Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed on September 16, 2021, Leola Dialysis was determined to be in substantial compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
494.62(b)(9) STANDARD
Dialysis Emergency Equipment
Name - Component - 00
§494.62(b)(9) Condition for Coverage:
[(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:]
(9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.
Observations:
Based upon a review of facility policy, treatment area observations, and an interview with the Group Facility Administrator, facility failed to ensure the Emergency Equipment Checklist weekly checks were conducted, per policy, for one (1) of one (1) observations (Observation #1).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m. Policy 1-02-08 'Emergency Equipment Checks' 'Policy' (3) states "The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: 'Weekly' Oxygen supply is adequate (At least one tank is either on or next to the emergency cart), Airways are available, Suction is available, AED is operational ......, Artificial resuscitator (ambu bag) is operational, Emergency cart (crash cart) is clean, operational and supplies/medications have not expired." (4) "The attached checklist may be used for documentation of emergency equipment checks." (5) The emergency checklist will be developed by the facility ....and will be used to verify that the cart has been checked."
Observations conducted in patient treatment area on 09/13/21 between approximately 7:45 a.m.-12:20 p.m. and on 09/15/21 between approximately 1:35 p.m.-2:20 p.m. revealed the following:
Observation #1: On September 13, 2021 at approximately 10:35 a.m. the Emergency Cart checklist was reviewed within the time frame of 01/04/21-09/13/21.
No documentation of weekly checks being conducted, per policy, from 01/25/21-04/30/21.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The Facility Administrator (FA) or designee will provide in-services starting on 9/28/21 for all licensed nurse teammates on policy 1-02-08 'Emergency Equipment Check's focusing on step 3: emergency equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional. Weekly: Oxygen supply is adequate, airways are available, suction is available, AED is operational, artificial resuscitator (ambu bag) is operational and supplies/medication have not expired. Step 4: checklist may be used for documentation of emergency equipment checks. Step 5: the emergency checklist will used to verify that the cart has been checked. A licensed nurse teammate will utilize the emergency checklist to verify that the cart has been checked and will sign off on checklist weekly. Verification of attendance will be evidenced by teammate signature on in-service sheet. The FA or designee will audit the emergency checklist weekly for four (4) weeks, then monthly for two (2) months. Instances of non-compliance will be addressed immediately. Results of the audits will be reviewed with teammates during homeroom meetings and with the Medical Director at Facility Health Meetings (FHM-QAPI) with the supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed on September 16, 2021, Leola Dialysis was determined to be in substantial compliance with 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:
494.20 STANDARD
COMPLIANCE WITH FED/STATE/LOCAL LAWS
Name - Component - 00
The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.
Observations:
Based on review of facility COVID-19 Response guidelines and an interview with the Group Facility Administrator, facility failed to ensure staff followed established guidelines for COVID-19 patient screening for one (1) of one (1) Entrance Evaluation Tracker Log (EETL) reviews (EETL #1).
Findings:
A review was conducted of facility policy/procedure on September 17, 2021 at approximately 3:50 p.m. 'COVID-19 Response' 'Entrance Evaluation Tracker (All Modalities) ("Current guidance as of August 23, 2021, subject to change") states "File completed Trackers in your COVID-19 binder." "Evaluate 100% of people entering your facility in a timely manner."
Review of facility EETL documentation conducted on September 14, 2021 at approximately 10:00 a.m. revealed the following:
EETL #1: On September 14, 2021 at approximately 10:00 a.m. the EETL was reviewed from 08/02/21-09/14/21.
On 08/02/21, no documentation provided of Employee #6 nor Employee#8 being evaluated for COVID-19 upon entering the facility.
On 08/04/21, no documentation provided of Employee #10 being evaluated for COVID-19 upon entering the facility.
On 08/05/21, no documentation provided of Employee #8 being evaluated for COVID-19 upon entering the facility.
On 08/11/21, no documentation provided of Employee #7 being evaluated for COVID-19 upon entering the facility.
On 08/18/21, no documentation provided of Employee #6, Employee #7, nor Employee #10 being evaluated for COVID-19 upon entering the facility.
On 08/25/21, no documentation provided of Employee #6 being evaluated for COVID-19 upon entering the facility.
On 09/01/21, no documentation provided of Employee #7 being evaluated for COVID-19 upon entering the facility.
On 09/08/21, no documentation provided of Employee #7 being evaluated for COVID-19 upon entering the facility.
On 09/13/21, no documentation provided of Employee #7 nor Employee #8 being evaluated for COVID-19 upon entering the facility.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will provide in-services starting on 9/28/21 for all clinical teammates regarding proper COVID-19 Entrance Evaluation Tracker screening per the DaVita COVID-19 playbook. 100% of teammates will wear a mask to come into the building and change to a clean mask for a timely entrance screening. Teammates will not screen themselves, they will have another teammate take their temperature and ask COVID-19 screening questions for verification. The first teammate that arrives at the facility may screen themselves. The facility will utilize the most up to date COVID-19 screening tracker with no prefilled names on screening sheets. All patient and teammate names will be written in real time and there will be no blanks. Any "Yes" answer on the screening form will have an advanced screening by a licensed nurse with appropriate follow up. Teammates will be screened on all days present in the facility whether patients or other teammates are present or not. Teammates entering the facility in the rear of the building will screen as they enter the rear of the building. A screening station with hand sanitizer, masks, thermometer and an entrance screener tracker will be placed at the rear entrance for teammates who do not use the front entrance. All persons entering the facility will be screened. Verification on attendance at in-service will be evidenced by teammates signature on the in-service sheet. The FA or designee will audit 100% of COVID-19 tracker daily for one (1) month, weekly for three (3) months, and monthly moving forward. Instances of non-compliance will be addressed immediately. Results of the audits will be reviewed with teammates during homeroom meetings and with the Medical Director at FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on review of facility policy/procedure, observations, and an interview with the Group Facility Administrator, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for three (3) of three (3) treatment area observations (Observation #1-Observation #3).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m.
Policy:1-05-01 'Infection Control for Dialysis Facilities' 'Teammate /Patient Safety' section (16) states "...PPE (personal protective equipment) is to be removed prior to leaving the treatment area. PPE is not to be worn in non-treatment areas ....teammate lounge...." Section (28) "Patients are not to share food or drinks with teammates......."
Policy 1-04-02B 'Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure' 'Notes' states "Use dialysis precautions and aseptic technique throughout procedure."
Observations conducted in patient treatment area on 09/13/21 between approximately 7:45 a.m.-12:20 p.m. and on 09/15/21 between approximately 1:35 p.m.-2:20 p.m. revealed the following:
Observation #1: During observations in the treatment area on 09/13/21 at approximately 12:00 p.m., Employee #3 did not remove her gloves and perform hand hygiene prior to exiting the treatment area into the rear hallway. Upon return to the treatment area Employee #3 was observed carrying a bag and taking the bag to station #9 where a patient was being treated. Employee #3 stated to the surveyor "I went to the staff lounge to get the patient's lunch."
Observation #2: During observation (2 of 2) of 'Access of AV fistula or Graft for Initiation of Dialysis' on September 15, 2021 at approximately 9:10 a.m., station #10, patient #7, Employee #1; Employee #1 did not remove gloves/perform hand hygiene/donn clean gloves after washing skin over access/evaluating access site and prior to applying antiseptic to skin over cannulation sites.
Observation #3: During observation (1 of 2) of 'Discontinuation of Dialysis with Central Venous Catheter' on September 15, 2021 at approximately 1:35 a.m., station #8, patient #6, Employee #3; Employee #3 was observed working on the computer and then proceeding to disconnect the patients venous bloodline without first performing hand hygiene/donning clean gloves.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will hold mandatory in-services starting on 9/28/21 for all teammates including a review of Policy 1-05-01 Infection Control for Dialysis Facilities focusing on section 16 PPE (personal protective equipment) is to be removed prior to leaving the treatment area. PPE is not to be worn in non-treatment areas. Section 28 Patients are not to share food or drinks with teammates. Additional focus on but not limited to: 1) Teammates will wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. 2) Teammates will remove gloves and perform hand hygiene between each patient and/or station and between clean and dirty tasks. 3) Teammates will remove gloves and perform hand hygiene before entering clean supply cart. 4) Teammates will perform hand hygiene every time gloves are removed. 5) Teammates will remove gloves and perform hand hygiene prior to exiting the treatment area. Upon returning to the treatment area, teammates will perform hand hygiene and don new gloves. Verification on attendance at in-service will be evidenced by teammates signature on the in-service sheet. The FA or designee will conduct infection control audits daily for (2) weeks then weekly for (2) weeks then monthly during internal infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA or designee will review results of the audits with teammates during homeroom meetings and with the Medical Director at FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for compliance with this 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 upon a review of facility policy, treatment area observations, and an interview with the Group Facility Administrator, facility failed to ensure expired items were discarded for one (1) of one (1) observations (Observation #1).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m. Policy 1-06-01 'Medication Policy' section (30) states "All medications in the facility are checked monthly. ....All medication are checked monthly for expiration dates."
Observations conducted in patient treatment area on 09/13/21 between approximately 7:45 a.m.-12:20 p.m. and on 09/15/21 between approximately 1:35 p.m.-2:20 p.m. revealed the following:
Observation #1: On September 13, 2021 at approximately 10:55 a.m. the following expired items were observed in the treatment area medication supply:
Eight (8) Pneumovax 23 single dose vials (0.5 ml) expired August 30, 2021.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will hold in-services starting on 9/28/21 for all licensed nurse teammates. Education will include a review of Policy 1-06-01 Medication Policy focusing on Step 30, all medication in the facility are checked monthly for expiration dates. Medications that are beyond their expiration date will be disposed of immediately in an appropriate manner. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet. The FA or designee will conduct observational audits for medication preparation and administration daily for (2) weeks then weekly for (2) weeks then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The FA or designee will review results of the audits with teammates during homeroom meetings and with the Medical Director at FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE
Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children
I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.
II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.
Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.
VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].
Observations:
Based upon a review of facility policy, treatment area observations, and an interview with the Group Facility Administrator, facility failed to ensure staff maintained aseptic technique for the care of all vascular accesses, including intravascular catheters, for two (2) of two (2) observations (Observation #1, Observation #2).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m. Policy 1-04-02B 'Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure' 'Notes' states "Use dialysis precautions and aseptic technique throughout procedure." 'Procedure' section (8) states "...clean exit site with ...alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a back and forth pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab."
Observations conducted in patient treatment area on 09/13/21 between approximately 7:45 a.m.-12:20 p.m. and on 09/15/21 between approximately 1:35 p.m.-2:20 p.m. revealed the following:
Observation #1: During observation (1 of 2) of 'Central Venous Catheter Exit Site Care' on September 13, 2021 at approximately 9:35 a.m., station #8, patient #6, Employee #2; Employee #2 cleansed area around the CVC exit site, starting from the insertion site and moving outward, then back towards the insertion site again with the same alcohol swab.
Observation #2: During observation (1 of 2) of 'Initiation of Dialysis with Central Venous Catheter' on September 13, 2021 at approximately 9:35 a.m., station #8, patient #6, Employee #2; Employee #2 disinfected the patients CVC hubs with antiseptic, left hubs exposed before attaching sterile syringes to each port and turned to work on the computer. During this time the patient lifted his right arm up to his face and adjusted his face mask. Patients right arm made contact with the exposed CVC hubs. CVC hubs were not disinfected again prior to attaching sterile syringes to each port.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will educate all clinical teammates starting on 9/28/21. Education will include a review of Policy 1-04-02B Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure specifically: 1) step #8, focusing on cleaning CVC exit site with 2% Chlorhexidine Gluconate 70% Isopropyl alcohol swab for a minimum of 30 seconds in a back and forth pattern from the insertion site to the periphery using both side of the swab. 2) Step #16-17 focusing on disinfecting each CVC hub with new alcohol prep pad for 15 seconds, hold the limbs until the antiseptic has dried and attach sterile
review of Policy 1-01-09 Prescribed Treatment Time Not Met focusing on: 1) step A #1, The RN will verify that a patient signs the early termination of treatment against medical advice for any time the patient requests to terminate their treatment earlier than the prescribed run time. 2) Step B #3, RN or PCT will document in the medical record/chairside Snappy amount of time shortened, why 10 ml syringes to the arterial and venous limbs. Verification of attendance will be evidenced by teammate signature on the in-service sheet. The FA or designee will audit daily for one (1) week and weekly for four (4) weeks then monthly during infection control audits to verify compliance. Instances of non-compliance will be addressed immediately. The results of the audits will be re viewed with the teammates during homeroom meeting and the with the Medical Director at the FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for the compliance with this plan of correction.
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based upon a review of facility policy, treatment area observations, and an interview with the Group Facility Administrator, facility failed to ensure staff maintained a safe environment for one (1) of one (1) observations (Observation #1).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m. Policy 8-04-01 'Physical Environment' section (9) states "....Access to patient treatment areas, water treatment systems, supply storage, and dialysis equipment is restricted to authorized personnel only."
Observations conducted in supply room area on 09/13/21 at approximately 7:55 a.m. revealed the following:
Observation #1: During the initial tour of the facility upon entry on the first day of the survey, the supply room entry/exit door in the rear of the facility was observed to be not completely latched and could be pushed open without the use of the doors security push bar.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will educate all facility teammates starting on 9/28/21. Education will include a review of Policy 8-04-01 Physical Environment emphasizing that access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only. Verification of attendance will be evidenced by teammate signature on the in-service sheet. The FA or designee will perform audits daily for one (1) week then weekly for four (4) weeks then monthly for two (2) months to verify compliance. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the teammates during homeroom meeting and the with the Medical Director at the FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for the 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 policy, medical records, patient treatment flow sheets, and an interview with the Group Facility Administrator, the facility failed to ensure the staff followed facility procedure for early termination of treatment for two (2) of five (5) medical records (MR) reviewed (MR#3, MR#5).
Findings include:
A review was conducted of facility policy/procedure on September 20, 2021 at approximately 4:00 p.m. Policy: 1-01-09 'Prescribed Treatment Time Not Met' section (A) (1) states "The RN will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time."
A review of medical records conducted on September 15, 2021 between approximately 12:30 p.m.-2:30 p.m. and on September 16, 2021 between approximately 10:00 a.m.-11:30 a.m. revealed the following:
MR#3 Date of Admission 08/06/21: Physician orders for Hemodialysis dated 08/11/21, 'In-Center Hemodialysis, Mo/We/Fri' (Monday/Wednesday/Friday), 'Tx (treatment) Time': "240" (minutes).
On 09/03/21, patient treatment flow sheet section: 'Duration' "214" (minutes). No comments in 'Notes' section nor 'Vitals' section as to why the treatment was terminated early. No documentation of the AMA Form being signed.
MR#5 Date of Admission 11/22/19: Physician orders for Hemodialysis dated 09/01/21, 'In-Center Hemodialysis, Mo/We/Fri' (Monday/Wednesday/Friday), 'Tx (treatment) Time': "240" (minutes).
On 09/10/21, patient treatment flow sheet section: 'Duration' "210" (minutes). 'Vitals' section '*Reason prescription treatment time not met: "Patient choice ..." No documentation of the AMA Form being signed.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will educate all clinical teammates starting on 09/28/21. Education will include a treatment shortened, if patient's nephrologist was notified and a description of all other interventions planned to address shortened treatment and a copy of the early termination of treatment against medical advice form signed by patient, if shortened voluntarily by patient will be placed in the medical records. Verification of attendance will be evidenced by teammate signature on the in-service sheet. The FA or designee will audit three (3) patient flowsheets on each shift daily for two (2) weeks and weekly for four (4) weeks then on ten percent (10%) monthly during medical records audits. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the teammates during homeroom meeting and the with the Medical Director at the FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for the compliance with this plan of correction.
494.90(a)(5) STANDARD
POC-VA MONITOR/PREVENT FAILURE/STENOSIS
Name - Component - 00
The patient's vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis.
Observations:
Based upon a review of facility policy, treatment area observations, and an interview with the Group Facility Administrator, facility failed to ensure patient's vascular access was monitored for two (2) of two (2) observations (Observation #1-#2).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m. Policy 1-04-01 'Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care' section (17) states "Cannulation sites and blood tubing connections......, and remain visible throughout the treatment."
Observations conducted in patient treatment area on 09/13/21 between approximately 7:45 a.m.-12:20 p.m. and on 09/15/21 between approximately 1:35 p.m.-2:20 p.m. revealed the following:
Observation #1: On September 13, 2021 at approximately 7:45 a.m., station #6, patient #4 access site was not visible and was covered with a blanket. At approximately 8:10 a.m. the patients access site was not visible and was covered with a blanket. The patients treatment flowsheet was reviewed and there were no entries in the 'Notes' section of staff educating patient on the importance of keeping access site uncovered.
Observation #2: On September 13, 2021 at approximately 8:00 a.m., station #8, patient #8 access site was not visible and was covered with a blanket. At approximately 8:35 a.m. the patients access site was not visible and was covered with a blanket. The patients treatment flowsheet was reviewed and there were no entries in the 'Notes' section of staff educating patient on the importance of keeping access site uncovered.
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will educate all clinical teammates starting on 09/28/21. Education will include a review of Policy 1-04-01 Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care focusing on step #17. Cannulation sites and blood tubing connections must remain visible throughout the treatment. If access and/or blood tubing connections are covered, teammates will uncover, educate the patient and document in the patient medical record. Verification of attendance will be evidenced by teammate signature on the in-service sheet. All patients will be re-educated on the importance of keeping access site and blood connections visible at all times during the dialysis treatment as evidenced by signed education form placed in the medical records. The FA or designee will audit daily all patients on all shifts for two (2) weeks then weekly on random shift for four (4) weeks then monthly for two (2) months. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the teammates during homeroom meeting and the with the Medical Director at the Facility Health Meetings (FHM-QAPI) with the supporting documentation included in the meeting minutes. The FA is responsible for the compliance with this plan of correction.
494.90(a)(6) STANDARD
POC-P/S COUNSELING/REFERRALS/HRQOL TOOL
Name - Component - 00
The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis.
Observations:
Based on review of facility policy, review of medical records, and an interview with the Group Facility Administrator, the facility failed to ensure that the standardized mental and physical assessment tool (KDQOL-36) (kidney disease and quality of life) was administered within the first four (4) months of initiating treatment and repeated at least annually for two (2) of five (5) in-center hemodialysis patient medical records (MRs) reviewed (MR#2, MR#5).
Findings:
A review was conducted of facility policy/procedure on September 17, 2021 at approximately 3:50 p.m. Policy 3-01-10 'Quality of Life Assessment Survey' 'policy' section 1 states " The Quality of Life (QOL) assessment survey is to be administered by the Social Worker to patients within the first four (4) months of initiating treatment, on an as needed basis, and repeated at least annually thereafter". Section 2 states "If a patient refuses to complete the KDQOL-36 at any time, the Social Worker needs to have the patient sign the Refusal of Permission to Survey to document the refusal".
A review of medical records conducted on September 15, 2021 between approximately 12:30 p.m.-2:30 p.m. and on September 16, 2021 between approximately 10:00 a.m.-11:30 a.m. revealed the following:
MR#2 Date of admission 11/20/20: Documentation of the KDQOL-36 being administered. No complete dates were listed on the forms, only "2020" and "2021".
MR#5 Date of admission 11/22/19: Documentation of the KDQOL-36 being administered. No complete dates were listed on the forms, only "2020" and "2021".
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will hold in-services for all clinical teammates and Social Worker starting on 09/28/21. Education will include a review of policy 3-01-10 Quality of Life Assessment survey emphasizing the Quality of Life assessment survey is to be administered by the Social Worker to patients within the first four (4) months of initiating treatment, on an as needed basis, and repeated at least annually thereafter. If the patient refuses to complete survey at any time, the Social Worker needs to have the patient sign the Refusal of Permission to Survey to document the refusal. The documents must have full date (month, date and year). The FA or designee will audit all KDQOL's monthly for three (3) months then ten percent (10%) monthly during medical records audits to verify compliance. Instances of non-compliance will be addressed immediately. The FA or designee will review results of the audits with teammates during homeroom meetings and with the Medical Director at FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on review of facility policy, review of medical records, and an interview with the Group Facility Administrator, the facility failed to ensure medication/treatment was administered as prescribed by physician for three (3) of five (5) in-center hemodialysis patient medical records reviewed (MR#1-MR#3); failed to ensure the Dialysis Delivery System Disinfect Log was completed, per policy, for one (1) of one (1) disinfection logs reviewed (Disinfection Log #1); failed to ensure the Patient Grievance Log was completed, per policy, for one (1) of one (1) patient grievance logs reviewed (Patient Grievance Log #1); and failed to ensure employees were screened for TB prior to hire for one (1) of three (3) employee files (EF) reviewed (EF#3).
Findings include:
A review was conducted of facility policy/procedure on September 16, 2021, at approximately 12:00 p.m.
Policy 3-02-03 'Physician Orders for Patient Care' 'Purpose' states "To verify that orders are ..... and implemented in a timely manner for patient care ...." Policy 1-06-01 'Medication Policy' section (9) states "Medications are administered as prescribed.....". Section (36) states "All medication errors are reported to the Facility Administrator/designee. She/He will then notify the patients physician of the event .... Physician will be notified of any medication errors prior to patient leaving the facility. Examples of medication errors include: ...Administration of an incorrect dosage of an ordered medication. ...A prescribed medication not administered to the patient."
A review of medical records conducted on September 15, 2021 between approximately 12:30 p.m.-2:30 p.m. and on September 16, 2021 between approximately 10:00 a.m.-11:30 a.m. revealed the following:
MR#1 Date of admission 03/04/19: Physician 'Ancillary Orders' dated 03/08/19 Blood Glucose Testing 1 each 3xqw (3 times every week, Monday /Wednesday/Friday).
Patient treatment flowsheet dated 09/08/21 'Medications and Ancillaries Administered' 'Blood Glucose Testing (In House)-Result: 0. 'Status' "Not given'. 'Reason not given:' "Missed." The physician ordered Blood Glucose Testing was not administered as ordered.
MR#2 Date of admission 11/20/20: Physician treatment time dated 08/16/21 ordered "240 minutes (4 hours). Physician 'Medication Orders' dated 08/16/21 'Heparin' "Load: 2000 Units", "Hourly Dose: 600 Units/Hr (hour)", "Stop: 0 minutes before the end of dialysis" (2400 units).
Patient treatment flowsheet dated 09/03/21 'Medications and Ancillaries Administered' "Heparin Pork Bolus 2000 units IVP "Given". Heparin Pork Bolus/Infusion 0 Units PM "Not Given". 'Reason not given' "Missed." The physician ordered 2400 Units total Heparin infusion dose was not administered as ordered. No documentation of medication error being reported to the Facility Administrator/designee and the patients physician being notified, per policy.
MR#3 Date of admission 08/06/21: Physician treatment time dated 09/06/21 ordered "240 minutes (4 hours). Physician 'Medication Orders' dated 09/06/21 'Heparin' "Load: 2000 Units", "Hourly Dose: 600 Units/Hr (hour)", "Stop: 60 minutes before the end of dialysis" (1800 units).
Patient treatment flowsheet dated 09/10/21 'Medications and Ancillaries Administered' "Heparin Pork Bolus 2000 units IVP "Given". Heparin Pork Bolus/Infusion 1400 Units PM "Given". The physician ordered 2400 Units total Heparin infusion dose was not administered as ordered. No documentation of medication error being reported to the Facility Administrator/designee and the patients physician being notified, per policy.
Policy 2-02-08 ' B Braun Dialog Dialysis Delivery System Cleaning and Disinfection Policy' '(4) Notes' states "All dialysis delivery systems ...are required to be disinfected at no more then the 72 hour interval. A dialysis delivery system that has not been disinfected within the 72 hour interval must be disinfected prior to the patient use." (6) states "Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log.... Cleaning and disinfection of dialysis delivery systems will be documented on this log."
A review was conducted of the facility Dialysis Delivery System Clean and Disinfection logs dated January 2021-August 2021 on September 16, 2021 at approximately 12:00 p.m. revealed the following:
Disinfection Log #1:
On 01/29/21 the Dialysis Delivery System Clean and Disinfection log for machine #4, #5, #8-#11, #15 was blank with no entries. Per the Group Facility Administrator on 09/16/21 at approximately 12:30 p.m. the machines were in use.
On 06/23/21 the Dialysis Delivery System Clean and Disinfection log for machine #1, #2, #7,#13, the pH section was not recorded and was left blank. The machines were marked "In use."
On 08/16/21 the Dialysis Delivery System Clean and Disinfection log for machine #9, #10, the Descale section was not circled. The machines were marked "In use."
Policy 3-01-06A 'Addressing Patient Grievances: Davita Teammate' 'Policy' (2) states "Complaints/Grievances should be documented on the facility Patient Grievance Log."
The facility Patient Grievance Log was requested for review on 09/13/21. A review conducted of the facility Patient Grievance Log at approximately 12:00 p.m. revealed the following:
Patient Grievance Log #1: The Log contained (4) entries with dates ranging from 09/10/18-12/23/20. The ESRD Network facility report was reviewed on 09/15/21 at approximately 10:00 a.m. The report section 'Have there been patterns of patient complaints about the facility? If yes, describe any patterns identified.' This section included a complaint involving MR#8.
No entries were in the facility Patient Grievance Log for MR#8, per policy.
Policy: 4-06-05 'Tuberculosis Monitoring and Follow-Up' "Baseline new hire requirements for all teammates ...... teammates will complete the following: (c) If exemption criteria for TST is not met, the following testing options are available: (1) Baseline TST (tuberculin skin test) using a two step ....(purified protein derivative)......"
EF#3 Date of hire 04/12/21: Documentation provided of EF#3 receiving a two-step TST on 09/01/21 and 09/08/21. (141 days after hire).
An interview with the Group Facility Administrator on September 16, 2021 at approximately 1:00 p.m. confirmed the above findings.
Plan of Correction:The FA or designee will educate all clinical teammates starting on 09/28/21. Education will include a review of: 1) Policy 3-02-03 Physician Orders for Patient Care focusing on emphasizing the purpose of policy is to verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care. 2) Policy 1-06-01 Medication Policy emphasizing all medications are administered as prescribed. All medication not administered as prescribed is consider a medication error and will be reported to the FA or designee. She/He will then notify the patient's physician of the event prior to the patient leaving the facility. Verification of attendance will be evidenced by teammate signature on the in-service sheet. The FA or designee will audit daily three (3) treatment flowsheets on each shift for one (1) week then weekly for four (4) weeks then on ten percent (10%) of the census during monthly medical record audits to verify compliance. The results of the audits will be re viewed with the teammates during homeroom meeting and the with the Medical Director at the FHM-QAPI with the supporting documentation included in the meeting minutes. The FA is responsible for the compliance with this plan of correction.
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