Initial Comments:
This report is the result of an unannounced full registration survey conducted on May 31, 2012, at Berger and Benjamin. It was determined that the facility was in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.
Plan of Correction:
Initial Comments:
This report is the result of an unannounced on-site pre-licensure and occupancy survey conducted on May 31, 2012, at Berger and Benjamin. Based on the occupancy survey, it was determined the facility was not in compliance with all applicable 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 (OTH), 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 four of four medical records reviewed (MR1, MR2, MR3, and MR4).
Findings include:
Review of MR1 on May 31, 2012, revealed this patient had a procedure on February 24, 2012. Further review of MR1's "Consent for operation and rendering of other medical services" revealed this form 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 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.
Review of MR2 on May 31, 2012, revealed this patient had a procedure on March 9, 2012. Further review of MR2's "Consent for operation and rendering of other medical services" revealed this form 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 MR2 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.
Review of MR3 on May 31, 2012, revealed this patient had a procedure on January 30, 2012. Further review of MR3's "Consent for operation and rendering of other medical services" revealed this form 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 MR3 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.
Review of MR4 on May 31, 2012, revealed this patient had a procedure on April 5, 2012. Further review of MR4's "Consent for operation and rendering of other medical services" revealed this form 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 MR4 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.
Interview with OTH1 on May 31, 2012, at approximately 2:45 PM, confirmed there was no documentation in MR1, MR2, MR3, and MR4 showing the physicians disclosed the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital to the patients.
Plan of Correction:Berger & Benjamin will rewrite their Consent for operation and rendering of other medical services to include disclosure of the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgery facility (ASF) instead of in a hospital. These forms will be reprinted and in use 45 days from the day of survey. The office and medical staff staff will receive an in-service about the form changes and their use. This will be reported to the quality assurance committee at the next meeting
553.1 Principle LICENSURE
CHAPTER 553 - Ownership,Goverance,Management
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553.1 PRINCIPLE
There shall be an organized governing body or designated person vested with
ownership who shall assume the full legal authority and responsibility for the conduct of the ASF.
Observations:
Based on an interview with staff (OTH), it was determined the facility failed to have documentation that described an organized governing body and designate a person who had full legal authority and responsibility for the conduct of the facility.
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 11:15 AM, for documentation that described the organized governing body structure and identified who was the designated person with the full legal authority and responsibility for the conduct of the ambulatory surgery facility (ASF). None was provided.
Interview with OTH1 on May 31, 2012, at approximately 11:15 AM, confirmed there was no documentation that described the organized governing body structure and identified the designated person with the full legal authority and responsibility for the conduct of the ASF. OTH1 also confirmed there was no documentation that a governing body adopted the governing body responsibilities as required under regulations 553.3.(1)-(16) and 553.4.(a)-(h).
Plan of Correction:Berger & Benjamin are in the process of writting a policy that described an organized governing body and designate a person who had full legal authority and responsibility for the conduct of the facility. This will include
documentation that a governing body adopted the governing body responsibilities as required under regulations 553.3.(1)-(16) and 553.4.(a)-(h). These will be finished in 45 days from the day of survey and incorporated in the policy and procedures
553.3 (8) LICENSURE
Governing Body Responsibilities
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553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
Observations:
Based on review of the Child Protective Services Law, facility documents, and staff interview (OTH), it was determined the facility failed to ensure processes were in place to meet the requirements for background checks as required by Act 179 of 2006 and Act 73 of 2007.
Findings include:
The Child Protective Services Law (CPSL), 23 Pa.C.S. 6344.2 requires employees hired after July 1, 2008, who have a significant likelihood of regular contact with children in the form of care, guidance, supervision or training must obtain three background checks as condition of employment: Pennsylvania State police Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check.
Review on May 31, 2012, of the facility's policy and procedure manual revealed no facility policy that required employees hired after July 1, 2008, who had a significant likelihood of regular contact with children in the form of care, guidance, supervision or training obtained the three background checks as condition of employment, i.e. the Pennsylvania State Police (PSP) Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check.
Telephone interview with OTH1 on June 6, 2012, confirmed the facility performed surgery on pediatric patients. Further interview with OTH1 confirmed there were no policies and procedures in place that required the three background checks for CPSL.
Plan of Correction:Berger & Benjamin have infrequent contact with minors and always with knowledge of a parent or guardian as required by the abortion control act. We are in the process of writting a Policy that requires required employees hired after July 1, 2008, who had a significant likelihood of regular contact with children in the form of care, guidance, supervision or training obtained the three background checks as condition of employment, i.e. the Pennsylvania State Police (PSP) Clearance, Department of Public Welfare (DPW) Childline Clearance and Federal (FBI) Criminal Background Check. Employees have benn notified and arangements for the backround checks are being made. This policy will be placed in the policy and procedure manual within 45 days from the day of survey The background checks will be placed in the Employee folders. Any negative reports will be acted apon based on the final policy. This will be ongoing as the backround checks come in and as new employees are hired
553.21 (a) LICENSURE
Admission, Transfer & Discharge - Principle
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553.21 Principle
(a) Written policies for admission, discharge, transfer and proper referral of patients
Observations:
Based on interview with staff (OTH), it was determined the facility failed to establish written policies and procedures for admission and discharge.
Findings include:
A request was made of OTH1 on May 31, 2012, at approximately 11:30 AM, for the facility's written policies and procedures for admission and discharge. None was provided.
Interview with OTH1 on May 31, 2012, at approximately 11:30 AM, confirmed the facility did not have written policies and procedures for admission and discharge.
Plan of Correction:Berger & Benjamin are in the process of writting policies and procedures for admission and discharge. These will be finished in 45 days from the day of survey and incorporated in the policy and procedure manual. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting.This will be added to current chart audit criteria,10 random charts are audited monthly by the office manager, results of which are reported to the medical director and quality assuarance committie
553.22 LICENSURE
Admission Criteria
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553.22 Admission criteria
The governing body , with the advice of and in conjunction with an medical staff shall establish medical criteria for admission under 555.22 (a) (relating to surgical procedures). Medical criteria shall be congruent with the assigned ASF class level stated on the facility license.
Observations:
Based on interview with staff (OTH), it was determined the governing body failed to establish written medical criteria for admission as required under 555.22(a).
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 11:45 AM, for the facility's written medical criteria for admission. None was provided.
Interview with OTH1 on May 31, 2012, at approximately 11:45 AM, confirmed there was no written medical criteria for admission established.
Cross reference 553.1 Principle - Ownership, Governance, Management
Plan of Correction:Berger and Benjamin and the governing body are in the process of writting medical criteria for admission as required under 555.22(a).
These will be finished in 45 days from the day of surveyand incorporated in the policy and procedure manual. The medical staff staff will receive an in-service about the admission policy. This will be reported to the quality assurance committee at the next meeting. The admitting physician is reponsible for following the medical criteria for admission. The medical director is responsible for educating the medical staff. The admission criteria will be monitored in chart audits. Ten random charts are audited monthly by the office manager and results reported to the quality assurance committee and medical director
553.31 (b) LICENSURE
Administrative Responsibilities
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553.31 Management and Administration of Operations
Administrative Responsibilities
(b) Administrative policies, procedures and controls shall be established, documented and implemented to assure the orderly and efficient management of the ASF.
Observations:
Based on interviews with staff (OTH), it was determined the facility failed to develop written administrative policies, procedures and controls to assure the orderly and efficient management of the ambulatory surgery facility.
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 11:50 AM, for the facility's written administrative policies, procedures and controls. None was provided.
Interview with OTH1 on May 31, 2012, at approximately 11:50 AM, confirmed written administrative policies, procedures and controls had not been developed.
Cross reference 553.1 Principle - Ownership, Governance, Management
Plan of Correction:Berger and Benjamin are in the process of writing administrative policies, procedures and controls to assure the orderly and efficient management of the ambulatory surgery facility.
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes from the head administrator. This will be reported to the governing body at the next meeting and incorporated into the policy and procedure manual. The governing body has resposibility for these policies
555.1 Principle LICENSURE
CHAPTER 555 - MEDICAL STAFF
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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 interview with staff (OTH), it was determined the facility failed to ensure there was an organized medical staff accountable to the governing body.
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 11:10 AM, for the facility's medical staff organizational structure. None was provided.
A request was made to OTH1 on May 31, 2012, at approximately 11:10 AM, for the facility's medical staff bylaws, which were approved by the Governing Body. None was provided.
Interview OTH1 on May 31, 2012, at approximately 11:10 AM, confirmed the facility did not have an organized medical staff appointed by the governing body. OTH1 also confirmed there were no written medical staff bylaws for the facility, which were approved by the governing body.
Plan of Correction:Berger and Benjamin are in the process of writing the facility's medical staff organizational structure. Bylaws are being written which will be submitted to the governing body for approval. The Policy and bylaws will be finished in 45 days from the day of survey and reviewed by the governing body by the following week. There are 3 Physicians at the facility only two doing procedures.There are 4 regular CRNAs only one on site at a time. There 4 RNs only one on site at a time. The medical director has the responsibility to educate the other physicians RNs and the CRNAs about the bylaws. This will be documented in the minutes of the QA committee
555.3 (a) LICENSURE
Requirements for membership & privileges
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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 interview with staff (OTH), it was determined the facility failed to develop written requirements for medical staff membership and privileges.
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 12:15 PM, for the facility's established requirements for medical staff membership and privileges to meet the requirements for 555.3(a)-(f). None was provided.
Interview with OTH1 on May 31, 2012, at approximately 12:15 PM, confirmed there were no written requirements for medical staff membership and privileges established by the facility to meet the requirements for 553.3 (a)-(f).
Plan of Correction:Berger & Benjamin are in the process of writting written requirements for medical staff membership and privileges These will be finished in 45 days from date of survey. and incorporated in the policy and procedure manual.There are 3 Physicians at the facility only two doing procedures.There are 4 regular CRNAs only one on site at a time. There are 4 RNs only one on site at a time. The medical director has the responsibility to review the written requirements with the medical staff. Staff credentials will be reviewed yearly and on expiration dates of credentialing materials by the credentialing committee
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 review of medical records and interview with staff (OTH), it was determined the facility failed to ensure the written instructions for preoperative procedures included an understanding that the patient may require admission to the hospital in the event of medical need in four of four medical records reviewed (MR1, MR2, MR3, and MR4).
Findings include:
Review of MR1 on May 31, 2012, revealed this patient had a procedure on February 24, 2012. Further review of MR1's "Preoperative Instructions," no date, revealed these instructions did not include an understanding that the patient may require admission to the hospital in the event of medical need.
Review of MR2 on May 31, 2012, revealed this patient had a procedure on March 9, 2012. Further review of MR2's "Preoperative Instructions," no date, revealed these instructions did not include an understanding that the patient may require admission to the hospital in the event of medical need.
Review of MR3 on May 31, 2012, revealed this patient had a procedure on January 30, 2012. Further review of MR3's "Preoperative Instructions," no date, revealed these instructions did not include an understanding that the patient may require admission to the hospital in the event of medical need.
Review of MR4 on May 31, 2012, revealed this patient had a procedure on April 5, 2012. Further review of MR4's "Preoperative Instructions," no date, revealed these instructions did not include an understanding that the patient may require admission to the hospital in the event of medical need.
Interview with OTH1 on May 31, 2012, at approximately 2:45 PM confirmed the written instructions for preoperative procedures in MR1, MR2, MR3, and MR4 did not include an understanding that the patient may require admission to the hospital in the event of medical need.
Plan of Correction:Berger and Benjamin are in the process of writing preoperative instructions that include an understanding that the patient may require admission to the hospital in the event of medical need. These will be incorporated in the patient chart and be distributed to the patient at the preop visit These will be in use in 45 days from date of survey. The office and medical staff staff will receive an in-service about the policy changes by the medical director This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The admission personel will be responsible for providing this form. A copy will remain on the chart. Routine chart audits wlll look for this form. Ten random charts are audited monthly by the office manager.
555.22 (e) LICENSURE
Surgical Services - Preoperative
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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 medical records, and interview with staff (OTH), it was determined the facility failed to ensure that the patient was properly identified prior to the procedure for four of four medical records reviewed (MR1, MR2, MR3, and MR4).
Findings include:
A request was made to OTH1 on May 31, 2012, for the facility's policy which addressed the requirement for the primary operating surgeon to properly identify the patient and procedure to be performed and document this in the patient's medical record.
Review of MR1 on May 31, 2012, revealed this patient had a procedure on February 24, 2012. Further review of MR1 revealed no documentation the primary operating surgeon properly identified the patient and procedure to be performed and documented this in the patient's medical record.
Review of MR2 on May 31, 2012, revealed this patient had a procedure on March 9, 2012. Further review of MR2 revealed no documentation the primary operating surgeon properly identified the patient and procedure to be performed and documented this in the patient's medical record.
Review of MR3 on May 31, 2012, revealed this patient had a procedure on January 30, 2012. Further review of MR3 revealed no documentation the primary operating surgeon properly identified the patient and procedure to be performed and documented this in the patient's medical record.
Review of MR4 on May 31, 2012, revealed this patient had a procedure on April 5, 2012. Further review of MR4 revealed no documentation the primary operating surgeon properly identified the patient and procedure to be performed and documented this in the patient's medical record.
Interview with OTH1 on May 31, 2012, at approximately 2:45 PM, confirmed there was no documentation in MR1, MR2, MR3, and MR4 the primary operating surgeon properly identified the patient and procedure to be performed and documented this in the patient's medical record.
Plan of Correction:Berger and Benjamin are in the process of writing a Policy for patient Identification. Patients are now given Id bracelets on admission and are Identified by the surgeon and anesthesia.They have the primary responsibility for patient identification Currently this is documented on the anesthesia chart.Charts will be modified to document ID by the surgeon and the anethesia personel as reflected in the policy. The ID policy is implemented Immediately,the policy and procedure and chart modification will be in place in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes from the medical director. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility. Ten random charts are audited monthly by the office manager to assure compliance.Findings are reviewed by the medical director
557.1 LICENSURE
CHAPTER 557 - QA & IMPROVEMENT - Policy
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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 facility documents, and interview with staff (OTH), it was determined the facility failed to ensure the Quality Assurance Program was comprehensive, as required under 557.2 Plan, 557.3 Quality Assurance and Improvement Program, and 557.4 Quality Assurance and Improvement Committee.
Findings include:
Review on May 31, 2012, of the facility's "Quality Management Program," undated, revealed the program consisted of the following: "A quality management program attempts to improve performance and reduce adverse events. Adverse sedation events must be captured as part of the quality management program. 1. Complication log include all of the following events ... need for reversal agents ... unscheduled admission to hospital. 2. Failure to document ... medical history (risk conditions) and physical examination ... informed consent ... monitoring of moderate sedation ... discharge status ... practice emergency drills must be conducted at a minimum of once a year. 2. All serious events must be reported to patient safety committee and PA Dept of Health by PSO."
Further review of the facility's "Quality Management Program," revealed it did not contain all the components as required under 557.2 Plan, 557.3 Quality Assurance and Improvement Program, and 557.4 Quality Assurance and Improvement Committee.
On May 31, 2012, surveyor requested the facility's Quality Assurance Meeting Minutes. None were provided.
Interview on May 31, 3012, with OTH1 confirmed the facility's "Quality Management Program" was not comprehensive. OTH1 confirmed there was no documentation the facility had conducted Quality Assurance Committee meetings.
Plan of Correction:Berger and Benjamin are in the process of writing a policy for the facility's "Quality Management Program. that will be comprehensive as required under 557.2 Plan, 557.3 Quality Assurance and Improvement Program, and 557.4 Quality Assurance and Improvement Committee. It will include a Complication log include all of the following events ... need for reversal agents ... unscheduled admission to hospital. 2. Failure to document ... medical history (risk conditions) and physical examination ... informed consent ... monitoring of moderate sedation and discharge status. Practice emergency drills will be conducted at a minimum of once a year. 2. All serious events must be reported to patient safety comand PA Dept of Health by PSO."
The facility will conduct Quality Assurance Committee meetings. These will be documented by minutes. The Policy and complication log will be in place in 45 days from survey. The staff will be educated on the QA plan by the medical director. The complication log will be monitored by the PSO and patient safety ocommittee. The Governing body has overall responsibility?
563.6 (a) LICENSURE
Preservation of Medical Records
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563.6 Preservation of medical records
(a) The facility shall have a written policy regarding the retention
of records. Medical records whether original, reproductions or microfilm,
shall be kept on file for a minimum of 7 years following the discharge of
patient.
Observations:
Based on interview with staff (OTH), it was determined the facility failed to ensure there was a written policy regarding the retention of medical records.
Findings include:
A request was made to OTH1 on May 31, 2012, at approximately 2:45 PM, for the facility's written policy regarding the retention of medical records. None was provided.
Interview with OTH1 on May 31, 2012, at approximately 2:45 PM, confirmed the facility did not have a written policy regarding the retention of medical records.
Plan of Correction:Berger and Benjamin are in the process of writing a written policy regarding the retention of medical records.
These will be finished in 45 days from date of survey and incorporated in the policy and procedure manual. The office and medical staff staff will receive an in-service about the policy changes by the medical director. The office staff responsible for medical records will assure and monitor compliance and document any issues with the medical record policy to the govrning body which has overall responsibility.
567.2 (1) LICENSURE
INFECTION CONTROL - Committee Responsibility
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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 review of facility policy and interview with staff (OTH), 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:
Review on May 31, 2012, of facility policy "Infection Control," undated, revealed it did not contain provisions for a Quality Assurance Committee or Infection Control Committee to be responsible for the prevention, control and investigation of infection in the ASF to assure the effectiveness of procedural techniques in all departments.
Request was made on May 31, 2012, for the Infection Control or Quality Assurance Committee meeting minutes. None were provided.
Interview on May 31, 2012, with OTH1 confirmed there was no documentation of Infection Control or Quality Assurance Committee meeting minutes for the facility.
Plan of Correction:Berger and Benjamin are in the process of rewritting policy for the prevention, control and investigation of infection in the ambulatory surgery facility (ASF) to assure the effectiveness of procedural techniques in all departments.
These will be finished in 45 days from the day of survey and incorporated in the policy and procedure manual. Infection Control and Quality Assurance Committees will be formed. Meetings will be held and documented as prescribed in the policy The office and medical staff staff will receive an in-service about the policy changes by the medical director. This will be reported to the quality assurance committee and infection controll committee at the next meeting and incorporated into the policy and procedure manual. The govrning body has overall responsibility.
567.3 (a) LICENSURE
Policies and Procedures
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567.3 Policies and procedures
(a) Only authorized persons, who are properly attired, shall be allowed int he surgical area.
Observations:
Based on review of facility policy and procedures and interview with staff (OTH), it was determined the facility failed to ensure Infection Control policies were established for authorized persons and the proper attire in the surgical area.
Findings include:
Review on May 31, 2012, of the facility policy "Infection Control," undated, revealed no provision for authorized persons with the proper attire in the surgical area.
Interview on May 31, 2012, with OTH1 confirmed the facility's "Infection Control" policies and procedures were not established for authorized persons and the proper attire in the surgical area.
Plan of Correction:Berger and Benjamin are in the process of writing Infection Control policies & procedures. These will include policies and procedures for authorized persons and the proper attire in the surgical area.
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the infection control committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility
567.3 (b) (1) LICENSURE
Policies and Procedures
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567.3 Policies and procedures
(b) Current written policies and procedures to assure definite and
valid infection control shall include,but not be limited to, the
following:
(1) Medical asepsis
Observations:
Based on interviews with staff (OTH), it was determined the facility failed to ensure current written policies and procedures to assure definite and valid infection control were developed and implemented.
Findings include:
Review of the facility's "Infection Control" policy, no date, revealed a standard that identified the need for an exposure control plan to be developed and observed. Continued reviewed revealed a discussion on how to develop an exposure plan. No other infection control policies and procedures were provided.
Interview with OTH1 on May 31, 2012, at approximately 2:30 PM, confirmed the facility failed to adopt infection control policies, as required under 567.3(b)(1); 567.3(b)(2); and 567.3(b)(5)-(17).
Plan of Correction:Berger and Benjamin are in the process of writing policies and procedures to assure definite and valid infection control are developed and implemented.Infection control policies
as required under 567.3(b)(1); 567.3(b)(2); and 567.3(b)(5)-(17). will be written
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to theinfection control committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility.
567.11 (2) LICENSURE
Operating Suite Equipment
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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 approprate
for the patients treated. The following equipment shall be available in the operating
suite and recovery area:
(2) Emergency call system
Observations:
Based on observation and interview with staff (OTH), it was determined the facility failed to adequately equip the operating room and recovery area with an emergency call system.
Findings include:
Observation on May 31, 2012, at approximately 10:30 AM, of Procedure Room B (operating room) and the recovery area revealed there were no emergency call systems located in Procedure Room B and the recovery area.
Interview on May 31, 2012, at approximately 10:30 AM with OTH1 confirmed there were no emergency call systems located in Procedure Room B and the recovery area.
Plan of Correction:Berger and Benjamin is a small facility and comunication is person to person between personel in the room and ancilary personel outside the room Berger and Benjamin are in the process of investigating the instilation of an intercom system in the or and recovery room. This will be acomplished with additional phones or a seperate intercom system. This system is under investigation an will be in place in 2 months. At the present time cell phones will be used for comunications if the need arises. The governing body will be responsible and has overall responsibility for arranging the emergency communication system. there will be documentation of a purchase or work estimate by the date of POC completion. This will be reported to the qa committee
567.32 LICENSURE
Policies and Procedures
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567.32 Policies and procedures
Procedures shall be developed for cleaning and care of equipment, for
establishment of cleaning schedules, for cleaning methods and for proper
use of cleaning supplies and disposal of waste. Suitable equipment shall be
provided to facilitate cleaning.
Observations:
Based on review of facility policies and interview with staff (OTH1), it was determined the facility failed to ensure written procedures were developed for the cleaning and care of equipment.
Findings include:
On May 31, 2012, the surveyor requested the written policies and procedures for the cleaning and care of the facility's equipment. None was provided.
Interview on May 31, 2012, with OTH1 confirmed there were no written policies and procedures for the cleaning and care of the facility's equipment.
Plan of Correction:Berger and Benjamin are in the process of writing procedures for the cleaning and care of equipment.
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility.
567.42 (a) LICENSURE
Policies and Procedures
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567.42 Policies and procedures
(a) A schedule of preventive maintenance shall be developed for the
physical plant, biomedical and all other equipment.
Observations:
Based on review of policies and procedures and interview with staff (OTH) it was determined the facility failed to ensure written procedures were developed for a schedule of preventive maintenance for the physical plant, biomedical, and other equipment.
Findings include:
On May 31, 2012, the surveyor requested the facility's written preventative maintenance policies and procedures. None were provided.
Interview on May 31, 2012, with OTH1 confirmed the facility did not have written preventative maintenance policies and procedures.
Plan of Correction:Berger and Benjamin are in the process of writing a schedule of preventive maintenance for the physical plant, biomedical, and other equipment These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility.
567.42 (b) LICENSURE
Policies and Procedures
Name - Component - 00
567.42 Policies and procedures
(b) Written procedures shall be readily available for employes to
follow in the event of a breakdown in equipment, mechanical systems or
utilities.
Observations:
Based on review of policies and procedures and interview with staff (OTH), it was determined the facility failed to ensure written procedures were readily available for employees to follow in the event of a breakdown in equipment, mechanical systems or utilities.
Findings include:
On May 31, 2012, the surveyor requested the facility's written environmental and maintenance policies and procedures. None were provided.
Interview on May 31, 2012, with OTH1 confirmed the facility did not have written environmental or maintenance policies and procedures.
Plan of Correction:Berger and Benjamin are in the process of writing procedures for employees to follow in the event of a breakdown in equipment, mechanical systems or utilities.
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility. Equiptment is maintained by outside biomedical company.
Mechanicals and utilities are maitained by building.
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 policies and procedures and interview with staff (EMP), it was determined the facility failed to ensure the ventilation system was 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 was provided in critical areas such as the surgical and recovery suites.
Findings include:
On May 31, 2012, the surveyor requested the facility's written policies and procedures for maintenance of the ventilation system and documentation of temperature and humidity levels. None were provided.
Interview on May 31, 2012, with OTH1 confirmed there were no written policies and procedures for maintenance of the ventilation system or for temperature and humidity levels for critical areas.
Plan of Correction:Berger and Benjamin are in the process of writing policy and procedure for temperature and humidity control.
Berger and Benjamin reside in commercial space rented in a larger medical building building. Maintainence is perfomed by the landlord but will be monitored by Berger and Benjamin in regards to the space. Berger and benjamin will purchase temperature and humidity monitors in critical areas. These will be in place in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The temperture and humidity will be documented. Out of range reading will be corrected. The governing body has overall responsibility.
569.13 LICENSURE
Testing Fire Warning Systems
Name - Component - 00
569.13 Testing Fire Warning Systems
Fire safety systems, including automatic fire extinguishing systems,
automatic and manual alarms, stand pipes and hose reels shall be of an
approved type. They shall be kept in good operating condition and inspected
by qualified ASF personnel at least every 3 months. Records of the
inspections shall be kept on file for the licensure period.
Observations:
Based on review of facility documents and interview with staff (OTH), it was determined the facility failed to ensure the automatic fire extinguishing systems, and the automatic and manual alarms were inspected by qualified ambulatory surgery facility (ASF) personnel at least every three months and records of the inspection were kept on file and failed to ensure fire extinguishers were readily available for staff use.
Findings include:
1) Review of the facility document "Fire Procedures," undated, revealed no procedures for the provision of the inspection of the automatic fire extinguishing systems, and the automatic and manual alarms by qualified ASF personnel at least every three months.
On May 31, 2012, the surveyor requested the inspection documentation of the automatic fire extinguishing systems, automatic and manual alarms. None was provided.
Interview on May 31, 2012, with OTH1 confirmed there was no documentation that the automatic fire extinguishing systems, automatic and manual alarms were inspected at least every three months by qualified ASF personnel.
2) Review on May 31, 2012, of the facility document "Fire Procedures," undated, revealed "Location of fire extinguishers: Front Reception by fuse closet, inside clinic by bookkeeping, Med Hallway, PACU [Post Anesthesia Care Unit] fire exit, Staff room."
Observation on May 31, 2012, revealed one fire extinguisher located outside of the facility in the hallway across from the elevator.
Interview on May 31, 2012, with OTH1 confirmed there was only one fire extinguisher available for staff to use in the event of a fire. OTH1 confirmed the one fire extinguisher was located outside of the facility.
Plan of Correction:The automatic fire alarms are provided and maintained and inspected by the landlord who maintains records for inspection. This system was recently installed to conform to the city fire code. These records are available from the landlord. Berger and Benjamin will attempt to obtain these records. The Proper Fire extinguishers will be purchased and in place in 45 days from the day of survey.. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. Quartely inspections and tests will be performed and documented The governing body has overall responsibility.These systems will be maintained according to ASF regulations? The governing body will obtain and retain the inspections from the landlords qualified personal.
569.14 LICENSURE
Internal Disaster and Fire Plans
Name - Component - 00
569.14 Internal Disaster and Fire Plans
The ASF shall have an internal disaster and fire plan incorporating
evacuation procedures and the safety of both closed records and the records
of those patients being evacuated. These plans shall be made available to
personnel and evacuation diagrams shall be posted throughout the ASF.
Observations:
Based on observation and interview with staff (OTH), it was determined the facility failed to ensure there was a facility fire plan incorporating the evacuation procedures available to personnel and failed to post evacuation diagrams throughout the facility.
Findings include:
Observation on May 31, 2012, revealed no postings of evacuation diagrams throughout the facility.
On May 18, 2012, the surveyor requested a copy of the facility's evacuation plan. None was provided.
Interview on May 18, 2012, with OTH1 confirmed there was no facility evacuation plan and there were no evacuation diagrams posted throughout the facility
Plan of Correction:Berger and Benjamin are in the process of writing a facility fire plan incorporating the evacuation procedures available to personnel and will post evacuation diagrams throughout the facility.
These will be finished in 45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee and documented in the minutes at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. This will be done quarterly The governing body has overall responsibility to ensure the POC
569.15 LICENSURE
Safety Education Program
Name - Component - 00
569.15 Safety Education Program
Employes shall participate in the safety program and perform the duties
delegated to them and be instructed in the operation of the fire warning
system, the proper use of fire fighting equipment and the procedure
to follow if electric power is impaired.
Observations:
Based on review of facility documents, personnel files (PF), and interview with staff (OTH), it was determined the facility failed to ensure employees were instructed in the operation of the fire warning sytem, the proper use of fire fighting equipment, and the procedure to follow if the electric power was impaired.
Findings include:
Review on May 31, 2012, of the facility document "Fire Procedures," undated, revealed documentation of the Non-Medical staff responsibilities during a fire emergency. Further review of the document revealed a staff signature area to confirm they had read and understood the emergency plan.
Review on May 31, 2012, of PF1, PF2, PF3, PF4, PF5, and PF6 revealed no documentation of a signed "Fire Procedures" document in the personnel files.
Interview on May 31, 2012, confirmed there was no documentation PF1, PF2, PF3, PF4, PF5, and PF6 had reviewed the facility's "Fire Procedures" document.
Plan of Correction:Berger & Benjamin will hold an inservice review for all staff to be sure they are instructed in the operation of the fire warning sytem, the proper use of fire fighting equipment, and the procedure to follow if the electric power was impaired.This instuction will be documented in the personnel files and performed yearly.Competant instructors will be obtained to perform the instruction. This will be completed in
45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance.The governing body has overall responsibility.
569.21 (a) LICENSURE
EVACUATION - Fire Drills
Name - Component - 00
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 documents and interview with staff (OTH), it was determined the facility failed to ensure fire and internal diaster drills were held at least quarterly for facility personnel under varied conditions.
Findings include:
Review on May 31, 2012, of the facility document "Fire Procedures," undated, revealed no provisions for fire and internal diaster drills to be held at least quarterly for facility personnel under varied conditions.
On May 31, 2012, the surveyor requested documentation of the quarterly fire and internal diaster drills. None were provided.
Interview on May 31, 2012, with OTH1 confirmed there was no documentation of quarterly fire or internal diaster drills.
Plan of Correction:Berger and Benjamin will implement fire and internal diaster drills at least quarterly for facility personnel under varied conditions. These will be Documented in the Policy and Procedure manual. the drills wil be scheduled starting
45 days from the day of survey. The office and medical staff staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The governing body has overall responsibility.The office manager will coduct the drills. The first drill will take place after the policies are in place. Completion will be documented in the QA committe minutes
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 interview with staff (OTH), it was determined the facility failed to request an annual inspection by its local fire department.
Findings include:
Review on May 31, 2012, of the facility document "Fire Procedures," undated, revealed no provision to request an annual inspection by the local fire department.
On May 31, 2012, the surveyor requested documentation of the request for an annual local fire department inspection. None was provided.
Interview on May 31, 2012, with OTH1 confirmed there was no documentation the facility requested an annual inspection by the local fire department.
Plan of Correction:Berger and Benjamin will request an inspection by the local fire department.
The request will be made within 45 days from the day of survey. The automatic alarm is maintained by the building. The governing body will request the yearly inspection report from the landlord and is responsible for this. These reports will be maintained and reported to the QA committee. The governing body has responsibility for the POC
569.34 LICENSURE
Electrical Safety
Name - Component - 00
569.34 Electrical Safety
Appliances, instruments and installations shall be tested before
use to determine compliance with grounding, current leakage and other
device safety requirements to ensure protection of patients and employees. A
program of routine maintenance shall be effectively enforced to ensure that
electrical receptacles and plugs, wires and connectors are safe. If an
appliance requiring three wire circuitry for grounding is attached to
as two wire outlet, the adaptor plug pigtail shall be attached to a
ground.
Observations:
Based on interview with staff (OTH), it was determined the facility failed to ensure there was a program of routine maintenance for the electrical receptacles, plugs, wires, and connectors.
Findings include:
On May 31, 2012, the surveyor requested the routine maintenance documentation of the facility's electrical testing for electrical receptacles. None were provided.
Interview on May 31, 2012, with OTH1 confirmed there was no documentation of routine maintenance for the electrical testing for electrical receptacles.
Plan of Correction:Policy and procedure will be written to reflect the need for inspections and document that the report of the inspections were received The electrical recepticals are maintained by the building. Berger & Benjamin will request an inspection program by the landlord. If the landlord will not comply Berger and Benjamin will hire an inspector and establish a program of routine maintainence. This will be acomplished in 45 days from the day of survey.The governing body has responsibility for the POC. Reports will be made yearly to the QA committee
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 (OTH), it was determined the facility failed to ensure it was in 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 "3.8-3.4.2.2 Cubicle curtains or other provisions for privacy during post-operative care shall be provided.
Observation on May 31, 2012, of the patient recovery room area revealed seven patient recovery chairs for post-operative care. There were no cubicle curtains for privacy for the seven recovery chairs.
Interview on May 31, 2012, with OTH1 confirmed the post-operative recovery room chairs did not have cubicle curtains for privacy.
2) Review 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 May 31, 2012, revealed the soiled work area and the clean work area were located together. Further observation of the area revealed the clean and soiled work areas were U shaped and were open to the hallway where patients and staff passed to access Procedure rooms A-1, A-2, and Exam 1. The handwashing sinks in the soiled area were also designated to use for the clean area. The counter space located in the soiled area was also designated to use for the wrapping of sterilized equipment.
Interview on May 31, 2012, with OTH1 confirmed the clean and soiled work areas shared the same U shaped space that was open to the hallway where patients and staff passed through.
3) Review 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 May 31, 2012, of the clean and soiled work area revealed wrapped sterile supplies stored directly on a wood shelf located directly above the autoclave. The wood shelf had paint damage on the edges. There were no temperature, humidity or ventilation monitors observed in this area where the sterile wrapped packages were stored.
Interview on May 31, 2012, with OTH1 confirmed the sterile supplies were stored on the wood shelf that was located in the physically combined clean and soiled work area. OTH1 confirmed there was no provision to monitor temperature, humidity or ventilation in the area where sterile packages were kept. OTH1 confirmed the steam and heat from the autoclave located below where the sterile supplies were stored caused the paint damage to the wood shelf.
Observation on May 31, 2012, of the facility's storage area revealed it contained a supply of intravenous fluid bags. There were no provisions in the storage area to monitor ventilation, temperature and humidity.
Interview on May 31, 2012, with OTH1 confirmed there were no provisions to monitor ventilation, temperature and humidity in the storage area where the intravenous fluid bag supply was stored.
4) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed "3.8-3.6.6 Drug Distribution Station Provision shall be made for storage and preparation of medication administered to patients."
Observation on May 31, 2012, of the combined clean and soiled work area revealed a locked cabinet located over the sink that contained five unopened packages containing 25 vials of Lidocaine 1%. There were numerous boxes of various gauge size needles stored in this cabinet.
Interview on May 31, 2012, with OTH1 confirmed medication and needles were stored in the combined clean and soiled work area.
5) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed "3.8-5.1.2.4 Soiled Holding Area (1) Space shall be provided for handling and storage of soiled materials and equipment separate from areas designated for storage of clean and sterile materials and equipment. (2) Appropriate receptacles for biohazardous waste shall be provided, and these shall be placed in the designated soiled holding area."
Observation on May 31, 2012, of the Medication Room revealed a locked cabinet and a refrigerator with medications. There were four red plastic sharps containers located on the floor in this room. One of the four red plastic sharps containers was full.
Interview with on May 31, 2012, with OTH1 confirmed the facility did not have a designated soiled holding area for biohazardous waste.
6) Review of the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities revealed "3.7-3.3.4 Emergency Communication System All operating rooms shall be equipped with an emergency communication system designed and installed to effectively summon additional qualified staff support with no more than push activation of an emergency call switch."
Observation on May 31, 2012, of patient procedure rooms "Procedure A-1 and Procedure A-2" revealed emergency intercoms located on the wall near the doorway in each of these rooms. Observation on May 31, 2012, of patient procedure room "Procedure B" revealed there was no intercom system located in this room.
Interview on May 31, 2012, with OTH1 confirmed the emergency intercoms in Procedure A-1 and Procedure A-2 were not functioning. Further interview with OTH1 confirmed there was no emergency intercom located in "Procedure B".
7) Review 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 May 31, 2012, of the patient restroom revealed the door opened inward.
Interview on May 31, 2012, with OTH1 confirmed the patient restroom door open inward and that patients were told not to lock the door when using the restroom.
Plan of Correction:Response to #1) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: The area of Berger and Benjamin's facility that has been designated and used as a patient recovery room will have curtains installed to insure patient privacy.
.
Response to #2) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: On June 6, 2012, Dr. Charles Benjamin and his architect met with a representative of the Division of Safety Inspection for an initial/sketch review of Berger and Benjamin's facility. At the plan review meeting, 3.8-5.1.2.1 and 3.8-5.1.2.2 were discussed at length. Berger and Benjamin is in the process of conferring with his architect to discuss possible feasible alterations to Berger and Benjamin's facility to satisfy the requirements for clean and dirty/soiled workrooms in the Guidelines. Additionally, Berger and Benjamin may seek limited, narrow exceptions from those Guidelines to the extent that Berger and Benjamin can propose a renovation or alteration agreeable to the Division of Safety Inspection. While the alteration process is ongoing, BB will ensure the safety of its patients by reviewing 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.
Response to #3) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: Consistent and in accordance with Berger and Benjamin's response to deficiency 20 (observation 6747), Berger and Benjamin's facility resides in commercial space rented in a larger medical building. Berger and Benjamin will purchase devices to monitor ventilation, temperature and humidity in critical areas, including the storage area where packs/intravenous bag supplies are stored. These will be be in place in 45 days from the date of the survey. The office and medical staff will receive an in-service about the policy changes. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and monitor compliance. The ventilation, temperature and humidity will be documented. Out of range reading will be corrected. The governing body has overall responsibility.
Response to #4) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: As noted in its response to number 2 (above), BB is in the process of conferring with his architect to discuss possible feasible alterations to Berger and Benjamin's facility to satisfy the requirements for clean and dirty/soiled workrooms in the Guidelines. Additionally, Berger and Benjamin may seek limited, narrow exceptions from those Guidelines to the extent that Berger and Benjamin can propose a renovation or alteration agreeable to the Division of Safety Inspection. Pending these alterations, the office and medical staff will receive an in-service about the policy changes with respect to the drug distribution station. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and regularly monitor compliance to ensure strict adherence to the guidelines. The governing body has overall responsibility
Response to #5) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: By 45 days from the date of the survey, Berger and Benjamin will assess its current layout to determine the best and most appropriate location for a soiled holding area for biohazardous waste in accordance with the guidelines and reconfigure and designate that section of its facility as a soiled holding area for biohazardous waste. The office and medical staff will receive an in-service about these policy and layout changes with respect to the soiled holding area for biohazardous waste. This will be reported to the quality assurance committee at the next meeting and incorporated into the policy and procedure manual. The medical director has the responsibility to educate the staff to these policies and regularly monitor compliance to ensure strict adherence to the guidelines. The governing body has overall responsibility
Response to #6) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: Consistent and in accordance with Berger and Benjamin's response to deficiency 16 (observation 6729), Berger and Benjamin is currently in the process of investigating, assessing and pricing the installation of an intercom system that will include an intercom in each procedure room (which have a dual function as recovery rooms). This system is under investigation an will be in place in 2 months. At the present time, cell phones will be used for communications if/when the need arises. The governing body will be responsible and has overall responsibility for arranging the emergency communication system. There will be documentation of a purchase or work estimate by the date of POC completion. This will be reported to the Quality Assurance committee.
Response to #7) The effective date for this regulation is June 19, 2012. Berger and Benjamin has taken the following steps to ensure compliance when this regulation takes effect: By 45 days from the date of the survey, Berger and Benjamin will reconfigure the doors on each of its restrooms so that the doors shall open outward and shall be in compliance with 3.8-7.2.2.2. At the present time, patients are told not to lock the door when using the restroom. The change to the restroom doors will be reported to the Quality Assurance committee
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