Initial Comments:
A focused fundamental survey was conducted May 17-20, 2022, to determine compliance with the requirements of the 42 CFR Part 483, Subpart I Requirements for Intermediate Care Facilities. The census during the survey was 21 and the core sample consisted of four individuals.
Plan of Correction:
483.420(d)(3) STANDARD
STAFF TREATMENT OF CLIENTS
Name - Component - 00
The facility must have evidence that all alleged violations are thoroughly investigated.
Observations:
Based on observations, review of a facility incident report and interview, it was determined the facility failed to ensure that all injuries of unknown origin were thoroughly investigated. This applied to one (#6) of 21 individuals at the facility. Findings included:
Observations were conducted in Cottage 2 on May 20, 2022, from 7:40 AM until 7:55 AM. During this observation, Individual #6 was observed to have a bruise under the left eye. A daylight staff person was interviewed at this time. The staff stated that when she came in to work on May 17, 2022, she noticed that Individual #6 had a black eye at which time she contacted the nurse.
As a result of this observation, the facility provided an incident report for this injury. A review of this facility incident report on May 20, 2022, revealed the nurse assessed Individual #6 on May 17, 2022, at 7:20 AM. The nurse identified a 2.3 centimeter (cm) by 1cm bruise under Individual #6's left eye.
An interview was conducted with the executive director on May 20, 2022, at 8:20 AM. The executive director confirmed this injury of unknown origin was not investigated.
Plan of Correction:Regarding individual #6, the QIDP began looking into the bruising under the eye on 5/20/22. The QIDP spoke with staff and obtained statements from the ADS and ICF staff who work predominantly with individual #6. At the end of all the inquiries, there was not substantive conclusion as to how the bruising occurred. The unusual incident report and all the staff statements have been finalized and are on file. As a result of this incident the unusual incident report has been revised to include a section under the nurse's section that asks "requires further investigation - yes or no". Inasmuch as the nurses are the first person to come into contact with injuries, this was deemed the best place to add this statement. This new process with regards to the unusual incident report was explained in detail to the nurses and administrative team by the Executive Director on 6/8/22. All unusual incident reports are reviewed during the daily 9:15am update meeting. The Director of IDD and/or Executive Director will be responsible for monitoring this area and will assure that unknown injuries that raise involve more than basic first aid (scratches, minor abrasions, minor cuts) are immediately looked into and/or formally investigated as soon as possible after discovery. All finalized unusual incident reports and investigative documentation (if warranted) are maintained in the Administrative Assistant's office.
483.450(b)(2) STANDARD
MGMT OF INAPPROPRIATE CLIENT BEHAVIOR
Name - Component - 00
Interventions to manage inappropriate client behavior must be employed with sufficient safeguards and supervision to ensure that the safety, welfare and civil and human rights of clients are adequately protected.
Observations:
Based on record review and interview it was determined that the facility failed to implement inventions to manage inappropriate behaviors with sufficient safeguards. This applied to one (#4) of four individuals in the core sample. Findings included:
Record review for Individual #4 was completed on May 19, 2022. This review revealed a current physician's order dated March 2, 2022, for "melatonin tab 5mg take 1 tablet by mouth 30 minutes prior to bedtime (7:30 PM) Dx: sleep aid." Further record review failed to reveal that that this intervention was implemented as part of the plan to address the individual's sleep. Further review failed to reveal that any consents were obtained and was monitored with sufficient safeguards.
Interview with the qualified intellectual disability professional (QIDP) was completed on May 19, 2022, at 2:20 PM. The QIDP confirmed that Individual #4 was currently receiving melatonin as a sleep aid and further stated that due to a miscommunication this medication was not incorporated into a plan and consents were not obtained for sufficient safeguards.
Plan of Correction:Regarding individual #4 and the melatonin, guardian consent was received on 5/19/22. Human rights authorization was also received on 5/19/22. To prevent this type of error from occurring in the future, the QIDP will obtain updated medication lists for all individuals and these lists will be used to cross reference all medication consents reviewed during the regularly scheduled monthly consent review meetings. The QIDP and/or the Director of IDD is responsible for monitoring this area. Thorough minutes are taken for all monthly consent review meetings and are maintained in the Administrative Assistant's office. Additionally, for all individuals currently taking Melatonin, a "sleep chart" will be developed and maintained in order to measure/monitor sleep habits of the specific individuals on Melatonin so as to review with the physician during scheduled appoints with the ultimate goal of potentially reducing or eliminating the medication if indicated.
483.460(c) STANDARD
NURSING SERVICES
Name - Component - 00
The facility must provide clients with nursing services in accordance with their needs.
Observations:
Based on observations, review of facility provided documentation, and interviews, it was determined that the facility failed to ensure that nursing services met the needs of the individuals. This applied to all 21 individuals living at the facility. Findings included:
Observations of the morning medication administration were completed on May 18, 2022, from 7:35 AM until 8:02 AM. On May 18, 2022, a review of current physician orders for Individual #1 and Individual #5 was completed in order to reconcile the morning medications. Further, a review was completed of the electronic and paper medication administration records (MAR) for both individuals. This review revealed that the facility nurse did not mark all observed medications as administered that morning. During an interview with the nurse on May 18, 2022, at 10:10 AM, the surveyor asked her to identify how she knew what time she administered the observed medications. The nurse confirmed that she was not able to say what time they were administered. The nurse further revealed that currently the facility utilizes a paper MAR as a backup to the electronic system the transition to digital records. This paper MAR was not marked during the morning medication observation.
Further review of the electronic MAR revealed that on multiple occasions nursing staff did not mark medications as administered until the next day or a couple days after. This was revealed as the electronic MAR shows the digital time stamp of each entry as well as the time the nurse enters as the time of administration. The review also revealed that nursing staff had pre-marked medications as administered up to two hours prior to the medications being administered. A review of both the paper and electronic MAR for Individual #5 revealed that on May 11, 2022, neither the electronic nor the paper MAR was marked for the administration of Individual #5's evening Depakote.
An interview was conducted with the director of nursing (DON) on May 20, 2022, at 10:10 AM. The DON confirmed that the current practice of the facility nursing staff is not in accordance with the facility policy. She confirmed that by this incorrect practice the nurses are not maintaining accurate MARs due to: not marking medications as administered until a substantial period after administration, pre-marking medications as administered, and not documenting administration for all medications for the individuals. The DON further confirmed that the facility was not providing nursing services in accordance with the needs for Individuals #1 and #5 and for others residing at the facility.
Facility provided incident reports were reviewed on May 17, 2022. This incident report review revealed the following injuries for Individuals #3, #7, and #8:
1. On May 4, 2022, Individual #3 has bruising on the left biceps and right shoulder
2. On May 4, 2022, Individual #7 has a layer of skin torn off the left pointer finger
3. On May 22, 2022, Individual #8 has an abrasion on the forehead
This review failed to reveal that on the above incident reports the injuries included the measurements in the nursing assessments to monitor the healing process.
On May 20, 2022, at 8:50 AM interview was conducted with the DON. The DON confirmed that it is the expectation that nurses include the measurements of the injuries in the nursing assessment in order to monitor for healing.
Evening observations were completed cottage two on May 17, 2022, at 3:40 PM to 6:15 PM. During this time, at 5:01 PM, Individual #8 was observed sitting in the living room of the cottage without out any foot coverings. This surveyor observed Individual #8's left great toe knuckle to have an area of skin missing the size of a quarter and appeared to have moist and red skin. When questioned during this observation, the nurse stated, " I was not aware of this."
On May 19, 2022, at 1:30 PM an interview with the nurse revealed that the nurse had not completed a written report of Individual #8's injury to monitor the healing process.
On May 20, 2022, at 8:50 AM the DON confirmed that their expectation is that a report be completed concerning Individual #8's injury and should be monitored for healing.
Plan of Correction:Regarding findings from the review of the electronic and paper medication administration records and nursing not marking all medications as administered, not utilizing the paper MAR, and not marking medications until the next day or pre-marking medications administered which do not follow facility policy. The Director of Nursing (DON) met with the nursing staff on 6-1-2022 and retrained nurses on documentation for medication administration and reviewed agency policy. Included in the training was information about how nursing is accessing the eMAR system. Prior to the survey findings, they were loading all clients during the specific time band to document med pass. The system has a history of being slow and not loading correctly when loading all clients at once. The nurses were documenting inappropriately to work around this issue. The system loads better when loading one client at a time. Nurses are now loading eMAR one client at a time when documenting med pass. If the eMAR is not accessible due to not loading properly or the computers are down, the nurses will utilize the paper MAR as a back-up when documenting med passes. The BLARS Lead Nurse is responsible for monitoring this area for compliance; the medication administration times will be audited by lead nurse weekly effective 6/8/22. These weekly audits will include two clients per cottage reviewed and a checklist completed that describes any discrepancies that are found and the corrective action taken at that time to fix the issue. This ensures documentation is being done per policy, in real time, and documented correctly.
On 6/8/22, one of the BLARS nurses followed up one final time on Individuals #3, #7, and #8. In all cases the individuals are fully healed from their reported bruising or skin issues. Progress notes were written as evidence of these checks. Regarding the incident reports not including measurements of injuries to monitor the healing process, the unusual incident report forms were updated on 5/20/22 to include an area that is titled "measurement of injury." This is included in the nursing assessment section of the report. All nurses were trained on this additional requirement on 6/1/22; any and all wounds, abrasions, scratches, bruises, etc. are to be measured and documented. The QIDP and/or the Director of IDD are responsible for monitoring this area for compliance by reviewing thoroughly all unusual incident reports during the daily 9:15am update meeting. At this meeting, the unusual incident reports will be assessed to ensure measurements have been documented. If measurements are incomplete, the QIDP and/or Director of IDD will send the report back to nursing to be completed. All injuries will then be followed by nursing through the healing process and documented in a nursing progress note.
483.460(k)(2) STANDARD
DRUG ADMINISTRATION
Name - Component - 00
The system for drug administration must assure that all drugs, including those that are self-administered, are administered without error.
Observations:
Based on observations, review of physician's orders, and interview, it was determined that the facility failed to ensure that all medications were administered without error. This applied to two (#1 and #5) of three individuals observed during the morning medication administration. Findings included:
1. Observations of the morning medication administration were completed on May 18, 2022, from 7:35 AM until 8:02 AM. Individual #5 was administered morning medications at 7:45 AM which included: Depakote 1000 milligrams(mg) and Levetiracetam 1500 mg.
A review of the current physician orders for Individual #5 was completed on May 19, 2022. This review revealed that there was no current physician order for the Depakote and Levetiracetam that were administered to Individual #5 on May 18, 2022.
An interview with the director of nursing (DON) was completed on May 20, 2022, at 10:25 AM. The DON confirmed that there were no current physician orders for the Depakote and Levetiracetam. The DON further confirmed that the administration of these medications on May 19, 2022, were errors as there was no current physician order to administer the medications.
2. Observations of the morning medication administration were completed on May 18, 2022, from 7:35 AM until 8:02 AM. Individual #1 was administered morning medications at 7:57 AM.
A review of physician orders for Individual #1, dated April 7, 2022, was completed on May 19, 2022, in order to reconcile the medication pass. This review revealed that Individual #1 had an order to receive "Fluticasone Spray 50mcg, administer 1 spray in each nostril daily." A review of a pharmacy recommendation to discontinue the daily Fluticasone spray and change it to an as needed basis was reviewed by the physician who commented "change to as needed" and signed the same day, April 7, 2022.
An interview was completed with the DON on May 20, 2022, at 9:11 AM. The DON confirmed that due to the conflicting documentation the signed physician order sheet, that orders the Fluticasone to be administered daily, would take precedence. The DON further confirmed that the medication was not administered in accordance with the physician's orders and that this was a medication error.
Plan of Correction:Regarding individual #5, the physician's orders for the Depakote and Levetiracetam was obtained on 5/20/22. Regarding individual #1, the correct physician's order for the Fluticasone Spray was obtained on 6/9/22.
Concerning the failure to administer medications without error, the medications will not be given until all physicians' orders are signed by physician and verified by nursing. The physician's orders will be reviewed by the receiving nurse and a second check will be done by a second nurse and both nurses will initial the physicians' orders to ensure orders have been double checked and verified. Immediately after orders are checked for accuracy, the physicians' orders will be faxed to pharmacy, added to eMAR/paper MAR, and filed in client's permanent record. The BLARS Lead Nurse is responsible for monitoring this area; she will monitor this process each month to verify physician orders have been signed and verified by two nurses, faxed to pharmacy, and added to eMAR/Paper MAR.
483.460(m)(1)(ii) STANDARD
DRUG LABELING
Name - Component - 00
Labeling for drugs and biologicals must include the appropriate accessory and cautionary instructions, as well as the expiration date, if applicable.
Observations:
Based on observation and interviews, it was determined that the facility failed to ensure that the label for a drug included the appropriate expiration date. This applied to one (#5) of five individuals that were observed receiving medications. Findings included:
Observations were completed during the morning medication administration in Cottage 1 on May 18, 2022, from 7:35 AM to 8:02 PM. Individual #5 was ordered to receive Lantus Solos Inj 100/ml, inject 30 units subcutaneously daily. The nurse handed the surveyor the medication, and it was noted on the medication label that the insulin pen expires in 28 days once opened. When verifying the information on the Lantus medication, the surveyor failed to find the expiration date marked on the insulin pen or medication label. During an interview with the nurse, on May 18, 2022, at 7:47 AM, she confirmed that the Lantus insulin pen was not labeled correctly, when it was opened, with the expiration date nor the date the insulin pen was opened. Therefore, the nurse discarded it at that time and opened a new insulin pen for the observed pass.
An interview was conducted with the director of nursing on May 20, 2022, at 9:14 AM. The DON confirmed that the Lantus insulin pen was not labeled appropriately with the expiration date. The DON further confirmed that it is the facility's policy to document on insulin pens the date they are opened as well as the appropriate expiration date.
Plan of Correction:With regards to Individual #5, the insulin pen that was observed to have been expired during the survey was discarded and a new one was opened and used moving forward from that time.
Regarding the failure to ensure that labels of medications include expiration date, medications will be labeled with open and expiration dates immediately upon opening and before first use. The BLARS Lead Nurse will conduct weekly periodic label checks to ensure policy and procedure for documenting open and expiration dates on medications is followed. A log will be created which shows when audits are done and if any corrective action was done, if any was needed. The BLARS Lead Nurse is responsible for monitoring this area for compliance.
483.430 (g)(1)-(3)(i)-(x) STANDARD
COVID-19 Vaccination of Facility Staff
Name - Component - 00
§ 483.430 Condition of Participation: Facility staffing.
(f) Standard: COVID-19 Vaccination of facility staff. The facility must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine.
(1) Regardless of clinical responsibility or client contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its clients:
(i) Facility employees;
(ii) Licensed practitioners;
(iii) Students, trainees, and volunteers; and
(iv) Individuals who provide care, treatment, or other services for the facility and/or its clients, under contract or by other arrangement.
(2) The policies and procedures of this section do not apply to the following facility staff:
(i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section; and
(ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with clients and other staff specified in paragraph (f)(1) of this section.
(3) The policies and procedures must include, at a minimum, the following components:
(i) A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility and/or its clients;
(iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;
(iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (f)(1) of this section;
(v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;
(vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law;
(vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the facility has granted, an exemption from the staff COVID-19 vaccination requirements;
(viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains:
(A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and
(B) A statement by the authenticating practitioner recommending that the staff member be exempted from the facility's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications;
(ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and
(x) Contingency plans for staff who are not fully vaccinated for COVID-19.
Effective 60 Days After Publication:
(ii) A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations;
Observations:
Based on documentation review and interview, it was determined that the facility failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. Findings included:
On May 17, 2022, the facility's policies and procedures related to the COVID-19 vaccination of facility staff was requested by the surveyors. The facility presented verification that they were in full compliance with the staff vaccination requirement; however, they did not provide any documented policy and procedures.
An interview was completed with the executive director on May 19, 2022, at 1:55 PM. The executive director stated the facility followed the centers for medicare and medicaid process for staff vaccination requirements. However, the executive director confirmed that the facility did not develop and implement policies for the facility staff for COVID-19 vaccination.
Plan of Correction:The BLARS Executive Director will create policy and procedure outlining that all staff in the ICF and ADS programs will be fully vaccinated, or have an approved medical or religious exemption as a condition of their employment. All requirements outlined in the Federal Mandate that was released in December 2021 will be followed and incorporated into the policy and procedure. The Executive Director will be responsible for this policy and procedure development and will assure that all staff review and understand the contents immediately following its approval. All staff will sign an "on-campus training form" as evidence of their review and understanding. These policy and procedure additions will be completed by 7/10/22.
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