QA Investigation Results

Pennsylvania Department of Health
DELAWARE VALLEY LASER SURGERY INSTITUTE
Health Inspection Results
DELAWARE VALLEY LASER SURGERY INSTITUTE
Health Inspection Results For:


There are  23 surveys for this facility. Please select a date to view the survey results.

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Initial Comments:
This report is the result of a full Medicare recertification survey conducted on
August 9, 2018, and completed on August 10, 2018, at Delaware Valley Laser Surgery Institute. It was determined that the facility was not in compliance with the requirements of 42 CFR, Title 42, Part 416 - Conditions of Participation for Ambulatory Surgical Centers.





Plan of Correction:




416.51(a) STANDARD
SANITARY ENVIRONMENT

Name - Component - 00
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.



Observations:

Based on review of facility policy, observations, and interview with staff (EMP) it was determined that the facility failed to follow their policy for hand hygiene.

Findings included:

Review on August 9, 2018, of facility policy "Handwashing and Hand Hygiene-Section 2.10" revealed "...Indications for Hand-washing/Hand Hygiene: Before and after situation in which hands are likely to become contaminated. Before and after contact with a patient's intact skin (e.g. taking a pulse or blood pressure, performing physical examinations, lifting the patient in bed). After contact with environmental surfaces in the immediate vicinity of a patient. Between patient contact. After glove removal."

1. Observation on August 9, 2018, at 12:21PM of EMP4 in the preoperative area providing care to MR1 revealed EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves.

Observation on August 9, 2018, at 12:25PM of EMP4 in the preoperative area providing care to MR2 revealed EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves.

An interview conducted on August 9, 2018, at 12:30PM with EMP1 confirmed that EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves in the preoperative area for MR1 and MR2.


2. Observation on August 9, 2018, at 2:02PM of EMP2 in OR1 during a surgical procedure for MR2 revealed EMP2 failed to perform hand hygiene after removing a soiled glove from the floor of OR1. Further observation of EMP2 in OR1 during a surgical procedure for MR2 revealed EMP2 opening and closing drawers of the anesthesia cart, medication administration during the surgical procedure and completing paperwork. EMP2 did not perform hand hygiene before and after each of the activities listed above and did not change gloves at anytime during these tasks.

An interview conducted on August 9, 2018, at 2:57 PM with EMP1 confirmed that EMP2 failed to perform hand hygiene after removing a soiled glove from the floor of OR1 during a surgical procedure for MR2 and performing various environmental activities during the surgical procedure without performing hand hygiene between each of the tasks. In addition, EMP2 stated "I think we have a lot of hand hygiene education to do so that we can comply with the facility's policy."

_______________________

Based on facility policy, observation, documents, and interview with staff (EMP), it was determined the facility failed to follow their policy regarding the administration of multi-dose vial medications in an immediate patient care area (pre-operative bay).

Findings include:

Review on August 9, 2018, of facility policy "Infection Control Plan" revealed, "I. Safe Injection Practices...6. Do not keep multidose vials in the immediate patient treatment area; discard if sterility is compromised or questionable."

Review on August 9, 2018, of document "Centers for Disease Control and Prevention" last revised August 16, 2016, revealed "If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only .... . Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays."

2. Observation on August 9, 2018, at 12:45PM, preoperative area Bay 2 revealed EMP4 administering the following eye drops to MR1: Ofloxacin Opthalmic 0.3%, Phenylephirne Hydrochloride Ophthalmic 2.5% and Proparacine Hydrochloride Ophthalmic 0.5%. Further observation at 12:50PM revealed EMP5 administering the following eye drops: Typicamide Ophthalmic Solution USP 1% and Brimonidine Tartrate Ophthalmic 0.2%. In addition, the dates on the ophthalmic solution bottles were labeled as opened on August 1, 2018, and each bottle had been previously opened and was partially empty.

Observation on August 9, 2018, at 12:58 PM, preoperative area Bay 3 revealed EMP4 administering the following eye drops to M2: Ofloxacin Opthalmic 0.3%, Phenylephirne Hydrochloride Ophthalmic 2.5% and Proparacine Hydrochloride Ophthalmic 0.5%. Further observation at 1:03 PM revealed EMP5 administering the following eye drops: Typicamide Ophthalmic Solution USP 1% and Brimonidine Tartrate Ophthalmic 0.2%. In addition, the dates on the ophthalmic solution bottles were labeled as opened on August 1, 2018, and each bottle had been previously opened and was partially empty.


An interview conducted on August 9, 2018, at 3:00PM with EMP1 confirmed that MRI and MR2 received multi-dose vial eye drops as listed above in Bay 1 and Bay 2 in the preoperative area. EMP1 also confirmed that EMP4 and EMP5 failed to follow the facility's policy and had administered the multi-dose ophthalmic solutions in Bay 2 and Bay 3 which was considered an immediate patient care area according to the facility's policy. In addition, EMP1 confirmed that the ophthalmic solutions were used for more than one patient in the bays of the preoperative area.























Plan of Correction:

The director of nursing/administrator, utilizing the CDC and AORN websites on Hand Hygiene developed a continuing education for each discipline (medical, clinical, anesthesia, and non- clinical staff) identifying the importance of correct hand hygiene/hand washing in protecting everyone from the spread of infection.
The policy for hand hygiene was reviewed with the clinical and non-clinical staff at the September staff meeting as documented on assign-in sheet The physicians and Anesthesia staff will receive the revised policy for Hand washing and Hand Hygiene to read, review, and sign which will then be placed in their credentialing file.
1. The Hand Hygiene – Hand washing education with posttest will be given to all Clinical and non-clinical staff, physicians and Anesthesia staff with the posttest placed in their files.
2. The Hand Hygiene-Hand washing education with posttest will become part of the annual education for all personnel working at Delaware Valley Laser Surgery Center.
3. The new Hand Hygiene audit, approved at the emergency Governing Board meeting on October 11, 2018 and reflected in the minutes will increase surveillance to every surgical day in a quarter, the information will be tallied and reported each quarter at the Governing Board, Medical Staff, QA/PI/Risk Management, and Infection Control meetings as demonstrated through their minutes. This audit will be completed every surgical day for 1 year (4 quarters) for each discipline (clinical, non-clinical, CRNAs and physician staff)
4. The DON/Administrator will be responsible for monitoring compliance as well as addressing noncompliance. Non-compliance with Clinical and non-clinical staff will result in disciplinary action, re-education of the policy and procedure for correct Hand Hygiene, and completion of the course "Hand Hygiene and other standard precautions to prevent Healthcare associated infections" found on the CDC website. Surgeons and Anesthesia personnel non-compliance will be addressed by the Medical Director and will include re-education of the policy and procedure for correct hand hygiene and the CDC course "Hand Hygiene and other standard precautions to prevent Healthcare associated infections.
The DON/Administrator is responsible to monitor continued compliance of this plan of correction.



The director of nursing/administrator revised the policy "Safe Medication Administration' to include eye drop bottles.
This policy revision includes the addition of the following:
Eye drop bottles:
Eye drop bottles are multi-dose bottles.
Eye drop bottles are to be kept on the small rolling medication cart outside of the individual patient care area as designated by the ceiling curtain tracks.
If there are any questions regarding the sterility of an eye drop bottle, it is to immediately be discarded and a new bottle opened.
If rolling medication cart is placed within the immediate patient care area, the eye drop bottles are considered single use and must be discarded when that patient no longer needs them.

Eye drops drawn up into a syringe must be considered single use, the syringe needs to be labeled with the name of the medication(s), the date and time drawn up, the time it should be discarded, and the name of the person who drew up the medication(s) initials.

Eye drops which are drawn up on site are good for 1 hour, then must be discarded.

For eye drops compounded at a pharmacy, the expiration date shall be per the pharmacy.

The changes to the policy was submitted and approved at the emergency Governing board meeting on October 11, 2018 and reflected in the minutes.
This revised policy will be reviewed by all Clinical, Non Clinical, and anesthesia personnel at the next staff meeting. The physicians will review this revised policy at the medical staff meeting on October 22, 2018.
An audit utilizing surveillance during eye drop application was created for data collection by the DON/Administrator. 10 patient observations will be done per month with the data reported on a quarterly basis at the QA/PI/Risk Management, Infection Control, Patient Safety, Medical Staff, Governing Board, and monthly nursing staff meetings as reflected in their minutes.
This audit will include the following observations:
Correct eye drop instillation without compromise to the bottle sterility was completed
The medication cart was stationed outside of the immediate patient care area
Correct hand hygiene was utilized before and after dispensing eye drops.
The DON/Administrator will monitor staff compliance with these changes, non-compliance will result in a review of our policy regarding safe medication practice as well as disciplinary action.
The DON/Administrator is responsible to monitor that continued compliance to the plan of correction occurs.



Initial Comments:

This report is the result of a State licensure survey conducted on August 9, 2018, and completed on August 10, 2018, at Delaware Valley Laser Surgery Institute. 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:




555.22 (b) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of patient's clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who shall participate in the surgery.


Observations:

Based on review of facility policy, observation, medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure that informed consent was properly obtained by the physician for two of two medical records review (MR1 and MR2).

Findings include:

Review on August 9, 2018, of facility policy "Informed Consent-General, Section 3.24" last revised March 25, 2015, revealed "... . The purpose of informed consent is to provide information to the patient/patient's authorized representative with which the decision may be made whether to consent to treatment. ... Procedure... . 6. It is the responsibility of the physician to obtain informed consent."

Observation on August 9, 2018, at 12:15 PM in the preoperative area revealed MR1 was given a document to sign by EMP5, a nurse. Further observation revealed that MR1 was signing a "Informed Consent" document. There was no documented evidence that the physician obtained the informed consent from MR1.

Observation on August 9, 2018, at 12:20PM in the preoperative area revealed MR2 was given a document to sign by EMP5, a nurse. Further observation revealed that MR2 was signing a "Informed Consent" document. There was no documented evidenced that the physician obtained the informed consent from MR2.

Interview on March 4, 2016, at 12:42PM, with EMP 1 stated "While the nurse may present the form to the patient to sign, at some point the physician should talk to the patient about the procedure. EMP1 further stated "I will review the consent process with my staff to ensure we are compliant with the state regulation. EMP1 was unable to produce additional documentation that the physicians for MR1 and MR2 had discussed and obtained the Informed Consent for the surgical procedures.

__________________________


Based on review of facility document, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure that a properly executed consent form was completed prior to the procedure for two of two medical records reviewed (MR1 and MR2).

Findings include:

A review on August 10, 2018, of facility document "Medical Staff Rules and Regulations" not dated revealed "Evidence that the physician or practitioner has obtained informed consent from a patient ... shall be in the form of a consent form signed by the patient ... and the physician or practitioner who actually obtains the informed consent."

A review on August 10, 2018, of MR1 revealed the patient was admitted to the facility for a procedure on August 9, 2018, and received monitored anesthesia care (MAC). There was no documentation in MR1 that the anesthesia consent form was signed by an anesthesiologist. Further review revealed no evidence in MR1 that the anesthesia consent form was signed by a provider.

A review on August 10, 2018, of MR2 revealed the patient was admitted to the facility for a procedure on August 9, 2018, and received monitored anesthesia care (MAC). There was no documentation in MR2 that the anesthesia consent form was signed by an anesthesiologist. Further review revealed no evidence in MR2 that the anesthesia consent form was signed by a provider.

An interview conducted on August 10, 2018, at 2:57 PM with EMP1 confirmed there was no documentation of a properly executed informed consent form in MR1 and MR2 confirmed the anesthesia consent form was not signed by an anesthesiologist. EMP1 also stated a provide should have cco-signed the anesthesia consent form .














Plan of Correction:

The DON/Administrator revised the current policy regarding Informed Consent – general to include the following revision:

1. Only the surgeon of record can obtain informed consent from a patient or a patient's representative. The clinical staff may witness the patient's signature but are not to obtain consent from the patient
2. The RN is not to obtain Informed Consent from the patient or the patient representative. The RN may only witness the patient's signature.
3. The consent form must be read to patients who are unable to read the form. In such instances, the patient must be asked whether he/she understands what he/she is signing and such acknowledgement must be noted in the patient's record. If the patient has limited English proficiency, a language line translator will be utilized and the translators' id number documented in the pre-op record
4. For the Anesthesia Informed Consent, the CRNA will ex plain the type of anesthesia being utilized, the medications used, documenting the risks and possible complications as well as the benefits and alternatives to monitored anesthesia care. The surgeon will ascertain prior to the procedure/treatment that the patient and/or patients' representative has no questions regarding the anesthesia they shall receive during their procedure/treatment, and will sign the anesthesia consent.
5. Pre-procedure medications may not be administered prior to the patient signing both the Surgical and Anesthesia consents.
The revision of this policy was approved at an emergency governing board meeting on October 15, 2018 as reflected in the minutes. The policy changes will be presented to the medical staff on October 22, 2018 and will be reflected in the minutes. The clinical and non-clinical personnel will be educated on the revision changes to this policy at the next staff meeting as shown through the sign-in and the minutes.
A QA/PI audit was developed utilizing surveillance during informed consent
1. Yes or no did the physician obtain consent from the patient /patient representative.
2. Yes or no did the physician answer any and all questions or concerns the patient/patient representative had.
3. Yes or no did the physician co-sign the anesthesia consent
1 patient/physician observation and chart review will take place each surgical day for 26 weeks with the data findings reported at the QA/PI/Risk Management, Medical Staff meeting, patient safety and Governing Board meeting and reflected in their minutes.

The DON/Administrator will be responsible for monitoring compliance of this plan of correction

10 patient/physician observations and chart reviews will take place during consent, on a weekly basis for 26 weeks with the data findings reported at the QA/PI/Risk Management, Medical Staff, Patient Safety and Governing Board meetings and reflected in their minutes.
The quarterly anesthesia peer review has been revised to include
1. The attending physician signed the anesthesia consent
2. The attending physician documented that the patient/patient representative understood the information regarding their anesthesia plan, and had no questions as documented in the pre-anesthesia & post-anesthesia record

The Medical Director will be responsible for monitoring compliance of this plan of correction with the assistance of the DON/Administrator


The revised Anesthesia consent and the revised Informed Consent policy was presented and approved at an emergency governing board meeting on October 11, 2018 as reflected in the minutes. The Anesthesia consent, Informed Consent policy revisions will be presented at the Medical staff meeting on October 22, 2018 which will be reflected in the minutes, and at the next staff meeting.(October 2018)




555.33 (d)(2) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(2) A review and documentation shall be made of the condition of the patient immediately prior to induction of anesthesia, including pertinent laboratory findings, time of administration and dosage of pre anesthesia medications.

Observations:
Based on a review of facility policy, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure that the patient's condition was reviewed and evaluated by an anesthesiologist immediately prior to the induction of anesthesia for two of two medical records reviewed (MR1 and MR2).

Findings include:

Review on August 10, 2018, of facility policy "Conduct of Anesthesia" revealed "Each patient scheduled to receive anesthesia will be evaluated by an anesthesiologist who will fill in the preoperative evaluation form. Among other matters, the evaluation will include a chart review...a physical evaluation... . "

Review on August 10, 2018, of MR1 admitted on August 9, 2018, revealed MR1 had monitored anesthesia care (MAC). The medical record did not contain documentation that the patient was preoperatively evaluated by an anesthesiologist immediately prior to the administration of MAC.

Review on August 10, 2018, of MR2 admitted on August 9, 2018, revealed MR2 had monitored anesthesia care (MAC). The medical record did not contain documentation that MR2 was preoperatively evaluated by an anesthesiologist immediately prior to the administration of MAC.

An interview conducted on August 10, 2018, at 2:10 PM with EMP1 confirmed MR1 and MR2 had received monitored anesthesia care for the August 9, 2018, surgical procedures. Further interview confirmed that MR1 and MR2 did not contain documentation that a preoperative evaluation was completed by an anesthesiologist immediately prior to the administration of MAC.









Plan of Correction:

A Director of Anesthesia Services was appointed at the October 11, 2018 emergency Governing Board meeting for the Delaware Valley Laser Surgery Institute. The appointment is reflected in the minutes of this meeting and effective immediately.
The Director of Anesthesia Services will oversee the CRNA, or direct the surgeon to oversee the pre-anesthesia assessment by the CRNA. The pre-anesthesia assessment will be signed by both the CRNA and the surgeon.
The following change was made to the intraoperative anesthesia record in the Pre-anesthesia assessment section:
"M.D. Signature: ____________________
The change was approved at the emergency governing board meeting on October 11, 2018 and is reflected in the minutes.
Revision of the following policy pertaining to Anesthesia care
Clinical Policy and Procedures/Section 4/Anesthesia
Policy 4.7 Anesthesia Peer Review
Under purpose: the following has been added: "anesthesiologists and/or CRNA's under the supervision of the physician and the Director of Anesthesia, utilizing established criteria."
All policy revisions were approved at an emergency Governing Board meeting on October 11, 2018 and reflected in the minutes. The current anesthesia peer review audit was revised to include:
1. M.D. signature on the anesthesia pre-assessment section of the anesthesia intra-operative record
2. Pre-op patient assessment completed prior to surgery
The current anesthesia peer review audit revisions were approved at an emergency Governing Board meeting on October 11, 2018 as reflected in the minutes.
10 charts per month
These changes will be presented to the Clinical and non-clinical and anesthesia staff at the next staff meeting, to the physicians at the quarterly Medical staff meeting on October 22, 2018, which will be reflected in each meetings minutes.
The DON/Administrator will be responsible to monitor continued compliance of this plan of correction, and report findings to the Director of Anesthesia services and the Medical Director.



555.33 (d)(8)(i-v) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) level of activity
(ii) respirations
(iii) blood pressure
(iv) level of consciousness
(v) oxygen saturation by pulse oximetry.

Observations:
Based on a review of facility policy, medical record (MR) and interview with staff (EMP), it was determined the facility failed to ensure that a complete post anesthesia evaluation was performed prior to discharge for two of two medical records reviewed (MR1 and MR2).

Findings include:

Review of facility's policy "Governing Body/Ownership" last revised April 10, 2015, revealed "Purpose: The Governing Body of the Surgery Center acts as a single managing body for that center. It has the ultimate authority and responsibility for the overall operations and the patient care within the Center."

Review of facility policy "Anesthesia Criteria for Discharge to PACU (Post Anesthesia Care Unit)" Section 4.8, effective October 17, 2017, revealed "Prior to discharge from the Operating Room Suite to the PACU the Anesthesia Provider shall evaluate and document the patient's condition. The following criteria will be evaluate: 1. Patient's destination-PACU or other. 2. Vital Signs (VS) prior to discharge from Operating Room. 3. The patient's condition after surgery. 4. Any complications. 5. The patient mentation after surgery. 6. The patient's level of activity after surgery."


Review on August 10, 2018, of MR1 admitted on August 9, 2018, for a right eye cataract extraction procedure revealed the patient's level of activity was not assessed by an anesthesiologist during the post anesthesia evaluation prior to discharge. Further review revealed MR 1 received conscious sedation through monitored anesthesia care.


Review of August 10, 2018, of MR2 admitted on August 9, 2018, for a right eye cataract extraction procedure revealed the patient's level of activity was not assessed by an anesthesiologist during the post anesthesia evaluation prior to discharge. Further review revealed MR2 received conscious sedation through monitored anesthesia care.


An interview conducted on August 10, 2018, at 1:25PM with EMP1 confirmed that MR1 and MR2 did not contain documentation that the patient's level of activity was assessed by an anesthesiologist during the post anesthesia evaluation prior to discharge. EMP1 confirmed that MR1 and MR2 received monitored anesthesia care.

Cross Reference:
Repeat Deficiency: October 10, 2017








Plan of Correction:

Prior to discharge, each patient will receive a post anesthesia assessment by the CRNA and surgeon which will include:
1. Level of activity
2. Vital Signs
3. Level of consciousness
4. Blood loss

This information will be documented in the post anesthesia assessment section of the anesthesia Intraoperative record with signatures of both the CRNA and the physician. The revised record was presented and approved at an emergency Governing board meeting on October 15, 2018.
This evaluation needs to be done by the anesthesia provider under the direct supervision of the physician

The revisions to the post–anesthesia assessment will be presented to all disciplines (clinical, non-clinical, anesthesia, physician, CRNA) at the next staff meeting, as reflected in the minutes and the sign-in sheet.

The following policy was reviewed, and revisions approved by the Governing Board as reflected in the minutes at an emergency Governing Board meeting held October 15, 2018
The following policy was revised:
Clinical Manual: Section 4-Anesthesia: policy 4.8 Anesthesia Criteria for Discharge to PACU
Procedure: Prior to discharge from the ASC, the CRNA and physician shall evaluate and document the patient's condition.

The following criteria will be evaluated:
1. The patient's destination-home or other __________
2. Vital signs prior to discharge
3 Any complications
4 The patient's mentation after surgery
5 The patient's level of activity after surgery
6 Patient blood loss

Clinical Manual: Section 4-Anesthesia: policy 4.1 Department of Anesthesia

Revisions were made to the section: Procedure: g. Patients who receive anesthesia care will be evaluated by a CRNA and the physician prior to discharge.
The clinical and non-clinical staff, as well as CRNA's will be presented with the revised policies and the additions to the post-assessment during the next staff meeting as reflected in the minutes and sign-in sheet

An audit was developed to review documentation of the post-anesthesia assessment prior to discharge. The audit will look for documentation of the following:

1. Vital signs
2. Level of activity
3. Level of consciousness

The audit will be done on each surgical day per month, data will be collected, and the results reported each quarter at the patient safety, medical staff, and governing board meetings.

The DON/Administrator will be responsible for collecting the data and reporting the findings to the Director of anesthesia and the Medical Director who will be responsible for the ongoing implementation of the plan of correction



567.1 Principle LICENSURE
CHAPTER 567 - ENVIRONMENTAL SERVICES

Name - Component - 00
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 review of facility policy, observations, and interview with staff (EMP) it was determined that the facility failed to follow their policy for hand hygiene.

Findings included:

Review on August 9, 2018, of facility policy "Handwashing and Hand Hygiene-Section 2.10" revealed "...Indications for Hand-washing/Hand Hygiene: Before and after situation in which hands are likely to become contaminated. Before and after contact with a patient's intact skin (e.g. taking a pulse or blood pressure, performing physical examinations, lifting the patient in bed). After contact with environmental surfaces in the immediate vicinity of a patient. Between patient contact. After glove removal."

1. Observation on August 9, 2018, at 12:21PM of EMP4 in the preoperative area providing care to MR1 revealed EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves.

Observation on August 9, 2018, at 12:25PM of EMP4 in the preoperative area providing care to MR2 revealed EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves.

An interview conducted on August 9, 2018, at 12:30PM with EMP1 confirmed that EMP4 failed to perform hand hygiene after direct contact with the patient's skin and prior to donning gloves in the preoperative area for MR1 and MR2.


2. Observation on August 9, 2018, at 2:02PM of EMP2 in OR1 during a surgical procedure for MR2 revealed EMP2 failed to perform hand hygiene after removing a soiled glove from the floor of OR1. Further observation of EMP2 in OR1 during a surgical procedure for MR2 revealed EMP2 opening and closing drawers of the anesthesia cart, medication administration during the surgical procedure and completing paperwork. EMP2 did not perform hand hygiene before and after each of the activities listed above and did not change gloves at anytime during these tasks.

An interview conducted on August 9, 2018, at 2:57 PM with EMP1 confirmed that EMP2 failed to perform hand hygiene after removing a soiled glove from the floor of OR1 during a surgical procedure for MR2 and performing various environmental activities during the surgical procedure without performing hand hygiene between each of the tasks. In addition, EMP2 stated "I think we have a lot of hand hygiene education to do so that we can comply with the facility's policy."

_______________________

Based on facility policy, observation, documents, and interview with staff (EMP), it was determined the facility failed to follow their policy regarding the administration of multi-dose vial medications in an immediate patient care area (pre-operative bay).

Findings include:

Review on August 9, 2018, of facility policy "Infection Control Plan" revealed, "I. Safe Injection Practices...6. Do not keep multidose vials in the immediate patient treatment area; discard if sterility is compromised or questionable."

Review on August 9, 2018, of document "Centers for Disease Control and Prevention" last revised August 16, 2016, revealed "If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only .... . Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays."

2. Observation on August 9, 2018, at 12:45PM, preoperative area Bay 2 revealed EMP4 administering the following eye drops to MR1: Ofloxacin Opthalmic 0.3%, Phenylephirne Hydrochloride Ophthalmic 2.5% and Proparacine Hydrochloride Ophthalmic 0.5%. Further observation at 12:50PM revealed EMP5 administering the following eye drops: Typicamide Ophthalmic Solution USP 1% and Brimonidine Tartrate Ophthalmic 0.2%. In addition, the dates on the ophthalmic solution bottles were labeled as opened on August 1, 2018, and each bottle had been previously opened and was partially empty.

Observation on August 9, 2018, at 12:58 PM, preoperative area Bay 3 revealed EMP4 administering the following eye drops to M2: Ofloxacin Opthalmic 0.3%, Phenylephirne Hydrochloride Ophthalmic 2.5% and Proparacine Hydrochloride Ophthalmic 0.5%. Further observation at 1:03 PM revealed EMP5 administering the following eye drops: Typicamide Ophthalmic Solution USP 1% and Brimonidine Tartrate Ophthalmic 0.2%. In addition, the dates on the ophthalmic solution bottles were labeled as opened on August 1, 2018, and each bottle had been previously opened and was partially empty.


An interview conducted on August 9, 2018, at 3:00PM with EMP1 confirmed that MRI and MR2 received multi-dose vial eye drops as listed above in Bay 1 and Bay 2 in the preoperative area. EMP1 also confirmed that EMP4 and EMP5 failed to follow the facility's policy and had administered the multi-dose ophthalmic solutions in Bay 2 and Bay 3 which was considered an immediate patient care area according to the facility's policy. In addition, EMP1 confirmed that the ophthalmic solutions were used for more than one patient in the bays of the preoperative area.



























Plan of Correction:

The director of nursing/administrator will develop an education for the Medical and Clinical and non- clinical staff including anesthesia personnel on the failure to follow the Delaware Valley laser Surgery Institute for hand hygiene.

1. The policy for hand hygiene was reviewed with the clinical and non clinical staff at the September staff meeting.
The physicians and Anesthesia staff will receive the revised policy for Hand washing and Hand Hygiene to read, review, and sign by October 12, 2018 which will then be placed in their credentialing file.
2. The Hand Hygiene – Hand washing education with post test will be given to all Clinical and non-clinical staff, physicians and Anesthesia staff by October 12, 2018. The Post test will be placed in their files.
3. The Hand Hygiene-Hand washing education with posttest will become part of the annual education for all personnel working at Delaware Valley Laser Surgery Center.
4. The current Hand Hygiene audit will increase surveillance to every surgical day in a quarter, the information will be tallied and reported each quarter at the Governing Board, Medical Staff, QA/PI/Risk Management, an d Infection Control and will be demonstrated through their minutes
5. The DON/Administrator is responsible for monitoring compliance as well as addressing noncompliance. Non-compliance with Clinical and non-clinical staff will result in disciplinary action re-education of the policy and procedure for correct Hand Hygiene and they will need to utilize the cdc website to take the course "Hand Hygiene and other standard precautions to prevent Healthcare associated infections" . Surgeons and Anesthesia personnel non-compliance will be addressed by the Medical Director and will include re-education of the policy and procedure for correct hand hygiene and the cdc course "Hand Hygiene and other standard precautions to prevent Healthcare associated infections




The director of nursing/administrator will revise the policy "Safe Medication Administration' to include eye drop bottles.
This policy revision includes the addition of the following:
Eye drop bottles:
Eye drop bottles are multi-dose bottles.
Eye drop bottles are to be kept on the small rolling cart outside of the individual patients 'care area. If there is any question regarding the sterility of the bottle, it is to immediately be discarded and a new bottle opened
If for whatever reason the small rolling medication cart is placed within the immediate patient care area, the eye drop bottles are considered single use and must be discarded when that patient no longer needs them.
Eye drops drawn up into a syringe must be considered single use, the syringe needs to be labeled with the name of the medication(s), the date and time drawn up, the time it should be discarded, and the name of the person who drew up the medication(s) initials.
Eye drops which are drawn up on site are good for 1 hour, then needs to be discarded.
For eye drops compounded at a pharmacy, the expiration date shall be per the pharmacy.

The changes to the policy will be submitted for approval to the Governing board at the next quarterly meeting with the approval reflected in the minutes.

The policy revision will be reviewed by all Clinical, Non Clinical, physicians, and anesthesia personnel and at the next monthly staff meeting.

An audit utilizing surveillance during eye drop application will be created for data collection with 10 patients' observations per month

This audit will include correct eye drop dispension without compromise to the bottle sterility; the medication cart stationed with the eye drops outside of the patients care area; correct hand hygiene utilized during patient medication
This information will be collected, correlated with the quarterly infection control information regarding post surgical site infection information which is given to the center by the physicians on a quarterly basis. the findings will be presented at the QA/PI/Risk Management, Infection Control, Patient Safety, Medical Staff, Governing Board and monthly Nursing staff meetings and will be reflected in their minutes.

Failure to comply with these changes by a staff member will result in a review of our policy regarding safe medication practice as well as disciplinary action.


The DON/Administrator will be responsible to monitor continued compliance of this plan of correction.