{
  "$schema": "https://spacemedicinefoundation.org/robotic-medicine/protocols/schema/protocol.schema.json",
  "schema_version": "0.3",
  "version": "0.6",
  "status": "draft",
  "conceptual": true,
  "not_for_clinical_use": true,
  "max_autonomy": 2,
  "missions": [
    "leo",
    "commercial",
    "moon",
    "mars"
  ],
  "updated": "2026-10-21",
  "review": {
    "state": "reviewed-ai-assisted",
    "requested": "2026-10-20",
    "reviewed": "2026-10-20",
    "human_clinician_review": false,
    "text": "AI-assisted clinical and source review by the Medical Research Assistant, Oct 20, 2026 (batch 2 review, 51 corrections); all corrections are applied in this version. No named human clinician has reviewed it."
  },
  "fixed_rules": {
    "flight_surgeon_is_medical_authority": true,
    "cmo_acts_under_delegated_care": true,
    "human_starts_and_restarts_robot": true,
    "robot_never_diagnoses": true,
    "no_drug_or_fluid_advice_by_robot": true,
    "safe_state_on_fault_or_no_response": true,
    "lost_link_pause_then_cmo_decides": true
  },
  "robot_lockouts": {
    "diagnosis": true,
    "drug_or_fluid_advice": true,
    "starting_stopping_or_adjusting_oxygen_or_any_medicine": true,
    "self_start_or_self_restart": true,
    "changing_own_protocol_thresholds_or_limits": true,
    "handing_over_a_mismatched_item_as_verified": true
  },
  "id": "RMP-RENAL-002",
  "slug": "rmp-renal-002",
  "title": "Trouble passing urine: bladder ultrasound support with the crew holding the probe, relay to the flight surgeon (diagnostic only)",
  "category": "renal",
  "tier": 1,
  "rung_note": "In this draft the CMO holds the ultrasound probe. The robot fetches, holds the screen, shows the scan guide and records. Robot-held probe scanning, as in RMP-RENAL-001, is left out of this protocol until it has been validated for this task.",
  "result_language": {
    "use": [
      "device estimate, for human review",
      "images acquired, for human review",
      "non-diagnostic (quality too low)"
    ],
    "never": [
      "normal",
      "no problem found",
      "all clear",
      "negative",
      "any diagnosis or cause",
      "bladder empty",
      "bladder full",
      "no retention",
      "catheter needed",
      "catheter not needed",
      "safe"
    ]
  },
  "scope": {
    "summary": "When a crewmember cannot pass urine, passes only small amounts, or feels the bladder has not emptied, the robot alerts the CMO and flight surgeon, asks red-flag questions first, brings the ultrasound device and the sealed catheter kit (unopened), turns its camera away, holds the screen where the CMO can see it, shows the pre-loaded bladder scan guide, and records the images and the device's bladder-volume estimate for the flight surgeon. The CMO holds the probe. Whether to catheterize, and any medicine, are human decisions. The robot never says the bladder is full or empty.",
    "why": "Urinary retention can happen in the first days of flight. NASA lists fluid shifts, a changed feeling of bladder fullness and changes in the voiding reflex among the contributors, and treats it with fluid management and intermittent catheterization as needed. US astronaut records list 9 events. In one reported case, an astronaut who had taken promethazine and scopolamine before launch could not pass urine on reaching orbit, had intermittent catheterization for the first 3 days and then a catheter left in place (supplies were short) for a total of 4 days, could pass urine again after day 7, had retention return on day 10 (1 day before landing), and had it recur for the first 24 hours of the next mission. Retention with back pain or saddle numbness can also signal cauda equina syndrome; a bladder scan must not be used on its own to decide, and a low volume does not rule out nerve compression.",
    "covers": [
      "Unable to pass urine, passing only small amounts, or feeling the bladder has not emptied, in a crewmember who is awake",
      "Repeat scans when the flight surgeon asks, including after a catheter is removed"
    ],
    "locked_out": [
      "Inserting, handling or removing a urinary catheter (the CMO does it; RMP-RENAL-005 covers supplies and hygiene only)",
      "Opening the sealed catheter kit",
      "Holding or moving the ultrasound probe (in this version)",
      "Deciding whether to catheterize, or what volume is too much",
      "Any drug or fluid advice, including whether to stop a medicine",
      "Saying the bladder is full or empty, or naming a cause",
      "Photographing or filming the patient; the robot camera faces away and stops recording while the patient is exposed",
      "Therapeutic ultrasound modes"
    ],
    "related": [
      "RMP-RENAL-001",
      "RMP-RENAL-004",
      "RMP-RENAL-005",
      "RMP-MSK-004",
      "RMP-NEURO-004",
      "RMP-INF-001",
      "RMP-PHARM-001"
    ]
  },
  "roles": {
    "medical_authority": "Flight surgeon (ground). Holds medical authority for every run.",
    "onboard_lead": "Crew medical officer (CMO), acting under delegated care; uses the pre-approved onboard checklist when there is no link.",
    "others": [
      "Patient: can stop at any time and chooses who is present",
      "Ground ultrasound expert: can guide the CMO live when the link allows"
    ],
    "robot_may": [
      "Fetch the ultrasound device, gel, the sealed catheter kit (unopened) and a privacy screen, and restrain them by the patient",
      "Turn its camera away and stop recording while the patient is exposed",
      "Hold the ultrasound screen where the CMO can see it and show the pre-loaded scan guide",
      "Check the catheter kit's seal and expiry, and that antiseptic and spare catheters are in stock, before bringing it",
      "Record the images and the device's own volume estimate (before and after passing urine, if the crewmember can), labeled \"device estimate, for human review\"",
      "Show the CMO and flight surgeon the human-entered dose log so the flight surgeon can review medicines that can contribute to retention (shown only; the robot names no medicine and gives no advice)",
      "Send everything to the flight surgeon; bag waste and clean equipment"
    ],
    "robot_may_not": [
      "Hold or move the probe, or touch the patient",
      "Open the catheter kit or handle a catheter",
      "Interpret images or say what the volume means",
      "Suggest catheterization, medicines or fluids",
      "Film or photograph the patient",
      "Start without a human command"
    ],
    "commercial": "On commercial flights, 'flight surgeon' and 'CMO' mean the operator's designated medical authority and trained onboard responder. If no trained responder is aboard, this protocol is not used. (NASA-STD-3001 requires two CMOs per vehicle for NASA programs [V1 3006]; FAA rules set no medical standards for spaceflight participants.)"
  },
  "preconditions": [
    {
      "id": "PRE-1",
      "text": "A crewmember started the run by command; the CMO is present and trained in bladder ultrasound and catheterization.",
      "check": "human_start == true and cmo_present == true",
      "refs": [
        "V2 10174",
        "V2 10168"
      ]
    },
    {
      "id": "PRE-2",
      "text": "Patient consent recorded; the patient chooses who is present."
    },
    {
      "id": "PRE-3",
      "text": "Patient, CMO, device and kits restrained.",
      "refs": [
        "V2 7046"
      ]
    },
    {
      "id": "PRE-4",
      "text": "Ultrasound device self-test passed and gel available; robot self-test passed.",
      "refs": [
        "V2 10161"
      ]
    },
    {
      "id": "PRE-5",
      "text": "Robot camera turned away and recording off before the patient is exposed.",
      "check": "robot_camera_recording == false"
    },
    {
      "id": "PRE-6",
      "text": "Link status and current delay known."
    }
  ],
  "consent": {
    "standard": "The patient agrees by voice or touch to the questions, the scan and the robot being present; logged.",
    "emergency": "If the patient cannot agree, this protocol is not used; the CMO and flight surgeon decide care directly.",
    "withdrawal": "The patient can stop at any time; the robot backs away."
  },
  "inputs": [
    {
      "id": "IN-1",
      "name": "Red-flag answers: fever or chills; back pain with leg weakness or numbness, or numbness between the legs; blood in urine; flank pain; lower belly pain or urge; severe pain; a recent catheter with fever, burning or cloudy urine",
      "source": "Patient, by voice or touch",
      "required": true,
      "if_missing": "Ask the CMO to ask in person; never treated as \"no\"."
    },
    {
      "id": "IN-2",
      "name": "Time of the last urine passed and how much (as reported)",
      "source": "Patient",
      "required": true,
      "if_missing": "Log \"not answered\"."
    },
    {
      "id": "IN-3",
      "name": "Bladder ultrasound images with the device quality score",
      "source": "Ultrasound device, probe held by the CMO",
      "required": true,
      "if_missing": "Label \"non-diagnostic (quality too low)\"; never report a volume."
    },
    {
      "id": "IN-4",
      "name": "Bladder-volume estimate calculated by the device (if it has that function), before and, if the crewmember can pass some urine, after",
      "source": "Ultrasound device",
      "required": false,
      "if_missing": "Log \"no device estimate\"; images still go to the flight surgeon."
    },
    {
      "id": "IN-5",
      "name": "Medicines given in the past <set by flight surgeon> hours, as logged by humans (shown so the flight surgeon can review medicines that can contribute to retention; the robot names no medicine and does not advise)",
      "source": "Medical record or dose log",
      "required": false,
      "if_missing": "Note \"no dose log available\"."
    },
    {
      "id": "IN-6",
      "name": "Catheter kit seal and expiry, antiseptic and spare catheters in stock",
      "source": "Inventory system",
      "required": true,
      "if_missing": "Report the shortfall to the CMO before the kit is needed."
    },
    {
      "id": "IN-7",
      "name": "Time since launch",
      "source": "Mission clock",
      "required": true,
      "if_missing": "Ask the CMO."
    },
    {
      "id": "IN-8",
      "name": "Link status and delay",
      "source": "Communications system",
      "required": true,
      "if_missing": "Treat as link down."
    }
  ],
  "steps": [
    {
      "id": "S1",
      "actor": "robot",
      "rung": 2,
      "action": "On a crew command, alert the CMO and, if the link is up, send a \"trouble passing urine\" alert to the flight surgeon (queued if the link is down).",
      "success": "CMO acknowledges; alert delivered or queued.",
      "refs": [
        "V2 10174",
        "V1 6003"
      ]
    },
    {
      "id": "S2",
      "actor": "robot",
      "rung": 2,
      "action": "Ask the red-flag questions first, then the time and amount of the last urine passed; log the answers word for word.",
      "success": "Answers logged, or marked for the CMO to ask."
    },
    {
      "id": "S3",
      "actor": "robot",
      "rung": 2,
      "action": "Bring the ultrasound device, gel, the sealed catheter kit (unopened, after checking its seal and expiry and that antiseptic and spare catheters are in stock) and a privacy screen; restrain them by the patient. Report any shortfall to the CMO.",
      "success": "Items restrained at the patient; any shortfall reported.",
      "limit": "<set by validation>",
      "refs": [
        "V2 7046"
      ]
    },
    {
      "id": "S4",
      "actor": "robot",
      "rung": 2,
      "action": "Turn the robot camera away from the patient and stop recording; show the camera-off indicator.",
      "success": "Camera off confirmed by the CMO.",
      "refs": [
        "V2 10161"
      ]
    },
    {
      "id": "S5",
      "actor": "crew",
      "action": "The CMO restrains the patient and, with the patient's agreement, exposes the lower belly.",
      "success": "Patient positioned."
    },
    {
      "id": "S6",
      "actor": "robot",
      "rung": 2,
      "action": "Hold the ultrasound screen where the CMO can see it and show the pre-loaded bladder scan guide (and the ground expert's live guidance when the link allows).",
      "success": "Screen and guide in view."
    },
    {
      "id": "S7",
      "actor": "crew",
      "action": "The CMO places the probe and scans the bladder as trained.",
      "success": "Scan done."
    },
    {
      "id": "S8",
      "actor": "robot",
      "rung": 2,
      "action": "Record the images and the device's estimate, labeled \"device estimate, for human review\", with the quality score; if the crewmember can pass some urine, record a scan before and after (both labeled \"device estimate, for human review\"). If quality is low, ask the CMO to rescan, up to <set by validation> times.",
      "success": "Images and estimates recorded, or labeled non-diagnostic."
    },
    {
      "id": "S9",
      "actor": "robot",
      "rung": 2,
      "action": "Show the CMO and flight surgeon the human-entered dose log for the past <set by flight surgeon> hours, so the flight surgeon can review medicines that can contribute to retention (shown only; the robot names no medicine and gives no advice).",
      "success": "Dose log shown, or \"no dose log available\"."
    },
    {
      "id": "S10",
      "actor": "robot",
      "rung": 2,
      "action": "Send the images, estimate, answers and dose log to the flight surgeon at once, or queue them and show the CMO the onboard checklist page.",
      "success": "Delivered or queued.",
      "refs": [
        "V1 6003",
        "V1 7001",
        "V1 7003"
      ]
    },
    {
      "id": "S11",
      "actor": "ground",
      "action": "The flight surgeon (or the CMO under the onboard checklist when there is no link) decides on catheterization, medicines and fluids; the robot logs the decisions.",
      "success": "Decision logged.",
      "refs": [
        "V1 3004"
      ]
    },
    {
      "id": "S12",
      "actor": "crew",
      "action": "If catheterization is decided, the CMO opens the kit and does it under the onboard checklist, with the robot outside its keep-out distance.",
      "success": "Procedure done and logged, or not needed."
    },
    {
      "id": "S13",
      "actor": "robot",
      "rung": 2,
      "action": "Bag waste per the biohazard procedure; clean the device and its own surfaces per RMP-INF-002; log supplies used and update inventory.",
      "success": "Cleaning and inventory logged.",
      "refs": [
        "V2 7059"
      ]
    },
    {
      "id": "S14",
      "actor": "robot",
      "rung": 2,
      "action": "Set reminders, on the flight surgeon's schedule, to ask whether urine has been passed and to offer a repeat scan. At each scheduled time the robot prompts the crewmember on their own screen; it approaches only when the crewmember (or the CMO) accepts, and a prompt never starts the robot. After a catheter, each reminder also asks about fever, chills, or burning or cloudy urine (RF10).",
      "success": "Reminders logged.",
      "refs": [
        "V2 10174"
      ]
    }
  ],
  "decisions": [
    {
      "id": "D1",
      "after": "S2",
      "decided_by": "robot",
      "question": "Is any red-flag answer \"yes\", or not answered?",
      "branches": [
        {
          "if": "Yes",
          "then": "Apply the action listed for each matching red flag (URGENT alert, stop, or private flag) now, with the answer itself. For back pain with leg or saddle symptoms (RF2), open RMP-MSK-004's red-flag set at once; a scan may go ahead only as an adjunct, if the CMO decides, and must not be used on its own to decide."
        },
        {
          "if": "Not answered",
          "then": "Ask the CMO to ask in person; never treated as \"no\"."
        },
        {
          "if": "All \"no\"",
          "then": "Continue to S3."
        }
      ]
    },
    {
      "id": "D2",
      "after": "S8",
      "decided_by": "robot",
      "question": "Did the images pass the device quality check within the allowed attempts?",
      "branches": [
        {
          "if": "Yes",
          "then": "Continue."
        },
        {
          "if": "No",
          "then": "Label \"non-diagnostic (quality too low)\"; report no volume; ask the ground expert to guide a rescan when the link allows."
        }
      ]
    },
    {
      "id": "D3",
      "after": "S10",
      "decided_by": "ground",
      "question": "Catheterize, treat or watch?",
      "branches": [
        {
          "if": "Link live",
          "then": "Flight surgeon decides; robot logs."
        },
        {
          "if": "Link down or delay too long",
          "then": "The CMO decides under the pre-approved onboard checklist; the flight surgeon reviews images and logs at the next contact."
        }
      ]
    },
    {
      "id": "D4",
      "after": "S14",
      "decided_by": "robot",
      "question": "Has trouble passing urine come back (no urine for the time the flight surgeon set, or symptoms return after a catheter is removed), or is there fever, chills, or burning or cloudy urine after a catheter?",
      "branches": [
        {
          "if": "Yes",
          "then": "URGENT alert to the CMO and flight surgeon; restart this protocol on a crew command; for fever after a catheter, the CMO starts RMP-INF-001."
        },
        {
          "if": "No",
          "then": "Keep the reminder schedule until the flight surgeon closes it."
        }
      ]
    }
  ],
  "stop_rules": [
    {
      "id": "X1",
      "trigger": "The patient (or the crewmember being examined) says stop, or withdraws consent",
      "action": "Robot stops all motion at once, backs away to its rest position and tells the CMO. Recording stops unless the patient agrees to keep it running.",
      "level": "stop",
      "refs": [
        "V2 10165"
      ]
    },
    {
      "id": "X2",
      "trigger": "Any crewmember presses stop or takes over control",
      "action": "Protective stop; robot holds its stopped position; only a human may restart it.",
      "level": "safe-state",
      "refs": [
        "V2 10165",
        "V2 10168",
        "V2 10174"
      ]
    },
    {
      "id": "X3",
      "trigger": "Robot fault, sensor fault, or a force, speed or reach limit is reached",
      "action": "Protective stop and hand control to the CMO; log the fault.",
      "level": "safe-state",
      "refs": [
        "V2 10172",
        "V2 10168"
      ]
    },
    {
      "id": "X4",
      "trigger": "CMO is asked to take over and does not respond (for example, the CMO is the patient)",
      "action": "Robot stays stopped; the next named crewmember is called.",
      "level": "safe-state",
      "refs": [
        "V2 10173",
        "V2 7045"
      ]
    },
    {
      "id": "X5",
      "trigger": "Loss of link, or delay longer than the limit for live guidance",
      "action": "Only the robot pauses; crew care never waits for the link or the robot. Robot pauses any movement in its stopped position and tells the CMO. The CMO decides whether to continue offline under the pre-approved onboard checklist; the robot resumes only on the CMO's confirmation. Everything is logged and sent to the flight surgeon at the next contact.",
      "level": "pause",
      "refs": [
        "V2 10172",
        "V2 10173"
      ]
    },
    {
      "id": "X6",
      "trigger": "Pain increases during the scan, or the patient asks for the robot to leave",
      "action": "Robot backs away to its rest position and tells the CMO; the CMO continues without the robot if needed.",
      "level": "stop"
    }
  ],
  "red_flags": [
    {
      "id": "RF1",
      "sign": "Fever or shaking chills",
      "threshold": "<set by clinical lead> °C or higher",
      "action": "URGENT alert; see RMP-INF-001",
      "source": "ng253"
    },
    {
      "id": "RF2",
      "sign": "Back pain with weakness or numbness in the legs, numbness between the legs, or loss of the feeling of needing to open the bowels",
      "threshold": "any",
      "action": "URGENT alert (possible cauda equina syndrome); open RMP-MSK-004's red-flag set at once. A bladder scan may go ahead only as an adjunct, if the CMO decides, and must not be used on its own to decide; a low volume does not rule out nerve compression.",
      "source": "girftces"
    },
    {
      "id": "RF3",
      "sign": "Blood in the urine, or flank pain",
      "threshold": "any",
      "action": "URGENT alert; the flight surgeon considers RMP-RENAL-001 (the risk of stones is raised in flight)",
      "source": "renal"
    },
    {
      "id": "RF4",
      "sign": "Unable to pass urine, with lower belly pain or urge",
      "threshold": "any (no waiting time)",
      "action": "URGENT alert to the CMO and flight surgeon"
    },
    {
      "id": "RF5",
      "sign": "No urine passed, without pain",
      "threshold": "for <set by clinical lead> hours",
      "action": "URGENT alert"
    },
    {
      "id": "RF6",
      "sign": "Device bladder-volume estimate above the alert level",
      "threshold": "<set by clinical lead> mL (device estimate)",
      "action": "URGENT alert to the CMO and flight surgeon"
    },
    {
      "id": "RF7",
      "sign": "The CMO cannot pass the catheter, or there is bleeding or severe pain during catheterization",
      "threshold": "any",
      "action": "URGENT call to the flight surgeon"
    },
    {
      "id": "RF8",
      "sign": "Retention comes back after a catheter is removed",
      "threshold": "within <set by flight surgeon> hours",
      "action": "URGENT alert",
      "source": "stepaniak"
    },
    {
      "id": "RF9",
      "sign": "Confusion or feeling very unwell",
      "threshold": "any",
      "action": "URGENT alert",
      "source": "ng253"
    },
    {
      "id": "RF10",
      "sign": "Fever, chills, burning or cloudy urine after catheterization",
      "threshold": "any",
      "action": "URGENT alert; the CMO starts RMP-INF-001",
      "source": "ng253"
    }
  ],
  "safety_limits": [
    {
      "id": "L1",
      "name": "Contact with the patient",
      "value": "not allowed",
      "enforced": "Keep-out zone in the robot controller",
      "refs": [
        "V2 10172"
      ]
    },
    {
      "id": "L2",
      "name": "Holding or moving the ultrasound probe",
      "value": "not allowed",
      "enforced": "Probe is not a robot-graspable item in this protocol"
    },
    {
      "id": "L3",
      "name": "Camera recording while the patient is exposed",
      "value": "not allowed",
      "enforced": "Camera turned away and recording blocked until the CMO ends the exposed phase"
    },
    {
      "id": "L4",
      "name": "Keep-out distance during catheterization",
      "value": "<set by validation>",
      "enforced": "Distance sensing; robot holds outside it"
    },
    {
      "id": "L5",
      "name": "Robot speed near the patient",
      "value": "<set by validation>",
      "enforced": "Hard limit",
      "refs": [
        "V2 10172"
      ]
    }
  ],
  "logs": [
    {
      "id": "LOG-1",
      "text": "Every input, robot action, decision (with who made it) and hand-off, time-stamped to the second.",
      "refs": [
        "V2 10163",
        "V2 10164"
      ]
    },
    {
      "id": "LOG-2",
      "text": "Mode changes and safety-limit events are announced to the operator as they happen and logged.",
      "refs": [
        "V2 10162",
        "V2 10172"
      ]
    },
    {
      "id": "LOG-3",
      "text": "Records are stored and sent as private medical data, encrypted, with access limited to the medical team.",
      "refs": [
        "V1 6003",
        "V1 7003"
      ]
    },
    {
      "id": "LOG-4",
      "text": "Results are kept in a permanent, retrievable format so the flight surgeon can see trends.",
      "refs": [
        "V1 7001"
      ]
    }
  ],
  "requirements": [
    {
      "id": "V1 3004",
      "use": "In-mission care includes imaging, performing procedures, personal protective equipment and privacy considerations; administering and managing medications is a human capability."
    },
    {
      "id": "V1 3006",
      "use": "Two crew medical officers per vehicle for NASA programs (see the commercial-flight note)."
    },
    {
      "id": "V1 3007",
      "use": "Evacuation for problems beyond onboard care; the flight surgeon decides."
    },
    {
      "id": "V1 6003",
      "use": "Logs and alerts sent to the ground are private medical communications."
    },
    {
      "id": "V1 7001",
      "use": "Records kept so the flight surgeon can see trends."
    },
    {
      "id": "V1 7003",
      "use": "Secure handling of medical records."
    },
    {
      "id": "V2 7045",
      "use": "Usable by non-physician crew, including when the CMO is the patient."
    },
    {
      "id": "V2 7046",
      "use": "Patient, CMO, device and kits restrained."
    },
    {
      "id": "V2 7059",
      "use": "Inventory updated with supplies used."
    },
    {
      "id": "V2 10161",
      "use": "Robot shows its status and health."
    },
    {
      "id": "V2 10162",
      "use": "Mode changes are announced to the operator."
    },
    {
      "id": "V2 10163",
      "use": "Robot records and shares its data."
    },
    {
      "id": "V2 10164",
      "use": "Shows whether the human or the robot is expected to act."
    },
    {
      "id": "V2 10165",
      "use": "Human can override and shut down the robot."
    },
    {
      "id": "V2 10168",
      "use": "Human can take over."
    },
    {
      "id": "V2 10172",
      "use": "Protective stop when a limit is exceeded."
    },
    {
      "id": "V2 10173",
      "use": "Robot stays stopped if no one takes over."
    },
    {
      "id": "V2 10174",
      "use": "Only a human starts or restarts the robot."
    }
  ],
  "validation": [
    {
      "stage": "simulation",
      "what": "Scripted retention cases with red-flag answers, low-quality scans and link loss, at station, Moon and Mars delays.",
      "pass": "Every red flag alerts; zero volumes reported from low-quality scans; zero cause statements; camera never records during the exposed phase."
    },
    {
      "stage": "training model",
      "what": "Bladder ultrasound training model (phantom); crew scan while the robot holds the screen and records.",
      "pass": "Image sets judged usable by an ultrasound expert at or above <set by clinical lead>."
    },
    {
      "stage": "Earth analog",
      "what": "Analog crews with remote ultrasound experts.",
      "pass": "Pass criteria set in advance."
    },
    {
      "stage": "flight use under flight surgeon supervision",
      "what": "First use for scheduled scans on healthy crew.",
      "pass": "No safety or privacy events; images usable."
    }
  ],
  "signoff": {
    "protocol": [
      "Clinical lead for the specialty (sets every clinical threshold marked <set by clinical lead>)",
      "Flight surgeon, as medical authority",
      "Robotics and medical-device safety board",
      "Program approval for the mission"
    ],
    "restart_after_stop": "Human only. After any emergency or protective stop, a crewmember must restart the robot; the robot never restarts itself.",
    "each_run": "Started by a crewmember. Flight surgeon agreement when the link allows; otherwise the CMO under the onboard checklist, with flight surgeon review of images and logs at the next contact."
  },
  "change_control": [
    "Every change gets a new version number and a written reason; earlier versions are kept.",
    "Any change to steps, thresholds, limits or software that touches the patient repeats validation from the simulation stage before use.",
    "Software and learned-skill updates follow a pre-agreed change plan (what may change, how it is tested, how to roll back), modeled on the FDA predetermined change control plan approach.",
    "If a new version misbehaves, the robot rolls back to the last validated version and the event is reviewed by the flight surgeon and safety board.",
    "The robot never changes its own protocol, thresholds or limits."
  ],
  "comms": {
    "live": "Low Earth orbit: the flight surgeon and a ground ultrasound expert can watch the ultrasound screen (not the patient) and guide the CMO live.",
    "loss_of_signal": [
      "Only the robot pauses; crew care never waits for the link or the robot.",
      "The robot pauses any movement and tells the CMO. The CMO decides whether to continue under the onboard checklist; the robot resumes only on the CMO's confirmation.",
      "Images, estimates and answers are queued and sent at the next contact."
    ],
    "mars_delay": [
      "No live guidance: the CMO scans from the pre-loaded guide and decides under the onboard checklist.",
      "Alert levels, the catheterization plan and the reminder schedule are set before flight."
    ],
    "max_delay_for_live_guidance": "<set by validation>"
  },
  "sources": [
    {
      "key": "stepaniak",
      "text": "Stepaniak PC, Ramchandani SR, Jones JA. Acute urinary retention among astronauts. Aviat Space Environ Med. 2007;78(4 Suppl):A5-A8.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/17511293/",
      "pmid": "17511293",
      "supports": "Case report: an astronaut who took promethazine and scopolamine before launch developed acute urinary retention on reaching orbit, had intermittent catheterization for the first 3 days with a single balloon-tipped catheter, which, because iodine solution was lacking on board and duties could not be interrupted, was left in place for a total of 4 days; voiding returned after day 7, retention returned on day 10 (1 day before landing), and recurred for the first 24 hours of the next mission; obstructive, medicine-related, psychogenic and nerve-related causes are discussed."
    },
    {
      "key": "mtb004",
      "text": "NASA OCHMO. Space Adaptation Sickness (SAS) and Space Readaptation Syndrome. Medical Technical Brief OCHMO-MTB-004 Rev A (Sept 25, 2025).",
      "url": "https://www.nasa.gov/wp-content/uploads/2025/09/ochmo-mtb-004-space-adaptation-sickness-sas.pdf",
      "supports": "Fluid shifts, reduced fluid intake, an altered sensation of bladder fullness, getting used to using the toilet in space, and changes affecting the voiding reflex can cause urinary retention in the first few days; crew are treated with fluid management and intermittent catheterization as needed."
    },
    {
      "key": "ermed",
      "text": "NASA Human Research Program. Evidence Report: Risk of Adverse Health Outcomes and Decrements in Performance due to In-Flight Medical Conditions (2017).",
      "url": "https://humanresearchroadmap.nasa.gov/evidence/reports/Medical.pdf",
      "supports": "Table 2: 9 urinary retention (space adaptation) events and 9 urinary tract infections among US astronauts (retention: 5 female, 4 male; Shuttle, Mir and ISS through 2006); dental and urological emergencies have been documented among astronauts."
    },
    {
      "key": "girftces",
      "text": "NHS England Getting It Right First Time (GIRFT). Spinal Surgery: National Suspected Cauda Equina Syndrome (CES) Pathway (February 2023). Also hosted by an NHS trust: https://www.gloshospitals.nhs.uk/media/documents/GIRFT_CES_Guidelines_2023_EJRRVj5.pdf (the copy that was read; the GIRFT-hosted copy could not be opened by automated retrieval).",
      "url": "https://gettingitrightfirsttime.co.uk/wp-content/uploads/2023/02/National-Suspected-Cauda-Equina-Pathway-February-2023-FINAL-V1-1.pdf",
      "supports": "Bladder scans should not be used in isolation or as a discriminator for cauda equina syndrome; if a patient is able to void, document the pre-void and post-void residual volumes. (The pathway's volume figures are not used as thresholds here.)"
    },
    {
      "key": "ng253",
      "text": "National Institute for Health and Care Excellence. Suspected sepsis in people aged 16 or over: recognition, assessment and early management. NICE guideline NG253 (2025, last updated Sept 23, 2026).",
      "url": "https://www.nice.org.uk/guidance/ng253/chapter/Face-to-face-assessment",
      "supports": "Trauma, surgery or invasive procedures in the last 6 weeks is a risk factor in the sepsis risk table; assess temperature, mental state and how often urine was passed."
    },
    {
      "key": "renal",
      "text": "NASA Human Research Program. Evidence Report: Risk of Renal Stone Formation (2024).",
      "url": "https://humanresearchroadmap.nasa.gov/evidence/other/2024%20Renal%20Evidence%20Report_Final.pdf",
      "supports": "The increased risk of renal stone formation occurs rapidly during spaceflight; stones can cause renal colic or severe flank pain, blood in the urine, infection or sepsis; there have been no symptomatic kidney stones in flight to date in US crewmembers on the ISS."
    },
    {
      "key": "tb044",
      "text": "NASA OCHMO. Medical Operations. Technical Brief OCHMO-TB-044 (2025).",
      "url": "https://www.nasa.gov/wp-content/uploads/2025/08/ochmo-tb-044-medical-operations.pdf",
      "supports": "The crew surgeon keeps medical authority when care is delegated; crew medical officers train on the JSC 48522 medical checklist."
    },
    {
      "key": "v1",
      "text": "NASA. NASA-STD-3001, Space Flight Human-System Standard, Volume 1: Crew Health, Revision C (2023).",
      "url": "https://www.nasa.gov/wp-content/uploads/2023/11/nasa-std-3001-vol-1-rev-c-with-signature.pdf",
      "supports": "Requirement IDs beginning V1."
    },
    {
      "key": "v2",
      "text": "NASA. NASA-STD-3001, Volume 2: Human Factors, Habitability, and Environmental Health (Rev F, 2026), including Section 10.6 Automated and Robotic Systems.",
      "url": "https://standards.nasa.gov/standard/NASA/NASA-STD-3001_VOL_2",
      "supports": "Requirement IDs beginning V2."
    },
    {
      "key": "marsdelay",
      "text": "NASA. Mars communications disruption and delay (fact sheet, 2023 Moon to Mars Architecture Concept Review).",
      "url": "https://www.nasa.gov/wp-content/uploads/2024/01/mars-communications-disruption-and-delay.pdf",
      "supports": "One-way Earth-Mars delay up to about 21-23 minutes, plus blackouts of about 2-3 weeks near solar conjunction."
    },
    {
      "key": "pccp",
      "text": "U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions (guidance).",
      "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence",
      "supports": "A model for planning, validating and rolling back software updates."
    },
    {
      "key": "faa460",
      "text": "U.S. Code of Federal Regulations, Title 14, Part 460: Human space flight requirements.",
      "url": "https://www.ecfr.gov/current/title-14/chapter-III/subchapter-C/part-460",
      "supports": "Federal rules for crew and spaceflight participants on licensed commercial flights; they set no medical standards for spaceflight participants."
    }
  ],
  "corrections": [
    {
      "date": "2026-10-20",
      "version": "0.2",
      "source": "AI-assisted clinical and source review by the Medical Research Assistant, Oct 20, 2026 (batch 2 review)",
      "items": [
        "Painful retention (unable to pass urine with lower belly pain or urge) is now URGENT with no waiting time; painless retention keeps the time placeholder (item 31).",
        "Back pain with leg or saddle symptoms opens RMP-MSK-004's red-flag set at once; a scan is only an adjunct and a low volume does not rule out nerve compression (item 32).",
        "Before-and-after scans are recorded when the crewmember can pass some urine; GIRFT volume figures are not used as thresholds (item 33).",
        "Before bringing the catheter kit, the robot checks its seal and expiry and that antiseptic and spare catheters are in stock (item 34).",
        "Added RF10: fever, chills, or burning or cloudy urine after catheterization goes URGENT to RMP-INF-001 (item 35).",
        "The Stepaniak 2007 case is described exactly as in the abstract (item 36).",
        "The dose log is shown so the flight surgeon can review medicines that can contribute to retention; the robot names no medicine (item 37).",
        "Each red-flag decision now applies the action listed for each matching red flag (URGENT alert, stop, or private flag), not URGENT for everything (review item 47).",
        "Repeat check-ins inside an open log are now on-screen prompts; the robot approaches only when the crewmember or CMO accepts, and a prompt never starts it (item 49, [V2 10174]).",
        "Red flags that had no source now cite one where a source fits; the rest are shown as general clinical red flags with no source cited (item 50).",
        "The \"item that failed a check\" lockout is kept and now notes that it applies when RMP-PHARM-001 is used (item 51).",
        "NASA evidence reports are cited as \"approved for public release\" (item 48)."
      ]
    },
    {
      "date": "2026-10-21",
      "version": "0.3",
      "source": "Batch 5 editorial (AI-assisted), Oct 21, 2026",
      "items": [
        "Renal evidence report citation now includes \"(approved for public release September 23, 2024)\", matching RMP-RENAL-004 (batch 4 optional item 44).",
        "Library-wide \"safe\" wording in inherited stop rules and requirement uses rewritten per batch 4 review item 49 (holds its stopped position / stays stopped / take over / Robot stays stopped). Schema level name safe-state unchanged."
      ]
    },
    {
      "date": "2026-10-21",
      "version": "0.4",
      "source": "Batch 6 editorial (AI-assisted), Oct 21, 2026",
      "items": [
        "Renal evidence report citation label changed from \"(approved for public release September 23, 2024)\" to \"(2024)\", the site's year-only citation convention."
      ]
    },
    {
      "date": "2026-10-21",
      "version": "0.5",
      "source": "Batch 7 editorial (AI-assisted), Oct 21, 2026",
      "items": [
        "Citation labels changed to the site's year-only convention: \"(approved for public release <date>)\" now reads \"(YYYY)\", and NASA-STD-3001 Volume 2 \"Revision F (approved July 14, 2026)\" now reads \"(Rev F, 2026)\" (sources: ermed, v2). Editorial; no change to steps, thresholds or limits."
      ]
    },
    {
      "date": "2026-10-21",
      "version": "0.6",
      "source": "Batch 7 review and batch 8 editorial (AI-assisted), Oct 21, 2026",
      "items": [
        "X5 and the comms loss-of-signal branch now open with \"Only the robot pauses; crew care never waits for the link or the robot.\" (batch 7 review suggestion 29). Editorial; robot behaviour unchanged."
      ]
    }
  ]
}
