|
MALTREATMENT INVESTIGATION MEMORANDUM Minnesota Statutes, section 626.557, subdivision 1 states, “The legislature declares that the public policy of this state is to protect adults who, because of physical or mental disability or dependency on institutional services, are particularly vulnerable to maltreatment.”
License Number and Program Type: 1096896-H_CRS (Home and Community-Based Services-Community Residential Setting) Investigator(s): Beth Virden 651-431-6572 Suspected Maltreatment Reported: It was reported that a vulnerable adult (VA) received a greater dose of his/her warfarin (anticoagulant) prescription, for a period of time, resulting in internal bleeding and the need for a blood transfusion. Date of Incident(s): Ongoing between October 12 and November 3, 2022
Nature of Alleged Maltreatment Pursuant to Minnesota Statutes, section 626.557, subdivision 9c, paragraph (b), and Minnesota Statutes, section 626.5572, subdivision 15, and subdivision 17, paragraph (a): The failure or omission by a caregiver to supply a vulnerable adult with care or services, including but not limited to food, clothing, shelter, health care, or supervision which is reasonable and necessary to obtain or maintain the vulnerable adult's physical or mental health or safety, considering the physical and mental capacity or dysfunction of the vulnerable adult and which is not the result of an accident or therapeutic conduct. Summary of Findings: Pertinent information was obtained during a site visit conducted on December 7, 2022; from documentation at the facility and medical records; and through interviews conducted with the VA’s guardian (G) who was also the VA’s family member, a facility staff person (P1) who was also a nurse, and supervisory staff persons (P2 and P3). At the time of the site visit, this investigator met the VA, and the VA declined to be interviewed. P1’s responsibilities included providing medical-related training to staff, being a resource for staff regarding medical-related questions or concerns, and completing monthly audits of the individuals’ medication administration records. P2’s responsibilities included providing house-level supervisory support for more than one home operated by the license holder; and P3’s included providing program-level supervisory support for multiple homes operated by the license holder. On October 1, 2022, the VA moved into the facility seeking supports and services relating to his/her diagnoses, including intellectual disability, Down syndrome, diabetes, and chronic kidney disease. Upon moving in, the facility developed an Interim Plan of Care, which listed known information about the VA. Relevant information, included 1) the VA had a blood clotting disorder; 2) the VA was cooperative with medical appointments and preventive treatments; 3) the VA needed to have an “INR lab[oratory] draw” completed monthly; and 4) the VA was sometimes unable to communicate his/her wants or needs. The VA used “short answers,” and might point at objects to assist with communication. [Note: The Interim Plan of Care did not provide additional information to the reader about the VA’s blood clotting disorder or “INR lab draw.”] At the time of the incident, October 12 through November 3, 2022, the facility had yet to develop an Individual Abuse Prevention Plan for the VA. This was a violation of Minnesota Statutes section 245A.65, subdivision 2, paragraph (b), which states, in part, an individual abuse prevention plan shall be developed for each new person as part of the initial individual program plan or service plan required under the applicable licensing rule or statute. The facility also had yet to develop procedures regarding their responsibilities to meet the VA’s health service needs. This was a violation of Minnesota Statutes section 245D.05, subdivision 1, paragraph (b), which states, in part, if responsibility for meeting the person's health service needs has been assigned to the license holder in the support plan or the support plan addendum, the license holder must maintain documentation on how the person's health needs will be met, including a description of the procedures the license holder will follow in order to monitor health conditions according to written instructions from a licensed health professional. [Note: Between November 3 and 10, 2022, the VA was hospitalized. By the time of his/her discharge, the facility had developed the VA’s Individual Abuse Prevention Plan, the VA’s Coordinated Service and Support Plan and Addendum, and the needed information about his/her health service needs] Regarding the VA’s blood clotting disorder and “INR lab draw,” Drugs.com at www.drugs.com, and the Mayo Clinic at www.mayoclinic.org, provided the following information: · The INR, or International Normalized Ratio, is a measure of how long it takes your blood to clot, which is determined by a blood test. · Patients, who are prescribed blood-thinning medication, like warfarin (anticoagulant), need to have their INR monitored. · An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking warfarin. When the INR is higher than the recommended range, it means that your blood clots more slowly than desired. When your INR is too high, you have an increased risk of bleeding. · What increases your risk for an elevated INR? Too much anticoagulant medicine (e.g. warfarin). · What are the signs and symptoms of an elevated INR? You may have small cuts that bleed more than normal, and for longer than normal. You may bruise easily, have frequent nosebleeds, or notice your gums bleeding. · How can you prevent an elevated INR? Have your INR measured regularly. · When should you contact your healthcare provider? You see blood in your urine or stool; you bruise or bleed more than usual; you have pain or swelling in your joints; your fingers or toes turn dark purple; and/or you have an increase in headaches. · When should you seek immediate care or call 9-1-1? You vomit blood; you have any kind of bleeding that does not stop within 15 minutes; your legs feel warm, tender, or painful; and/or you have signs of stroke. The G said that on October 12, 2022, the VA, accompanied by a facility staff person, went to the clinic for a routine INR lab draw. The facility did not follow-up with the clinic to obtain the INR lab results. On October 28, 2022, staff noticed unexplained bruising on the VA’s abdomen. On November 2, 2022, the facility notified the G of the VA’s bruises, and at that time, the G asked that the VA be seen by a doctor; this was not done. On November 3, 2022, a staff person brought the VA to an urgent care facility where it was discovered the VA’s INR level was “extremely high.” The G said that it was further learned that the INR lab draw, which occurred on October 12, 2022, showed a high INR level. According to the G, this should have been immediately addressed by lowering the VA’s warfarin dosage. However, since there was no follow-up for the lab results, the VA’s INR level remained high, which caused internal bleeding presenting as bruises on the VA’s skin. The VA was hospitalized and underwent a blood transfusion. The VA also sustained kidney damage from this incident. P1-P3, the VA’s medical records, and facility documentation provided the following information: · On October 1, 2022, the VA moved into the facility having come from a different residential program that was owned and operated by a different company. According to P1, the facility received the VA’s medication administration record, which listed the VA’s medications, dosages, routes, etc. One of the VA’s medications was warfarin to be administered as 2 milligrams (mg) every Wednesday, and 4 mg all other days of the week. · The facility also received a list of the VA’s medical providers, but no appointments were pending. A staff person called the various providers to determine and/or schedule the VA’s next appointments. The VA’s INR clinic was contacted and the VA’s next INR lab draw was scheduled for October 12, 2022. This, would be the first INR lab draw facilitated by the facility since the VA moved in on October 1, 2022. [Note: Although the VA had just moved into the facility on October 1, 2022, the VA had been going to this same clinic prior to moving.] · P1-P3 provided consistent information that whenever staff, typically a direct care staff person, took an individual to an appointment, they were to have the healthcare professional complete or fill-in portions of the facility’s Consultation Form. The staff person then uploaded the Consultation Form into the facility’s electronic system. Direct care staff were not responsible for reviewing the Consultation Forms and/or following-up in any way. P1 said that a facility supervisor should be reviewing the Consultation Forms when they were uploaded. However, P2 and P3 each said that this was the facility nurse’s responsibility. P3 added, however, that if the appointment did not result in a “new order” then there was nothing to follow-up on. · The Consultation Form for the VA’s INR lab draw, on October 12, 2022, was signed by a lab technician who confirmed the INR lab draw occurred; the lab technician did not fill-in any additional information regarding follow-up or next steps. The staff person, who brought the VA to this appointment, uploaded the Consultation Form into the VA’s electronic file as required. The staff person also uploaded the VA’s INR lab result, which was 3.6. The staff person did not upload any additional items indicating medication changes or other needed follow-up. · P1-P3 provided consistent information that they did not hear anything from the clinic following the VA’s INR lab draw on October 12, 2022. The clinic did not call the facility or reach out in any manner. P2 did not believe s/he was supposed to call the clinic because, as put by P2, “Why would I call a clinic to see if there is a med change? Doesn’t make sense … The clinic needed to call us and let us know.” P1, who was the facility nurse, also did not believe it was his/her responsibility to reach out to the clinic. P1 said that a facility supervisor was responsible for following-up on lab results. However, P2 and P3 each said that this was the facility nurse’s responsibility. P2 added that the direct care staff would not know to call or follow-up on a lab result. · As of October 12, 2022, P1-P3, nor the facility, had access to the VA’s MyChart account, which was a secure online portal allowing the electronic release of medical records and secure messaging with healthcare professionals. The VA’s former provider had access to the VA’s MyChart account. P2 said that s/he had reached out to the supervisor at the VA’s former provider three times around the beginning of October 2022, with no response. [Note: More information regarding the VA’s MyChart account is included in the forthcoming paragraphs.] · P1 and P2 each said that the facility provided services to another client (C), who lived at a different home operated by the license holder and went to a different clinic than the VA. However, similarly, the C also had a warfarin prescription and also attended routine INR lab draws. The C’s clinic always called or faxed information to the facility, “within 24 hours” of the lab draw, whether changes were needed or not. P1 and P2 had expected this would be the same for the VA’s clinic and lab results. P1 and P2 were waiting on a call from the clinic. · P1-P3 each said that, in following up after this incident, they learned that the clinic might have been calling the wrong phone number to get ahold of the facility. However, information was also provided that the clinic did have the correct phone number. A staff person questioned this with the clinic, and was told that sometimes healthcare professionals used a “cheat sheet” with phone numbers, which was not always updated when changes were made in the patient’s electronic file. P1 told this investigator that the staff person who took the VA to his/her INR lab draw on October 12, 2022, said that they told the receptionist about the change in contact information. P1-P3 expressed concern that if the clinic was calling the wrong phone number, and/or if the clinic was unable to get ahold of the facility, why was there no additional follow-up by the clinic to obtain the correct contact information. [The G told this investigator that when s/he called the clinic at some point after November 3, 2022, the clinic had the correct phone number for the facility.] · This investigator requested the VA’s Allina Health Medical Records regarding the clinic’s call logs, including attempts to contact the facility, answered and unanswered calls to the facility, voicemails left, etc., between October 12 and 28, 2022. The clinic notified this investigator that there were no notes regarding this information in the VA’s medical records. · The facility’s General Event Report, dated October 28, 2022, stated that a staff person noticed two bruises on the VA’s abdomen while assisting with the VA’s shower. “[The bruises] are reddish/purple – one is like two inches long. [The VA] says there is no pain.” The staff person notified P1 and P2. A photograph was attached to the incident report, and the description appeared consistent with photo. If the larger bruise was about two inches, according to the staff person’s description, then the second bruise was about half an inch and they were approximately one inch apart. · The General Event Report had a Review/Follow-up Comments section, which included various comments and follow-up by staff, including P1 and P2; these comments included the following: o On October 29, 2022, P1 documented, “Continue to monitor and update nursing if any changes, new bruising, or other concerns. [The VA] is on warfarin, which is a blood thinner and will make [him/her] more prone to bruising … STOP&WATCH has also been initiated to monitor.” (Note: P2 provided information that a STOP&WATCH meant that a progress note was completed and categorized as having “high” importance, which would alert staff of the need to review. The words “STOP&WATCH” were also written within the progress note.) o On October 31, 2022, P2 documented, “Bruise is purplish in color and looks to be several days old. Stated it doesn't hurt. It is located on Left lower belly area. [The VA] said [s/he] bumped into something when asked but couldn't say what. The bruised area lines up with [the VA’s] end table in [his/her] room or a dining room chair. As nursing indicated, [the VA] will bruise easy due to medication. [The VA] replied no when asked if anyone hurt [him/her].” o On November 1, 2022, P1 documented, “Writer was onsite today and looked at [the VA’s] bruise … Writer is in agreement that since [the VA] rearranges [his/her] room and items daily, it is very likely that the bruises came from bumping into things such as a chair or table …[The VA] also takes warfarin … This medication is an anticoagulant, and one of the side effects is bruising. The bruising that was found has not increased in size or density. Also, there is no lump under the bruise and [the VA] denied any pain when asked by writer. [The VA] had [his/her] last INR draw lab on 10/12/22 to determine the proper dose of warfarin. [The] last INR was 3.6 and [s/he] is scheduled for a follow-up INR on 11/9/22 … [The VA’s family member] asked if [the VA] should be seen. [However,] since the bruising has not increased, there is no new bruising, lumps under the bruising, or any abnormal bleeding noted, or new or increased pain noted that [the VA] should be fine for us to monitor and we will continue to do so.” (Note: This investigator asked P1 about this documentation, which listed the VA’s INR value as being 3.6. This investigator asked if, at the time of the documentation, P1 considered whether the VA’s bruises might be related to having an INR value of 3.6. P1 said that his/her understanding of the INR was that the high-end of the acceptable range was 3.5, and so the VA’s value of 3.6 was not significantly elevated in P1’s opinion. P1 further reiterated that the VA’s bruises did not change over time, which might suggest an ulterior cause, but that the bruises seemed consistent with having been sustained from bumping into something. In addition, the clinic did not reach out to the facility with any concern, on their end, regarding the VA’s INR value of 3.6.) o On November 2, 2022, P2 documented on the incident report, “[The G] was concerned about the area that the bruise was located and wants [the VA] to be seen by [his/her primary care physician] due to [the VA’s] stint and [his/her] kidney issues. Info passed onto [P1] and staff at the home will make an appointment.” o On November 4, 2022, a supervisory staff person documented on the incident report, “[The VA] had additional bruising noted on [his/her] bottom on [November 2, 2022] night. Also, staff reported to [P3] that [the VA] was limping a little. I requested that [the VA] remain home on 11/3/22 to see [his/her] primary care physician. Due to unavailability, [the VA] was taken to Urgent Care.” · The VA’s Allina Health Medical Records stated that on November 3, 2022, at 10:13 a.m., the VA arrived at urgent care accompanied by a staff person. “Per [staff person], patient was noted to have multiple bruises on [his/her] torso, lower extremities, and abdomen about 2 days ago. However, today, [the VA] was noted to be very lethargic and was brought to the [urgent care] for further evaluation … Patient and [staff person] reported no blood in stool, hemoptysis (bloody cough), or hematemesis (blood in vomit) … [Staff person] additionally reports that the patient has had increased fatigue, cough, sore throat, rhinorrhea (runny nose), “gagging,” mild “breathing changes,” left knee pain, and mild difficulty walking … No other symptoms. No shortness of breath, chest pain, or fever … Patient [at urgent care] with [facility staff person]. Reports INR elevated 3.6, per records was drawn on 10/12 and called to [former provider] … Patient informed of their triage designation to be seen in [emergency department] – [urgent care] is not open to ensure they will receive the care most appropriate for their condition.” · Medical records – An emergency room physician noted, “Patient was promptly examined. Overall [his/her] presentation is a bit concerning given [his/her] history of Down syndrome, initial soft blood pressure, and malaise (fatigue). [S/he] certainly has an upper respiratory syndrome on exam. Overall I am not too concerned about [his/her] ecchymosis (bruising) given that [his/her] INR has been elevated. There does not seem to be any distribution to suggest a more sinister internal source of bleeding. I do think this is just some superficial bruising due to the anticoagulation.” · Medical records – “In the [emergency department], [the VA] was found to have an INR of 5.8. hemoglobin 8.7, creatine 4.13 from a baseline of 2, bicarb 18 … Urinalysis was positive for proteinuria (protein), moderate blood, and negative nitrate (infection) and leukoesterase (infection).” · Medical records – The VA was diagnosed with supra-therapeutic INR, and acute on chronic anemia, and admitted to the hospital. · Medical records – On November 4, 2022, the VA’s INR value was 3 when checked in the morning, and 2.4 when rechecked at noon. The VA remained hospitalized to monitor his/her hemoglobin. If the VA’s hemoglobin dropped below 7, s/he would likely need a red blood cell transfusion. On November 9, 2022, the VA’s hemoglobin dropped below 6, and as such, s/he received a blood transfusion without complications. On November 10, 2022, the VA was stable and discharged back to the facility. · Facility records – On November 10, 2022, the facility implemented a Warfarin Medication Therapy and Safety Protocol for the VA. This included information about warfarin, possible side effects, signs of unusual bleeding, and when to call emergency services. [Note: P1 provided information that the C did not have a warfarin protocol and had never needed one or had issues similar to the VA. The facility did not automatically create a warfarin protocol for every client who was prescribed warfarin.] · Regarding the facility’s response to the VA’s bruises, which were first observed on October 28, 2022, P1-P3 believed these were likely caused by the VA bumping into something. At that time, P1-P3 were not aware, or informed, of the VA having blood in his/her stools or urine, or any other concerning signs and symptoms. · P1 added that s/he had previous experience working with an individual who had an elevated INR value, and had witnessed this individual develop bruising as a result. In P1’s experience, these bruises typically had a lump and were tender. The VA’s bruises did not have a lump and were not tender. The VA’s bruises did not raise alarms for P1. P1 added that an elevated INR might also cause a person to act confused or anxious, or have joint pain; P1 was not informed of anything similar regarding the VA. As previously stated, at the time of the VA’s INR lab draw on October 12, 2022, the facility did not have access to the VA’s MyChart account; however, around mid-November, they did. At the time of this investigation, P1 looked back at the MyChart messages and appointment notes for the VA’s INR lab on October 12, 2022. P1 provided copies of what had been posted by the clinic in the VA’s MyChart account at that time. This included an After Visit Summary, dated October 12, 2022, which listed the VA’s warfarin prescription as being 2 mg every Wednesday, and 4 mg all other days of the week. Also posted by the clinic on October 12, 2022, was a document titled PROTIME-INR – Details; Comments from the Doctor’s Office. The VA’s INR value, which was collected at 9:08 a.m. that morning, was listed on this document as being 3.6. The VA’s doctor commented, at 7:35 p.m., on October 12, 2022, “Continue taking the Coumadin (brand name for warfarin) as planned with the INR nurse and recheck as scheduled.” The facility’s Medication Procedures stated the following relevant information: · A signed order is required for every medication prescribed; including over the counter medications, for an individual; the order can be written or electronically authorized. [Note: P2 said that when the VA moved into the facility, the facility received signed orders for the VA’s medications, including his/her warfarin prescription, which stated that warfarin should be administered as 2 mg every Wednesday, and 4 mg all other days of the week.] · All new orders/changes in medication will be transcribed to the person’s medication administration record upon receipt of the medication and communicated to the team in a timely manner. · Information about desired and adverse effects for each medication/treatment the person uses will be available to the persons administering/assisting with medications. [Note: P2 was not sure if the facility had this information for the VA’s warfarin prescription prior to November 3, 2022, when the VA was initially admitted to the hospital. In looking through the VA’s file, P2 found a copy of the warfarin’s desired and adverse effects dated November 10, 2022, when the VA was discharged from the hospital. At the time of this investigation and site visit, the VA was no longer prescribed warfarin.] · In the event of a suspected drug adverse reaction, immediately report this to the prescriber or primary physician and follow any instructions given. This investigator reviewed seven staff persons’ training records, including those of P2. These were the staff working at the facility between October 12 and November 3, 2022. The records showed that each staff person received training on the VA’s Interim Care Plan, the facility’s Medication Procedures, and the Reporting of Maltreatment of Vulnerable Adults Act. P1-P3 also received training on the Reporting of Maltreatment of Vulnerable Adults Act; but were not required to receive training on the VA’s support plans. Conclusion: Consistent information was provided that on October 12, 2022, the VA attended an INR lab draw. On October 28, 2022, staff noticed two unexplained bruises on the VA’s abdomen. On November 3, 2022, staff brought the VA to urgent care, and at that time, the VA’s INR value was 5.8, and s/he was admitted to the hospital. Regarding the follow-up to obtain the VA’s INR lab results: Following the VA’s INR lab draw on October 12, 2022, the VA’s Consultation Form was filled-in by a lab technician, but with no additional follow-up noted. The Consultation Form was then uploaded into the VA’s electronic file along with the INR lab result of 3.6. P1-P3 each said that the clinic did not reach out regarding any medication changes or additional follow-up. October 12, 2022, was the facility’s first time working with the VA’s clinic regarding an INR lab draw. The facility’s previous experience with INR labs included the clinic reaching out to them to share lab results or needed changes. P1 and P2 had expected the VA’s clinic to operate in a similar manner, and so were waiting on a call from the clinic. At the time of this investigation, P1 looked back at the MyChart messages and appointment notes for the VA’s INR lab on October 12, 2022. (Note: The facility did not have access to the VA’s MyChart account until mid-November 2022.) The clinic had posted two documents following the VA’s INR lab draw on October 12, 2022. One was an After Visit Summary, which listed the VA’s warfarin prescription as being 2 mg every Wednesday, and 4 mg all other days of the week. Also posted by the clinic on October 12, 2022, was a document titled PROTIME-INR – Details; Comments from the Doctor’s Office. The VA’s INR value, which was collected at 9:08 a.m. that morning, was listed on this document as being 3.6. The VA’s doctor commented, at 7:35 p.m., on October 12, 2022, “Continue taking the Coumadin (brand name for warfarin) as planned with the INR nurse and recheck as scheduled.” Although the facility did not follow-up regarding the VA’s elevated INR value of 3.6, given the aforementioned Comments from the Doctor’s Office, it appeared that the VA’s doctor was aware of the VA’s INR value of 3.6, and that the doctor was not ordering any changes in the VA’s medications at that time; therefore, there was not a preponderance of the evidence whether there was a failure to supply the VA with care or services, which were reasonable and necessary to maintain the VA’s health and safety. It was not determined whether neglect occurred (the failure or omission by a caregiver to supply a vulnerable adult with care or services, including but not limited to food, clothing, shelter, health care, or supervision which is reasonable and necessary to obtain or maintain the vulnerable adult's physical or mental health or safety, considering the physical and mental capacity or dysfunction of the vulnerable adult and which is not the result of an accident or therapeutic conduct). Regarding the facility’s response to the VA’s bruising: According to www.drugs.com and www.mayoclinic.org, the signs and symptoms of an elevated INR include bruising easily or bruising more than usual. At the time the bruises were first noticed by staff, the VA had been living at the facility for 27 days, and there was no information in his/her Interim Care Plan regarding “usual” bruising for the VA. The VA denied pain associated with the bruises, and the bruises appeared to line-up with furniture that staff believed the VA might have bumped into. The VA told P2 that s/he had bumped into something. The VA did not have other obvious signs and symptoms typical of an elevated INR level. The facility monitored the VA’s bruises for five days and did not observe any changes, including increasing size or density. On the sixth day, the VA developed more bruises and became lethargic; and in response to this, the facility immediately brought the VA to urgent care. On the VA’s medical records following his/her admittance to the hospital a doctor stated, “Overall I am not too concerned about [his/her] ecchymosis (bruising) given that [his/her] INR has been elevated. There does not seem to be any distribution to suggest a more sinister internal source of bleeding. I do think this is just some superficial bruising due to the anticoagulation.” Given that the facility did not know the VA’s history with bruises, there were no other concerning signs and symptoms, and the facility monitored the bruises and took immediate action when the VA’s condition changed, there was not a preponderance of the evidence whether there was a failure to supply the VA with care or services, which were reasonable and necessary to maintain the VA’s health and safety. It was not determined whether neglect occurred (the failure or omission by a caregiver to supply a vulnerable adult with care or services, including but not limited to food, clothing, shelter, health care, or supervision which is reasonable and necessary to obtain or maintain the vulnerable adult's physical or mental health or safety, considering the physical and mental capacity or dysfunction of the vulnerable adult and which is not the result of an accident or therapeutic conduct). Action Taken by Facility: The facility completed an internal review, and determined the following: “Although policies and procedures were followed, a gap was identified in making sure the needed follow-up was completed following the lab appointment for Warfarin levels. The clinic was calling the wrong number, so results were not communicated. A protocol was developed to seek out the information following the appointment.” “New protocol has been added in [the VA’s] chart and staff have been trained. Medication changes were ordered by [his/her] physician: Warfarin was discontinued, Eliquis [factor Xa inhibitor] was started. Three time weekly lab draws have been discontinued. Staff have been trained on the new ordered medication (Eliquis) protocol.” Action Taken by Department of Human Services, Office of Inspector General: On February 3, 2023, the facility was issued a Correction Order for the violations outlined in this report, regarding the development of the VA’s support plans upon his/her admittance to the facility.
|
