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Based on observation, interview, and review of documents, the facility failed to ensure all equipment was identified as currently inspected and tested for performance and safety including equipment in the Inpatient/Swing Bed and Obstetrical units, the Surgical Services Department, and in Central Supply. This can lead to staff using untested equipment, with potential negative outcomes for all patients receiving care at this facility.


Findings include:


1. An observation of the Inpatient/Swing Bed and Obstetrical (OB) units was conducted in the presence of the Director of Nursing (DON) on 06/04/18 at 10:30 AM. The following pieces of electrical equipment were found to be in use and to have either no inspection sticker or an out-of-date sticker: four patient beds, one blanket warmer, two "Vitals machines (used to take blood pressure, temperature, heart rate and oxygen percentage in the blood)," two charging bases for glucometers (used to check patient blood sugar), two sequential compression devices (SCDs) (devices used to inflate and deflate leg covers to prevent blood clots in bedridden patients), one infant scales, one infant isolette (warmer), and one "Bili light" (used to treat infant jaundice).


During an interview with the DON on 06/04/18 at 11:15 AM, the DON stated he/she had been unaware of the lack of inspection stickers on the items named above and stated the inspections were the responsibility of the facility's Engineering Department.


2. An observation of the Surgical Services Department and Central Supply was conducted in the presence of the department Nurse Manager (RN19) and Operating Room Consultant (ORC) on 06/05/18 at 2:30 PM. The following pieces of electrical equipment were found to be in use and to have either no inspection sticker or an out-of-date sticker: five "Vitals machines," six beds, one portable ultrasound machine (imaging method that uses high-frequency sound waves to produce images of structures within your body), two blanket warmers, two charging bases for temperature and humidity monitors, one charging base for an electric shaver, one endoscope reprocessing unit (automated machine that provides high level disinfection of an instrument that can be introduced into the body to give a view of its internal parts), and the unit's steam sterilization unit (machine used to decontaminate items such as surgical instruments by exposing them to saturated steam at high temperatures).


During an interview with RN19 and the ORC on 06/04/18 at 3:15 PM, they agreed they had not been aware of the lack of inspection stickers on the items named above and stated the inspections were the responsibility of the facility's Engineering Department.


An interview was conducted with the facility's Engineering Director (ED) on 06/07/18 at 9:50 AM. The ED stated most of the items found during the above observations were new pieces of equipment in the facility and had been safety and performance tested by the manufacturer. He/she was unable to provide documentation of this testing. The ED stated equipment testing at this facility had been provided by a contracted company and stated he/she could not provide documentation of the inspections. The ED stated the facility had identified this as a problem. The ED stated, "all equipment is safety checked before patient use," but also stated he/she did not identify or tag the pieces of equipment in any way to notify staff of the completion of the inspection. He/she stated he/she currently had no system for tracking and documenting inspections or re-inspections following repairs.


Review of the facility's policy titled, "Electrical Safety," last revised 2105, revealed, "Any device, which is electrically operated and defined as patient-care equipment, shall be inspected and certified safe by the Engineering Department prior to being put to use in the hospital. This includes both hospital-owned and physician-owned equipment."

Based on observation, interview and record review, the facility failed to ensure staff followed appropriate infection control procedures by: not performing hand hygiene during one of one observations of patient care involving an invasive procedure Patient (P) (P 1); maintaining supplies accessible to all staff, patients, and visitors in three of three Labor/Delivery/Recovery/Postpartum (LDRP) patient rooms; not monitoring temperatures of refrigerators containing patient food items, or available for refrigeration of mother's breast milk (two refrigerators located in the Nourishment Room of the Inpatient/Swing Bed unit and the OB nurses' station and the Neonatal Observation Room (newborn nursery). This failure can lead to cross contamination from pathogens (bacteria and viruses) and/or food-borne illnesses, and placed all in-patients at this facility at risk of infection.


Findings include:


1. An observation of patient care was conducted on 06/04/18 on the Inpatient/Swing Bed Unit at 11:45 AM. Registered Nurse (RN) 22 entered the room of P1 for the stated purpose of using a glucometer to check the patient's blood sugar (requiring the RN to draw blood from the patient's finger). RN 22 failed to perform hand hygiene (washing of the hands with soap and water or using an alcohol based hand rub) prior to donning clean gloves. Following the procedure, RN 22 discarded the soiled gloves, and left the patient's room without performing hand hygiene.


During an interview with RN 22 on 06/04/18 at 11:50 AM following the observation noted above, RN 22 correctly stated that the facility's policy required hand hygiene prior to patient care and following removal of gloves and was unable to explain why he/she had not performed hand hygiene.


During an interview with the Director of Nursing (DON) on 06/04/18 at 11:52 AM, the above observations were described. The DON stated that the facility's policy and expectation was for staff to perform hand hygiene prior to patient care and following removal of gloves.


Review of the facility's policy titled, "Hand Hygiene," last revised 01/18, revealed, "Indications for use: a. Before and after having direct contact with patients ...i. after removing gloves."


2. On 06/04/18 at 12:15 PM, an observation, attended by the DON, was conducted of three of three Labor/Delivery/Recovery/Postpartum (LDRP) rooms on the Obstetric (OB) Unit. Each room had large unlocked cupboards containing medical supplies, including those used for intravenous (IV) site care and dressings (such as sterile gauze pads).


During an interview with the DON on 06/04/18 at 12:25 PM, he/she stated the supplies in the LDRP cupboards are used by nursing staff during and after deliveries in the rooms. The DON stated both adults and children visit the LDRPs without supervision by staff. Upon questioning, the DON agreed visitors in the LDRPs could access the supplies without staff knowledge.


The facility's policy titled, "Care of IV and Dressing Carts/Trays," last revised 01/18, was provided upon request. Upon providing the policy on 06/07/18 at 12:45 PM, the DON stated, "We used to use carts, so this is the policy we use for our clean supplies." Review of the policy revealed, "3. Supply carts shall not be stored in patient rooms ...6. Trays/carts will not be taken into patient rooms."


3. On 06/04/18 at 12:00 PM, observation with the DON, was conducted of the patient refrigerators on the Inpatient/Swing Bed unit and the OB unit. The two refrigerators located in the Nourishment Room of the Inpatient/Swing Bed unit and the OB nurses' station had patient food inside and had thermometers inside the appliances. The refrigerator located in the Neonatal Observation Room (newborn nursery) had no food and had no thermometer inside the appliance.


During an interview with the DON on 06/04/18 at 12:05 PM, the DON agreed the temperature of the refrigerator in the newborn nursery could not be monitored without a thermometer, and the refrigerator was intended to be available to mothers to store breast milk at a controlled temperature.


Review of the refrigerator temperature monitor logs of all three refrigerators referenced above revealed the following: The log sheet used for the Inpatient/Swing Bed unit, titled "Nourishment Refrigerator Temperature Record 2018," contained multiple dated spaces with no temperature recorded in each of the months of January, February, March, April, May, and June 2018. The log sheet used for the OB nurses' station refrigerator, titled, "Nourishment Refrigerator Temperature Record, Dept. OB, 2018," was filled in for only the dates 06/05/18, 06/06/18, and 06/07/18. The log sheet used for the newborn nursery refrigerator, titled, "Breastmilk Refrigerator Temperature Record," was filled in for only the dates 06/05/18, 06/06/18, and 06/07/18.


During an interview with the DON on 06/07/18 at 11:45 AM, the DON stated all refrigerators containing patient foods are required to be monitored daily for correct temperature. The DON stated the documentation indicated the refrigerator used for the Inpatient/Swing Bed refrigerator had not been monitored daily. The DON stated the refrigerators used in the OB nurses' station and the newborn nursery were new, but had been in use for approximately two weeks and, according to the documentation, had not been monitored daily since installation and use began.


Review of facility's policy titled, "Refrigerators Policy and Procedure," last revised January 2008, revealed, "All refrigerator temperatures shall be logged daily ...If temperature is inappropriate, contact maintenance if it cannot be adjusted."

Based on interview and review of hospital documentation, it was determined the facility failed to ensure laboratory services were provided under a current Clinical Laboratory Improvement Act (CLIA) certificate or waiver for all tests performed and meet the laboratory requirements specified in 42 CFR Part 493. This deficient practice had the potential to affect all patients in the facility.


Findings include:


A review of the facility's CLIA certificate revealed the certificate's expiration date was 02/06/18.


During an interview on 06/05/18 at 10:30 AM, the Chief Executive Officer (CEO) confirmed the hospital was aware of the CLIA certificate's expiration date prior to 02/01/18. The CEO stated the facility notified the state agency responsible for renewing the certificate and had been informed the facility would have to operate with an expired CLIA certificate due to the agency's inability to conduct a survey of the facility's laboratory before 02/06/18. The CEO stated the state agency informed the hospital's Laboratory Director (LD) that a CLIA survey would be conducted within the next six (6) months.


Interview on 06/06/18 at 11:00 AM, the LD confirmed that he/she was aware of the expiration of the CLIA certificate on 02/01/18 and on 02/01/18 attempted to get information related to the renewal of the certificate from the hospital's laboratory consultant. The LD stated he/she had not received any information from the consultant or the state agency related to the renewal of the facility's CLIA certificate.

Based on interview, record review, and review of the facility's policy, it was determined the facility failed to ensure patient records were documented with a referral from the Organ Procurement Organization (OPO) for 1 Patient (P) (P22) of 2 death records reviewed.


Finding include:


Review of P22's medical record revealed the facility failed to ensure a referral number was obtained from the OPO after the death of the patient. P22 was seen in the Emergency Department (ED) of the hospital on 03/15/18 and later admitted to an acute care inpatient bed in the facility for additional observation. Further review of the record revealed P22 expired on 03/22/18. Progress notes in P22's record revealed Registered Nurse (RN) 20 notified the patient's family, a local funeral home, and the OPO of the patient's death on 03/22/18. However, P22's medical record did not have a referral number from the OPO documented in the patient's record to validate the OPO was notified of the patient's death.


Interview on 06/06/18 at 2:00 PM, the Director of Nursing (DON) confirmed that RN20 failed to document in P22's medical record that the facility had obtained a referral number from the OPO related to P22's death. The DON stated RN20 should have documented in P22's medical record, but could not provide any explanation for the failure to obtain the referral number from the OPO.


Interview on 06/07/18 at 9:00 AM, RN20 confirmed that he/she was the nurse who failed to properly document the death notifications to the OPO for P22. RN20 stated he/she recalled notifying the OPO after P22 expired and obtaining a referral number from the OPO. However, RN20 could not provide an explanation as to why she failed to document the referral number in the patient's record.


Review of the facility's policy titled, "Organ, Tissue, and Eye Donation", dated revised 04/2016, indicated, "Documentation in the patient's medical record is to include the following: a. Notification to physician and order to release the body, b. The OPO referral number and call information, c. Any correspondence with the OPO, d. Donation outcome, e. interventions ordered by the OPO, f. Release time and location of body." In addition, the policy indicated, "a disclosure form is to be completed" related to notifying the OPO and the funeral home.