Masonic Care Community of New York
June 23, 2016 Complaint Survey

Standard Health Citations

FF09 483.13(c)(1)(ii)-(iii), (c)(2) - (4):INVESTIGATE/REPORT ALLEGATIONS/INDIVIDUALS

REGULATION: The facility must not employ individuals who have been found guilty of abusing, neglecting, or mistreating residents by a court of law; or have had a finding entered into the State nurse aide registry concerning abuse, neglect, mistreatment of residents or misappropriation of their property; and report any knowledge it has of actions by a court of law against an employee, which would indicate unfitness for service as a nurse aide or other facility staff to the State nurse aide registry or licensing authorities. The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency). The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: June 23, 2016
Corrected date: August 22, 2016

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, observation, and interview conducted during the abbreviated survey (NY 123), it was determined for 1 of 4 sampled residents (Resident #4), the facility did not ensure potential violations involving mistreatment, neglect, or abuse were thoroughly investigated. Specifically, an investigation was not completed in a timely manner when Resident #4 sustained an embolic stroke after her INR level (international normalized ratio, a laboratory test used to monitor blood clotting) was subtherapeutic. The facility did not ensure the incident was reported to the NYS DOH (New York State Department of Health) as required. Findings include: The facility's Abuse and Adverse Incident Prevention and Reporting policy, revised 4/2016, documented that the facility would ensure that all alleged violations, including neglect, were reported immediately to the Administrator of the facility and to all other officials in accordance with State and Federal laws (including to the State DOH) through established procedures. Resident #4's primary [DIAGNOSES REDACTED]. The physician order [REDACTED]. The comprehensive care plan dated 3/21/2016 documented the resident was at risk for bleeding due to being on an anticoagulant medication for [MEDICAL CONDITION], and interventions were implemented. The physician's renewal orders dated 4/19/2016 contained standing orders that documented to obtain the resident's PT/INR twice a week, and once on 5/31/2016. Documentation on the resident's Diagnostic Result from the laboratory (lab), dated 5/2/2016, included documentation of clinical indications with associated INR therapeutic range values as follows: - [MEDICAL CONDITION]: INR 2-3; and - [MEDICAL CONDITION]: INR 2-3. The 5/2016 Medication Administration Record [REDACTED]. The resident's INR was subtherapeutic (according to lab recommended ranges) at 1.9 on 5/2/2016, subtherapeutic at 1.6 on 5/5/2016, and subtherapeutic at 1.2 on 5/9/2016. The 5/2016 MAR indicated [REDACTED]. The resident's INR was subtherapeutic at 1.6 on 5/12/2016, subtherapeutic at 1.9 on 5/16/2016, and subtherapeutic at 1.8 on 5/19/2016. The 5/2016 MAR indicated [REDACTED]. The MAR for 5/21/2016 had the nurse's initials with an asterisk under her initials. The comment section of the 5/2016 documented 3 mg [MEDICATION NAME] was not administered on 5/21/2016, as awaiting delivery. The resident's INR was therapeutic at 2.3 on 5/23/2016. The 5/2016 MAR indicated [REDACTED]. The 5/2016 MAR indicated [REDACTED] - 5/24/2016 at 8:00 PM; - 5/25/2016 at 8:00 AM and 8:00 PM; and - 5/26/2016 at 8:00 AM. The resident's INR was elevated at 4.7 on 5/26/2016. The physician order [REDACTED]. The resident's INR was therapeutic at 2.3 on 5/31/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.8 on 6/2/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.2 on 6/6/2016. The 6/2016 MAR indicated [REDACTED]. The nursing progress note dated 6/7/2016 documented the resident was noted to have difficulty eating, slightly slurred speech, loss of peripheral vision on the left, and left sided [MEDICAL CONDITION] (weakness). The progress note documented Physician #1 assessed the resident, and the resident was to be sent to the emergency room for a possible embolic stroke. The hospital Discharge Summary dated 6/10/2016 documented the CT (computed tomography) imaging study of the resident's head showed right parietal (lobe of brain) changes that were new since 5/19/2016. The discharge [DIAGNOSES REDACTED]. The Discharge Summary documented, The stroke occurred due to subtherapeutic INR on [MEDICATION NAME] ([MEDICATION NAME]). The resident was observed on 6/16/2016 at 9:30 AM in the dining area of the unit. The resident was positioned in a positioning chair, with a pillow behind her head, and her feet were elevated. The resident was being fed oatmeal and honey-thick apple juice by the Speech-Language Pathologist. During an interview with the Administrator on 6/16/2016 at 9:00 AM, she stated she was notified by the QA (Quality Assurance) Coordinator on 6/13/2016 that the resident was transferred to the hospital on [DATE] due to an embolic stroke. The Administrator stated the resident had an increased INR on 5/26/2016 of 4.7, and the [MEDICATION NAME] was discontinued by Physician #7. The INRs were repeated per the resident's schedule of two times per week. The Administrator stated that the resident's INR on 5/31/2016 was approximately 2.4 (therapeutic), and was reviewed by Physician #1. The resident's INR on 6/2/2016 was 1.8 (subtherapeutic), and was reviewed by nurse practitioner (NP) #8. The resident's INR on 6/6/2016 was 1.2 (subtherapeutic), and was reviewed by Physician #1 and NP #8; the [MEDICATION NAME] was then restarted. During an interview with the Director of Nursing (DON) on 6/6/2016 at 1:55 PM, she stated an investigation was initiated. She did not think there was a system problem, as there was an order for [REDACTED]. During an interview with the DON on 6/22/2016 at 2:35 PM, she stated that her role in the facility included overseeing the nursing staff and facility investigations. The DON stated the incident was not reported to the NYS DOH, as it was not reportable until 24 hours after the determination of abuse or neglect was met. The DON stated that when the surveyor arrived to the facility, the facility was in the middle of their investigation. During an interview with the Administrator on 6/22/2016 at 3:00 PM, she stated that her role as an Administrator included involvement with the investigation process. The Administrator stated this case was not reported to the NYSDOH, as the reporting requirement was 5 working days per the incident reporting manual, and the surveyor was onsite during the middle of the facility investigation. The Administrator stated neglect did occur for Resident #4. During an interview with the Medical Director on 6/23/2016 at 9:05 AM, she stated her role in the facility included assisting with policy decisions and oversight of the medical staff. The Medical Director stated an INR result during anticoagulation treatment was used for [MEDICATION NAME] adjustment. She would expect a practitioner to look at the [MEDICATION NAME] dose (when reviewing an INR result). The Medical Director stated it was difficult to say if a INR of 1.8 (such as the resident's on 6/2/2016) was therapeutic, especially for those with an increased risk for bleeding, such as the elderly. The Medical Director stated she was involved with investigations to determine if abuse/neglect had occurred. She stated she became involved with this case after the fact, and was aware the resident sustained [REDACTED]. The Medical Director did not consider the case as neglect toward the resident. 10NYCRR 415.4(b)(2)

Plan of Correction: ApprovedJuly 14, 2016

What corrective action(s) will be accomplished for the resident found to have been affected by deficient practice?
Resident #4: The incident has been reviewed by the Medical Director, Physician, Nurse Practitioner, Administrator, Director of Nursing and ADON/Quality Assurance Coordinator.
How will we identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken?
? All residents could be at risk for this deficient practice.
What measures will be put in place or what systemic changes will you make to ensure that the deficient practice will not recur?
? The Abuse and Adverse Incident Prevention and Reporting policy will be reviewed for any necessary revisions.
? All staff will receive education on resident abuse, mistreatment and neglect including the investigative process and reporting requirements.
? All new staff will receive education during their orientation on resident abuse, mistreatment and neglect including the investigative process and reporting requirements.
? Reported Concern of Alleged Abuse, Mistreatment or Neglect Guideline will be developed to document alleged violations involving mistreatment, neglect, or abuse and investigative process.
? Nursing Supervisory staff will be educated on the Reported Concern of Alleged Abuse, Mistreatment or Neglect Guideline.
How the corrective action(s) will be monitored to ensure the deficient practice will not recur, i.e., what quality assurance program will be put into practice?
? Each alleged concern of abuse, mistreatment or neglect will be documented onto the Reported Concern of Alleged Abuse, Mistreatment or Neglect Guideline form. This form will be audited for completion and compliance with the Abuse and Adverse Incident Prevention and Reporting policy. This audit will be completed monthly for a total of 1 year to ensure 90-100% compliance. If sustained compliance is not achieved, auditing will continue. Audit will be reported to the Quality Assurance Committee on a monthly basis throughout the auditing period.
Responsible Person: Administrator

FF09 483.40(b):PHYSICIAN VISITS - REVIEW CARE/NOTES/ORDERS

REGULATION: The physician must review the resident's total program of care, including medications and treatments, at each visit required by paragraph (c) of this section; write, sign, and date progress notes at each visit; and sign and date all orders with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved facility policy after an assessment for contraindications.

Scope: Isolated
Severity: Actual harm has occurred
Citation date: June 23, 2016
Corrected date: August 22, 2016

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, observation, and interview conducted during the abbreviated survey (NY 123), it was determined for 1 of 4 residents (Resident #4) reviewed for [MEDICATION NAME] ([MEDICATION NAME], a blood thinner) use, the facility did not ensure provision of adequate medical supervision/management in terms of care and monitoring of the resident's INR (international normalized ratio, a laboratory test used to monitor blood clotting) in relationship to her medications. Resident #4's [MEDICATION NAME] was not restarted after her INR was no longer elevated, but was within therapeutic range. Resident #4's INR became subtherapeutic, and she was transferred to the hospital with the admitting [DIAGNOSES REDACTED].#4 that was not immediate jeopardy. Findings include: Resident #4's primary [DIAGNOSES REDACTED]. The physician order dated 10/9/2015 contained standing orders that documented to obtain the resident's PT ([MEDICATION NAME] time) and INR (both lab tests used to monitor anticoagulation status/blood clotting) twice a week. The physician renewal orders dated 4/19/2016 contained standing orders that documented to obtain the resident's PT/INR twice a week, and once on 5/31/2016. Documentation on the resident's Diagnostic Result from the lab, dated 5/2/2016, included documentation of clinical indications with associated therapeutic range values for INR as follows: - [MEDICAL CONDITION]: INR 2-3; and - [MEDICAL CONDITION]: INR 2-3. The 5/2016 Medication Administration Record [REDACTED]. The resident's INR was subtherapeutic (according to lab recommended ranges) at 1.9 on 5/2/2016, subtherapeutic at 1.6 on 5/5/2016, and subtherapeutic at 1.2 on 5/9/2016. The 5/2016 MAR indicated [REDACTED]. The resident's INR was subtherapeutic at 1.6 on 5/12/2016, subtherapeutic at 1.9 on 5/16/2016, and subtherapeutic at 1.8 on 5/19/2016. The 5/2016 MAR indicated [REDACTED]. The MAR for 5/21/2016 had the nurse's initials with an asterisk under her initials. The comment section of the 5/2016 documented 3 mg [MEDICATION NAME] was not administered on 5/21/2016, as awaiting delivery. The Minimum Data Set (MDS) assessment dated [DATE] documented the resident had severely impaired cognition. She required extensive assistance, with assist of 2 for transfers, bed mobility, toileting, dressing, and personal hygiene. The resident required limited assistance with eating. She did not have functional limitations in her range of motion. The resident's INR was therapeutic at 2.3 on 5/23/2016. The 5/2016 MAR indicated [REDACTED]. The 5/2016 MAR indicated [REDACTED] - 5/24/2016 at 8:00 PM; - 5/25/2016 at 8:00 AM and 8:00 PM; and - 5/26/2016 at 8:00 AM. The resident's INR was elevated at 4.7 on 5/26/2016. The physician order dated 5/26/2016 documented to discontinue 3 mg [MEDICATION NAME] and Bactrim DS 800 mg-160 mg. The resident's INR was therapeutic at 2.3 on 5/31/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.8 on 6/2/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.2 on 6/6/2016. The 6/2016 MAR indicated [REDACTED]. The nursing progress note dated 6/7/2016 documented the resident was noted to have difficulty eating, slightly slurred speech, loss of peripheral vision on the left, and left sided [MEDICAL CONDITION] (weakness). The progress note documented Physician #1 assessed the resident, and the resident was to be sent to the emergency room for a possible embolic stroke. The hospital Discharge Summary dated 6/10/2016 documented the CT (computed tomography) imaging study of the resident's head showed right parietal changes that were new since 5/19/2016. The discharge [DIAGNOSES REDACTED]. The Discharge Summary documented, The stroke occurred due to subtherapeutic INR on [MEDICATION NAME] ([MEDICATION NAME]). The resident was observed on 6/16/2016 at 9:30 AM in the dining area of the unit. The resident was positioned in a positioning chair, with a pillow behind her head, and her feet were elevated. The resident was being fed oatmeal and honey-thick apple juice by the Speech-Language Pathologist. The resident was observed on 6/16/2016 at 10:15 AM in bed. The resident had the call bell in her right hand. The resident answered basic questions, but did not initiate or continue conversation. During an interview with the Administrator on 6/16/2016 at 9:00 AM, she stated she was notified by the QA (Quality Assurance) Coordinator on 6/13/2016 that the resident was transferred to the hospital on [DATE] due to an embolic stroke. The Administrator stated the resident had an increased INR on 5/26/2016 of 4.7, and the [MEDICATION NAME] was discontinued by Physician #7. The INRs were repeated per the resident's schedule of 2 times per week. The Administrator stated that the resident's INR on 5/31/2016 was approximately 2.4 (therapeutic), and was reviewed by Physician #1. The resident's INR on 6/2/2016 was 1.8 (subtherapeutic), and was reviewed by nurse practitioner (NP) #8. The resident's INR on 6/6/2016 was 1.2 (subtherapeutic), and was reviewed by Physician #1 and NP #8; the [MEDICATION NAME] was then restarted. The Administrator stated a new plan of action was begun after the resident's hospitalization , and a policy was developed that each time a PT/INR lab result is reviewed in the electronic system by medical staff, a notation indicating review of the current anticoagulation order will be documented in the comment section. During interviews with licensed practical nurses (LPNs) #9 and 10 on the morning of 6/16/2016, they stated they do not notify the physician of lab results, as the lab sends the results to the physicians electronically via the computer system. During an interview with registered nurse (RN) #11 on 6/16/2016 at 10:00 AM, she stated that medical providers were no longer able to put meds on hold. She stated hopefully when a PT/INR comes back low and the resident was not on [MEDICATION NAME], the provider would check and reinstate the medication. During an interview with the resident's attending Physician #1 on 6/16/2016 at 11:20 AM, he stated he had cared for the resident since she was admitted to the facility. Physician #1 stated he placed the resident on a three day course of Bactrim, as the resident had a diagnosed UTI (urinary tract infection) and staff reported the resident was not acting right. Physician #1 stated the resident's PT/INR was drawn twice a week, as her INRs were variable. Physician #1 stated that the resident's INR was elevated to between 3-4 and he stopped the [MEDICATION NAME] ([MEDICATION NAME]). The physician stated he remembered that this was on a holiday weekend and the resident's INR would not be drawn until Tuesday (5/31/2016). Physician #1 stated he kept a sheet of paper with him that identified residents he needed to see, and Resident #4 was not on the list. Physician #1 stated that on Tuesday (5/31/2016) he signed off on the resident's PT/INR, and her INR was 2.3. He stated he should have had a system to remind him that the resident was not receiving [MEDICATION NAME]. Physician #1 stated two days later (6/2/2016), the resident had another INR done, and it remained therapeutic (1.8). Per the provider that signed off on the INR (NP #8), this did not seem like a significant change. The following Monday (6/6/2016), the resident's INR was 1.2 and [MEDICATION NAME] was restarted. Physician #1 stated that he assumed the resident had a stroke from not being on [MEDICATION NAME]. Physician #1 offered clarification and stated when the resident's INR came back elevated and the [MEDICATION NAME] was discontinued, he did not create a system for himself (when reviewing future lab results) to trigger awareness the resident was not on [MEDICATION NAME]. During a second interview with the Administrator on 6/16/2016 at 12:10 PM, she stated that there was an interface between the laboratory and the computer software system the nursing home utilized. When the lab results come in, the medical providers go directly into the computer software system and review alerts; the providers review the labs and sign off the labs were reviewed electronically. The medical providers have access to the computer software system on and off site. During an interview with the Director of Nursing (DON) on 6/6/2016 at 1:55 PM, she stated an investigation was initiated. She did not think there was a system problem, as there was an order for [REDACTED]. During an interview with NP #8 on 6/16/2016 at 2:30 PM, she stated that on 6/2/2016, the computer system alerted her the resident's INR was 1.8. She reviewed the resident's INRs and saw that the INR was 2.3 on 5/31/2016. NP #8 stated that she saw two therapeutic INRs, and she did not look to see how much [MEDICATION NAME] the resident was on. The NP stated that on 6/6/2016, the computer system alerted her that the resident's INR was 1.2, and that was when she noticed the resident was not on [MEDICATION NAME]. NP #8 stated she does not routinely review the resident's medications in the computer system when she signs off for labs, as it depended on what the lab was for, such [MEDICATION NAME] (heart medication) or [MEDICATION NAME] ([MEDICAL CONDITION] medication). NP #8 stated an INR of 1.8 was within the therapeutic range; she did not have a documented reference source for that information. NP #8 stated that with an INR of 1.8, she does not increase the [MEDICATION NAME]. During an interview with the Medical Director #3 on 6/23/2016 at 9:05 AM, she stated her role in the facility included assisting with policy decisions and oversight of the medical staff. The Medical Director stated an INR result during anticoagulation treatment was used for [MEDICATION NAME] adjustment. She would expect a practitioner to look at the [MEDICATION NAME] dose (when reviewing an INR result). The Medical Director stated it was difficult to say if a INR of 1.8 (such as the resident's on 6/3/2015) was therapeutic, especially for those with an increased risk for bleeding, such as the elderly. The Medical Director stated she was aware the resident sustained [REDACTED]. 10NYCRR 415.15(b)(1)(i)(iii)

Plan of Correction: ApprovedJuly 14, 2016

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** What corrective action(s) will be accomplished for the resident found to have been affected by deficient practice?
Resident #4: The incident has been reviewed by the Medical Director, Physician, Nurse Practitioner, Administrator, Director of Nursing and ADON/Quality Assurance Coordinator.
[MEDICATION NAME] changed to Xarelto during course of hospitalization ; PT/INR monitoring not indicated.
How will we identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken?
All residents receiving [MEDICATION NAME] ([MEDICATION NAME]) and/or on PT/INR monitoring are at risk for this deficient practice. Full house audit was completed to ensure medication and/or proper monitoring was in place. No additional residents identified.
What measures will be put in place or what systemic changes will you make to ensure that the deficient practice will not recur?
Anticoagulant Monitoring policy developed.
Medical staff educated on the Anticoagulant Monitoring policy.
Anticoagulant Monitoring Log developed. A form will be initiated for each resident on [MEDICATION NAME] ([MEDICATION NAME]) and/or on current PT/INR monitoring. Daily PT/INR results will be documented onto the log. This will also include current anti-coagulant medication order and any changes per physicians order. Lab results will be reviewed in the EHR to ensure that a comment has been added to the lab result by the medical provider. The medical provider will review on a weekly basis.
All new medical staff will be educated on the Anticoagulant Monitoring policy and the Anticoagulant Monitoring Log.
How the corrective action(s) will be monitored to ensure the deficient practice will not recur, i.e., what quality assurance program will be put into practice?
Each resident receiving [MEDICATION NAME] ([MEDICATION NAME]) and/or on current PT/INR monitoring will have an Anticoagulant Monitoring Log initiated. This log will be audited for completion and compliance with the Anticoagulant Monitoring policy. This audit will be completed monthly for a total of 1 year to ensure 90-100% compliance. If sustained compliance is not achieved, auditing will continue. Audit will be reported to the Quality Assurance Committee on a monthly basis throughout the auditing period.
Responsible Person: Medical Director

FF09 483.25:PROVIDE CARE/SERVICES FOR HIGHEST WELL BEING

REGULATION: Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: June 23, 2016
Corrected date: August 22, 2016

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, observation, and interview conducted during the abbreviated survey (NY 123), it was determined the facility did not ensure for 1 of 4 sampled residents (Resident #4) received the necessary care and services to attain or maintain the highest practicable physical well-being. Specifically, the facility did not ensure Resident #4's [MEDICATION NAME] ([MEDICATION NAME], an anticoagulant/blood thinner) was restarted after her INR (international normalized ratio, a laboratory test used to monitor blood clotting) was no longer elevated, but was within therapeutic range. Resident #4 required hospitalization for an embolic stroke related to subtherapeutic anticoagulation (thicker blood clotting level below desired thinner therapeutic range). Findings include: The policy Reviewing Lab Results documented that lab results in the electronic system can be marked as reviewed and then as signed off. If results have been marked as reviewed, but not signed off on by the physician, there will be a sign off icon under the Actions column. Resident #4's primary [DIAGNOSES REDACTED]. The physician order [REDACTED]. The comprehensive care plan dated 3/21/2016 documented the resident was at risk for bleeding, as she was on an anticoagulant medication for [MEDICAL CONDITION], and interventions were implemented. The physician renewal orders dated 4/19/2016 contained standing orders that documented to obtain the resident's PT/INR twice a week, and once on 5/31/2016. Documentation on the resident's Diagnostic Result from the lab, dated 5/2/2016, included documentation of clinical indications with associated therapeutic range values for INR as follows: - [MEDICAL CONDITION]: INR 2-3; and - [MEDICAL CONDITION]: INR 2-3. The 5/2016 Medication Administration Record [REDACTED]. The resident's INR was subtherapeutic (according to lab recommended ranges) at 1.9 on 5/2/2016, subtherapeutic at 1.6 on 5/5/2016, and subtherapeutic at 1.2 on 5/9/2016. The 5/2016 MAR indicated [REDACTED]. The resident's INR was subtherapeutic at 1.6 on 5/12/2016, subtherapeutic at 1.9 on 5/16/2016, and subtherapeutic at 1.8 on 5/19/2016. The 5/2016 MAR indicated [REDACTED]. The MAR for 5/21/2016 had the nurse's initials with an asterisk under her initials. The comment section of the 5/2016 documented 3 mg [MEDICATION NAME] was not administered on 5/21/2016, as awaiting delivery. The Minimum Data Set (MDS) assessment dated [DATE] documented the resident had severely impaired cognition. She required extensive assistance, with assist of 2 for transfers, bed mobility, toileting, dressing, and personal hygiene. The resident required limited assistance with eating. She did not have functional limitations in her range of motion. The resident's INR was therapeutic at 2.3 on 5/23/2016. The 5/2016 MAR indicated [REDACTED]. The 5/2016 MAR indicated [REDACTED] - 5/24/2016 at 8:00 PM; - 5/25/2016 at 8:00 AM and 8:00 PM; and - 5/26/2016 at 8:00 AM. The resident's INR was elevated at 4.7 on 5/26/2016. The physician order [REDACTED]. The resident's INR was therapeutic at 2.3 on 5/31/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.8 on 6/2/2016. There was no documented evidence in the resident's medical record that the [MEDICATION NAME] was restarted. The resident's INR was subtherapeutic at 1.2 on 6/6/2016. The 6/2016 MAR indicated [REDACTED]. The nursing progress note dated 6/7/2016 documented the resident was noted to have difficulty eating, slightly slurred speech, loss of peripheral vision on the left, and left sided [MEDICAL CONDITION] (weakness). The progress note documented Physician #1 assessed the resident, and the resident was to be sent to the emergency room for a possible embolic stroke. The hospital Discharge Summary dated 6/10/2016 documented the CT (computed tomography) imaging study of the resident's head showed right parietal changes that were new since 5/19/2016. The discharge [DIAGNOSES REDACTED]. The Discharge Summary documented, The stroke occurred due to subtherapeutic INR on [MEDICATION NAME] ([MEDICATION NAME]). The resident was observed on 6/16/2016 at 9:30 AM in the dining area of the unit. The resident was positioned in a positioning chair, with a pillow behind her head, and her feet were elevated. The resident was being fed oatmeal and honey-thick apple juice by the Speech-Language Pathologist. The resident was observed on 6/16/2016 at 10:15 AM in bed. The resident had the call bell in her right hand. The resident answered basic questions, but did not initiate or continue conversation. During an interview with the Administrator on 6/16/2016 at 9:00 AM, she stated she was notified by the QA (Quality Assurance) Coordinator on 6/13/2016 that the resident was transferred to the hospital on [DATE] due to an embolic stroke. The Administrator stated the resident had an increased INR on 5/26/2016 of 4.7, and the [MEDICATION NAME] was discontinued by Physician #7. The INRs were repeated per the resident's schedule of 2 times per week. The Administrator stated that the resident's INR on 5/31/2016 was approximately 2.4 (therapeutic), and was reviewed by Physician #1. The resident's INR on 6/2/2016 was 1.8 (subtherapeutic), and was reviewed by nurse practitioner (NP) #8. The resident's INR on 6/6/2016 was 1.2 (subtherapeutic), and was reviewed by Physician #1 and NP #8; the [MEDICATION NAME] was then restarted. The Administrator stated a new plan of action was begun after the resident's hospitalization , and a policy was developed that each time a PT/INR lab result is reviewed in the electronic system by medical staff, a notation indicating review of the current anticoagulation order will be documented in the comment section. During interviews with licensed practical nurses (LPNs) #9 and 10 on the morning of 6/16/2016, they stated they do not notify the physician of lab results, as the lab sends the results to the physicians electronically via the computer system. During an interview with registered nurse (RN) #11 on 6/16/2016 at 10:00 AM, she stated that medical providers were no longer able to put meds on hold. She stated hopefully when a PT/INR comes back low and the resident was not on [MEDICATION NAME], the provider would check and reinstate the medication. During an interview with Physician #1 on 6/16/2016 at 11:20 AM, he stated he had cared for the resident since she was admitted to the facility. Physician #1 stated he placed the resident on a three day course of Bactrim, as the resident had a diagnosed UTI (urinary tract infection) and staff reported the resident was not acting right. Physician #1 stated the resident's PT/INR was drawn twice a week, as her INRs were variable. Physician #1 stated that the resident's INR was elevated to between 3-4 and he stopped the [MEDICATION NAME] ([MEDICATION NAME]). The physician stated he remembered that this was on a holiday weekend and the resident's INR would not be drawn until Tuesday (5/31/2016). Physician #1 stated he kept a sheet of paper with him that identified residents he needed to see, and Resident #4 was not on the list. Physician #1 stated that on Tuesday (5/31/2016) he signed off on the resident's PT/INR, and her INR was 2.3. He stated he should have had a system to remind him that the resident was not receiving [MEDICATION NAME]. Physician #1 stated two days later (6/2/2016), the resident had another INR done, and it remained therapeutic (1.8). Per the provider that signed off on the INR (NP #8), this did not seem like a significant change. The following Monday (6/6/2016), the resident's INR was 1.2 and [MEDICATION NAME] was restarted. Physician #1 stated that he assumed the resident had a stroke from not being on [MEDICATION NAME]. Physician #1 offered clarification and stated when the resident's INR came back elevated and the [MEDICATION NAME] was discontinued, he did not create a system for himself (when reviewing future lab results) to trigger awareness the resident was not on [MEDICATION NAME]. During a second interview with the Administrator on 6/16/2016 at 12:10 PM, she stated that there was an interface between the laboratory and the computer software system the nursing home utilized. When the lab results come in, the medical providers go directly into the computer software system to review the labs and sign off the labs were reviewed electronically. The medical providers have access to the computer software system on and off site. The policy Reviewing Lab Results documented that lab results in the electronic system can be marked as reviewed and then also as signed off. If results have been marked as reviewed, but not signed off on by the physician, there will be a sign off icon under the Actions column. During an interview with the Director of Nursing (DON) on 6/6/2016 at 1:55 PM, she stated an investigation was initiated. She did not think there was a system problem, as there was an order for [REDACTED]. During an interview with NP #8 on 6/16/2016 at 2:30 PM, she stated that on 6/2/2016, the computer system alerted her the resident's INR was 1.8. She reviewed the resident's INRs and saw that the INR was 2.3 on 5/31/2016. NP #8 stated that she saw two therapeutic INRs, and she did not look to see how much [MEDICATION NAME] the resident was on. The NP stated that on 6/6/2016, the computer system alerted her that the resident's INR was 1.2, and that was when she noticed the resident was not on [MEDICATION NAME]. NP #8 stated she does not routinely review the resident's medications in the computer system when she signs off for labs, as it was dependent on what the lab was for, such [MEDICATION NAME] (heart medication) or [MEDICATION NAME] ([MEDICAL CONDITION] medication). NP #8 stated an INR of 1.8 was within the therapeutic range; she did not have a documented reference source for that information. NP #8 stated that with an INR of 1.8, she does not increase the [MEDICATION NAME]. During an interview with the Medical Director on 6/23/2016 at 9:05 AM, she stated her role in the facility included oversight of the medical staff. The Medical Director stated an INR result during anticoagulation treatment was used for [MEDICATION NAME] adjustment. She would expect a practitioner to look at the [MEDICATION NAME] dose (when reviewing an INR result). The Medical Director stated it was difficult to say if a INR of 1.8 (such as the resident's on 6/3/2015) was therapeutic, especially for those with an increased risk for bleeding, such as the elderly. The Medical Director stated she was aware the resident sustained [REDACTED]. 10NYCRR 415.15(b)(1)(i)(iii)

Plan of Correction: ApprovedJuly 14, 2016

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** What corrective action(s) will be accomplished for the resident found to have been affected by deficient practice?
Resident #4: The incident has been reviewed by the Medical Director, Physician, Nurse Practitioner, Administrator, Director of Nursing and ADON/Quality Assurance Coordinator.
[MEDICATION NAME] changed to Xarelto during course of hospitalization ; PT/INR monitoring not indicated.
How will we identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken?
All residents receiving [MEDICATION NAME] ([MEDICATION NAME]) and/or on PT/INR monitoring are at risk for this deficient practice. Full house audit was completed to ensure medication and/or proper monitoring was in place. No additional residents identified.
What measures will be put in place or what systemic changes will you make to ensure that the deficient practice will not recur?
Anticoagulant Monitoring policy developed.
Medical staff educated on the Anticoagulant Monitoring policy.
Anticoagulant Monitoring Log developed. A form will be initiated for each resident on [MEDICATION NAME] ([MEDICATION NAME]) and/or on current PT/INR monitoring. Daily PT/INR results will be documented onto the log. This will also include current anti-coagulant medication order and any changes per physicians order. Lab results will be reviewed in the EHR to ensure that a comment has been added to the lab result by the medical provider. The medical provider will review on a weekly basis.
All new medical staff will be educated on the Anticoagulant Monitoring policy and the Anticoagulant Monitoring Log.
How the corrective action(s) will be monitored to ensure the deficient practice will not recur, i.e., what quality assurance program will be put into practice?
Each resident receiving [MEDICATION NAME] ([MEDICATION NAME]) and/or on current PT/INR monitoring will have an Anticoagulant Monitoring Log initiated. This log will be audited for completion and compliance with the Anticoagulant Monitoring policy. This audit will be completed monthly for a total of 1 year to ensure 90-100% compliance. If sustained compliance is not achieved, auditing will continue. Audit will be reported to the Quality Assurance Committee on a monthly basis throughout the auditing period.
Responsible Person: Medical Director