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Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, interviews, and record review conducted during the Recertification and survey from 03/12/2025 to 03/19/2025, the facility did not ensure biologicals were stored in accordance with professional principles. This was evident for 1 (Unit 2) of 5 medication storage areas reviewed. Specifically, controlled medications were not properly stored in a double cabinet in the Unit 2 medication room. This was observed during the Medication Storage task. The findings are: The facility policy titled Controlled substances revised 12/15/2024 stated the facility will comply with all laws, regulations, and other requirements related to handling, storage, disposal and documentation of Schedule II and other controlled substances. The policy also stated that controlled substances must be stored in the medication room in a locked container, separate from containers from any non-controlled medication. This container must remain locked at all times, except when it is accessed to obtain medications for residents. On 03/14/2025 at 12:51 PM to 1:24 PM, the Unit 2 medication room was observed with Registered Nurse # 1. Registered Nurse #1 unlocked the first door for the cabinet. The second door of the cabinet was observed to be ajar and when Registered Nurse #1 inserted the key into the second door, they were unable to turn the lock. Multiple controlled medications were observed in the unlocked cabinet including [MEDICATION NAME] sulfate 100mg per 5 ml 3 boxes, [MEDICATION NAME] 4mg tab -90 tablets, [MEDICATION NAME] immediate release 5mg-30 tablets, [MEDICATION NAME] 2mg -24 tablets, [MEDICATION NAME] 5mg - 21 tablets, [MEDICATION NAME] - 25 mg-30 tablets, [MEDICATION NAME] 0. 5mg -31 tablets, and [MEDICATION NAME] 1mg-30 tablets. On 03/14/25 at 01:21 PM, the maintenance book was observed with entries from 02/13/2025-03/14/2025 and there were no entries related to the narcotic box lock. On 03/14/2025 at 02:08 PM, Licensed Practical Nurse #2 was interviewed and stated they noticed two days ago that the narcotic cabinet lock was not closing, and when they tried the narcotic lock yesterday evening the key was not turning so they called maintenance and the Assistant Director of Nursing. Licensed Practical Nurse #2 also stated that maintenance attempted to fix the lock and were unsuccessful and stated they would return but they did not. On 03/17/2025 at 03:21 PM, Registered Nurse #1 was interviewed and stated last Thursday (03/13/2025) they were informed by Licensed Practical Nurse #3 that the narcotic lock was not working. Registered Nurse #1 also stated the following day (03/14/2025) they were informed that the lock was still sticking but they were not aware that it had not been fixed. Registered Nurse #1 further stated that medication should not be kept in the cabinet if both locks are not working, and the medication should have been moved and stored properly. On 03/19/2025 at 1:18 PM, the Assistant Director of Nursing was interviewed and stated that the narcotic lock box needs to be secure and if the lock is not functional the narcotics should be removed from the area and placed in locked area until the issue with the lock is resolved. The Assistant Director of Nursing also stated that the nurses should communicate with the unit directors and nursing administration when they have concerns with the narcotic storage. The Assistant Director of Nursing further stated that they were not informed that the narcotic box was not functional, and that staff were not able to secure the medication. On 03/19/2025 01:33 PM, the Director of Nursing was interviewed and stated that the last time they looked at the narcotic boxes was 2 weeks ago, and they did not observe, and were not informed of, any issues at that time. The Director of Nursing also stated that they should be notified if the key is broken, maintenance should be informed, and if the issue is not fixed during the shift they should be informed of that. The Director of Nursing further stated that they were informed of the issue about medication narcotic box on the 2nd floor last week. 10 NYCRR 415. 18(e)(1-4) | Plan of Correction: ApprovedApril 8, 2025 Corrective Actions for Residents Identified All controlled substances were removed from the cabinet and locked in appropriate storage immediately on 3/14/2025 The double locked cabinet for controlled medications (substances) on the Unit 2 was fixed on 3/14/25 to ensure both locks are functioning The RNS # 1, LPN #2 and LPN #3 were in-serviced on medication storage on (MONTH) 14, 2025. Residents at Risk All residents have the potential to be affected by this practice. All medication carts and storage rooms were inspected for medications and biologicals beyond their expiration date and none were found. Systemic Change The facility policy titled ?ôControlled Substances?Ø was reviewed, and no revision needed. All nurses are being in-serviced on ?ôControlled Substances?Ø policy and procedure. New process is being implemented for medication storage monitoring to ensure compliance (LPN to check med carts daily; Unit RN to check med rooms daily) All nurses are being in-serviced on this process by DNS The audit tool was developed to monitor for compliance. Monitoring of Corrective Action On a weekly basis for one quarter, DNS or designee will inspect 2 med rooms and 2 med carts, to ensure compliance with controlled medication storage. Any outstanding issues will be addressed immediately. On a monthly basis, DNS or designees will report findings to Administrator. On a monthly basis, DNS or designees will report the findings to QAPI Committee QAPI Committee to determine if further action is required. Responsible person: Director of Nursing |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, staff interviews and record review conducted during the Recertification Survey from 03/12/2025 to 03/19/2025, the facility did not ensure that residents receive treatment and care in accordance with professional standards of practice and the comprehensive person-centered care plan. This was evident for 1 (Resident #40) of 6 residents observed for Medication Administration task. Specifically, Resident #40, admitted with a [DIAGNOSES REDACTED]. Further, there was no documentation of a physician's orders [REDACTED]. The findings are: The facility's policy titled Medication Order Reconciliation created (MONTH) (YEAR), last reviewed (MONTH) 2025, stated the facility is to ensure that all medications orders are reconciled to prevent errors, maintain resident safety, and comply with applicable regulations. The policy also stated that reconciliation will occur during admissions, discharges, transfers, order changes, and routine reviews. The facility's policy titled Medication Orders created 03/2016, last revised 07/22 stated that the purpose of this procedure is to establish uniform guidelines in the receiving and recording of medication orders, and that a current list of orders must be maintained in the clinical record of each resident. Resident #40 had [DIAGNOSES REDACTED]. The Admission Minimum Data Set assessment dated [DATE] documented that Resident #40 had moderately impaired cognition and received insulin injections on 7 of 7 days. The physician's orders [REDACTED]. 150. The physician's orders [REDACTED]. The Comprehensive Care Plan focus documented Resident #40 has type 2 Diabetes Mellitus, created 2/18/25 documented a goal of Resident #40 will have no complications related to diabetes through the review date. Interventions included Diabetes medication as ordered by doctor, and to monitor/document for side effects and effectiveness. The Nursing Admission Summary note dated 2/17/25 documented Resident #40 was admitted from the hospital with [DIAGNOSES REDACTED]. The hospital's After Visit Summary and Medication List dated 2/17/25 documented Flash glucose scanning reader, use medications as directed by provider. A nursing note dated 3/5/25 documented Resident #40 is alert and responsive, self-checked their blood glucose via the Freestyle Libre 3 Plus Sensor and the result is 324 mg/dl. On 03/14/25 at 09:21 AM, during the Medication Administration task, Licensed Practical Nurse #3 was observed administering medications to Resident #40 in the hallway. Licensed Practical Nurse #3 asked Resident #40 if they checked their blood sugar and Resident #40 replied that they had, and that it was 269. Licensed Practical Nurse #3 then checked the Electronic Medical Record and informed Resident #40 that they will get the coverage. Licensed Practical Nurse #3 then proceeded to instill 5 units of Insulin [MEDICATION NAME] to Resident #40 without first verifying Resident #40's blood sugar level. On 03/14/25 11:58 AM, Licensed Practical Nurse #3 was interviewed and stated that Resident #40 has had the Freestyle Libre device since admission and is able to read their own blood sugars. Licensed Practical Nurse #3 also stated that they did not know if there was an order for [REDACTED]. On 03/14/25 at 12:20 PM, Registered Nurse #3 was interviewed and stated that they were aware that Resident #40 had the Freestyle libre device and they had it when they were admitted from the hospital. Registered #3 also stated that Resident #40 reads the blood sugar results, and the Licensed Practical Nurse is supposed to verify the reading on the device. Registered Nurse #3 further stated that any type of device that a resident has been provided with is documented in the Electronic Medical Record. Registered Nurse #3 stated that the order for the device must have been missed for Resident # 40. On 03/14/25 at 12:32 PM, the Director of Nursing was interviewed and stated that the Licensed Practical Nurses are supposed to actually see the blood sugars readings before administering any insulin, and that the Freestyle Libre device should be included in the physician's orders [REDACTED]. On 03/19/25 at 01:29 PM, Physician #1 was interviewed and stated that they are the Primary Physician for Resident # 40. Physician #1 also stated that they did not realize that an order had not been placed for the Freestyle Libre device initially, but they had an order placed after 03/14/2025, once they were made aware. Physician #1 further stated that there should have been an order in place for the device when Resident #40 was admitted . 10 NYCRR 415. 12 | Plan of Correction: ApprovedApril 8, 2025 Corrective Actions for Residents Identified For Resident # 40 RN reviewed the blood sugar levels there were no negative outcome from the deficient practice as evidenced by the stable blood sugar levels between 122 and 301. Licensed Practical Nurse #3 was in-serviced on Medication Administration with an emphasis on the verification of blood sugar prior to Insulin injection on (MONTH) 14, 2025. Registered Nurse # 3 was in-serviced on Medication Order Reconciliation policy on (MONTH) 14, 2025. The order for Continuous Glucose Monitoring device was reviewed and revised on (MONTH) 14, 2025 Residents At Risk All residents receiving Insulin injections have the potential to be affected by this practice. An audit of all residents receiving Insulin injections admitted in the past 3 months is being done to ensure all orders are reconciled and accurate. Any outstanding findings will be addressed immediately Systemic Changes The policy and Procedure ?ôMedication Order Reconciliation?Ø was reviewed by DNS on (MONTH) 14 2025, and no revision needed The policy and procedure titles ?ôMedication Orders?Ø was reviewed by DNS on (MONTH) 14 2025,, and no revision needed All nurses are being in-serviced by the ADNS on ?ôMedication Order Reconciliation?Ø and ?ôMedication Orders?Ø Policies All nurses are being in-serviced by the ADNS on Personal Glucose Monitoring Devices and Continuous Glucose Monitoring (CGM) System?Ø policy and procedures. ?ôUse of Personal Glucose Monitoring Devices and Continuous Glucose Monitoring (CGM) System?Ø policy and procedure was developed and being implemented. The procedure includes specific steps for nurses to follow to ensure the blood glucose readings are verified prior to Insulin administration. The medication administration competency observation was revised, Continuous Glucose Monitoring System was added The audit tool was developed for monitoring compliance Monitoring Of Corrective Actions On a weekly basis for one quarter, ADNS or designee will audit new admission/re-admission orders [REDACTED]. Any outstanding issues will be addressed immediately and reported to DNS On a weekly basis for one quarter, ADNS or designee will interview and observe, when applicable 2-4 nurses for competency with Continuous Glucose Monitoring System. On a monthly basis, ADNS or designee, will report findings to DNS On a monthly basis DNS or designee will report findings to Administrator On a quarterly basis DNS or designee will report findings to QAPI Committee QAPI Committee to determine if further action is required Responsible party: Director of Nursing |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review, and interviews conducted during the Recertification Survey from 03/12/2025 to 03/19/2025, the facility did not ensure each resident was treated with respect and dignity. This was evident for 1 (Resident #40) of 1 resident reviewed for Dignity out of 39 total sampled residents. Specifically, the Licensed Practical Nurse administered insulin to Resident #40 while they were seated in the hallway without providing any form of privacy. The findings are: The facility's policy titled Quality of Life- Dignity, implemented 07/2017 and last reviewed 01/12/24, stated that staff shall promote, maintain, and protect resident privacy, including bodily privacy during assistance with personal care and during treatment procedures. Resident #40 had [DIAGNOSES REDACTED]. The Admission Minimum Data Set assessment dated [DATE] documented that Resident #40 had moderately impaired cognition and received insulin injections on 7 of 7 days. The physician's orders [REDACTED]. 150. The physician's orders [REDACTED]. On 03/18/25 at 09:21 AM, during the Medication Administration task Licensed Practical Nurse #3 was observed administering medications to Resident #40 who was sitting on their rollator, in the hallway. Licensed Practical Nurse #3 asked Resident #40 if they checked their blood sugar and Resident #40 replied that they had. Licensed Practical Nurse #3 then reviewed the Electronic Medical Record and informed Resident #40 that they will get insulin coverage, and asked which area of their body they would like to receive it. Licensed Practical Nurse #3 then proceeded to give the insulin to the right side of Resident #40's abdomen while they sat in the hallway, where other residents were walking, without providing any form of privacy. On 03/14/25 11:58 AM, Licensed Practical Nurse #3 was interviewed and stated that Resident #40 does not stay in their room and does not stay still to get the insulin administered. Licensed Practical Nurse #3 also stated that they try to ensure Resident #40's privacy, but Resident #40 does not listen and gets impatient. On 03/14/25 at 12:20 PM, Resident Nurse Manager #3 was interviewed and stated that sometimes Resident #40 gets impatient and would refuse to go to their room to receive insulin. Resident Nurse Manager #3 also stated that they usually give insulin injections to Resident #40 while they are in their room, and the Licensed Practical Nurses know they are supposed to ensure privacy. On 03/14/25 at 12:32 PM, the Director of Nursing was interviewed and stated that the Licensed Practical Nurses are supposed to provide privacy for the residents, even if the resident refuses and if the insulin is administered in the hallway. The Director of Nursing also stated that there are screens that are available for use to ensure privacy. 10 NYCRR 415. 5(a) | Plan of Correction: ApprovedApril 9, 2025 Corrective Actions for Residents Identified For Resident # 40 there were no negative outcome from the deficient practice as evidenced by vocalization and observation Licensed Practical Nurse #3 was in-serviced on residents dignity on (MONTH) 14, 2025. Residents At Risk All residents have the potential to be affected by this practice. All nurses were assessed for competency. DNS and designee observed random medication administration to ensure compliance. Systemic Changes The policy and Procedure ?ôQuality of Life-Dignity?Ø was reviewed, and no revision needed All nurses are being in-serviced on ?ôQuality of Life-Dignity?Ø Policy and Procedure, with emphasis on privacy during medication administration The medication administration competency observation was revised, dignity during med pass was added. The audit tool was developed for monitoring compliance Monitoring Of Corrective Actions On a weekly basis for one quarter, ADNS or designee will observe 1-3 nurses during medication pass to ensure residents dignity is maintained. Any outstanding issues will be addressed immediately and reported to DNS On a monthly basis, ADNS or designee, will report findings to DNS On a monthly basis DNS or designee will report findings to Administrator On a quarterly basis DNS or designee will report findings to QAPI Committee QAPI Committee to determine if further action is required Responsible person: Director of nursing |
Scope: Pattern
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Based on observation and interview it was determined that facility did not ensure the patio gate to the public way was kept unobstructed. Reference is made to a key to a padlock not being instantly available upon request. The Finding is: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm,a life safety survey conducted and the following observations made: - a patio located outside of the main floor was observed to be locked with a padlock. Upon request to open the gate, thekey was not instantly available and staff had to re-enter the building to locate the key. On 3/12/25 at approximately 11:31 am, maintenance director stated this concern would be corrected and all staff would have access, so the gate would instantly open if the need arises. LSC NFPA [PHONE NUMBER] edition, 19. 2. 1 NYCRR 711. 2(a)(1) | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action A break box with the key to the gate was installed on 4/4/25 near the emergency exit for easy access in case of an emergency. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. An audit of all exit areas leading to the street was conducted. No other outstanding issues were found. III. Systemic Changes Maintenance was in-serviced regarding the need for easy access to exit the building and property in an event of an emergency. A comprehensive review of all exits was done, no other issues were noted. IV. Monitoring On monthly basis for one quarter, Director of Maintenance or designee, will check the facility exits to the public way for potential obstruction. Any outstanding issues will be reported to the Administrator and corrected immediately. On a quarterly basis, Director of Maintenance or designee, will report findings to QAPI Committee QAPI committee to determine if further action is required Responsible Party: Director of Maintenance |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Based on observation and interview it was determined that the facility did not ensure lighting in all means of egress was continuously maintained. Reference is made to a manual switch on the wall which can disable all lights in the means of egress. The findings are: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm, a life safety survey was conducted and the following observations made: - During a tour of the basement, a storage room (B23) was observed with multiple caged areas for multiple storage purposes and all areas were luminated. However, a manual switch on thr wall was able to disable the lights, leaving the area in total darkness. - A ramp area observed leading to the public way on the exterior of facility, approximately 20 -30 ft in area, was not provided with egress lighting. In an interview with the Maintenance Director on 3/13/25 at approximately 10:13 am, they stated this concern would be corrected. 2012 NFPA 101: 7. 8. 1. 1, 7. 8. 1. 2, 7. 8. 1. 3*, 7. 9. 1. 2, 7. 9. 2 10 NYCRR 711. 2 (a)(1) | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action Maintenance removed the light switch and replaced it with a metal plate for the basement in order to prevent the light from being turned off. lights were added to the ramp area to ensure continuous illumination. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. An audit of facility lighting in all means of egress was conducted. No outstanding issues were found. III. Systemic Changes The Maintenance department was in-serviced and educated about Illumination of Means of Egress. Continuous illumination was added to the to the monthly environmental rounds. IV. QA Monitoring The facility will conduct a review of all lighting by means of egress on a quarterly basis. This report will be done by the Director of Maintenance or his designee and submitted to the QA committee for review. On a quarterly basis, Director of Maintenance or designee, will report findings to QAPI Committee QAPI committee to determine if further action is required Responsible Party: Director of Maintenance |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Based on observation and interview it was determined that the facility did not ensure EXIT signs and NO EXIT signs were provided in the path of egress where appropriate. This was observed on 2 out of 5 floors. The findings are: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm, a life safety survey wasnconducted and the following observations made: - On the main floor, a door to the outside patio was not provided with NO EXIT signage. - A family room on the main floor was observed with multiple doors and ' EXIT' signage not provided. - The door to the outside patio on the 2nd floor was not provided with 'NO EXIT ' signage. On 3/12/25 at approximately 11:15 am, the Maintenance Director stated staff are advised to put up signs where appropriate. 711. 2 (a)(1) 2012 NFPA 101 7. 10. 8. 3. 1 and 7. 10. 8. 3. 2 | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action A ?ôno exit?Ø sign was posted immediately on the patio door and on the 2nd floor patio. Exit signs were posted in the family room. All signs were added the day it was pointed out on 3/ 12. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. An audit of all areas that require exit and directional signs to be displayed was conducted. No outstanding issues were noted III. Systemic Changes Maintenance was in-serviced regarding proper signage that needs to be posted around the building and has done a comprehensive review of all signage posted in the building. IV. QA Monitoring The facility will conduct an inspection of all signage on a quarterly basis. This report will be done by the Director of Maintenance or his designee and submitted to the QA committee for review. QAPI committee to determine if further action is required Responsible Party: Director of Maintenance |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Gas Equipment - Other Based on observation and interview it was determined that the facility did not ensure oxygen tanks were stored properly in accordance with NFPA 99. Reference is made to two (2) tanks not secured in holders. This was observed on 2 out of 5 floors. The Finding is: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm, a life safety survey was conducted and the following observations made: - Oxygen closets on floors 2 and 1 wereobserved with single oxygen tanks not secured and freely placed on the concrete floor. In an interview with the Maintenance Director on 3/13/25 at approximately 11:20 am, they stated that they advised staff to secure all oxygen tanks. Chapter 11 (NFPA 99) | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action The cylinders were placed in the proper holders during the survey after it was pointed out. All facility staff were educated on the safe storing of Gas Equipment. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. III. Systemic Changes All staff were in-serviced and educated about safe storing of Gas Equipment. The maintenance department will check and track daily compliance, using a daily tracking sheet. IV. QA Monitoring The Director of Maintenance will review all logs on a quarterly basis. This report will be done by the Director of Maintenance or his designee and submitted to the QA committee for review. QAPI committee to determine if further action is required Responsible Party: Director of Maintenance and Director of Nursing |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Based on observation and interview it was determined that the facility did not ensure the soiled linen room was protected with proper fire resistive material. This was observed in the basement area of the five floor facility. The Finding are: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm, a life safety survey was conducted and the following observations made: -The hydraulic motor room in the basement area was surveyed and a penetration consisting of a 1ft x 1 ft area wall cut out was observed with pink fiberglass material. On 3/13/25 at approximately 11:00 am, the Maintenance Director stated this material will be removed and appropriate fire/smoke sealant will be used. NFPA 101 2012 19. 3. 2. 1 10NYCRR 711. 2(a)(1) | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action Maintenance filled the hole on 3/28/25 with concrete. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. The maintenance department inspected the entire building to ensure compliance. No outstanding issues were noted. III. Systemic Changes The Maintenance department was in-serviced about Hazardous Areas - Enclosure. Maintenance will inspect all areas after any construction work is done. Responsible Party: Director of Maintenance |
Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: March 19, 2025
Corrected date: N/A
Citation Details Based on observation and interview, the facility did not ensure smoke barrier doors when manually tested , were designed to resist fire and smoke for in accordance with NFPA 101. This was observed on 1 out of 5 floors. The Findings are: On 3/12/25 and 3/13/25, during the hours of 9:30 am - 3:00 pm,a life safety survey was conducted and the following observations made: - Smoke barrier doorswere tested manually on the first floor and a four (4) inch gap was observed between door leafs. In an interview with maintenance director on 3/13/25 at approximately 10:45 am, stated this would be corrected immediately. 2012 NFPA 101: 19. 3. 7. 6 10 NYCRR 711. 2 (a) | Plan of Correction: ApprovedApril 4, 2025 I. Immediate Corrective Action The doors were adjusted on 4/1/25 and tested to ensure compliance. II. Identification of Other Residents The facility respectfully states that residents could potentially be affected by this deficient practice. The maintenance department split up to inspect all doors in the building. No outstanding issues were noted. III. Systemic Changes The Maintenance department was in-serviced about Smoke Barrier Construction. Maintenance will inspect all areas of service after any construction is completed. IV. QA Monitoring All smoke barriers will be inspected monthly for one quarter. The Director of Maintenance will review all logs on a quarterly basis. This report will be done by the Director of Maintenance or his designee and submitted to the QA committee for review. QAPI committee to determine if further action is required Responsible Party: Director of Maintenance |