§483.75(a) Quality assurance and performance improvement (QAPI) program.
Each LTC facility, including a facility that is part of a multiunit chain, must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life. The facility must:
§483.75(a)(1) Maintain documentation and demonstrate evidence of its ongoing QAPI program that meets the requirements of this section. This may include but is not limited to systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events; and documentation demonstrating the development, implementation, and evaluation of corrective actions or performance improvement activities;
§483.75(a)(2) Present its QAPI plan to the State Survey Agency no later than 1 year after the promulgation of this regulation;
§483.75(a)(3) Present its QAPI plan to a State Survey Agency or Federal surveyor at each annual recertification survey and upon request during any other survey and to CMS upon request; and
§483.75(a)(4) Present documentation and evidence of its ongoing QAPI program's implementation and the facility's compliance with requirements to a State Survey Agency, Federal surveyor or CMS upon request.
§483.75(b) Program design and scope.
A facility must design its QAPI program to be ongoing, comprehensive, and to address the full range of care and services provided by the facility. It must:
§483.75(b)(1) Address all systems of care and management practices;
§483.75(b)(2) Include clinical care, quality of life, and resident choice;
§483.75(b)(3) Utilize the best available evidence to define and measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for residents of a SNF or NF.
§483.75(b) (4) Reflect the complexities, unique care, and services that the facility provides.
§483.75(f) Governance and leadership.
The governing body and/or executive leadership (or organized group or individual who assumes full legal authority and responsibility for operation of the facility) is responsible and accountable for ensuring that:
§483.75(f)(1) An ongoing QAPI program is defined, implemented, and maintained and addresses identified priorities.
§483.75(f)(2) The QAPI program is sustained during transitions in leadership and staffing;
§483.75(f)(3) The QAPI program is adequately resourced, including ensuring staff time, equipment, and technical training as needed;
§483.75(f)(4) The QAPI program identifies and prioritizes problems and opportunities that reflect organizational process, functions, and services provided to residents based on performance indicator data, and resident and staff input, and other information.
§483.75(f)(5) Corrective actions address gaps in systems, and are evaluated for effectiveness; and
§483.75(f)(6) Clear expectations are set around safety, quality, rights, choice, and respect.
§483.75(h) Disclosure of information.
A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section.
§483.75(i) Sanctions.
Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.
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Observations:
Based on review of select facility policy and reports and clinical records and resident and staff interviews, it was determined that the facility failed to demonstrate the implementation of ongoing QAPI programs, to include the use of systems for investigating and analyzing the root cause of adverse events as evidenced by one resident out of six sampled (Resident B1).
Findings include:
Review of the facility policy titled "Quality Assurance and Performance Improvement" last reviewed in January 2024, revealed that the facility shall develop, implement and maintain an effective, comprehensive, data-driven QAPI program that is focused on indicators of the outcomes of care and quality of life for the residents.
The policy guidance of the QAPI program is to:
(1)Maintain documentation and demonstrate evidence of its ongoing QAPI program which may include but is not limited to:
a.systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events; and
b.documentation demonstrating the development, implementation, and evaluation of corrective actions or performance improvement activities;
(2) Present QAPI plan to State Survey Agency as requested;
(3)Presents its QAPI plan to State Survey Agency or Federal surveyor at each annual recertification survey; and
(4)Present documentation and evidence of its ongoing QAPI program's implementation and the facility's compliance with requirements to a State Survey Agency, federal surveyor or CMS upon request.
Clinical record review revealed that Resident B1 was admitted to the facility on August 1, 2015, with diagnoses to include end stage renal disease, dependence on renal dialysis (process of removing waste products and excess fluid from the body when the kidneys are not able to adequately filter the blood), and diabetes (failure of the body to produce insulin).
A review of a significant change Minimum Data Set assessment (MDS - a federally mandated standardized assessment conducted at specific intervals to plan resident care) dated June 7, 2024, revealed that the resident was cognitively intact with a BIMS (brief interview to assess cognitive status) score of 15 (score of 13-15 indicated that the resident was cognitively intact), and required partial/moderate assistance to perform rolling tasks.
Review of the resident's care plan, dated September 21, 2016, revealed that she utilized assist bars as enablers for bed mobility. The care plan also indicated that Resident B1 had multiple pressure related skin failures related to impaired mobility, moisture , history of diabetes, end state renal disease, atherosclerosis, incontinence and mechanical lift use,
A nurses note dated May 8, 2024, at 2:10 PM indicated that after receiving wound care treatment from the wound care physician, Resident B1 required a bed linen change. While turning the resident toward the nurse, the nurse heard/felt a pop near the resident's right knee in her thigh. The nurse indicated that the resident's body was in correct alignment during turning. The resident called out in pain. Areas assessed by RN once lying flat, no swelling noted, pain with palpation.
Continued review of nurses notes dated May 8, 2024, at 3:00 PM revealed that an attempt was made to contact the physician at 2:15 PM to obtain an x-ray, however the physician did not respond. The facility contacted the on-call answering service and received an x-ray order at 2:55 PM.
Review of the mobile x-ray report of the right hip, femur and knee dated May 8, 2024, at 4:57 PM revealed no acute fracture.
Review of the facility incident report dated May 8, 2024, at 3:15 PM revealed that wound rounds were completed with the consultant wound care physician and nurse aide. Linens needed to be changed after treatment. While turning the resident towards the nurse to change the linens with the wound care nurse aide, they heard/felt a pop near her right knee, in her thigh. Body in correct alignment during turning. Resident yelled out in pain.
Review of the witness statement from Employee 1 (registered nurse) dated May 8, 2024 (no time indicated) revealed that "after wound care, the wound care nurse aide and I were changing soiled bed linens. I went to turn her \ toward me, felt/heard a pop in right leg, and heard \ cry in pain. Proper turning was being performed by staff."
Review of the witness statement from Employee 2 (wound care nurse aide) dated May 8, 2024, (no time indicated), revealed "that while changing soiled linen, \ and I properly turned her The resident complained of pain in her knee while being turned."
At the time of the survey ending June 21, 2024, the facility was unable to provide documented evidence that a witness statement from the cognitively intact Resident B1 was obtained to obtain the resident's account of the incident that resulted in her injury on May 8, 2024.
Review of nurses notes dated between May 9, 2024, and May 31, 2024, revealed that Resident B1 continued to experience increased pain in her right knee. On May 15, 2024, a new physician's order for an MRI of the right knee was obtained. An MRI was not performed until May 30, 2024.
Review of the MRI results dated May 31, 2024, revealed that the resident had sustained a right lateral femoral condyle fracture extending from the posterior margin of the condyle through the anterior weight bearing surface. 2 mm articular surface step-off anteriorly. No displacement or articular malalignment.
(The knee comprises of the thigh bone (femur), the kneecap (patella) and the shin bone (tibia) joining together. The femoral condyles are on the ball-shaped end of the femur which meet at the knee joint. Each leg has two condyles, one medial (to the inner side of the knee) and one lateral (to the outer side of the knee). Thus, fractures to this structure are either a medial femoral condyle fracture or a lateral femoral condyle fracture. The cause of medial and lateral femoral condyle fractures are mostly due to traumatic injuries, such as falling or jumping and landing from a great height. The force of this event may even fracture other bones within the knee or legs)
During an interview with Resident B1 on June 21, 2024, at 11:00 AM while she was lying in bed, she stated that no one in the facility approached her to take her statement regarding the incident that occurred on May 8, 2024, during which she fractured her leg. She stated that she had just finished her wound treatment with the wound doctor and \ "told me to roll over. Well, you know how \ is- she is fast at everything she does. I can do it (roll), but I wasn't fast enough for her, and she just grabbed my knee and pulled it. It popped and it hurt so bad, and I said "Oh, you broke my leg!"
Continued interview with Resident B1 on June 21, 2024, revealed that the resident uses bilateral assist bars to help her roll side to side in bed. Resident B1 demonstrated to the surveyor how she was able to reach and hold onto the assist bar and pull her upper body toward the bar. Resident B1 reported that when rolling to the left the day of the incident on May 8, 2024, Employee 1 did not place her hand on the resident's shoulder or her hip to try to assist in rolling, she just pulled on her knee, which resulted in a significant injury, a right lateral femur fracture.
Interview with the Nursing Home Administrator (NHA) and Director of Nursing (DON) on June 21, 2024, at 11:45 AM, confirmed that the facility did not obtain a witness statement from Resident B1 although she is cognitively intact with a BIMS score of 15 . The NHA and DON further stated that they did not feel it was necessary to obtain a statement from Resident B1 to obtain the resident's account since both employees stated in their witness statement that proper turning was performed.
During an interview with Employee 1 on June 21, 2024, at 11:50 AM she stated that she utilized a proper rolling technique when rolling Resident B1 on May 8, 2024. When asked to clarify proper rolling technique, Employee 1 stated she placed her hands on the resident's shoulder and hip/thigh region. The resident, when interviewed during the survey ending June 21, 2024, stated that Employee 1 did not use the technique described to the surveyor, and had not placed her hand the resident's shoulder or hip.
Multiple attempts were made to contact Employee 2 at the time of the survey ending June 21, 2024, but the employee did not answer or return the telephone calls.
At the time of the survey ending June 21, 2024, the facility had not thoroughly investigated this adverse event during which Resident B1 was seriously injured. The facility failed to obtain a witness statement from a cognitively intact resident, and therefore was unable to assure accurate identification of the root cause of the incident.
Resident B1's statement obtained from the surveyor during the survey ending June 21, 2024, and the statements the facility obtained from the employees involved, were not consistent. The facility was unable to show any corrective actions developed as a result of the QAPI review of this event, as the investigation was incomplete. There was no evidence that the facility had fully investigated the circumstances surrounding the resident's injury to fully ascertain the underlying cause or contributing factors to this incident and to demonstrate the facility's good faith efforts to verify that Employee 1 and Employee 2 had in fact used proper technique and that remedial or corrective actions were not required with these employees to prevent injury to residents.
There was no evidence at the time of the survey that the facility demonstrated an effective QAPI program to include outcomes of quality of care and quality of life by investigating resident incidents and maintaining thorough documentation to support their analysis of the data collected and any corrective actions developed and implemented.
28 Pa. Code 201.18 (b)(1)(3)(e)(1)(4) Management
28 Pa. Code 211.12(c) Nursing Services
| | Plan of Correction - To be completed: 07/09/2024
1. Resident B1 statement obtained for incident report.
2. Facility completed baseline audit of the last 2 weeks of incident reports to ensure resident statement was obtained if applicable.
3. Facility completed AD HOC QAPI with IDT team and findings included educating licensed staff to obtain resident statements for each incident report and facility wide education with licensed staff on proper body mechanics. DON also to educate the 2licensed staff separately for this specific incident.
4. NHA will audit monthly QAPI to ensure topic discussed and investigations are completed with resident statements in place and that body mechanic were followed properly for applicable incidents.
5. Audits will be reviewed in monthly QAPI meetings.
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