving the infant unattended was provided to the parents:
- Mother/father/significant other were encouraged to ask questions when their infant was taken from them while in the facility to ensure that only authorized staff members were doing so.
- Parents were encouraged to become familiar with the hospital staff working on the maternity unit.
- Parents were instructed to question any unfamiliar person who entered the room or who was asking questions specifically about their baby, even if the individual was wearing a uniform.
- Patents were encouraged to call the nurses' station and notify them of any unfamiliar individual attempting to remove their infant from the room.
- Bassinets should be placed near the mother, and when possible the Mother's bed should be between the bassinet and the doorway.
- Mothers were instructed to alert nurses if an when she was unable to supervise the infant.
- All visitors would be identified and designated by the patient, as support persons at the time of admission to the MCU, by a visitor's badge.
- Visitors after delivery would be required to wear a visitor's pass
- Under the Access Control and Security Devices section it was noted that emergency exits would not be used by visitors and would have audible alarms.





18617


On 8/15/17, at 1:45 p.m. RN-M, the director of surgical services, was interviewed and indicated three registered nurses (RN-O, RN-P, RN-Q) and one certified orthopaedic technician (OTC)-A routinely performed surgical wound closure. RN-M identified RN-P had completed the credentials and was certified as an RN first assistant (RNFA), however, had not been hired in the facility as an RNFA, but rather was hired in the position of an RN, and worked as a circulating nurse in the operating room. Further, RN-M stated OTC-A was a certified orthopaedic technologist, however, review of OTC-A's personnel record revealed OTC-A's OTC certification had expired.

A review of the personnel records for RN-O, RN-P, RN-Q, and OTC-A revealed the following:

RN-O was hired on 9/11/2002, as a registered nurse. RN-O's personnel record indicated RN-O received 14.5 ongoing education credits during 5/4/2006-5/6/2006, for attending a semi-annual wound management workshop. There was no evidence that RN-O had received training or shown competency for surgical wound closure.

RN-P was hired on 5/21/1997, as a registered nurse. RN-P's personnel record indicated RN-P had completed ongoing education and training for the credentials of registered nurse first assistant, and received a certificate of completion for First Assistant SurgiSkills (Trademark) Workshop on 12/18/04. There was no evidence that RN-P had shown competency in wound closure. Additionally, review of the Registered Nurse-First Assistant policy last revised on September 10, 2004, revealed that the RNFA scope of practice did not include suturing and independently closing the wound.

RN-Q was hired on 3/2/1995, as a registered nurse. RN-Q's personnel record indicated RN-Q received 14.5 ongoing education credits during 5/4/2006-5/6/2006, for attending a semi-annual wound management workshop. There was no evidence that RN-Q had received training or shown competency for surgical wound closure.

OTC-A was hired on 1/12/11. OTC-A's personnel record indicated OTC/A held certification as an orthopaedic technologist certified from 6/29/17-12/31/14. OTC-A's personnel record had not included evidence of current OTC certification or current training and competency for surgical wound closure.

A facility policy that described a surgeon's delegated tasks including suturing, and surgical wound closure was requested but not provided.

On 8/17/17, at 1:00 p.m. the senior vice president of hospital operations and clinical services (VP-HOCS) was interviewed and confirmed the facility did not have a policy that described a surgeon's delegated tasks including suturing and surgical wound closure, which directed the surgical RN's parameters regarding suturing and wound closure, including training and competency requirements.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure intravenous (IV) solutions were appropriately stored in the emergency department's (ED) warming cabinet according to manufacturer's guidelines. In addition, the CAH failed to ensure 6 of 6 registered nurses (RN-A, RN-B, RN-C, RN-D, RN-E, and RN-F) who compounded IV medication had documentation they had been trained and determined to be competent to compound sterile preparations.

Findings include:

On 8/14/17, at 2:05 p.m. there was observed within the ED a two compartment warming cabinet. Registered nurse (RN)-G confirmed the upper compartment of the warmer held IV solutions, and the lower compartment held blankets. The temperature reading on the upper compartment of the warming cabinet read 112 degrees Fahrenheit (F). Within this upper compartment, there was observed fourteen 1000 milliliter (ml) bags of normal saline (NS), and two 1000 ml bags of lactate ringers (LR) IV solution in clear plastic covered pouches. All IV solution bags were dated, and found to be within 14 days of expiration. Taped to the door of the warming cabinet was the Daily Cabinet Temperature Log for the month of August 2017. This log indicated the temperatures of the upper chamber of the warming cabinet ranged from 107 degrees F to 111 degrees F. On the bottom section of this log it indicated that each compartment temperature would be recorded daily; the temperature for solutions should not exceed 110 degrees F, and IV bags would be dated when placed in the cabinet with an expiration date of 30 days. RN-G stated the IV solutions were dated when placed in the warmer, and they were discarded after 15 days.

On 8/15/17, at 8:24 a.m. the IV solution compartment of the warming cabinet in the ED was observed to read 109 degrees F.

On 8/15/17, at 2:47 p.m. the pharmacy director (P-A) stated the nursing departments were responsible for maintaining the appropriate temperatures for the warming cabinets that store IV solutions. P-A stated she thought the IV solutions could be stored in the warming cabinets for up to 15 days, however, was unsure of the appropriate temperature range for the warmer.

On 8/16/17, at 1:56 p.m. the director of the ED (RN-H) confirmed the current temperature of the upper chamber of the warming cabinet in the ED was 110 degrees F. RN-H stated she was unsure who had developed or where the temperature parameters on the Daily Cabinet Temperature Log for the warming cabinet log had come from. RN-H stated it would be the expectation of the CAH to follow the IV solutions manufacturer's guidelines for the temperature parameters for the warming cabinet.

On 8/17/17, at 10:00 a.m. P-A confirmed the CAH should have been following the manufacturer guidelines for temperature and duration parameters for IV solutions stored in warming cabinets. P-A verified the CAH's current warming cabinet policy dated 12/2016, did not follow manufacturer guidelines.

The Baxter Healthcare Corporation guidelines dated 8/15/17, indicated IV solutions of volumes of 150 ml or great could be warmed in their plastic over pouches to temperatures not to exceed 104 degrees F, and for a period no longer than 14 days.

The CAH's Warming Cabinet policy dated 12/2016, indicated the temperature of solutions should not exceed 110 degrees F, and could be placed into the warming cabinet for up to 30 days.

On 8/17/17, at 9:00 a.m. the vice president of hospital operations and clinical services (VP-HOCS) confirmed the CAH lacked documentation that RN-A had been deemed competent for compounding IV medications. VP-HOCS stated all nursing supervisors currently compounded IV medications under the laminar hood in the pharmacy after hours and on weekends.

On 8/17/17, at 10:02 a.m. P-A confirmed the following nursing supervisors compounded medications in the pharmacy after hours and on weekends: RN-A, RN-B, RN-C, RN-D, RN-E, and RN-F, and the CAH lacked documentation that these RNs had been trained and deemed competent to compound medications.

A policy on sterile compounding was requested, but not received.

Based on interview and document review, the critical access hospital (CAH) failed to ensure the list of services furnished under arrangement or agreement included the key components of these services provided to the CAH. This had the potential to affect all patients who received services at the CAH.

Findings include:

Review of the facility's Service Agreements undated lacked identification of what service was being contracted, whether the services were being offered on or off-site, whether there was a limit on the volume or frequency of the services provided; and when the services were available.

On 11/16/17, at 11:00 a.m. the chief executive officer (CEO) confirmed the list of services provided by contract/agreement lacked identification of what service was being contracted, whether the services were being offered on or off-site, whether there was a limit on the volume or frequency of the services provided, and when the services were available.

Based on interview and document review, the critical access hospital (CAH) failed to ensure the required 10% sampling of active and closed records had been reviewed as part of the annual CAH evaluation. This had the potential to effect all current and future patients of the CAH.

Findings include:

On 8/15/17, at 1:00 p.m. the director of quality improvement (DQI) stated the facility recently realized they were not ensuring the records reviewed totaled 10% of active and closed records. The DQI stated she believed they reviewed more than 10% of the records in various departmental reviews, but confirmed they are unable to verify if the CAH had met the requirement for 10% review of active and closed records.

A list of active and closed records reviewed to compare to the total to ensure 10% review rate was requested but not provided.

Based on interview and document review, the critical access hospital (CAH) failed to ensure quality assurance/performance improvement (QAPI) projects were current, comprehensive and incorporated into the CAH's QAPI program for the following areas: pharmacy, health information services (HIS) and ambulance.

Findings include:

On 8/15/17, at 2:47 p.m. pharmacy director (P-A) confirmed the pharmacy department had no current formal QAPI project. P-A stated the pharmacy department had not reported to the CAH's QA committee in the past 1 ½ years that she had been director. P-A confirmed there had been a gap in pharmacy reporting to the CAH's QA committee, and the pharmacy department was just getting on board with regards to QAPI and reporting. P-A confirmed pharmacy services was scheduled to provide a QA report to the CAH's QA committee in August 2018, and then would be scheduled to report annually.

On 8/17/17, at 8:17 a.m. the director of quality improvement (DQI) confirmed pharmacy services had not reported on any PI projects to the QA committed over the past 1 ½ years. DQI was unsure of the last time pharmacy services had reported to the QA committee. DQI confirmed the plan was to have pharmacy services to report annually to the QA committee, with their next reporting date scheduled for August 2018. DQI confirmed all CAH departments should be a part of the CAH's QAPI program.

On 8/16/17, at 11:13 a.m. the HIS coding lead (CD) stated he was unaware of a current or past QA project for HIS.

On 8/17/17, at 8:25 a.m. DQI confirmed the HIS department had not had a current or past PI project identified over the past 1 ½ years. DQI verified HIS had not reported on a PI project to the CAH's QA committee.

On 8/17/17, at 8:28 a.m. DQI confirmed the contracted services should be incorporated into the CAH's QAPI program. DQI confirmed ambulance services was a contracted service, and DQI was unsure of a current or past PI project for this department. DQI verified ambulance services had not reported on a PI project to the CAH's QA committee.

The CAH's draft Quality Improvement Plan, which had been approved by the medical staff on 8/2/17, indicated the QI plan would be continuous and would involve all individuals and departments.

Based on interview and document review, the critical access hospital (CAH) failed to ensure medication variances were incorporated into the CAH's quality assurance performance improvement (QAPI) program.

Findings include:

On 8/15/17, at 2:47 p.m. pharmacy director (P-A) confirmed the pharmacy department had not reported to the CAH's QA committee in the past 1 ½ years that she had been director. P-A stated pharmacy reviewed all medication variances, and they complete their follow up if needed, however, pharmacy services had not really trended or analyzed the medication variances. P-A confirmed the pharmacy department had not reported anything specific to the QA committee regarding PI initiatives identified through medication variances review.

On 8/17/17, at 8:20 a.m. the director of quality improvement (DQI) confirmed the number of medication errors were reported to the pharmacy and therapeutics committee, however, medication variance review, analysis and trending had not been incorporated into the CAH's QAPI program.

The CAH's Medication Errors - Adverse Drug Events - Drug Compatibility policy dated 12/2016, indicated risk management prepared a quarterly analysis of medication errors. The trending reports would be sent to the appropriate directors for review. The directors were then responsible for analyzing their departments data, and responding with performance improvement activities.