HospitalInspections.org

Based on a review of facility documents, policies and procedures, medical records (MR) and interview with staff (EMP), it was determined the Governing Body failed to ensure patients primary care physician were notified of admission (A-0133); by failure to ensure patient privacy in an outpatient treatment center (A-0142); by failure to ensure QAPI projects were implemented for safety of services (A-0297); by failure to ensure vital signs were completed for blood transfusion patients (A-0409); by failure to ensure the protection of patient records(A-0441); by failure to ensure established guidelines were followed for the compounding of hazardous drugs (A-0489); by failure to ensure established procedures for hand hygiene and donning protective garb were followed for the compounding of hazardous drugs and sterile preparations, failure to ensure proper protocols were followed for IV preparation in the cancer center pharmacy, failure to ensure the proper physical environment for the cancer center pharmacy and failure to ensure the proper transportation for hazardous drugs and sterile preparations (A-0501); by failure to ensure access to medications were limited to authorized personnel (A-0504); by failure to ensure ongoing daily cleaning and sanitation of the dietary department (A-0620); by failure to ensure patient care supplies and equipment were maintained (A-0724); by failure to ensure proper temperature controls were maintained in operating rooms (A-0726); by failure to ensure a sanitary environment (A-0747); by failure to ensure infection control protocols were developed for the cancer center, failure to provide oversight for the dietary department (A-0749); by failure to ensure unauthorized access to restricted areas (A-0951); by failure to ensure adequate prov

Findings include:

Review on April 9, 2018, of facility policy "Transition of Care Summary," revised November 2, 2017, revealed it did not contain a provision to notify the patient's own physician promptly of the patient's hospital admission.

Review on April 9, 2018, of MR9, MR47, MR48, MR49 and MR50 revealed no documentation of a prompt notification to the patient's own physician of the hospital admission.

Interview with EMP13 on April 9, 2018, at 1:30 PM, confirmed the facility policy does not contain a provision to notify the patient's own physician promptly of the patient's hospital admission and there was no documentation in any of the medical records for physician notification.

Review on April 12, 2018, of the facility's "Floor Plan for the Cancer Center," not dated, revealed that the treatment area provided privacy curtains and equipment for seven patient treatment bays.

Interview on April 12, 2018, with EMP36, confirmed that the facility added two additional recliners to the treatment area for patient overflow but failed to provide patient privacy curtains for the two additional recliners.

Interview on April 12, 2018, with EMP30, confirmed that the facility failed to ensure privacy for all patients in the Cancer Center.

Based on a review of facility documents and interview with staff (EMP), it was determined the facility failed to document specific quality improvement projects that were conducted in the Cancer Center Pharmacy.

Findings include:

Review on April 13, 2018, of established guidelines for the processing of compounded sterile preparations "U.S. Pharmacopeia, USP-NF-General Chapter <797> " dated 2012, revealed, "Quality Assurance Program, A provider of CSPs (Compounded Sterile Preparations) shall have in place a formal QA (Quality Assurance) program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes."

Review on April 13, 2018, of facility document "Quality Improvement Plan," dated March 2018, revealed "Purpose ... Through an interdisciplinary and integrated process, patient care and processes that affect patient care outcomes shall be continuously monitored and evaluated to promote optimal achievement, with appropriate accountability assumed by the Governing Board, Medical Staff, Administration, and support personnel ... Hospital Departments, The Department Leaders are accountable to Administration, the Quality Improvement Council and the Board for the quality and safety of care/services and performance of their staff and departments. Department Directors and Managers are responsible for the systematic monitoring and analysis of the quality and safety of care provided in their departments."

A request was made on April 11, 2018, at 10:00 AM to EMP34 for quality projects conducted in the Cancer Center Pharmacy. None provided.

Based on review of facility policy and procedures, medical records (MR), and interview with staff (EMP), it was determined the facility failed to follow adopted policies related to blood transfusion for two of three medical records reviewed (MR52 and MR53).

Findings include:

Review on April 11, 2018, of facility policy, "Blood and Blood Component Administration" dated March 2018, revealed "... Purpose: To provide staff with direction when administering blood and blood components ... 5. A qualified health care professional remains with the patient for the first 15 minutes from transfusion start time ... A. Vital signs and lung sounds are documented ... B. Lung sounds are documented: a. Pre-transfusion prior to requesting blood product b.15 minutes after start of transfusion (after the blood actually enters the body) c. One hour after completion of transfusion (inpatient only) 6. All transfusion documentation is completed in the patient's EMR ..."

Review on April 11, 2018, of MR52, physician orders, revealed a blood transfusion order for April 8, 2018. Further review of MR52 nursing documentation, dated April 8, 2018, revealed the blood transfusion was initiated at 16:56 and completed at 23:24. Continued review of MR52 nursing documentation of lung sounds revealed, "Breath Sounds Assessment ... 1900 ... 23:14 ... 00:25." Further review revealed no documented evidence lung sounds assessments were completed pre-transfusion or 15 minutes after start of transfusion, as required by facility policy.

Review on April 11, 2018, of MR53, physician orders, revealed a blood transfusion order for November 30, 2017. Further review of MR53, nursing documentation, dated April November 30, 2017, revealed the blood tr

Based on a review of facility policy, observation and interview with staff (EMP), it was determined that the facility failed to ensure medical records were secured from unauthorized access.

Findings include:

Review on April 9, 2018, of the facility's "Location and Storage of Medical Records" policy, undated, revealed, "Policy: It is the policy of this facility that medical records be maintained in a secure and confidential manner ... Acute Care Setting: Areas housing health information shall be restricted to authorized personnel only and these areas will be locked at all times ... Records should not be kept in closed/and or offsite departments of the hospital overnight unless there is a process in place for accessing and obtaining these records during off-hours for patient care purposes ... ."

Observation on April 9, 2018, at 12:00 PM, of the Cancer Center revealed opened shelving that stored patient medical records located above two nursing work stations. Further observation revealed one floor to ceiling shelving unit with four shelves that stored patient medical records.

Interview on April 9, 2018, at 12:20 PM, with EMP36, confirmed the above findings and that the facility failed to ensure patient medical records were secure from unauthorized access.

Based on a review of facility documents, observation and interview with staff (EMP), it was determined that the facility failed to ensure performance improvement projects were established for the Cancer Center Pharmacy (A-0297); by failure to protect patient records (A-0441); by failure to ensure established protocols and procedures were followed for compounded sterile preparations and hazardous drugs (A-0501); by failure to ensure air flow and pressure monitoring for environment (A-0726); by failure to ensure an infection control and prevention plan were implemented (A-0747); and by failure to ensure proper protocols were followed (A-0749).

Immediate Jeopardy was called on April 12, 2018, at 3:17 PM and abated April 12, 2018, at 10:03 PM

cross refernce with:
482.12 Governing Body
482.21(d) QAPI Performance Improvement Projects
482.24(c)(1) Medical Records Service
482.25(b)(1) Pharmacist Supervision of Services
482.41(c)(4) Ventilation, Light, Temperature Controls
482.42(a)(1) Infection Control Program

Based on review of facility documents, observation and interview with staff (EMP), it was determined that the facility failed to follow established guidelines and policy for the processing of sterile compounded preparations in the Cancer Center Pharmacy.

Findings include:

Review on April 12, 2018, of facility policy "Compounded Sterile Products- Hand Hygiene and Garbing Procedure" reviewed 10/2017, revealed, "The purpose of this policy is to standardized the process by which all authorized personnel prepare to enter the controlled environments of the ante-area and buffer /clean room to further reduces sources of viable contamination... 1.7 Personnel must don the garb and perform hand hygiene in an order that proceeds from dirtiest to cleanest activities."

Review on April 9, 2018, of facility policy "Hazardous Materials and Substances-Drug Compounding Techniques," dated December 1, 2015, revealed "Purpose-This Policy communicates information and established work practice requirements that specifically apply to activities associated with compounding hazardous drugs ... 1.0 Policy-1.3- Engineering controls alone are not sufficient to protect and safeguard either the sterility of CSPs or the safety of the workers handling HDs. 1.4 Specialized Personal Protective Equipment (PPE) must be used during the handling of HDs."


Observation on April 12, 2018, at 9:20 AM, revealed EMP33 was preparing and compounding medications in the ISO Class 5 hood. Further observation revealed EMP33 was not wearing personal protective equipment (PPE) or the required garb.

Interview on April 12, 2018, at 9:35 AM, with EMP33, confirmed t

Based on review of facility policy, observation and interview with staff (EMP) it was determined the facility failed to ensure only authorized personnel had access to medications.

Findings include:

Review on April 10, 2018, of facility policy "Medication Administration " approved May 2014, revealed provisions related to personnel authorized to access locked medication storage.

Review on April 11, 2018, of facility policy "Pharmacy, Storage: General," effective March 2017, revealed no provisions related to personnel authorized to access locked medication storage.

Review on April 10, 2018, of facility document "Pottstown Memorial Medical Center, Position Description/Competency Based Evaluations," revealed no documented evidence for the approval of the employee to have access to locked medication storage. Further review revealed the Position Description was signed with the name of EMP26 and dated July 31, 2017.

Based on review of facility policies and procedures, facility documents, and interviews with staff (EMP), it was determined that the facility Director of Dietary Services failed to ensure the ongoing, daily management and oversight of cleaning and sanitation within the Dietary Services Department.

Findings include:

Review on April 10, 2018, of the facility policy, "Leadership: Contractual Relationship of Facility/Community and the Company", dated, "2/18", revealed "... Procedures: The Director, an associate of The Company, is responsible for organizing and operating the Department in accordance with policies and procedures established jointly by The Company and the administrative body of Pottstown Hospital Tower Health ..."

Review on April 10, 2018, of the facilty policy, "Sanitation and Infection Prevention/Control: Area and Equipment Cleaning", dated, "2/18", revealed "Policies: Written procedures are available, detailing daily and weekly (as needed) cleaning for all areas and equipment in the department. The procedures are written to cover all necessary safety precautions ... Management/supervisory Personnel assigns weekly and special cleaning to be completed each day ..."

Review on April 10, 2018, of the facility policy, "Sanitation and Infection Prevention/Control: Sanitation Inspection and Checklist", dated, "2/18", revealed "Policy: A basic sanitation inspection is conducted at least once per month to ensure that established procedures are being followed and that sanitation standards are maintained ... Procedures: Director/Designee The department basic Sanitation Checklist is completed during the sanitation inspection ... Action Plans are developed for all areas not meeting standa

The Physical Environment Condition was found to be out of compliance during a Life Safety Survey completed on March 15, 2018. Further details are outlined in that Division of Life Safety Survey Report.

Based on review of facility documents, observation and interview with staff (EMP), it was determined the facility failed to maintain and store equipment to ensure an acceptable level of safety.

Findings include:

Review on April 9, 2018, of facility policy "Infection Prevention, IC.02.02.01," not dated revealed "The hospital reduces the risk of infections associated with medical equipment, devices and supplies ... 4. The hospital implements infection prevention and control activities when doing the following: Storing medical equipment, devices and supplies."

Observation on April 9, 2018, of the Emergency Department (ED) Decontamination Room revealed a metal stretcher used in the transportation of patients arriving to the ED. Further observation revealed the metal stretcher had numerous areas of orange-brown colored areas on the stretcher, side rails, wheels and supports.

Review on April 11, 2018, of facility policy "Scheduled Equipment Maintenance," effective 10/20/2014, revealed "Purpose: to define the procedure for inspection, maintenance and repair of significant equipment and components of utilities systems deemed essential for normal medical operations...Procedure: ...2. The assigned individual performs the maintenance in accordance with the instructions included in the work order and documents the maintenance, including any significant observations."

Review on April 11, 2018, of facility document "4-Preventive Maintenance Work Order" dated November 21, 2017, revealed maintenance for the stretcher was completed on December 29, 2017. Further review revealed the stretcher was approved to remain in use.

Interview on April 9, 2018, at 11:10 AM, with EMP9, confirmed the areas of disc

Review on April 11, 2018, of the facility policy, "Monitoring of Humidity and Temperature in Operating Rooms", dated, "August 2011", revealed "Purpose: The temperature and humidity levels in operating rooms must remain within specific parameters. Maintaining specified parameters helps to inhibit bacterial growth. The range is one that most patients can tolerate and one that is comfortable for personnel ... Policy: The temperature and humidity will be monitored in every surgical suite on a daily basis. Appropriate and immediate action will be implemented in the event that a temperature or humidity parameter is exceeded. Daily Monitoring The temperature and humidity of each operating room will be recorded on the Temperature/Humidity Log (see attached) on [sic] daily basis. Acceptable temperature range is between 68 and 73 degrees Fahrenheit (20 to 23 degrees centigrade). Room temperatures of 68 to 76 degrees Fahrenheit (20 to 24 Centigrade) inhibit bacterial growth ... Policy: If either temperature or humidity range is exceeded, contact the Facilities Department immediately. Documentation of corrective action will be noted by facilities Department and note if problems not resolved ... A copy of completed monthly logs will be forwarded to the Infection Control Manager ..."

Review on April 11, 2018, of the facility document, "Temperature, Humidity & Pressure Log, Operating Room 1", dated, "March 2018", revealed documented evidence that Operating Room (OR) 1 was not with

Based on review of facility policies and procedures, review of facility documents, observations, and interviews with staff (EMP), it was determined the facility failed to comply with the Infection Control Condition of Participation by failing to ensure the Infection Control Program monitored the ongoing activities of hospital-wide, infection control prevention and surveillance measures (A-0749); by failing to ensure that quality data for outpatient Pharmacy services were maintained (A-0297); by failing to ensure that the Pharmacy Condition of Participation was met (A-0489); by failing to ensure that Pharmacy Services were supervised (A-0501); by failing to ensure that Dietary Services were supervised (A-0620); by failing to ensure temperature controls were maintained within Surgical Services (A-0726); by failing to ensure the Infection Control Program had oversight of Pharmaceutical and Dietary Services (A-0749); by failing to ensure that restricted areas were maintained within Surgical Services (A-0951); and by failing to ensure that infection control standards were maintained within Outpatient Services (A-1081).

Cross Reference:
482.21(a),(b)(2)(i),(b)(3) Data Collection & Analysis
482.25 Condition of Participation: Pharmaceutical Services
482.25(b)(1) Pharmacist Supervision of Services
482.28(c)(1): Director of Dietary Services
482.41(c)(4): Ventilation, Lights, and Temperature Controls
482.41(c)(2): Facilities, Supplies, and Equipment Maintenance
482.42(a)(1): Infection Control Program
482.51(b): Operating Room Policies
482.54: Standard Tag for Outpatient Services

Based on review of facility documents and interview with staff (EMP) it was determined the facility failed to ensure an infection control program was developed for the Cancer Center pharmacy and failed to ensure enviromental microbial samples were evaluated.

Findings include:

Review of facility document "United States Pharmacopeia/National Formulary, General Chapter <797> revealed "Environmental Viable Airborne Particle Testing Program- The risk of contaminating a CSP (Compounded Sterile Preparation) prepared under low-risk level, and medium risk level condition is highly dependent on proper hand hygiene and garbing practices ... and the presence of surface contamination ... A sampling program in conjunction with an observational audit is designed to evaluate the competency of compounding personnel ...Actions levels, Documentation, and Data Evaluation-The value of viable data microbial sampling of the air in the compounding environment is realized when the data are used to identify and correct unacceptable situation. Sampling data shall be collected and reviewed periodic basis as a means of evaluating the overall control of the compounding environment. If an activity consistently shows elevated levels of microbial growth, competent microbiology personnel shall be consulted."

Review of facility document "Environmental Task Logs," dated 05/01/2017 -3/31/2018 revealed the following environmental sampling results;
1."ISO Class 5 4 ft. Germfree Negative Pressure Hood" revealed 2 incidents of microbe growth without documented follow-up.
2.ISO Class7 Oncology Room Air near Entry to Hood Area" revealed 6 incidents of microbe growth without documented follow-up.
3.ISO Class7 Onco

Findings include:

Review on April 12, 2018, of facility's policy, "Provision of Care Plan," dated March 2018, revealed, " ... Operating Room: ... Scope of Service: The Department of Surgical Services is in operation for any patient who receives surgical intervention. Specialties include: ... Pediatric Outpatient Surgery ... Post Anesthesia Care Unit (PACU) ... Scope of Service: The Post Anesthesia Care Unit provides intensive observation and care of patients of all ages following an operative procedure, ... Unit goals: To provide the highest level of safe patient care with dignity, compassion, respect and quality of care during the pre, intra, and post-operative phase of a patient's surgical experience."

Review on April 12, 2018, of facility's policy, "PACU Rules and Regulations," dated October 2012, revealed, "All patients receiving a general or spinal anesthetic will be admitted to the Post Anesthesia Care Unit or if PACU is closed, to Intensive Care Unit (ICU) for recovery until such time they are judged stable enough to return to their room by an anesthesiologist. Pediatric patients ages 13 years and younger must be recovered in PACU not ICU."

Review on April 12, 2018, of facility's, "Transfer Agreement," dated April 16, 2008, revealed, " ... the transfer of patients will be properly effected between AIDHC [Alfred

Based on a review of medical records (MR), review of facility documents and interview with staff (EMP), it was determined that the facility failed to develop policies for anesthesia procedures performed on pediatric patients and failed to develop anesthesia policies that address infection control measures and safety practices in all anesthetizing areas.

Findings include:

Review on April 12, 2018 of facility's policy, "Scope of Care and Practice Clinical Patient Care Areas: Anesthesia Department," dated November 2017, revealed, "Purpose: To provide optimum anesthesia care to those patients requiring surgical intervention and related procedures in a manner consistent with standards of practice....Description of Services: ... Major Clients Served: Inpatients, Outpatients, Surgical Staff, Medical Staff. Age Groups Served: 1 year to 12 years, 13 years to 17 years, 18 years to 64 years, 65+ years."

Request was made on April 12, 2018, to EMP2 for anesthesia policies that address infection control measures and safety practices in all anesthetizing areas. None provided.

Request was made on April 12, 2018, to EMP2 for a list of anesthetizing areas in facility. Provided highlighted list, "Hospital Departments/Locations."

Review on April 12, 2018, of facility document, "Hospital Departments/Locations," revealed the following anesthetizing areas: CVIR [Cardiovascular Interventional Radiology], Maternity Women's Health Center, Endoscopy and Operating Room.

Review on April 12, 2018, of MR67, MR68, MR69, MR70, MR71, revealed the patients related to these medical records had a pediatric outpatient surgical procedure performed. Further revealed, patients related to MR67, MR68,

Based on a review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure outpatient services were ordered by a practitioner authorized in accordance with State law and policies adopted by the medical staff, and approved by the governing body.

Findings include:

Review of the facility's "Medical Staff Bylaws of the Pottstown Memorial Medical Center" approved September 2016, revealed no provisions for a non-medical staff practitioner to write orders for outpatient rehabilitation services.

Interview on April 9, 2018, at 12:00 PM, with EMP17, confirmed that the facility failed to ensure outpatient services were ordered by a practitioner authorized in accordance policies adopted by the medical staff and approved by the governing body.

Based on review of facility policies and procedures, facility documents, observations, and interview with staff (EMP), it was determined that the facility failed to ensure that safe and acceptable standards of practice were provided to the patients who received services within the outpatient Endoscopy Unit.

Findings include:

Review on April 11, 2018, of the facility policy, "Cleaning & Sterilizing Video and Fiberoptic Endoscopes and Use of [manufacturer name] Unit", dated, "February 2015", revealed the policy was no longer applicable as the [manufacturer name] units were removed from the Endoscopy outpatient area and replaced with a different manufacture endoscope automated cleaning unit.

Review on April 11, 2018, of the facility document, "[manufacturer name] Peracetic Acid Test Strips" instructions for use, printed on the outside of the test strip box, dated, no date provided, revealed "[manufacturer name] Peracetic Acid (High level chemical disinfectant/sterilant used in the process of cleaning endoscope's) Test Strips provide an easy, rapid and convenient means of determining levels of peracetic acid. The test is designed to indicate peracetic acid in concentrations of 2000 ppm (parts per million). Peracetic acid concentrations of 2000 ppm or greater test positive ... Quality control As needed, a freshly prepared [manufacturer name] Use-Solution can be used as a quality control to verify functionality of the test strips ..."

Observations on April 11, 2018, of the outpatient Endoscopy Unit, between approximately 9:35 AM, and 10:15 AM, revealed one endoscope processing room. Further observation of the endoscope processing room revealed two[manufacturer name] automated endoscope cleaning units. Further review of the cleanin