Initial Comments:
This report is the result of an unannounced, on-site pre-licensure and occupancy survey conducted on June 6, 2012, at Planned Parenthood of NorthEast and Mid- Penn, Reading. 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 edition 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
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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 medical records and interview with staff (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 for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5 and MR6).
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed the informed consent did not contain information regarding the physician's disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital. There was no documentation in MR1-MR6 showing the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital were disclosed to the patient.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the informed consent did not address the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital were disclosed to the patient.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Consent form (CIIC � In-Clinic Abortion � Suction- VII-A-2a) has been revised by the Pennsylvania affiliates
� Revised consent form has been sent (06/14/12) to the Planned Parenthood national governing body for approval
� Expect approval for form by 06/31/12
� Revised form will be given out to Center Managers on 07/02/12
* Center Managers will train their staff and produce a sign off sheet to forward to HR by 07/09/12
� Center Managers, facility staff and Medical Services Administration perform audits on 10 surgical abortion charts a month and 20 more surgical abortion charts every other month
* Failure to adhere to this policy will result in re-training or disciplinary action by Medical Services Administration.
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 interview with staff (EMP), it was determined the facility failed to ensure at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support.
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the requirement that at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support. None was provided.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy regarding the requirement that at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support.
Plan of Correction:Plan of Correction:
As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Policy has been drafted (06/11/12) by the VP for Medical Services and Human Resources Department.
� It will be approved by the Governing Body on 08/08/12.
� The requirement for ACLS has been included in new contracts for all abortion providers and/or medical staff who work in abortion locations.
� Contracts will be signed by 07/01/12
� Contracts and credentialing will be approved by the Governing Body on 08/08/12
� Human Resources will ensure that a copy of the policy and a facsimile of the contract will be in the facility ASF notebook
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 medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure that nausea and vomiting were evaluated prior to discharge for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5, and MR6).
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed that the MR did not contain documentation that the patients were assessed for nausea and vomiting prior to discharge.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the medical records did not contain documentation that the patients were assessed for nausea and vomiting prior to discharge.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Form # 6-MR/AB was changed 06/01/12, prior to the survey, to include nausea and vomiting. The charts reviewed by the surveyor were from before the form change
� All staff have been notified of the change and have signed off (06/02/12) on the form change
� Abortion charts are audited by different staff every month for compliance to all policies
� Failure to comply will result in re-training or disciplinary action by Medical Services Administration
555.3 (e) LICENSURE
Requirements
Name - Component - 00
555.3 Requirements for membership and privileges
(e) Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.
Observations:
Based on review of credential files (CF) and interview with staff (EMP), it was determined that the facility failed to ensure that physicians and Certified Registered Nurse Practitioners (CRNP) were reappraised and reappointed at regular intervals no longer than every two years for two of two credential files reviewed (CF1 and CF2).
Findings include:
1) A review on June 6, 2012, of CF 1 and CF2 revealed that they were not reappraised and reappointed every two years.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that CF 1 and CF2 were not reappraised and reappointed every two years.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Policy has been drafted (06/11/12) by the VP for Medical Services and Human Resources Department.
� It will be approved by the Governing Body on 08/08/12
� The Human Resource department will review all personnel files (before July 1) to ensure that all physicians and CRNPs are reappraised and reappointed
� The reappraisal every two years will be added to the Risk & Quality work plan by the RQM coordinator
� The work plan will include an action to be brought before the Governing Body by the VP for Medical Services for re-appointment of licensed staff every two years
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 a review of credential files (CF), and interview with staff (EMP), it was determined that the facility failed to request and consider reports from the National Practitioner Data Bank (NPDB) for two of two credential files reviewed (CF1 and CF2).
Findings include:
1) A review on June 6, 2012, of CF1 and CF2 revealed that there were no reports from the National Practitioner Data Bank in the physician credential files.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the facility had not obtained a report from the National Practitioner Data Bank prior to re-credentialing CF1 and CF2.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Reports from the National Practitioner Data Bank are were obtained by our billing/credentialing staff and were placed in the physicians credential files on 06/06/12
� This was added to the Risk and Quality Management work plan by the RQM coordinator to be checked at initial hire and every two years after that by the Human Resource department/credentialing during the credentialing process
� NPDB results will be reviewed with the Governing Body for any new hire or ongoing credentialling
555.22 (c)(1-5) LICENSURE
Surgical Services - Preoperative Care
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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 a review of medical records (MR) and interview with staff (EMP), it was determined that the facility failed to provide written pre-operative instructions to the patient or responsible person for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5 and MR6)
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed that there was no evidence that the patients or a responsible person had received written pre-operative instructions.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that there was no evidence in MR1-MR6 that the patients or a responsible person had received written pre-operative instructions.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The survey appears to be incorrect
� Preoperative written instructions are given to each surgical abortion patient at the state mandated information session (24 hour) on the following forms:
-1-R & C/AB
-5-AB/INS 8
-19-CIIC/AB
� There is an "in-clinic" couseling checklist that staff check off when patient receives the information
* The Center Manager will ensure that a copy of these forms are put into the facility ASF notebook by 07/01/12
555.24 (a) LICENSURE
Surgical Services - Postoperative Care
Name - Component - 00
555.24 Postoperative Care
(a) The findings and techniques of an operation shall be accurately and completely written or
dictated immediately after procedure by the practitioner medical staff member who performed the operation. If a physician assistant or certified registered nurse practitioner performed part of the operation, the findings and techniques of the procedure shall be accurately and completely recorded and the report shall be countersigned by the medical staff member. This description shall become a part of the patient's medical record.
Observations:
Based on a review of medical records (MR) and interview with staff (EMP), it was determined that the facility failed to provide written post-operative instructions to the patient or responsible person for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5 and MR6)
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed that there was no evidence that the patients or a responsible person had received written post-operative instructions.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that there was no evidence in MR1-MR6 that the patients or a responsible person had received written post-operative instructions.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The survey appears to be mistaken
� Written post-op instructions �Form 11-CIIC/AB- are given to all patients in the recovery room-
� At the top section of the recovery room form there is a box to check �given 11-CIIC/AB.� This is the form that gives all of the post-op instructions.
� The Center Manager will ensure that a copy of these forms are put into the facility ASF notebook by 07/01/12
* The DOH will be given a copy of the written instructions and it will be illustrated where the documentation is to show they were given to a patient
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 interview with staff (EMP), it was determined the facility failed to ensure that at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support.
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the requirement that at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support. The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy regarding the requirement that at least one medical professional in the facility when patients were present was currently certified in advanced cardiac life support.
Plan of Correction:Plan of Correction:
As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Policy has been drafted (06/11/12) by the VP for Medical Services and Human Resources Department.
� It will be approved by the Governing Body 08/08/12.
� The requirement for ACLS has been included in new contracts and job descriptions to ensure that at least one medical professional in the facility when patients are present is currently certified in ACLS
� The Center Manager will ensure that a copy of the policy and a facsimile of the contract will be in the facility ASF notebook
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 a review of medical records (MR) and interview with staff (EMP), it was determined that the facility failed to provide written post-operative instructions to the patient or responsible person for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5 and MR6)
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed that there was no evidence that the patients or a responsible person had received written post-operative instructions.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that there was no evidence in MR1-MR6 that the patients or a responsible person had received written post-operative instructions.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The survey appears to be mistaken
� As explained in response to observation 554A, written post-op instructions �Form 11-CIIC/AB-is given to all patients in the recovery room
� At the top section of the recovery room /discharge form there is a box to check �given 11-CIIC/AB.� This is the form that gives all of the post-op instructions
� The Center Manager will ensure that these forms will be put into the facility ASF notebook
559.1 Nursing Department LICENSURE
CHAPTER 559 - NURSING SERVICES
Name - Component - 00
559.1 Nursing Department
The ASF shall have an organized nursing department under the supervision of a registered nurse who has responsibility and accountability for the Nursing Service.
Observations:
Based on review of facility documents and staff interview (EMP), it was determined the facility failed to have a Director of Nursing who was responsible and accountable to the person in charge of the facility.
Findings include:
1) A review on June 6, 2012, of the facility's organizational chart revealed there was not a position for a Director of Nursing (DON).
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the facility did not have a position for a DON, and there was no Registered Nurse responsible and accountable for the Nursing Service.
Plan of Correction:Plan of Correction:
As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� PPNMP- Reading requested an exception from this requirement -559.1 -to permit the organized nursing department to be under the supervision of the Medical Director
� By letter from Department of Health dated April 19, 2012, the Department granted this exception
� The Human Resource department will ensure that the facilities organizational chart will be updated to indicate that the Medical Director is the Director of Nursing by 07/01/12
561.13 LICENSURE
Storage
Name - Component - 00
561.13 Storage
The area in the ASF where drugs are stored shall be periodically checked by a responsible pharmacist or practitioner and proper logs maintained.
Observations:
Based on interview with staff (EMP) it was determined the facility ailed to ensure that the area in the ASF where drugs were stored were periodically checked by a responsible pharmacist or practitioner and proper logs were maintained.
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the requirement that the area in the ASF where drugs were stored were periodically checked by a responsible pharmacist or practitioner and proper logs were maintained. The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy regarding the requirement that the area in the ASF where drugs were stored were periodically checked by a responsible Pharmacist or practitioner and proper logs were maintained.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� A revised policy and log will be developed by our Associate Medical Director. It will be presented and reviewed with the Center Managers on 6/28/12. The facility staff will review and sign off with completion by 07/21/12
� PPNMP Governing Body will be informed of this deficiency and any corrective action at its meeting on 08/08/12
� Failure to comply with this policy will result in re-training and/or disciplinary action by Medical Services Administration
563.6 (c) LICENSURE
Preservation of Medical Records
Name - Component - 00
563.6 Preservation of medical records
(c) If an ASF discontinues operation, it shall make known to the
Department where its records are stored. Records are to be stored in a
facility offering retrieval services for at least 5 years after the closure
date. Prior to destruction, public notice shall be made to permit former
patients or their representatives to claim their own records. Public notice
shall be in at least two forms, legal notice and display advertisement in a
local newspaper of general circulation.
Observations:
Based on interview with staff (EMP) it was determined that the facility failed to ensure there was a written policy regarding the preservation of medical records.
Findings include:
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the preservation of medical records. The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy regarding the preservation of medical records.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The survey appears to have been mistaken
� There is a policy on discontinuation of an ASF operation in the organization�s by-laws that address preservation of medical records
� The organizations by-laws are currently in the facility ASF notebook.
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 interview with staff (EMP) it was determined that the facility failed to ensure there was a written policy for ownership of medical records that specified who had access to medical records, under what conditions records could be removed from the ASF, and under what conditions medical record information could be released; that medical records were the property of the ASF, and they could not be removed from the premises except for court purposes.
Findings include:
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the ownership of medical records. The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy regarding the ownership of medical records.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The Risk and Quality Management coordinator wrote the new policy on 06/15/12
� The policy will be reviewed by Medical Services Administration with Center Managers on 06/28 and all facility staff will sign off by 07/13/12
� The new policy will be approved by the Governing Body on 08/08/12
� Failure to comply with this policy will result in re-training and/or disciplinary action by Medical Services Administration
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 interview with staff (EMP), it was determined the facility failed to ensure that each entry in each medical record was dated, and authenticated by the person making the entries for six of six medical records reviewed (MR1, MR2, MR3, MR4, MR5, and MR6).
Findings include:
1) A review on June 6, 2012, of MR1-MR6 revealed that the physician's pre-operative admission order set and inter-operative note did not each contain a separate physician signature.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the physician's pre-operative admission order set and inter-operative note for MR1-MR6 did not each contain a separate physician signature.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Consent form (CIIC � In-Clinic Abortion � Suction- VII-A-2a) has been revised by the Pennsylvania affiliates
� Revised consent form has been sent (06/14/12) to the Planned Parenthood national governing body for approval
� Expect approval by Planned Parenthood national governing body for form by 06/31/12
� Revised form will be given out to staff on 07/02 with training provided by the Center Manager and a sign off sheet for all abortion staff will be back to HR by 07/09/12
� Failure to comply with this policy will result in re-training or disciplinary action by Medical Services Administration
567.2 (1) LICENSURE
INFECTION CONTROL - Committee Responsibility
Name - Component - 00
567.2 Committee responsibilities
The quality assurance committee shall be responsible for:
(1) The prevention, control and investigation of infection in the ASF
and for assuring the effectiveness of current procedural techniques in all
departments.
Observations:
Based on interview with staff (EMP), it was determined the facility failed to ensure a committee was established for the prevention, control and investigation of infection in the ambulatory surgery facility (ASF) to assure the effectiveness of procedural techniques in all departments.
Findings include:
1) A request was made on June 6, 2012, for the Infection Control Committee meeting minutes. The facility was not able to provide the meeting minutes.
2) An interview conducted on June 6, 2012, with EMP1 confirmed there was no documentation of Infection Control meeting minutes for the facility.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The Risk & Quality Management committee is responsible for prevention, control and investigation of infection
� All infection control issues will be discussed and listed separately in the quarterly RQM meeting minutes
� Monthly audit of abortion charts by various medical staff under the direction of the RQM coordinator will ensure the all issues relating to infection control and prevention are brought forward
� The Governing Body will review any non-compliant issues and the corrective actions at their next board meeting
567.2 (2)(i) LICENSURE
Committee responsibilities
Name - Component - 00
The quality assurance committee shall be responsible for:
(2) The designation of one full-time or one part-time employee responsible for developing and monitoring the infection control program including, but not limited to:
(i) Written standards for ASF sanitation and asepsis.
Observations:
Based on interview with staff (EMP), it was determined the facility failed to ensure there was written policies for the prevention, control and investigation of infection in the ambulatory surgery facility (ASF) to assure the effectiveness of procedural techniques in all departments.
Findings include:
1) A request was made on June 6, 2012, for the facility's written policy for the prevention, control and investigation of infection in the ambulatory surgery facility (ASF). The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, with EMP1 confirmed there was no written policy for the prevention, control and investigation of infection in the ambulatory surgery facility (ASF).
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� The survey appears to be mistaken
� There is an Infection Control manual in the facility that addresses prevention and control of infection
� The RQM Coordinator will add language regarding the investigation of infection to the policy by 07/21/12
� Staff will be re-trained by an outside consultant on all infection control, prevention and procedures to investigate infection by 07/21/12
� Failure to comply with any of these policies will result in re-training and/or disciplinary action by the Medical Services Administration
567.2 (2) (iv) LICENSURE
Committee Responsibilities
Name - Component - 00
The quality assurance committee shall be responsible for:
(2) The designation of one full-time or one part-time employee responsible for developing and monitoring the infection control program including, but not limited to:
(iv) Maintaining records of infections which originate in the ASF among patients and personnel to trace the source of infection and to identify epidemic situations.
Observations:
Based on interview with staff (EMP), it was determined the facility failed to ensure that there was one full-time or one part-time employee responsible for developing and monitoring the infection control program and maintaining records of infections which originate in the ASF among patients and personnel to trace the source of infection and to identify epidemic situations.
Findings include:
1) A request was made on June 6, 2012, for the facility's employee job description for the staff member responsible for developing and monitoring the infection control program surgery facility (ASF). None was provided.
An interview conducted on June 6, 2012, with EMP1 confirmed there was no employee job description for the staff member responsible for developing and monitoring the infection control program surgery facility (ASF).
2) A request was made on June 6, 2012, for the facility's infection log. The facility was not able to provide an infection control log.
An interview conducted on June 6, 2012, with EMP1 confirmed there was no infection log.
Plan of Correction:Plan of Correction:
As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� A part-time employee will be identified by Medical Services Administration as responsible for developing and monitoring the infection control program by 07/21/12
� The employees job description will be edited appropriately by 07/21/12
� The RQM Coordinator will develop an infection log by 07/21/12
� The RQM Coordinator will present the infection log at the Center Manager call on 07/26/12
� Each Center Manager will ensure that facility staff understand and sign off on this log and forwards that to HR/Training Manager
� Failure to comply with any of these policies will result in re-training or disciplinary action by Medical Services Administration
567.3 (b) (12) LICENSURE
Policies and Procedures
Name - Component - 00
567.3 Policies and procedures
(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(12) Infection control inservice education for personnel
Observations:
Based on review of personnel files (PF), and interview with staff (EMP), it was determined that the facility failed provide Infection Control training or education to three of three personnel files reviewed (PF1, PF2, and PF3).
Findings include:
1) A review on June 6, 2012, of PF1-PF3 failed to reveal any documentation of Infection Control training or education.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that there was no documentation in PF1-PF3 of Infection Control training or education.
Plan of Correction:Plan of Correction:
As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Infection control training is part of the facilities new staff orientation and should have been documented in the employee personnel files
� The HR department will do an audit on all facility employees to determine which staff are missing this training by 06/29/12
� Training will be done by Medical Services Administration and/or an outside consultant for all staff deficient in this component by 07/08
� An audit of new employee personnel files will be performed by the RQM coordinator/Training Manager 3 months after each hire to ensure completion of all training.
� All non-compliant issues will be discussed at the RQM meeting and forwarded to the Governing Body
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 interview with staff (EMP) it was determined that the facility failed to monitor the temperature and humidity levels in the procedure rooms and recovery area.
Findings include:
1) A request was made to EMP1 on June 6, 2012 for the written policy regarding the monitoring of temperature and humidity levels in the procedure rooms and recovery area. The facility was not able to provide a policy.
2) An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the facility did not have a policy for the monitoring of temperature and humidity levels in the procedure rooms and recovery area.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Temperature & humidity monitors for procedure rooms and recovery room will be purchased by our purchasing department by 06/29/12
� A policy will be developed by Medical Services Administration/RQM regarding the monitoring of temperature and humidity levels in the procedures rooms and recovery room.
� Center Managers and staff will be trained by Training Manager/Medical Services administration on how to use this monitor by 0713/12
� A log will be developed by the RQM coordinator to document temperature and humidity levels
� The use of the log will be part of the training
� Regular audits will be done by Medical Service administration to ensure policy is being followed and temperature and humidity are noted
569.21 (a) LICENSURE
EVACUATION - Fire Drills
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569.21 Fire Drills
(a) Fire, internal disaster and evacuation drills shall be held at
least quarterly for ASF personnel and under varied conditions.
Observations:
Based on review of facility documentation and interview with staff (EMP), it was determined the facility failed to ensure that quarterly fire drills were conducted.
Findings include:
1) A review on June 6, 2012, of facility documents revealed no evidence that fire drills were conducted quarterly.
2) An interview conducted on June 6, 2012, 1:30 PM with EMP1 confirmed that the facility did not conduct quarterly fire drills.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. The effective date for this regulation is June 19, 2012, and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� A fire drill was conducted on 06/04/12
� The fire drill policy will be reviewed and revised if necessary. An audit of fire/safety drills will be conducted quarterly by the Center Manager or Medical Services Administration.
� Documentation of those drills will be forwarded to the RQM coordinator and put on the agenda for the RQM quarterly meetings
� RQM quarterly meetings are reviewed with the Governing Body
� Failure to adhere to the schedule will result in disciplinary action for the Center Manager
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 the facility failed to ensure it was in compliance with the current construction guidelines.
Findings include:
1) A review on June 6, 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 June 6, 2012, of the patient recovery room area revealed patient recovery chairs for post-operative care. There were no cubicle curtains for privacy for the recovery chairs.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the post-operative recovery room chairs did not have cubicle curtains for privacy.
2) A review on June 6, 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 ... (2) This workroom shall have a hand-washing station. (3) This room shall contain appropriate and sufficient workspace and equipment for terminal sterilizing of medical and surgical equipment and supplies. ... ."
Observation of the facility on June 6, 2012, revealed the soiled work area and the clean work area were located together.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the clean and soiled work areas shared the same space.
3) A review on June 6, 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 on June 6, 2012, 12, of the clean and soiled work area revealed wrapped sterile supplies stored in a wall cabinet above the sink area and autoclave. There were no temperature, humidity or ventilation monitors observed in this area where the sterile wrapped packages were stored.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the sterile supplies were stored in wall cabinets and that there was no provision to monitor temperature, humidity or ventilation in the area where the sterile packages were kept.
4) A review on June 6, 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 Door openings ... (2) Toilet room doors for patient use shall open outward or be equipped with hardware that permits access from the outside in emergencies. ... ."
Observation on June 6, 2012, of the patient restroom revealed the door opened inward.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed the patient restroom door open inward.
5) A review on June 6, 2012, of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed: "3.7-7.2.3.4 Ceilings: Ceiling finishes shall be appropriate for the areas in which they are located and shall be as follows: ...(2) Restricted areas. (a) Ceilings in restricted areas such as operating rooms shall be monolithic, scrubbable, and capable of withstanding chemicals. Cracks or perforations in these ceilings is not allowed, (b) All access openings in ceilings in restricted areas shall be gasketed. ... ."
Observation on June 6, 2012, of the procedure rooms revealed that the ceilings consisted of textured tiles that were not scrubbable or gasketed.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the ceilings in the procedure rooms were textured tiles that were not scrubbable or gasketed.
6) A review on June 6, 2012, of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed: "3.8-3.6.5 Scrub facilities ... 3.8-3.6.1 Hands free scrub station(s) shall be provided outside of but near the entrance to each operating room. ... ."
Observation on June 6, 2012, of the procedure room area revealed that there were no scrub sinks located outside of the operating rooms. Further observation revealed that the sinks inside the procedure rooms were not hands free.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that there were no scrub sinks located outside of the procedure rooms and that the sinks in the room were not hands free.
7) A review on June , 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 ... (2) Vinyl composition tiles or similar products shall not be permitted in these areas. ... ."
Observation on June 6, 2012, of the procedure rooms revealed that the floors were tiles composite.
An interview conducted on June 6, 2012, at 1:30 PM with EMP1 confirmed that the floors were tile composite.
Plan of Correction:As per our letter to Division of ACUTE & AMBULATORY CARE dated June 11, 2012, our facility is seeking accreditation as a Class A ASF. Our accreditation survey is scheduled for July 25, 2012. We are optimistic that we will be able to obtain accreditation, but in the event that we are not successful, we will pursue licensure as a Class B ASF. To that end, if the Class A accreditation process concludes unsuccessfully, we will pursue the alternate plan of compliance submitted by the Planned Parenthood health centers seeking licensure as Class B ASF, adjusting the dates as appropriate. Accordingly, at that time and if necessary, PPNMP- Reading � will confer with its architect and Division of Safety and Inspection to identify feasible alterations to its health center and seek exceptions to the construction requirements of 28 PA. Code section 571.1 where necessary.
The effective date for this regulation is June 19, 2012 and the survey took place on June 6, 2012. PPNMP-Reading has taken the following steps to ensure compliance.
� Temperature and humidity monitors will be installed in the wall cabinets where the wrapped sterile instruments are stored
� Toilet rooms will have breakaway door jambs
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