QA Investigation Results

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


There are  12 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:


Based on the findings of an on-site unannounced Medicare recertification survey completed on 9/25/2023, PDI Johnstown 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 completed 9/25/2023, PDI Johnstown was found 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:




494.40(a) STANDARD
BACT OF H20-MAXIMUM & ACTION LEVELS

Name - Component - 00
4.1.2 Bacteriology of water: max & action levels
Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL

The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels.



Observations:


Based on review of water log testing results, facility policy, and an interview with the facility administrator, the facility failed to ensure re-culturing of site following original sample within seven (7) days for results requiring action per policy for one (1) of one (1) bacteria/endotoxin reports reviewed.

Findings included:

Review the agency policy on 8/28/2023 at approximately 8:38 AM revealed, "TITLE: WATER CULTURE POLICY...POLICY: 1. The Facility Administrator or designee is responsible for verifying that cultures are obtained, results recorded, reviewed and necessary actions taken, as applicable. 2. The Medical Director documents a review of all water culture results monthly. 3. Results and trends are reviewed during the Facility Health Meeting (FHM) and documented in the meeting minutes. 4. Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Monthly is defined as within a calendar month...8. Interpreting culture results: Acceptable level: *Below 50 cfu/ml, Action level: 50-90 cfu/ml, Unacceptable level: 100 cfu/ml or greater 9. Required responses to action or unacceptable culture results: *Single site at or above the action level (all other results in acceptable range): *Notify Medical Director of results within 48 hours of receiving the result. *Reculture of the site within 7 days of original sample collection date. *If repeat sampling result is below the action level, no further action is required. If repeat sampling result is at or above the action level, notify the facility Administrator/designee, Biomedical Services, Medical Director and enter Troubleshooting Mode..."

Bacteria/Endotoxin report review was conducted on 9/21/2023 at approximately 10:20 AM which revealed the following:

Water Log Review #1: Gave the following results from the (Agency) Bacteria/Endotoxin report: "All Results For Service dates: 03/22/23-09/18/23...D.O.S. 07/13/2023, Water Culture 70H, Water LAL <0.10 ...Name (First Last) FIRST H2O OUT ... " Water samples were not drawn again until 8/3/2023. The results were "Water Culture 10, Water LAL <0.10 ...FIRST H2O OUT..." EMP3 confirmed a repeat culture was not completed for the above action level reading within seven (7) days of 7/13/2023.

An exit interview was conducted with the group facility administrator and (via phone) clinical services specialist on 9/25/2023 at approximately 2:40 PM which confirmed the above findings.









Plan of Correction:

V 0178

The Facility Administrator or designee held mandatory in-services for all clinical and biomed teammates starting on 10/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 2-06-01 "Water Culture Policy" with emphasis on but not limited to: 1) The Facility Administrator or designee is responsible for verifying that cultures are obtained, results recorded, reviewed and necessary actions taken, as applicable. 2) The Medical Director documents a review of all water culture results monthly. 3) Results and trends are reviewed during the Facility Health Meeting (FHM) and documented in the meeting minutes. 4) Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Monthly is defined as within a calendar month. 5) Interpreting culture results: Acceptable level = below 50 cfu/ml; Action level = 50 – 99 cfu/ml; Unacceptable level = 100 cfu/ml or greater. 6) Required responses to action or unacceptable culture results for single site at or above the action level: a. Notify Medical Director of results within 48 hours of receiving the result. b. Re-culture of the site within 7 days of original sample collection date. c. If repeat sampling result is below the action level, no further action is required. d. If repeat sampling result is at or above the action level, notify the Facility Administrator/designee, Biomedical Services, Medical Director and enter Troubleshooting Mode...
Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheets. Any staff member not present will review the in-service with the Facility Administrator or designee upon returning to work.
The Facility Administrator or designee will conduct audits on water culture results to verify results are within acceptable range and if not, the appropriate actions have been taken within the appropriate timeline of seven (7) days: monthly for two (2) months with ongoing compliance monitored monthly per policy. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment 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.




494.40(a) STANDARD
RO-MEETS AAMI/MONITORED, RECORDED ON LOG

Name - Component - 00
5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log
Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2.

5.2.7 Reverse osmosis
Users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters.

6.2.7 Reverse osmosis
All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review.




Observations:


Based on the review of the facilities policy and procedures, daily waterlog sheets and staff (EMP) interviews the agency failed to complete documentation required for water treatment and monitoring to ensure that the RO is operated within its design parameters.

Findings included:

A review was conducted of facility policy on 9/27/2023 at approximately 1:15 PM which revealed, "Policy 2-04-03 TITLE: MONTHLY WATER TREATMENT SYSTEM MONITORING...POLICY: 1. All observations and test results must be recorded on the Monthly Water Treatment Log. 2. Biomed teammates who have been trained to perform the observations and testing required to complete the Monthly Water Treatment Log will observe, test and document their findings...5. All observations and test results are to be within the Acceptable Limits specified on the Monthly Water System Monitoring Log. If observations or test results are found outside the Acceptable Limits, notify the Facility Administrator/designee and take and record corrective actions as necessary. 6. The initials and signature of the Biomed teammate performing and recording all observations and test results are entered where indicated on the Monthly Water System Monitoring Log..."

Review on 9/21/2023 at approximately 10:20 PM revealed, "(Agency) DAILY WATER TREATMENT LOG" from 8/7/2023 to 9/21/2023, readings for "#32 End of Day Hardness Test Result
No documentation was provided by the agency to confirm the daily readings were completed.

An exit interview was conducted with the group facility administrator and (via phone) clinical services specialist on 9/25/2023 at approximately 2:40 PM which confirmed the above findings.








Plan of Correction:


V 0199

The Facility Administrator or designee held mandatory in-services for all clinical and biomed teammates starting on 10/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 2-04-02A "Daily Water Treatment Log" with emphasis on but not limited to: 1) All observations and test results must be recorded on the approved Daily Water Treatment Log and required IT Clinical System entries. 2) Only teammates who have been trained to perform the observations and testing required to complete the Daily Water Treatment Log will be permitted to observe, test and document their findings. 3) Observations and test results listed on the Daily Water Treatment Log and in the IT Clinical System are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments, except for hardness testing, done at the end of the treatment day. 4) The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log. A separate entry of time and initials is provided for the teammate performing end of day hardness testing. 5) A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheets. Any staff member not present will review the in-service with the Facility Administrator or designee upon returning to work.
The Facility Administrator or designee will conduct audits of Daily Water Treatment Logs to verify a separate entry of time and initials is provided for the teammate performing end of day hardness testing: daily for two weeks, then weekly for two (2) weeks, then monthly for tow (2) months. Ongoing compliance will be monitored for Facility Monthly Report. Instances of non-compliance will be addressed immediately
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment 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.



494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

(2) Evaluation of the appropriateness of the dialysis prescription,




Observations:

Based on a review of facility policies and procedures, medical records (MR) and staff (EMP) interviews, the facility failed to ensure the evaluation of the appropriateness of the dialysis prescription for the following: blood flow rates (BFR) and dialysate flow rate (DFR) for two (2) of six (6) in-center hemodialysis medical records (MR) reviewed (MR1 and MR2).

Findings include:

Review of facility policies conducted on 9/27/2023 at approximately 10:35 AM revealed: "TITLE: CWOW-PRE-INTRA-POSTTREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT...2. 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). a. The assessment includes the following components...iii Verification of prescription including machine parameters...3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. 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. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow..."

MR #1 admit date 8/3/2023, was reviewed on 9/20/2023, at approximately 12:32 PM. A review of the "Treatment Details Report...Dialysate Flow Rate 600.00 ml/min " for 9/16/2023 was conducted, the DFR was delivered lower than prescribed at 500 ml/min from 1:13 PM to 3:29 PM. Documentation was completed on the treatment sheet by three staff members.

MR #2 admit date 7/22/2023, was reviewed on 9/22/2023, at approximately 1:15 PM. A review of the "Treatment Details Report...Blood Flow Rate 250 ml/min" for 9/12/2023 was conducted, the BFR was delivered higher than prescribed on 9/12/2023 at 350 ml/min for the entire treatment. Documentation was completed on the treatment sheet by four staff members.

A review of the "Treatment Details Report...Blood Flow Rate 250 ml/min" for 9/09/2023 was conducted, the BFR was delivered higher than prescribed on 9/9/2023 at 350 ml/min for the entire treatment. Documentation was completed on the treatment sheet by three staff members.

There was no documentation within MR1 and MR2 to confirm, on the dates referenced, that the patient had the inability to achieve blood flow or notification to the physician was initiated.

An exit interview was conducted with the group facility administrator and (via phone) clinical services specialist on 9/25/2023 at approximately 2:40 PM which confirmed the above findings.









Plan of Correction:

V 0503

The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 10/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection Monitoring and Nursing Assessment" with emphasis on but not limited to: 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment with the exception of blood flow rate (BFR) which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment. Prescription components include but are not necessarily limited to: Blood flow rate... 2) Intra dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes vital signs and treatment monitoring at least every thirty (30) minutes. 3) If the dialysis prescription is not being met [including dialysis flow rate or change to/inability to obtain prescribed blood flow rate] the reason will be documented and the licensed nurse informed. 4) 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. 5) The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 6) All findings, interventions and patient response will be documented in the patient's medical record. Verification of attendance at in-service will be evidenced by teammate's signature on the in-service sheets. Any staff member not present will review the in-service with the Facility Administrator or designee upon returning to work.
The Facility Administrator or designee will conduct audits to verify accurate and complete documentation and nurse notification as required per policy: on twenty five percent (25%) of the treatment records daily for two weeks (2) then weekly for two weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review the audit results with teammates during homeroom meetings and with the Medical Director during monthly Quality Assessment 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.




494.80(a)(3) STANDARD
PA-IMMUNIZATION/MEDICATION HISTORY

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

Immunization history, and medication history.




Observations:


Based on a review of agency policy, medical record (MR) and staff (EMP) interview, it was determined that the agency failed to maintain an accurate medication profile to ensure review of all medications the patient was taking in order to identify and address potential adverse effects, drug reactions and significant side effects for one (1) of seven (7) MR's reviewed (MR6).

Findings Included:

Review of facility policies conducted on 9/27/2023 at approximately 10:45 AM revealed: "Policy: 3-02-28 TITLE: HISTORY AND PHYSICAL (H&P) POLICY PURPOSE: A comprehensive medical History and Physical (H&P) that addresses the patient's renal disease is to be completed or obtained for all patients within 30 days of admission and in accordance with DaVita policy and state regulations. POLICY: 1. A comprehensive H&P shall be obtained within 30 days of admission...Recommended Elements of a History and Physical (H&P) 1. Patient Name, MPI#, and Date of Birth...5. Current Medications with dosage including Over the Counter medications and vitamins...9. Allergies 10. Review of Systems/Physical Exam 11. Assessment/Impression 12. Plan..."

Review of MR6 on 9/25/2023 at approximately 9:16 AM revealed, start of care date of 10/17/2012. The agencies "Patient Summary Report" listed under section "ALLERGIES, DAPTOmycin ...Lisinopril ...Morphine ..." The surveyor reviewed a document within the chart, "...HISTORY & PHYSICAL NOTE..." (dated 11/29/2022) listed under section "ALLERGIES ...Daptomycin ...Iodinated Contrast Media ...Lisinopril ...Morphine ..." The facility staff was notified that allergies listed on the documents did not match.

An exit interview was conducted with the group facility administrator and (via phone) clinical services specialist on 9/25/2023 at approximately 2:40 PM which confirmed the above findings.







Plan of Correction:

V 0506

The Facility Administrator or designee held mandatory in-service(s) for all clinical teammates starting on 10/06/23. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-02-28 History and Physical (H&P) Policy" and Policy 3-02-01A "1st Document Recommended Medical Record – HD" rev 1023 with emphasis on but not limited to: A. H&P 1) A comprehensive medical History and Physical (H&P) that addresses the patient's current presentation and health status, including the patient's medical condition related to his or her renal disease, is to be completed or obtained for all new patients within 30 days of admission and in accordance with DaVita policy and state regulations. 2) Recommended Elements of a History and Physical (H&P): 1. Patient Name, MPI#, and Date of Birth...5. Current Medications with dosage including Over the Counter medications and vitamins...9. Allergies 10. Review of Systems/Physical Exam 11. Assessment/Impression
12. Plan..." B. Medical Record: 1) 1) Allergy stickers placed on outside Front Cover of Record (If applicable); remains on active record; update as needed. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheets. Any staff member not present will review the in-service with the Facility Administrator or designee upon returning to work.
The Facility Administrator or designee will conduct audits on one hundred percent (100%) of patients' medical records to verify allergies listed on History and Physical document and allergy labels on the charts are in agreement, by 10/20/23. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audit. Instances of non-compliance will be addressed immediately.
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.