QA Investigation Results

Pennsylvania Department of Health
PDI - EPHRATA
Health Inspection Results
PDI - EPHRATA
Health Inspection Results For:


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Initial Comments:

Based upon the findings of an unannounced onsite Medicare recertification survey conducted on September 11, 2023 through September 14, 2023, PDI-Ephrata Dialysis was identified to have the following standard level deficiencies that 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 on observation, review of agency policies, emergency cart logs, and interview with facility administrator (FA), agency failed to replace expired emergency cart medications in seven (7) out of seven (7) weekly staff checks; and failed to document completed daily AED equipment check in one (1) of twenty-one (21) observations. OBS #1.


Findings include:


Observation #1 and review conducted on September 11, 2023, at approximately 10:50 AM, of agency 2023 Emergency Equipment Checklist and Daily Philips Heart Starter/AED and Emergency Medication Lock Logs revealed: Observed top of locked medication box had written note of expiration dates for Benadryl (diphenhydramine) for 7/23 and Epinephrine injectors for 8/23; reviewed Emergency Equipment Checklist document, dates 7/31/23, 8/7/23, 8/14/23, 8/21/23, 8/28/23 (RN noted Benadryl expired 7/23, no action taken by staff), 9/4/23, and 9/11/23 are checked as "ok"; and reviewed "Daily Philips Heart Starter/AED and Emergency Medication Lock Log" document noted missing daily check for 7/11/23.


Review conducted on September 11, 2023, at approximately 1:00 PM, of agency policy 1-02-08 "Emergency Equipment Checks" revealed: "3. The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Daily: Check Status Indicator light for green check for Zoll AED ... Weekly: Emergency cart (crash cart) is clean, operational, and supplies/medications have not expired." ; and policy 1-06-01 "Medication Policy" stated "31. Medications are ordered and replaced prior to expiration. 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from treatment and inventory areas and disposed of per state/local regulations."


Interview conducted on September 11, 2023, at approximately 3:00 PM with FA confirmed the above findings.









Plan of Correction:

The Facility Administrator or designee held mandatory held in-services with all clinical teammates starting on 09/27/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-02-08 "Emergency Equipment Checks" and Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: A. Emergency equipment checks: 1) The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional: Daily: Check Status Indicator for green check for Zoll AED; break away lock is intact. Weekly: Emergency cart (crash cart) is clean, operational and supplies/medications have not expired. 2) A list of all dated supplies will be posted, with the expiration dates, on the cart and is to be checked weekly by licensed nurse teammate assigned to check the emergency cart. B. Medication policy: 1) Medications are ordered and replaced prior to expiration. 2) Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations. Verification of attendance is evidenced by teammate's signature on in-service sheet.
On 09/11/23 the Facility Administrator immediately removed expired medication from emergency cart and appropriately disposed of it.
The Facility Administrator or designee will perform audits of emergency equipment cart to verify checks are being performed and fresh supplies are available: daily for two (2) weeks, then weekly for two (2) weeks, and monthly for two (2) months. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during the monthly Quality Assessment 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.



494.62(d)(3) STANDARD
ESRD Patient Orientation Training

Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.

Observations:

Based on review of medical records (MRs), agency policy review, and interview with facility administrator, agency failed to maintain documentation of completed emergency preparedness (EP) fire safety quarterly patient education in one (1) out of seven (7) medical records reviewed (MR #2).


Findings include:


Review conducted on September 14, 2023, at approximately 9:00 AM to 1:30 PM, of medical records revealed:

MR#1 start of care (soc) 6/16/23, no finding.

MR#2 soc 10/19/22, contained no documentation of EP Fire Safety Preparedness training for 2023 quarters 1 and 2.

MR#3 soc 3/9/23, no finding.

MR#4 soc 5/30/22, no finding.

MR#5, soc 7/5/23, no finding.

MR#6, soc 8/10/22, no finding.

MR#7, soc 2/16/22, no finding.


Review conducted on September 14, 2023, at approximately 2:00 PM, of agency policy 4-07-01 Facility Emergency Management Plan (ICD, HOME) pages 26-27 of 37, "b. Patients: ... ii. Quarterly 1. Fire Safety Preparedness. ... v. Document training on applicable forms."


Interview conducted on September 14, 2023, at approximately 2:15 PM, with facility administrator confirmed above findings.







Plan of Correction:

The Facility Administrator or designee held mandatory in-services all clinical teammates starting on 9/27/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 4-07-01 "Facility Emergency Management Plan (EMP)" with emphasis on but not limited to: 1) the Facility Administrator or designee, is responsible to conduct fire safety drills. 2) Fire Safety drills: a. Required on a quarterly basis; one drill to be conducted for each shift of patients; b. Include patient emergency takeoff procedure, policy: Termination of Dialysis in an Emergency; c. Document training for both teammates and patients; d. Complete exercise evaluation and teammate attendance sheet; e. Document in Governing Body and maintain with facility EMP. Verification of attendance is evidenced by teammate's signature on in-service sheet.


The Facility Administrator or designee will audit one hundred percent (100%) of patient medical records for the documentation of quarterly fire safety preparedness trainings: quarterly for three (3) quarters. Ongoing compliance will be monitored by the Facility Administrator or designee with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with the Medical Director during the monthly Quality Assessment 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.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 11, 2023 through September 14, 2023, PDI-Ephrata Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the 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(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 observation (OBS), agency policy review, and an interview with the facility administrator, the agency failed to ensure the clinical staff performed hand hygiene and glove changes per policies for one (1) of one (1) observation for discontinuation of dialysis treatment and obtaining blood culture specimens from patient with central venous catheter (CVC) access (Observation #1).


Findings include:


Review conducted on September 14, 2023, at approximately 1:30 PM, of policies revealed: 1-05-01 Infection Control for Dialysis Facilities, "HAND HYGIENE 1. All teammates, Physicians and Non-Physicians (NNP) will perform hand hygiene ... d. after patient and dialysis delivery system contact, ... g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse components."


Observation #1 conducted on September 11, 2023, at approximately 11:15 AM to 11:25 AM, at station #13 revealed: During discontinuation of dialysis treatment and obtaining blood culture specimens procedures for MR#7, PCT EF#3 was observed touching the hemodialysis machine screen with gloved hands, then touching the patient's CVC limbs at 11:21 AM, no glove change/hand hygiene performed; continued discontinuation of external treatment tubing, and touched machine screen at 11:23 AM to silence machine alarms, no glove change/hand hygiene performed; then initiated obtaining blood cultures, flushed both CVC limbs, and applied end caps without a change of gloves/hand hygiene performed.


Interview conducted on September 11, 2023, at approximately 3:00 PM, with facility administrator confirmed the above finding.













Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/27/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities with emphasis on but not limited to: 1) All teammates ... will perform hand hygiene b. prior to gloving and immediately after removal of gloves... d. after patient and dialysis delivery system contact ... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. 2) Gloves should be changed when: going from a "dirty" area or task to a "clean" area or task. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.
The Facility Administrator or designee will conduct infection control audits to verify glove wearing and changing with hand hygiene per policy: daily for two (2) weeks, then weekly for two (2) week. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during the monthly Quality Assessment 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.



494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.



Observations:

Based on review of agency policy/procedure, equipment documentation logs, and interview with facility administrator (FA), agency failed to complete assessment with documentation of fixed eyewash equipment in one (1) of four (4) weekly checks (week 8/28/23); and failed to complete daily glucometer quality control checks in two (2) of twenty-eight (28) days check during August 1- 31, 2023.


Findings include:


Review conducted on September 11, 2023, at approximately 10:50 AM, of agency glucometer (serial number EE20CA03152) log dated 8/1-31/23 revealed: Missing daily quality control checks for 8/29/23 and 8/30/23.


Review conducted on September 11, 2023, at approximately 10:52 AM, of agency "Weekly Eyewash Inspection" log revealed one missed week inspection for 8/28/23.


Review conducted on September 11, 2023, at approximately 1:00 PM, of agency policy 1-08-06 revealed: policy 6. Quality control testing is completed prior to the first use of the day ... ."


Review conducted on September 11, 2023, at approximately 1:00 PM, of agency policy 4-08-09 Eyewash Station/Sink/Drench Shower /Hose Checks revealed: "Plumbed eyewash stations/sinks/drench showers/hoses are to be activated weekly to flush the line and verify operation."; policy 1-08-06C EMBRACEPRO Blood Glucose Monitor: Quality Control (QC) "Procedure 1. QC procedures are performed and documented every day the monitor is used ... ."


Interview conducted on September 11, 2023, at approximately 3:00 PM with FA confirmed the glucometer is used daily and confirmed the above findings.











Plan of Correction:

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 09/27/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment", Policy 4-08-09 "Eyewash Station / Sink / Drench Shower / Hose Checks" and Policy 1-08-06 "Blood Glucose Testing" with emphasis on but not limited to:
A. Physical environment: 1) the dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer's recommendations.
B. Eyewash station: 1) Plumbed eyewash stations/sinks/drench showers/hoses are to be activated weekly to flush the line and verify proper operation. 2) Inspections will be documented on the Weekly Eyewash and Drench Shower/Hoses Inspection log.
C. Blood glucose testing: 1) Quality control testing is completed prior to the first use of the day when the DaVita approved blood glucose monitor is used for patient blood glucose testing... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits of:
A. Glucose control log to verify control tests are performed and documented prior to first use of each treatment day: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly infection control audits. Instances of non-compliance will be addressed immediately.
B. Weekly Eyewash ... Inspection log to verify activation to flush line and verify operation: weekly for four (4) weeks and monthly for two (2) months. Ongoing compliance will be monitored with the Monthly OSHA and Safety Checklist. Deficiencies not corrected immediately will be documented on the Monthly OSHA and Safety Plan of Correction [last page of the checklist] outlining the: deficiency, cause of the deficiency and corrective action: expected date of correction and actual date of correction.
The Facility Administrator or designee will review the results of the audits with teammates during homeroom meetings and with the Medical Director during monthly Quality Assurance and 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.



494.150(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 medical records (MR), agency policies/procedures, and interviews with facility administrator and clinical coordinator registered nurse (RN), agency failed to complete initial comprehensive assessment within 30 days or 13 treatments of admission in one (1) of seven (7) reviewed medical records (MR#2); failed to administer ordered medication to one (1) of five (5) dialysis patients (MR #4); and failed to timely document required nursing pre-treatment patient assessments as per agency policy in nineteen (19) out of forty (40) patient dialysis treatments reviews medical records (MR #1-4, and #7).



Findings include:


Review of medical records conducted on September 13, 2023, appropriately 12:30 PM to 4:00 PM, and September 14, 2023, approximately 9:00 AM to 1:30 PM, revealed:

MR#1 start of care (soc) 6/16/23

-dialysis treatment (TX) report 8/25/23, TX initiated 3:10 PM, nurse documentation of pre-treatment assessment was 5:01 PM, one (1) hour, 51 minutes after TX initiation.
-TX report 9/1/23, initiated TX 3:27 PM, nurse documentation of pre-treatment assessment at 5:23 PM, one (1) hours fifty-six (56) minutes after TX initiation.
-TX report 9/4/23, initiated TX 2:32 PM, nurse documentation of pre-treatment assessment at 5:34 PM, three (3) hours two (2) minutes after TX initiation.
-TX report 9/8/23, initiated 12:48 PM, nurse documentation of pre-treatment assessment at 4:58 PM, four (4) hours ten (10) minutes after TX initiation.

MR#2 soc 10/19/22,
-No initial interdisciplinary team (IDT) comprehensive assessment in November 2023, first IDT assessment on 1/19/23 (90 day), stable
-No finding for missed medications
-Dialysis TX report 8/28/23, TX initiated 7:44 AM, nurse documentation of pre-treatment assessment was 1:03 PM, five (5) hours nineteen (19) minutes after TX initiation.
-TX report 9/6/23, initiated TX 7:51 AM, nurse documentation of pre-treatment assessment at 9:05 AM, one (1) hour fourteen (14) minutes after TX initiation.
-TX report 9/8/23, initiated TX 7:42 AM, nurse documentation of pre-treatment assessment at 10:27 AM, two (2) hours forty-five (45) minutes after TX initiation.

MR#3 soc 3/9/23,
-Dialysis TX report 8/25/23, TX initiated 10:34 AM, nurse documentation of pre-treatment assessment was 11:56 AM, one (1) hour twenty-two (22) minutes after TX initiation.
-TX report 8/28/23, initiated TX 10:29 AM, nurse documentation of pre-treatment assessment at 2:34 PM, four (4) hours four (4) minutes after TX initiation.
-TX report 9/1/23, initiated TX 11:50 AM, nurse documentation of pre-treatment assessment at 1:00 PM, one (1) hour ten (10) minutes after TX initiation.
-TX report 9/8/23, initiated TX 10:51 AM, nurse documentation of pre-treatment assessment at 12:34 PM, one (1) hour forty-three (43) minutes after TX initiation.

MR#4 soc 5/30/22,
-Dialysis treatment record 8/25/23 ordered medications revealed: Clinical staff (EF#1) did not administer ONS DaVita Formulary [protien drink], 1 Serving, Oral, every dialysis treatment; clinical staff documented "not given" and reason for missed medication administration was "missed administration" with no additional information documented
-Dialysis TX report 8/28/23, TX initiated 10:47 AM, nurse documentation of pre-treatment assessment was 1:35 PM, two (2) hours forty-eight (48) minutes after TX initiation.
-TX report 8/30/23, initiated TX 10:51 AM, nurse documentation of pre-treatment assessment at 4:44 PM, five (5) hours, fifty-three (53) minutes after TX initiation.
-TX report 9/1/23, initiated TX 10:35 AM, nurse documentation of pre-treatment assessment at 1:04 PM, two (2) hours fourteen (14) minutes after TX initiation.
-TX report 9/8/23, initiated TX 10:46 AM, nurse documentation of pre-treatment assessment at 12:32 PM, one (1) hour forty-six (46) minutes after TX initiation.


MR#7, soc 2/16/22, no findings for late initial assessment or missed medication; and
-Dialysis TX report 8/28/23, TX initiated 6:59 AM, nurse documentation of pre-treatment assessment was 9:14 AM, two (2) hours, fifteen (15) minutes after TX initiation.
TX report 9/1/23, initiated TX 6:58 AM, nurse documentation of pre-treatment assessment at 8:53 AM, one (1) hour fifty-five (55) minutes after TX initiation.
-TX report 9/6/23, initiated TX 7:19 AM, nurse documentation of pre-treatment assessment at 9:07 AM, one (1) hour forty-eight (48) minutes after TX initiation.
-TX report 9/8/23, initiated TX 6:46 AM, nurse documentation of pre-treatment assessment at 8:22 AM, one (1) hour thirty-six (36) minutes after TX initiation.


Review conducted on September 15, 2023, at approximately 1:30 PM, agency policies revealed: Policy 1-14-01 IDT Patient Assessment and Plan of Care, page 2 "4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines."; policy 1-06-01 Medication Policy page 2, "9. Medications are administered as prescribed and then documented in the patient's medical record."; and policy 1-03-08 CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, "page 3, #8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation."


Interview conducted on September 14, 2023, at approximately 2:15 PM, with facility administrator and clinical coordinator RN confirmed no 30 day initial IDT assessment was performed.


Telephone interview conducted on September 15, 2023, at approximately 1:30 PM with clinical coordinator RN revealed no additional information was documented for this missed medication administration and confirmed missed medication administration.














Plan of Correction:

A Governing Body meeting was held on 9/25/2023 with the Medical Director, Facility Administrator, Director of Nursing and Regional Operations Director to review the results of the survey ending on 09/14/23. The Governing Body reviewed Policy COMP-DD-017 "Medical Director Qualifications and Responsibilities" with the Medical Director, who acknowledges that he/she is responsible to ensure that 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 non-physician providers. Plans of correction have been developed and initiated to correct identified deficiencies and to sustain compliance.
The Facility Administrator or designee held mandatory in-services for all clinical teammates, including the Interdisciplinary Team (IDT) starting on 09/27/23. Surveyor observations were reviewed. Education included but was not limited to a review of facility policies with areas of emphasis on but not limited to:
1. Policy 1-14-01 IDT Patient Assessment and Plan of Care" with emphasis on but not limited to: 1) a comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 2) An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. Verification of attendance is evidenced by teammate's signature on the in-service sheet.
The Facility Administrator or designee will audit one hundred percent (100%) of new patients' medical records monthly for three (3) months to verify that initial patient assessment and plan of care documents are completed within thirty (30) days or thirteen (13) hemodialysis treatments per policy. Ongoing compliance will be monitored by the monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately.
2. Policy 1-3-08 "CWOW - Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). 2) The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. 3) The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation. The Facility Administrator or designee will conduct audits to verify the nurse assessment is completed on each patient within one (1) hour of treatment initiation: on twenty five percent (25%) of treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately.
3. Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) Medications are administered as prescribed and then documented in the patient's medical record. The Facility Administrator or designee will conduct audits to verify medications given match medications ordered per physician: on twenty five percent (25%) of treatment records daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
Verification of attendance at all in-services will be evidenced by teammates' signatures on the in-services sheets. The Medical Director will review progress of teammate education, results of all audits, and adherence to this plan of correction during monthly Quality Assessment Performance Improvement meetings known as the Facility Health Meeting. The Facility Administrator will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in the meeting minutes. Action plans will be evaluated for effectiveness, new plans developed as applicable to achieve compliance with teammate adherence to policy and procedure. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction.