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Based on the findings under QAPI, infection control, and patient rights, it was determined that the governing body (GB) failed to demonstrate responsibility, leadership, and accountability for the governance and day-to-day operations of the dialysis unit. Failure of the governing body to provide the oversight for the operations of the dialysis unit, and to ensure the health care and safety of patients and staff associated with the dialysis unit, posed a risk of harm. The governing body also failed to provide oversight of the QAPI process for the dialysis unit.

The findings include:

1. A review of the facility's current dialysis policies and procedures that were provided for review on 5/23/18 showed that 79 of the 80 policies or 98.8% of the policies, were outdated or had not been reviewed by the facility in more than 3 years, which was the standard provided by the CEO, during an interview on 5/24/18.

2. The GB did not provide oversight for the water culture and endotoxin test results, for the disinfection of the dialysis machines, for the test results and disinfection of the 3 portable reverse osmosis machines, and for the daily water logs. It was noted that water test results for 9/2017, 10/2017, 11/2017, 12/2017, 1/2018, 2/2018, 3/2018, 4/2018, and 5/2018 had not been signed off by the dialysis unit's medical director or the medical director for the hospital.

3. The GB did not ensure there was a staff member who held ultimate responsibility for the dialysis unit. During a review of multiple job descriptions of various staff positions at the hospital, none of the job descriptions specifically identified a position that was responsible for the dialysis unit. The job descriptions reviewed included: Renal Technician II, AVP Integrated Nursing Operations for MGSH & MUMH, Registered Nurse II (Renal), Director Clinical Engineering Multisite, Clinical Engineering Senior, Technician - Clinical Engineering, Specialist Clin Engineering I (Imaging), and Administrative Assistant (Clinical Engineering).

4. The GB did not ensure a biomedical staff member who was responsible for the dialysis unit's water system, was adequately trained in dialysis water system, preventative maintenance of the dialysis machines, care of the portable reverse osmosis machines; and had familiarity with the dialysis test strips.

5. The GB did not ensure the biomedical staff member had a back-up in case of emergency situations, and that this biomedical staff member was adequately trained.

Based on a thorough survey of the inpatient dialysis center's policies and procedures, interviews with staff, and observations of care, it was determined that the hospital failed to safeguard patients undergoing dialysis by failing to maintain the dialyzers in a safe and sanitary condition, and by failing to adequately train either staff who were responsible for maintaining the machines or staff providing dialysis.

In addition, the hospital failed to protect the rights of patients in restraint or seclusion and failed to protect the rights of Medicare beneficiaries who may want to appeal their discharges.

Based on a review of 5 open and 8 closed patient records, policy and interview it was determined that the hospital failed to 1) give an initial Important Message (IM) to patients #1 and #2; 2) Failed to follow policy for notification of Medicare Rights; and 3) failed to allow adequate discharge appeal times when it gave the final IMs to patients #3 and #5 at the time of discharge.

Review of closed records for Medicare recipients #1, and #2 revealed IM forms with entries indicating that patients #1 and 2 were unable to sign. According to policy, "Medicare Beneficiary Discharge Appeal Rights Patient Rights Policy (version 7/14/2017), in the event a patient was unable to sign, the Admitting/Registration office would give the notice to the patient representative, call the representative, and if needed, send the IM notice by certified mail to the representative to give the IM rights information. No evidence of this provision process to give patients #1, and #2 notice of their rights was found.

On review of open records for Medicare recipients #6 and #8, no initial IMs were found, though both patients had been admitted for greater than a weeks' time.

Additionally, it was determined that the hospital created an electronic copy of the IM form, which, according to a RN interviewed on 5/23/18, would be printed out and given to the patient with other paperwork at the time of discharge. This practice eliminated the notification of discharge appeal rights within two days prior to discharge.

Review of discharged Medicare recipients records for #3 and #5, revealed no IM was given until the multiple pieces of discharging paperwork were printed. It is not known if patients #3 and #5 were ever shown the IM as neither patient signed the respective notices.
Based on all information, the hospital failed to conduct the Important Message policy process consistently and within regulatory time frames.

Based on a review of policy "Complaint Handling" (dated 12/1/1017), it was determined that the policy failed to document approval and delegation by the Governing Body of the Grievance process to the Grievance Committee and failed to define and distinguish the elements of a complaint from a grievance.

Additional review revealed no definition distinguishing a grievance from a complaint, and the terms "Complaint" and "Grievance" was used interchangeably within the grievance processes. Based on this, complaints which otherwise would have met the definition of grievances, might not have been identified and processed as such. A review of the grievance log revealed that the hospital had identified less than five grievances since 11/17. The other patient/family expressions of dissatisfaction were categorized as complaints. The failure to differentiate grievances from complaints in policy and practice meant that there was insufficient quality tracking of the timeliness of completion or the adequacy of the response to the complainant.

Based on a review of policy, and patient #4's record, it was determined that the hospital, 1) obtained a consent for treatment without identifying who gave verbal consent; and 2) failed to certify an incapacity prior to requesting surrogate decision-making and consent.

Review of hospital policy titled, "Patient Consent to Treatment" stated in part, "Certification of lack of capacity in an individual" - "(ii) Two physicians licensed by the State of Maryland, after attempting to consult with the patient regarding the proposed healthcare, must certify in writing that clear and convincing evidence exists that the person is incapable of making an informed decision regarding the proposed healthcare ..."

Patient #1 (P1) was an adult of 70+ years who presented to the emergency department (ED) in February 2018 following an unwitnessed fall at a care facility. P1 had a previous diagnosis of dementia which was described by the ED attending as "Severe." An ED physician progress note stated in part, "Time of my assessment (P1) is awake but confused answering questions with difficulty but (P1) was able to tell me (P1) name, (P1) understood that (P1) has a fracture and (P1) knew that (P1) is at (hospital)." Based on this assessment, P1 was oriented to person, place and situation at that time.

Record documentation revealed that P1 had no identified surrogate decision maker. An Important Message from Medicare and a Consent to Treat were noted in the record to be signed, "Verbal consent." No information identified if P1 or a surrogate gave the verbal consent.

A detailed plan was made to address P1's condition which included the potential for multiple surgeries. These options were discussed with a family member (FM). An attending progress note stated in part, " ...explained the risk and benefits of proceeding with the procedure and not delaying it any further because of the fact that the circumstances are not going change in a day or 2 (FM) is agreeable ...," and "I reviewed the x-ray results myself discussed and coordinated the plan with the patients (FM) who is the power of attorney ..."

Further review of the record revealed no evidence of a Power of Attorney and no evidence of two physician certifications of an incapacity prior to requesting decision-making and consent from the surrogate FM for surgery, anesthesia, and blood.

Based on a review of the personnel files, and interviews with the biomedical staff and facility's administration, the governing body (GB), medical director, and facility's administration failed to ensure that all operators of the water/dialysate system equipment were trained on at least an annual basis. In addition, the facility failed to maintain the dialysis machines according to the manufacturer's instructions. This failure posed a potential risk of harm to all patients.

Findings include:

1. On 5/24/18 during a review of personnel files, it was noted that 9 of the 9 clinical treatment staff members or 100% of the clinical staff, lacked at least annual water/dialysis training that included daily water log review and documentation, hardness testing, and testing for residual bleach after water system disinfection.

2. During an interview of the biomedical staff member on 5/23/18 it was noted that this staff member had been covering the dialysis facility's water room since January, 2018. According to this staff member he observed how to collect water specimens "1 or 2 times," could not remember whether he had been observed in the collection of water samples, could not convey to the surveyor how many carbon tanks were in the water room, could not identify where the city water entered the water room, could not perform a walk-through of the water room, did not know the empty bed contact time of the carbon system, and had not been sent for water training. When asked who his back-up staff member was, he responded that he did not have a back-up staff member.

3. The preventative maintenance manufacturer's instructions state "The Phoenix Preventive Maintenance program is to be completed a minimum of every 4,000 hours of machine operation or at least one time a year (whichever comes first)." During a review of the preventative maintenance records of the dialysis machines on 5/23/18 at 12:00 p.m. it was noted that 9 of the 9 in-center dialysis machines were out of compliance with the annual maintenance or maintenance performed every 4,000 hours of use, whichever came first. The following was noted:

a. Machine PH 29744 was maintained on 4/22/15, then on 5/2/16, which was a difference of 13 months; this placed the facility out of compliance with the annual requirement.

b. Machine PH 29745 was maintained on 9/10/13 then on 6/8/15, which was a 21 month difference, and placed the facility out of compliance with the annual requirements.

c. Machine PH 16761 was maintained on 9/8/14 then on 11/16/15, which was a 14 month difference, and placed the facility out of compliance with the annual requirement. There was a maintenance performed on 11/1/16 and then "1/18" which placed the facility out of compliance by at least 2 months with the annual maintenance requirements.

d. Machine PH 22318 was maintained on 9/12/14, then on 11/16/15, which was a 14 month difference. It was maintained "1/ /17" and then 2/9/18, which was a 13 month difference. Both findings placed the facility out of compliance with the annual requirement.

e. Machine PH 16830 was maintained on 9/8/14 then on 11/11/5, which was a 14 month difference.

f. Machine PH 11910 was maintained on 9/9/14 then on 12/1/15, which was a 15 month difference. This machine was then maintained on 11/14/16 and then on 12/13/17, which was a 13 month difference. Both findings placed the facility out of compliance with the annual requirement.

g. Machine PH 22313 was maintained 9/9/14, and then on 12/7/15 which was a 15 month difference.

h. Machine PH 16758 was maintained on 9/10/14, then on 10/27/15, which was a 13 month difference. Another PM was performed on 1/12/17, then 2/8/18, which was a 13 month difference. Both findings placed the facility out of compliance with the annual requirement.

i. Machine PH 28495 was maintained on 4/10/16, and then on 5/23/17, which was a 13 month difference.


These findings were confirmed by the hospital's administration on 5/24/18.

Based on a review of restraint/seclusion policy and one restraint record for patient #13, it was determined that for face to face assessments; 1) a disparity exists between the hospital policy guidance, and actual face to face assessment practices; and 2) the hospital altered regulatory and policy face to face elements to include pre-printed and pre-determined assessment findings which were neither contemporaneous, objective, nor definitive as to whether to continue or terminate restraint/seclusion.

Hospital policy "Violent Restraint or Self Destructive Behavior/Seclusion Use (effective 12/2/2017) revealed in part, the face to face elements as:

i) The patient immediate situation
ii) the patient's reaction to the intervention
iii) The patient's medical and behavioral condition
iiii) The need for continuation or restraint or seclusion

However, review of a hospital pre-printed face to face form revealed check boxes with pre-printed assumptions of assessment findings which replaced the required face to face questions. They were:

1. "The intervention attempted to modify the patient's behaviors as documented on the flowsheet necessitates seclusion/restraints since attempt to modify risky behaviors were unsuccessful." This statement referred to the justification for restraint, but failed to document the patient's actual immediate situation.

2. "The reaction to the intervention is favorable and safe." This assumption did not document objective information related to the patient reaction to restraint/seclusion.

3. "The medical and behavioral condition is stable and safe." This assumption failed to document objective information related to the actual medical and behavioral condition.

4. "Restraint/seclusion needs to be terminated as soon as patient is safe." This statement failed to answer the question of whether or not the patient could be released from restraint/seclusion at the time of the assessment. In addition, a restrained patient must be released from restraint as soon as the dangerous/destructive behaviors cease. "Safe" is not an objective assessment of the need to discontinue restraints.

Based on interviews with a hospital-contracted off-duty police officer (HCODPO) and the Emergency Department (ED) Manager, and review of the officer's job description and training, it was determined that the hospital failed to train the off-duty officer in restraint use in a therapeutic environment.

An HCODPO in full police uniform including forensic weapons was observed sitting at a podium in the waiting room of the ED. Inquiry in part at approximately 0945 on 5/23/18 regarding occasions in which the HCODPO used manual restraints on persons in ED areas revealed that the HCODPO had used manual restraint "at times," and to do so, used training received from the Police Department. When asked if the hospital had given the HCODPO manual restraint training as had been received by security and nursing, the officer denied ever receiving manual restraint training from the hospital.

The ED Manager among other staff stated that the HCODPO worked within his capacity as a police officer while on duty at the hospital, and no administrative staff indicated any expectation that the HCODPO required clinical oversight for manual restraint processes. Interview with the Human Resources Director indicated that there was no expectation of the HCODPO to restrain persons, though the "Armed Officer" job description revealed in part under Primary Duties and Responsibilities, "Assists with restraining as needed."

Based on this information, the HCODPO could autonomously and without clinical decision-making or oversight, restrain anyone, including those presenting for care. Findings indicated the hospital failed to train all staff who may be in a position to apply manual restraint in the acceptable and safe application of manual restraint.

Based on review of the hospital's Quality Assessment and Performance Improvement (QAPI) meeting minutes and measures, and interviews with facility staff, the hospital's QAPI process did not include a review of the dialysis facility. This failure denied patients' their rights to high quality dialysis related health care.

Findings include:

The QAPI process must include collection of patient treatment outcome data and the analysis of the aggregate patient data with the goal to improve and sustain optimal patient care. These regulations require the monitoring of specific data which include (but is not limited to) dialysis treatment adequacy, anemia management, vascular access management, infection rates, incident reports, morbidity and mortality rates.

The Measures Assessment Tool (MAT) includes Water and Dialysate Quality, Patient Assessments, Patients' Plans of Care, Nutritional Status, Dose of Dialysis, Mineral Metabolism, Anemia, Vascular Accesses, Psychosocial Status, Patient Education and Training, Health Outcomes, Adequacy, Renal Bone Disease, Medical Injuries and Medical Errors identification, Patient Satisfaction and Grievances, Infection Control, and Vaccinations.

1. During an interview with hospital administration on 5/24/18 it was learned that quality assurance, as it related to the Dialysis Program had not been reviewed by the hospital QAPI team since 6/2017. It was noted that the dialysis unit's medical director did not attend the QAPI meetings.

2. On 5/24/18 it was noted that dialysis water cultures and endotoxin test results had not been signed by a medical director for the past 9 months (from 9/2017 - 5/2018).

3. On 5/24/18 it was learned that training for dialysis staff members, including the biomedical staff member, who held ultimate responsibility for the water system of the dialysis unit, was out of compliance with dialysis standards throughout the industry. For dialysis staff members the water training covered chlorine testing but did not cover water log documentation, strips to be used after water system disinfection, and other water-related training. For the biomedical staff member, water training and preventative maintenance for the dialysis machines and portable reverse osmosis machines was not provided.

4. The hospital QAPI meetings did not review and evaluate any dialysis data-driven QAPI measures, including those on the Measures Assessment Tool (MAT) and the CMS Clinical Performance Measures (CPMs).

Based on review of the facility's personnel files, and interviews with the facility's administration, the governing body, medical director, and facility's administration failed to ensure staff working at the facility on the clinical treatment floor had up-to-date Infection Control Practice Training, and Blood Borne Pathogen Training. This failure placed all patients, visitors, and staff at potential risk for exposure to blood borne pathogens and infectious diseases.

Findings include:

During a review of the personnel files on 5/24/18, it was noted that 5 out of 28 of the clinical staff members or 17.9% of the clinical staff, lacked current Infection Control that was completed on at least an annual basis.

During a review of the "MedStar Union Memorial Clean and Disinfect Log(s)" on 5/24/18 it was noted that 6 of 7 (85.7%) of the machine disinfection logs provided to the surveyor for review, were out of compliance with weekly disinfection. The following was noted:

a. Machine #42 was not disinfected from 3/29/18 - 4/6/18, which was an 8 day difference; this placed the facility out of compliance with the weekly disinfection by 1 day.

b. Machine #43 was not disinfected from 2/28/18 - 3/10/18, which was a 10 day difference, and placed the facility out of compliance by 3 days with the weekly disinfection.

c. Machine #45 was not disinfected from 4/9/18 - 4/21/18, which was a 12 day difference; this placed the facility out of compliance by 5 days for the weekly disinfection.

d. Machine #46 was not disinfected from 4/11/18 - 4/20/18, which was an 11 day difference; this placed the facility out of compliance by 4 days with the weekly disinfection requirements. Machine #46 was not disinfected from 3/6/18 - 3/23/18, which was a 17 day difference and showed that the facility missed 2 weekly disinfections during this time period.

e. Machine #47 was not disinfected from 2/10/18 - 2/20/18, which was a 10 day difference; this placed the facility out of compliance by 3 days with the weekly requirement for disinfection. There was no disinfection from 4/7/18 - 4/21/18, which was a 14 day difference and showed the facility missed 2 weekly disinfections during this time period. There was no disinfection from 4/24/18 - 5/3/18, which was a 9 day difference, and placed the facility out of compliance by 2 days with the weekly disinfection requirement.

f. Machine #50 was not disinfected between 1/30/18 - 2/8/18, which was a 9 day difference, and placed the facility out of compliance by 2 days with the weekly disinfection requirement. This machine was not disinfected from 4/2/18 - 4/14/18, which was a 12 day difference; this placed the facility out of compliance by 5 days with the weekly disinfection requirement.

The facility's administration confirmed these findings on 5/24/18 during an interview/discussion.