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Based on clinical record review, interview and policy review, for two of three patients who filed a grievance (Patient #137 and #102), the hospital failed to respond in accordance with facility policy. The findings include the following:

a. Patient #137 presented to the Emergency Department (ED) on 10/31/16 at 8:51 AM with complaints of lower back pain that extended to the groin. Review of the clinical record failed to reflect that a pain assessment was completed upon arrival. Review of facility documentation identified that Patient #137 filed a telephone complaint with patient relations on 11/4/16 related to rude staff and failure to address pain. The patient claimed that the triage nurse was very rude, rough and lacked compassion. Interview with the VP of Quality on 5/17/18 at 2:20 PM stated the facility was unable to find any follow-up to the complaint. Interview with the Nurse Manager of the ED on 5/18/18 at 10:15 AM stated she was notified of the complaint and discussed the case with RN #21.

Review of the facility policy directed that any statement by a patient or representative that a situation was unsatisfactory or unacceptable is considered a complaint. The policy indicated that once a complaint is filed the complainant should be contacted within 24 hours by the Manager, document the initial complaint in the RL solutions-feedback module and in part provide a follow-up response to the complainant as appropriate.


b. Patient #102 was evaluated in the ED on 3/21/16 with complaints of vomiting. Review of facility documentation indicated on 8/9/16 a letter was sent to an outside billing agency (not employees of Hospital #1) with complaints about care received by Patient #102 in the ED and charges for services rendered on 3/21/16.

During an interview with the Chief Compliance and Privacy Officer on 5/21/18 at 12:30 PM he/she indicated the hospital became aware of P#137's concerns on 8/22/16 and was registered as a grievance. According to the Network Chief Compliance and Privacy Officer the subsequent documentation dated 10/31/16 informed P#137 that an investigation related to P#137's concerns about the care he/she received on 3/21/16 had been completed and the results of that investigation (50 days after initial complaint filed as a grievance by the hospital).

During an interview with the Quality Manager on 5/21/18 at 1:25 PM he/she indicated the hospital could not provide an inital response letter to P#137 in response to the grievance filed by the hospital on 8/22/16.

The hospital Patient Complaint and Grievance policy indicated all grievances should be acknowledged, if not resolved within 7 business days but no more than 14 business days and have a 30 business day time frame for final follow-up.

The Condition of Participation of Medical Staff has not been met.
Based on a review of clinical records, staff interviews and a review of hospital documentation for one of two mother/infant dyads reviewed in the intrapartum stage of labor (Patient # 134 and #134A), the hospital failed to accurately assess a non-reassuring fetal tracing and subsequently implement interventions timely to promote the highest level of well-being.

Please refer to A347

Based on medical record reviews, review of facility policies and interviews for one of three patients who had eye surgery (Patient #127), the facility failed to ensure that the correct lens implant was performed.
The finding includes:

Patient #127 was admitted for left phacoemulsification with intraoperative lens implant (IOL) on 3/7/18. The consent form dated 2/15/18, signed by MD #13 and Patient #127, identified left phacoemulsification with IOL. The operative record and/or operative report dated 3/7/18 noted that a "time out" was performed prior to incision and a 17.0 diopter lens was placed in the left eye. Review of MD #13's office note dated 3/8/18 indicated that, although the hospital was notified of a lens change for the Patient, the myopic lens was still inserted (in error) and Patient #127 agreed to go forward with a lens exchange. The operative report dated 3/8/18 identified that the Patient had an IOL exchange and had a 14.0 diopter lens implanted following removal of the previous lens.

Interview with RN #11 on 5/17/18 at 10:13 AM noted that she pulled the lenses for all MD #13's eye cases on 3/2/18 and the lens order sheet with the change in Patient #127's lens was not present at that time. Interview with the OR Scheduler on 5/7/18 at 10:40 AM and review of the revised lens order sheet indicated that she received the changed lens order sheet on 3/2/18 at 2:24 PM and placed it backwards on the hall cork board per usual. Interview with the RN #12 (Circulator Nurse for 3/7/18) on 5/18/18 at 10:11 AM indicated that once lenses were pulled, the board was not checked for updates and the correct lens was inserted per the first lens order sheet. MD #13 was unavailable for interview at the time of the investigation. The facility Universal Protocol policy identified, in part, that a "Time Out" will be performed by the surgical team.


29049

Based on a review of the clinical record, staff interviews and a review of facility documentation for one of one sampled patient (Patient #133), reviewed for the retention of surgical packing following an operative procedure, the facility failed to remove vaginal packing prior to discharge.
The finding included:

Review of the clinical record identified Patient #133 was admitted to the hospital on 2/9/18 who underwent a bilateral salpingo-oopherectomy and a TVT (tension-free vaginal tape) due to pelvic pain and a right ovarian nodule. Vaginal packing was inserted at the end of the procedure due to bleeding. Patient #133 was discharged to home on 2/10/18. Further review of the clinical record indicated Patient #133 called from home to inform the discharging unit that she removed the vaginal packing at home.
Interview with RN #41 on 5/17/18 at 10:15 AM, who was the circulating nurse in the operating room, identified vaginal packing was not part of the operative count. RN #41 indicated she does not recall if vaginal packing was inserted or if that information was communicated to her.
Interview with MD #41 on 5/17/18 at 11:55 AM, who was the surgeon, indicated she should have written an order to remove the vaginal packing immediately following the operative procedure and did not.
Interview with Quality Manager #2 identified it was the responsibility of the surgeon to write an order to remove the packing prior to discharge. Subsequent to the event an operating room report checklist was developed that in part included the presence or absence of packing.


2. Based on interview and a review of the hospital's policy and procedure for the administration of Nitrous Oxide, the policy failed to indicate a dose, frequency or duration for the administration of Nitrous Oxide.
The finding included:

Review of the Nitrous Oxide Policy and interview with Nurse Manager #2 on 5/14/18 at 10:20 AM identified Nitrous Oxide would be inhaled as a 50-50 blend of Oxygen and Nitrous Oxide however, the policy failed to identify a dose, frequency or duration of administration and should have.


3. Based on a review of clinical records, staff interviews and a review of hospital documentation for one of two mother/infant dyads reviewed in the intrapartum stage of labor (Patient # 134 and #134A), the hospital failed to accurately assess a non-reassuring fetal tracing and subsequently implement interventions timely to promote the highest level of well-being.

The finding included:

Review of the clinical record identified Patient #134 was admitted to the hospital on 8/11/16 at 11:25 PM who presented in labor at thirty eight weeks gestation. Interview and review of the fetal tracing with the Chief of Obstetrics on 5/22/18 at 4:30 PM from 11:25 PM through 11:58 PM identified moderate variability (variability is defined as fluctuations in the fetal heart rate and is an indicator of a normal functioning central nervous system). On 8/12/16 at 12:15 AM minimal variability (persistent minimal or absent fetal heart rate (FHR) variability is a sign of fetal compromise), was present absent accelerations of the fetal heart rate, (a fetal heart acceleration is an increase in the FHR greater or equal to ten beats per minute above the baseline with a duration of ten seconds or more from the most recently calculated baseline accelerations and is considered a sign of fetal well-being) until 12:59 AM. Ten liters of oxygen via a non-rebreather was administered to Patient #134 at this time. Further interview and review of the clinical record with the Chief of Obstetrics indicated at 1:09 AM and 1:10 AM possible late decelerations (late decelerations indicates an increased risk of fetal acidosis secondary to utero-placental insufficiency) occurred. From 1:10 AM through 2:01 AM minimal variability continued without FHR accelerations. At 1:55 AM a position change to high fowlers was made. A popsicle and juice was provided at 1:20 AM and 1:30 AM respectively. Late decelerations recurred at 2:02 AM and 2:05 AM. From 2:06 AM through 2:28 AM the tracing continued with minimal variability and lacked accelerations. At 2:29 AM MD #43 and (Nurse Midwife) NM #5 had reviewed the fetal tracing at the nurse's station. At 2:32 AM a late deceleration was identified. At 2:43 AM a bolus of intravenous fluid was administered. Minimal variability and absent accelerations continued from 2:33 AM through 3:48 AM despite resuscitative interventions. An epidural was administered at 3:24 AM. Late decelerations were noted at 3:49 AM, 3:53 AM and 4:00 AM. The fetal tracing from 4:01 AM through 5:02 AM continued with absent accelerations and minimal variability. At 5:03 AM the baseline FHR decreased from 140 beats per minute to 120 beats per minute. At 5:12 AM, a prolonged deceleration to 60 beats per minute was identified. At 5:20 AM, MD #43 performed a vaginal exam, ruptured membranes and applied an internal fetal electrode that verified the FHR of 60 beats/minute. Thick dark meconium fluid was noted. Patient #134 was taken to the operating room at 5:24 AM for a stat Caesarean Section. Patient #134A was delivered at 5:36 AM with apgar scores of 0, 0, and 4. Positive pressure ventilation was immediately administered and Patient #134A was intubated at 2 minutes of life. Chest compressions were initiated and Epinephrine was administered via the endotracheal tube with a heartrate above 60 beats/minute at 8 minutes of life. Patient #134A was transferred to the neonatal intensive care unit with an initial PH of 6.89. (Normal value 7.35-7.45). The neurological examination revealed abnormal reflexes, minimally reactive pupils, central hypotonia with extremity hypertonia and generalized clonus. The clinical impression was that of severe neonatal encephalopathy and a concern for long term neurologic impairment was prognosticated. Patient #134A was transferred to an alternate acute care facility for therapeutic hypothermia.

Review of the transferring hospital documentation identified hypothermia was induced for 72 hours with subsequent warming. Patient #134A required vasopressors for support and was extubated on 8/16/16. A percutaneous gastrostomy tube was surgically placed on 9/6/16 for continuous feedings. Hypoxic-ischemic encephalopathy stage three was diagnosed with probable electrographic seizures and a poor clinical outcome. Multiple consultations were obtained throughout hospitalization and several outpatient providers were recommended at the time of discharge and included a home health agency, surgery, neurology, ophthalmology, pediatric services and birth to three.

Further interview and review of the fetal tracing with the Chief of Obstetrics on 5/22/18 at 4:30 PM identified the first half hour of the fetal tracing was not concerning as moderate variability with fetal accelerations were identified however, after the first half hour, minimal variability, absent accelerations and a contraction pattern that was intermittently indeterminate ensued. At 1:09 AM, 1:10 AM, 2:02 AM and 2:05 AM late decelerations were present despite several resuscitative interventions. The Chief of Obstetrics indicated the standard of care would have been to perform a Cesarean Section at approximately 2:00 AM, after two hours of resuscitative interventions did not improve the fetal tracing.

Subsequent to the surveyors inquiry an immediate plan of correction dated 5/23/18 directed in part that the medical staff would be educated in the management of fetal monitoring. Mandatory education would be provided as part of continuing education. In addition, immediate education would be provided by one to one mentoring in the management of electronic fetal monitoring to the providers that were involved in the case, by the Department Chair or designee until formal education was provided.

Based on a review of clinical records, staff interviews and a review of hospital documentation for one of two mother/infant dyads reviewed in the intrapartum stage of labor (Patient # 134 and #134A), the hospital failed to accurately assess a non-reassuring fetal tracing and subsequently implement interventions timely to promote the highest level of well-being.

Please refer to A 395

Based on a review of clinical records, interview and policy review, for two of three patients reviewed for pain (Patient #136 and #137), the hospital failed to ensure the patient's pain was assessed and/or reassessed following the administration of medication in accordance with facility policy. The findings include the following:

a. Patient #136 presented to the Emergency Department (ED) on 3/18/17 at 8:14 PM with complaints of weakness and being dizzy for several weeks. Review of the physician note dated 3/18/17 at 10:48 PM indicated that the patient's symptoms were moderate to severe and worse when standing. The record reflected that intravenous fluids were administered and that an "ambulatory trial" was completed however the patient felt that he/she was not able to go home. A nurse's note dated 3/19/17 at 12:00 AM identified that the patient complained of back pain and that Tylenol 1000 milligrams (mg) was administered at 1:20 AM. The record failed to reflect an assessment of the patient's level of pain and/or a reassessment of the patient's level of pain to determine if the Tylenol was effective.

Review of the facility policy indicated that the patients will have their level of pain reassessed after medication administration or an intervention provided to relieve pain.

b. Patient #137 presented to the ED on 10/31/16 at 8:51 AM with complaints of lower back pain that extended to the groin. Review of the clinical record with the Nurse Manger on 5/18/18 at 10:15 AM failed to reflect that a pain assessment was completed on arrival. The record indicated that Dilaudid 1 mg and Toradol 30 mg intravenously were administered at approximately 9:30 AM although there was no pain assessment documented.




29049

Based on a review of the clinical record, staff interviews and a review of facility documentation for one of three sampled patients reviewed for infant falls (Patient #132), the facility failed to observe the mother infant dyad hourly in accordance with the hospital policy. The finding included:

Review of the clinical record identified Patient #131 was admitted to the hospital on 6/16/17 at forty one weeks gestation for an induction of labor. Patient #132 was delivered via a spontaneous vaginal delivery on 6/16/17 at 2:11 PM. On 6/17/17, at 11:45 PM Patient #131 received Tylenol for pain and a comprehensive reassessment was completed on 6/18/17 at 12:45 AM. On 6/18/17 at 3:45 AM, Patient #131 called for a nurse and indicated she was awakened by her infant crying. The infant was found on the floor of the patients room. The patient's bed was noted to be in the high position (3.5 feet), when the nursing staff entered the room. Patient #131 indicated she last fed the baby at 2:00 AM. Patient #131 was transferred to the nursery for an examination and observation. An immediate assessment did not identify trauma or neurological abnormalities. On 6/18/17 at 5:00 AM, Patient #131 experienced central apneic episodes with oxygen desaturation that required vigorous stimulation to recover. At 7:30 AM, Patient #131 was transferred to an alternate hospital for a higher level of care.

Interview and review of the clinical record on 5/17/18 at 10:30 AM with RN #42, who was the patient's nurse, identified the last time a staff member was in the room was on 6/18/17 at 12:45 AM, three hours before the infant fell. Although the patient indicated she feed the infant at 2:00 AM that was a verbal report provided by the patient and not a direct observation.

Interview with RN #43 on 5/17/18 at 11:55 AM, who was a staff nurse on duty indicated she does not recall the time or if the infant was in the arms of the patient but does recall she informed Patient #131 that the hospital bed needed to be in the lowest position. RN #43 lowered the patient's bed at some point during the night shift.

Interview and review of the clinical record with Nurse Manager #2 on 5/17/18 at 2:30 PM failed to identify that the staff had conducted hourly rounds. Nurse Manager #2 indicated it was the expectation to visually observe the mother and infant dyad hourly.

Review of the transferring hospital discharge summary identified Patient #132's imaging revealed a small subarachnoid hemorrhage overlying the left frontal-parietal area. Neurosurgery was consulted and not further workup was recommended. Patient #132 was discharged to home on 6/25/17.

The hospital policy entitled Newborn Fall Prevention and Management directed in part that at any time that adult caretaker(s) plan to sleep or feel that they are close to falling asleep, the infant must be in a crib for safety. The policy further directed that staff members would open doors to patient rooms at least hourly, identify self, and ensure that if the infant is in arms, the adult holding him/her is not asleep or does not appear sleepy. If both mother and infant are asleep in their respective beds, they would be visualized and not disturbed.




2. Based on a review of clinical records, staff interviews and a review of hospital documentation for one of two mother/infant dyads reviewed in the intrapartum stage of labor (Patient # 134 and #134A), the hospital failed to accurately assess a non-reassuring fetal tracing and subsequently implement interventions timely to promote the highest level of well-being. The finding included:

Review of the clinical record identified Patient #134 was admitted to the hospital on 8/11/16 at 11:25 PM who presented in labor at thirty eight weeks gestation. Interview and review of the fetal tracing with the Chief of Obstetrics on 5/22/18 at 4:30 PM from 11:25 PM through 11:58 PM identified moderate variability (variability is defined as fluctuations in the fetal heart rate and is an indicator of a normal functioning central nervous system). On 8/12/16 at 12:15 AM minimal variability (persistent minimal or absent fetal heart rate (FHR) variability is a sign of fetal compromise), was present absent accelerations of the fetal heart rate, (a fetal heart acceleration is an increase in the FHR greater or equal to ten beats per minute above the baseline with a duration of ten seconds or more from the most recently calculated baseline accelerations and is considered a sign of fetal well-being) until 12:59 AM. Ten liters of oxygen via a non-rebreather was administered to Patient #134 at this time. Further interview and review of the clinical record with the Chief of Obstetrics indicated at 1:09 AM and 1:10 AM possible late decelerations (late decelerations indicates an increased risk of fetal acidosis secondary to utero-placental insufficiency) occurred. From 1:10 AM through 2:01 AM minimal variability continued without FHR accelerations. At 1:55 AM, a position change to high fowlers was made. A popsicle and juice was provided at 1:20 AM and 1:30 AM respectively. Late decelerations recurred at 2:02 AM and 2:05 AM. From 2:06 AM through 2:28 AM the tracing continued with minimal variability and lacked accelerations. At 2:29 AM, MD #43 and (Nurse Manager) NM #5 had reviewed the fetal tracing at the nurse's station. At 2:32 AM, a late deceleration was identified. At 2:43 AM, a bolus of intravenous fluid was administered. Minimal variability and absent accelerations continued from 2:33 AM through 3:48 AM despite resuscitative interventions. An epidural was administered at 3:24 AM. Late decelerations were noted at 3:49 AM, 3:53 AM and 4:00 AM. The fetal tracing from 4:01 AM through 5:02 AM continued with absent accelerations and minimal variability. At 5:03 AM, the baseline FHR decreased from 140 beats per minute to 120 beats per minute. At 5:12 AM, a prolonged deceleration to 60 beats per minute was identified. At 5:20 AM, MD #43 performed a vaginal exam, ruptured membranes and applied an internal fetal electrode that verified the FHR of 60 beats/minute. Thick dark meconium fluid was noted. Patient #134 was taken to the operating room at 5:24 AM for a stat Caesarean Section. Patient #134A was delivered at 5:36 AM with apgar scores of 0, 0, and 4. Positive pressure ventilation was immediately administered and Patient #134A was intubated at 2 minutes of life. Chest compressions were initiated and Epinephrine was administered via the endotracheal tube with a heartrate above 60 beats/minute at 8 minutes of life. Patient #134A was transferred to the neonatal intensive care unit with an initial PH of 6.89. (Normal value 7.35-7.45). The neurological examination revealed abnormal reflexes, minimally reactive pupils, central hypotonia with extremity hypertonia and generalized clonus. The clinical impression was that of severe neonatal encephalopathy and a concern for long term neurologic impairment was prognosticated. Patient #134A was transferred to an alternate acute care facility for therapeutic hypothermia.

Review of the transferring hospital documentation identified hypothermia was induced for 72 hours with subsequent warming. Patient #134A required vasopressors for support and was extubated on 8/16/16. A percutaneous gastrostomy tube was surgically placed on 9/6/16 for continuous feedings. Hypoxic-ischemic encephalopathy stage three was diagnosed with probable electrographic seizures and a poor clinical outcome. Multiple consultations were obtained throughout hospitalization and several outpatient providers were recommended at the time of discharge and included a home health agency, surgery, neurology, ophthalmology, pediatric services and birth to three.

Further interview and review of the fetal tracing with the Chief of Obstetrics on 5/22/18 at 4:30 PM identified the first half hour of the fetal tracing was not concerning as moderate variability with fetal accelerations were identified however, after the first half hour, minimal variability, absent accelerations and a contraction pattern that was intermittently indeterminate ensued. At 1:09 AM, 1:10 AM, 2:02 AM and 2:05 AM late decelerations were present despite several resuscitative interventions. The Chief of Obstetrics indicated the standard of care would have been to perform a Cesarean Section at approximately 2:00 AM, after two hours of resuscitative interventions did not improve the fetal tracing.

Interview with RN #45 on 5/22/18 at 11:30 AM indicated that she documented moderate varability and the presence of accelerations intermittently in the clinical record when today she would have identified the varability as minimal and lacking accelerations. RN #45 also indicated she did not recognize the late decelerations in the fetal tracing. RN #45 identified at the time of this case she had been a labor and delivery nurse for less then a year and that the lack of experience was likely why she did not interprete the tracing correctly. RN #45 indicated the providers were present during labor and she relied on the practitioners who were present to intervene if needed.

Interview with Nurse Manager #2 on 6/6/18 at 10:50 AM identified RN #45 should have been able to identify the abnormal fetal tracing. Subsequent to the surveyors investigation RN #45 was provided individual training on abnormal fetal tracings. Further interview with Nurse Manager #2 indicated although the hospital policy entitled Fetal Monitoring and Interpretation defined terminology for the assessment of fetal tracings it failed to direct interventions and a reporting mechanism when fetal tracings were abnormal or concerning.

Subsequent to the surveyors inquiry an immediate plan of correction dated 5/23/18 directed in part that the nurse incolved in the case would be mentored by the nurse educator in the assessment and recognition of abnormal fetal tracings. In addition, all nursing staff would be obtaining certification in the interpretation of fetal monitoring over the next eighteen months

Based on a review of clinical records, interview and policy review, for two of three patients reviewed in the outpatient behavioral health clinic (#147 and #149), the hospital failed to ensure that the treatment plans were updated in accordance with facility policy. The findings include the following:

a. Patient #147 presented to the facility on 4/26/18. The clinical record indicated that the patient was evaluated, a treatment plan was completed and the patient was placed in the partial hospital program. The 5/14/18 physician re-evaluation recommended that the patient be admitted to the intensive outpatient program (IOP). The patient started in the IOP on 5/15/18 and a weekly case review was completed on 5/18/18. Review of the record with the Program Director on 5/24/18 failed to reflect that the treatment plan was updated when the patient's level of care had been changed.

b. Review of Patient #149's clinical record indicated that in April of 2017 the patient had been in the IOP and was transitioned to outpatient care. The clinical record indicated that on 5/15/18 the patient requested IOP secondary to the reemergence of suicidal ideation. The patient restarted IOP on 5/15/18 however review of the record with the Program Director on 5/24/18 failed to reflect that a treatment plan was completed.

Review of the treatment plan policy indicated that treatment plans are to be updated every thirty days for PHP/IOP patients or as the level of care changes.

Based on medical record review, review of facility policies and interviews for one of three patients who was administered a medication that required titration (Patient #143), the facility failed to ensure that patient assessments were completed as per facility policy.
The finding includes:

Patient #143 was admitted to the ICU (intensive care unit) on 5/14/18 with possible overdose and required mechanical ventilation. Review of physician orders dated 5/15/18 at 6:00 PM directed Propofol 1000mg/100ml with an initial rate of 5mcg/kg/min. The order further directed to titrate by 5mcg/kg every 5 minutes to achieve a SAS (sedation/agitation scale) of 0 to -1. Review of the Propofol infusion rates and hourly SAS on 5/17/18 at 12:54 PM identified that the documentation was lacking on 5/16/18 at 12:00 AM, 1:00 AM, 7:00 AM, 3:00 PM and 11:00 PM. In addition, documentation of the hourly Propofol drip rate and SAS were not documented for the entire night shift on 5/17/18 from 12:00 AM to 7:00 AM. Interview with the ICU Manager on 5/17/18 at 1:27 PM indicated that hourly documentation of the Propofol infusion and SAS was required in the ICU. The ICU Manager further identified that the RNs would document the missing data and, per policy, nurses had 24 hours to add an addendum to the record. Although the documenting corrections and addenda policy identified that addenda are documented in the legally accepted method no greater than 24 hours, the Propofol policy identified that documentation included the rate and a SAS every hour.

Based on a review of the clinical record, staff interviews and a review of the hospital policy for one sampled patient reviewed for the administration of Nitrous Oxide (Patient #117), the facility failed to ensure a telephone order was sign timely in accordance with the hospital policy. The finding included:


Review of the clinical record identified Patient #117 was admitted to the hospital on 5/2/18 in labor. Physician's orders directed the use of Nitrous Oxide for analgesia. Interview and review of the clinical record with Nurse Manager #2 on 5/14/18 at 10:00 AM indicated the order was received by a nurse via a telephone order on 5/2/18 at 11:36 PM. The physician failed to sign the order until 5/7/18 at 10:44 AM. Further interview with Nurse Manager #2 indicated the order should have been signed on the same day in was entered and was not. The hospital policy entitled Medical Orders directed in part that a registered nurse can accept and document telephone or verbal orders from a practitioner. All telephone or verbal orders should be entered in the patient's medical record immediately, reviewed, and countersigned by the prescriber as soon as possible.

Based on medical record reviews, review of facility policies and interviews for one of three patients who had a blood transfusion (Patient #114), the facility failed to ensure that transfusion documentation was accurately recorded.

The finding includes:

Patient #114 was admitted to the ambulatory infusion area for a blood transfusion on 5/15/18. Observations on 5/15/18 at 11:23 AM noted Patient #114 in the chair with one unit of blood infusing. The transfusion record dated 5/18/18 identified that the blood was initiated at 11:10 AM. The record also noted that although the signature of the Transfusionist was present, the second signature of the verifying individual was left blank. Interview with RN #14 on 5/15/18 at 11:26 AM noted that she verified the blood for patient #114 prior to infusion initiation and forgot to sign the transfusion record. The facility policy for transfusion therapy identified that both verifying staff must sign their names on the infusion therapy paper.

Based on observation of the Radiology Department, staff interviews and a review of the facility documentation, the hospital failed to ensure an acceptable level of safety and quality. The finding included:


On 5/14/18 at 2:00 PM a tour of the Magnetic Resonance Imaging (MRI) area identified multiple needles were stored in a cabinet that was left unlocked. This area was not in direct observation of a staff member. Interview with the Clinical Quality Educator of Radiology on 5/14/18 at 2:05 PM indicated the cabinet should have been secured and was not. Subsequent to surveyor inquiry, the Clinical Quality Educator of Radiology locked the cabinet.

Based on clinical inspection of radiological services, the hospital failed to ensure that safety precautions were maintained. The findings include:

In accordance with Section 19-24-7 Surveys:

(A) (1.) As used in section 19-24-1-19-24-14 inclusive "survey" means an evaluation of the radiation hazards incident to the receipt, transfer, possession, manufacture, storage, use, operation, handling, transportation or disposal of radioactive materials or other sources of radiation under a specific set of conditions. Where appropriate, such evaluation shall include a physical survey of the location of materials and equipment and measurements of levels of radiation or concentrations of radioactive material present.
(2.) Each owner of an installation shall make or cause to be made such surveys as may be necessary to comply with sections 19-24-1 through 19-24-14 inclusive.
(3.) The adequacy of surveys shall be subject to the review of the department's representatives.
(B.) Each owner shall maintain records showing the results of the surveys.

Contrary to these requirements, surveys in the lung perfusion study room failed to adequately evaluate radiological hazards associated with Xe-133. Specifically:
" The Victoreen instrument utilized to measure Xe-133 gas radioactivity was not maintained within manufacturer's guidance for calibration. Manufacturer guidance requires annual calibration. Calibration records showed that the instrument was last calibrated over one year ago (by Manchester Hospital maintenance staff).
" Failure to maintain gas intake flow port filter resulted in excessive filter loading that prevented proper survey of radiation concentrations. DEEP personnel identified to Manchester Hospital Staff that the manufacturer label near the flow intake port states "clean filter weekly". Filter loading level buildup indicating that this maintenance was not performed weekly. Measurements of Xe-133 are not representative of maximum concentrations. Xe-133 gas is heavier than air. The instrument is placed at a breathing zone level to conduct surveys. The instrument should be placed in a location more indicative of a true measurement of the maximum airborne concentrations in the room (near floor).

Observations:
1.) Information/calculations concerning airborne concentrations of radioactive material are still listed in Maximum Permissible Concentrations (MPC's). MPC's were replaced by Derived Airborne Concentration values in the early 1990's.
2.) Annual Audit- 10 CFR 20, Section 20.1101 "Radiation Protection Program" subpart (C) states: "The license shall periodically (at least annually) review the radiation protection program content and implementation." The only audit the program performs is a quarterly audit, which does not meet the requirements of this section. It was pointed out to Manchester Memorial staff that they should utilize NRC NUREG 1556 Volume 9, Specific Guidance for Medical Licensees, Appendix L, "Annual Program Audit" as a guide for his annual program audit.

1. Based on a tour of the surgical department, review of facility policies, observations and interview, the facility failed to ensure proper hair coverage in the restricted surgical suites.
The finding includes:

A tour of the surgical department was conducted with the Director of Perioperative Services on 5/15/18. Observations at 9:44 AM identified the ST (surgical technician) and the physician in OR #6 with bouffant hair covering on and hair not completely contained in the hair covering. Observations at 9:48 AM of OR #7 and/or 9:49 AM of OR #5 (both during total joint cases) and/or 9:55 AM of OR #1 identified the Anesthesia Provider and/or the Patient Care Assistant and/or the Physician's Assistant with beard and/or sideburns exposed. Observations at 9:51 AM noted the surgeon, during the surgical procedure, had donned a bouffant hair covering and hair was exposed at the nape of the neck.

Interview with the Director of Perioperative Services on 5/15/18 at 9:46 AM indicated that the surgical area follows the standards of AORN (Association of periOperative Registered Nurses) and all hair must be enclosed. The facility policy for surgical attire identified that all head and facial hair will be covered by an approved disposable or reusable hat/hood in restricted and semi- restricted areas.


2. Based on medical record reviews, review of facility policies, observations and interviews the facility failed to ensure appropriate glove changes and/or hand sanitization during patient care. The finding includes:

A tour of the wound center was conducted on 5/16/18 with the Program Director and Patient #119's dressing change was observed at 10:02 AM. The observation identified that RN #15 removed her gloves after using a gloved hand to open a drawer and donned clean gloves without the benefit of sanitizing hands. She then proceded to dress the Patient's wound. Interview with RN #15 on 5/16/18 at 10:20 AM indicated that she was nervous. The facility handwashing policy identified to sanitize hands after glove removal.






15482

Based on observation during tour, the facility failed to ensure supplies that were ready for use had not expired and/or the environment was maintained in a sanitary manner. The findings include the following:

a. During a tour of the Geri psychiatric unit on 5/16/18 at 10:30 AM, culture swabs stored in the supply room were observed with expiration dates in 10/2010, 10/2013, 3/16, 11/2016 and 2/2017.

b. In addition, staple remover kits expired in 7/2015 and 3/2017, steri-strips expired in 7/2017 and glucose control solution expired in 11/2017.

c. Tour of the Adolescent psychiatric unit on 5/16/18 at 9:30 AM identified balls of dust hanging off the observation mirror and the door frame to the nursing area had peeling paint.


26703

Based on a review of Hospital documentation it was identified that the hospitals Infection Control and Prevention committee did not consistently review required testing in the pharmacy compounding area. The findings include:

A review of the monthly Infection Control and Prevention committee meeting minutes dated December 2015 through February 2018 failed to indicate the results of environmental monitoring of the pharmacy compounding area were monitored and/or reviewed by Infection Prevention.
Review of Environmental testing reports from January 2016 to current identified no actionable levels of environmental samples had been identified.

During an interview with the Vice President of Quality and Patient Excellence on 5/16/18 at 12:15 PM he/she indicated environmental testing is completed and monitored by the Director of Pharmacy however in review of Infection Control and Prevention committee meeting minutes it was identified that from January 2016 through February 2018 the environmental testing had not been report and/or reviewed by Infection Prevention.

Interview with the Infection Prevention Nurse on 5/16/18 at 1:30 PM identified the results had not been discussed in the Infection Control and Prevention committee meetings. He/she indicated the lack of reporting was recently identified as an issue during a separate facility review. The Infection Prevention Nurse indicated going forward he/she would gather the data pertaining to the pharmacy compounding area and the data will become a standing agenda item at the infection prevention committee meetings. The results will be reported every 6 months or should an issue be identified.

Medical Staff Bylaws indicated the purpose and duties of the infection control committee shall be responsible for surveillance of infection potentials, review and analysis.

Based on medical record reviews, review of facility policies and interviews for one of six surgical patients
(Patient #112), the facility failed to ensure that the anesthesia recovery assessment was performed timely.
The finding includes:

Patient #112 was admitted to the hospital on 5/15/18 for left eye surgery. The anesthesia record dated 5/15/18 identified that the Patient had monitored anesthesia care during the operative procedure. Review of nursing documentation dated 5/15/18 indicated that the Patient arrived in the recovery area at approximately 10:30 AM. Further review of the anesthesia record noted that the anesthesia recovery assessment by the anesthesiologist was conducted at 10:20 AM at the end of the surgical case and when the Patient was still in the OR.

Interview with the Quality Manager on 5/15/18 at 11:11 AM indicated that the anesthesia recovery assessment should be later than the anesthesia end time and be performed when the patient was in the PACU (post anesthesia care unit). The facility policy for post-operative care identified that a post- anesthesia evaluation will be completed within 48 hours after surgery and the 48 hours begins at the point the patient is moved to the designated recovery room.

Based on clinical record review and interview, for one patient reviewed for medication errors (Patient #136), the hospital failed to ensure that an antipsychotic medication was ordered for the correct patient resulting in a medication error. The finding include the following:

Patient #136 presented to the Emergency Department (ED) on 3/18/17 at 8:14 PM with complaints of weakness and being dizzy for several weeks. Review of the physician note dated 3/18/17 at 10:48 PM indicated that the patient's symptoms were moderate to severe and worse when standing. The record identified that intravenous fluids were administered and that an "ambulatory trial" was completed however the patient felt that he/she was not able to go home. Review of a physician's order (MD #11) dated 3/18/17 at 12:56 AM directed to administer Seroquel 400 milligrams. The nursing progress note dated 3/19/17 indicated that Seroquel 400 mg was administered at 1:19 AM. A physician's order dated 3/19/17 at 1:49 AM directed that an EKG be performed for dizziness and giddiness. The EKG result identified that the patient had sinus bradycardia with a rate of 54 beats per minute. The nurse's note on 3/19/17 at 2:00 AM indicated that the patient was sleeping, answers questions appropriately and remained sluggish. The patient did not feel s/he could be discharged home and was subsequently admitted to the special observation unit at 3:09 AM.

A narrative note authored by the ED Director dated 3/20/17 at 10:35 AM identified that he met with the patient and significant other to inform them that while the patient was in the ED, s/he inadvertently had ordered and administered 400 mg of Seroquel and the patient was kept in the ICU for monitoring.

Interview with MD #10 on 5/18/18 at 9:51 AM stated on 3/18/17, MD #11 was asked by a RN to write a seroquel order, however, the order was inadvertantly ordered for Patient #136 resulting in a medication error. The patient did experience somulence and hypothermia and was admitted to the ICU as a precautionary measure.