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Based on observation, interview and policy and document review, it was determined that the hospital failed to meet the Conditions of Participation for Governing Body as evidenced by:


The Governing Body did not ensure all services offered and provided met the Medicare Conditions of Participation. Areas of noncompliance identified included: Patient Rights and Quality Assessment and Performance Improvement (QAPI).


The hospital failed to protect and promote the rights of each patient. (Please refer to A115, A123, A144, A171, & A182).


The hospital failed to integrate its departmental Quality Assessment and Performance Improvement (QAPI) program, specifically Hemodialysis data, into the hospital wide program. (Please refer to A263 & A283).


The finding includes the following:

Review of the Quality Assessment Plan identified that the Board of Directors had the responsibility for monitoring all aspects of patient care and safety.

Based on observation, interview and policy review, it was determined that the hospital failed to meet the Conditions of Participation for Patient Rights by failing to protect and promote each patient's right as evidenced by:


The hospital failed to ensure that a venous drip chamber ("dummy"drip chamber) was not stored in the treatment area where hemodialysis was being administered. This device is used to bypass the dialysis machine's air detector and can result in an undetected infusion of air which can cause an air embolism and death. Access to utilize the dummy drip chamber posed an immediate and serious threat to the patients' health and safety resulting in immediate jeopardy. Please refer to A144.

The hospital failed to ensure that grievances were responded to in accordance with hospital policy for one patient (Patient #2). Please refer to A171.

The hospital failed to ensure that the use of physical restraints as an intervention for three of four patients were in accordance with the Medicare Requirements (Patient #42, 55 & 56). Please refer to A182.

Based on review of the clinical record, review of hospital policy, review of hospital documentation, and interview for one patient, Patient #2, who verbalized a complaint, the hospital failed to respond in writing to the patient in accordance with the hospital grievance policy. The findings include:


Patient #2 had a phlebotomy completed on 3/3/12 at the outpatient Pequot laboratory. Review of hospital documentation and interview with the Patient Relations Manager on 1/9/13 at 1:00 PM identified that Patient #2 reported a complaint regarding care and services he/she received during the outpatient visit on the same day, 3/3/12 and that the complaint had not been resolved. Documentation and interviews failed to reflect that a written response was completed and forwarded to Patient #2 in accordance with the grievance policy. Review of the hospital Grievance Policy directed that an unresolved verbal complaint would be considered a grievance and that a written response would be made within 10 business days, as well as a written closure response within 30 days.

Based on observation, interview and policy review, the hospital failed to ensure that a safe environment was maintained in the dialysis unit when a dummy drip chamber was observed to be available for use in the treatment area resulting in immediate jeopardy. The finding includes the following:

During the initial tour of the hospital conducted with the Nurse Manager of the dialysis unit and the Biomedical Equipment Manager on 1/7/13 at 1:05 PM, two patients were observed receiving hemodialysis. Further observation identified that in an unlocked drawer located in the patient care area, a drip chamber testing device also known as a "dummy drip chamber" was found. The "dummy drip chamber" is a hospital manufactured device utilized to bypass the dialysis machine's air detector. The "dummy" can be used during set-up of a dialysis machine prior to patient use to silence the alarms for staff convenience. The practice of using the dummy drip chamber to prepare the dialysis machines for patient use creates the risk to infuse undetected air into a patient's blood system creating an air embolism (presence of air in a blood vessel) which created the potential to result in death of a patient.


During an interview with the Nurse Manager conducted on 1/7/13 at 1:15 PM the Manager stated she was unaware that a "dummy drip chamber" was located on the unit and should not be present in the patient treatment area.

During an interview with the dialysis Biomedical Equipment Technician conducted on 1/7/13 at 1:20 PM, the Technician stated he was unaware that a dummy drip chamber was in the treatment area and should not be stored in the treatment area. The Technician further stated that although he utilizes a dummy drip chamber to complete repairs and/or calibrate machines, he carries the dummy drip chamber with him and/or leaves it in the biomedical repair area. Subsequent to surveyor observation, the "dummy drip chamber" was immediately removed from the unit.

The Chief Quality & Patient Safety Officer, Director of Risk Management, was notified on 1/7/13 at 3:00 PM that Immediate Jeopardy conditions existed for failure to ensure that a dummy drip chamber was secured and not present in the treatment room.

During an interview with the Nurse Manager conducted on 01/07/13 and subsequently the Chief Quality & Patient Safety Officer Director of Risk Management on 01/08/13 indicated that the hospital did not have a policy related to the use of dummy drip chambers.


The IJ was abated on 1/7/13 at 3:30 PM, in the presence of the Chief Quality & Patient Safety Officer Director when an acceptable plan of correction was presented to the survey team. Review of the plan identified that the dummy drip chamber was immediately removed from the unit, staff were educated regarding the use of a dummy drip chamber, that the dummy drip should not be in the dialysis unit, except when being used by a Biomedical Technician with a biomedical sticker placed on every dummy drip chamber. The hospital is in the process of developing a policy outlining the use of a dummy drip chamber.

Based on clinical record reviews, review of hospital policies and procedures and interviews with hospital personnel for one of four sampled patients who required restraints (Patient #42), the hospital failed to ensure that physician orders were obtained for the continuation of restraints for violent behavior. The finding include:


Patient #42 was admitted to the hospital for alcohol detoxification. Review of the physician orders dated 11/30/12 identified that the patient was unable to follow directions, was cognitively impaired and was placed in two point restraints. On 12/1/12 the patient was placed in four point restraints due to being unable to follow directions and combativeness. Patient #42 remained in four point restraints from 12/1/12-12/3/12 for being combative, yelling and trying to get out of bed. Review of restraint documentation identfied that this was the least restrictive considering the patient current state. Further review failed to identify that the physician had renewed/evaluated the patient and/or restraint orders per hospital policy.


Interview with the Nursing Director of Patient Care Services on 1/10/13 identified that the restraint policy was not followed.


Review of hospital policy identified that a restraint/seclusion order is documented in the patient record. Each documented order for restraints for violent/self destructive patient is limited to four hours for adults. In addition, if a patient remains restrained or in seclusion for 24 hours after the original order, the physician must see and evaluate the patient face to face before writing a new order. The face evaluation is documented in the record.

Based on clinical record reviews, review of hospital policies and procedures and interviews with hospital personnel for three of four patients who required restraints (Patient #42, Patient #55 & Patient #56), the hospital failed to ensure that a physician assessment was completed with the initiation/continuation of restraints. The findings include:


a. Patient #55 was admitted to the hospital on 1/5/13 for right hip fracture. Review of the physician orders dated 1/5/13 identified that the patient was put in restraints for attempting to remove lines. Review of the progress notes dated 1/5/13-1/8/13 failed to identify that a physician assessment was completed with the initiation and/or continuation of restraints.


b. Patient #56 was admitted to the hospital on 1/5/13 for acute respiratory failure. Review of the physician orders dated 1/5/13 identified that the patient was put in restraints to prevent self extubation and patient safety. Review of the progress notes dated 1/5/13-1/8/13 failed to identify that a physician assessment was completed with the initiation and/or continuation of restraints.


c. Patient #42 was admitted to the hospital for alcohol detoxification. Review of the physician orders dated 11/30/12 identified that the patient was placed in two point restraints for being unable to follow directions and being cognitively impaired. On 12/1/12 the patient was put in four point restraints for being unable to follow directions and being combative. Patient #42 remained in four point restraints from 12/1/12-12/3/12 for being combative, yelling and trying to get out of bed. Further review failed to identify that the physician had renewed/evaluated the patient and/or restraint orders per hospital policy.


Interview with the Nursing Director of Patient Care Services on 1/10/13 identfied that the restraint policy was not followed.


Review of hospital policy identfied that the initiation/continued use of restraints beyond the first 24 hours requires clinical justification and authorization by a physician. The new order is issued no less often than once each calendar day and is based on the physician examination of the patient.

Based on a review of hospital documentation and interviews with hospital personnel, the hospital's Quality Assessment and Performance Improvement program failed to ensure that quality assurance data pertaining to the hemodialysis unit was incorporated into the hospital's quality improvement program.


Based on review of the hemodialysis QA data, the hospital failed to ensure that the Hemodialysis program focused on indicators related to improved health outcomes.


Refer to A283

Based on a review of hospital documentation and interview the hospital failed to ensure that quality assessment data pertaining to the hemodialysis unit was incorporated into the hospital's quality assessment and improvement program. The finding includes the following:

Cross Reference A144.

Interview with Nurse Manager #2 on 1/9/13 at 11:00 AM identified that the unit monitors the numbers of patient treatments, endotoxin levels, and reasons for admission (i.e. access issues, congestive heart failure, hyperkalemia). The Nurse Manager identified that the unit data is reviewed with the Medical Director of Nephrology, however, is not sent to the Quality Council Committee. The program failed to include measurable indicators to improve health outcomes and/or patient care data in the hospital's Dialysis Unit.

Interview with Nursing Director #2 on 1/9/13 at 1:15 PM who is responsible for oversight of the Hemodialysis Unit indicated that she does not receive and/or review QA information from the dialysis unit on a routine basis. The Director stated she is notified if there is a problem but does not receive Quality data regarding the hemodialysis unit. Review of the Quality Council meeting minutes provided for the period of 1/5/11 through 12/5/12 failed to identify that information pertaining to the hemodialysis unit was reviewed and/or reported.

Interview with the Director of Quality Improvement on 1/10/13 at 11:00 AM identified that departments report to Quality Council on a scheduled basis. Review of the 2012 calendar failed to reflect that hemodialysis data had been presented to the Quality Council. The hospital failed to ensure an ongoing QAPI program was conducted that achieved measurable improvement in health outcomes and/or focused on high risk areas and/or that that hemodialysis QAPI data was incorporated into the hospital's Quality Assessment program.

Review of the Quality Assessment Plan identified that the Board of Directors had the responsibility for monitoring all aspects of patient care and safety. The primary goal of the Quality/Performance improvement plan is to systematically plan, design, measure, assess and improve performance of hospital wide key functions and processes relative to patient care and safety; and to improve healthcare outcomes while reducing and preventing errors and preventable adverse outcomes.