Bringing transparency to federal inspections
Tag No.: A0115
Based on observation, record review, and interview, the hospital failed to meet the requirements of the Condition of Participation of Patient Rights. The hospital failed to protect and promote each patient's rights as evidenced by:
1) Failure to ensure the nurse call system was properly functioning (see Tag A0144);
2) Failure to ensure the current glucometer was indicated for multi-patient use (see Tag A0144);
3) Failure to ensure the current glucometer control solutions and blood glucose test strips were within the vial's first opened date range (see Tag A0144);
4) Failure to ensure the emergency code cart was secured (see Tag A0144).
Tag No.: A0489
Based on observation, record review, and interview, the hospital failed to meet the requirements of the Condition of Pharmaceutical Services. The hospital failed to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use as evidenced by:
1) Failure to ensure glucometer control solutions and blood glucose test strips were within the vial's first opened date range (see Tag A0505);
2) Failure to ensure emergency medications were not outdated (see Tag A0505);
3) Failure to ensure medications were removed and returned to the pharmacy or properly destroyed upon a patients discharge (see Tag A0505); and
4) Failure to ensure medications available for patient use were properly labeled (see Tag A0505).
Tag No.: A0747
Based on observation, record review, and interview, the hospital failed to meet the requirements of the Condition of Participation of Infection Prevention Control ABX Stewardship. The hospital failed to employ methods for preventing and controlling the transmission of infections within the hospital as evidenced by:
1) Failure to properly clean the glucometer after patient use (see Tag A0749); and
2) Failure to properly clean equipment after patient use (see Tag A0749).
Tag No.: A0505
Based on observation, record review, and interview, the hospital failed to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. This deficient practice was evidenced by:
1) Failure to ensure glucometer control solutions and blood glucose test strips were within the vial's first opened date range;
2) Failure to ensure emergency medications were not outdated;
3) Failure to ensure medications were removed and returned to the pharmacy or properly destroyed upon a patients discharge; and
4) Failure to ensure medications available for patient use were properly labeled.
Findings:
1) Failure to ensure glucometer control solutions and blood glucose test strips were within the vial's first opened date range
A review of hospital policy, "Nursing: Point of Care Devices Blood Glucose Monitor," no policy number, effective date, indication of governing body approval available and presented as the policy related to the glucometer, revealed in part: "All devices will be used according to the manufacturer's guidelines unless otherwise specified by an authoritative body with the knowledge to override the manufacturer's specifications for use. The monitor will be calibrated according to the manufacturer's guidelines. There will be a record of these readings kept with the nurses at the nurses' station."
A review of the "True Metrix Self Monitoring Blood Glucose System Owner's Booklet" for the current True Metrix Monitor (RE4TVH09) that was being used, revealed in part: "Expiration Dates (EXP) - Write date first opened on vial label. Discard vial and unused test strips if either the open vial expiration date or the date printed next to EXP on vial label has passed, whichever comes first. See the test strip Instructions for Use for open vial expiration date. Caution! Use of test strips or control solution past the Expiration Dates may give incorrect test results. Expiration Dates (EXP) - Write date first opened on bottle label. Control Solution: Discard bottle if either 3 months after first opening or date printed next to EXP on bottle label has passed, whichever comes first."
A review of the "True Metrix Self Monitoring Blood Glucose Test Strips Instructions for Use" package insert revealed in part: "Blood Glucose Testing: 1. Check opened date and printed date on test strip vial label. Do not use if after either date printed on the test strip vial label or 4 months after date opened, whichever comes first. Discard vial and test with new vial."
Observations during a walk-through of the hospital on 05/12/2025 from 3:15 PM to 4:45 PM revealed True Metrix Blood Glucose Test Strips currently in patient use without a first open date being recorded on the label. Further observations revealed the True Metrix Control Solutions (Level 1 vial, Level 2 vial, Level 3 vial) currently being used to perform quality control testing without a first open date being recorded on the label. The use of out of date and/or expired test strips and/or control solutions had a potential safety risk associated with the patient being treated or not treated for an incorrect capillary blood glucose result.
In an interview on 05/12/2025 at 4:15 PM, S5LPN confirmed the above mentioned findings and further confirmed she was not sure when the test strips and control solutions were first open. S5LPN further confirmed the patient safety risk involved with using out of date or expired supplies and/or inaccurate reading not identified during quality control testing.
2) Failure to ensure emergency medications were not outdated
A review of hospital policy, "Nursing Crash Cart & Emergency," no policy number, effective date or indication of governing body approval available and was presented as the policy related to the crash cart, revealed in part: "Licensed professionals will be assigned to check the crash cart lock and defibrillator monitor daily at the beginning of the day shift. Any equipment found to be non-functioning or in questionable operating condition will be reported immediately. Medications dates and integrity will be check to ensure no medications have expired. The pharmacy consult will inspect the crash cart on a monthly basis. Procedure: Crash Cart: Tamper locks are to be inspected daily. Drawers one (1) and two (2) if tamper lock is broken, the drawer will be checked for missing items and the items replaced immediately. A new lock will be installed by pharmacy. The entire contents of the drawers will be checked against the supply checklist on the clipboard located on top of the crash cart."
Observations during a walk-through of the hospital on 05/12/2025 from 3:15 PM to 4:45 PM revealed drawer 1 of the emergency code cart containing Dopamine 400mg/40ml vial, quantity 25, expired 04/2025 and available for patient use.
In an interview on 05/12/2025 and present during the hospital walk-through, S4DON confirmed the above mentioned findings.
3) Failure to ensure medications were removed and returned to the pharmacy or properly destroyed upon a patients discharge
A review of the document titled, "Bethesda Rehabilitation Hospital Pharmacy Procedure," and presented as a pharmacy policy related to the return of medications after a patient is discharged, revealed in part: "5. Weekly, staff will go through all medications in use and removed damaged or expired packages out of use. 6. During pharmacy pickup, any expired or out of use medication can be returned to the pharmacy. 7. Upon discharge, all patient medication will be removed from the medication cart. This medication can be sent home with the patient (except narcotics which will require a prescription), or returned to pharmacy.
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed labeled medications in the medication refrigerator remaining after patient discharge and available for patient use. Patient #R6 was discharged 03/24/2025 and Novolog U100, 100unit/ml vial, 1 vial was found with Patient #R6 on the attached prescribed label. Patient #R7 was discharged on 03/26/2025 and Lantus Solostar U100, 100units/ml injectable 3ml pens, quantity 11 pens was found with Patient #R7 on the attached prescribed label.
In an interview on 05/12/2025 at 4:20 PM, S5LPN confirmed the above mentioned findings and further confirmed these medications should have been returned to the pharmacy.
4) Failure to ensure medications available for patient use were properly labeled
A review of the document titled, "Bethesda Rehabilitation Hospital Pharmacy Procedure," and presented as a pharmacy policy related to the return of medications after a patient is discharged, revealed in part: "5. Weekly, staff will go through all medications in use and removed damaged or expired packages out of use. 6. During pharmacy pickup, any expired or out of use medication can be returned to the pharmacy. 7. Upon discharge, all patient medication will be removed from the medication cart. This medication can be sent home with the patient (except narcotics which will require a prescription), or returned to pharmacy.
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed unlabeled medications in the medication refrigerator remaining after patient discharged and available for patient use. The following medications had no prescribing label attached identifying the patient the medications were assigned: Lantus Solostar U100, 100units/ml injectable 3ml pen, quantity 1 pen and Trulicity 0.75mg/0.5ml single dose injection pen, quantity 2 pens. The following medications prescribing label, including the patient's name, had been partially torn off the packaging: Novolog U100, 100unit/ml vial, quantity 1 and Lantus U100, 100unit/ml vial, quantity 1.
In an interview on 05/12/2025 at 4:20 PM, S5LPN confirmed the above mentioned findings and further confirmed these medications should have been returned to the pharmacy.
Tag No.: A0701
Based on observation and interview, the hospital failed to ensure the condition of the physical plant and the overall hospital environment was maintained in such a manner that the safety and well-being of patients are assured. This deficient practice was evidenced by the failure to secure the weather strip surrounding the entry door of Room "a."
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed approximately 2 inches of weather stripping around Room a's entry door pulled away from the door frame at the bottom left side. This end of the weather stripping was protruding towards the center of the doorway, which created an unsafe condition and the potential for patient injury if the patient were to make contact with this protruding piece which appeared to have sharp and jagged edges.
In an interview on 05/12/2025 and present during the hospital walk-through, S1CEO confirmed the above mentioned findings.
Tag No.: A0724
Based on record review and interview, the hospital failed to ensure facilities, supplies and equipment must be maintained to ensure an acceptable level safety and quality. This deficient practice is evidenced by:
1) Failure to ensure Glucometer quality controls were performed daily; and
2) Failure to ensure Emergency Cart checks were performed daily.
Findings:
1) Failure to ensure Glucometer quality controls were performed daily
A review of hospital policy, "Nursing: Point of Care Devices Blood Glucose Monitor," no policy number, effective date, indication of governing body approval available and presented as the policy related to the glucometer, revealed in part: "All devices will be used according to the manufacturer's guidelines unless otherwise specified by an authoritative body with the knowledge to override the manufacturer's specifications for use. The monitor will be calibrated according to the manufacturer's guidelines. There will be a record of these readings kept with the nurses at the nurses' station."
A review of the "True Metrix Self Monitoring Blood Glucose System Owner's Booklet" for the current True Metrix Monitor (RE4TVH09) that was being used, revealed in part: "We recommend performing Control Tests for practice before using your meter for the first time to test your blood. Control Tests should be performed: o For practice to ensure your testing technique is good, o Occasionally as you use a vial of test strips, o When opening a new vial of test strips, o If results seem unusually high or low, o If a vial has been left opened or exposed to extreme heat or cold, or humidity, o Whenever a check on performance of the system is needed, o If meter damage is suspected (meter was dropped, crushed, wet, etc.)"
A review of the Glucometer Log revealed no documentation of the quality controls being performed on 05/08/2025 and 05/09/2025. This had the potential to affect the outcome of treatment being performed on 2 (#R2, #R3) of 2 (#R2, #R3) patients having capillary blood glucose monitoring being performed with subsequent treatment being administered based on these results.
In an interview on 05/12/2025 at 4:15 PM, S4LPN confirmed the above mentioned findings, the quality controls should be performed daily, and during the days mentioned in the above findings Patient #6 and #7 blood glucose was monitored via the glucometer without quality controls being performed.
2) Failure to ensure Emergency Cart checks were performed daily
A review of hospital policy, "Nursing Crash Cart & Emergency," no policy number, effective date or indication of governing body approval available and was presented as the policy related to the crash cart, revealed in part: "Licensed professionals will be assigned to check the crash cart lock and defibrillator monitor daily at the beginning of the day shift. Any equipment found to be non-functioning or in questionable operating condition will be reported immediately. Medications dates and integrity will be check to ensure no medications have expired. The pharmacy consult will inspect the crash cart on a monthly basis. Procedure: Crash Cart: Tamper locks are to be inspected daily. Drawers one (1) and two (2) if tamper lock is broken, the drawer will be checked for missing items and the items replaced immediately. A new lock will be installed by pharmacy. The entire contents of the drawers will be checked against the supply checklist on the clipboard located on top of the crash cart."
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed the emergency code cart located on the main hallway in front of the nursing station with no tamper resistant lock securing the medication drawer.
A review of the Emergency Cart Checklist revealed no documentation of the emergency cart being checked: 01/01/2025 to 01/09/2025; 01/13/2025 to 01/31/2025; 02/01/2025 to 02/12/2025; 02/15/2025 to 02/28/2025; 03/01/2025 to 03/26/2025; 03/28/2025 to 03/31/2025; 04/01/2025 to 04/09/2025; and 04/11/2025 to 04/30/20/2025.
In an interview on 05/12/2025 and present during the hospital walk-through, S4DON confirmed the above mentioned findings.
Tag No.: A0749
Based on observation, record review and interview, the hospital failed to ensure the infection prevention and control program, as documented in its policies and procedures, employed methods for preventing and controlling the transmission of infections within the hospital. This deficient practice was evidenced by:
1) Failure to properly clean the glucometer after patient use; and
2) Failure to properly clean equipment after patient use.
Findings:
1) Failure to properly clean the glucometer after patient use
A review of hospital policy, "Policy and Procedure: Infection Control" no policy number, effective date or indication of governing body approval available. A date at the bottom of the page was partially blotted out with white out. This policy revealed in part: "The Hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control and investigation of infections and communicable diseases. The facility maintains an infection control program. The facility is monitored for cleanliness routinely. The facility employees housekeeping staff that is trained on infection control practices. There is an infection control manual that is used as a reference to follow. There is an infection control specialist that rounds and makes recommendations as necessary. The Director of Nursing will review with Administration as necessary to make the recommendations as applicable."
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed S5LPN cleaning the True Metrix Blood Glucose Monitor with 2 x 2 alcohol pads.
In an interview on 05/12/2025 at 4:20 PM, S5LPN confirmed the above mentioned findings and further confirmed Santi-wipe was not used to clean the meter.
2) Failure to properly clean equipment after patient use
A review of hospital policy, "Policy and Procedure: Infection Control" no policy number, effective date or indication of governing body approval available. A date at the bottom of the page was partially blotted out with white out. This policy revealed in part: "The Hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control and investigation of infections and communicable diseases. The facility maintains an infection control program. The facility is monitored for cleanliness routinely. The facility employees housekeeping staff that is trained on infection control practices. There is an infection control manual that is used as a reference to follow. There is an infection control specialist that rounds and makes recommendations as necessary. The Director of Nursing will review with Administration as necessary to make the recommendations as applicable."
Observations during a hospital walk-though on 05/12/2025 from 03:15 PM to 4:45 PM revealed the following surfaces containing remnants of substances that do not allow for the proper cleaning of surface to prevent infectious disease from harboring and remaining in these areas:
Room "a" had tan/brown crusty substances on the left hand rail and the chair next to the bed had black sticky substance approximately 1 inch by 1 inch on the seat cushion;
Room "d" had 2 area on the left side rail containing clear tape wrapped around the top edging;
2 Mindray Vital Sign Monitors on rolling carts. Both monitors had numerous areas of sticky substance resembling the prior placement of stickers on either side of the monitor's plastic enclosures. Also the associated oxygen saturation finger probe of each of these monitors had tape wrapped around them;
Medline No-touch Forehead Thermometer found in the supply basket of one of the vital sign carts had tape holding the battery in place; and
Portable SaO2 monitor found in the supply basket of one the vital sign carts had tape holding the battery in place.
In an interview on 05/12/2025 and present during the hospital walk-through, S1CEO confirmed the above mentioned findings and further confirmed these surfaces had not been properly cleaned and the surfaces identified with tape and stickiness could not be properly cleaned in their present condition.