675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0755
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Some
Provide pharmaceutical services to meet the needs of each resident and employ or obtain the services of a licensed pharmacist. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review the facility failed to establish a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation and follow a policy to provide pharmacy services in accordance with State and Federal laws or rules of the Drug Enforcement Administration for 12 of 12 months ([DATE] until [DATE]) reviewed for pharmacy services. The facility did not have a licensed pharmacist and witnesses initial the attached pages of medication destruction inventory sheets. The facility did not have a licensed pharmacist sign the statement for destruction of dangerous and controlled drugs for long term care facilities (cover sheet) for [DATE], [DATE] and [DATE]. And The facility failed to attach proof of destruction documents from the waste disposal company to the signed and witnessed Drug Destruction records for [DATE] until [DATE]. (12 months) This failure could put residents at risk for misappropriation and drug diversion.
Findings: During a record review of the facility's drug destruction log for the last 12 months, the drug destructions dated [DATE],[DATE], and [DATE] indicated attached pages of medication destruction did not include the initials of the consultant pharmacist and witnesses. There were no proof of destruction documents from the waste disposal company attached to the signed and witnessed Drug Destruction records for [DATE] until January2023. (12 months) During an interview on [DATE] at 3:30 PM, the DON stated she oversaw the facility drug destructions and was not aware that each inventory page required initials of pharmacist and witnesses. The DON stated she had only worked there for 3 months, and she had not obtained the destruction sheets and attached them as required by policy. The DON said she was not working at the facility when the Pharmacist did not sign the coversheet last August. The DON said she did not know that the witness had to initial each page of the destruction log along with the Pharmatist since she had never read the policy. The DON stated the risk of not accounting and destroying medications per regulation could be a drug diversion. The DON stated going forward the facility would follow the regulation and reconcile the medications with initials to each inventory sheet as required. During an interview on [DATE] at 2:43 PM the ADM stated he would make sure the policy was being
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675519
675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0755
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Some
followed and would in-service the responsible staff to see that it was done correctly. The ADM stated the risk could vary but a drug diversion could occur if medications are not destroyed and appropriately accounted for. Record review of the facility's policy and procedure titled, Drug Destruction dated 09/2018 indicated, .it is the policy of [the facility], in accordance with applicable federal and state regulations, to ensure the proper disposal of expired, discontinued, or otherwise unused medications remaining after discontinuation or a patient's discharge or death. 9. The Director of Nursing shall be responsible for attaching the pickup manifest and the proof of destruction documents from the waste disposal service company to the signed and witnessed Drug Destruction Record(s). Record review of 22 TAC §303.1 Destruction of Dispensed Drugs accessed online [DATE] at https://texreg.sos.state.tx.us/ indicated; (a) Drugs dispensed to patients in health care facilities or institutions. (1) Destruction by the consultant pharmacist. The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, is authorized to destroy dangerous drugs dispensed to patients in health care facilities or institutions. A consultant pharmacist may destroy controlled substances as allowed to do so by federal laws or rules of the Drug Enforcement Administration. Dangerous drugs may be destroyed provided the following conditions are met. (A) A written agreement exists between the facility and the consultant pharmacist. (B) The drugs are inventoried, and such inventory is verified by the consultant pharmacist. The following information shall be included on this inventory: (i) name and address of the facility or institution. (ii) name and pharmacist license number of the consultant pharmacist. (iii) date of drug destruction. (iv) date the prescription was dispensed; (v) unique identification number assigned to the prescription by the pharmacy; (vi) name of dispensing pharmacy; (vii) name, strength, and quantity of drug; (viii) signature of consultant pharmacist destroying drugs; (ix) signature of the witness(es); and (x) method of destruction.
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0755
Level of Harm - Minimal harm or potential for actual harm
C) The signature of the consultant pharmacist and witness(es) to the destruction and the method of destruction specified in subparagraph (B) of this paragraph may be on a cover sheet attached to the inventory and not on each individual inventory sheet, provided the cover sheet contains a statement indicating the number of inventory pages that are attached and each of the attached pages are initialed by the consultant pharmacist and witness(es).
Residents Affected - Some v) any two individuals working in the following capacities at the facility: (I) facility administrator; (II) director of nursing; (III) acting director of nursing; or (IV) licensed nurse.
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0761
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review the facility failed to ensure drugs and biologicals used in the facility were labeled in accordance with currently accepted professional principles in 1 (Blue Bonnet) of 2 medication storage rooms reviewed during medication room for labeling and storage. The facility did not ensure the TST (TB skin test) testing vial in the Blue Bonnet medication storage room was labeled correctly with initials, date opened and that the vial was discarded after 30 days from label date on box containing vial of 12/11/22. (Discard date 01/22/23) These failures could place residents who receive medications at risk of not receiving the intended therapeutic benefit of the medications, decreased quality of life, and hospitalization.
Findings included: During an observation and interview of the Blue Bonnet storage room on 02/08/23 at 9:00 a.m., with LVN A revealed a vial of TST expiration date 4/2024 with the box labeled opened 12/11/22 with no initals and the vial was labeled 8/22 with no initals (same lot #on box and vial) with no initials was found in the refrigerator (There was no way to verify when the vial was actually opened). LVN A said that she had worked there for 4 months and the nurses check medication rooms once a month for expired medications but they do not document that anywhere. LVN A said she did not know who opened the vial or when the TST expired after opening, maybe 2-3 months. LVN A said she was not sure when multi dose vials expired, maybe 60 days. LVN A said the vial was in current use and the vial did not have much solution left in it because they had recently had a lot of admissions. LVN A said TST is administered by the nurse on the floor to any resident needing a TB test. LVN A said using the TST after it had expired to residents could be adverse reactions, medication not as strong as it should be, and false readings. During an interview with the DON on 2/08/23 at 9:20 a.m. the DON said there was no way to verify if the vial had been opened on 8/22, as dated on the vial or opened 12/11/22 as on the box. The vial was expired either way and she would discard the remaining solution. She said she would conduct an inservice with the staff and expected going forward for expired medications not be used in the facility. The DON said it is the policy and standard of care for multi-dose vials to be discarded after 30 days and staff should put a date and initials on the vial. In-services have been done on expiration of multi dose vials and will be conducted again to ensure adherence to the policy of discarding after 30 days opened. The risk to residents could be adverse reactions, medication not as strong as it should be, and false readings. During an interview on 2/08/23 at 9:30 a.m. the Regional Nurse Consultant stated the charge nurse on the shift is responsible for administering TB tests to new residents that need it and are to check the vial for expiration and date open prior to administration. She said that the vial had expired in August 22 or on January 11, 2023, either way the vial was expired now. She said it is the policy and standard of care for multi-dose vials to be discarded after 30 days and staff should put a date and initials on the vial. In-services have been done on dating multi dose vials but will be conducted with staff again. The risk to residents could be adverse reactions, medication not as strong as it should be, and false readings. Her expectation is to in-service all nursing staff on the use by date
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0761
versus expiration date and monitor for compliance by spot checking.
Level of Harm - Minimal harm or potential for actual harm
During an interview on 2/8/2023 at 11:00 the ADM stated he does not know the process for TB testing as that is the DON's responsibility. The ADM said the TST should not be given after the use by date. He expects that staff are trained accordingly and will oversee the DON to ensure all staff are trained.
Residents Affected - Few Record review of an undated Consultant Pharmacist Services policy indicated, . 2.b. Right drug. Verify prescription dates label to MAR .note expiration dates .12.i . Date vials that are multi-dose with date opened. Record review of Tuberculin Mantoux PPD package insert states to dispose of medication 30 days after opening. Record review of https://www.fda.gov document dated 11/9/2020 reference 22. [NAME] S, et al. Effect of oxidation on the stability of tuberculin purified protein derivative (PPD) In: International Symposium on Tuberculin and BCG Vaccine. Basel: International Association of Biological Standardization, 1983. Dev Biol Stand 1986;58:545-552. (Dispose of Vial 30 days after opening)
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0868
Have the Quality Assessment and Assurance group have the required members and meet at least quarterly
Level of Harm - Minimal harm or potential for actual harm
Based on interview and record review, the facility failed to maintain a quality assessment and assurance committee consisting at a minimum the required committee members for 7 of 12 meetings (January 2022, March 2022, June 2022, August 2022, October 2022, November 2022 and December 2022) reviewed for QAPI.
Residents Affected - Some
The facility did not ensure that the medical director or designee, DON, administrator, infection preventionist and 2 other members were present at the monthly QAPI meeting. This failure could place residents at risk for quality deficiencies being unidentified, improper review of infection control program, no appropriate guidance and plans of action developed and implemented.
Findings: Record review of QAPI meeting minutes and attendees for the last 12 months indicated that 7 of 12 months the committee members did not consist of the required members per regulation. On 01/14/2022 the meeting did not consist of the DON and the infection preventionist, the 3/11/2022 meeting did not consist of the medical director or designee, the 6/10/2022 meeting did not consist of the DON and the infection preventionist, the 8/12/2022 meeting did not consist of the DON and the administrator, the 10/14/2022 meeting did not consist of the DON and the infection preventionist, the 11/11/2022 meeting did not consist of the DON and the infection preventionist, and the 12/09/2022 meeting did not consist of the medical director or designee. During an interview on 02/08/23 at 01:47 PM the DON stated that QAPI meetings are held monthly and that the DON, medical director, Infection Preventionist, and administrator must be present and she was not sure on who else needed to be present. The DON stated the risk of not having all members could be the facility not developing a full comprehensive plan for improvement. The DON stated she was new in the DON position and would review facility policies and put a plan in place to ensure everyone was aware of meeting dates and that meeting was mandatory for attendance. During an interview on 02/08/23 at 01:55 PM the RNC stated she was not sure why the required members were not present at QAPI meetings. The RNC stated it was important for the required members to be present so that there was a full review and follow through with the performance improvement plan. The RNC stated the facility would educate and in-service all members on the QAPI requirements and ensure required members are present monthly. During an interview on 02/08/23 at 02:27 PM the ED stated that he expects that all QAPI members attend the meetings. He stated going forward he would see that everyone knows when the meeting was scheduled and that each member is in attendance. Record review of facility policy and procedure titled Quality Assurance and Performance Improvement, dated February 2018 indicated, 1. The QAPI committee must include at a minimum the executive director, DON, medical director, and three staff members from both line positions and management positions. 2. The QAPI committee must meet once per month. Policy and procedure did not include infection preventionist requirement per regulation.
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0880
Provide and implement an infection prevention and control program.
Level of Harm - Minimal harm or potential for actual harm
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility did not maintain an infection prevention program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections for 1 of 6 residents reviewed for infection control. (Resident #121)
Residents Affected - Few
The facility did not ensure the Activity Director wore a N95 mask or eye protection when she entered the room of Resident #121 who was on contact precautions for COVID-19. The facility did not ensure CMA B wore a gown, gloves, N95 and eye protection when she entered the room of Resident #121 who was on contact precautions for COVID-19. These failures could place residents at risk of exposure to communicable diseases and infections.
Findings included: Record review of a face sheet for Resident # 121 dated 2/8/2023 indicated he admitted to the facility on [DATE] and was [AGE] years old with diagnoses of COVID-19, BPH (enlarged prostate), and hemiplegia (weakness/paralysis on one side of the body). Record review of an admission MDS assessment dated [DATE] for Resident #121 indicated it was created on 2/6/2022 and was in progress. Record review of a care plan dated 2/8/2023 for Resident #121 indicated he was at risk for infection, signs/symptoms of COVID-19. Status: Active (Current) with an intervention to follow facility protocol for COVID-19 screening/precautions. During an observation on 2/06/2023 at 10:08 AM, Resident #121 had a sign on his door that read to stop and see the nurse before entering with the door closed. PPE was noted outside of the door in the hallway in a container. During an observation on 2/06/2023 at 10:16 AM, the Activity Director entered the room of Resident #121 wearing gloves, gown, and a surgical mask and was not wearing a N95 mask or eye protection of a face shield or goggles. Resident #121 was not wearing any source control. The Activity Director was in the room passing out the activities monthly calendar and was standing by the over bed table. She was in the room for about 2 minutes. Resident #121 did not have any symptoms of COVID-19. She doffed (removed) PPE in the room with the door open and placed the PPE in the biohazard box in the room. During an observation and interview on 2/06/2023 at 12:35 PM, CMA B was in the room of Resident #121 who was on isolation for COVID-19. The door was open, and CMA B was observed in the room only wearing a surgical mask as she placed Resident #121's lunch tray on his over bed table. CMA B was not wearing a N95 mask, eye protection of a face shield or goggles, a gown, gloves. The DON was observed outside of the door in the hallway by the food cart. CMA B said she did not know the resident was on isolation because she worked another hall and was only over there to pass lunch trays. CMA B asked the DON why the resident was on isolation, and the DON told CMA B that Resident #121 was COVID positive. CMA B said she could get COVID-19 if she entered rooms of someone who was on isolation for CoVID-19.
675519
Page 7 of 11
675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0880
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
During an interview on 2/06/2023 at 12:39 PM, the RNC asked what happened outside of Resident #121's room and she was informed about CMA B entering the room of Resident #121 who was positive for COVID without wearing appropriate PPE and she instructed the DON to do a 1 on 1 (teaching with the instructor and1 person individually) with CMA B. During an interview on 2/08/2023 at 7:58 AM, the DON said she had been employed at the facility since October 2022. She said she in-serviced the Activity Director and CMA B along with other staff on appropriate PPE for residents in isolation for COVID-19 and proper donning (to put on) on 2/8/2023. She said she instructed them about the sign on the door of Resident #121 and the reason it was there, and they should go to the nurse and ask before entering. She said a major outbreak could occur with staff not wearing appropriate PPE when going into rooms where residents were on isolation. She said she was not aware the Activity Director was not wearing the appropriate PPE. She was aware of CMA B after she exited Resident #121's room. She said all staff that enter rooms of residents in isolation should wear the appropriate PPE and for COVID-19 should include gloves, gown, N95, and eye protection of either a face shield or goggles. She said Resident #121 was admitted to the facilty on 2/3/2023 with COVID-19. She said Resident #121 had been in isolation since 2/3/2023 on the date of admission. Record review of a facility policy titled Covid Response Testing, Exposure, and PPE dated November 20, 2022, indicated, .The facility should ensure that appropriate PPE and infection control precautions are taken to decrease the risk of transmission when dedicated staff is not possible. c. Anyone entering must wear full PPE (gowns, gloves, N95 respirator or higher and eye protection). d. It is important that all infection prevention and control protocols be followed by staff, including the donning, doffing of PPE, proper hand hygiene, cleaning and disinfecting. Record review of a facility policy titled PPE Use When Caring for Residents with COVID-19 undated indicated, .HCP should wear all suggested PPE when caring for residents with COVID-19 infection and suspected COVID-19 infection, in accordance with CDC guidance. Per the CDC, all suggested PPE includes: N95 respirator, eye protection, gloves, and gown .
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0883
Develop and implement policies and procedures for flu and pneumonia vaccinations.
Level of Harm - Minimal harm or potential for actual harm
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, and record review, the facility failed to develop and implement policies and procedures that ensure the resident's medical record included documentation that indicates the resident received education on the influenza (flu) and the pneumococcal immunizations for 4 of 4 residents reviewed for immunizations, (Resident #1, #55, #57, and #203) in that:
Residents Affected - Few
1.The facility failed to ensure Resident #1's medical record contained evidence of education on the influenza vaccine when the vaccine was declined by the resident. 2. The facility failed to ensure Resident #55's medical record contained evidence of education on the pneumococcal immunization when the vaccine was declined by the resident. 3. The facility failed to ensure Resident #55's medical record contained evidence of education on the influenza vaccine when the vaccine was administered to the resident. 4. The facility failed to ensure Resident #57's medical record contained evidence of education on the pneumococcal immunization when the vaccine was declined by the resident. 5. The facility failed to ensure Resident #203's medical record contained evidence of education on the influenza vaccine when the vaccine was declined by the resident. These failures could place residents at risk for not making informed decisions regarding vaccinations and placing them at risk of contracting a viral disease that could spread through the facility and cause respiratory complications, and potential adverse health outcomes.
Findings included: Review of a face sheet dated 02/08/23 for Resident #1 indicated he was [AGE] years old with an admission date of 1/10/23. Diagnosis included Sepsis due to bacterial infection, osteomyelitis (bone Infection), and pain. Review of a face sheet dated 02/08/23 for Resident #55 indicated she was [AGE] years old with an admission date of 6/23/22. Diagnosis included cerebral Infarction, nausea and vomiting, and diabetes (high glucose levels in the blood). Review of a face sheet dated 02/08/23 for Resident #57 indicated he was [AGE] years old with an admission date of 1/13/23. Diagnosis included fracture of femur, overactive bladder, and muscle weakness. Review of a face sheet dated 02/08/23 for Resident #203 indicated she was [AGE] years old with an admission date of 4/11/22. Diagnoses included cognitive impairment, kidney disease, and weakness. During a record review of immunizations in the electronic medical record the 4 vaccination sampled residents reflected all had no documentation of educational material provided for Flu or Pneumonia vaccine to the family or RP in the medical record for: Resident #1 No education given before acceptance or declination of flu vaccine on 01/13/23.
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675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0883
Resident #55 No education given before acceptance or declination of flu vaccine on 10/06/22 or pneumococcal vaccine on 12/02/22.
Level of Harm - Minimal harm or potential for actual harm
Resident #57 No education given before acceptance or declination of pneumococcal vaccine on 01/13/23.
Residents Affected - Few
Resident #203 No education given before acceptance or declination of flu vaccine on 10/24/22. During a Record review of an admission packet for resident or representative reflected the packet had an acknowledgment form for vaccination education but there was no education material attached. No educational material was included from the CDC as stated in policy. During a record review of an acknowledge of receipts of attachments from the admission packet for resident or resident representatives and attachments reflected a check off list for resident education containing items 1. through 38. Including: 34. Influenza (Flu) Information 35. Pneumococcal Vaccine information No Flu or Pneumonia Education was in the packet. During a record review and interview on 02/08/23 at 04:45 p.m. the admission Coordinator said she had worked at the facility since October 2022. She stated she is responsible for providing written education to the resident or the RP on admission and documentation of materials in the packet. She said the packet does not have any information or educational materials on Flu or Pneumococcal vaccine. She said she does not have and has never had the information from the CDC website outlined in the policy reviewed with this surveyor and has not given any information on vaccine to new admissions since her employment. She said she had never received education on the educational material or read the policy. During an interview on 02/08/23 at 05:00 PM the Regional Nurse Consultant, said that every resident should be getting education on Flu and Pneumonia vaccines from the CDC website. She said that she expects the admission packet to be updated with the newest information from the CDC website and all residents will receive the information as outlined in the policy. She said the risks are that the resident and family might not be able to make an informed decision concerning vaccines. She said not receiving education may result in them choosing not to get the vaccine which could result in outbreaks, infections and serious complications. During an interview on 02/08/23 at 05:05 PM the ADM said that every resident should be getting education on Flu and Pneumonia vaccines from the CDC website. She said that she expects the admission packet to be updated with the newest information from the CDC website and all residents will receive the information as outlined in the policy. The Admin said the risks are that the resident and family not receiving education may result in them choosing not to get the vaccine which could result in outbreaks, infections and serious complications. During a record review of an Infection Control Policy dated 10/2019, Vaccination of Residents reflected .
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Page 10 of 11
675519
02/08/2023
Larkspur
201 South John Redditt Drive Lufkin, TX 75904
F 0883
Level of Harm - Minimal harm or potential for actual harm
Policy Statement: All residents will be offered vaccines that aid in preventing infectious diseases unless the vaccine is medically contraindicated, or the residents has already been vaccinated .Policy interpretation and Implementation: 1.
Residents Affected - Few Prior to receiving vaccinations, the resident or legal representative will be provided information and education regarding the benefits and potential side effects of the vaccinations. (See current vaccination information statements at https://www.cdc.gov/vaccines/hcp/vis/index.html for educational materials.) 2. Provision of such education shall be documented in the resident's medical record. During a record review of a Nursing Services Policy and Procedure Manual for Long Term Care-Pneumococcal Vaccine Policy Revision October 2019 Infection Control Policy Statement reflected: All residents will be offered pneumococcal vaccines to aid in preventing pneumonia/pneumococcal infections. Policy Interpretation and Implementation . 2. Assessments of pneumococcal vaccination status will be conducted within 5 working days of the resident's admission. 3. Before receiving a pneumococcal vaccine, the resident or legal representative shall receive information and education regarding the benefits and potential side effects of the pneumococcal vaccine. (See current vaccination statements at (https://www.cdc.gov/vaccines/hcp/vis/index.html for educational materials) for educational materials.) Provision of such education shall be documented in the resident's medical record.
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