HospitalInspections.org

1. Based on observation, interview and policy review, for two of two patients' (P# 48, 44), the facility failed to provide privacy during the provision of care. The findings include the following:

a. During tour of a nursing unit with the Nurse Manager and the VP of nursing on 7/19/17 at 9:45 AM, Patient #48 was observed being changed with the curtain open exposing portions of the patient. The staff member failed to close the privacy curtain during the provision of care.

b. During tour of a nursing unit with the Nurse Manager and the VP of nursing on 7/19/17 at 10:45 AM, Patient #44 was observed in a room by the door having his/her foot dressing being changed, visible to people in the hallway.

Review of the policy indicated that the patient has the right to receive high quality care that is respectful and considerate.


27691




2. Based on observation, clinical record review, review of hospital investigation, hospital policies and procedures, and interviews, for 1 of 4 patients who received care and services, the hospital failed to ensure that the patient's dignity and comfort was maintained when a care partner of the opposite gender spent the night in the room with his/her elderly parent. The findings include:

Patient #34 was admitted to the hospital on 5/7/2016. Diagnoses included hematemesis with upper GI endoscopy, osteoarthritis, status post left total knee replacement with staples in place, obstructive sleep apnea and diabetes mellitus. The patient was transferred from the ED to a four bed room on the ninth floor. The endoscopy was performed on 5/9/16 at 12:04 PM and the patient was transferred to a two bed room on seventh floor (room 722 B) for telemetry at 10:16 PM and discharged the following day at 3:14 PM.

Review of the clinical record and interview with RN #5 on 7/18/17 at 11:36 AM identified that a patient has the right to have a care partner of any gender stay with them, including through the night. In the case where the care partner is of a different gender than the roommate, the staff would ask the care partner to leave during administration of personal care (to the roommate) and/or make a room change as soon as possible. According the RN #5, the hospital currently lacks a written policy, procedure, or protocol related to care partners of the opposite gender than the patient or his/her roommate.

Tour and observation of room 722 (currently room 542) on 7/20/17 at 10:03 AM with RN #5 and RN #10 identified that the semi-private room was rectangular in shape. Beds were positioned next to each other on the long wall with headboards against the the wall. "A" bed was closest to the door, hall way and bathroom. "B" bed was closest to the window and a closet. Each bed included individual privacy curtains on a track that would enclose 3/4 of the bed, however, the foot of each bed would remain exposed. a curtain could be drawn between each bed. RN #10 identified that if a visitor was utilizing a recliner chair to spent the night with a family member, the chair would be positioned parallel to the patient's bed with the top of the recliner against the wall. If a patient from the "B" bed needed to utilize the bathroom, he/she would need to walk past the recliner chair in order to enter the bathroom. This presented an issue of privacy and dignity for the "B" bed patient.

Interview with Patient #34 on 7/20/17 at 9:48 AM identified that he/she was uncomfortable with a visitor of another gender spending the night with his/her family member in the room. Patient #34 identified that he/she was not informed that there would be a visitor of another gender in the room during that night and was not given any choice regarding possible room change and/or other accommodations such as asking the visitor to leave the room temporarily if he/she needed to use the bathroom. Patient #34 further identified that he/she asked for a room change but was informed that, due to his/her need for telemetry, no other appropriate beds were available. When Patient #34 rang for bathroom assistance, as directed, the staff offered the bedpan even though the Patient was capable of ambulating to the bathroom with a one person assist. Patient #34 was concerned about his/her urinary frequency. Patient #34 expressed the feeling that his/her rights were not respected and that he/she did not matter to the staff.

Patient Rights and Responsibilities Policy identified that the patient has the right to care in a safe and secure environment that preserves dignity.

1. Based on clinical record review and interview for 2 (P#31 and P#32) of 3 patients reviewed for fall risk the hospital failed to ensure a patient who was high risk for falls was monitored according to hospital policy. The findings include:

a. P#31 was admitted to the hospital from his/her physician office with altered mental status after an unwitnessed fall at home. P#31 had a history of a subdural bleed 8 months prior and was currently on an anticoagulant.

Physical Therapy (PT) assessment dated 6/10/16 5:10 PM indicated P#31 required fall precautions. The patient required an assist of 2 when getting out of bed (OOB) with a rolling walker (RW).

Fall risk assessment completed on 6/12/16 at 10:00 AM high fall risk per clinical judgement. Plan of care identified safety rounds and fall prevention program.

Nurses notes indicated on 6/12/16 at 12:40 PM P#31's bed alarm was activated and P#31 had made no attempts to get (OOB). Frequent rounding was done.

A Nurse Practitioner (NP) note dated 6/12/16 at 3:30 PM indicated he/she had evaluated P#31 after an unwitnessed fall. P#31 was exhibiting baseline confused and upon physical exam P#31 was noted to have right sided facial redness. Imaging of head, neck and facial bones identified a segmental fracture of the right zygomatic arch. An ear, nose and throat (ENT) consult was obtained. No treatment recommended and P#31's anticoagulant was discontinued.

During an interview with Nurse Manager #1 and Director of Risk Management on 7/21/17 at 9:30 AM it was identified during a review of the incident that at the time of the fall P#31's bed had not been on. Nurse Manager #1 indicated bed alarms are checked at change of shift and the oncoming shift had not yet physically checked that P#31's bed alarm was activated prior to the fall.

Manufacturers recommendations indicated alarm function should be checked every time before leaving a patient unattended.

Hospital Adult Inpatient Fall Prevention and Management policy indicated patients who are assessed as high fall risk will have bed/chair alarms activated however the policy did not identify how frequently the bed/chair alarms were to be checked.




b. P#32 was evaluated in the Emergency Department (ED) and subsequently admitted to the hospital from his/her physician office after complaints of dizziness and nausea. Past medical history included anemia, atrial fibrillation treated with oral anticoagulants (Coumadin), chronic kidney disease, coronary artery disease, diabetes mellitus, hypertension and long term (current ) use of anticoagulants and was identified as being non-compliant with taking his/her prescribed medications. Upon evaluation in the ED P#32 was noted to be hypertensive. His/her hypertension was treated and P#32 was placed on heparin for anticoagulation due to a sub therapeutic INR. Neurochecks were completed post fall.

Fall risk assessment dated 3/4/17 indicated P#32 was considered a low fall risk however was determined to be a high fall risk based on clinical judgement. The patient plan of care identified P#32 as a high fall risk and interventions included the "Stay with Me" program.

According to hospital documentation on 3/5/17 P#32 attempted to get up from the toilet unassisted and fell. P#32 indicated he/she had not struck his/her head and did not lose consciousness. A head CT scan identified a small acute right ganglia infarct (stroke) with no acute hemorrhage. Basal ganglia is one of the areas most commonly affected by hemorrhagic strokes due to uncontrolled hypertension.

During an interview with Patient Care Technician (PCT) #1 and Nurse Manager (NM) #2 on 7/21/17 at 10:30 AM PCT#1 indicated on 3/5/17 he/she assisted P#32 to the bathroom. P#32 had been compliant with using the call bell for assistance therefore PCT#1 ensured the call bell was accessible and instructed P#32 to call when ready that PCT#1 would ensure privacy and wait outside the door. While outside the bathroom door PCT#1 heard a bang and found P#32 on the floor in the bathroom. Upon surveyor inquiry PCT#1 was aware that "Stay with Me" intervention indicated the patient should be in direct visualization however PCT#1 had not been aware P#32 required direct visualization when in the bathroom. NM #2 indicated fall risk interventions in place are reviewed with shift change report conducted PCT to PCT. NM #2 indicated PCT#1 should have been aware and not left P#32 unattended in the bathroom.

Hospital Adult Inpatient Fall Prevention and Management policy indicated patients who are assessed as high fall risk will have interventions including "Stay With Me" which indicated staff were required to stay with the patient when toileting (Bathroom/commode) and when transferring.








2. Based on observation of the Behavioral Health Unit, staff interviews and a review of the facility documentation for three of three patients (Patient #56, #57 and #58), the hospital failed to timely conduct safety checks in accordance with the physician's order and hospital policy. The findings included:

a. Review of the clinical record identified Patient #56 was admitted to the hospital on 7/12/17 for stabilization of psychosis with diagnosis that included schizophrenia. Physician's orders dated 7/12/17 directed that the patient would be visualized every fifteen minutes around the clock for safety.

b. Review of the clinical record identified Patient #57 was admitted to the hospital on 7/5/17 for stabilization of psychosis and mood. The patient's diagnosis included schizoaffective and bipolar disorder. Physicians' orders dated 7/16/17 directed that the patient would be visualized every fifteen minutes around the clock for safety.

c. Review of the clinical record identified Patient #58 was admitted to the hospital on 7/5/17 for decompensation after medication noncompliance. The patient's diagnosis included schizophrenia. Physicians' orders dated 7/13/17 directed that the patient would be visualized every fifteen minutes around the clock for safety. On 7/17/17 at 2:17 PM an observation of Psychiatric Technician #1 who was assigned to the safety checks made observations of Patient #56, #57 and #58 (who were located in their room), for both the 2:00 PM and 2:15 PM. Review of the fifteen minute observation log at 2:17 PM failed to identify that 2:00 PM safety checks had been conducted for all three patients. Interview with Psychiatric Technician #1 indicated she was late conducting the 2:00 PM safety checks for Patient #56, #57 and #58 and she had provided a snack for the patients that were in the dining area. Interview with Nurse Manager #3 on 7/17/17 at 2:30 PM identified Psychiatric Technician #1 should have conducted safety checks first prior to any other unit task. The hospital policy entitled Patient Monitoring directed in part that upon admission to the unit all patients would be placed on fifteen minute safety checks unless the need for a more intensive monitoring was ordered and/or a nursing assessment indicated its use. The patient's behavior and location would be recorded every fifteen minutes. Staff members would be assigned for maintaining the safety checks on the staff assignment sheet. During this assigned time, staff would be on the unit and would perform no other tasks to ensure full attention to patient monitoring. The policy further directed that the staff member assigned to safety checks was responsible for continuing rounds until the rounds board is formally relinquished to the next assigned staff member.




29049

Based on clinical record review and interview for 1 (P#30) of 3 patients reviewed for access to requested medical records the hospital failed to ensure a medical record request was completed in its entirety. The findings include:

Patient (P) #30 was evaluated in the ED on 9/27/15 as a result of a motor vehicle accident.

A medical record request dated 4/15/16 along with authorization to disclose health information dated 4/13/16 by Person #30, on behalf of Patient (P) #30, was sent to the Hospital #1. The letter requested a copy of P#30's medical record and bill concerning his/her treatment at Hospital #1. A subsequent letter from Person #30 dated 5/16/16 indicated he/she had received the copies of the medical record however did not receive a copy of the bill.

Hospital #1 documentation indicated the request for medical record copies was received on 4/20/16, processed and fulfilled on 4/29/16 however, Hospital #1 could not provide documentation to support that the requested bill was sent to Person #30.

In an interview with the Director of Risk Management on 7/18/17 at 11:45AM he/she indicated the medical record was copied as requested and the request for a copy of the bill had been sent to the billing department. He/she indicated the medical records department billing department had no knowledge of the request by Person #30 however P#30 had been sent a billing statement on 12/9/15, 1/10/16 2/9/16 and 3/10/16.

According to the Legal Health Record (LHR) policy the contents of the the LHR is a collection of information created and maintained to document healthcare services provided to a patient. According to the policy the The LHR includes the patients billing records.

In an expansion of the sample medical record requests submitted by P#36 and P#66 were reviewed. No issues were identified.

Based on clinical record review, interview and policy review, for one of three patients' reviewed for restraints (#42), the facility failed to ensure that medications administered were considered a standard treatment to address behaviors resulting in a chemical restraint. The finding includes the following:

Patient #42 was brought to the ED on 7/17/17 by the police secondary to suicidal ideation. A physician's note on 7/17/17 at 9:46 AM indicated that the patient was highly agitated initially, however was not currently physically violent but given his/her behavior this morning was a risk given previous agitation. The note further identified "will take out of handcuffs, but will give soft restraints until sedation takes effect". Will give IM sedation as patient not reliable to take oral.

A physician's order dated 7/17/17 directed the administration of Versed 5 mg IM, Benadryl 50 mg IM and Haldol 5 mg IM. The record failed to reflect the behaviors that warranted the use of the chemical restraints and/or that the patient was monitored following the administration of Versed used for conscious sedation. Interview with MD #6 on 7/20/17 at 1:10 PM stated Versed is not a medication typically used to treat a patient with a psychiatric disorder and that the physician's order/record should have noted the patient's behaviors required for the use of the identified medication.

Review of the Moderate Sedation policy directed that sedation monitoring will be documented every fifteen minutes. Review of the Restraint policy indicated that a chemical restraint is any medication when it is used as a restriction to limit the patients behavior and/or freedom of movement and is not standard treatment or dosage for the patients condition.

Based on clinical record review and policy review, the facilty failed to ensure that for one patient reviewed for restraints (#42) exhibited behaviors that warranted the use of physical restraints. The finding includes the following:

Patient #42 was brought to the ED on 7/17/17 at approximately 9:18 AM by the police secondary to suicidal ideation. The patient presented to the ED in handcuffs. The physician's note documented on 7/17/17 during the period of 9:46 AM and 1:47 PM indicated that the patient was highly agitated initially, however was not currently physically violent but given behavior of the morning was a risk given previous agitation. The note further identified "will take out of handcuffs, but will give soft restraints until sedation takes effect". Will give IM sedation as patient not reliable to take oral medication. Review of clinical record dated 7/17/17 reflected an order for bilateral wrist restraints and a 1:1 sitter. A nurse's note indicated that the patient was talkative with rapid speech, will immediately be taken out of handcuffs and soft restraints will be applied. The note indicated that the patient was asleep within thirty-minutes of the administration of medications and restraints were then removed. The record failed to reflect the specific behaviors that warranted the use of bilateral wrist restraints.

Review of the Restraint policy indicated that the use of restraints should be based on a comprehensive patient assessment and may only be used to ensure that immediate physical safety of the patient, staff and others.

Based on a review of clinical records, facility documentation, and interviews, the facility failed to provide appropriate supervision to medical students and/or resident physician's for one of three patients' with surgical drain placement (Patient #37), resulting in a retained drain. The finding includes:

Patient#37 was seen in the surgical clinic and admitted on 10/1/16 for incision and drainage of perianal abscess and placement of a Penrose drain. Patient #37 was discharged on 10/2/16. Review of the discharge instructions dated 10/2/16 informed Patient #37 to leave the surgical drain in place and that he/she will be assessed for drain removal at the follow up appointment.

Review of the clinic progress note dated 10/13/16 identified Patient#37 was initially examined by a medical student. The note identified the wound was evaluated and assessed to be healing with mild purulent drainage present, no erythema or tenderness and prescription for 10 day course of antibiotics ordered. Follow-up instructions directed to return to the clinic on 10/24/16.

Review of the clinic progress note dated 10/24/16 identified that the patient had a small incision near anal canal, pus expelled with pressure, no erythema and no swelling. Packing inserted to area and patient to follow up in three days.

Review of the clinic progress note dated 10/27/16 identified Patient #37 had completed antibiotic course, denies fever, pain tolerable, perianal abscess on right buttock drained some pus with blood, wound packed afterwards.

Review of the clinic progress note dated 11/3/16 identified the patient's right peri-rectal wound was healing well, no erythema, drainage, non tender and packed with iodoform gauze. Follow-up instructions directed no further packing needed, cover with dry gauze only and follow up in 1.5 weeks.

Review of the clinic progress note dated 11/14/16 identified the patient's perianal wound with minimal serous drainage, no flatulence or erythema, wound appears clean, no pus like drainage. Follow-up instructions directed to apply dry dressing as needed and return to clinic in two weeks.

Review of the clinic progress note date 11/28/16 identified the patient's perianal abscess was healing, small serous collection expressed and space probed approximately 2 mm depth. Follow-up instructions directed to apply dry dressing as needed, no need to pack wound and to follow up as needed.

Review of the clinical progress notes from 10/13/16 through 11/28/16 identified that a chief resident physician and the attending physician agreed with the evaluation, assessment and plan for the perianal abscess wound.

The clinic progress note dated 1/9/17 identified Patient #37 returned to the clinic complaining of discomfort and sensation of something retained in the healed area. Assessment of the wound identified a small opening which was probed and noted a Penrose drain in the cavity. The drain was removed intact and the patient was directed to follow-up as needed.

In an interview on 7/19/17 at 1:45 PM, MD#9 (Surgical Resident) identified he performed an incision and drainage of the perianal abscess and secured the Penrose drain with a stitch. MD#9 further identified the patient was instructed to follow up in the surgical clinic for assessment.

Review of the clinical record and interview with MD#11 on 7/20/17 at 1:30 PM stated the surgical clinic is managed by the chief resident whose responsibility is to assess patients and implement a plan of care which will then be reviewed by the attending physician on site. MD#11 identified on 10/13/16, Patient#37 was initially examined by a medical student supervised by MD#14 (Chief Resident). MD#11 identified the progress note did not reflect that a drain was present on the assessment dated 10/13/16 and in addition would expect the chief resident to thoroughly review the clinical record to ascertain the reason for the patient's visit. MD#11 further identified he was the attending physician that day, did not exam the patient but reviewed the patient's assessment with MD#14 and concurred with the plan of care.

Review of the Corrective Action Plan (CAP) with the Director of Risk Management on 7/21/17 at 11:00 AM identified that subsequent to this event, staff received education on the changes to the outpatient surgery clinic process with audits initiated to monitor compliance.

1. Based on a review of clinical records and policy review, for two of three patients' reviewed for pain (#40 and 41), the facility failed to document pain assessments and/or reassessments in accordance with the facility policy. The findings include the following:

a. Patient #40 was admitted on 7/16/17 after a fall at home with multiple rib fractures. The patient was admitted to the floor on 7/16/17 at 9:56 PM. The physician's orders dated 7/16/17 directed Ultram 50 mg every six hours for moderate pain and 100 mg for severe pain as needed. The record indicated that on 7/16/17 the patient received Ultram 100 mg at 10:08 PM, however the record failed to reflect that the patient's level of pain had been assessed prior to administration and/or after the medication was administered.

b. Patient #41 was admitted to the facility on 6/22/17 status post fall with hip fracture and subsequently developed a small bowel obstructions. Review of the clinical record indicated that on 7/17/17 at 10:00 PM the patient had a pain level of 10 on a 1-10 scale (10 being the worst possible pain). The patient was medicated with Dilaudid 0.5 mg however review of the record on 7/18/17 at 10:00 AM failed to reflect that the patient's level of pain had been reassessed.

c. Patient #41's clinical record indicated that on 7/17/17 at 6:00 PM the patient had a pain level of 10 on a 1-10 scale. The patient was medicated with Dilaudid 0.5 mg however review of the record failed to reflect a reassessment of the intervention to determine the efficacy.

d. Additionally review of the MAR indicated that on 7/18/17 at 4:30 AM, Patient #41 received Dilaudid 0.5 mg. The record failed to reflect a pre-assessment and/or a post assessment of the patient's level of pain.

Review of the facility policy indicated that the patient's level of pain should be reassessed after an intervention and continue to reassess until acceptable pain goal is achieved.


2. Based on a review of clinical records, interview, and policy review, for two of two patients (#45 and #46) withdrawing from alcohol, the facility failed to monitor the patients in accordance with facility policy. The findings include the following:

a. Patient #46 was admitted on 7/11/17 with a history of alcohol abuse. Review of the physician's order dated 7/11/17 directed the use of the Clinical Institute Withdrawal Assessment (CIWA) non-ICU protocol. Record review and interview the the Manager and RN on 7/18/17 stated that on 7/11/17 the patient was monitored at 1:00 PM (score 11), then again at 9:50 PM (score 8) with the next evaluation completed on 7/12/17 at 7:41 AM (score 9). The facility failed to monitor the patient every four hours per policy.

Review of Patient #46's clinical record dated 7/12/17 reflected that the patient was evaluated at 10:00 PM (score 8) then six hours later on 7/13/17 at 4:00 AM (score 8). The subsequent assessment was not completed until 7/14/17 at 12:00 PM, more than 24 later.

Review of Patient #46's clinical record 7/14/17 reflected after the 12:00 PM assessment no further assessments were completed until 1:00 AM on 7/15/17. The 7/15/17 flow sheet indicated that at 12:27 PM the patient had a score of 17 and was not re assessed until 5:00 PM.

Review of the CIWA policy indicated that for a score <8 reassess every four hours, 8-15 -moderate withdrawal the patient should be reassessed every two hours and >15 reassess every hour.

b. Patient #45 was admitted to the facility on 7/17/17 with a history of depression and alcohol abuse. Review of the CIWA flow sheets indicated that patient was assessed at 1:33 PM with a score of 4 and was not assessed again until 9:00 PM (score 8). The subsequent assessment was not until 6:00 AM on 7/18/17.


3. Based on clinical record review, policy review and interview, the facility failed to ensure that for one patient identified with malnutrition (#47) that the patient's weight was monitored and/or for one patient requiring oxygen (#49) that the oxygen order was comprehensive to include titration parameters. The findings include the following:

a. Patient #47 was admitted to the facility on 7/12/17 with a urinary tract infection and question of anorexia. Review of the record indicated that on 7/13/17 the patient developed a stage 1 pressure ulcer on his/her sacral area. The registered dietician's note dated 7/13/17 indicated that the patient was severely malnourished and requested that a current weight be obtained. Record review and interview with the RN and Nurse Manager on 7/19/17 stated the only weight in the clinical record was dated 6/29/17 (a previous admission) which reflected the patient weighed 49.5 kg's (109.12 pounds). The record failed to reflect that the patient was weighed upon admission and/or upon the RD request. Subsequent to surveyor inquiry, the patient's weight was obtained that identified a weight of 40.9 kg's (90.16 lbs). The RD note dated 7/19/17 directed the completion of a calorie count, the initiation of nutrition supplements and the provision of frequent small meals.

b. Patient #49 was admitted on 7/6/17 with congestive heart failure, hypertension and pleural effusions. A physician's order dated 7/6/17 directed Oxygen 0-5 liters/minute to maintain a saturation greater or equal to 92%, document saturation and final liter flow within 20 minutes, may discontinue if patient is able to maintain a saturation greater than or equal to 92%. Review of the clinical record indicated that on 7/17/17 at 1:20 PM the patient was on 2 liters of oxygen with an oxygen saturation of 97%, at 5:15 PM had a saturation of 98% on 1.5 liters, at 8:30 PM had a saturation of 95% on 1.5 liters and at 8:45 AM on 7/18/17, had a saturation of 96% on 1.5 liters. The record failed to reflect continued titration of the Oxygen and/or that the orders were comprehensive to include the frequency of titration and by what amount. Interview with the Quality Liaison on 7/19/17 at 10:00 AM indicated that the hospital does not have a policy that directs the titration of Oxygen.

Based on clinical record review and interviews for 1 of 4 patients (Patient #33) reviewed for care and services provided in the Emergency Department (ED), the hospital failed to ensure the accuracy of the clinical record. The findings include:

Patient #33 was brought to the ED on 2/18/17 at 3:59 PM by his/her parent following ingestion of 590 milligrams (MG) of liquid Benadryl over the previous 48 hours to reduce symptoms of clonazepam (Klonopin) taper. Past medical history included: anxiety, hypertension, Lyme disease, and psychogenic dystonia. The clinical impression/final diagnoses documented by MD #18 included diphenhydramine overdose (undetermined intent), movement disorder, tachcardia, and elevated lactic acid level. The patient was transferred to the ED observation unit. A Medical/Surgical Discharge Summary dated 2/19/17 by MD #17 identified that Patient #33 denied self-injurious intent, was alert and oriented with no evidence of altered mental status and was able to report events and understands what had happened. The patient remained lucid but requested to leave at approximately 1:00 AM. MD #17 advised the patient to remain in the hospital until the afternoon. Risk and benefits were explained. The patient reported an understanding of the serious risk of mixing different sedatives that could potentially result in another overdose and fatal outcome. The patient decided to leave Against Medical Advise (AMA), and signed the hospital AMA form. An RN note identified that Patient #33 signed out on 2/19/2017 at 1:06 AM.

Patient #33 arrived in the ED again on 2/19/17 at 5:58 AM with a chief complaint of psychotic symptoms. He/she had been found wandering in the hospital's main parking garage (by security) and reported having been run over by a van, sustaining broken legs, and being followed. The patient was screaming and, according to MD #16, clearly psychotic. An ED Psychiatric Evaluation documented by MD #15 at 9:27 AM identified that the patient was alert but too symptomatic to focus and/or engage in the interview with significant thought blocking noted. His/her thought process was loose and difficult to follow. According to MD #15 the patient met criteria for inpatient hospitalization, had poor insight into her illness, was unable to care for him/herself, and unable to provide for her basic needs because of mental illness and needed immediate treatment. Diagnoses included unspecified psychotic disorder, rule out sedative, hypnotic, or anxiolytic withdrawal.

Review of a PEC completed by MD #15 on 2/19/17 identified that Patient #33's history included that he/she eloped from the ED, however, the clinical record identified that Patient #33 signed out AMA. Interview with MD #15 on 7/19/17 at 9:25 AM identified that he/she was unaware of what had occurred during the patient's original visit to the hospital but had been informed by the nursing staff during morning report that Patient #33 had eloped from the ED earlier in the morning of 7/19/17.

Based on a review of facility documentation and staff interviews the facility failed to conduct biannual smoke studies and/or failed to utilize the assistance of a competent microbiologist, industrial hygienist or inflectional control professional when highly pathogenic microorganisms were identified in the ante and hazardous compounding area of the pharmacy in accordance with United States Pharmacopeia (USP) 797. The findings included:

a. Interview and review of the mechanical certification report indicated mechanical testing with smoke studies was conducted on 11/3/16 however mechanical testing on 5/5/17 failed to include smoke studies. Interview with the Director of the Pharmacy on 7/21/17 at 1:00 PM indicated smoke studies were only necessary annually. According to the Certification for Sterile Compounding Facilities (CETA) for engineering control performance airflow smoke pattern testing (an observation using smoke to visualize airflow under dynamic operating conditions to confirm laminarity of the air is undisturbed) was part of the testing required for certification. USP 797 directs that certification for sterile compounding would be performed every six months by a qualified individual.

b. Review of the environmental testing conducted in the positive pressure room on 5/5/17 identified 1 colony forming unit (CFU) of mold (aspergillus) in the air. Review of environmental testing in the anti-room on 5/5/17 identified 5 cfu's of mold (2 arthrospore, 3 penicillium) in the air. Interventions included a 12 hour beyond use date (BUD) and terminal cleaning of both rooms. On 6/1/17 retesting in all three rooms was conducted and testing passed in the positive pressure room however failed in both the negative pressure room and the anti-room. Review of the environmental testing in the negative pressure room dated 6/1/17 identified nine CFU's of mold (3 acremonium, 2 aspergillus and 4 penicillium) in the air. The anti-room testing identified 13 CFU's of mold (9 aspergillus, 3 penicillium and 1 verticillium) in the air. Interventions included terminal cleaning, a plasmair air scrubber placed in the anteroom, the replacment of the Hepa filter in the anteroom and continued compounding with a 12 hour BUD. Retesting was conducted on 6/14/17 (2 acremonium, 1 penicillium) and on 6/21/17 (2 acremonium, 2 penicillium) that continued to identify mold in the air of the anteroom. Interventions included terminal cleaning, neutralizing pressure in the main pharmacy and air balancing. Pharmacy compounding resumed normal dating on 6/28/17 after a team decision was made that included the pharmacy director, and the infection control team. On 7/6/17 the results of the 6/21/17 sampling identified an increase of mold in the air of the anteroom (2 acremonium, 2 penicillium and 2 aspergillus) and compounding was reduced back to a 12 hour BUD. Interview with the Director of the Pharmacy on 7/21/17 at 1:10 PM identified she notified the Department of Drug Control on 7/14/17 of the continued and increasing mold formation despite multiple interventions. The Director of the Pharmacy indicated although the hospital did not consult with a microbiologist or industrial hygienist they did consult with the infection control nurse who they identified as a competent infection control professional. Interview and review of the facility documentation with the Infection Control nurse on 7/17/17 at 1:15 PM identified he was not formally trained in USP 797. According to USP 797 highly pathogen microorganisms (mold) can be fatal to patients receiving compounding sterile products and must be remedied regardless of the cfu count, with the assistance of a competent microbiologist, inflectional control professional, or industrial hygienist.

Based on a review of documents and/or observations, the hospital failed to ensure that the radiation protection program/policies were reviewed in the appropriate time frames. The findings include:

For Federal violations: 10 CFR 20.1101 Radiation Protection Programs- (c.) The licensee shall periodically (at least annually) review the radiation protection program and content. Contrary to this, there was no evidence that the program was ever reviewed. This is also a violation of 10 CFR 20.2102 Records of Radiation Protection Programs.

Based on a review of documents and/or observations, the hospital failed to ensure that staff were trained in the safe handling of radioactive materials. The findings include:

Sec. 19-24-9. Shipment in compliance with federal regulation
Shipment of radioactive materials shall be deemed in compliance with these
regulations if packaged and labeled in compliance with regulations of the U.S.
Department of Transportation and the other federal agencies having jurisdiction.
(Effective October 1, 1982)

Contrary to this, Bridgeport hospital had staff involved with radioactive material incidental to the transportation process which had not received the proper training required in 49 CFR 172.704. Hospital staff were aware that one individual was not trained, but allowed him/her to continue to perform the task.

29049

1. 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 in accordance with the facilities policy and procedure. The findings included:

a. On 7/18/17 at 1:00 PM a tour of the Radiology Department was conducted and identified in the Ultrasound (USN) area multiple paracentesis kits that included sharps and vials of injectable Lidocaine 1 % were stored in a cabinet that was left unlocked. Further observation of this area failed to identify that a staff member was in constant observation of the USN/storage area.

b.Observation of the Fluoroscopy area identified an unlocked treatment cart that included barium sulfate used to assess abnormalities in the esophagus and stomach. Interview with the Director of Radiology on 7/18/17 at 1:30 PM identified all sharp objects and medications should be secured at all times. Subsequent to the surveyors inquiry all cabinets were locked. The hospital policy entitled Medication Storage and Handling directed in part all medications including syringes and needles would be stored in the Automated Medication Dispensing Machines or a designated locked storage area.




2. Based on a review of documents and/or observations, the hospital failed to ensure that proper safety precautions were posted and/or that containers were properly labeled radioactive versus non-radioactive. The findings include:

a. Section 19-34-8 Radiation Information Labeling States- "(A) Each radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the word "danger" may be substitute for word "caution" in the signs and labels prescribed by this section. CAUTION * RADIATION AREA. This provision shall not apply to areas or rooms where x-ray equipment is used solely for diagnostic purposes by or under the direction of a healing arts practitioner as authorized by law. Contrary to this, Bridgeport Hospital had every room which had X-Ray equipment post "Caution Radiation Area" instead of "Caution X-Rays", which is required per regulations. Additionally, the entrance to the CAT scan from the CAT scan work area was not posted with any precautionary signage.

b. 10 CFR 20.1904 Labeling of Containers paragraph (b.) "Each licensee shall, prior to removal or disposal of empty uncontaminated container to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive material". Contrary to this an empty vessel which had been used to contain radioactive material was still clearly labeled as radioactive material and was being used as a "dumbbell" outside of a restricted area.

Based on a review of documents and/or observations, the hospital failed to ensure that staff were adequately monitored for the amount of radiation exposure. The findings include:

a. Section 19-24-5 Maximum Doses- Lens of the Eye- 1.25 Rem per calendar quarter. Contrary to this one individual exceeded this limit for the 4th quarter of 2015 and the 2nd quarter of 2016 and another individual exceeded this limit for three times, once in the 4th quarter of 2016 and for the 1st and 2nd quarter of 2017.

b. 10 CFR 19.13 Notification and Reports to Individual's paragraph (b.) "Each licensee shall make dose information available to workers as shown in records maintained by the licensee under the provisions of 10 CFR 20.2106. The licensee shall provide an annual report to each individual monitored under 10 CFR 1502 of the dose received in that monitoring year if: The individual's occupational dose exceeds 100 mrem Total Effective Dose Equivalent (TEDE). Contrary to this, a worker had received greater than 100 mrem TEDE and had not received an annual report. Staff identified that annual reports used to be given, but the practice was stopped about two years ago.

A. The facility did not ensure that piped in medical gas systems are in compliance with chapter 5 of NFPA 99.
On 07/19/17 at 11:00 AM the surveyor was not provided with documentation from facility staff that would indicate that the deficiencies noted on the medical gas inspection report dated 12/06/16 have been corrected. i.e; medical gas testing contractor noted on the report that the facility lacks WAGD inlets in anesthetizing locations within the facility, not complying with section 5.1.5.16 of NFPA 99.

B. The facility did not ensure doors protecting corridor doors were capable of resisting the passage of smoke as required by section 18.3.6.3.1 of NFPA 101 Life Safety Code.
On 07/18/17 at 09:00 AM the surveyor, accompanied by the Director of Maintenance, observed that the construction barrier and corridor door within the Antenatal Testing Area on the fifth (5th) floor had penetrations, and missing pieces of drywall, negating the assembly's ability to resist the passage of smoke as required by the referenced LSC standard.

C. The facility did not ensure that vertical openings between floors were enclosed with construction having a resistance to the passage of smoke as required by section 8.6.1 of NFPA 101 Life Safety Code.
On 07/18/17 at 09:00 AM the surveyor, accompanied by the Director of Maintenance, observed vertical opening voids and penetrations between the fifth (5th) and sixth (6th) floor within the Antenatal Testing Area, not meeting the requirements of the referenced LSC standard.

Based on observation during tour, review of facility documentation and interview, the hospital failed to ensure that the anesthesia machines and/or sevoflurane canisters were labeled as having been biomedically evaluated prior to use. The finding includes:

During tour of the two operating rooms and procedure room at the off-site surgical center on 7/20/17 with the Nurse Manager and VP of Nursing Services, observations were made that two (2) of the three (3) anesthesia machines located in these rooms failed to have a biomedical sticker (label) with the date that the anesthesia machine had undergone its operational check. A sticker, dated April 2016 was located at the back of the machines that identified that the machines were put into service in April 2016.
Additionally, the Sevoflurane canister, which is removable, located at the front of the machines, failed to have a label that it had ever been calibrated/checked for operational readiness by the hospital.
During interview on 7/20/17 at approximately 2:00 PM, the biomedical technician contacted by the hospital personnel stated that his employee was "given the job but must have not completed it".
Although the hospital provided evidence of a service contract and the paperwork relevant to servicing the equipment, there was no evidence of policy for labeling of equipment for use within the hospital such that medical staff would know that the medical device had cleared inspection. Additionally, the information provided failed to reflect maintenance about the canister that dispenses medication (sevoflurane) to the patient.