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| GEISINGER MEDICAL CENTER | 100 NORTH ACADEMY AVENUE DANVILLE, PA 17822 | Oct. 25, 2019 |
| VIOLATION: Condition of Participation: Pharmaceutical Se | Tag No: A0489 | |
| Based on review of facility documents, medical records (MR), and staff interview it was determined the Pharmacy failed to meet the needs of the Neonatal Intensive Care Unit (NICU) patients for the preparation of donor breast milk (DBM) and infant formula. The Pharmacy failed to clean and sanitize the equipment used to prepare DBM and infant formula in the pharmacy. Findings include: Review on October 17, 2019, of the facility "Enterprise Pharmacy Acute Care Platforms Scope of Service Performance Improvement Plan," January 2019 version, revealed. "Purpose: The Enterprise Pharmacy Department is an active member of the Geisinger care team. Its central responsibility is medication purchasing, control, distribution and proper storage within the facility. Maintaining compliance with state, federal and standards governing the profession are an essential part of its role ... the pharmacy assures quality pharmaceutical care is provided to improve patient quality of life and outcomes in a fiscally responsible manner ... Treatments/Procedures Provided: The Enterprise Pharmacy Acute Care platforms assure the acquisition, procurement, dispensing, storage, preparation, administration and dispositions of medications are in compliance with applicable federal, state and local regulations, hospital bylaws and the accepted pharmacy standard of practice. ... This includes individual dose compounding of sterile and non-sterile products, parenteral nutrition, and chemotherapy and certain enteral feed products ... Review on October 9, 2019, of a word document provided by the facility, no date of approval, revealed a typewritten process for " 1. Nutrition preparation process in pharmacy including: a. Old Process (prior to 9/30/19): ... " There were eight steps in this Old Process. The last step revealed " ... viii. Graduated cylinder cleaned with hot tap water and [name] soap and store upside down to dry. " The word document continued " b. New Process (9/30/19 afternoon and forward): ... " There were eight steps in this process. Interview with EMP11 at 1330 on October 9, 2019, confirmed the word document for the preparation of donor breast milk was not an official facility policy. Email interview with EMP19 at 1433 on October 17, 2019, revealed the facility had no written policy for routine cleaning of the graduated cylinders, cylinder brushes and blender used for preparation of the DBM and infant formula in the pharmacy. Interview with EMP7 on October 10, 2019, at 1015 revealed on October 1, 2019, the facility took environmental samples of their water from the faucets from all 22 sinks in NICU, one sink in pharmacy, Enclosed incubator beds (NICU patient bed), TPN, donor breast milk, the graduated cylinder in Pharmacy used to mix donor breast milk, the brush in Pharmacy that was used to clean the graduated cylinder, and ventilators. The only positive environmental cultures for pseudomonas aeruginosa were detected in the Pharmacy ' s graduated cylinder, the Pharmacy brush used to clean the graduated cylinder, and the donor breastmilk that was left over from MR8 at the time of demise. EMP7 related the facility recalled any common lot numbers of donor breast milk after the positive culture for pseudomonas aeruginosa detected in the leftover donor breast milk of MR8. There was a common lot of donor breast milk that was found and tested . This batch was processed under the "new process" in pharmacy using a disposable, single use syringe. This sample was negative for pseudomonas. The NICU was restricted on accepting patients less than 28 weeks. Interview with EMP6 on October 11, 2019, at approximately 1130 revealed the facility will no longer individually compound TPN. They will buy commercially-prepared TPN as of October 11, 2019. EMP6 stated that on the AM of October 1, 2019, they started the new process for mixing donor breast milk in pharmacy using sterile syringes. EMP6 confirmed that the milk bank supplier is responsible for the pasteurization process, testing for communicable diseases such as hepatitis and HIV, and culturing and waiting for the results prior to releasing the donor breast milk lots to the hospital. EMP6 stated they are 99% sure the source was identified in the Pharmacy's equipment. They won't say they are 100% sure until all the environmental and patient genetic testing returns. Telephone interview with OTH1 RN at the Department Bureau of Epidemiology at 0900 on October 18, 2019, revealed a blender used to mix infant formula should be rinsed after each use. OTH1 also stated an aseptic process should be utilized when processing the DBM. OTH1 revealed the facility was instructed to move the graduated cylinders and brushes hanging above the sink in the enteral feeding preparation area in the pharmacy on October 7, 2019, because the items were in the splash zone of the sink. Tour of the Pharmacy enteral feeding preparation area at approximately 1330 on October 18, 2019, revealed one graduated cylinder hanging on the wall within the splash zone of the sink. EMP10 was observed using the sink to wash their hands and to wash the pitchers and blender used to prepare infant formula in the sink. The sink was noted to have two bowls. EMP10 was observed washing the pitchers and blender with dishwashing soap between each preparation of formula. Interview with EMP5, an infection control specialist, at approximately 1345 on October 18, 2019, confirmed the graduated cylinder should not be hanging on the wall within the splash zone of the sink. EMP5 stated the splash zone was within three feet. EMP5 stated one bowl of the sink should be labeled dirty and the other bowl labeled clean. EMP5 revealed best practice would be to take the blender apart for each washing. Interview with EMP21 at approximately 1350 on October 18, 2019, revealed the equipment used to prepare the infant formula and other enteral feedings was not sanitized on a regular basis. Interview with EMP5 at approximately 1355 on October 18, 2019, confirmed the equipment used to prepare the infant formula and other enteral feedings should be sanitized daily. Immediate Jeopardy was identified on October 18, 2019, at 1445, based on the facility's failure to have a written policy for the sanitization of equipment used to prepare donor breast milk, enteral feedings and infant formula. The facility submitted a plan to correct the identified Immediate Jeopardy, which was accepted on October 18, 2019, at approximately 1730. The immediate jeopardy was abated on October 18, 2019, at 1931, based on full implementation of the plan. The plan included the development of written policy related to donor breast milk and infant formula preparation and processing, and equipment sanitation. Cross Reference: 482.42 Infection Control 482.42(a)(1) Infection Control Program |
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| VIOLATION: INFECTION CONTROL | Tag No: A0747 | |
| Based on the systemic nature of the standard-level deficiencies related to Infection Control, it was determined the hospital failed to substantially comply with this Condition. Findings include: Review on October 9, 2019 of the facility's "Infection Prevention, Surveillance and Control Plan," last revised February 22, 2019, revealed "Purpose The purpose of the Infection Prevention, Surveillance, and Control Program is to improve our quality of care by protecting all individuals (patients, healthcare workers, family members and visitors) from hospital-acquired infections, and to comply with regulatory requirements regarding infection prevention and control. ... Objectives 1. To reliably determine health associated infection rates and establish acceptable internal and/or external comparative benchmarking. 2. To establish departmental policies that comply with current infection prevention and control practices. ... " The following standard was cited and showed a systemic nature of non-compliance with regards to Infection Control as follows: (482.42(a)(1) Tag A-0749) The information reviewed during the survey provided evidence that the facility failed to have policies in place to process donor breast milk (DBM); failed to have policies in place for cleaning and sanitizing the equipment used to process DBM and infant formula; failed to maintain a sanitary environment as evidenced by storage of linens directly on the floor, storage of clean patient equipment without protective coverings in a hallway, and improper temperature storage of human donor breast milk. |
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| VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES | Tag No: A0749 | |
| Based on review of facility documents, observation and staff (EMP) interview, it was determined the facility failed to have policies in place to process donor breast milk (DBM); failed to have policies in place to clean and sanitize the equipment used to process DBM and infant formula; and failed to maintain a sanitary environment as evidenced by: storage of soiled linens directly on the floor, storage of clean patient equipment without protective coverings in a hallway and improper temperature storage of human donor breast milk in refrigerators and freezers. Findings include: Review on October 9, 2019 of the facility's "Infection Prevention, Surveillance and Control Plan," last revised February 22, 2019, revealed "Purpose The purpose of the Infection Prevention, Surveillance, and Control Program is to improve our quality of care by protecting all individuals (patients, healthcare workers, family members and visitors) from hospital-acquired infections, and to comply with regulatory requirements regarding infection prevention and control. ... Objectives 1. To reliably determine health associated infection rates and establish acceptable internal and/or external comparative benchmarking. 2. To establish departmental policies that comply with current infection prevention and control practices. ... " Review on October 16, 2019, of Centers for Disease Control and Prevention article "How to Clean, Sanitize, and Store Infant Feeding Items," https://www.cdc.gov/healthywater/hygiene/healthychildcare/infantfeeding/cleansanitize.html, last reviewed October 31, 2018, revealed "Follow these steps for cleaning your infant's feeding items to help prevent germs from contaminating the milk you feed your baby. ... Clean Infant Feeding Items in the Dishwasher (if Dishwasher-Safe) ... Clean Infant Feeding Items by Hand 1. Wash hands ... 2. Take apart ... 3. Rinse. Rinse bottle parts and any other feeding items by holding them under running water. Do not set them in the sink ... 4. Wash feeding items. a. Place all items in a clean basin or container used only to clean infant feeding items. Do not wash directly in the sink because it may contain germs that could contaminate these items. b. Fill wash basin with hot water and add soap. c. Scrub items using a clean brush that is used only to clean infant feeding items ... 5. Rinse again ... 6. Allow to air-dry. Place bottle parts, wash basin, and bottle brush on a clean, unused dish towel or paper towel in an area protected from dirt and dust ... Allow to air dry thoroughly ... 7. Clean wash basin and bottle brush. Rinse the wash basin and brush well and allow them to air-dry after each use. Wash them every few days, either in a dishwasher with hot water and a heated drying cycle ... or by hand with soap and warm water. If your baby is less than 3 months old, was born prematurely, or has a weakened immune system ... wash basin and bottle brush after every use. For Extra Protection, Sanitize ... For extra germ removal, sanitize feeding items at least once daily. Sanitizing is particularly important when your baby is younger than 3 months, was born prematurely, or has a weakened immune system ... Q & A ... Sanitizing is an extra step to kill more germs on items that have been cleaned. Sanitizing feeding items provides more protection against all infections ... The safest method of mixing formula is by shaking or swirling the formula and water inside the feeding bottle. Blenders can be difficult to clean, and blenders used to prepare infant formula have been linked to illnesses among babies ..." Review on October 9, 2019, of a word document provided by the facility, no date of approval, revealed "Old Process: 1. Donor Breast Milk (DBM) thawed in warmer with tap water for 30 minutes water changed at the end of the day. 2. Technician to use hair net and gloves prior to preparation of product. 3. Thawed DBM measured in graduated cylinder to ordered amount. Graduated cylinder rinsed with sterile water between regular DBM orders and DBM with liquid protein added. 4. If ordered, liquid protein is transferred to a plastic medication bottle with disposable adaptor top. 3.75 ml [milliliter] of liquid protein added to each bottle of DBM. Liquid protein bottle labeled with a 3 day expiration. 5. DBM transferred to plastic medication bottle and labeled with [name of charting program] label and refrigerate auxiliary sticker. 6. DBM delivered immediately after preparation to patient care area refrigerator. 7. Unused thawed DBM is kept in feeds refrigerator with a 24 hour expiration placed on the bottle. 8. Graduated cylinder cleaned with hot tap water and [name] soap and stored upside down to dry. New Process: 1. Donor Breast Milk (DBM) thawed in warmer with sterile water for 30 minutes. Water is changed after each use. 2. Technician to use hairnet, gloves and mask prior to preparation of product. 3. If ordered, liquid protein is transferred to a plastic medication bottle with a disposable adaptor top. 3.75 ml of liquid protein is added to each DBM bottle. The liquid protein bottle is labeled and disposed of at the end of each dispense. 4. Thawed DBM measured in sterile [name] syringes from original container. 5. Each syringe is labeled with [name of charting system] label and refrigerate auxiliary sticker. 6. Syringes placed into bag with [name of charting system] label and refrigerate axillary [sic] sticker. 7. DBM delivered immediately after preparation to patient care area refrigerator. 8. Unused thawed DBM is disposed of after dispenses." Review on October 11, 2019, of the facility's "Linen Policy," last reviewed/revised by the facility on July 01, 2019, revealed "Purpose: The Infection Control Linen Policy establishes guidelines to ensure safe storage and handling of clean and soiled linen...2. Defines infection prevention and control practices that will ensure the safety of patients, employees and visitors by minimizing the risk of acquisition and transmission of health care associated infections. ..." The "Linen Policy" did not address avoiding direct storage of soiled linen bags on the floor to prevent cross-contamination. Review of facility policy "Low-Level Disinfection and Storage of Non-Critical Patient Care Equipment," last reviewed/revised by the facility on July 26, 2019, revealed "... This policy provides guidelines for recognition of clean or soiled non-critical patient care equipment and guidelines for storage or treatment after use. The following procedures define and establish standards for assuring non-critical, shared patient care equipment is clean before use and that all used contaminated equipment is appropriately cleaned before reuse... Selection of EPA (Environmental Protection Agency) registered disinfectants is done in collaboration with Environmental Services and Infection Prevention and Control. ... Procedure: Patient care equipment managed by patient care units must be wiped with an EPA registered hospital-approved disinfectant between patient use or in circumstances where it is unclear whether patient care equipment has been disinfected. ... 2. Once the patient care equipment is not in an in-use status, it will be cleaned and disinfected per manufacturer instructions and identified as clean with a visual cue. The patient care equipment will be placed in a designated clean storage area. a. If an item requires it be charged due to battery needs, the item can be covered with a plastic bag only if supported by manufacturer's instructions for storage to ensure electrical safety. b. Only clean equipment is stored in the designated clean equipment areas. c. If the item is stored in a common area, not a confined location designated for clean equipment the item must be inspected, cleaned and disinfected before patient use..." Review of the "Human Milk Banking Association of North America" standards as written in the facility "NICU (Neonatal Intensive Care Unit) Breastmilk Storage and Handling Policy" revealed the following temperature recommendations for the storage of expressed breast milk for hospitalized infants. "... b. Refrigeration (1 to 4 C; 35 to 40 F) up to 96 hours (4 days) c. Frozen: (- 18 to - 20 C: 0 to 4 F) up to 9 months ... 4. Thawed, previously frozen breast milk must be refrigerated and used within 24-hours. 5. Fortified breast milk should be refrigerated immediately, not be frozen, and used within 24-hours. ... " Review of the facility's "NICU (Neonatal Intensive Care Unit) Breastmilk Storage and Handling Policy," last reviewed/revised October 23, 2018, revealed "... Persons Affected: All direct healthcare personnel caring for newborns who receive breast milk. Policy: To ensure proper storage of breast milk for newborns in the NICU while using current evidence-based practice. Definitions: Fresh Breast Milk- Breast milk that has never been frozen. Donor breast milk- Breast milk that has been received from an accredited Human Milk Bank. Fortified Breast Milk- Breast milk that has been enhanced for increased caloric/nutritional needs. Responsibilities: 1. The Human Milk Banking Association of North America provides the following temperature recommendations for the storage of expressed breast milk for hospitalized infants. ... b. Refrigeration (1 to 4 C; 35 to 40 F) up to 96 hours (4 days) c. Frozen: (- 18 to - 20 C: 0 to 4 F) up to 9 months ... 4. Thawed, previously frozen breast milk must be refrigerated and used within 24-hours. 5. Fortified breast milk should be refrigerated immediately, not be frozen, and used within 24-hours. ... " Review on October 18, 2019, of pharmacy's policy "Temperature/Humidity Monitoring," last reviewed/revised February 14, 2019, revealed "... Persons affected Staff assigned to Geisinger facilities in which there is a requirement to monitor temperature of products ... based on applicable regulations or standards. 1. The following basic temperature requirements apply to ... patient nourishment refrigerators ... a. Patient nourishment refrigerators must be capable of maintaining 32- 41 (degrees) F (Fahrenheit) or 0- 5 (degrees) C (Celsius). ... c. Freezers must be maintained at temperatures at or below (+5 F) or (-15 C) ... " Observation at 1300 on October 9, 2019, of the preparation of infant formula revealed a blender is used to mix the formula. Graduated cylinders and brushes were noted hanging above the sink in the enteral feeding preparation area. Interview with EMP11 at 1330 on October 9, 2019, revealed the new DBM process went into effect on September 30, 2019. EMP11 stated the pharmacy follows food preparation standards when preparing enteral feedings and donor breast milk. EMP11 stated there were no standards for preparing donor breast milk. EMP11 revealed the graduated cylinders that were previously used for the DBM and the ones currently used for the other enteral feedings were washed with dish soap and water at the end of every day. The brushes used to clean the cylinders were cleaned daily and replaced quarterly. EMP11 revealed the facility did not have a process for preparing DBM and infant formula or for cleaning the equipment used in the preparation of DBM and infant formula in a policy/procedure format. Telephone interview with OTH1 from the Department of Health Bureau of Epidemiology at 0900 on October 18, 2019, revealed a blender used to mix infant formula should be rinsed after each use. OTH1 also stated an aseptic process should be utilized when processing the DBM. OTH1 revealed the facility was instructed to move the graduated cylinders and brushes hanging above the sink in the enteral feeding preparation area in the pharmacy on October 7, 2019, because the items were in the splash zone of the sink. Tour of the pharmacy enteral feeding preparation area at approximately 1330 on October 18, 2019, revealed one graduated cylinder hanging on the wall within the splash zone of the sink. EMP10 was observed using the sink to wash their hands and to wash the pitchers and blender used to prepare infant formula in the sink. The sink was noted to have two bowls. EMP10 was observed washing the pitchers and blender with dishwashing soap between each preparation of formula. Interview with EMP5, an infection control specialist, at approximately 1345 on October 18, 2019, confirmed the graduated cylinder should not be hanging on the wall within the splash zone of the sink. EMP5 stated one bowl of the sink should be labeled dirty and the other bowl labeled clean. EMP5 revealed best practice would be to take the blender apart for each washing. Interview with EMP21 at approximately 1350 on October 18, 2019, revealed the equipment used to prepare the infant formula and other enteral feedings were not sanitized on a regular basis. Interview with EMP5 at approximately 1355 on October 18, 2019, confirmed the equipment used to prepare the infant formula and other enteral feedings should be sanitized daily. Observation tour of the dirty linen room on the Children's Lower Level outside the Neonatal Intensive Care Unit (NICU) was completed on October 10, 2019, at approximately 1:45 PM and revealed a locked room with a linen chute and seven dirty linen bags stored directly on the floor. The linens were protruding from the tops of the bags. Interview with EMP14, on October 10, 2019, at approximately 1:45 PM, confirmed the dirty linen room is a locked room on the Children's Lower Level outside the NICU and there were seven dirty linen bags stored directly on the floor. EMP14 stated the dirty linen bags come down the laundry chutes from other floors in the hospital and land directly on the floor. Interview with EMP7 on October 11, 2019, at approximately 2:00 PM, confirmed the facility did not include in their linen policy avoiding direct storage of soiled linen bags directly on the floor to prevent cross-contamination. Observation tour of the NICU unit on October 10, 2019, at 2:25 PM revealed storage of three enclosed incubator beds labeled clean in a restricted hallway outside of the clean storage room approximately two feet away from a sink. There was no protective covering over the three enclosed incubator beds. Interview on October 10, 2019, at 2:25 PM with EMP4 revealed the enclosed incubator bed storage in the hallway was due to the clean storage room being filled to capacity. Further interview with EMP4 stated the hallway was restricted for use as a staff entrance. Further interview with EMP4 related that the environmental services used the sink for breakdown and cleaning of dirty patient equipment. Further interview with EMP4 confirmed there was no barrier to prevent cross-contamination on the clean-stickered enclosed incubator beds. Interview on October 18, 2019, at 1745 with EMP22 confirmed that the facility should have a consistent policy in pharmacy and NICU that follows the Human Milk Banking Association of North America standards. Review on October 18, 2019, of the pharmacy's donor breast milk average daily refrigerator temperatures revealed temperatures out of range in accordance with the Human Milk Banking Association of North America standards for 15 out of 30 days during the month of September 2019 (September 01, 2019 + or positive 41. 2F, September 02, 2019 +41.2 F, September 03, 2019 +41 F, September 04, 2019 +41 F, September 05, 2019 +40.9 F, September 06, 2019 +41.5 F, September 07, 2019 +40.3 F, September 08, 2019 +40.2 F, September 09, 2019 +40.3 F, September 10, 2019 +40.6 F, September 13, 2019 +41.9 F, September 14, 2019 +40.8 F, September 15, 2019 +40.5 F, September 22, 2019 +40.1 F, and September 25, 2019 +40.2 F); and 2 out of 18 days during the month of October 2019 (October 3, 2019 +40.5 F and October 13, 2019 +40.4 F). Review on October 18, 2019, of the pharmacy's human donor breast milk average daily freezer temperatures revealed temperatures out of range in accordance with the Human Milk Banking Association of North America standards for 30 out of 30 days during the month of September 2019 (September 1, 2019 - or (negative) 10.2 F, September 02, 2019 -10.4 F, September 03, 2019 -10.5 F, September 04, 2019 -10.7 F, September 05, 2019 -9.1 F, September 06, 2019 -9.8 F, September 07, 2019 -11.2 F, September 08, 2019 -11.1 F, September 09, 2019 -11.7 F, September 10, 2019 -11.1 F, September 11, 2019 -11.5 F, September 12, 2019 -12.3 F, September 13, 2019 -11.7 F, September 14, 2019 -11.6 F, September 15, 2019 -10.2 F, September 16, 2019 -10.6 F, September 17, 2019 -10.5 F, September 18, 2019 -10.6 F, September 19, 2019 -11.0 F, September 20, 2019 -7.8 F, September 21, 2019 -8.5 F, September 22, 2019 -9.0 F, September 23, 2019 -9.0 F, September 24, 2019 -9.1 F, September 25, 2019 -9.0 F, September 26, 2019 -8.3 F, September 27, 2019 -9.1 F, September 28, 2019 -9.6 F, September 29, 2019 -9.8 F and September 30, 2019 -9.8 F); and out of range 17 out of 17 days during the month of October 2019 (October 01, 2019 -9.6 F, October 02, 2019 -9.6 F, October 03, 2019 -9. 2F, October 04, 2019 -9.9 F, October 05, 2019 -10.1 F, October 06, 2019 -10.5 F, October 07, 2019 -11.1 F, October 08, 2019 -10.9 F, October 09, 2019 -10.1 F, October 10, 2019 -10.3 F, October 11, 2019 -10.1 F, October 12, 2019 -9.6 F, October 13, 2019 -9.6 F, October 14, 2019 -10.6 F, October 15, 2019 -11.6 F, October 16, 2019 -11.4 F, and October 17, 2019 -10.6 F). Review on October 18, 2019, of the NICU's breast milk freezer revealed the average daily temperatures revealed temperatures out of range in accordance with the Human Milk Banking Association of North America standards and facility policy for 9 out of 30 days during the month of September 2019 (September 11, 2019 -1.5 F, September 17, 2019 +6. 2F, September 22, 2019 -0. 2F, September 24, 2019 -0.4 F, September 26, 2019 -2.3 F, September 27, 2019 -1.6 F, September 28, 2019 -2.1 F, September 29, 2019 -0.4 F and September 30, 2019 -2.4 F); and out of range 17 out of 17 days during October 2019 (October 01, 2019 -2.8 F, October 02, 2019 -1.9 F, October 03, 2019 -4. 2F, October 04, 2019 -1.9 F, October 05, 2019 -2.9 F, October 06, 2019 -3. 2F, October 07, 2019 -1.0 F, October 08, 2019 -3.0 F, October 09, 2019 -2.7 F, October 10, 2019 -4.0 F, October 11, 2019 -2.6 F, October 12, 2019 -1.6 F, October 13, 2019 -2. 2F, October 14, 2019 -1.3 F, October 15, 2019 -1.0 F, October 16, 2019 -2.4 F, and October 17, 2019 -1.2 F). Interview on October 18, 2019, at 1735 with EMP22 confirmed the readings were out of range with the Human Milk Banking Association of North America standards. Further interview confirmed that according to the facilities department, the alarms were set to go off at ranges outside of range 36 F to 46 F for the pharmacy donor breast milk refrigerator, outside of range -40 F to 5 F for the pharmacy breast milk freezer and NICU breast milk storage freezer outside of range -20 F to +26 F. Cross-reference 0747 Tag 482.42 Infection Control |
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