QA Investigation Results

Pennsylvania Department of Health
PLANNED PARENTHOOD OF WESTERN PA (WHS)
Health Inspection Results
PLANNED PARENTHOOD OF WESTERN PA (WHS)
Health Inspection Results For:


There are  19 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 an unannounced onsite pre-licensure and occupancy survey conducted on May 31-June 1, 2012, at Planned Parenthood of Western PA WHS. It was determined that 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 and the current of the Guidelines for Design and Construction of Hospital and Health Care Facilities.







Plan of Correction:




551.21 (e)(1-3) LICENSURE
Criteria for ambulatory surgery

Name - Component - 00
551.21 Criteria for ambulatory surgery

(e) In obtaining informed consent, the practitioner performing the surgery shall be responsible for disclosure of:
(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.
(2) The risks, benefits and alternatives associated with the procedure which will be performed.
(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.

Observations:

Based on review of facility documents and staff interview (EMP) it was determined the facility failed to ensure practitioners documented informed consent that included the disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital.

Findings include:

Review of the facility's informed consent forms revealed the forms did not include the comparative risks, benefits, and alternatives associated with performing the procedure in the Ambulatory Surgical Facility (ASF) instead of the hospital.

Interview on May 31, 2012, at 12:50 PM with EMP1 confirmed the lack of documentation and revealed, "We know we have to update the consent to include that."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP consulted with the Consortium of Abortion Providers (CAPS) regarding the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital. CAPS is submitting the revised Client Information for Informed Consent (CIIC) for In-Clinic Abortion to the Planned Parenthood Federation of America (PPFA) for approval on 6/25/12. Upon PPFA approval, all staffs will be informed of the revision by the Medical Director and instructed to implement the new form upon receipt. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor that the revised CIIC is being provided to all clients by conducting a random chart audit for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


551.22 (a)(4) LICENSURE
Criteria for Performance of Pediatric Patient

Name - Component - 00
551.22. Criteria for Performance of Ambulatory Surgery on Pediatric Patients

(a) 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.
(4) A medical professional who has successfully completed a course in advanced pediatric life support offered by the American Academy of Pediatrics and either the American College of Emergency Physicians or the American Heart Association shall be present in the facility.

Observations:

Based on review of credential files, and staff interviews (EMP), it was determined the facility failed to make sure a medical professional that successfully completed a course in advanced pediatric life support offered by the American Academy of Pediatrics and either the American College of Emergency Physicians or the American Heart Association was present in the facility.
Findings include:
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 identified by the facility as all of the physicians that practiced there including one Physician Assistant (PA-C), on May 31, 2012 between 11:00 AM and 11:30 AM revealed no documentation that any medical professional had completed a course in advanced pediatric life support (PALS) offered by the appropriate organizations.
Interview on May 31, 2012, at approximately 1:00 PM with EMP1 confirmed the above findings, that the facility did not employ any RNs, and revealed, "EMP5 is currently taking ACLS and PALs training."








Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 21012. PPWP has taken the following steps to ensure compliance: Two staff members are scheduled for PALS training on September 19 and 20, 2012 with the American Academy of Pediatrics and American Health Association, which is the soonest date a training course is available.

Monitoring for compliance will include staff education by the VP of Operations for the staff scheduler to ensure there is awareness and understanding of the requirements for PALS trained staff.

The Quality Assurance calendar currently used by human resources to monitor expiration of licenses, CPR and credentialing on a monthly basis has been modified to include ACLS and PALS expiration dates. Human resources staff will monitor expiration dates and notify staff 4 months prior to any item expiring.

The Surgical Site Supervisor or designee will monitor by doing random site inspections to ensure that a PALS certified staff member is on the premises when a minor is in the facility during clinic hours. The random checks will occur weekly for three months following completed certification.

Monitoring of the Governing Board’s review of completion of PALS training will be the responsibility of the CEO, who will ensure this is included on the Governing Board’s meeting agenda and will sign off on all board minutes to verify discussion of this information at the board meeting.

The PPWP RQM Oversight Committee will be informed of the corrective action taken and the Governing Body will be informed of the deficiency and its resolution.




553.3 (5)(i)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(5) Adopting bylaws or similar rules and regulations for the orderly development and management of the ASF, which:
(i) Describe the authority delegated to the person in charge and to the medical staff.
(ii) Require the governing body to review and approve the bylaws, or similar rules and regulations, of the medical staff.

Observations:

Based on review of facility documents and staff interview it was determined the governing body failed to adopt Bylaws, or similar Rules and Regulations that described: 1) The authority delegated to the medical staff, 2) The requirement that the medical staff review and approve the bylaws or similar rules and regulations of the medical staff, 3) The requirement that personnel policies mandated that licensed staff would only be hired after obtaining written references, 4) Reviewing legal and ethical matters concerning the ASF including the reports and disposition of unusual incidents
Findings include:
Review of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc." revealed no mention of what authority is delegated to the medical staff or the need for the governing body to approve the bylaws or similar rules and regulations of the medical staff.
Interview on June 1, 2012, at approximately 11:30 AM with EMP2 confirmed there was nothing in the bylaws that spelled out the authority delegated to the medical staff and there was no requirement for the policies, protocols, etc. of the facility to be approved by the governing body at this time.








Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Board of Directors adopted a Board policy on June 4, 2012 and adopted a second more comprehensive policy on June 20, 2012 that clearly outlines all governing board responsibilities, including a requirement that each medical staff member to sign a job description that includes the responsibilities of that position and the authority delegated to that staff member. The policy also states that the Governing Board approves the PPWP medical standards and guidelines, which serve as the rules and regulation of the medical staff, and the job responsibilities signed by the medical staff acknowledges that services will be delivered and policies followed according to the clinical standards and guidelines. This same policy states that written references must be obtained for the medical staff and states the Governing Body’s responsibility to review legal and ethical matters concerning the ASF including reports of unusual incidents.

Monitoring of this policy will occur with any changes made to this policy to ensure the changes are put into effect.

Monitoring of the elements of the policy will be done to ensure compliance policies through a checklist maintained by human resources staff for the personnel files. This checklist will monitor the medical staff member signature of the job responsibilities and the authority delegated to them, verify that written references were obtained and provide documentation of all other required elements of the personnel file. The CEO will monitor compliance through periodic review of the checklist and review of the documentation in the personnel file.

Monitoring will also be done through an employment law attorney who will review all job descriptions, and this legal review will be monitored through a log maintained by human resources staff showing which job descriptions are under review, the date the review is completed and the date the job description is re-signed if needed.

Monitoring the review of all legal and ethical matters including unusual events will include training staff responsible for patient safety and quality assurance to be aware that these matters and events must be brought to the attention of the CEO for presentation to the Governing Board.

Monitoring of the Governing Board’s review of all legal and ethical matters will be the responsibility of the CEO, who will ensure this is included on the Governing Board’s meeting agenda and will sign off on all board minutes to verify discussion of this information at the board meeting.

PPWP RQM Oversight Committee will be informed of the policy change and the corrective action taken.





553.3 (8)(i) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(i) Require the employment of personnel with qualifications commensurate with a job's responsibilities and authority, including appropriate licensure and certification.


Observations:

Based on review of facility documents, credential files (CF), personnel files (PF), and staff interview (EMP), it was determined the governing body failed to recognize their responsibility to establish personnel policies and procedures requiring the employment of personnel with qualifications commensurate with the job's responsibilities and authority.

Findings include:

Review on June 1, 2012, of the March 9, 2011 "Bylaws of Planned Parenthood of Western Pennsylvania, Inc." revealed no requirement for the governing body to establish policies and practices that require the employment of personnel with appropriate certifications. Review of credential files and personnel files on May 31, 2012, failed to reveal any documentation of staff with current Advance Life Support certifications or pediatric certifications. Interview on May 31, 2012, at approximately 1:00 PM with EMP1 confirmed the above findings and revealed, "EMP5 is currently taking ACLS and PALS training."

Review of the October 2011 "Health Care Assistant-Counseling" job description revealed the qualifications were high school diploma or GED and 2 years additional educational and/or work experience. Further review revealed, "Essential Functions-Duties and Responsibilities Pre-procedure Counseling Responsibilities A. Obtains and interprets pulse, temperature, ... B. Discreetly interviews patient: -discusses options -assess readiness for abortion and provides emotional support -educates about surgery and medication abortion, discomfort and coping skills -reviews PAB instructions -obtains signature on consent forms and 24 hour certification -refers for other services or further counseling if necessary ... E. Collects lab results ... Abortion Procedure Room Counseling/Flow Facilitator Responsibilities ... Logs all medical abortion medications and have everything in the room except for the Mifiprex prior to the MD entering the room... E. Discusses pain management with patient and support person, if applicable ... Assists in emergency procedures as trained... K. After procedure, assist patient, escorts to recovery area, documents chart and relays pertinent information regarding patient to recovery room nurse, measures blood pressure... N. Accompanies patients during lamicel insertion, emergency visits and sonograms..."

Review of the October 2011 job description "Patient Contact Coordinator" revealed qualifications for the job were a high school diploma or GED and two years educational and/or work experience after high school. "Serves a s a liaison between the patient and physician. Explains test results, clinical problems and recommendations for treatment or followup as directed by the physician. Also performs some or all of the tasks of a Health-Care Assistant... D. Informs patients of abnormal test results and communicates treatment or followup plan as directed by MD or ACHD... E. Call pharmacists with prescriptions ordered by MD... Pre-procedure Counseling Responsibilities A. Obtains and interprets pulse, temperature, blood pressure ... B. Discreetly interviews patient: -discusses options ... educates about surgery and medication abortion, discomfort and coping skills -reviews PAB instructions -obtains signature on consent forms and 24 hour certification ... Abortion Procedure Room Counseling Responsibilities ... G. Assists in emergency procedures as trained..."

Review of the October 2011 job description for "Purchasing and Clinic Coordinator" revealed, "Responsible for purchasing clinic and laboratory supplies serving as administrative back-up to the Surgical Site Supervisor, and performing all tasks of the Health Care Assistant ... Clinical Coordinator Responsibilities -Serves as staff in charge as assigned by the Surgical Site Supervisor... Purchasing Responsibilities ...Compiles DEA forms to buy controlled substances and maintains the controlled substances inventory log... -Stocks crash cart and updates log. -Obtains and interprets pulse, temperature, blood pressure and measures height and weight of patient... -discusses options ,,, -educates about surgery and medication abortion, discomfort and coping skills -reviews PAB instructions -obtains signature on consent forms and 24 hour certification ... Abortion Procedure Room Counseling Responsibilities ... Assists in emergency procedures as trained... -Takes patient's blood pressure after procedure with sedation. -After procedure, assists patient, admits to recovery area, documents chart and relays pertinent information regarding patient to recovery room nurse... Qualifications -High-school diploma or GED. -Must have two years educational and/or work experience after high school..."

Review of the September 2010 job description for "Nurse" revealed, "Plans and provides for delivery of optimal patient care. Facilitates and coordinates activities of recovery room. Identifies patient care priorities and uses available resources for delivery of care. The Nurse also assists in the procedure room ... Responsibilities A. Assess and admits patients to recovery room post-Ab; reviews medical history, operative report, physician orders for recovery and discharge. Charts blood pressure, pulse and level of discomfort. B. Administers medications before abortion procedure and in recovery room in accordance with established medical and nursing standards. C. Inserts IV's when needed... G. Initiates or assists in emergency care delivery in accordance with established medical standards... N. Trains staff to perform blood pressure, use of thermometer and emergency equipment... S. Performs ultrasound examination to determine gestational age and provides ultrasound guidance during second trimester abortion procedures... Qualifications A. Current license as a practical nurse in Pennsylvania. B. One year of experience preferred C. Current CPR certification..."

Review of the October 2011 "Front Receptionist" job description revealed, "The receptionist may perform some or all of the duties of the health care assistant... Pre-procedure Counseling Responsibilities A. Obtains and interprets pulse, temperature, blood pressure ... B. Discreetly interviews patient: -discusses options -assess readiness for abortion and provides emotional support -educates about contraceptive options ... Abortion Procedure Room Counseling Responsibilities ... E. Assists physician with instruments during the procedure... G. Assists in emergency procedures as trained. Calls for assistance when needed ... H. Takes patient's blood pressure after procedure with sedation. I. After procedure, assists patient, admits to recovery area, documents chart and relays pertinent information regarding patient to recovery room nurse... L. Accompanies patients during lamicel insertion, emergency visits and pelvic exams... Qualifications A. High-school diploma or GED. B. Must have two years educational and/or work experience after high school..."






Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Board of Directors adopted a Board policy on June 20, 2012 that requires the establishment of policies and practices to ensure employment of personnel with appropriate certifications. One staff member has completed ACLS training and a second staff member is registered for the training. Both of these staff members are scheduled for PALS training on September 19 and 20, 2012 which is the first date a training class is available with the required certification. Monitoring of the completion of the required ACLS and PALS course will be done by human resource staff through a checklist of required staff training. The CEO will notify the Governing Board when training is completed and include this notification in the Board minutes.

Each of the agency ASF job descriptions will be revised by management and reviewed by PPWP’s employment law attorney to ensure that the job qualifications, skills and training are appropriate for the responsibilities of the position. All agency job descriptions that are revised will be re-signed by the staff member.

Human resource staff will be responsible for monitoring the review of job responsibilities and ensuring the re-signing of job descriptions and responsibilities. The legal review will be monitored through a log maintained showing which job descriptions are under review, the date when the review is completed and the date the job description is re-signed, if applicable. Any future revisions of job responsibilities and job descriptions for medical staff will be reviewed by the employment law attorney and monitored according to this procedure. The CEO will monitor completion of this work and include on the governing board’s meeting agenda a report of the job description review and the outcome of the review.

Any staff member who is cross trained for a second position will have evidence of required training for both positions in their personnel file. Currently, there is no planned change in positions or cross training but if someone new is hired or cross-training is needed, the human resource staff will monitor the training and documentation to ensure both are complete and included in the personnel file.

The PPWP RQM Oversight Committee will be informed of the corrective action taken and the Governing Body will be informed of the deficiency and its resolution.



553.3 (8)(ii) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(ii) Applications for positions requiring a licensed person shall be hired only after obtaining verification of their licenses, records of education, and written references.



Observations:

Based on review of facility documents, credential files (CF), personnel files (PF), and staff interview (EMP), it was determined the governing body failed to establish personnel policies and practices which mandated that applicants for positions requiring a licensed person would only be hired after obtaining written references.

Findings include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc." revealed no mention of the need for the governing body to establish policies and practices that licensed staff be hired only after appropriate verification of work experience and obtaining written references for licensed staff.
Review of CF1, CF2. CF3, CF4, CF5, CF6, CF7, CF8, CF9, and PF1 and PF14, on May 31, 2012, failed to reveal written references prior to hire for licensed staff.
Interview on May 31, 2012, at approximately 3:00 PM with EMP2 confirmed the lack of written references.











Plan of Correction:

The effective date for this regulation was June
19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The governing board adopted a comprehensive policy on June 20, 2012 that requires the establishment of policies and procedures that licensed staff be hired only after appropriate verification of work experience, and obtaining written references for licensed staff. This policy is included in PPWP’s Human Resource Policies.

Monitoring will be done by human resource staff as new people are hired to ensure the proper information is gathered and included in the personnel file. A checklist will be used to monitor the documents included in the file and to verify that the required information was obtained and that the staff member was hired only after appropriate verification of work experience and after written references were obtained. The CEO will monitor this checklist and periodically review the contents of the personnel file. The governing board will monitor compliance through reports presented by the CEO at the board meeting. The Governing Board minutes will document when ASF medical staff is hired and that all required documentation was obtained for the personnel file.

The PPWP RQM Oversight Committee will be informed of the change and the corrective action taken.



553.3 (9) LICENSURE
Governing Body Responsibilities

Name - Component - 00
553.3 Governing Body responsibilities include:
(9) Reviewing legal and ethical matters concerning the ASF including
the reports and disposition of unusual incidents.



Observations:

Based on review of facility documents, and staff interview (EMP), it was determined the governing body failed to review legal and ethical matters concerning the ASF including the reports and disposition of unusual incidents.

Findings include:

Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc." revealed no mention of the requirement for the governing body to review legal and ethical matters concerning the ASF including the reports and disposition of unusual incidents.

Review on June 1, 2012, of the "Board of Directors Meeting" on January 11, 2012, March 14, 2012, and May 9, 2012, failed to reveal any review of reports and disposition of unusual incidents.

Interview on June 1, 2012, at approximately 2:00 PM with EMP2 confirmed the above findings.











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The governing board adopted a policy on June 20, 2012 that requires the board to review legal and ethical matters concerning the ASF including reports of unusual incidents. Future board meeting agendas will include an agenda item for this review as stated in the board policy.

Compliance will be ensured and monitored through staff education to make them aware that legal and ethical matters concerning the ASF including reports of unusual incidents must be brought to the attention of the CEO for presentation to the Governing Board.
Monitoring of the Governing Board’s review of all legal and ethical matters will be the responsibility of the CEO, who will ensure this is included on the Governing Board meeting agenda and is included in board minutes to verify discussion of this information at the board meeting.

The PPWP RQM Oversight Committee will be informed of the change and the corrective action taken.



553.3 (13)(i-iv) LICENSURE
Govern Body Responsibilities

Name - Component - 00
Governing Body responsibilities include:
(13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including, those concerning;
(i) The employment for contractual arrangements with practitioners and others providing direct patient care.
(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology , anesthesia and pharmaceutical services.
(iii) The provision of care by other health care organizations.
(iv) The provision of education to students and post graduate trainees.



Observations:

Based on review of facility documents, credential files (CF), and staff interview, it was determined the governing body failed to make a provision for all treatment related services including anesthesia.

Findings include:

Review of 28 Pa. Code 551.3 Definitions revealed, "Anesthesia- The use of pharmaceutical agents to induce the loss of sensation. For the purpose of this chapter, the term applies when any patient, in any setting receives, for any purpose, by any route, one of the following: ... (ii) sedation (with or without analgesia), for which there is a reasonable expectation that, in the manner used, will result in the loss of protective reflexes for a significant percentage of a group of patients."

Review of 28 Pa.Code 555.32(a) revealed, "Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetists and dentist anesthetists or practitioners..."

Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc." revealed no mention of the need for the governing body to make provisions for anesthesia staff to be in the facility as required by regulation whenever anesthesia was administered.

Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 did not reveal any documentation that any staff member was an anesthesiologist or certified registered nurse anesthesthetist (CRNA).

Interview on May 31, 2012, at approximately 3:00 PM with EMP2 confirmed the facility did not employ any anesthesiologists or CRNAs. "We do not give anesthesia. Only sedation."











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Board of Directors appointed the PPWP Medical Director as Director of Anesthesia Service at its June 4, 2012 Board of Directors meeting. This responsibility is documented in the Medical Director’s signed job description. The Governing Board adopted a Board policy on June 4, 2012 stating the Board’s responsibility for appointing the Director of Anesthesia.

Compliance will be monitored by the CEO who will notify the Governing Board of any change in the Medical Director and be responsible for making sure the Governing Board appoints another physician as Director of Anesthesia if the position is no longer filled. The PPWP RQM Oversight Committee will be informed of the change and the corrective action taken.




553.3 (16) LICENSURE
Govern Body Responsibilities

Name - Component - 00
553.3
Governing Body responsibilities include:
(16) Assuring that at least one medical professional in the facility when patients are present is currently and on an ongoing basis certified in advanced cardiac life support, or its successor. If a pediatric patient is present in the facility, the certification of the medical professional shall be in advanced pediatric life support as defined in section 551.22 (A)(4).


Observations:

Based on review of facility documents, credential files (CF), personnel files (PF), and staff interviews, it was determined the governing body failed to make sure that at least one medical professional in the facility is certified in advanced cardiac life support (ACLS) when patients are present and/or at least one medical professional in the facility is certified in advanced pediatric life support (PALS) when a pediatric patient is present in the facility.

Findings include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc" revealed no requirement for the governing body to ensure that one medical professional certified in ACLS is in the facility any time there is a patient in the facility or one medical professional certified in PALS when there is a pediatric patient in the facility.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, CF9 and PF1, and PF14 revealed no documentation of any medical professionals being currently certified in ACLS or PALS.
Interview on May 31, 2012, at approximately 1:00 PM with EMP1 confirmed the above findings and revealed, "EMP5 is currently taking ACLS and PALs training."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Governing Board adopted a Board policy on June 4, 2012 that requires the governing body to ensure medical staff certification for ACLS and PALS as required in 553.3 and 551.22. One staff member is trained on ACLS and a second staff member has registered for the training. Both of these staff members are scheduled for PALS training on September 19 and 20, 2012 which is the first date a training course is available with the required certification.

Monitoring for compliance will include staff education by the VP of Operations for the staff scheduler to ensure there is awareness and understanding of the requirements for ACLS and PALS trained staff on the premises during clinic hours.

The Surgical Site Supervisor or designee will monitor by doing random site inspections to ensure that ACLS trained staff is always on the premises during clinic hours and that a PALS certified staff member is on the premises when a minor is in the facility during clinic hours. The random checks will occur weekly for three months following completed certification.

The Quality Assurance calendar currently used by human resources to monitor expiration of licenses, CPR and credentialing on a monthly basis has been modified to include ACLS and PALS expiration dates. Human resources staff will monitor expiration dates and notify staff 4 months prior to any item expiring.

Monitoring of the Governing Board’s review of completion of PALS and ACLS training will be the responsibility of the CEO, who will ensure this is included on the Governing Board’s meeting agenda and will sign off on all board minutes to verify discussion of this information at the board meeting.

The PPWP RQM Oversight Committee will be informed of the corrective action taken and the Governing Body will be informed of the deficiency and its resolution.




553.4 (d) LICENSURE
Other Functions

Name - Component - 00
553.4 OTHER FUNCTIONS

(d) If the governing body is comprised of only one member, or if a majority of the members of
the governing body are not practitioners, the ASF bylaws or similar rules and regulations shall
specify a procedure for establishing medical review by practitioners for the purpose of recommending to the
governing body for its approval - based on evidence of the education, training, and current competence - initial appointments and reappointments, and assignment or curtailment of clinical privileges of the practitioners.


Observations:

Based on review of facility documents, credential files (CF) and staff interview (EMP), it was determined the ASF bylaws or similar rules and regulations failed to specify a procedure for establishing medical review by practitioners for the purpose of recommending to the governing body for its approval-based on evidence of the education, training, and current competence-initial appointments and reappointments, and assignment or curtailment of clinical privileges of the practitioners.
Findings include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc" revealed no requirement for a procedure establishing medical review by practitioners for the purpose of recommending to the governing body for its approval-based on evidence of the education, training, and current competence-initial appointments and reappointments, and assignment or curtailment of clinical privileges of the practitioners.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 failed to reveal documentation that the governing body approved the practitioners based on evidence of the education, training, and current competence-initial appointments and reappointments, and assignment or curtailment of clinical privileges of the practitioners.
Interview on June 1, 2012, at approximately 11:45 AM with EMP2 confirmed the requirement was not included in the bylaws or other similar rules and regulations.











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Governing Board adopted a policy on June 4, 2012 that requires the establishment of procedures for the medical review by the medical director of practitioners for recommendation for appointment to the governing body. The policy and procedure for physician appointment is included in PPWP’s Human Resources Manual.

Compliance will be monitored when physicians are hired. A checklist will be used to monitor the documents included in the personnel file and to verify that the required information was obtained for the physician appointment. The CEO will monitor compliance through periodic review of the checklist and the documentation in the personnel file.

The board minutes will document the process for physician appointment and compliance with the established procedure. The CEO is responsible for including physician appointment on the Governing Board agenda and for monitoring board minutes to ensure the process is accurately documented.

The PPWP RQM Oversight Committee will be informed of the policy adoption and the corrective action taken.



553.25 (1-6) LICENSURE
Discharge Criteria

Name - Component - 00
553.25 Discharge Criteria

A patient may only be discharged from an ASF if the following physical status criteria are met:
(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient's age or at preoperative levels for that patient.
(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at his usual level considering limitations imposed by the surgical procedure.
(3) Mental status. The patient is awake, alert or functions at his preoperative mental status.
(4) Pain. The patient's pain can be effectively controlled with medication.
(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.
(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.

Observations:

Based on review of facility documents, medical records (MR), and staff interview, it was determined the medical record contains no documentation that nausea and vomiting are controlled and consistent with that expected from the surgical procedure prior to patient discharge.
Findings include:
Review of facility policies and other documents provided by the facility failed to address assessment of nausea and vomiting prior to patient discharge.
Review of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, failed to reveal documentation of an assessment regarding nausea and vomiting prior to patient discharge.
Interview on June 1, 2012, at approximately 3:00 PM with EMP2 confirmed that there is no documentation that nausea and vomiting are controlled prior to the patient discharge..













Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: the PPWP Recovery Room page is in the process of being revised to correct this deficiency as well as deficiency 554D. The nausea and vomiting criteria were added to the client discharge criteria and to the PPWP medical protocol. The finalized form will be presented to all staffs involved in the discharge process and they will be educated about the protocol change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor by conducting a random chart audit for the documentation of nausea and vomiting upon discharge for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.1 Principle LICENSURE
CHAPTER 555 - MEDICAL STAFF

Name - Component - 00
555.1 Principle

There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of medical care provided to patients and for the ethical conduct and professional practice of its members and other practitioners who have been granted clinical privileges in the ASF.


Observations:

Based on staff interview (EMP), it was determined the facility failed to have an organized medical staff accountable to the governing body, which has the responsibility for the quality of medical care provided to patients and for the ethical conduct and professional practice of it's members and other practitioners who have been granted clinical privileges in the ASF.

Findings include:

A request was made for the medical staff bylaws approved by the governing body on May 31, 2012, at approximately 10:00 AM. No medical staff bylaws were provided.

Interview on June 1, 2012, at approximately 11:00 AM with EMP1 confirmed there was not an organized medical staff and there were no medical staff bylaws approved by the governing body that met the requirements of 555.1 Principle, 555.2 Medical staff membership and 555.3 Requirements for membership and privileges.








Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 21012. PPWP has taken the following steps to ensure compliance:
The Governing Board adopted a Board policy on June 4, 2012 and adopted a second more comprehensive policy on June 20, 2012 that specifies that the appointed physicians constitute the organized medical staff and the PPWP clinical standards and guidelines serve as the rules and regulations of the medical staff. The Governing Board appointed physicians to the medical staff and approved the PPWP clinical standards and guidelines as the rules and regulations of the medical staff at the June 4, 2012 meeting.

Monitoring will be done for compliance if any changes are made to the Governing Board Policy for the ASF and if any changes are made to the rules and regulations of the medical staff.

The CEO is responsible for bringing these changes to the Governing Board for discussion and approval and for monitoring board minutes to ensure the process is accurately documented.

The PPWP RQM Oversight Committee will be informed of the policy adoption and the corrective action taken.




555.2 LICENSURE
Medical staff membership

Name - Component - 00
555.2 Medical Staff Membership

A member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The governing body of the ASF, after considering the recommendations of the medical staff, may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgement. Members of the medicals staff and others granted clinical privileges shall currently hold licenses to practice in this Commonwealth.


Observations:

Based on review of facility documents, credential files (CF), and staff interview (EMP), it was determined the governing body, after considering the recommendations of medical staff, failed to grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience, and demonstrated competence and judgement.
Findings include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc" revealed no requirement for a procedure for establishing medical review by practitioners for the purpose of recommending to the governing body for its approval-based on evidence of the education, training, and current competence-initial appointments and reappointments, and assignment or curtailment of clinical privileges of the practitioners.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 failed to reveal documentation that the applicants for credentialing or recredentialing were approved by the governing body based on education, training, and current competence.
Interview on June 1, 2012, at 11:00 AM with EMP1 confirmed the lack of governing body approval in the credential files and indicated that the medical director signed off on applicants. "Now, the board will sign off. That will happen Monday at the meeting."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Governing Board has adopted a Board policy on June 4, 2012 requiring a procedure for recommending to the Governing Board for its approval the initial, reappointment, assignment and curtailment of privileges to practitioners. A policy and procedures for physician appointment is included in PPWP’s Human Resources Manual. The Governing Board received and approved the Medical Director recommendation for physician appointments at its June 4, 2012 Board meeting. The recommendations were made after Medical Director review of complication rates, performance and peer review by the medical director, third party credentialing, physician education and prior work experience.

Monitoring of this procedure will occur as new physicians are hired. Physician appointment, reappointment, assignment and curtailment procedures will be monitored by the VP for Operations and CEO to ensure the appropriate documentation for appointment purposes is obtained and reviewed by the medical director, presented to the Board and included in the personnel file. The Medical Director will monitor physician qualifications through peer review for periodic performance assessment and for incidences that occur and this documentation will be retained and used for re-appointment. Supervising staff will be educated to notify the CEO of any incidences that have occurred and peer review completed so this information can be presented to the Governing Board and included in the physician file for reappointment purposes. The CEO is responsible for monitoring the Governing Board meeting agenda for inclusion of appointment and reappointment responsibilities, and for monitoring board minutes to ensure the process is accurately documented.


The PPWP RQM Oversight Committee will be informed of the policy adoption and the corrective action taken.




555.3 (a) LICENSURE
Requirements for membership & privileges

Name - Component - 00
555.3 Requirements for membership and privileges.

(a) In order to receive favorable recommendations for appointment, or reappointment, members of the medical staff shall always act in a manner consistent with the highest ethical standards and
levels of professional competence.



Observations:

Based on review of facility documents, credential files (CF), and staff interview, it was determined the facility failed to require medical staff to always act in a manner consistent with the highest ethical standards and levels of professional competence.
Findings include:
Review of documents provided by the facility failed to include requirements for medical staff to always act in a manner consistent with the highest ethical standards and levels of professional competence.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 failed to reveal any requirements for medical staff to always act in a manner consistent with the highest ethical standards and level of professional competence.
Interview on June 1, 2012, at 11:20 AM with EMP1 confirmed there was nothing that made that a requirement for medical staff, "There is nothing in there yet."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Governing Board adopted a Board policy on June 4, 2012 that requires medical staff to always act in manner consistent with the highest ethical standards and levels of professional competence. This requirement is included in the appointment/reappointment letter physicians receive and is included as a requirement in the physician job description.

The Medical Director will monitor physician performance, including peer review for routine assessment and unusual incidents and document this review in the personnel file. Physician credentials and National Provider Data Bank reports will be obtained by human resources staff for appointment and reappointment procedures in order to monitor physician compliance with ethical standards and professional competence as required. The CEO will monitor credentialing reports and the Medical Director review of physician performance and advise the Governing Board if a situation occurs where a physician is not acting with the highest ethical standards and level of professional competence so appropriate Governing Board action can be taken regarding with the appointment process.

The PPWP RQM Oversight Committee will be informed of the policy adoption and the corrective action taken.



555.3 (f) LICENSURE
Requirements

Name - Component - 00
555.3 Requirements for membership and privileges.

(f) The governing body shall request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

Observations:

Based on review of facility documents, credential files (CF), and staff interview (EMP), it was determined the governing body failed to request and consider reports from the National Practitioner Data Bank for each practitioner who requested privileges.
Findings include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc" revealed no established policies and procedures for the governing body to request and consider reports from the National Practitioner Data Bank for each practitioner who requested privileges.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 revealed background checks were performed by an outside company. There was no copy of a report from the National Practitioner Data Bank in the files.
Interview on June 1, 2012, at 10:05 AM with EMP1 when asked if the NPDB was checked, revealed, "The company that does our checks, searches it [NPDB]. There is not a copy of the report in the files."









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 21012. PPWP has taken the following steps to ensure compliance: Planned Parenthood of Western Pennsylvania has registered with the National Provider Data Bank and submitted the required notarized documents. PPWP is waiting for approval to access the Data Bank and obtain the required physician reports, which will be included in the physician appointment file and presented to the Board of Directors at its next meeting on September 12, 2012.

Monitoring of the acquisition of Data Bank reports will be done through a checklist maintained by human resources staff of items required for the personnel files. The CEO will monitor compliance through periodic review of the checklist and the documentation in the personnel file. The Governing Board will receive Data Bank reports as part of the appointment and reappointment process and the CEO will monitor the Board meeting agenda and minutes to ensure this information is provided to the Governing Board and review is documented.

The PPWP RQM Oversight Committee will be informed of the corrective action taken and the Governing Body will be informed of the deficiency and its resolution.



555.11 (a) LICENSURE
MEDICAL ORDERS - Written

Name - Component - 00
555.11 Medical orders
Written orders

(a) Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope
of the practitioner's license.


Observations:

Based on review of medical records (MR) and staff interview (EMP), it was determined the facility staff failed to document that medications were administered by authorized persons.
Findings include:
Review of "Analgesia and Sedation Services" revised December 31, 2011, revealed, "Analgesia is the diminution or elimination of pain. This can be accomplished using oral or intramuscular drugs. Local anesthesia is the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug... Sedation and analgesia describes a state that allows a client to tolerate an unpleasant procedure while maintaining adequate cardio-respiratory function and the ability to respond purposefully to verbal command and tactile stimulation. The Joint Commission defines four levels of sedation and analgesia: 1. Minimal sedation (anxiolysis) in which the client responds normally to verbal commands. Cognitive function and coordination may be impaired. 2. Moderate sedation/analgesia, is where the client is less responsive. the client purposefully responds to commands, either alone or accompanied by light tactile stimulation. 3. Deep sedation/analgesia, in which the client is not easily aroused, but responds purposefully to repeated or painful stimulation..."
Review of MR6, MR12, MR20 revealed the patients were given medications during the procedure. The documentation of the administration of the medications was listed on a page signed by a counselor and the physician, without any documentation of who actually administered the medication.
Interview on June 1, 2012, at approximately 3:00 PM with EMP2 confirmed there was no way to tell from the documentation who administered the medication.











Plan of Correction:

PPWP has taken the following steps to ensure compliance: the PPWP Operative Reports are in the process of being revised to correct this deficiency as well as deficiencies 551E, 552E, 5559, 6407 and 6413. The form is being revised for clarity to sufficiently reveal that the physician administers all medications. The finalized forms will be presented to the physicians and physician assistants and they will be educated about the form change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure to ensure that the changes to the form were effective in making it clear that the physicians are administering medications at PPWP. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.13 LICENSURE
Administration of Drugs

Name - Component - 00
555.13 Administration of drugs

Drugs shall be administered only upon the proper order of a practitioner acting within the scope of the practitioner's license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Physician assistants and certified registered nurse practitioners shall be permitted to administer drugs within their authorized scope of practice. Further policies on the administration of drugs shall be established by the medical staff in conjunction with pharmaceutical services or personnel.

Observations:

Based on review of medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure that medications were administered only by practitioners qualified according to the medical staff bylaws, rules, and regulations.
Findings include:
Review of documents provided by the facility failed to designate who was allowed to administer medications. The review further failed to reveal any medical staff rules and regulations.
Review of MR6, MR12, MR20 revealed the patients were given medications during the procedure. The documentation of the administration of the medications was listed on a page signed by a counselor and the physician, without any documentation of who administered the medication.
Interview on June 1, 2012, at approximately 3:00 PM with EMP2 confirmed there was no way to tell from the documentation who administered the medication.











Plan of Correction:

PPWP has taken the following steps to ensure compliance: the PPWP Operative Report is in the process of being revised to correct this deficiency as well as deficiencies 551A, 552E, 5559, 6407 and 6413. The form is being revised for clarity to sufficiently reveal that the physician administers all medications. The finalized form will be presented to all staffs and they will be educated about the form change by the Medical Director Monitoring will be done through staff education of the Medical Director and VP for Operations so they are aware of the need to notify the CEO if any changes are made to the PPWP clinical standards and guidelines, which have been approved by the Governing Board as the rules and regulations of the medical staff. The CEO is responsible bringing changes recommended by the Medical Director to the Governing Board for their review and approval, and monitoring the Governing Board meeting agenda so approval is documented in the meeting minutes. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the revised operative reports are in use for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.22 (a)(1-2) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
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 medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure that pertinent medical histories and physicals were documented the day of surgery for one of 20 patients.
Findings include:
Review of the H&P for MR2 failed to reveal a complete history and physical for the patient.
Interview on June 1, 2012, at approximately 2:00 PM with EMP2 confirmed the lack of documentation of a complete history and physical.














Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: On 6/21/2012 the Surgical Site Supervisor followed up with all staff responsible for ensuring that the medical history and physical exams are completed. The Surgical Site Supervisor will complete an audit of 50 randomly selected charts by 7/20/2012 to ensure complete documentation of history and physical for the patient. If the results of all of the above are less than 100%, it will be determined on 7/2712 what additional measures need to be implemented and monitored with ongoing audits. . The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.22 (c)(1-5) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Pre-operative Care

(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.


Observations:

Based on review of facility documents, and staff interview (EMP), it was determined the facility failed to provide written instructions for pre-operative procedures that include and understanding that the patient may require admission to the hospital in the event of medical need and failed to provide written instructions for preoperative procedures that included a responsible person would escort the patient that received sedation home.
Findings include:
Review of the written pre-operative instructions failed to reveal written instructions that the patient may require admission to the hospital in the event of medical need or that patients receiving sedation would require a responsible person to escort them home.
Interview on June 1, 2012, at approximately 11:30 AM with EMP2 confirmed the lack of documentation that the patient might require admission to the hospital in the event of medical need or that patients receiving sedation were required to have a responsible person to escort them home.










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Consortium of Abortion Providers (CAPS) is submitting the revised Client Information for Informed Consent for In-Clinic Abortion to the Planned Parenthood Federation of America (PPFA) for approval on 6/25/12. PPWP requested language that clarified the patient may require admission to the hospital in the event of medical need rather than the current statement that PPWP could send the client to the hospital for a problem. Upon PPFA approval, all staffs will be informed of the revision and instructed to implement the new form upon receipt. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the revised CIIC is in use for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.
It was not necessary to submit a request to add written instructions for preoperative procedures that included a responsible person would escort the patient that received sedation home to the Client Information for Informed Consent for In-Clinic Abortion because the Client Information for Informed Consent for Minimal Sedation and the Client Information for Informed Consent for Moderate Sedation Intravenous (IV) Sedation do contain the required documentation.



555.22 (d) LICENSURE
Surgical Services - Preoperative Care

Name - Component - 00
555.22 Preoperative Care

(d) Preoperative diagnostic studies, if performed shall be evaluated, annotated, signed and entered into the patient's medical record before surgery.

Observations:

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure that preoperative diagnostic studies performed were evaluated, annotated, signed, and entered into the patient ' s medical record before surgery.
Findings include:
Review of facility policies and other documents failed to reveal a requirement for preoperative studies performed to be evaluated, annotated, signed, and entered into the patient's medical record prior to surgery.
Review of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, and MR20 revealed preoperative testing including preoperative hematocrits, urine testing for pregnancy, and blood types were included in the medical record with no documentation of evaluation, annotation, or signature of the person evaluating the test.
Interview on June 1, 2012, with EMP2 at approximately 11:45 AM confirmed the lack of documentation of evaluation, annotation or signature of the person evaluating the preoperative studies in the medical record.












Plan of Correction:

PPWP has taken the following steps to ensure compliance: the PPWP Laboratory page is in the process of being revised to correct this deficiency. The form is being revised to provide documentation of evaluation, annotation and signature of the person evaluating the tests.The finalized form will be presented to all staffs and they will be educated about the form change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the revised Laboratory page is in use and that there is documentation of evaluation, annotation and signature of the lab staffs and the person evaluating the tests for the next three months. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.22 (e) LICENSURE
Surgical Services - Preoperative

Name - Component - 00
555.22 Pre-operative Care

(e) Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administrating anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient's medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.

Observations:

Based on review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to have a written policy regarding the identification by the operating surgeon and person administering anesthesia of the patient and the procedure to be performed and documentation for seven of 20 medical records (MR2, MR3, MR4, MR5, MR6, MR12, and MR20).
Findings include:
Review of facility policies failed to reveal a policy for the proper identification and documentation of the identification of the patient and procedure prior to the procedure.
Review of MR2, MR3, MR4, MR5, MR6, MR12, and MR20, revealed no documentation of the identification of the patient and procedure prior to the administration of sedation/anesthesia.
Interview on June 1, 2012, at 11:40 AM with EMP2 confirmed the there was no policy, and revealed, "At this point the doctor identifies the patient by the first and last name. I don't know if [he/she] state they are about to perform an abortion." EMP2 further confirmed the process was not documented in the medical record.











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Medical Director and the VP for Operations are in the process of reviewing resources on best practices for time-out in preparation for a written PPWP time-out policy to add to the PPWP medical protocol. The PPWP Operative Report is in the process of being revised to provide written documentation that the policy is being carried out by all staffs and to correct this deficiency as well as deficiencies 551A, 551E, 5559, 6407 and 6413. All staff that participate in the performance of a procedure will be educated about the new time-out policy and the finalized form will be presented by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the new policy is being implemented by verifying documentation of the identification of the patient and procedure prior to the administration of sedation/anesthesia for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.23 (b) LICENSURE
Surgical Services - Operative Care

Name - Component - 00
555.23 Operative Care

(b) Tissue and exudates removed during surgery procedure shall be properly labeled and sent to a laboratory with for examination by a pathologist. The specimen shall be accompanied by pertinent clinical information, including its source and the preoperative and postoperative diagnosis. The pathologist's signed report of the examination shall be made a part of the patient's medical record. Certain tissues and exudates may be exempt from laboratory examination. The exemptions shall be those that are consistent with current medical practice and are in writing and approved by the governing body.


Observations:

Based on review of facility documents and staff interviews (EMP), it was determined the facility failed to send all tissue and exudates removed during surgery to a laboratory for examination by a pathologist and failed to have an exemption consistent with current medical practice in writing and approved by the governing body.
Findings include:
Review of facility documents including policies and procedures failed to reveal an exemption consistent with current medical practice in writing and approved by the governing body for tissues and exudates removed during surgery on products of conception under fourteen weeks.
Interview on June 1, 2012, at 11:40 AM with EMP2 confirmed there was no exemption and revealed, "The board is to sign off June 4, 2012."









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The PPWP governing body reviewed and approved the agency clinical standards and guidelines for pathology and laboratory including the policies and procedures related to tissue and exudates removed during surgery at its Board meeting on June 4, 2012.

The agency clinical standards and guidelines for pathology and laboratory including the policies and procedures related to tissue and exudates did not change with the approval the by the governing board.

Monitoring of the changes related to pathology, laboratory and management of tissue will be done if the policy and procedures change in the future.
Monitoring to ensure changes are brought to the Governing Boards attention will be done through staff education of the Medical Director and VP for Operations so they are aware of the need to notify the CEO if any polices related to pathology and laboratory are changed.

The CEO is responsible bringing any policy and procedure changes recommended by the Medical Director to the Governing Board for their review and approval, and monitoring the Governing Board meeting agenda so approval is documented in the meeting minutes.
The PPWP RQM Oversight Committee will be informed of the policy adoption and the corrective action taken.

The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the unchanged POC protocol continues to be followed after it was formally approved by the Governing Board.

The Surgical Site Supervisor or designee will monitor to ensure the unchanged POC protocol continues to be followed since it was formally approved by the Governing Board. She will conduct a random chart audit of five charts/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits.



555.23 (f) LICENSURE
Surgical Services - Operative Care

Name - Component - 00
555.23 Operative Care

(f) There shall be a written agreement in effect with an ambulance service staffed by certified EMT personnel, for the safe transfer of a patient to a hospital in an emergency situation, or as the need arises.

Observations:

Based on review of facility documents, and staff interview (EMP), it was determined the facility failed to have a written agreement in effect with an ambulance service staffed by certified EMT personnel for the safe transfer of a patient to a hospital in an emergency situation, or as the need arises.
Findings include:
Review of facility written agreements failed to reveal an agreement with an ambulance service staffed by certified EMT personnel.
Interview on June 1, 2012, at 11:50 AM with EMP2 confirmed there was no agreement and revealed, "Allegheny County told us that we didn't need an agreement, we just call 911 and whatever ambulance is available will respond."









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: VP for Operations spoke with the Director of Operations at an EMS service after multiple telephone attempts. He stated that in a life-threatening event and for a serious event, PPWP must call 911 first. He said he would contact the VP for Operations to present a contract by 6/25/12. The VP for Operations contacted Director of Operations on 6/26/12 to follow up in order to be in compliance by 7/13/12. He scheduled a PPWP visit for 6/27/12 but cancelled because he is a medic and had to respond to a call. He did not call back later that day as scheduled. The VP for Operations followed up on 6/28/12. The Director of Operations stated the contracts would be ready on 6/29/12. The VP for Operations will continue to monitor the status of acquiring an agreement by contacting him again on 7/2/12, if necessary. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.24 (b) LICENSURE
Surgical Services - Postoperative Care

Name - Component - 00
555.24 Postoperative Care

(b) A patient who has received anesthesia shall be observed in the facility by a registered nurse, physician assistant or practitioner for a period of time which is sufficient to ensure no immediate postoperative complications are present.

Observations:

Based on observations, review of medical records (MR), and staff interview (EMP), it was determined the facility failed to have a registered nurse, physician assistant or practitioner observe patients that had received sedation/anesthesia for a period of time to ensure no immediate postoperative complications are present.
Findings include:
Review of MR2, MR3, and MR4, revealed the recovery room sheet was signed by a licensed practical nurse (LPN).
Interview on May 31, 2012, at approximately 11:45 AM with EMP2 revealed. "We don't have an RN. The LPN works under the supervision of the physician and the physician assistant.
Telephone interview on June 11, 2012 at 11:55 AM with EMP4 confirmed that EMP8 was scheduled and worked the recovery room on June 1, 2012.














Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: Beginning 6/19/12, when the regulation became effective, only the Physician Assistant was assigned to supervise clients in the Recovery Room at all times. The LPN job description was revised to exclude Recovery Room supervision and supervision of sedated clients. The Surgical Site Supervisor who schedules staffs was educated about the delineation of responsibilities. As of 6/29/12 LPNs will not be scheduled to work at the ASF until and unless a waiver request is submitted and granted for the supervision of non-sedated patients in the Recovery Room by the LPN. If the policy is changed as a result, the Scheduler will be educated of the current practice and schedules will be monitored. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.24 (d) LICENSURE
Surgical Services - Postoperative Care

Name - Component - 00
555.24 Postoperative Care

(d) A medical professional certified in advanced cardiac life support shall be present until patients operated on that day have been discharged from the facility. If a patient receives general anesthesia, regional anesthesia or IV sedation, an anesthetist shall remain present until the patient has been discharged from the facility.


Observations:

Based on review of credential files (CF), personnel files (PF), and staff interviews (EMP), it was determined the facility failed to have a professional certified in advanced cardiac life support (ACLS) present until patients operated on that day were discharged from the facility and failed to have an anesthetist present until patients receiving IV sedation were discharged from the facility.
Findings include:
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, CF8, and CF9 revealed no documentation of any employees certified in ACLS. Further review revealed no anesthesiologist or anesthetist.
Review of PF1 and PF14, licensed staff, revealed no documentation of staff certification in ACLS.
Interview on June 1, 2012, at 12:00 noon with EMP2 revealed, "The physician assistant is going for ACLS and PALs training as we speak."









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: One staff member completed ACLS training and is certified. A second staff member is registered for the training. The PPWP Recovery Room page is in the process of being revised to correct this deficiency as well as deficiency 3250. The form is being revised for clarity to sufficiently reveal that there was an ACLS staff present in the facility until discharge and that the anesthetist was present until patients receiving IV sedation were discharged from the facility. The finalized form will be presented to the physicians and physician assistants and they will be educated about the protocol change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure there is documentation of the ACLS staff and the anesthetist on the revised Recovery Room page is for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.24 (f)(1-7) LICENSURE
Surgical Services - Postoperative Care

Name - Component - 00
555.24 Post Operative Care

(f) Protocols approved by the medical staff shall be established for instructing patients in self-care after surgery, including written instructions which, at a minimum shall include the following:

(1) The symptoms of complications associated with procedures performed
(2) An explanation of prescribed drug regime, including directions for use of any medications.
(3) Limitations and restrictions on activities of the patient, if necessary.
(4) Specific phone number to be used by the patient, if a complication or question arises.
(5) Date for follow-up or return visit
(6) Instructions on the care of dressing and wounds
(7) Instructions on dietary restrictions

Observations:

Based on review of medical records (MR), the facility failed to provide discharge instructions that included limitations on physical activities and dietary limitations.

Findings include:

Review of MR6, MR12, and MR20 revealed limitations on activities and dietary limitations were not included in the discharge instructions.


Interview with EMP1 on May 31, 2012 at 2:00 PM confirmed the discharge instructions did not include instructions for limitations on activities or dietary limitations..








Plan of Correction:

PPWP has taken the following steps to ensure compliance: The PPWP Client Information and Instructions (CI), Taking Care of Yourself After an Abortion, which is given to clients to take home in order to care for themselves after the abortion, were revised and approved by the medical director to add an instruction that the client may resume normal diet. Revisions for limitations on activities were not necessary because the form already states, “Plan on relaxing for the rest of the day. Don’t drive if you had any sedation. Most women return to their normal activities the next day, but do NOT do hard work or heavy exercise for several days. This includes swimming, lifting heavy things, bicycling, or jogging.” The finalized form will be presented to all staffs and they will be educated about the form change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the revised CI is in use for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.




555.31 (a) LICENSURE
ANESTHESIA SERVICES - Principle

Name - Component - 00
Anesthesia Services

555.31 Principle
(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF licence.

Observations:

Based on facility documents and staff interview (EMP), it was determined the governing body failed to approve techniques for anesthesia services that were recommended by the medical staff.
Findings include:
Review of anesthesia policies/procedures revealed no documentation of the governing body approval or recommendations of the medical staff of anesthesia techniques (techniques were signed by the medical director).
Interview on June 1, 2012, at approximately 12:00 PM with EMP2 revealed, "The governing body doesn't currently sign off on medical standards and guidelines."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The PPWP Governing Boad reviewed and approved the agency clinical standards and guidelines for the anesthesia service, including the policies and procedures for anesthesia techniques at its Board meeting on June 4, 2012. The PPWP RQM Oversight Committee will be informed of the corrective action taken.

Monitoring will be done through staff education of the Medical Director and VP for Operations so they are aware of the need to notify the CEO if any polices related to the anesthesia service are changed. The CEO is responsible bringing any policy and procedure changes recommended by the Medical Director to the Governing Board for their review and approval, and monitoring the Governing Board meeting agenda so approval is documented in the meeting minutes.



555.32 (a) LICENSURE
Administration of Anesthesia

Name - Component - 00
Anesthesia Services

555.32 Administration of anesthesia

(a) Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetist and dentist anesthetists as defined in 551.3 (relating to definitions).


Observations:

Based on review of facility documents, credential files (CF), medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure that anesthetics were administered by anesthesiologists and certified registered nurse anesthetist or dental anesthetists.
Findings include:
Review of policies and procedures failed to reveal the need for anesthetic agents to be administered by an anesthesiologist, CRNA, or dental anesthetist.
Review of credential files failed to reveal any anesthesiologist, CRNA, or dental anesthetist.
Review of MR6, MR12, MR20 revealed the patients received conscious sedation for their procedures.
Interview on May 31, 2012, at approximately 4:00 PM with EMP1 confirmed the facility does not have an anesthesiologist, CRNA, or dental anesthetist.










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: In ASFs where there is no anesthesiologist, the governing body shall designate a physician or dentist to function as the Director of Anesthesia Services, who shall be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF which shall be approved by the governing body. The PPWP Medical Director was appointed by the Board as the Director of Anesthesia Services on 6/4/12. On that date the Board also approved the physician anesthetists who were credentialed by the Director of Anesthesia Services.





555.33 (b) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(b) In ASF's where there is no anesthesiologist, the governing body
shall designate a physician to function as the Director of Anesthesia Services, who shall be
responsible for directing the anesthesia services and establishing the general policies and procedures
for the administration of anesthesia in the ASF which shall be approved by the governing body.



Observations:

Based on review facility documents, credential file (CF), and staff interview (EMP), it was determined the governing body failed to designate a physician to function as the Director of Anesthesia Services, to be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF.
Findings Include:
Review on June 1, 2012, of the March 9, 2011, "Bylaws of Planned Parenthood of Western Pennsylvania, Inc" revealed no designation of a physician to function as the Director of Anesthesia Services.
Review of CF1, CF2, CF3, CF4, CF5, CF6, CF7, and CF8 revealed no identification of of any physician assigned to function as the Director of Anesthesia Services.
Interview on June 1, 2012, at approximately 12:15 PM with EMP2 revealed, "It will be in the job description. [He/she] will be officially appointed at the [governing body] meeting on Monday night."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The Governing Board appointed the PPWP Medical Director as Director of Anesthesia Service at its June 4, 2012 Board of Directors meeting. This responsibility is documented in the Medical Director’s signed job description.

Compliance will be monitored by the CEO who will notify the Governing Board of any change in the Medical Director and be responsible for making sure the Governing Board appoints another physician as Director of Anesthesia if the position is vacant.

The PPWP RQM Oversight Committee will be informed of the change and the corrective action taken.




555.33 (d)(1) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.


Observations:

Based on review of medical records (MR) and staff interview (EMP), it was determined the pre-anesthesia evaluation for the patient that received anesthesia did not contain pertinent information regarding the choice of anesthesia for three of three medical records (MR6, MR12, and MR20).
Findings include:
Review of MR6, MR12, MR20, revealed the patients received conscious sedation and the preanesthesia evaluations documentation did not explain why that type of sedation was chosen for those patients.
Interview on June 1, 2012, at 12:25 PM with EMP2 confirmed the documentation did not explain why the type of anesthesia was chosen for the patients.










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The PPWP Operative Report is in the process of being revised and a new Sedation Record is being created to correct this deficiency as well as deficiencies 551A, 551E, 552E and 6413. The physicians and physician assistants will be advised to document that the clients elected their type of sedation, as is the case at the PPWP facility, along with the current practice of documenting the pre-anesthesia assessment for anesthesia contraindications. The finalized form will be presented to the physicians and physician assistants by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure documentation that explains why the type of anesthesia was chosen for the patients for three months after sedation services resume. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


555.33 (d)(6)(i-iv) LICENSURE
Anesthesia Policies and Procedures

Name - Component - 00
555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(6) Intraoperative physiologic monitoring shall include the following at a minimum:
(i) The use of oxygen saturation by pulse oximetry.
(ii) The use of End Tidal C02 monitoring during endotracheal anesthesia
(iii) The use of EKG monitoring
(iv) The use of blood pressure monitoring.

Observations:

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility staff failed to provide intraoperative physiologic monitoring that included the use of EKG monitoring.
Findings include:
Review of facility policies did not include the need for EKG monitoring during procedures.
Review of MR6, MR12, MR20 revealed the patients received conscious sedation for the procedure and there was no documentation that there was EKG monitoring during the procedure.
Interview on June 1, 2012, at 12:25 PM with EMP2 when asked if there was EKG monitoring during the procedures revealed, "Not yet. We are trying to decide which one to get." EMP2 further stated at 12:30 PM, "It is not required in the current protocol."










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The PPWP medical protocol was revised to require EKG monitoring during sedation procedures. The operative report and the Recovery Room form are in the process of being revised for documentation of EKG monitoring. EKG machines were purchased and are on site. They are scheduled to be inspected by a biomedical company on 7/12/12. Sedation services are not being provided until all above are implemented and physicians and physician assistants are educated and trained to operate the equipment. The expected date of compliance is 7/24/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit for three months after resuming sedation services to ensure there is documentation in the medical record that the EKG Monitoring was applied. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


557.1 LICENSURE
CHAPTER 557 - QA & IMPROVEMENT - Policy

Name - Component - 00
557.1 Policy

The ASF, with active participation of the medical and nursing staff, shall conduct an ongoing quality assurance and improvement program designed to objectively and systematically monitor
and evaluate the quality and appropriateness of patient care, pursue opportunities to improve
patient care and resolve identified problems.


Observations:

Based on review of information and documents provided by the facility and staff interview (EMP), it was determined the facility with active participation of the medical and nursing staff failed to conduct an ongoing quality assurance and improvement program (QA) designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care and pursue opportunities to improve patient care and resolve identified problems.
Findings include:
Review of QA documents on June 1, 2012 revealed that the facility did not have an infection control plan.
Interview on June 1, 2012, at 11:30 am with EMP2 revealed, "We don't have a way to track infections."











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: The VP for Operations is in the process of reviewing and revising the current PPWP OSHA Compliance Program which contains protocols for occupational health and an exposure control plan to include additional ASF requirements for infection control. Infections are being reported and are included in in the complications statistics for each physician. It has been the standard practice at PPWP for the Medical Director to review the statistics quarterly and discuss them at the PPWP RQM Oversight Commttee meeting quarterly. The physicians review their own statisics quarterly as well. The RQM Coordinator will be notified the future the RQM minutes must contain more detail about the items reviewed and discussed so that it is more obvious for compliance surveys. The minutes will be monitored by the Medical Director for the next year, evidenced by her initialing them. The expected date of compliance is 7/13/12. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


557.4 (a)(1-4) LICENSURE
Quality Assurance & Improvement Committee

Name - Component - 00
557.4 Quality Assurance & Improvement Committee

(a) The committee shall consist of the following:
(1) A practitioner who is not an owner,
(2) A representative of administration,
(3) A registered nurse,
(4) Other health care personnel, as appropriate.


Observations:

Based on review of the facility documents and staff interview (EMP), it was determined the facility failed to include a registered nurse on the Quality Assurance and Improvement Committee.
Findings include:
Review of the quality assurance plan and meeting minutes revealed there was no registered nurse on the committee.
Interview on June 1, 2012, at 2:10 PM with EMP2 confirmed there was no RN on the committee and revealed, "The PA [physician assistant] is on the committee.










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP intends to submit a waiver request to permit a physician assistant to serve on the committee to be consistent with the waiver already granted by the PA DOH for a physician assistant to supervise sedation clients and to be the PALS certified staff on the premises when minors are in the facility at PPWP rather than an RN with the justification that it would be a higher standard of care. We will monitor that the PA is taking part in RQM activities and in attendance at the RQM Oversight Meetings by having the Medical Director initial the meeting minutes.The Governing Body will be made aware of the deficient practice and corrective action.


557.4 (b)(1-5) LICENSURE
Quality Assurance & Improvement Committee

Name - Component - 00
557.4 Quality Assurance and Improvement Committee

(b) Committee functions shall include:
(1) Evaluating data submitted as part of the quality assurance program,
(2) Reviewing credentials,
(3) Reviewing tissue examination reports,
(4) Reviewing infection control program,
(5) Reviewing the standards of practice in all specific areas of the ASF.


Observations:

Based on review of facility documents and staff interview (EMP), it was determined the quality assurance committee failed to review the infection control program.
Findings include:
Review of the quality assurance plan and committee minutes on June 1, 2012 failed to reveal the inclusion of the infection control program.
Interview on June 1, 2012, at 11:30 AM with EMP2 revealed, "We don't have a way to track infections."












Plan of Correction:

The VP for Operations is in the process of revising the current PPWP OSHA Compliance Program. The PPWP policies for occupational health will be updated to include a plan for tracking staff illnesses for trending purposes to identity potential infections in the workplace. Staff will be educated about the revisions in the new plan by the VP for Operations.
PPWP already tracks infections related to the abortion procedure. The Medical Director and the Patient Safety Committee reviews all cases of infection and the Risk and Quality Management Oversight Committee receives those reports. A review of the standards of practice will be documented in those cases going forward and The minutes will be monitored by the Medical Director for the next year, evidenced by her initialing them. The expected date of compliance is 7/13/12. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.



559.3 (a) LICENSURE
Nursing Personnel

Name - Component - 00
559.3 Nursing Personnel

(a) An adequate number of licensed and assistive personnel shall be on duty to assure that staffing levels meet the total nursing needs of patients based on the number of patients in the facility and their individual needs. Class B and Class C ASF's which provide surgical services to pediatric patients shall have nursing staff with documented experience in the postoperative care of such patients.

Observations:

Based on review of facility documents, personnel files (PF), and staff interview, it was determined the facility failed to have documented evidence that the nursing staff had experience in postoperative care of pediatric patients.
Findings include:
Review of "Surgical Abortion Services Client Selection" revised December 31, 2011, revealed, "Indications-surgical abortion may be performed for a client who is age 18 years or older ... Abortion series may be performed for any woman under age 18 who meets the above criteria ... "
Findings include:
Review of personnel files on June 1, 2012 failed to include documentation that staff had experience in the postoperative care of pediatric patients.
Interview on June 1, 2012, at approximately 1:30 PM with EMP2 revealed, "Does their years of working here qualify as experience?"










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: A training addendum was created and it will be reviewed by the Medical Director and added to the personnel file of the existing Physician Assistant at PPWP on 6/26/12. The PPWP credentialing form for licensed staffs was revised to include the documentation of postoperative care of pediatric patients for new PA and RN hires going forward. Compliance will be monitored by human resources staff by adding this training requirement to the HR checklist used to monitor the documents included in the personnel file and verify that required information was obtained. The CEO will monitor compliance through periodic review of the checklist and the documentation in the personnel file.

The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.



561.15 LICENSURE
Locked Storage

Name - Component - 00
561.15 Locked Storage

Special locked storage space shall be provided to meet requirements for storage of controlled substances, alcohol and other prescribed drugs as set forth in Chapter 25 (relating to controlled substances, drugs, devices and cosmetics) and 49 Pa Code 27.16 (4) and 27.17 (relating to construction requirements and security for Schedule II controlled substances).


Observations:

Based on observations, review of facility documents, and staff interview (EMP), it was determined the facility failed to provide special locked storage space of controlled substances as set forth in Chapter 25 during times treatment rooms were unoccupied by staff.
Findings include:
Observation of the treatment room on May 31, 2012, at approximately 1:45 PM revealed versed and fentanyl that were not double locked.
Interview on May 31, 2012, at approximately 1:45 with EMP7 confirmed that the versed and fentanyl were not double locked.













Plan of Correction:

• Revised POC: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: Beginning 6/22/2012 a fanny pack was worn by all physicians during clinic hours which contains controlled substances not included in this citation. The fanny pack will be used until a locksmith alters the crash cart to include a second lock the drawers where narcotics are stored at which time staffs responsible for the security of controlled substances will be educated about the new procedures. The Surgical Site Supervisor or designee will monitor by doing ongoing random crash cart inspections to ensure that the controlled substances are double locked at all times. This quality assurance check will be added to the PPWP Risk and Quality Management weekly activities schedule. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


563.10 LICENSURE
Ownership

Name - Component - 00
There shall be written policies and procedures which specify who has access to medical records, under what conditions records may be removed from the ASF, and under what conditions medical record information may be released. Medical records are the property of the ASF, and they may not be removed from the premises except for court purposes. Copies may be made available for authorized purposes, such as insurance claims and practitioner review.


Observations:

Based on review of facility documents, and staff interview (EMP), it was determined the facility failed to have a policy and procedure outlining under what conditions the medical record could be removed from the premises.
Review of medical record policies on June 1, 2012 failed to reveal any policy restricting the removal of medical records from the premises except for court purposes.
Interview on June 1, 2012, at 2:20 PM with EMP2 confirmed the lack of a policy addressing this issue.









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. On those dates PPWP did have a policy and procedure outlining under what conditions the medical record could be removed from the premises. The PPWP policy did not restrict the removal of medical records from the premises except for court purposes. PPWP has taken the following steps to ensure compliance: The PPWP protocol was revised on 6/18/12. All staffs will be educated by 7/13/12 and adherence to the revised policy will be monitored by logging the date that the original record was removed from the premises for court and the return date. The Clerical Coordinator who is responsible for the medical records storage will be charged with maintaining the log and ongoing monitoring to make sure that the only reason records are removed are for court purposes. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


563.12 (6) LICENSURE
Form and Content of Record

Name - Component - 00
563.12 Form and content of record

The ASF shall maintain a separate medical
record for each patient. Each record shall be accurate, legible and
promptly completed. Patient medicals shall be constructed to stand alone and be easily identified as ASF records. Medical records must include at least the following:
(6) Entries related to anesthesia administration

Observations:

Based on review of medical records (MR), and staff interview, it was determined the facility failed to maintain medical records that accurately reflected who administered anesthesia/sedation.
Review of MR6, MR12, MR20, revealed the patients had medications administered for conscious sedation during procedures. It was unable to be determined which of the two people signing the operative documentation administered the medications.
Interview on June 1, 2012, at 2:25 PM with EMP1 confirmed it was unable to be determined from the documentation which staff person had administered the medication.











Plan of Correction:

PPWP has taken the following steps to ensure compliance: the PPWP Operative Report is in the process of being revised and a new Sedation Record are being created to correct this deficiency as well as deficiencies 551A, 551E, 552E, 5559 and 6413. The Sedation Record will provide clarity to accurately reflect that the anesthetist administered anesthesia/sedation. The finalized form will be presented to the physicians and they will be educated about the form change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the Sedation Record is in use with complete documentation; to confirm the documentation of which staff person administered the medication for three months after sedation services resume. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.


563.13 (a) LICENSURE
Entries

Name - Component - 00
563.13 Entires

(a) Entries in the record shall be dated and authenticated by the person making the entry.

Observations:

Based on review of medical records (MR) and staff interviews (EMP), it was determined that all entries in the medical record were not dated and authenticated by the person making the entry.
Findings include:
Review of MR6, MR12, MR20 on June 1, 2012 revealed intraoperative procedure notes on a form that contained the signatures of two staff persons. It was unable to be determined from the documentation who administered medications.
Interview on June 1, 2012, at 2:25 PM with EMP1 confirmed it was unable to be determined from the documentation which staff person had administered the medication.











Plan of Correction:

PPWP has taken the following steps to ensure compliance: the PPWP Operative Report is in the process of being revised to correct this deficiency as well as deficiencies 551A, 551E, 552E, 5559 and 6407. The form is being revised for clarity to sufficiently reveal that the physician administers all medications. The finalized form will be presented to the physicians and they will be educated about the form change by the Medical Director. The expected date of compliance should be on or before 7/13/12. The Surgical Site Supervisor or designee will monitor the plan of correction by conducting a random chart audit to ensure the revised operative reports are in use for the next three months. Five charts must be audited/week for a total of 65 charts by October 11, 2012. If the results are less than 100%, it will be determined on October 18, 2012 what additional measures need to be implemented and monitored with ongoing audits. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.




565.16 LICENSURE
Facilities

Name - Component - 00
565.16 Facilities

If radiology services are provided by the ASF, adequate space, equipment
and supplies shall be provided to perform the volume of work with
optimal accuracy, precision, efficiency and safety.



Observations:

Based on observations and staff interview (EMP), it was determined that the facility failed to provide adequate space to perform the volume of work with optimal accuracy, precision, efficiency and safety.

Observation on May 31, 2012, at approximately 1:45 PM revealed that Exam room 1 located on the fifth floor was 117 square feet.

Interview on May 31, 2012, at approximately 1:45 PM with EMP4 confirmed that ultrasound exams were completed in the exam room.










Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP intends to seek exceptions to the Guidelines requirements of minimum operating room sizes. PPWP will follow the compliance timeline submitted on June 11, 2012 to achieve full compliance by December 19, 2012.


567.11 (5) LICENSURE
Operating Suite Equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size appropriate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(5) Cardiac monitor and defibrillator - required only if general anesthesia or intravenous sedation are used.


Observations:

Based on observations and staff interview (EMP), it was determined the facility failed to have a cardiac monitor and defibrillator available in each operating room and the recovery area.
Findings include:
Observations on May 31, 2012, at approximately 1:45 revealed one cardiac defibrillator with monitoring capability located between the operating rooms and the recovery area.
Interview on June 1, 2012, at 2:55 PM with EMP2 confirmed the facility currently only had one defibrillator capable of cardiac monitoring so there was not one in each operating room and recovery room.














Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP purchased cardiac monitors and defibrillators for the remaining procedures rooms and the recovery room. The defibrillators are currently on site and the cardiac monitors were backordered and are scheduled to arrive 6/29/12. Upon arrival equipment will staffs responsible for using the equipment will be informed and instructed to ensure the equipment is in operating condition at the beginning of each clinic day. An equipment inspection will be performed by an external biomedical company before the equipment is used and annually thereafter as required by the PPWP Risk and Quality Work Plan.


567.11 (7) LICENSURE
Operating Suite Equipment

Name - Component - 00
567.11 Operating suite equipment

The operating suite shall be adequately equipped with age appropriate
equipment for the types of procedures to be performed and the recovery area shall
be adequately equipped for the proper care of postanesthesia recovery
of surgical patients. All equipment and supplies shall be age and size appropriate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(7) Tracheostomy and necessary pulmonary reexpansion supplies

Observations:

Based on observations and staff interview (EMP), it was determined the facility failed to have required equipment available in the operating suite and the recovery room.
Findings include:
Observations on May 31, 2012 at approximately 1:45 PM failed to reveal any tracheostomy or necessary pulmonary reexpansion supplies available in the operating rooms.
Interview on June 1, 2012, at 2:55 PM with EMP2 confirmed the facility did not have the equipment. "We are trying to find out what is needed. It takes some investigating."















Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: Tracheostomy and pulmonary reexpansion supplies were ordered for the procedure rooms and the recovery room. The pulmonary reexpansion supplies are on site. The tracheostomy supplies were backordered and the expected date of delivery is 7/1/12. Upon arrival of equipment, staffs responsible for using the equipment will be informed. Those staffs and purchasing staffs were educated about equipment requirements in the ASF including the location of the equipment. An equipment check will be performed monthly for expiration dates and purchasing needs.




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 staff interview (EMP) it was determined the facility failed to ensure that temperature and humidity was maintained in the surgical and recovery suites to provide a properly conditioned air supply.
Findings include:
Review of facility documents provided on June 1, 2012, at approximately 2:30 PM failed to reveal any documentation that the surgical and recovery areas met properly conditioned air supply.
Interview on May 21, 2012 at approximately 2:00 PM with EMP 7 confirmed there was no documentation of temperature and humidity in the surgical and recovery areas.











Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP staffs have been and are currently monitoring the temperature and humidity and keeping a log to document that temperature and humidity are appropriate in procedure rooms and recovery daily and when staffs suspect atmospheric changes. The quality assurance check or monitoring which is the responsibility of the Surgical Site Supervisor or designee has been added to the PPWP Risk and Quality Management schedule of daily activities in the work plan. PPWP intends to seek exceptions to the Guidelines requirements in June 2012. PPWP will follow the compliance timeline submitted on June 11, 2012 to achieve full compliance by December 19, 2012.


569.32 LICENSURE
Fire Inspection

Name - Component - 00
569.32 Fire Inspection

The ASF shall request an annual inspection by its local fire
department.


Observations:

Based on review of facility documents and staff interview (EMP), it was determined the facility failed to request an annual inspection by the local fire department.
Findings include:
Review of documents provided by the facility regarding fire safety failed to reveal any documentation of a request for an annual inspection by the local fire department.
Interview on June 1, 2012, at approximately 3:30 PM with EMP1 confirmed the facility had not requested an annual inspection by the local fire department.









Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: A fire inspection of the faclity was completed by the local fire department on June 25, 2012.

Compliance with the annual fire inspection will be monitored through the annual quality management calendar which lists all required compliance issues, when they must be completed and the staff member who is responsible for completing the task. The Risk and Quality Management Coordinator will be responsible for adding this requirement to the list, monitoring its completion and reporting to the Risk Management Committee.

The PPWP RQM Oversight Committee will be informed of the corrective action taken and the Governing Body will be informed of the deficiency and its resolution.



571.1 LICENSURE
CHAPTER 571 - Construction Standards

Name - Component - 00
571.1 Minimum Standards

ASF construction shall be in accordance with the latest edition of the "Guidelines for Design and Construction of Hospital and Health Care Facilities," as published by the American Institute of Architects/Academy of Architecture for Health including those guidelines established for various outpatient facilities. In the alternative, a facility shall meet the construction guidelines for specified types of surgical procedures as listed in appendix A. Where renovation or replacement work is performed within an existing facility, all new work or additions shall comply with the requirements for new construction.

Observations:

Based on review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, observation, and interview with staff (EMP), it was determined that the facility failed to ensure compliance with the current construction guidelines.

Findings include:

1. Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-3.3 (Ambulatory Operating Rooms. Operating Rooms shall meet requirements as described in Section 3.7-3.3 (Ambulatory Operating Rooms...3.7-3.3.1.1 Space requirements. Class B operating rooms shall have a minimum clear floor area of 250 square feet (23.23 square meters) with a minimum clear dimension of 15 feet (4.57). 3.7-3.3.3.2 Clearances. Room arrangement shall permit a minimum clear dimension of 3 feet 6 inches (1.07 meters) at each side, the head , and the foot of the operating table."

Observation on May 31, 2012, at approximately 12:45 PM revealed that the operating room was less than 120 square feet.

Interview on May 31, 2012, at approximately 12:45 PM, with EMP4, confirmed that the square footage was less than 120 square feet and that there was not a 3 feet 6 inch clearance at the head , side and foot of the operating table.

Interview on June 1, 2012, at approximately 12:45 PM, with EMP2, confirmed that the square footage was less than 120 square feet.

Interview on June 1, 2012, at approximately 12:45 PM, with EMP2, confirmed that the square footage was less than 120 square feet.

2. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-3.4.2.2 Cubicle curtains or other provisions for privacy during post-operative care shall be provided."

Observation on May 31, 2012, at approximately 1:00 PM revealed four patient recovery room chairs for post-operative care. There were no cubical curtains or screens for privacy for the four recovery chairs.

Interview on May 31, 2012, at approximately 1:00 PM, with EMP4, confirmed the post-operative recovery room chairs did not have cubicle curtains for privacy.

3. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-3.6.5.2 One scrub station shall be permitted to service two operating rooms if needed."

Observation on May 31, 2012, at approximately 12:45 PM revealed that one scrub station outside of the operating rooms serviced three operating rooms.

Interview on May 31, 2012, at approximately 12:45 PM with EMP4 confirmed that that there is only one scrub station outside of the operating rooms which services three operating rooms.

4. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-3.6.6.1 A refrigerator for pharmaceuticals and double-locked storage for controlled substances shall be provided.

Observation on May 31, 2012, at approximately 1:45 PM revealed a crash cart outside of the operating room 4.

Interview on May 31, 2012, at approximately 1:45 PM, EMP4 confirmed that narcotics are normally stored in the crash cart during surgery hours, which has only one lock, not two.

5. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-5.1.2.1 Soiled workroom. This room shall be physically separated from all other areas of the facility. ...3.8-5.1.2.2 Clean/assembly workroom. Clean and soiled work areas shall be physically separated..."

Observation of the facility on May 31, 2012, at approximately 1:00 PM revealed the soiled work area and clean work area were located together.

Interview on May 31, 2012, at approximately 1:00 PM with EMP4 confirmed the clean and soiled work areas were shared and that the clean and soiled work counters were connected.

6. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-5.1.2..3 Storage for clean/sterile supplies (1) storage for packs, etc. shall include provisions for ventilation, humidity and temperature control.

Observation of the facility on May 31, 2012, at approximately 1:15 PM revealed wrapped sterile supplies stored directly on a cabinet located in the clean storage area. There were no humidity or ventilation monitors observed int this area where the sterile wrapped packages were stored.

Interview on May 31, 2012, at approximately 1:15 PM with EMP4 confirmed that there were no provisions to monitor humidity or ventilation in the area where sterile packages were kept.

7. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-7.2.3.4 "Ceilings (2) Ceiling finishes in operating rooms shall conform with the requirements in 3.7-7.2.2.2...#.7-7.2.3.4 Ceilings.(2) ...Restricted areas (a) Ceilings in restricted areas such as operating rooms shall be monolithic, scrubbable, and capable off withstanding chemicals. Cracks or perforations in these ceilings are not allowed..."

Observation of the facility on May 31, 2012, at approximately 2:30 PM revealed Operating room #2, #3, and #4 had dropped ceiling tiles that were not monolithic, scrubbable and capable of withstanding chemicals.

Interview on May 31, 2012, at approximately 2:00 PM with EMP4 and EMP7 confirmed that OR #2, #3, and #4 had dropped ceiling tiles that were not monolithic, scrubbable and capable of withstanding chemicals.

8. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-7.2.3.2 "Flooring (1) Seam welds in sheet flooring shall utilize manufacturer's weld product recommendations. (2) Vinyl composition tile (VCT) or similar products shall not be permitted in these areas."

Observation of the facility on May 31, 2012, at approximately 2:00 PM revealed Operating room 3 had 9 cracked tiles, operating room 4 had 3 cracked tiles, and operating room 2 had 7 cracked tiles.

Interview on May 31, 2012, at approximately 2:00 PM with EMP4 and EMP7 confirmed that there were cracked tiles in each operating room.

9. Review on May 31, 2012 of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed, "3.8-7.2.2.2 (1) "...except that door openings requiring gurney/stretcher access (as defined by functional program) shall have a nominal width of 3 feet 8 inches (1.11 meters). (2) Toilet room doors for patient use shall open outward or be equipped with hardware that permits access from the outside in emergencies."

Observations on May 31, 2012, at approximately 1:45 PM, revealed that the door width to the operating room was only 3 feet wide and the door to two patient bathrooms one in the waiting room and one in he recovery room opened inward.

Interview on May 31, 2012, at approximately 1:45 PM with EMP4 confirmed that the doors to the operating rooms were only 3 feet wide and that two patient bathrooms, one in the waiting room and one in he recovery room, opened inward.























































Plan of Correction:

The effective date for this regulation was June 19, 2012, and the survey took place May 31 and June 1, 21012. PPWP has taken the following steps to ensure compliance:
1. Procedure room sizes: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP intends to seek exceptions to the Guidelines requirements of minimum operating room sizes.

2. Cubicle curtains: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP is in the process of conferring with its architect to discuss possible options for installing cubicle curtains for patient privacy, and will have further conversations with the Division of Safety Inspection upon further planning related to this item.

3. Scrub sinks: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP sought an exception to the requirement on April 30, 2012, and the Department deferred decision on that request by letter dated June 1, 2012. PPWP intends to submit further information to the Department in support of its pending exception request.

4. Double locked storage for controlled substances: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: Beginning 6/22/2012 a fanny pack was worn by all physicians during clinic hours which contains controlled substances not included in this citation. Both fentanyl and versed are not being offered to patients and will, therefore, are stored under double lock at all times. The fanny pack will be used until a locksmith alters the crash cart to include a second lock the drawers where narcotics are stored at which time staffs responsible for the security of controlled substances will be educated about the new procedures. The Surgical Site Supervisor or designee will monitor by doing ongoing random crash cart inspections to ensure that the controlled substances are double locked at all times. This quality assurance check will be added to the PPWP Risk and Quality Management weekly activities schedule. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.

5. Clean/dirty work rooms: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP is in the process of conferring with its architect to discuss possible feasible alterations to the health center to satisfy the requirements for the separation of clean and dirty/soiled workrooms. PPWP’s architect will engage in further conversations with the Division of Safety Inspection upon the development of a plan the meets the Guidelines requirements, and if necessary, may seek limited exceptions from the Guidelines in furtherance of a renovation or alteration that is agreeable to the Division of Safety Inspection.
While this process continues, PPWP will review with its staff the proper infection protocols for handling soiled, clean and sterile instruments and avoiding cross-contamination. The quality assurance committee will be tasked with reviewing this protocol and recommending any necessary improvements at its next meeting.

6. Monitoring humidity and ventilation in sterile storage: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: Humidity and temperature monitors will be purchased and implemented in the autoclave area where wrapped sterile supplies are stored on 6/26/2012. A log will be maintained to document that temperature and humidity are appropriate in the area where sterile packages are kept. The PPWP RQM Oversight Committee will be informed of the change and the Governing Body will be made aware of the deficient practice and corrective action.

7. Ceiling coverings: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP is in the process of conferring with its architect to discuss possible feasible alterations to its health center to satisfy the requirements. PPWP’s architect will engage in further conversations with the Division of Safety Inspection upon the development of an acceptable solution. PPWP intends to seek limited exceptions from the Guidelines as necessary in furtherance of a renovation or alteration that is agreeable to the Division of Safety Inspection.

8. Floor coverings: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP’s architect has conferred with a representative of the Division of Safety Inspection about this regulation at length. PPWP is in the process of conferring with its architect to discuss possible feasible alterations to its health center to satisfy the requirements. PPWP’s architect will engage in further conversations with the Division of Safety Inspection upon the development of an acceptable solution. PPWP intends to seek limited exceptions from the Guidelines as necessary in furtherance of a renovation or alteration that is agreeable to the Division of Safety Inspection.

9. Door width and toilet room doors: The effective date for this regulation was June 19, 2012, and the survey took place on May 31 and June 1, 2012. PPWP has taken the following steps to ensure compliance: PPWP is in the process of conferring with its architect to discuss possible options, and will have further conversations with the Division of Safety Inspection upon further planning related to this item.

The PPWP RQM Oversight Committee and the Governing Board will be updated on all the status of all of these deficiencies and corrective actions.
PPWP will follow the compliance timeline submitted on June 11, 2012 to achieve compliance as indicated by December 19, 2012.