Pennsylvania Department of Health
SURGERY CENTER OF CHESTER COUNTY, THE
Patient Care Inspection Results

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Minimal Citation - No Harm Minimal Harm Actual Harm Serious Harm
SURGERY CENTER OF CHESTER COUNTY, THE
Inspection Results For:

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SURGERY CENTER OF CHESTER COUNTY, THE - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:

This report is the result of a full Medicare recertification survey conducted on September 5, 2024, at The Surgery Center of Chester County. It was determined the facility was in substantial compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions for Coverage for Ambulatory Surgical Centers.





 Plan of Correction:


Initial comments:

This report is the result of a State licensure survey conducted on September 5, 2024, at The Surgery Center of Chester County. 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:


416.44(a)(1) STANDARD PHYSICAL ENVIRONMENT:Not Assigned
The ASC must provide a functional and sanitary environment for the provision of surgical services.
Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to follow their own documented guidance for humidity levels in the pre-operative area.

Review on September 5, 2024, of "Pre-Op Temperature and Humidity Log" revealed humidity levels are to be maintained between 20% and 60%. Abnormal levels are to be reported to nurse manager or administrator.

Review on September 5, 2024, of the August 2024 Humidity Log for the pre-operative area revealed the following: August 5, 2024 humidity at 74%; August 6, 2024, humidity at 72%; August 7, 2024, humidity at 84%; August 8, 2024 humidity at 87%; August 9, 2024, humidity at 84%; and August 12, 2024 humidity at 72%.

Documentation was requested to show these abnormal levels were reported to the Nurse Manager or Administrator. Documentation showed the issue was not reported until August 9, 2024.

Interview with EMP1 on September 5, 2024, confirmed the above findings.









 Plan of Correction - To be completed: 11/08/2024

1. The center will update our temperature and humidity log sheets to include a designated area where the recorder can "check off" that any out-of-spec issues were reported to their supervisor. Our temp and humidity policy will also be updated to include a requirement for staff to document the reporting of out-of-spec levels. Staff will be trained on these new recording sheets and the updated policy.
2. Patients will be protected by ensuring that our staff are educated on humidity and temperature reporting policies, and by reviewing any out-of-spec reports during our daily team huddles. When temperature and humidity is reported out of spec, corrective action will be taken during the same business day.
3. The facility will ensure that the problem does not recur by updating our policy on temp and humidity levels so that it includes verbiage that requires staff to document any temperatures or humidity levels that are found to be out of spec, as well as to document the reporting of these out-of-spec levels. The facility will ensure that staff are trained in the updated policy.
4. The facility will monitor the performance of this plan of correction by establishing an audit of temp and humidity logs. This audit will be carried out by a RN on our Infection Control Committee. Ten log sheets per month from each monitored area will be audited for three months. Following this, five log sheets per month from each monitored area will be audited for another three months. Results will be analyzed and reported to our Infection Control Committee and forwarded to our Quality Assurance Committee. If issues persist from the results of this audit, further training will be performed and the audit will be repeated for another 6 months.
5. This corrective action will be fully implemented by 11/8/2024

416.51(b) STANDARD INFECTION CONTROL PROGRAM:Not Assigned
The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevent program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.



Observations:

Based on review of the facility policy, observation, and staff interview (EMP) it was determined the facility failed to ensure the infection control practices and CDC recommendations were followed.

Findings include:

Review on September 5, 2024, of facility policy,"Disposal of Needles, Syringes and Sharps and Safe Use of Injectable's and Syringes" revised 7/2024, revealed "Purpose: To eliminate the possibility of cross contamination between patients during surgery and to prevent employee exposure to blood borne pathogens as well as OPIM (other potentially infectious material) ... Follow proper infection control practices during the preparation and administration of all IV solutions and injectable medications ... Reference: CDC Guidelines: Preventing Transmission of Infection Agents in Healthcare Settings US Dept. HHS, CDC 2007. Released March 2008, Injection Safety Information for Providers."

Review on September 5, 2024, of facility policy, "Aseptic technique" revised 7/2024, revealed "Purpose: To describe principles of aseptic technique ... The edges of sterile containers are not considered sterile once the package is opened ..."

Review on September 5, 2024, of CDC recommendations for Injection Safety, revealed, "... Use of aseptic technique. Use a new needle and syringe for every infection. Be sure to clean your hands immediately before handling any medication. Disinfect the medication vial by rubbing the diaphragm with alcohol. Draw up all medications in a clean medication preparation area ..."

Observation on September 5, 2024, at approximately 10:05 AM of EMP3, revealed, EMP3 did not alcohol swab the medication vial access diaphragm prior to inserting syringe to withdraw medication.

Interview with EMP2 on September 5, 2024, confirmed above and stated wiping the vial prior to drawing up medication is a relatively new practice.






 Plan of Correction - To be completed: 11/08/2024

1. The Center will enforce its current policies by holding an in-service for physicians on correct technique for drawing up meds. This training will also be incorporated into the physician's annual training packet. Additionally, our anesthesia site director will conduct an immediate refresher training with all our contracted anesthesia providers.
2. Patients will be protected by ensuring that our staff and contracted providers are educated on safe injection practices. Particular emphasis will be placed on educating the medication drawing process with respect to new vials of medications, which some may interpret as sterile but which still need to be disinfected as a precaution by swabbing the top of the vial with alcohol before a needle is inserted to draw up meds.
3. The facility will ensure that the problem does not recur by ensuring that staff and contracted service providers are following our existing policies on safe injection practices and infection control. Our annual physician education packet will be updated to place greater emphasis on the need to disinfect new vials before medication is drawn from them.
4. The facility will monitor the performance of this plan of correction by conducting a quality assurance study on proper medication drawing techniques. A RN from our patient safety committee will conduct periodic, random audits of staff and physicians and will document their medication draw-up technique. Ten audits per month will be conducted for the three months, followed by five audits per month for another three months. Results will be documented and reviewed at quarterly Patient Safety committee meetings, with results forwarded to our Quality Assurance committee. If the problem persists, additional education will be carried out followed by a repeat of the audit process.
5. This corrective action will be fully implemented by 11/8/2024


551.22 (2) LICENSURE Criteria for performance Of Pediatric Patient:State only Deficiency.
551.22. Criteria for Performance of Ambulatory Surgery on Pediatric Patients

In addition to the criteria set forth at 551.21 (relating to criteria for ambulatory surgery), the following criteria shall apply to the performance of ambulatory surgery on children under 18 years of age.
(2) The medical record shall include documentation that the child's primary care provider was notified by the surgeon in advance of the performance of a procedure in an ambulatory surgical facility and that an opinion was sought form the primary care provider regarding the appropriateness of the use of the facility for the proposed procedure. When such an opinion from the child's primary care provider is not obtainable, the medical record shall include documentation which explains why such an opinion could not be obtained.
Observations:

Based on review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to provide documentation that the child's primary care physician (PCP) was notified by the surgeon in advance of the performance of a procedure, and that an opinion was sought from the primary care provider regarding the appropriateness of the use of the facility for the proposed procedure for one of two pediatric medical records reviewed (MR18).

Findings include:

Review of the policy "CARE OF THE PEDIATRIC PATIENT PURPOSE" revised on May 2024, revealed: To describe the criteria for the performance of surgery on children under 18 years of age. ... PROCEDURE: In addition to the criteria relating to ambulatory surgery the following criteria apply to the performance of ambulatory surgery on children under the age of 18 years: ... 2. The medical record shall document that the child's primary care provider (PCP) was notified by the surgeon in advance of the performance of a procedure in an ASF and that an opinion was sought from the PCP regarding the appropriateness of the use of the facility for the proposed procedure. Whan an opinion from the child ' s PCP cannot be obtained, the medical record shall include documentation which explains why the opinion could not be obtained. ..."

A medical record review conducted on September 5, 2024, of MR18 lacked documented evidence that the surgeon obtained the opinion of the PCP regarding the appropriateness of the use of the facility for the proposed procedure. Further review revealed no documentation which explained why an opinion could not be obtained.

Interview with EMP2 at approximately 11:45 AM confirmed there was no documentation of notification to the PCP.




 Plan of Correction - To be completed: 11/08/2024


1. The center will work with our credentialed physician's offices to ensure that they are aware of the requirement to notify their pediatric patient's PCP of upcoming surgery, and their need to provide the surgery center with documentation that this notification took place. The surgery center will have the scheduling physician's office include this documentation as part of their History and Physical that they provide to our center. If the surgeon does not get a response from the PCP, the surgeon will document this in the H&P note. Physicians that schedule pediatric patients will be provided with an immediate training module on this requirement, and this module will also be included in their annual refresher training.
2. Patients will be protected by ensuring that our schedulers, PAT staff, medical records staff, physicians, and physician schedulers are educated on the need to provide advanced notice to a pediatric patient's PCP and to provide documentation of that notification to the surgery center. In addition to immediate in-services, Physicians will be educated by adding a training module to their annual physician education packet. Facility staff will be educated with an in-service that reinforces our existing policies on this matter. Physician office staff will be educated by the surgery center's PAT nursing staff.
3. The facility will ensure that the problem does not recur by ensuring that staff and physicians are following our existing policies on pediatric patients. Our annual physician education packet will be updated to include a module on the need to inform the pediatric patient's PCP in advance of upcoming surgery.
4. The facility will monitor the performance of this plan of correction by conducting a quality assurance study on pediatric patient charts. Our medical records specialist will audit 100% of pediatric charts that come through the facility for a period of 3 months. This audit will include an inspection of the record to ensure that there is documentation of the patient's PCP having been notified in advance of surgery. Following this, 50% of ped charts will be audited for another three months. Results will be documented and reviewed at quarterly Quality Assurance committee meetings. If issues persist, additional training will be carried out and the audit will repeat for another 6 months.
5. This corrective action will be fully implemented by 11/8/2024

553.21 (d) LICENSURE Principle:State only Deficiency.
553.21 Principle

(d) A patient shall be discharged only with appropriate discharge instructions under 555.24 (relating to postoperative care.)
Observations:

Based on review of facility policy, medical records (MR) and staff interview (EMP), it was determined the facility failed to document physician signature on the medication reconciliation form for six of 21 medical records reviewed ( MR1, MR6, MR7, MR8, MR11 and MR21)

Findings include:

Requested a policy for the Medication Reconciliation Form and none was provided.

Review of facility form "Medication Reconciliation Form" revealed ... Current Medications which includes Medication, Dose, Frequency and Last Dose ... Discharge Instructions for Medications: includes Resume your current medication (as listed above), no medications at this time ... Below are the medications prescribed by your physician today: Medication, Dose, Frequency Rx Given to Patient ... Physician Signature, Date/Time, Patient/Responsible Party, Date/Time, Nurse's Signature, Date/Time ..."

Review of MR 1 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Review of MR6 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Review of MR7 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Review of MR8 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Review of MR11 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Review of MR21 on September 5, revealed the Medication Reconciliation Form did not have a physician signature, date, or time completed.

Interview with EMP2 on September 5, 2024, at approximately 11:30 AM confirmed there was no physician signature on the Medication reconciliation form.







 Plan of Correction - To be completed: 11/08/2024

1. Redundant medication reconciliation forms will be eliminated from the patient charts, and only one form will be used for the med rec form. This will be the form generated from the One Medical Passport system, which will be printed and placed into the patient chart. This form will also be placed in a standardized area of the chart, next to the physician's order sheet, such that staff and physicians will always know where to locate it to obtain necessary signatures prior to patient discharge. Additionally, our discharge policy will be updated to include language such that a physician must sign the med rec form prior to patient discharge.
2. Patients will be protected by ensuring that our staff and physicians are educated on the medication reconciliation process, the new med rec form, and the updated policy citing the need for a physician signature to be on that form before patient discharge from the facility.
3. The facility will ensure that the problem does not recur by ensuring that staff and physicians are following our updated patient discharge policy, which will include the need for a physician to sign the med rec form prior to patient discharge. Staff will be in-serviced on this policy update, and our annual physician education packet will be updated to include this information.
4. The facility will monitor the performance of this plan of correction by conducting a quality assurance study on randomly selected charts. A RN from our patient safety committee will audit ten charts per month for a period of three months. Following this, five charts per month will be audited for another three months. This audit will include an inspection of the record to ensure that there is a physician signature on the med rec form. Results will be documented and reviewed at quarterly Patient Safety Committee meetings and forwarded to our Quality Assurance Committee. If the issue persists, additional training will be conducted and the audit will be repeated.
5. This corrective action will be fully implemented by 11/8/2024

567.3 (b) (1) LICENSURE Policies and Procedures:State only Deficiency.
567.3 Policies and procedures

(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(1) Medical asepsis
Observations:

Based on review of the facility policy, observation, and staff interview (EMP) it was determined the facility failed to ensure the infection control practices and CDC recommendations were followed.
Findings include:
Review on September 5, 2024, of facility policy, "Disposal of Needles, Syringes and Sharps and Safe Use of Injectable's and Syringes" revised 7/2024, revealed "Purpose: To eliminate the possibility of cross contamination between patients during surgery and to prevent employee exposure to blood borne pathogens as well as OPIM (other potentially infectious material) ... Follow proper infection control practices during the preparation and administration of all IV solutions and injectable medications ... Reference: CDC Guidelines: Preventing Transmission of Infection Agents in Healthcare Settings US Dept. HHS, CDC 2007. Released March 2008, Injection Safety Information for Providers."
Review on September 5, 2024, of facility policy, "Aseptic technique" revised 7/2024, revealed "Purpose: To describe principles of aseptic technique ... The edges of sterile containers are not considered sterile once the package is opened ..."
Review on September 5, 2024, of CDC recommendations for Injection Safety, revealed, "... Use of aseptic technique. Use a new needle and syringe for every infection. Be sure to clean your hands immediately before handling any medication. Disinfect the medication vial by rubbing the diaphragm with alcohol. Draw up all medications in a clean medication preparation area ..."
Observation on September 5, 2024, at approximately 10:05 AM of EMP3, revealed, EMP3 did not alcohol swab the medication vial access diaphragm prior to inserting syringe to withdraw medication.
Interview with EMP2 on September 5, 2024, confirmed above and stated wiping the vial prior to drawing up medication is a relatively new practice.






 Plan of Correction - To be completed: 11/08/2024

1.The Center will enforce its current policies by holding an in-service for physicians on correct technique for drawing up meds. This training will also be incorporated into the physician's annual training packet. Additionally, our anesthesia site director will conduct an immediate refresher training with all our contracted anesthesia providers.
2.Patients will be protected by ensuring that our staff and contracted providers are educated on safe injection practices. Particular emphasis will be placed on educating the medication drawing process with respect to new vials of medications, which some may interpret as sterile but which still need to be disinfected as a precaution by swabbing the top of the vial with alcohol before a needle is inserted to draw up meds.
3.The facility will ensure that the problem does not recur by ensuring that staff and contracted service providers are following our existing policies on safe injection practices and infection control. Our annual physician education packet will be updated to place greater emphasis on the need to disinfect new vials before medication is drawn from them.
4. The facility will monitor the performance of this plan of correction by conducting a quality assurance study on proper medication drawing techniques. A RN from our patient safety committee will conduct periodic, random audits of staff and physicians and will document their medication draw-up technique. Ten audits per month will be conducted for the three months, followed by five audits per month for another three months. Results will be documented and reviewed at quarterly Patient Safety committee meetings, with results forwarded to our Quality Assurance committee. If the problem persists, additional education will be carried out followed by a repeat of the audit process.
5.This corrective action will be fully implemented by 11/8/2024

567.42 (b) LICENSURE Policies and Procedures:State only Deficiency.
567.42 Policies and procedures

(b) Written procedures shall be readily available for employes to
follow in the event of a breakdown in equipment, mechanical systems or
utilities.

Observations:

Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to follow their own documented guidance for humidity levels in the pre-operative area.

Review on September 5, 2024, of "Pre-Op Temperature and Humidity Log" revealed humidity levels are to be maintained between 20% and 60%. Abnormal levels are to be reported to nurse manager or administrator.

Review on September 5, 2024, of the August 2024 Humidity Log for the pre-operative area revealed the following: August 5, 2024 humidity at 74%; August 6, 2024, humidity at 72%; August 7, 2024, humidity at 84%; August 8, 2024 humidity at 87%; August 9, 2024, humidity at 84%; and August 12, 2024 humidity at 72%.

Documentation was requested to show these abnormal levels were reported to the Nurse Manager or Administrator. Documentation showed the issue was not reported until August 9, 2024.

Interview with EMP1 on September 5, 2024, confirmed the above findings.








 Plan of Correction - To be completed: 11/08/2024

1. The center will update our temperature and humidity log sheets to include a designated area where the recorder can "check off" that any out-of-spec issues were reported to their supervisor. Our temp and humidity policy will also be updated to include a requirement for staff to document the reporting of out-of-spec levels. Staff will be trained on these new recording sheets and the updated policy.
2. Patients will be protected by ensuring that our staff are educated on humidity and temperature reporting policies, and by reviewing any out-of-spec reports during our daily team huddles. When temperature and humidity is reported out of spec, corrective action will be taken during the same business day.
3. The facility will ensure that the problem does not recur by updating our policy on temp and humidity levels so that it includes verbiage that requires staff to document any temperatures or humidity levels that are found to be out of spec, as well as to document the reporting of these out-of-spec levels. The facility will ensure that staff are trained in the updated policy.
4. The facility will monitor the performance of this plan of correction by establishing an audit of temp and humidity logs. This audit will be carried out by a RN on our Infection Control Committee. Ten log sheets per month from each monitored area will be audited for three months. Following this, five log sheets per month from each monitored area will be audited for another three months. Results will be analyzed and reported to our Infection Control Committee and forwarded to our Quality Assurance Committee. If issues persist from the results of this audit, further training will be performed and the audit will be repeated for another 6 months.
5. This corrective action will be fully implemented by 11/8/2024


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