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Tag No.: A0118
Based on interview and record review, the facility failed to follow its established grievance policy and process for 4/5 grievances reviewed (Patient ID #s: 1, 2, 4 and 5). The facility failed:
1) to follow their policy for acknowledging the grievance within 7 days
2) investigating the grievance thoroughly in a timely fashion and
3) failed to follow-up with a written response with-in 21 days to the complainant.
Findings Included:
Record Review of facility policy titled "Patient Grievance and Complaint Management", effective 10/2021, stated stated "Purpose: to establish a process for timely referral, prompt review, investigation and resolution of patient grievances and complaints." It further defined "Patient Grievance is a written or verbal complaint by a patient, or the patient's representative, regarding the patient's care, abuse or neglect, issues related to compliance with the CMS Conditions of Participation or a Medicare beneficiary billing complaint related to rights and limitations ..." "2. Upon receipt of a grievance, the appropriate department director/manager will be contacted to review, investigate and resolve with the patient or patient representative, with the goal of resolution within 7 days of receipt of grievance ... 3. If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the complainant should be informed that the facility is still working to resolve the grievance and that the facility will follow-up with a written response within twenty-one (21) days. 4. In resolution of the grievance, a written notice of the decision must be provided to the complainant which should contain the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance investigation, and the date of completion."
Record Review of Grievances from the facility's grievance log dated May 2023 - November 30, 2023 and the supporting documentation to Patient ID #1, 2, 4 and 5 stated:
Patient ID #1, there was no grievance recorded in the electronic tracking system
Patient ID # 4, grievance entered 10/6/23 for "quality of care concern." 7 day letter sent 10/20/23 and investigation resolution letter sent 11/29/23.
Patient ID # 2, grievance entered 11/10/23. There was no acknowledgement letter sent. There was limited investigation and no acknowledgment letter sent.
Patient ID # 5, grievance entered 8/18/23 for "discharge complaints." The 7 day letter was sent on 11/28/23. There was no evidence of investigation in a timely manner.
Interview with Patient Safety Director Staff ID # 55 on 11/30/23 at 2:45 pm, she stated that the department had attrition which resulted in the facility's inability to document, investigate and follow-up on grievances. She confirmed Patient ID #1 family had arrived to facility, in person, to discuss issues with Patient ID #1 care, communication, discharge coordination and planning. She confirmed these issues and meeting request met threshold for grievance. She confirmed there was no acknowledgment, investigation was not completed on the issues relayed and therefore no follow-up had occurred. She confirmed that Patient ID # 1, 2, 4 and 5, had not had grievance investigation, notification and resolution process/ follow-up.
Tag No.: A0750
Based on interview and record review, the facility failed to effectively implement their Infection Prevention and Control Program/Plan.
a.) Four (4) of 4 incidents of contaminants in the operating room were not documented as occurrences/variances. This deficient practice resulted in a failure in a full investigation and oversight by infection control practitioner.
b.) Two (2) two sterile processing staff failed to have documented skills for use of facility specific disinfection/sterilization equipment.
Findings included:
Record review of facility document titled "Infection Prevention & Control Program/Plan," showed the following:
PROGRAM OVERVIEW: To evaluate, assess, and prevent harm to our patients, team members, and visitors. The Infection Prevention Program at HCA Houston Clear Lake, HCA Houston Mainland, and its affiliated campuses utilizes multi-faceted surveillance activities to target the implementation of evidence-based practices in the prevention and control of infections.
PURPOSE: To evaluate, assess, and prevent infectious harm to our patients, team members, and visitors ...
Prioritized 2023 Clear Lake and Mainland goals are:
VII. To ensure infection prevention procedures related to decontamination, disinfection and sterilization process meet all requirements.
i. Ensure all team members completion of annual competencies for high-level disinfection (HLD), quality assurance processes, and any additional competencies requires for use of particular disinfection/ sterilization equipment.
ii. Ensure all team completion of annual competencies for low-level disinfection, quality assurance processes, and any additional competencies required for disinfection of equipment utilized.
iii. Conduct defined periodic rounds and audits of environmental and equipment disinfection, reporting back to facility and unit/departmental leadership.
a.) Record review of Infection Prevention Committee Meeting Minutes dated August 24, 2023, showed the following:
-Surgical Services- no issues Q1 and Q2
Record review of incident/variance reports for surgical services for August 2023-November 29, 2023, showed no record of instrument decontamination/sterilization issues or equipment failures.
Interview with surgeon (ID#96) on 11/29/23 at 7pm, he stated that last week he canceled cases because there was a bug in one instrument set and the next two sets had residual bone and cement still visible, one set was still wet. He stated that there was another surgeon who had similar issues.
Interview with Surgical Technologist (ID#85) on 11/30/23 at 1105am stated that last week on Wednesday there were multiple sets that had to be cleaned and re-sterilized due to cement or old blood that was still visible on the instrument tray or on an instrument. There has been a gnat found in the instrument set before.
Interview with operating room (OR) nurse (ID#86) on 11/30/23 at 11:15am, she stated that instruments that come to the operating room that have been sterilized but that are still dirty has been happening more frequently lately, it comes in waves. She also confirmed previous statements from staff (ID#85) regarding instruments sets being contaminated last Wednesday. She stated that she is not sure if there is an incident report, she never has done one. She stated that it gets reported to the OR management team or service lead.
Interview with sterile processing (SPD) manager (ID#88) on 11/30/23 at 1135am he stated that the only piece of equipment out of service is the ultrasonic machine used for decontamination. He went on to say that recently there had been issues with loaner sets coming into the facility late and that they were going to have to enforce the vendor policy stating that the sets need to be received by a certain time. We determined that staff were feeling rushed to get them completed for the next day. He stated that last week there were quite a few instances for the same doctor due to bioburden issues. He also stated that in the past, there was an issue with bugs in the SPD department; facility maintenance installed a bug light to control the issue.
Interview with OR Manager (ID#99) on 11/30/23 at 1145am when asked about instrument set contamination due to bugs or residual bioburden, he stated that they do not always get incident reports. He went on to say that "we do not have a policy in place that instruct staff to do that."
Interview with infection preventionist (ID#84) on 12/1/23 at 9:44am he stated that the infection prevention team typically tacks immediate use sterilization, machine failures and out of service equipment. He also stated that he was not aware of any instances of bug found in the instrument sets/packaged items, recent issues with bioburden being left on surgical instruments or that the ultrasonic machine was out of service.
Interview with surgeon (ID# 97) on 12/1/23 at 1030am stated that he has occasionally had residual bone or cement left on an instrument/tray. He stated recently there was a bug in a packaged item. The item was a purchased sterile item, not something that was sterilized at the facility. He stated that the operating room administrative staff had contacted the vendor.
b.) Record review of SPD employees (ID#s 89 and 90) showed computer based sterile procession competencies via HealthStream. No evidence of equipment specific or skills checkoffs were found.
Interview with infection preventionist (ID#84) on 12/1/23 at 9:50am he stated that when he rounds on the department the staff seem to be knowledgeable of their duties, as he is not familiar with the tasks or equipment specifically.
Interview with Director of Patient safety (ID# 55) at 12:00pm she confirmed that the SPD staff had no documented skills/equipment check offs.
Tag No.: A0802
Based on interviews and record review, the facility failed to ensure the discharge planning process included the regular re-evaluation of the patient's condition to identify changes that required modification to the discharge plan. The discharge plan was not updated to reflect referrals, changes to post-acute planning and failed to fully document case management activities. The facility failed to document planning, acquisition, education and training for durable medical equipment needed for safe discharge. The facility failed to confirm completion of patient/family education prior to patient's discharge home. The facility failed to provide contact information and specialty contact information for medical follow-up care (Patient ID #1).
Findings Included:
HHSC Intake for Patient ID #1 was received via email on 11/2/2023 for Patient ID #1. Complainant stated "(Patient ID #1) was moved to the stroke unit, I let manager of the nurses, Staff ID #76 know that discharge home was unacceptable as he could not climb the 30 steps needed to access the home. She said she began to work with case managers to locate a charity bed (rehab). I was told repeatedly 'options were being explored' as we continued to wait for a bed. There was not a follow-up after that." Complainant went on to state "After (patient ID #1) was discharged home, I went back to the facility to have a meeting ... I told them in great detail my ordeal. I was not put in touch with a social worker, given a prescription for a wheelchair ... I told them how I literally almost pulled my arms out of place trying to move my husband without anything. (Patient ID #1) weighs 313 pounds ... I was not given even brief use of any equipment to help move Patient ID #1 safely around our home ... There was no care plan meeting. There was no training about how to get Patient ID #1 out of the condo if an emergency arises. There was no wheelchair given. There was no loaner equipment given to temporarily assist."
Record Review of facility's "Scope of Service - Stroke Program", last reviewed 03/2022, stated "The mission of the Stroke Program ... is to reduce the incidence and impact of stroke by utilizing evidence based standardized stroke order sets, facility available technology, providing education to health providers, community and patients with a focus on prevention, treatment rehabilitation and support for all impacted by stroke. This is accomplished through multi-disciplinary, facility team with collaboration of ideas, resources and knowledge."
Record Review of facility's "Discharge Planning and Care Coordination" policy, last approved 02/2023, stated "Discharge Planning Evaluations (DPE) are documented in Midas. Documentation in the medical record includes: the complete evaluation, the patient's choice for post-acute providers, participation of patient and/or patient's representative, family or support persons who will be providing care, the patient's goals and preferences, education and training to patient's self-care and physician order to execute post-acute discharge planning." It further stated "Procedure: G. If the patient is ready for discharge, confirmation of post-discharge arrangements is required. H. Document all assessments, interventions and follow up within the medical record. 2. Case Management C. Develop a post hospitalization plan based on patient's assessed needs/resources and in collaboration with other members of the patient care team. D. Provide counseling, information, resources, referrals, transfer coordination and follow-up care as appropriate. F. Document discharge planning and social work assessments and interventions in the medical record."
Record Review of Patient ID #1 Medical Record on 11/30/23 at 2:45 with IT Specialist Staff ID # 83:
Physical Therapy Inpatient Evaluation completed by Staff ID #95 dated 9/17/23 stated "Post Tx comments: Patient motivated towards return if function. Patient at max. assistance at this time due to flaccid tone on R side of body. Patient will benefit from inpatient rehab prior to DC home for optimum level of functional mobility. Comment: Post acute: IRF."
Occupational Therapy Inpatient Evaluation completed by Staff ID #94 dated 09/19/23 stated "Discharge Recommendations: IP Rehab."
Case management staff ID #69 note on 9/18/22 2:02 pm CM spoke to PT (redacted)she stated that patient will need bariatric W/C with elevated leg rests at DC, will discuss with pt and wife"
Case management staff ID #73 note on 9/19/23 10:51 am stated "CM received notification that patient' wife received cost for WC with Duke is $575; patient's wife declined. CM notified nursing. Family training will need to be done before initiating DC to home; CM notified nursing."
Case management staff ID #73 note on 9/20/23 9:42 am stated "CM received notification that patient has stairs in his home and will need to try and work with PT for DC home. Patient at this time is Max-Dep; wife stated to nursing patient is waiting for charity bed. Patient does not qualify for charity rehab. Will need to initiate family training and transition DC to home."
Case management staff ID#68 note on 9/20/23 3:21 pm stated "Pt verified she would need DME resources for pt wheelchair when the time came ... SW informed colleague and case management available to assist with DME resources needed."
Case management staff ID #72 note 9/20/23 4:24 pm stated "Wife reported her husband has had a stroke and needs rehab and does not want to leave HCA, wants to be transferred there. Case manager staff ID #73 reported there are no charity beds and that Mr. Hunter does not meet medical qualifications for this program."
Case management staff ID #74 note 9/28/23 11:37 am stated "CM dir in to speak to ptn and wife to discuss d/c options. Have sent referral to HCA home health and pending response. d/c plan: d/c to home with HH."
Physician Staff ID # 93 discharge summary signed on 9/29/23 at 11:52 pm stated "Hospital Course: He was waiting for Inpatient Rehab. We discussed DC plan with family. He will go home with HH ... Discharge Instructions: DC to Home/Self Care. Discharge Instructions: PCP Followup, Consultant Followup. Activity: Resume Normal Activity, As Tolerated. PCP Follow-up (No Primary or Family Physician) in 2-3 weeks." No consultant specialties or practice names and contact information were located.
Interview with Acute Rehabilitation Unit Interim Director on 11/30/23 at 3:15pm. She stated that the decision for in-patient rehab, outpatient rehab or home are joint decisions by the patient, family, physician, therapy services and case management and includes consideration of many factors including payor source. She stated that patients must meet medical necessity and that they should be able to participate in 3 hours a day of therapy. She stated this at times would be difficult to determine as the acute care hospital lacks resources to provide near that intensity of rehab care. Therefore, age and willingness/motivation to work were also factors. She stated that therapy services consider safety and home arrangement prior to recommending home discharges. She stated she had reviewed Patient ID #1's medical record. She could not locate a physical medicine and rehab consultation. She stated she could not locate the referral to the facility's inpatient rehabilitation unit. She could not locate evidence of that referral in the patient's medical record. She validated that the medical record and therapy notes revealed patient was "lower level" (meaning maximal assistance) but she saw repeated documentation of therapy recommendations for inpatient rehabilitation. She confirmed there was no evidence of patient/family training regarding the bariatric wheelchair or any other mobilization assistance, like hoyer lift. She believed a hoyer lift would have been indicated for safe discharge planning to home, given the patient's degree of deficits and habitus. She stated durable medical equipment that is needed for an inpatients discharge home would be discussed by therapists and case managers prior to discharge planning for home discharges.
Interview with Case Management Director Staff ID # 75 on 12/1/23 at 11:15 am. She stated patient ID #1 caregiver refused to participate in education and training. She stated she "watched" at the bedside. She confirmed the case managers failed to document the patient's caregiver refusal to participate in teaching with discharge education. Staff ID #75 stated that case managers had attempted to locate charity inpatient rehabilitation beds for Patient ID #1 at 4 facilities owned by the acute care hospital corporation via telephone call. She was unable to locate the documentation which stated the date, time, or personnel involved in these telephone referrals and denials. Staff ID #75 stated the patient's caregiver had refused to accept bariatric wheelchair, hoyer lift or equipment necessary for safe discharge and had refused education on the equipment. She was unable to locate this documentation in the medical record. Staff ID #75 stated the patient was supposed to follow up with Harris Health doctors when the patient's Gold Card application was accepted. She was unable to identify in the medical record which primary care clinic or which specialty offices/services that patient should follow-up with after discharge as this was omitted from the discharge instructions.
Interview with Neuroscience Director Staff ID #66 on 12/1/23 at 12:10 pm, she confirmed that the discharge instructions for the Patient ID #1 stated "follow-up with PCP in 2-3 weeks" and "consultant follow-up." She confirmed that the instructions failed to state which primary care physician or clinic and consultant(s) the patient should follow-up with and how to reach them for an appointment.
Tag No.: A0951
Based on record review and interview the facility failed to ensure surgical services were consistent with needs by:
a.) failing to perform preventative maintenance on washers and sterilizers per manufacturers guidelines.
b.) follow surgical instrumentation instructions for use (IFU) for decontamination.
Findings include:
a.) Interview with sterile processing (SPD) manager (ID#88) on 11/30/23 at 1135am he stated that the IFUs are what is used to determine equipment is maintained and instruments are processed properly. All staff have access to IFUs via OneSource on the computer.
Record review of Operator Manual for Amsco Steam Sterilizer showed the following: Weekly Maintenance: Flush Chamber Drain
Record Review of operator Manual for Vision 1300 Series Washer/ Disinfector showed the following: Preventative maintenance is essential in keeping this equipment in optimal working condition.
ONCE PER DAY: clean debris screen in chamber
ONCE PER WEEK: Inspect traveler spray arm assemblies for clogged holes, Clean if necessary.
While cycle is in progress, look through chamber door window to verify traveler spray arm assembly for free movement.
Verify if DECONTAMINATION Cycle warning message is displayed on control..
Clean washer/disinfector exterior.
Inspect all spray arms ...
ONCE PER MONTH: Brush each door gasket to clean, then disinfect using germicidal detergent.
Verify door gasket ...
Record review of Operator Manual for Reliance Synergy washer/disinfector showed the following:
Maintenance procedures described in this section must be performed as required at the suggested frequency. The indicated frequencies are minimums ...
Daily Cleaning: Each day, clean the washer as follows ...
Weekly Cleaning: Clean unit exterior as outlined.
Clean wash chamber rotary spray arm assembly as follows.
Clean rotary spray arm as follows ...
Record review of SPD Maintenance logs were not in accordance with manufacturers owner manual guidelines.
Interview with SPD staff (ID# 89) on 11/3023 at 1205 pm stated that she is not aware of daily or weekly maintenance of machines.
b.) Record review of IFUs for Stryker Triathlon total knee loaner instrumentation for surgical cases 11/22/23 provided by SPD staff (ID# 89) showed the following:
Pre-Cleaning: Equipment required: Ultrasonic bath large enough to allow complete immersion of the reusable instrument. (A frequency of 25-50 kHz is recommended ...).
Interview with SPD staff (ID# 89) on 11/3023 at 1208 pm stated that the ultrasonic cleaner/disinfector was not currently working. When asked if instrument specific IFUs require the use of ultrasonic equipment, what is done., she replied "we just skip that step."
Interview with Stryker (vendor) Representative (ID# 100) on 11/30/23 at 4:25pm confirmed the IFUs were correct for Triathlon knee instrumentation. She also stated that any information printed in the IFUs are mandatory steps.
Work order for Ultrasonic cleaner showed the machine broke 11/14/23.