Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on January 31, 2022 through February 1, 2022, Harbison Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on January 31, 2022 through February 1, 2022, Harbison Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS
Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on review of facility policy, patient treatment area observations, and an interview with the staff, it was determined the facility failed to follow its policy to ensure clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials for one (1) of seven (7) observations conducted (OBS #1).
Findings include:
A review of facility policy, 1-06-01, "Medication Policy," revealed the following: "Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured).... Each vial is labeled with the initials of the person opening the vial and the expiration date."
The CDC (Centers for Disease and Control) (https://www.cdc.gov/injection safety/providers/provider_faqs_multivials.html) website states the following: "The United States Pharmacopeia (USP) General Chapter 797 [16 ] recommends the following for multi-dose vials of sterile pharmaceuticals: "If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."
Observations conducted in the patient treatment area on January 31, 2022 between approximately 10:05 AM and 1:00 PM revealed the following:
OBS #1: Medication vials stored in medication refrigerator at nurses' station included an opened vial of Epogen 20,000 units/2 mL, expiration date 8/23 - no label as to date it was opened, or initials of staff that had opened it; an opened vial of Hectorol 4 mcg/2 mL, expiration date 6/23 - no label as to date it was opened, or initials of staff that had opened it.
An interview with the covering facility administrator, manager of clinical services, regional operations director, biomedical technician, and biomedical operations manager on February 1, 2022 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for the Registered Nurse (RN) on 2/06/2022. Using the surveyor observations, education included a review of Medication Policy 1-06-01 emphasizing that Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations and that each vial is labeled with the initials of the person opening the vial and the expiration date. The in-service was documented on an in-service sign-in sheet. The facility administrator or designee will conduct a weekly audit for four (4) weeks and then monthly during the Medication Administration portion of the DaVita Monthly Infection Control Audit to verify compliance. The Facility Administrator will address instances of noncompliance immediately and will share results of the audit with the Nurse during homeroom meetings and with the Medical Director during Quality Improvement and Monthly Performance Improvement meetings known as Facility Health Meetings with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on review of facility policies and procedures, medical records (MR), dialysis treatment documentation, and an interview with the staff, the facility did not follow its policy for reporting and documentation of abnormal findings pre, post, and during dialysis for one (1) of (5) medical records reviewed (MR #3).
Findings include:
A review of policy, 1-03-08, "Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment," included the following: "Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately.... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary.....If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge....In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient's condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings." Under the subtitle, "Abnormal Findings,": "Blood pressure: Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg... Blood pressure Intra-Dialytic: Difference of 20 mm/Hg increase or decrease from patient's last intradialytic treatment BP reading.....Blood pressure Post Treatment: If the patient can stand: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg; standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg....... Heart or Pulse Rate Pre/Intra/Post: less than 60 beats per minute or greater than 100 beats per minute an/or an irregular heart beat...... Pre/Intra/Post Patient Reports/Complaints and/or teammate observation of: .... cramping...."
A review of medical records and dialysis treatment records conducted on February 1, 2022 between approximately 11:30 AM and 2:15 PM revealed the following:
MR #1, Start of Care: 10/1/2021, Dialysis treatment orders from 12/132021: Target Weight: 90 kg; Frequency: Monday-Wednesday-Friday; Dialyzer: Gambro Revaclear 300; Dialysate: 2 K Ca 2.5 Na 134; Blood Flow Rate (BFR): 450; Dialysate Flow Rate (DFR): 600 mL/min; Treatment Duration: 4 hours.
Treatment record for 12/13/2021:
06:32 AM, Pre-treatment: Blood pressure sit: 183/100, Blood pressure stand: 150/91, Pulse: 75, Weight: 95.5 kg.
06:32 AM BP 159/102, pulse 65, "Treatment initiated 200 mL normal saline prime given" documented by Patient Care Technician (PCT).
06:33 AM BP 175/105, pulse 68, "Cannulated without difficulty" documented by PCT.
07:01 AM 161/94, pulse 59, "No complaints" documented by PCT.
07:31 AM BP 176/111, pulse 66, "No complaints" documented by PCT.
08:01 AM BP 155/109, pulse 64, "Eyes closed, resting comfortably" documented by RN.
08:31 AM BP 150/105, pulse 65, "Eyes closed, resting comfortably" documented by PCT.
09:01 AM BP 164/113, pulse 62, "No complaints" documented by PCT.
09:31 AM BP 118/85, pulse 69, "No complaints" documented by PCT.
10:01 AM 133/94, pulse 65, "Patient watching television" documented by PCT.
10:31 AM 150/89, pulse 49, "Pt c/o cramping; pt requested to turn UF off" documented by PCT.
10:33 AM 128/79, pulse 65, "Treatment terminated, with 250 mL normal saline rinse back" documented by PCT.
No follow-up note addressing abnormal blood pressures from RN after PCT documentation, decrease in blood pressure at 9:31 AM in which a difference greater than 20 mm/Hg from last intradialytic blood pressure was noted, drop in pulse rate at 7:01 AM and 10:31 AM, or post-assessment from RN addressing diastolic blood pressures greater than 90 mm/Hg, or patient's complaint of cramping.
Treatment record for 12/15/2021:
06:47 AM, Pre-treatment: Blood pressure sit: 135/94, Blood pressure stand: 165/112, Pulse: 78, Weight: 94.1 kg.
06:47 AM BP 135/94, pulse 74, "Treatment initiated, 200 mL normal saline prime given" documented by PCT.
06:54 AM BP 159/110, pulse 71, "Cannulated without difficulty" documented by PCT.
07:03 AM BP 144/94, pulse 65, "No complaints" documented by PCT.
07:31 AM BP 151/98, pulse 67, "No complaints" documented by PCT.
08:01 AM BP 153/107, pulse 57, "No complaints" documented by RN.
08:31 AM BP 161/117, pulse 69, "Patient watching television" documented by RN.
09:01 AM BP 171/114, pulse 64, "Patient watching television" documented by PCT.
09:31 AM BP 180/107, pulse 49, "Pt c/o cramping; pt requested to turn UF off" documented by PCT.
10:01 AM BP 153/119, pulse 56, "No complaints" documented by PCT.
10:31 AM BP 117/94, pulse 54, "No complaints" documented by PCT.
10:52 AM BP 151/101, pulse 71, "Treatment terminated, with 250 mL normal saline rinse back" documented by PCT.
10:52 AM, Post-treatment: Blood pressure sit: 158/95, Blood pressure stand: 117/101, Pulse: 58, Weight: 90.2 kg.
No follow-up note addressing abnormal blood pressures from RN after PCT documentation, decrease in blood pressure at 10:31 AM in which a difference greater than 20 mm/Hg from last intradialytic blood pressure was noted, drop in pulse rate at 8:01 AM, 9:31 AM, 10:01 AM and 10:31 AM, or post-assessment from RN addressing diastolic blood pressures greater than 90 mm/Hg, patient's complaint of cramping, or post-treatment vital signs.
Treatment record for 12/20/2021:
08:01 AM, BP 170/110, "Eyes closed, resting comfortably" documented by RN.
08:31 AM, BP 167/115, "Eyes closed, resting comfortably" documented by PCT.
09:01 AM, BP 165/108, "Patient watching television" documented by PCT.
09:31 AM, BP 182/114, "Patient watching television" documented by PCT.
10:01 AM, BP 171/105, "CO cramping; patient requested to turn UF off" documented by PCT.
10:31 AM, BP 190/114, "No complaints" documented by PCT.
10:44 AM, BP 158/106, "Treatment terminated, with 250 mL normal saline rinse back" documented by PCT.
10:44 AM, Post-treatment: Blood pressure sit: 158/111, Blood pressure stand: 147/83.
No follow-up note addressing abnormal blood pressures from RN after PCT documentation, or post-assessment from RN addressing diastolic blood pressures greater than 90 mm/Hg, patient's complaint of cramping, or post-treatment vital signs.
An interview with the covering facility administrator, manager of clinical services, regional operations director, biomedical technician, and biomedical operations manager on February 1, 2022 at approximately 3:15 PM confirmed the above findings.
Plan of Correction:The Facility Administrator or designee will hold mandatory in-service(s) for all Clinical Teammates by 2/11/2022 on Policy 1-03-08 Pre-Intra-Post treatment Data Collection Monitoring and Nursing Assessment. Using the surveyor's observations, education will include but not be limited to: 1) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient's condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. 2) Abnormal findings that must be reported to the nurse and documented are as follows: "Blood pressure: Pre dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg... Blood pressure Intra-Dialytic: Difference of 20 mm/Hg increase or decrease from patient's last intradialytic treatment BP reading.....Blood pressure Post Treatment: If the patient can stand: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg; standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg....... Heart or Pulse Rate Pre/Intra/Post: less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat... Pre-Intra-Post Patient Reports/Complaints and/or teammate observation of: ... cramping... The in-service will also introduce a new laminated chairside tool that condenses the abnormal findings into three short lists pre-treatment, during treatment, and post-treatment parameters to be used as both a reminder and a quick reference of abnormal findings stated in the policy. Verification of attendance at the in-service will be evidenced by teammate's signature on in-service sheet. The Facility administrator or designee will audit twenty-five percent (25%) flowsheets weekly for four (4) weeks and then ten percent (10%) monthly during facility chart audits to verify compliance and will review the results in homeroom meetings with the clinical team. Results will also be reviewed with the Medical Director monthly during Facility Health Meetings with supporting documentation in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.
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