Pennsylvania Department of Health
BERKSHIRE EYE SURGERY CENTER
Patient Care Inspection Results

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BERKSHIRE EYE SURGERY CENTER
Inspection Results For:

There are  35 surveys for this facility. Please select a date to view the survey results.

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BERKSHIRE EYE SURGERY CENTER - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of a State licensure survey conducted on January 18, 2024, at Berkshire Eye 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:


51.31 LICENSURE Exceptions - Principle:State only Deficiency.
51.31. Principle

The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.

Observations:

Based on a review of facility documents and interview with staff (EMP), it was determined that Berkshire Eye Surgery Center failed to comply with requirements, as outlined in the letter from the Department, granting the Exception related to administrative responsibilities.

Findings include:

Review of the document approving the exception request granted by the "Department", dated April 25, 2006, revealed "... The Department of Health is in receipt of your request for an exception to 28 Pa. Code 553.31(a), relating administrative responsibilities. You specifically requested that the facility Administrator and the Director of Nursing be the same individual at the Berkshire Eye Surgery Center (BESC). ... In your request, you stated that BESC is an ASF with two operating rooms and one procedure room. Staffing at the present time consists of five full-time clinical staff, one part-time clinical staff, two full-time business office staff and one full-time RN director (that individual to serve as the Administrator and the Director of Nursing). At present, the operating room time is approximately 16 hours per week. Based on that information, your request is granted. The Department expects that when patient volumes and operating room times increase, a full-time Administrator will be hired. The Department of Health reserves the right to revoke the exception for justifiable reason. ..."

An interview conducted on January 18, 2024, at approximately 9:30 A.M. with EMP1 revealed that the Administrator/Director of Nursing position provides about seven hours a week in patient care and oversees the facility which now provides about 30 hours of operating room time. Further interview revealed that the increase in operating room time occurred approximately 1.5 years ago.










 Plan of Correction - To be completed: 01/31/2024

Tag: S 0043
Tag: S 0043
The plan of correction is prepared in compliance with state/federal regulations and is intended as Berkshire Eye Surgery Center's (the "center") credible allegation of compliance. The submission of the plan of correction is not an admission by the facility that it agrees that the citations are correct or that it violated the law.
Organization Minutes:
The confidential and privileged minutes are being retained at the facility for agency review and verification if required.
Exhibits:
All exhibits including revisions to Medical Staff Bylaws, reviewed/revised or promulgated policies and procedures, documentation of staff and medical staff training/education are retained at the facility for agency review and verification upon request.
Tag: S 0043 51.31 Exceptions-Principle
Policy & Procedures:
The Clinical Director reviewed "Administrative Services" policy to confirm it meets standards and regulations. There were no revisions to the policy required.
Completion date: 01/25/24
Other Corrective Actions:
1. Regional CEO and Regional Vice President notified of revocation of the exception for Director of Nursing and Administrator to be the same individual on January 23, 2024.
2. Governing Body notified via email on January 25, 2024 of revocation of the exception for Director of Nursing and Administrator to be the same individual.
3. Administrator will be hired within a 60 day time period.
Completion date: 04/01/24
Monitoring:
Governing Body will review all DOH exceptions annually at the first quarter meeting.
Completion date: First quarter Governing Body Meeting January 2025 ongoing
Responsible Person(s):
Regional Vice President
Regional CEO
Administrator



Disciplinary Action:
Non-compliance with corrective action by center staff will result in immediate remediation and appropriate disciplinary action in accordance with the center's Human Resources policies and procedures.
Medical Staff members demonstrating non-compliance with corrective action will be referred for peer review in accordance with Medical Staff bylaws, as appropriate.

555.22 (a)(1-2) LICENSURE Surgical Services - Preoperative Care:State only Deficiency.
555.22 Pre-operative Care

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities documented day of surgery or one of the following:
(1) If medical evaluation, examination and referral are made from a private practitioner's office, hospital or clinic, pertinent records thereof shall be available and made part of the clinical record at the time the patient is registered and admitted tot he ASF. This information is considered valid no more than 30 days prior to the date of surgery.
(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.


Observations:

Based on review of facility policy, medical records (MR) and staff interview (EMP), it was determined that the facility failed to ensure pertinent medical histories were performed within thirty days of the procedure for 4 of 10 medical records reviewed (MR1, MR2, MR3, and MR4).

Findings include:

On January 18, 2024, at approximately 10:30 AM a review of facility policy titled "History, Physical, and Pre-Surgical Assessment" with an effective date of October 31, 2023 revealed "A comprehensive medical history and physical assessment will be completed not more than 30 days before the date of the surgery. No patient will be transported to the operating room without a completed signed, dated, and timed H&P."

On January 18, 2024, at approximately 10:00 AM. a review of medical records revealed MR1, MR2, MR3, and MR4 did not contain documentation of pertinent medical histories performed within thirty days of the procedure.

MR1 revealed the comprehensive medical history was completed January 31, 2023. The date of the procedure was March 9, 2023.

MR2 revealed the comprehensive medical history was completed May 2, 2023. The date of the procedure was July 5, 2023.

MR3 revealed the comprehensive medical history was completed January 31, 2023. The date of the procedure was March 18, 2023.

MR4 revealed the comprehensive medical history did not contain documentation of a date. The date of the procedure was February 6, 2023.

January 18, 2024, at approximately 10:30 AM an interview with EMP1 confirmed comprehensive medical histories were not performed within thirty days of the procedure for MR1, MR2, MR3, and MR4 did not contain a date.












 Plan of Correction - To be completed: 01/31/2024

Tag: S 552A
The plan of correction is prepared in compliance with state/federal regulations and is intended as Berkshire Eye Surgery Center's (the "center") credible allegation of compliance. The submission of the plan of correction is not an admission by the facility that it agrees that the citations are correct or that it violated the law.
Organization Minutes:
The confidential and privileged minutes are being retained at the facility for agency review and verification if required.
Exhibits:
All exhibits including revisions to Medical Staff Bylaws, reviewed/revised or promulgated policies and procedures, documentation of staff and medical staff training/education are retained at the facility for agency review and verification upon request.
Tag: S 552A 555.22 Surgical Services-Preoperative Care
Policy & Procedures:
Clinical Director reviewed and revised Policy "History, Physical and Pre-Surgical Assessment" to include "Medical/Anesthesia History Form will be completed by the patient or surrogate within 30 days of the scheduled surgery date. Upon arrival to the Center if the Medical/Anesthesia History Form is out of date the patient/surrogate will be required to complete a new Medical/Anesthesia History form pre-operatively before admission into the Pre-operative area." The revised policy was presented to the Governing Body (GB) for approval. Policy amended on 01/31/2024 after GB Approval.
Completion date: 01/31/24
Other Corrective Actions:
Clinical Director implemented a process where the Medical/Anesthesia History form date of completion will be checked for timeliness during the pre-chart nurse review two days prior to surgery. If the date of completion is not within 30 days of scheduled surgical procedure the patient will be asked to arrive 10 minutes earlier on the day of surgery to complete a new Medical/Anesthesia History form. Notification to the patient will be documented under "Needed" items on the pre-procedure call checklist.
Completion date: 02/16/24
Training:
1. Clinical and Business Office Staff has received education on Policy revision during a staff meeting on 01/26/24. The staff was required to verbalize understanding of the policy and attest to the fact they received a copy of the policy by initialing the policy in the new/revised policy binder. Staff not present at the meeting are required to read the meeting minutes and initial revised policy in the new/revised policy binder.
2. The staff was shown the Medical/Anesthesia History Form and where to find the date of completion on the form.
3. Medical Staff, Anesthesia Staff and Physician office, where Medical/Anesthesia History form originates from, were notified to the Policy change on 01/30/24.
Completion date: 02/16/24
Monitoring:
Clinical Director will audit 10 charts weekly for 1 month followed by an audit of 30 charts per month for 3 months for compliance with patient/surrogate completing the Medical/Anesthesia History form within 30 days of scheduled surgery. Once 3 consecutive months of 100% compliance has been achieved random audits will be performed as part of the monthly QAPI chart audits. Audit reports will be reported quarterly to the Quality Committee and Medical Executive Committee.
Completion date: 02/16/24 ongoing

Responsible Person(s):
All clinical staff is responsible to prevent this occurrence. Clinical Director, Administrator and all nursing staff.

Disciplinary Action:
Non-compliance with corrective action by center staff will result in immediate remediation and appropriate disciplinary action in accordance with the center's Human Resources policies and procedures.

561.25 LICENSURE Distressed drugs, devices and cosmetics:State only Deficiency.
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 interview with staff (EMP), it was determined that the facility failed to ensure outdated items were removed from stock.

Findings include:

On January 18, 2024, at approximately 12:30 PM review of facility policy titled "Procurement, Distribution, Storage, and Disposal of Medications" with an effective date of 4/11/23 revealed "Medications shall be checked monthly for the manufacturer's expiration date. These medication shall be pulled from inventory and placed into a container labeled medication outdates. The contracted reverse distribution center shall be called for pickup of outdated meds. A detailed accounting of the number and types of medication shall be provided to our materials manager. The list is filed and maintained for three years."

On January 18, 2024, at approximately 12:00 PM observation during the facility tour revealed KY Jelly (4 oz) located in the crash cart in the operating room hallway had an expiration date of 01/2021. Sensicare Ice Powder Free Nitrile Exam Gloves located in the Yag Laser room (107) had a date of manufacturer as 10/2012.

On January 18, 2024, at approximately 12:30 PM an interview with EMP1 confirmed the above to be out of date.













 Plan of Correction - To be completed: 01/31/2024

Tag: S 6142
The plan of correction is prepared in compliance with state/federal regulations and is intended as Berkshire Eye Surgery Center's (the "center") credible allegation of compliance. The submission of the plan of correction is not an admission by the facility that it agrees that the citations are correct or that it violated the law.
Organization Minutes:
The confidential and privileged minutes are being retained at the facility for agency review and verification if required.
Exhibits:
All exhibits including revisions to Medical Staff Bylaws, reviewed/revised or promulgated policies and procedures, documentation of staff and medical staff training/education are retained at the facility for agency review and verification upon request.
Tag: S 6142 Distressed Drugs, devices and cosmetics
Policy & Procedures:
Clinical Director reviewed the "Procurement, Distribution, Storage and Disposal of Medication" policy to confirm it meets current standards and regulations. There were no revisions to the policy required.
Clinical Director reviewed and revised "Procurement and Supply Chain Management Manufactured Sterile Items" policy to include non-sterile items; "All manufactured sterile items and unsterile items such as exam gloves, hand sanitizer and liquid hand soap will be reviewed monthly and upon issuance in respect to expiration dates." The revised policy was presented to the Governing Body (GB) for approval. Policy revised on 01/31/2024 after GB approval.
Completion date: 01/31/24
Other Corrective Actions:
1. Exam gloves and KY Jelly were disposed according to policy.
2. Medline sterile lubricating jelly has been added to the monthly medication expiration date list.
3. Medline sterile lubricating jelly has been added to drug formulary after consult with pharmacist and GB approval on January 31, 2024.
Completion date: 02/16/24
Training:
1. During a staff meeting on January 26, 2024 staff was notified of the addition of Medline sterile lubricating jelly to the crash cart and anesthesia carts in the OR's.
2. During a staff meeting on January 26, 2024 staff was notified of the policy revision to add unsterile products such as exam gloves, hand sanitizer and hand soap to the monthly expiration dates checks. Staff was required to verbalize understanding of the policy revision and to initial the policy in the new/revised policy binder. Staff not present at the meeting are required to read the meeting minutes and initial the revised policy in the new/revised policy binder.
3. Staff was shown a box of exam gloves and where to find the expiration date on the box.

Completion date: 02/02/24
Monitoring:
Clinical Director will do a monthly spot check of expiration dates for a period of 3 months. After receiving 100% compliance 3 months in a row random spot checks will be completed by the clinical director in addition to the required monthly expiration checks. Audits will be reported quarterly to the QAPI committee and at the Medical Executive Meetings.
Completion date: 02/16/24 ongoing
Responsible Person(s):
Administrator, Clinical Director and all staff.

Disciplinary Action:
Non-compliance with corrective action by center staff will result in immediate remediation and appropriate disciplinary action in accordance with the center's Human Resources policies and procedures.

563.1 LICENSURE CHAPTER 563 - MEDICAL RECORDS - Principle:State only Deficiency.
563.1 Principle

The ASF shall maintain complete, comprehensive and accurate medical
records for every patient to ensure adequate patient care.

Observations:

Based on review of facility documents, medical record (MR), and interview with staff (EMP), it was determined the facility failed to maintain a complete, comprehensive, and accurate medical record to ensure adequate patient care for one of ten medical records reviewe (MR9).

Findings:

On January 18, 2024, at approximately 11:00 AM review of facility policy titled "Anesthesia Requirement" with an effective date of May 20, 2022, revealed "Patient consent for Anesthesia services, to include an Anesthesia consultation with the patient and documentation of the consult."

On January 18, 2024, at approximately 11:30 AM review of MR9 revealed no documentation of the Anesthesia Consent form.

On January 18, 2024, at approximately 11:30 AM an interview with EMP1 confirmed MR9 did not contain documentation of the Anesthesia Consent form.





 Plan of Correction - To be completed: 01/31/2024

Tag: S 6310
The plan of correction is prepared in compliance with state/federal regulations and is intended as Berkshire Eye Surgery Center's (the "center") credible allegation of compliance. The submission of the plan of correction is not an admission by the facility that it agrees that the citations are correct or that it violated the law.
Organization Minutes:
The confidential and privileged minutes are being retained at the facility for agency review and verification if required.
Exhibits:
All exhibits including revisions to Medical Staff Bylaws, reviewed/revised or promulgated policies and procedures, documentation of staff and medical staff training/education are retained at the facility for agency review and verification upon request.
Tag: S 6310 563.1 Chapter 563-Medical Records-Principle
Policy & Procedures:
The Clinical Director reviewed Clinical Policy "Anesthesia Requirement" to confirm it meets current standards and regulations. There were no revisions to the policy required.
Completion date: 01/25/24
Other Corrective Actions:
1. Staff notified during a staff meeting on January 26, 2024 there was an anesthesia consent missing from an audited chart.
2. Charts are to be reviewed at the end of the day for completion by utilizing the chart review in Advantx.
3. Notified Governing Body (GB) on January 25, 2024.
Completion date: 02/02/24
Training:
1. Reviewed Anesthesia Requirement policy with staff during a staff meeting on January 26, 2024. Staff was required to verbalize understanding after reviewing policy. Policy placed in new/revised policies, labeled as "review only" for staff to initial. Staff not present at the staff meeting are required to read meeting minutes and sign the policy in the new/revised policy binder that they reviewed the policy.
2. Clinical Director showed a copy of an anesthesia consent.
3. Reviewed the need to review all charts for completeness at the end of surgery day and to utilize the chart review in Advantx during a staff meeting on January 26, 2024. Staff verbalized understanding of chart review at the end of each surgical day.

Completion date: 02/16/24
Monitoring:
Clinical Director will audit 10 charts a week for a 1 month period followed by 30 charts per month for a 3 month period or until 3 months of compliance with all consents verified. Once 3 consecutive months of 100% accuracy has been achieved random audits will be performed as part of the monthly QAPI chart audits. Audit reports will be reported quarterly at the QAPI committee meeting and at the Medical Executive Meeting.
Completion date: 02/16/24 ongoing

Responsible Person(s):
All clinical staff is responsible to prevent this occurrence. Administrator, Clinical Director and all nursing staff.

Disciplinary Action:
Non-compliance with corrective action by center staff will result in immediate remediation and appropriate disciplinary action in accordance with the center's Human Resources policies and procedures.


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