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Based on interview and record review, the Medical Staff failed to conduct appropriate reappraisals of its current members for reappointment, by not ensuring that each practitioner provided the necessary peer references evaluating the practitioner's qualifications and current clinical competencies, in accordance with the Medical Staff Bylaws.

This deficient practice had the potential for patients being seen by unqualified medical staff.

Findings:

On 11/19/19 at 0900, during review of the medical staff credential files in presence of the Medical Staff Services Director, two of the sampled files (Physician 1 and Physician 2), one of the peer references was noted to be missing for the most recent reappointment period. Documentation in each of these files indicated references had been requested from two individuals but only one was received.

During a concurrent interview, the Medical Staff Services Director stated two references were required for reappointment of members to the Medical Staff. Granting practitioners continued membership in the Medical Staff despite incomplete submission of necessary documents had the potential to bring into question and undermine the integrity of the hospital's medical staff reappointment process.

Section 5.8-2, "Documentation of Current Clinical Competency," under Reappointment Process in the Medical Staff Bylaws, effective 9/25/14, states the hospital utilizes a combination of methods including peer review evaluations to determine current clinical competency of practitioners.

Based on observation, interview, and record review, the facility failed to formulate a plan of care addressing the patient's most pressing needs, and failed to formulate a plan of care within 24 hours of admission, in accordance with the facility's policy and procedure, for two of 31 sampled patients (Patient 8 and 22).

This deficient practice had the potential for the patients' needs not to be addressed.

Findings:

1. On 11/20/19, at 2:23 PM, during a concurrent interview and record review, the registered nurse (RN 9) stated Patient 8 was brought in by ambulance to the emergency department for respiratory arrest. RN 9 stated Patient 8 was admitted to the facility on 4/1/19 from the emergency department. RN 9 further stated that care plans relating to infection, pain, risk for aspiration, skin integrity were initiated upon admission. RN 9 stated there was no care plan relating to the respiratory issues, in which there should have been addressing upon admission.

A review of Patient 8's medical record indicated Patient 8 was admitted to the facility on 4/01/19 for acute respiratory failure status post (s/p) intubation (tube insertion into the trachea for ventilation), pneumonia (inflammatory condition of the lung, affecting the small air sacs), urinary tract infection (UTI), and sepsis (a life-threatening complication of an infection).

Patient 8's respiratory assessments on 4/1/19 at, 4 PM, indicated Patient 8 had coarse breath sounds upon auscultation of the lungs. On 4/1/19 at 4:05 PM, documentation indicated that lung sounds were clear and diminished, there was an inline artificial airway, sputum amount was moderate, and sputum was cream and green color, and the consistency was mucoid.

2. On 11/20/19, at 9:39 AM, Patient 22 was observed in bed, awake and alert. Patient 22 had a moderate sized bruise on the left side of the lip. Patient 22 stated she had been in a car accident and was requiring pain medication.

On 11/20/19 at 9:46 PM, during a review of Patient 22's medical record, RN 5 stated that Patient 22 was admitted on 11/18/19. RN 5 stated a care plan had not been initiated yet, and she was working on it that morning.

A review of Patient 22's medical record indicated Patient 22 was admitted to the facility on 11/18/19 at 5:50 PM for a rib fracture resulting from a motor vehicle collision with roll over. Multiple photos were taken upon admission, indicating Patient 22 had multiple bruising throughout her body. There was no care plan in the medical record.

The facility's policy and procedure titled, "Interdisciplinary Plan of Care (IPOC), dated 2/2016, indicated that the plan of care is a communication tool that identifies and prioritizes patient care and treatment needs, including outcome, interventions, indications, and goals. The interdisciplinary plan of care will be initiated as soon as possible after the admission of each patient and operational within 24 hours of patient admission. As patient care needs are identified, it is the responsibility of the interdisciplinary healthcare team to prioritize the care and services delivered to assure that the patient's most pressing needs are met.

Based on observations, interviews, and record review, the hospital failed to:
1. Ensure one (1) of 31 sampled patients would receive fentanyl (a potent opioid to treat pain) continuous intravenous (IV) infusion (drip) at the rate ordered by the physician (Patient 16);
2. Ensure nurses would document pain assessment and RASS (Richmond Agitation-Sedation Scale, a medical scale used to measure patient's agitation and sedation level) Score for 3 patients (Patients 16, 17, and 18);
3. Ensure patient's identity would be confirmed.
These deficient practices had the potentials for medication errors and/or adverse event that may or may not affect patient's health condition.


Findings:

1. On 11/19/2019 at 2 p.m., during an electronic medical record (eMR) review with the assistance from a registered nurse (RN 9) and a pharmacist supervisor (Pharm 1), Patient 16 had an order of fentanyl drip entered electronically by a physician on 11/14/2019 at 2:15 a.m. The order indicated initiate continuous infusion at 25 micrograms per hour (mcg/hr) and titrate at increment of 25 mcg every 30 minutes until pain relief, up to max 100 mcg/hr.
During a concurrent review of eMR and interview, both RN 9 and Pharm 1 indicated the aforementioned drip began on 11/14/2019 at 2:43 a.m. at a rate of 50 mcg/hr.
On 11/19/2019 at 2:25 p.m. during an interview, the clinical nurse specialist (CNS) and the Critical Care unit (CCU, where Patient 16 was under the care of) manager both acknowledged the initial start rate of the aforementioned IV drip was higher (double) than physician's order.
2. On 11/19/2019 at 2:25 p.m. during an interview, the CNS and CCU manager indicated the policy for patient receiving continuous fentanyl (an opioid to treat pain) drips was to assess pain and RASS score every 1 hour for first 4 hours. A concurrent review of Patient 16's eMR indicated there was a documented assessment for pain and RASS on 11/14/2019 at 4 a.m. and 6 a.m. Both CNS and the CCU manager confirmed nurses were monitoring at every 2 hours instead.
On 11/19/2019 at 2:35 p.m. during an interview and a concurrent review of Patient 17's eMR, Patient 17 had an order for a fentanyl IV drip started on 11/18/2019 at 1:03 a.m.
During a concurrent interview, the CNS and CCU manager confirmed Patient 17's pain and RASS score were documented at 2 a.m., 4 a.m., and 6 a.m. on 11/18/2019.
A review of Patient 18's eMR indicated there was an order for a hydromorphone (a potent opioid) 30 milligrams (mg) per 30 milliliters (ml) PCA (patient controlled analgesic device with medication) on 11/15/2019 at 7:54 p.m and started at 10:35 p.m.

On 11/19/2019 at 2:55 p.m. during an interview and concurrent review of Patient 18's eMR, the CNS and CCU manager indicated the monitoring nurses did not document the 1 a.m. and 2 a.m. assessments of pain and RASS.
A review of the hospital's policy and procedure, Pain Management, effective 5/2019, indicated " ...Continuous IV infusions of Opioids: Assess pain, RASS and respiratory rate every 1 hour [times] 4 hours, then [every] 4 hours ..."
A review of the hospital's policy and procedure, PCA-Pain Management via Patient Controlled Analgesia (Adults and Pediatrics), effective 11/2016, indicated " ...Patient assessment and monitoring [at] initiation: vital signs, pain level, ... and RASS score within one hour of initiation, then every 1 hour [times] 4, then every four hours ..."
3. {LYNN's finding}


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Based on observation, interview, and record review the facility failed to ensure that standard of practice was followed while administering medication to 1 of 31 sampled patients (Patient 28), by failing to check the patient's identification on the patient's wrist band.

This deficient practice had the potential for medication error.

Findings:

While observing RN 1 administering medication to Patient 28 on 11/20/2019 at 9:45 AM, RN 1 explained that Patient 28 was scheduled to be given an intravenous (IV, delivered by use of a plastic catheter inserted into a vein) dose of antibiotic at 10:00 AM. At that time, RN 1 was accompanied by a student whom she was instructing on the procedure on how to administer this medication. RN 1 checked the name on the unit of medication, scanned the medication barcode, attached the medication to the pump (mechanical device for infusing fluids and medication), and started the pump.

When asked what information should be checked before administering medication, RN 1 stated that the patient's identification on her wrist band should be verified before giving the patient's medication; which she did not do before starting the IV medication.

A review of Patient 28's physician orders indicated that 100 milligrams doxycycline IV (antibiotic usually prescribed for a wide range of conditions including intestinal and urinary tract infections) was to be given every 12 hours over the period of 1 hour. According to the patient's 'PCCM History and Physical' report, the patient was being treated for urinary and lung infections.

According to the facility's policy concerning medication administration titled, "Medication Use, Administration and Routes" effective 9/2018, there are six 'rights' for medication administration: right patient (verified by 2 identifiers), right medication, right dosage, right route, right time and/or frequency, right indication for use and monitoring following administration. This policy states how the patient's identification is validated; the patient's ID band is scanned; subsequently the barcode of the appropriate medication to be given is scanned while the person administering the medication addresses any patient concerns.

Based on observation, interview, and record review, the facility failed to ensure medical records were complete for two of 31 sampled patients (Patient 1 and 22).

This deficient practice had the potential for inaccurate medical records and potential for lost property.

Findings:

1. On 11/20/19 at 9:39 a.m., during a tour, Patient 22 was observed siting on the bed, awake and alert. Patient 22 stated her belongings consisted of a cell phone, eye glasses and two bracelets. Patient 22 stated she had all her belongings and nothing was missing.

On 11/20/19 at 9:46 a.m., during an interview, the registered nurse (RN 5) stated that upon admission, nursing staff make a list of the patient's belonging and go over it with the patient, then the patient signs the list of belongings upon admission, and upon discharge to indicate they received all their belongings before leaving the facility.

On 11/20/19 at 10:15 a.m., the risk manager and the patient safety officer reviewed the medical record, and stated that the list of belonging was not signed by Patient 22, but it should have been signed by the patient.

A review of Patient 22's medical record indicated Patient 22 was admitted to the facility on 11/18/19 for a rib fracture resulting from a motor vehicle collision with roll over.

A document for Patient 22 titled, "Patient Property/Valuables Inventory," dated 11/18/19, indicated that Patient 22's belongings included a cell phone, glasses, and jewelry. The document was not signed or dated by Patient 22.

The facility's policy and procedure titled, "Valuables And Property," dated 3/2014, indicated nursing will complete the Patient Property/Valuables Inventory form for those patients who refuse safekeeping and/or have large items, clothing, etc. that cannot be stored in the safe. It is the registered nurse's responsibility to be sure the patient valuables/property documented is completed and signed. Nursing obtains patient's signature on the valuables receipt. If this is not possible, not the reason and obtain another witnesses' signature.



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2. A review of Patient 1's record titled, "Adult Patient Discharge Instructions" revealed that Patient 1 had been admitted to the facility on 1/5/2017 and discharged 1/29/2019. The printed instructions included medications that should be continued after discharge from the facility; care instructions post nephrectomy (removal of one or both of the kidneys) were also included. The patient and attending nurse did not sign and date page 38 (of 40 pages) that acknowledged that the nurse had given the instructions to the patient and that the patient had received them.

During a conversation with the Patient Safety Officer, on 11/21/2019 at 11:15 AM, she stated that the nurse in charge of Patient 1 probably forgot or lost the signed documents and the information is probably lost in the patient's file. The Patient Safety Officer did, however, comment that the patient's personal belongings were reconciled correctly.

A review of the facility's 'Huntington Hospital Clinical Policy & Procedure - Discharge From Hospital' Effective 3/2017 indicated that "The electronic Patient Discharge Instruction is completed and a copy sent home with the patient in the Patient Discharge Folder with resources to help at home and intradisciplinary instructions. The Registered Nurse responsible for the patient makes an entry in the electronic health record describing the patient's physical and mental condition on the day of discharge."

Based on observation, interview and document review, the hospital failed to ensure two (2) sampled adult crash carts (crash cart is a set of trays/drawers on wheels used in hospitals for transporting and dispensing of emergency medication/equipment during life support protocols to potentially save life) had a content list attached to the crash cart.

This deficient practice had a potential for delay during emergency code situation that may or may not affect patient's outcome.

Findings:

On 11/20/2019 at around 2:30 p.m. during a tour of the medication storage areas on fifth floor with the director of pharmacy (DOP), there was a crash cart in a hallway between 2 nursing stations. Upon closer look, there was no content list attached to the cart. There was a binder in one of the side racks, however, the DOP confirmed there was no medication content list in the binder as well.

On 11/20/2019 at around 2:45 p.m. during a tour of the medication storage areas at the Critical Care Unit (CCU) with DOP, 1 of 2 crash carts also did not have a medication content list, on the outside cover or in the binder.

On 11/20/2019 at 3:08 p.m. during an interview, DOP indicated the hospital's policy was to keep a content list in the binder that would usually be placed on top of the cart or near the cart. The DOP acknowledged that the local state regulation required the contents of the container be listed on the outside cover.

Based on observation, interviews and record reviews, the hospital failed to:
1. Ensure the records of sterile (germ-free) compounding process (a process of making sterile intravenous, IV, medications) contained the preparation date and time, and the beyond use dates (BUD, expiration dates which describe when the medications should no longer be used) which would be determined from the preparation time and the classification of the compounding areas. The hospital also failed to ensure the correct BUD would be printed or written on the labels of the compounded IV medications prepared in the main IV room.
2. Ensure the designated environmental services (EVS) staff for cleaning the segregated sterile compounding area (SCA) in the Pediatric Satellite Pharmacy were able to clean the exterior surfaces in the left and back sides of the laminar flow hood (an equipment in which sterile IV medications were made);
3. Ensure the implementation of the cleaning procedure in all the sterile compounding areas (main IV room and Pediatric SCA). The EVS staff failed to document their cleaning activities consistently. For the weekly terminal cleaning, a sporicidal agent was used in the main IV room, however, a non-sporicidal agent was used in the Pediatric SCA. The hospital also failed to ensure EVS staff used designated mop for the cleaning of the Pediatric SCA.
4. Ensure the designated EVS staff who performed the cleaning of SCA in the Pediatric Satellite Pharmacy had completed annual competency evaluation.

These deficient practices had the potential of incomplete records for quality assurance purposes, as well as the potential of exposing patients to avoidable contamination for those who were requiring IV medications, which may or may not have affected the patients' health conditions.

Findings:

1. On 11/18/2019 at around 1 p.m. during an interview, the director of pharmacy (DOP) indicated the hospital had two (2) sterile compounding areas, the main IV room and the segregated compounding area (SCA) inside the Pediatric satellite pharmacy.

On 11/20/2019 at around 2 p.m. in the pediatric satellite pharmacy, the pediatric pharmacist (Pharm 2) presented the records of sterile compounding products (or IV medications) prepared in the SCA. Those records indicated there were six IV medications prepared from the SCA in the last 3 months. Pharm 2 stated the majority of the pediatric and neonatal IV medications were prepared in the main IV room.

During a concurrent review of the aforementioned compounding records, Pharm 2 verified that six out of six IV compounding records did not indicate the time of preparation documentation, and 5 out of 6 did not contain a documented BUD.

On 11/20/2019 at 2:20 p.m. in the main pharmacy with the DOP and Pharm 3, there was an IV medication on a counter. The label on the aforementioned IV bag indicated a pre-printed BUD, "expires in 72 [hours]".

During a concurrent interview, the DOP indicated the aforementioned IV medication was considered a low-risk compounding and the BUD was incorrectly; the BUD should be expiring in 48 hours from the preparation date and time.

2. On 11/20/2019 at around 1:15 p.m. during a tour of the pediatric satellite pharmacy with DOP, the satellite pharmacy had a segregated compounding area (SCA) with an IV hood located at a corner of the pharmacy. While facing the IV hood, there was approximately 12-15 inches gap between the right side of the hood from the wall; there was approximately 6 inches gap between the back side of the hood from the back wall; there was approximately 1-inch gap between the left side of the hood from the cabinet on the left.

During a concurrent interview, Pharm 2 indicated the EVS performed the cleaning of the exterior surfaces of the aforementioned IV hood.

On 11/20/2019 at 1:35 p.m. during an interview, the EVS stated she could not clean the left exterior of the IV hood and she could not completely clean the back of the IV hood that would be beyond the arm's length.

A review of the hospital's policy and procedure, Sterile Compounding Facility & Segregated Compounding Environmental Cleaning, dated 3/2019, indicated " ... In addition to the daily facility clean, the following will be included for the weekly facility terminal clean: ... top and sides of the laminar flow hoods ..."

3. On 11/20/2019 at around 1:15 p.m. during a tour of the pediatric satellite pharmacy with DOP, there was a EVS cleaning log hung on a shelving near the SCA. During a concurrent interview and review of the log, Pharm 2 indicated the log was incomplete. There were 6 days in the current month that the EVS staff did not document the daily cleaning. There were 9 days in the previous month, 10/2019, that EVS staff did not document their cleaning.

On 11/20/2019 at 1:40 p.m. during an interview in the presence of the DOP and Pharm 2, the EVS staff pulled out the mop from the equipment cart and indicated that was the mop they would use in the pediatric satellite pharmacy but it was not a dedicated mop; EVS staff indicated the same mop would be used to clean other area of the hospital.

During a concurrent interview, EVS staff presented the cleaning agent, Virex Plus, used for terminal cleaning in the SCA. The DOP confirmed Virex Plus was not the same agent being used in the main IV room. The DOP also indicated Virex Plus was not sporicidal (an agent that destroys bacterial and mold spores). The DOP stated the cleaning agent for terminal cleaning in the sterile compounding areas should be sporicidal.

4. On 11/20/2019 at 9:55 a.m. during an interview, Pharm 3 indicated there designated EVS staff trained to clean the main IV room. Pharm 3 presented the Sterile Compounding Facility Validation EVS Department sheet dated on 12/15/2017 with a list of 10 EVS staff names and signatures. and indicated that was the most recent record. A concurrent review did not indicate the process of competency validation.

On 11/20/2019 at around 1:15 p.m. during an interview, Pharm 2 indicated there were 2 EVS staff designated to clean the pediatric satellite pharmacy and the SCA within.

During a concurrent interview, when requested for the competency evaluation of those 2 designated EVS staff, the DOP confirmed there was no record of competency evaluation performed for the aforementioned EVS staff. Also, the names of those 2 EVS staff designated for SCA were not listed on the previously reviewed Sterile Compounding Facility Validation sheet.

A review of the hospital's policy and procedure, Sterile Compounding Facility & Segregated Compounding Environmental Cleaning, dated 3/2019, indicated "To ensure the compounding facilities within the Pharmacy department are appropriately cleaned, disinfected, and maintained to minimize the risk of environmental contact as a source of microbial contamination of compounded sterile preparations ... Personnel involved in the cleaning of the compounding facilities will complete an annual competency training ..."

Based on observation, interview and record review, the facility failed to:

1. Ensure surgical tray or package not to be used in IUSS (Immediate use steam sterilization) cycles, in accordance with the Association of PeriOperative Registered Nurse (AORN) Standards.

2. Ensure the room temperature, humidity, and ventilation were controlled and monitored in four Sub-Sterile Rooms with steam sterilizers between the Operating Rooms (OR).

Findings:

During the tour to Operating Room (OR) with Employee 3 (Manager of Central Supply) on November 18, 2019 between 2:22 p.m. and 3:30 p.m., the followings were observed in the Sub-Sterile Room between Operating Room (OR) # 1 and #2:

1. There was a sterilizer with a thermometer but no humidity display. During the concurrent interview with Employee 3, he stated there was no humidity display in the Sub-Sterile Room. The facility services monitored the temperature and ventilation. Employee 3 stated they there were four Sub-Sterile Rooms. Each Sub-Sterile Room had one autoclaves being actively used. Employee 3 further stated those four autoclaves were used to any flush single instrument.

A review of the IUSS Sterilization Record with Employee 3 on November 19, 2019 at 12:05 p.m., indicated a am "Ortho Development Tray" had been sterilized in the sterilizer in the Sub-Sterile Room between Operating Room (OR) # 1 and #2. During the concurrent interview, Employee 3 stated the "Ortho Development Tray" should not be used in IUSS (Immediate use steam sterilization) cycles.

According to the Association of PeriOperative Registered Nurse (AORN) Standards, Recommended Practice: Sterilization:

Recommendation VIII

Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner

VIII.b. Packaging and wrapping (eg, textiles, paper-plastic pouches, non-oven wrappers should not be used in IUSS cycles unless the sterilizer are specifically intended and labeled for this use."

2. During the interview on November 19, 2019 at 12:30 p.m., Employee 4 (Director, Facility Services) stated the facility had not been monitoring room temperature, humidity, and ventilation for the Sub-Sterile Rooms in the OR.

According to the Association of PeriOperative Registered Nurse (AORN) Standards, Recommended Practice: Sterilization:

Recommendation III

Items to be sterilized should be cleaned, decontaminated, inspected, packaged, sterilized, and stored in a controlled environment and in accordance with the AORN "Recommended practices for cleaning and care of surgical instruments and powered equipment" "and the device manufacture's validated and written instructions for use.

III.c. Room temperature, humidity, and ventilation must be controlled and monitored in accordance with local, state, and federal policy and regulation. Table 2 provides parameters for the controlled environment.

Based on record review and interview, the facility failed to:

1. Ensure the Post Operative/Procedure Note was completed immediately following the procedure, based on the facility's Medical Staff, tilted" General Staff Rules and Regulations", for two of 31 sampled patients (2 and 5).

2. Ensure the operative report written and signed by the surgeon within 24 hours, based on the facility's Medical Staff, tilted" General Staff Rules and Regulations", for two of 31 sampled patients (2 and 7).

This deficient practice had the potential for nursing or medical staff to be unaware of the details or any complications that occurred during the surgical procedures.

Findings:

1a. A review of the clinical record indicated Patient 2 was admitted to the facility on November 18, 2019 for posterior laminectomy (a surgical procedure that removes a portion of the vertebral bone) L5 -S1.

Further review of the "Main OR Intraoperative Record" indicated the surgical procedure of posterior laminectomy L5 -S1 for Patient 2 had been completed in the operating room at 9:24 a.m. on 11/18/19.

1b. A review of Patient 2's "Immediate Post Operative/Procedure Note" with RN 1 (Registered Nurse) and Employee 1 (Manager of Post Op) at 1:57 p.m. on November 18, 2019, indicated the notes had been completed and electronically signed by Physician 1 at 2:45 p.m., on 11/18/19.

During the concurrent interview, Employee 1 stated the Post Operative/Procedure Note should be completed immediately after the completion of the procedure.

During an interview on November 19, 2019 at 1:40 p.m., Employee 4 stated the operative report for Patient 2 had not been completed yet.

2. On 11/18/19 at 1:49 p.m., during a concurrent interview and review of Patient 5's medical record, RN 8 stated that Patient 5's surgical procedure was completed and the patient was recovering in the post-anesthesia care unit (PACU). RN 8 stated that an immediate post-operative note was not documented in the medical record. RN 8 stated there should be an immediate post-operative note documented in the medical record immediately after the completion of a surgery or procedure.

On 11/19/19 at 9:50 AM, the risk manager provided a document titled, "Immediate Post Operative/Procedure Note, signed and dated on 11/18/19 at 2:44 p.m., for Patient 5.




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3. On 11/19/19 at 11:22 a.m., a review of Patient 7's medical record indicated Patient 7 had coronary artery bypass surgery (CABG, a surgical procedure to restore normal blood flow to an obstructed artery in the heart) on 11/18/19.

Patient 7's "Main OR Intraoperative Record", dated 11/18/19 at 11:29 a.m., indicated the surgical procedure started at 8:20 a.m., and stopped at 11:29 a.m..

Patient 7's "Immediate Post Operative/Procedure Note, was dated and signed on 11/18/19 at 11:37 a.m..

On 11/19/19 at 11:35 a.m., review of Patient 7's "Operative Report" indicated it was an anticipated document and had not been completed yet.

Concurrently, RN 6 stated that the operative report for Patient 7 had not been completed.

According to the facility's Medical Staff's, document titled, "General Staff Rules and Regulations", dated 1/2015, an immediate post op note (operative progress note) is entered into the medical record immediately after any procedure. Postoperative diagnosis operative and Procedure reports shall be dictated or written immediately following procedure. The completed operative report shall authenticated and made available in the medical record as soon as possible after the procedure. Per Section 4.42 if the rules and Regulations Operative Reports are considered delinquent at 24 hours post procedure.