Initial Comments:
This report is the result of a State licensure survey initiated onsite on January 4, 2024 and completed offsite on January 8, 2024 at Montgomery Surgery Center. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
553.12 (b)(7) LICENSURE
Implementation
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553.12
(b) The following are the minimal provisions for the patient's bill of
rights:
(7) The patient has the right to good quality care and high
professional standards that are continually maintained and reviewed
Observations:
Based on observation, review of facility policy and procedures, and interviews with staff (EMP), it was determined the facility failed to provide good quality care and high professional standards that are continually maintained and reviewed as evidenced by failure to follow the facility's established policy and procedure for outdated patient supplies.
Findings include:
Observation of Anesthesia work room during tour, conducted on January 4, 2024, at 11:07 AM, revealed outdated supplies stocked on storage cart. Items found include:
Nine (9) oral endotracheal tubes 5.0 mm with manufacture's expiration date November 28, 2022.
Eight (8) cuffed oral/nasal endotracheal tube 8.0 mm with manufacture's expiration date January 1, 2024.
Observation of sterile storage room during tour, conducted on January 4, 2024, at 11:15 AM, revealed outdated supplies stocked on storage cart. Items found include:
Thirty-four (34) heat and moisture exchanger for tracheostomy with manufacture's expiration date April 28, 2023.
Review on January 4, 2024, of facility policy, "Outdated and Rotation of Stock ", dated November 8, 2011, revealed 'Policy: Supply areas will be monitored by Nursing personnel on a weekly basis ...Special supply areas are to be checked weekly for outdated by assigned personnel ... Storage cupboards are to be checked weekly for outdated by nursing personnel ...'
Interview on January 4, 2024, at 11:07 AM with EMP1 confirmed the above findings of expired patient care items.
Plan of Correction:During the week of 01/08/24 through 01/11/24 all storage areas in the facility were thoroughly assessed for outdates by the Administrator and all expired items were immediately removed from patient care and storage areas.
Administrator reviewed the Policy and Procedure for "Outdated and Rotation of Stock" with Quality Assurance Committee and Governing Body. P&P was updated and approved to specify each storage area in the facility that needs to be checked for outdates which will be listed on the "Outdates Check Log" for each area to be completed monthly by assigned staff. Updated policy and procedures were presented to staff on 01/15/24.
Starting 01/11/24 and monthly thereafter for a duration of 6 months until 06/11/24, the Administrator or Director of Nursing will audit and sign off on each stock check in the Outdates Check Log to assure staff has completed accurately. These audits will be presented to the Patient Safety Committee at each quarterly meeting and shared with the Quality Assurance Committee and Governing Body.
561.25 LICENSURE
Distressed drugs, devices and cosmetics
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561.25 Distressed drugs, devices and cosmetics
Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.
Observations:
Based on observation, review of facility policy and procedures, and interview with staff (EMP) it was determined the facility failed to adhere to facility policy and procedures by ensuring outdated medications were removed from service.
Findings include:
Observation of treatment room adjacent to pre-operative area during tour, conducted on January 4, 2024, at 10:41 AM, revealed one (1) opened bottle of tropicamide ophthalmic solution 1% labeled with orange facility sticker containing open date of November 21, 2023, and expiration date of December 19, 2023.
Review on January 4, 2024, of facility policy, "Outdated and Rotation of Stock", dated November 8, 2011, revealed 'Policy: Supply areas will be monitored by Nursing personnel on a weekly basis... Special supply areas are to be checked weekly for outdated by assigned personnel... Storage cupboards are to be checked weekly for outdated by nursing personnel ...'
Interview on January 4, 2024, at 10:42 AM with EMP1 confirmed above findings of outdated and unlabeled medications.
Plan of Correction:During the week of 01/08/24 through 01/11/24 all storage areas in the facility were thoroughly assessed for outdated medications by the Administrator and all expired items were immediately removed. All opened multi-dose and multi-patient medications were also reviewed for current facility stickers to ensure that each medication was properly labeled with a 28 day expiration date from time of opening.
Administrator reviewed the Policy and Procedure for "Outdated and Rotation of Stock" with Quality Assurance Committee and Governing Body. P&P was updated and approved to specify each storage area in the facility that needs to be checked for outdates which will be listed on the "Outdates Check Log" for each area to be completed monthly by assigned staff. Updated policy and procedures were presented to staff on 01/15/24.
Starting 01/11/24 and monthly thereafter for a duration of 6 months until 06/11/24, the Administrator or Director of Nursing will audit and sign off on each stock check in the Outdates Check Log to assure staff has completed accurately. These audits will be presented to the Patient Safety Committee at each quarterly meeting and shared with the Quality Assurance Committee and Governing Body.
567.1 LICENSURE
Principle
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567.1 Principle
The ASF shall have a sanitary environment, properly constructed,
equipped and maintained to protect surgical patients and ASF personnel from
cross-infection and to protect the health and safety of patients.
Observations:
Based on observation and interviews with staff (EMP) it was determined that the facility failed to ensure that patients were protected from cross-infection.
Findings include:
Observation of treatment room adjacent to pre-operative area during tour, conducted on January 4, 2024, at 10:41 AM, revealed one (1) opened bottle of purified water 98.3% ophthalmic solution eyewash, manufacture's label noted "single patient use", was open with approximately one quarter of volume missing.
Interview on January 4, 2024, at 10:42 AM with EMP1 confirmed the ophthalmic solution eyewash label states it is single patient use.
Interview on January 4, 2024, at 12:45 PM with EMP2 confirmed that ophthalmic solution eyewash is used on multiple patients.
Plan of Correction:During the week of 01/08/24 through 01/11/24 all storage areas in the facility were thoroughly assessed for opened medications to determine if they were multi-dose / multi-patient medications or single patient use. Any opened medications that were for single patient use were immediately discarded.
Administrator reviewed the Policy and Procedure for "Monthly Inspection of Medication Storage" with Quality Assurance Committee and Governing Body. P&P was updated and approved to include assessment of whether medications are multi-patient or single patient use and to assure that opened, multi-patient medications are properly labeled with a 28-day expiration date from opening, and that single-patient medications are discarded after one patient use. Updated policy and procedures were presented to staff on 01/15/24.
Administrator will create a list of medications stored in each location, identifying each medication as single or multi patient use, and recording the soonest expiration dates of each medication. Updated policy and procedures were presented to staff on 01/15/24. Staff have been instructed to review list daily upon opening of facility to ensure that no expiration dates had passed, and assigned staff will update the list upon receipt of new medications and during monthly outdate checks.
Starting 01/15/24 and monthly thereafter for a duration of 6 months until 06/15/24, the Administrator or Director of Nursing will audit and sign off on each medication check in the Outdates Check Log to assure staff has completed accurately. The Administrator or Director of Nursing will also audit and sign off on the medication lists posted at each location where medication is stored starting 01/15/24 and continuing monthly thereafter for a duration of 6 months until 06/15/24. Both of these monthly audits will be presented to the Patient Safety Committee at each quarterly meeting and shared with the Quality Assurance Committee, Infection Control Committee, and Governing Body.
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