HospitalInspections.org

Based on a review of the clinical record and policy review, the hospital failed to ensure that a contracted dialysis company provided quality care to one sampled hemodialysis patient (Patient #13) in that the physician's order was not comprehensive to include the blood flow rate (BFR) and the dialysate flow rate (DFR) prior to administration. The findings include the following:

Review of Patient #13's clinical record indicated the patient was admitted on 1/16/18 for chest pain. The patient was also receiving hemodialysis three times a week. Review of the clinical record on 3/19/18 with the Quality representative identified a physician's order dated 1/17/18 that directed three hour hemodialysis treatments utilizing a 2 potassium and 2.5 calcium bath with blood flow (BFR) and dialysate flow rate (DFR) parameters as "max". The physician's order failed to direct a specific dose based on the specific needs/goals of the patient.

a. Review of the hemodialysis treatment sheets dated 2/21/18 indicated a BFR of 200 ml/min and a DFR of 600 ml/min, the flow sheet dated 2/26/18 indicated a BFR of 400 ml/min and a DFR of 600 ml/min.

b. The flow sheets dated 2/23/18, 3/9/18, 3/12/18, 3/14/18, 3/16/18 and 3/19/18 identified a BFR of 300-350 ml/min and a DFR of 600 ml/min was administered.

c. The flow sheet dated 2/28/18, 3/2/18, 3/5/18, and 3/7/18, identified that a BFR of 300 ml/min and a DFR of 800 ml/min was administered.

The hospital failed to ensure that hemodialysis was administered based on a specific physician's order.

Review of the Prescription verification procedure indicated that all staff will verify the dialysis orders to ensure that the patient receives a safe and effective treatment. Staff should verify and document in part the prescribed dialyzer and blood flow rate to ensure that the patient prescription is initiated prior to treatment.

Based on clinical record review and policy review, for one of four patients' reviewed for restraints (Patient #4), the hospital failed to ensure that a specific physician's order was written for restraint application in accordance with the hospital's protocol. The finding includes the following:

Review of Patient #4's clinical record indicated that the patient was admitted on 3/9/18 with left shoulder pain, and overall physical decline. The patient was noted to have a dislocated left shoulder and a fracture of the greater tuberosity of the left humerus. Review of the orthopedic Physician Assistant's (PA) note dated 3/18/18 at 12:45 PM indicated that the plan was to continue conservative treatment of the left shoulder dislocation and fracture and that the patient's left arm should remain in the sling at all times with no range of motion to the left shoulder.

The record reflected that the patient was extubated on 3/18/18. Review of the physician's order dated 3/18/18 directed "restrain patient using the least restrictive method per protocol". The physician/Licensed Independent Practitioner (LIP) order failed to direct the type of restraint to be utilized. Review of the restraint monitoring flow sheet indicated that the patient was placed in bilateral wrist restraints by the RN absent a specific order.

Review of the medical line, dressing and Tube Protection Protocol indicated if a restraint is needed the nurse must notify the Physician or APRN and obtain an order for the restraint as soon as possible. The order must indicate the behavior requiring the restraint, type of restraint and criteria for discontinuation.

Based on clinical record review, interviews with staff and policy review for 1 of 4 patients' reviewed for restraint and seclusion (Patient #1), the hospital failed to ensure that seclusion was discontinued at the earliest possible time. The findings include:

Patient #1 was admitted on 1/29/18 with diagnoses of Post Traumatic Stress Disorder (PTSD) and bulimia nervosa. A physician order for seclusion dated 2/4/18 at 1:00 PM identified Patient #1 exhibited violent and aggressive behaviors, was screaming, threatening, not contracting for safety and was a danger to self. Criteria for discontinuation included calm behavior and verbalization of a desire to cooperate. Patient #1 was identified as willingly going into seclusion. Review of the restraint flow sheet identified that Patient #1 was in seclusion from 1:00 PM to 3:00 PM. However, between 1:30 PM and 3:00 PM Patient #1 was identified as calm, talking to staff and sitting or laying down but remained in seclusion. Review of nursing documentation in this time frame failed to identify that Patient #1 was anything other than calm, as identified on the flow sheet.

Interview with Clinical Coordinator #1 on 3/19/18 at 10:40 AM identified that she recalled that on 2/4/18 Patient #1 continued to be agitated, yelling and threatening between 1:30 PM and 3:00 PM which was not documented in the monitoring sheet and should have been.

The hospital policy for restraint/seclusion identified that that a restraint must be changed to a less restrictive method as soon as possible and that assessment for discontinuation of restraints/seclusion must be on-going.

Based on clinical record review, interview and policy review, for one of four patients' reviewed for restraints (Patient #4) the hospital failed to ensure that alternatives were documented as attempted prior to the initiation of restraints. The finding includes the following:

Review of Patient #4's clinical record indicated that the patient was admitted on 3/9/18 with left shoulder pain, and overall physical decline. The patient was noted to have a dislocated left shoulder and a fracture of the greater tuberosity of the left humerus. Review of the orthopedic PA note dated 3/18/18 at 12:45 PM indicated that the plan was to continue conservative treatment of the left shoulder dislocation and fracture and that the patient's left arm should remain in the sling at all times with no range of motion to the left shoulder.

The record reflected that the patient was extubated on 3/18/18. Review of the monitoring flow sheet dated 3/18/18 at 3:00 PM identified that the patient was in bilateral wrist restraints. Review of the clinical record indicated that for alternatives attempted identified that the patient's "room near the nursing station" however the patient was in the ICU and all of the rooms are located around the nursing station. The clinical record failed to documentation of the behaviors that warranted restraints and/or alternatives tried prior to the application of bilateral wrist restraints. Interview with the Charge Nurse on 3/19/18 at 10:30 AM stated that the patient was pulling lines and initially the patient's right arm was secured however the patient kept moving the left arm therefore that arm was subsequently secured. Interview with the Orthopedic PA on 3/20/18 at 1:15 PM stated that she was on duty on 3/18/18 and did not receive a call that the patient was going to be restrained and that based on his/her injury the left arm should not have been restrained. The PA further stated that if a restrain was required, securing the patient's arm to his/her trunk (pappoosing) would have been ideal.

Review of the facility policy indicated alternatives to restraints must be considered and determined to be ineffective in the protecting the patient prior to the application of restraints.

Based on clinical record review, interviews with staff and policy review for 1 of 4 patients reviewed for restraint and seclusion (Patient #2), the hospital failed to ensure that the intervention and patient response to the intervention of seclusion and/or 4-point restraint was documented. The findings include:

Patient #2 was admitted on 2/7/18 with diagnoses of Post Traumatic Stress Disorder (PTSD), major depression and anorexia nervosa. A physician order for 4-point restraint dated 3/1/18 at 10:10 PM identified Patient #2 exhibited violent and aggressive behaviors and was refusing necessary medical treatment. The restraint order was for a duration of 4 hours. Criteria for discontinuation included calm behavior and verbalization of a desire to cooperate. Corresponding nursing notes identified Patient #2 was screaming and pushing staff and was placed in 4-point restraints to complete the medical treatment. Despite a physician order and nursing documentation identifying Patient #2 was placed in 4-point restraints, review of the restraint monitoring flow sheet failed to identified that Patient #2 was in restraints. The flow sheet indicated that Patient #2 was on 1:1 supervision and was pacing, agitated, struggling, and in bed quiet and/or sleeping in this time frame. In addition, a nurses note dated 3/1/18 identified the Patient #2 exhibited aggressive, combative and violent behaviors, was a danger to self and others, and was placed in seclusion from 10:48 PM to 10:53 PM. Review of the restraint/seclusion monitoring flow sheet failed to identify that Patient #2 was in seclusion.

Interview with Clinical Coordinator #1 on 3/19/18 at 10:45 AM identified that Patient #2 was in 4-point restraints on the night of 3/1/18 into the morning of 3/2/18 and that staff should have documented on the restraint flow sheet that the patient was in restraints and/or seclusion and should have documented appropriate interventions.

The hospital restraint/seclusion policy identified that the restraint flow sheet was to include documentation of proper application of a device, limb release/range of motion, respiratory/circulatory/sensation status, skin integrity and care delivery codes.

Based on a review of staffing schedules, review of the staffing plan, review of facility documentation, and interviews, the facility failed to ensure that adequate staffing was maintained in the ICU (intensive care unit). The findings include:

a. Review of the ICU assignment sheet dated 3/12/18 on the night shift (11:00 PM to 7:00 AM) indicated that the unit had a census of 8 patients with 3 registered nurses (RN) and 1 certified nursing assistant (CNA) working. The staffing matrix directed that for a census of 8 patients (all 3 shifts) staffing should include 4 licensed staff and 1 CNA.

b. The assignment sheets dated 3/11/18 and 3/10/18 indicated that on the night shift there were 3 RN's for 8 patients.

c. The assignment sheet dated 3/7/18 indicated that on the evening shift (3:00 PM to 11:00 PM) there were 3 RN's and no CNA for 8 patients.

d. The assignment sheet dated 3/8/18 and 3/2/18 indicated that for the night shift there were 6 patients and 2 RN's. The evening shift on 3/8/18 also had 6 patients and 2 RN's. Review of the matrix directed that for a census of 6 patients staffing should include 3 licensed staff.

e. The assignment sheet dated 3/6/18 indicated that for the day (7:00 AM to 3:00 PM) and evening shift there were 9 patients in the ICU with 3 RN's. Review of the matrix directed that for a census of 9 patients staffing should include 4 licensed staff.

Review of the assignment sheets and interview with the Nurse Manager on 3/20/18 at 11:40 AM stated the staffing "matrix" is more of a suggestion and is submitted to the state. The Manager further stated that staffing is based on acuity however the facility failed to have an acuity policy and/or system in place that determined the patient's acuity status. The Manager indicated that staff may have had three or more patients if the patients were "boarders" but staff would never have more than two patients at a time if they are on ventilators.

f. Review of the assignment sheet dated 3/12/18 with the Manager on 3/20/18 at 11:40 AM indicated that 1 RN was assigned to three (3) patients, two (2) of which required mechanical ventilation. The Manager stated that there have been staffing issues in the ICU however she has recently hired 4 new RN's.

g. Review of the assignment sheets dated 3/11/18 evening shift, 3/10/18 day and evening shift, and 3/8/18 night and evening shift identified that one RN was assigned to (3) three patients, two (2) of which required mechanical ventilation.

Based on a review of clinical records and policy review, for one of three patients reviewed for pain (Patient #3), the hospital failed to ensure the patient's level of pain was assessed in the ED in accordance with hospital policy. The finding includes the following:


a. Patient #3 presented to the ED on 11/09/17 at 2:43 AM with the complaint of left shoulder pain. Although the patient's vital signs were obtained during triage, the patient's level of pain was not determined. A physician's note indicated that the patient had left shoulder pain for two months however failed to quantify the patient's level of pain. A shoulder x-ray was completed that was negative for a fracture and/or dislocation. Review of the clinical record identified that Dilaudid 1 mg IM was administered at 3:13 AM. The record failed to reflect the patient's level of pain prior to the administration of the medication and/or following the administration to determine the efficacy of the intervention. The patient was subsequently discharged at 4:15 AM.

Review of the hospital policy directed that all patients will be assessed for their level of pain. The policy further indicated that the patient will be reassessed following an intervention to determine the effectiveness.

Based on clinical record review, interviews with staff and policy review for 2 of 4 patients reviewed for restraint and seclusion (Patient #2), the hospital failed to ensure that restraint and seclusion documentation the clinical record was complete and/or accurate. The findings include:

a. Patient #1 was admitted on 1/29/18 with diagnoses of Post Traumatic Stress Disorder (PTSD) and bulimia nervosa. A physician order for seclusion dated 2/4/18 at 1:00 PM identified Patient #1 exhibited violent and aggressive behaviors, was screaming, threatening, not contracting for safety and was a danger to self. Criteria for discontinuation included calm behavior and verbalization of a desire to cooperate. Patient #1 was identified as willingly going into seclusion. Review of the restraint flow sheet identified that Patient #1 was in seclusion from 1:00 PM to 3:00 PM. However, between 1:30 PM and 3:00 PM Patient #1 was identified as calm, talking to staff and sitting or laying down but remained in seclusion. Review of nursing documentation in this time frame failed to identify that Patient #1 was anything other than calm, as identified on the flow sheet.

Interview with Clinical Coordinator #1 on 3/19/18 at 10:40 AM identified that she recalled that on 2/4/18 Patient #1 continued to be agitated, yelling and threatening between 1:30 PM and 3:00 PM which was not documented in the monitoring sheet and should have been.


b. Patient #2 was admitted on 2/7/18 with diagnoses of Post Traumatic Stress Disorder (PTSD), major depression and anorexia nervosa. A physician order for 4-point restraint dated 3/1/18 at 10:10 PM identified Patient #2 exhibited violent and aggressive behaviors and was refusing necessary medical treatment. The restraint order was for a duration of 4 hours. Criteria for discontinuation included calm behavior and verbalization of a desire to cooperate. Corresponding nursing notes identified Patient #2 was screaming and pushing staff and was placed in 4-point restraints to complete the medical treatment. Despite a physician order and nursing documentation identifying Patient #2 was placed in 4-point restraints, review of the restraint monitoring flow sheet failed to identified that Patient #2 was in restraints. The flow sheet indicated that Patient #2 was on 1:1 supervision and was pacing, agitated, struggling, and in bed quiet and/or sleeping in this time frame. In addition, a nurses note dated 3/1/18 identified the Patient #2 exhibited aggressive, combative and violent behaviors, was a danger to self and others, and was placed in seclusion from 10:48 PM to 10:53 PM. Review of the restraint/seclusion monitoring flow sheet failed to identify that Patient #2 was in seclusion.

Interview with Clinical Coordinator #1 on 3/19/18 at 10:45 AM identified that Patient #2 was in 4-point restraints on the night of 3/1/18 into the morning of 3/2/18 and that staff should have documented on the restraint flow sheet that the patient was in restraints and/or seclusion and should have documented appropriate interventions.

The hospital restraint/seclusion policy identified that the restraint flow sheet was to include documentation of proper application of a device, limb release/range of motion, respiratory/circulatory/sensation status, skin integrity and care delivery codes.

Based on review of hospital documentation related to compounding services the hospital failed to ensure required media fill testing and gloved finger tip testing for 1 of 5 staff members was completed according to USP 797. The findings include:


During a review of pharmacy staff compounding competencies and United Stated Pharmacopeia (USP) 797 required testing, it was identified that Pharmacy Technician #10 had completed media fill testing and gloved fingertip testing in 2016 but had not completed the required annual testing in 2017.

During an interview with the Pharmacy Director on 3/20/18 at 11:10 AM he/she indicated documentation could not be found that Pharmacy Technician #10 had completed the required annual testing and the Director of Pharmacy was sure it had not been completed in 2017 and should have been completed. The Pharmacy Director indicated the Pharmacist who had been responsible to oversee the competencies and required testing of the staff no longer was employed by the hospital however ultimately it was the Pharmacy Directors responsibility to ensure the testing was completed.

The Hospital General Pharmacy Department Policy and Procedure indicated personnel preparing or dispensing sterile products must receive training and competency evaluation including aseptic technique and process simulation before beginning duties and at least annually.

According to USP 797 Compounding personnel shall perform didactic review and pass written testing of aseptic manipulative skills, at least annually thereafter for low- and medium-risk level compounding, and semiannually for high-risk level compounding.

Based on a review of facility records and interview of the Hospital Emergency Management Director, Engineering Director-ECHN and ECHN Environmental Safety Officer and the Chief Operating Officer - Eastern Connecticut Health Network, the Hospital failed ensure that Condition of Physical Environment was met.



See CMS form 2567 tags A701 & A724, E004, E 0030, E0031, E0037, E0037, E0042, K300, K311, K353 & K374

Based on a review of facility records and interview with the Hospital's Emergency Management Director, Engineering Director, Environmental Safety Officer, and the Chief Operating Officer of the Eastern Connecticut Health Network, the Hospital failed ensure that the condition of the physical plant and the overall hospital environment was developed and maintained in such a manner that the safety and well-being of patients are assured. The findings include the following:

a. On 03/20/18 at 10:30 AM the surveyor was provided with documentation by the Hospital Emergency Management Director, Engineering Director, the Environmental Safety Officer, and the Chief Operating Officer of the Eastern Connecticut Health Network that identified the annual door inspection was not completed by 01/01/18 as required by S&C 17-38-LSC.

b. The facility did not ensure that the required automatic sprinkler system was continuously maintained in reliable operating condition and was inspected and tested periodically, as required by section # 19.7.6 of the referenced "Life Safety Code".


Cross reference CMS 2567 tags A724, E004, E 0030, E0031, E0037, E0037, E0042, K300, K311, K353 & K374.

The facility failed to ensure that a water management plan in place to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires' Disease (LD) as required by the Centers for Medicare and Medicaid services survey and certification letter S&C 17-30-ALL issued June 2, 2017 and as required by 42 CFR §482.42 for hospitals:

"The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases."

On 03/20/18 at 10:30 AM, the surveyor was not provided with documentation by the Hospital Emergency Management Director, Engineering Director-ECHN and ECHN Environmental Safety Officer and the Chief Operating Officer - Eastern Connecticut Health Network that identified that the facility had a comprehensive water management plan in place as required by S&C 17-30 ALL. The facility was in the process of securing contractors to survey the facility and develop their water management plan, however this has not been completed to date. The facility does have an active cooling tower maintenance and testing plan in place.

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

A review of the monthly Infection Control Committee meeting minutes and/or communication with the Infection Control Committee dated November 2015 and November 2016 indicated the results of environmental monitoring of the pharmacy compounding area, conducted every 6 months, was reviewed. However the monthly Infection Control Committee meeting minutes and/or communication with the Infection Control Committee failed to identify the environmental monitoring results conducted in April 2016, April 2017 and October 2017 were reviewed by the committee.

Interview with the Director of Pharmacy on 3/19/19 at 9:00 AM, the Director of Pharmacy indicated he/she was a member of the Infection Control committee however reports from the pharmacy compounding area were not discussed in the meetings.

Interview with the Infection Prevention Nurse on 3/20/18 at 1:45 PM identified that rounds are conducted in the pharmacy and a review of environmental monitoring results was conducted with the pharmacists however the results had not been discussed in the Infection Control Committee meetings. He/she indicated the lack of reporting was recently identified as an issue during a separate agency review. The Infection Prevention Nurse indicated going forward he/she would gather the data pertaining to the pharmacy compounding area and present it at appropriate committee meetings.

The hospital Clean Room Environmental Testing policy indicated all results for viable testing will be shared with the Infection Control Committee.