Initial Comments:
This report is the result of a full State Licensure survey conducted on May 21, 2026, at Harrisburg Endoscopy and 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:
561.25 LICENSURE Distressed drugs, devices and cosmetics Name - Component - 00 561.25 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Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible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 a review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure multi-dose vials, medications and supplies were not expired, properly dated, and stored properly.
Findings include:
On May 21, 2026, review of facility policy "MEDICATIONS ADMINISTRATION, ADVERSE REACTION, STORAGE, USAGE AND DISPOSAL" last reviewed March 19, 2026, revealed "Purpose: Registered Nurse or anesthetist will safely prepare, dispense, and administer medications. Medications with be properly secured in order to prevent loss and/or misuse. Only approved medications are routinely stocked and stored. Medications will be utilized and disposed of in an appropriate, safe, and legal manner. ... Storage Procedure: ... All expired, damaged and/or contaminated medications are discarded immediately using Rx Destroyer with the exception expired narcotics which will be destroyed using reverse distributor. ... USAGE AND DISOSAL OF SINGLE AND MULTIDOSE VIALS Procedure: Single Dose Intravenous Medications ... Dispose of medication vial immediately. Glass vials will be disposed in the sharp ' s container. Plastic bags will be emptied and disposed of in regular waste. Single dose vials must only be used for one patient. Procedure: Multi Dose Intravenous Medication If multidose vials must be used for more than one patient, they should not be kept or accessed in the immediate treatment area. If the vial is accessed in an immediate patient treatment area, it should be dedicated to that patient only and discarded after use. ... If a medication needs to be saved for reuse: Label remaining medication with the date in which the vial was opened, and the initials of the individual who opened the vial and discard date. All vials expire no longer than 28 days after they have been opened unless manufacturer instructions require expiration sooner than 28 days."
A request was made for facility policy regarding expired supplies, none was provided.
1. Observation in Procedure room 2 on May 21, 2026, one opened multi-dose vial of Esmolol Hydrochloride 100mg/10ml was being stored in the anesthesia cabinet in a patient treatment area. The vial did not have an open date, discard date or initial of the person who accessed the vial.
2. Observation in Procedure room 2 on May 21, 2026, one opened multi-dose vial of Labetalol 100mg/20ml was being stored in the anesthesia cabinet in a patient treatment area. The vial did not have a discard date on the vial.
3. Observation in Procedure room 2 on May 21, 2026, one opened single dose vial of Atropine Sulfate O.4mg/ml with an expiration date of September 2024. The vial was stored in the anesthesia cabinet in a patient treatment area.
4. Observation in Procedure room 2 anesthesia cabinet on May 21, 2026, two Nasopharyngeal Airway 30Fr. 7.5mm/ 10mm with expiration date of January 28, 2026.
5. Observation in Procedure room 2 anesthesia cabinet on May 21, 2026, one Nasopharyngeal Airway 32Fr. 10.7 mm with expiration date of November 28, 2025.
6. Observation in Procedure room 2 anesthesia cabinet on May 21, 2026, one Hi Lo Oral Nasal tube cuffed with expiration date of December 1, 2026.
7. Observation in Procedure room 2 anesthesia cabinet on May 21, 2026, one Adult Colorimetric CO2 retention Detector with expiration date of November 12, 2025.
Interview with EMP1 on May 21, 2026, EMP1 confirmed the above documentation is complete and accurate.
Plan of Correction: Issue #1 561.25: Distressed Drugs, devices and cosmetics Violation of this standard "the facility failed to ensure multi-dose vials, medications and supplies were not expired, properly date and stored properly." Policy The administrator developed the policy titled "GENERAL SUPPLY AND MEDICATION INVENTORY MANAGEMENT" to ensure that principles of supply management are followed in the facility. This policy applies to all supplies and medications. Below is the policy:
Purpose: To ensure the proper receipt, storage and disposal of supplies within the facility.
General Principles: 1. The facility attempts to minimize the variety of supply options of similar purpose to standards for all providers to reduce cost, simplify training and improves patient safety. 2. The facility follows the FIFO methodology for inventory management. This methodology dictates that the oldest supplies are the first ones to be used if unexpired. 3. Maintain order to facilitate location and removal of items from shelving. 4. There will be regular monitoring of the facility supplies to ensure they are used timely, to prevent waste and to ensure disposal of expired supplies. 5. Expired supplies will be discarded according to the guidelines for disposal according to the manufacturer. 6. Staff will monitor supplies based on their role, proximity or assignment. 7. Use proper body mechanics when handling supplies: a. Bend at the knees for lifting, using legs, not the back. b. Utilize carts for transfer of items. c. Carry items close to the body, not on your body or up under individual's arms for transfer. d. Utilize step stool for placement of items on higher shelving. e. Do not carry more than can be carried properly and easily. 8. Items should be stored a minimum of eight inches off the floor and eighteen inches from the ceiling. 9. Outside shipping cartons will not be stored in clean areas. 10. Store excess cartons of sterile goods in the clean Storage Room. Boxes must be kept on shelving. 11. Sterile supplies should be stored in a well-ventilated area with controlled humidity and temperature that is free of all vermin.
Procedure: Storage room 1. Vendors and shipping companies bring deliveries through the southwest entrance to the facility. The supplies are deposited in the hallway outside the "Storage" closet. 2. Employees open and put away supplies destined for the "Storage" closet on the same day they are delivered. 3. To ensure FIFO process for supplies, the inventory of each item that is already in the storage area/s, is reviewed for expiration date. Expired items are disposed. Supplies already on the shelf are rotated according to the below guideline. 4. Older supplies (i.e. supplies most recently received) are stored in front and to the right side of multiple rows. These supplies must be used first.
Procedure Rooms and Operating Room 1. Employees follow the same principles for inventory management when the supplies are brought to locations other than the "Storage" room. 2. Supplies are managed in the rooms according to the role of caregivers in the room on a given day. a. Anesthesia i. These providers are responsible for maintaining the cabinet where anesthesia supplies are stored in the room. ii. The provider in the room at the beginning and the end of the day audits the closet for expired and needed medications and supplies. iii. The provider takes the appropriate action in each of the above cases, either discarding or replenishing supplies and/or medications. b. GI Assistants or Surgical Technologists i. These caregivers are responsible for maintaining the appropriate supplies for all other areas in the rooms. ii. By the end of each day, the employee must audit the room for expired and needed supplies. iii. The caregiver takes the appropriate action in each of the above cases, either discarding or replenishing supplies and/or medications.
Nurse's station and Anesthesia workroom 1. The Director of Nursing and/or their delegate will, on the same day as delivery, open medications shipped to the facility. 2. To ensure FIFO process for supplies, the inventory of each item that is already in the storage area/s will be reviewed for expiration date. Expired items are disposed. Medications already on the shelf are rotated according to the below guideline. 5. Older medications (i.e. medications most recently received) are stored in front and to the right side of multiple rows. These medications must be used first. 3. There are a separate location and log maintained for all narcotics. This log is updated whenever the narcotics are added, dispensed or discarded from the narcotic cabinet.
Steps to ensure compliance with the above policy: The Lead Technologist and/or her designee will in-service all employees and anesthesia staff on the new policy by June 30, 2026. The trainer will cover the general principles of supply management, storage and disposal of outdated supplies. The trainer will emphasize the safety aspects of supply management during the session. Employees and anesthesia staff will complete a quiz covering the above concepts immediately following the in-service and annually thereafter. All employees and anesthesia staff will sign off that they attended the in-service. The Lead Technologist and/or her designee will conduct random audits once a quarter to ensure that supplies are being stored and, managed and disposed of according to the policy. Results of the audits will be discussed at the board meeting and a decision made on whether the audits are no longer necessary on a quarterly basis but can be spread over a longer time span (e.g. annually) Repeat incidents of employee's and anesthesia staff not following the policy will be addressed 1) employees via the employee performance improvement and discipline process and 2) anethesia staff under the contract requirements.
Steps to ensure compliance with medication management policies. Leadership will review the policy titled "MEDICATIONS ADMNISTRATION, ADVERSE REACTION, STORAGE, USAGE AND DISPOSAL". The Director of Nursing and/or her designee will in-service the nursing staff on this policy by June 30, 2026.The trainer will cover the topics of monitoring, expiration, storage, removal and disposal of medications since these are the areas noted in the PA DOH citation. The trainer will give special attention to the use and management of multi-dose vials and will emphasize the safety aspects of supply management during the session. Employees will complete a quiz covering the above concepts immediately following the in-service and annually thereafter. The Administrator will join the Medical Director in the quarterly audit of medication storage areas to give a second set of eyes to facility compliance in this area. The medication storage audit will be discussed at the quarterly QAPI meeting and a plan developed if non-compliance with policy or procedure is uncovered in the audit. This will be documented in the minutes of the meeting. Repeat incidents of employee's not following the policy will be addressed via the employee performance improvement and discipline process.
567.43 LICENSURE Ventilation System Name - Component - 00 The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under Chapter 571 (relating to construction standards).
Observations:
Based on review of facility documents and employee interview (EMP) it was determined the facility failed to follow their approved policy for out-of-range humidity levels.
Findings include:
On May 21, 2026, review of facility policy "Temperature and Humidity Control" last revised April 4, 2016, revealed "Policy: The temperature to be maintained in the Operating/Procedure rooms will be chosen on the basis of the well-being of the patient and the operating team. In accordance with the Health Care Facilities Handbook 1999 (NFPA 99), a recommendation concerning room temperature range from 68 - 73 degrees F will be maintained. The Relative Humidity is to be between 35% and 60% in the Endoscopy rooms and the Operating Room. This is monitored daily in the Endoscopy rooms. The temperature and humidity in the Operating Room are monitored on the days the room is used. If the temperature or humidity levels are outside the range stated and it is not able to be corrected by adjustment of the HVAC system, the Administrator will notify the HVAC contractor immediately. The Operating/Procedure room will be closed until the HVAC contractor has corrected the problem and is able to bring the room back to the proper levels."
On May 21, 2026, review of facility temperature and humidity logs for 2025 revealed:
Procedure room 1: January 7, 2025, humidity level 68%; April 7, 8, and 30, 2025 humidity level 68%; May 5, 2025, humidity level 69%; May 13, and 15, 2025, humidity level 68%; September 12, and 26, 2025, humidity level 68%; October 16, 2025, humidity level 70%.
Procedure room 2: June 26, 2025, humidity level 68%; August 15, and 25, 2025, humidity level 62%.
Procedure room 3: July 16, and 17, 2025, humidity level 63%; July 18, 2025, humidity level 62%; September 18, and 19, humidity level 61%; September 23, 2025, humidity level 68%; September 25, 2025, humidity level 76%; October 7, and 8, 2025, humidity level 70%; October 10, and 11, 2025, humidity level 73%.
Procedure room 4: March 31, 2025, humidity level 70%; April 1, and 2, 2025, humidity level 69%; August 25, 2025, humidity level 61%; September 25, 2025, humidity level 77%; October 27, and 28, 2025, humidity level 69%; October 29, 2025, humidity level 65%; November 19, 2025, humidity level 70%.
OR 1: September 26, 2025, humidity level 70%; October 14, 2025, humidity level 73%; December 4, 2025, humidity level 75%.
A request was made for documentation of HVAC system adjustment, HVAC contractor notification or closure of procedure rooms. None provided.
Interview with EMP1 on May 21, 2026, EMP1 confirmed the above information is true and accurate.
Plan of Correction: Issue #2 567.43 Ventilation System The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under Charter 571 (relating to construction standards) The administrator revised the policy titled "TEMPERATURE AND HUMIDITY CONTROL" to ensure that addresses the concerns of the survey. The "NOTE" at the bottom of the policy clarifies how and why standards have changed. Below is the revised policy:
Policy: Temperature and Humidity Control
The temperature to be maintained in the Operating/Procedure rooms will be chosen on the basis of the well-being of the patient and the operating team. In accordance with the Health Care Facilities Handbook 1999 (NFPA 99), a recommendation concerning room temperature range from 68 75 degrees F will be maintained. The Relative Humidity is to be between 35% and 60% in the Endoscopy rooms and the Operating Room. This is monitored daily in the Endoscopy rooms. The temperature and humidity in the Operating Room are monitored on the days the room is used.
If the temperature or humidity levels are outside the range stated and it is not able to be corrected by adjustment of the HVAC system, the Administrator will notify the HVAC contractor immediately. The Operating/Procedure room will be closed until the HVAC contractor has corrected the problem and is able to bring the room back to the proper levels.
NOTE: HESC has vacillated between following the required humidity ranges of 20 60% or 35 60% depending on whether the OR and radiologic equipment were in use at the facility. At this time and for the foreseeable future, the OR is closed. Given this fact, HESC will now operate according to the 20 60% humidity range as of the date of this revision. If in the future the facility acquires or uses equipment that requires a stricter humidity guideline, this policy will be revised to reflect that change.
Developed 04/00 Review Dates: Revision Dates: 4/01/01, 4/02/02, 4/10/03 4/10/04, 5/04/04, 4/08 4/13/04, 4/2/05, 1/06, 1/07 4/30/13, 04/04/16, 6/2/26 1/08, 1/09, 1/10, 1/11, 1/12 1/13,1/30/14, 1/29/15, 1/29/16
The Administrator will revise the temperature and humidity log to meet the needed changes. These changes will include a section for commenting on whether a room or area meets the temperature and humidity standards and what action was taken if these standards were not in compliance with the policy ranges. The log will display the acceptable ranges for temp and humidity so that it is easy to observe a discrepancy from the standards. The Administrator and/or his designee will in-service the staff on this change in policy by June 30, 2026. The nurses and technical staff will sign off on an attendance sheet that they received the in-service. The new logs will go into effect as of July 1, 2026. The in-service will include a review of the policy, i.e. the acceptable temperature and humidity ranges, who to inform if they are out of range, and what and where to document actions taken if a correction is needed. The staff will complete a brief quiz to ensure that they understand the new policy and procedures involved. This quiz will be taken on an annual basis. Repeat incidents of employee's not following the policy will be addressed via the employee performance improvement and discipline process.
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